Tamiflu

MINIMUM INFORMATION TO BE PRINTED ON BLISTER OR STRIP
Blister

1. NAME OF THE MEDICINAL PRODUCT

Tamiflu 30 mg capsule
oseltamivir

2. NAME OF THE MARKETING AUTHORISATION HOLDER

COMMERCIO
Roche Registration GmbH.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

INFORMATION TO BE INDICATED ON THE SECONDARY PACKAGING
Outer packaging

1. NAME OF THE MEDICINAL PRODUCT

Tamiflu 45 mg hard capsules
oseltamivir

2. QUALITATIVE AND QUANTITATIVE COMPOSITION IN TERMS OF ACTIVE

SUBSTANCE
Each hard capsule contains oseltamivir phosphate equivalent to 45 mg of oseltamivir.
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENT
10 hard capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the instructions in the package leaflet before use.
Oral use.

6. SPECIAL PRECAUTION INSTRUCTIONS TO KEEP THE MEDICINE

KEEP OUT OF SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children
7. OTHER SPECIAL PRECAUTION(S), IF NECESSARY
8. EXPIRY DATE
Exp.

9. SPECIAL STORAGE PRECAUTIONS

Do not store above 25°C

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINE OR WASTE DERIVING FROM SUCH MEDICINE, IF NECESSARY

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/222/004

13. BATCH NUMBER

Batch

14. GENERAL SUPPLY CONDITION

Medicinal product subject to medical prescription
15. INSTRUCTIONS FOR USE
16. BRAILLE INFORMATION
tamiflu 45 mg

17. UNIQUE IDENTIFIER – TWO-DIMENSIONAL BARCODE

18. UNIQUE IDENTIFIER - DATA MADE READABLE

PC
SN
NN
MINIMUM INFORMATION TO BE INDICATED ON BLISTER OR STRIP
Blister

1. NAME OF THE MEDICINAL PRODUCT

Tamiflu 45 mg capsule
oseltamivir

2. NAME OF THE MARKETING AUTHORISATION HOLDER

COMMERCIALISATION
Roche Registration GmbH.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

INFORMATION TO APPEAR ON THE OUTER PACKAGING
Outer packaging

1. NAME OF THE MEDICINAL PRODUCT

Tamiflu 75 mg hard capsules
oseltamivir

2. QUALITATIVE AND QUANTITATIVE COMPOSITION IN TERMS OF ACTIVE

SUBSTANCE
Each hard capsule contains oseltamivir phosphate equivalent to 75 mg of oseltamivir.
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENT
10 hard capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the leaflet before use.
Oral use.

6. PARTICULAR WARNING TO KEEP THE MEDICINAL PRODUCT

OUT OF SIGHT AND REACH OF CHILDREN
Keep out of sight and reach of children
7. OTHER PARTICULAR WARNING(S), IF NECESSARY
8. EXPIRY DATE
Exp.

9. SPECIAL STORAGE PRECAUTIONS

Do not store above 25°C

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINE OR WASTE MATERIAL DERIVED FROM SUCH MEDICINE, IF REQUIRED

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

FOR PLACING ON THE MARKET
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/222/001

13. LOT NUMBER

Lot

14. GENERAL SUPPLY CONDITION

Medicinal product subject to medical prescription
15. INSTRUCTIONS FOR USE
16. BRAILLE INFORMATION
tamiflu 75 mg

17. UNIQUE IDENTIFIER – TWO-DIMENSIONAL BARCODE

18. UNIQUE IDENTIFIER - READABLE DATA

PC
SN
NN
MINIMUM INFORMATION TO BE PRINTED ON BLISTER OR STRIP
Blister

1. NAME OF THE MEDICINAL PRODUCT

Tamiflu 75 mg capsule
oseltamivir

2. NAME OF THE MARKETING AUTHORISATION HOLDER

COMMERCIALISATION
Roche Registration GmbH.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

INFORMATION TO APPEAR ON THE OUTER PACKAGING
Outer packaging

1. NAME OF THE MEDICINAL PRODUCT

Tamiflu 6 mg/mL powder for oral suspension
oseltamivir

2. QUALITATIVE AND QUANTITATIVE COMPOSITION IN TERMS OF ACTIVE

SUBSTANCE
1 bottle contains 390 mg of oseltamivir. The final volume of the bottle after reconstitution is 65 mL.
Each mL of suspension contains 6 mg of oseltamivir.

3. LIST OF EXCIPIENTS

Contains sorbitol.
Read the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 vial
Also contains 1 plastic vial adapter, 1 plastic graduated cup (55 mL), 1 plastic 3 mL oral dosing dispenser, and 1 plastic 10 mL oral dosing dispenser.

5. METHOD AND ROUTE OF ADMINISTRATION

Read the leaflet before use.
For oral use after reconstitution.
Shake the bottle well before use.
Caution: graduated dosing device in millilitres (mL).

6. SPECIAL PRECAUTION INSTRUCTING TO KEEP THE MEDICINE

OUT OF SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7. OTHER SPECIAL PRECAUTION(S), IF NECESSARY
8. EXPIRY DATE
Exp.

9. SPECIAL STORAGE PRECAUTIONS

Powder: store below 30°C.
After reconstitution, store below 25°C for 10 days.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINE OR WASTE DERIVING FROM SUCH MEDICINE, IF NECESSARY

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

FOR RELEASE ON TO THE MARKET
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

12. MARKETING AUTHORISATION NUMBERS

EU/1/02/222/005

13. LOT NUMBER

Lot No.

14. GENERAL SUPPLY CONDITION

Medicinal product subject to medical prescription.
15. INSTRUCTIONS FOR USE
16. BRAILLE INFORMATION
tamiflu

17. UNIQUE IDENTIFIER – TWO-DIMENSIONAL BARCODE

18. UNIQUE IDENTIFIER – READABLE DATA

PC
SN
NN
MINIMUM INFORMATION TO BE INDICATED ON SMALL PRIMARY PACKAGING
Label of the vial

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Tamiflu 6 mg/mL powder for oral suspension
oseltamivir

2. METHOD OF ADMINISTRATION

For oral use after reconstitution.
Shake the bottle well before use.

3. EXPIRY DATE

Exp.

4. BATCH NUMBER

Batch number

5. CONTENT IN WEIGHT, VOLUME OR UNITS

The volume of the reconstituted suspension is 65 mL
1 mL contains 6 mg of oseltamivir

6. LIST OF EXCIPIENTS

Powder: store at a temperature not exceeding 30°C
Oral suspension: store at a temperature below 25°C for 10 days

Package leaflet: information for the user

Tamiflu 30 mg hard capsules

oseltamivir
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:
1. What Tamiflu is and what it is used for
2. What you need to know before taking Tamiflu
3. How to take Tamiflu
4. Possible side effects
5. How to store Tamiflu
6. Contents of the pack and other information

1. What Tamiflu is and what it is used for

• Tamiflu is used in adults, adolescents, children and infants (including full-term newborns) for the treatment of influenza. It can be used when you have influenza-like symptoms and the influenza virus is circulating in the community.
• Tamiflu may also be prescribed to adults, adolescents, children and infants over 1 year of age, on a case-by-case basis, for the prevention of influenza, for example if you have been in close contact with someone who has influenza.
• Tamiflu may be prescribed to adults, adolescents, children and infants (including full-term newborns) as preventive treatment under exceptional circumstances, for example during a global influenza epidemic (influenza pandemic) when the seasonal influenza vaccine does not provide sufficient protection.

Tamiflu contains oseltamivir, which belongs to a group of medicines called neuraminidase inhibitors. These medicines prevent the spread of the influenza virus in the body and thus help to relieve or prevent symptoms caused by influenza virus infection.
Influenza is a viral infection. Influenza symptoms often include sudden fever (above 37.8°C), cough, runny or stuffy nose, headache, muscle pain and extreme fatigue. These symptoms may also be caused by other infections. True influenza infection occurs only during annual epidemics when the influenza virus is spreading within the local community. Outside the epidemic period, influenza-like symptoms are generally caused by a different type of illness.

2. What you need to know before taking Tamiflu

Do not take Tamiflu

• if you are allergic ( hypersensitive ) to oseltamivir or to any of the excipients of Tamiflu listed in section 6. Consult your doctor if this applies to you. Do not take Tamiflu.

Warnings and precautions
Before taking Tamiflu, make sure that your prescribing doctor knows

• if you are allergic to other medicines
• if you have any kidney disease. In this case, a dose adjustment may be necessary
• if you have a serious health condition that may require immediate hospitalization
• if your immune system is not functioning properly
• if you have chronic heart or respiratory diseases.

During treatment with Tamiflu, inform your doctor immediately

• if you notice changes in behaviour or mood (neuropsychiatric events), especially in children and adolescents. These may be symptoms of rare but serious side effects.

Tamiflu is not an influenza vaccine
Tamiflu is not a vaccine: it treats infection or prevents the spread of the influenza virus. A vaccine
provides antibodies against the virus. Tamiflu does not affect the efficacy of an influenza vaccine, and
your doctor may prescribe both.
Other medicines and Tamiflu
Inform your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those without a prescription.
The following medicines are particularly important:

• chlorpropamide (used to treat diabetes)
• methotrexate (used to treat, for example, rheumatoid arthritis)
• phenylbutazone (used to treat pain and inflammation)
• probenecid (used to treat gout).

Pregnancy and breastfeeding
Inform your doctor if you are pregnant, think you might be pregnant, or are trying to become pregnant, so that
your doctor can decide whether Tamiflu is suitable for you.
The effects on breastfed infants are unknown. If you are breastfeeding, inform your doctor so that
they can decide whether Tamiflu is suitable for you.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Tamiflu does not affect your ability to drive or operate machinery.
Information about some excipients of Tamiflu
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially ‘sodium-free’.

3. How to take Tamiflu

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
Take Tamiflu as soon as possible, ideally within two days of the onset of flu symptoms.
Recommended doses
For the treatment of influenza: Take two doses daily. It is usually convenient to take one dose
in the morning and one in the evening. It is important that you complete the full 5-day course,
even if you start to feel better quickly.
In patients with a weakened immune system, treatment will last for 10 days.
For the prevention of influenza or after contact with an infected person, take one dose daily for
10 days. It is best to take this dose in the morning with breakfast.
In special situations, such as widespread influenza or for patients with a weakened immune system,
treatment may continue for up to 6 or 12 weeks.
The recommended dose depends on the patient's body weight. You must use the amount of capsules or
oral suspension prescribed by your doctor.
Adults and adolescents aged 13 years and older

*In patients with a weakened immune system, treatment lasts for 10 days.
**75 mg can be composed of one 30 mg capsule plus one 45 mg capsule.
Children from 1 to 12 years

*In children with weakened immune systems, treatment lasts for 10 days.
**75 mg may consist of one 30 mg capsule plus one 45 mg capsule.
Infants under 1 year of age (0 - 12 months)
The administration of Tamiflu to infants under 1 year of age for influenza prevention during an influenza pandemic should be based on the physician's judgment after considering the potential benefits and potential risks for the child.

*In infants with weakened immune systems, treatment lasts for 10 days.
**mg per kg = mg per kilogram of the child's body weight. For example:
if a 6-month-old infant weighs 8 kg, the dose is
8 kg x 3 mg per kg = 24 mg

Method of administration
Swallow the capsules whole with water. Do not break or chew the capsules.
Tamiflu may be taken with or without food, although taking it with food may reduce the likelihood of feeling unwell (nausea or vomiting).

People who have difficulty swallowing capsules can use the liquid preparation,
Tamiflu oral suspension. If you need Tamiflu oral suspension but it is not available at the pharmacy,
it is possible to prepare the Tamiflu solution from the capsules. For instructions,
see page Preparing Tamiflu liquid at home.

If you take more Tamiflu than you should
Stop taking Tamiflu and contact your doctor or pharmacist immediately.
In most cases of overdose, people have not reported any adverse effects. When adverse effects have been reported, they were similar to those observed with normal doses as described in section 4.
Overdose cases have been reported more frequently when Tamiflu was administered to children compared to adults and adolescents. Exercise caution when preparing Tamiflu solution for children and when administering Tamiflu capsules or Tamiflu oral suspension to children.

If you forget to take Tamiflu
Do not take a double dose to make up for the missed capsule.

If you stop taking Tamiflu
There are no adverse effects when Tamiflu administration is stopped. However, if Tamiflu is stopped earlier than instructed by your doctor, influenza symptoms may return.
Always complete the course of treatment prescribed by your doctor.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Many of the side effects listed below may also be caused by influenza itself.
The following serious side effects have been reported rarely since oseltamivir has been marketed:

• Anaphylactic or anaphylactoid reactions: severe allergic reactions with swelling of the face and skin, itchy rash, low blood pressure, and breathing difficulties;
• Liver disorders (fulminant hepatitis, liver function disorders, and jaundice): yellowing of the skin and whites of the eyes, change in stool color, changes in behaviour;
• Angioedema: sudden onset of severe swelling of the skin, especially around the head and neck, including eyes and tongue, with breathing difficulties;
• Stevens-Johnson syndrome and toxic epidermal necrolysis: a severe allergic reaction that may be fatal, characterized by severe inflammation of the skin and internal mucous membranes, initially accompanied by fever, sore throat, feeling of fatigue, skin rash, followed by blistering, skin peeling, and extensive areas of dermo-epidermal detachment, possible breathing difficulties, and low blood pressure;
• Gastrointestinal bleeding: prolonged bleeding from the large intestine or vomiting of blood;
• Neuropsychiatric disorders, as described below.

If you notice any of these symptoms, seek immediate medical help.
The most frequently reported side effects (very common and common) with Tamiflu are feeling unwell or malaise (nausea, vomiting), stomach ache, stomach disorders, headache, and pain. These side effects mostly occur after the first dose of the medicine and usually resolve with continued treatment. The frequency of these side effects is reduced if the medicine is taken with food.
Rare but serious side effects: consult a doctor immediately
( may affect up to 1 in 1,000 people )
Rare events have been reported during treatment with Tamiflu, including:

• seizures and delirium, including altered level of consciousness
• confusion, abnormal behaviour
• delirium, hallucinations, agitation, anxiety, nightmares
  These events have been reported mainly in children and adolescents and often occurred suddenly and resolved rapidly. In a few cases, they progressed to self-injury (impulse to harm oneself), which in some cases led to death. Such neuropsychiatric events have also been reported in patients with influenza who did not take Tamiflu.
• Patients, especially children and adolescents, should be closely monitored for the behavioural changes described above. If you notice any of these symptoms, particularly in younger patients, seek immediate medical advice.

Adults and adolescents aged 13 years and older
Very common side effects:
(may affect more than 1 in 10 people)

• Headache
• Nausea

Common side effects
(may affect up to 1 in 10 people)

• Bronchitis
• Cold sores (herpes labialis)
• Cough
• Dizziness
• Fever
• Pain
• Limb pain
• Runny nose
• Sleep disorders
• Sore throat
• Stomach ache
• Feeling of fullness in the upper abdomen
• Upper respiratory tract infections (inflammation of the nose, throat, and nasal sinuses)
• Stomach disorders
• Vomiting

Uncommon side effects
(may affect up to 1 in 100 people)

• Allergic reactions
• Altered level of consciousness
• Seizures
• Abnormal heart rhythm
• Mild to severe liver function abnormalities
• Skin reactions (skin inflammation, red itchy rash, skin peeling)

Rare side effects:
(may affect up to 1 in 1,000 people)

• Thrombocytopenia (low platelet count)
• Visual disturbances

Children aged 1 to 12 years
Very common side effects
(may affect more than 1 in 10 people)

• Cough
• Nasal congestion
• Vomiting

Common side effects
(may affect up to 1 in 10 people)

• Conjunctivitis (red eyes, eye discharge, or eye pain)
• Ear inflammation and other ear disorders
• Headache
• Nausea
• Runny nose
• Stomach ache
• Feeling of fullness in the upper abdomen
• Stomach disorders

Uncommon side effects
(may affect up to 1 in 100 people)

• Skin inflammation
• Tympanic disorders

Infants under 1 year of age
The side effects reported in infants from 0 to 12 months of age are mostly similar to those reported in older children (1 year and above). Diarrhoea and diaper rash (erythema) have also been reported.
If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist. In addition,

• if you or the child frequently become ill, or
• if influenza symptoms worsen or fever persists,
  inform your doctor as soon as possible.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tamiflu

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp/EXP. The expiry date refers to the last day of the month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tamiflu contains

• Each hard capsule contains the equivalent of 30 mg oseltamivir.
• Excipients:
  Capsule contents: pregelatinized starch, talc, povidone, sodium croscarmellose, sodium stearil fumarate
  Capsule shell: gelatin, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171)
  Printing ink: shellac (E904), titanium dioxide (E171), FD&C Blue No. 2 (indigotine E132)

Description of the appearance of Tamiflu and package contents
The 30 mg hard capsule consists of an opaque light yellow body marked with the word
“ROCHE” and an opaque light yellow cap marked with “30 mg”. The markings are in blue.
The 30 mg hard capsules of Tamiflu are available in blisters in packs of 10.

Marketing Authorization Holder and Manufacturer
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Roche Pharma AG
Emil-Barell-Str. 1,
D-79639 Grenzach-Wyhlen
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
N.V. Roche S.A. UAB “Roche Lietuva”
Tél/Tel: +32 (0) 2 525 82 11 Tel: +370 5 2546799

България Luxembourg/Luxemburg
Рош България ЕООД (Voir/siehe Belgique/Belgien)
Тел: +359 2 818 44 44

Česká republika Magyarország
Roche s. r. o. Roche (Magyarország) Kft.
Tel: +420 - 2 20382111 Tel: +36 - 23 446 800

Danmark Malta
Roche a/s (See Ireland)
Tlf: +45 - 36 39 99 99

Deutschland Nederland
Roche Pharma AG Roche Nederland B.V.
Tel: +49 (0) 7624 140 Tel: +31 (0) 348 438050

Eesti Norge
Roche Eesti OÜ Roche Norge AS
Tel: + 372 - 6 177 380 Tlf: +47 - 22 78 90 00

Ελλάδα Österreich
Roche (Hellas) A.E. Roche Austria GmbH
Τηλ: +30 210 61 66 100 Tel: +43 (0) 1 27739

España Polska
Roche Farma S.A. Roche Polska Sp.z o.o.
Tel: +34 - 91 324 81 00 Tel: +48 - 22 345 18 88

France Portugal
Roche Roche Farmacêutica Química, Lda
Tél: +33 (0) 1 47 61 40 00 Tel: +351 - 21 425 70 00

Hrvatska România
Roche d.o.o Roche România S.R.L.
Tel: +385 1 4722 333 Tel: +40 21 206 47 01

Ireland Slovenija
Roche Products (Ireland) Ltd. Roche farmacevtska družba d.o.o.
Tel: +353 (0) 1 469 0700 Tel: +386 - 1 360 26 00

Ísland Slovenská republika
Roche a/s Roche Slovensko, s.r.o.
c/o Icepharma hf Tel: +421 - 2 52638201
Sími: +354 540 8000

Italia Suomi/Finland
Roche S.p.A. Roche Oy
Tel: +39 - 039 2471 Puh/Tel: +358 (0) 10 554 500

Kύπρος Sverige
Γ.Α.Σταμάτης & Σια Λτδ. Roche AB
Τηλ: +357 - 22 76 62 76 Tel: +46 (0) 8 726 1200

Latvija United Kingdom
Roche Latvija SIA Roche Products Ltd.
Tel: +371 - 6 7039831 Tel: +44 (0) 1707 366000

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/ .

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Information for the user

For people who have difficulty swallowing capsules, including very young children, a liquid preparation, Tamiflu oral suspension, is available.
If you need the liquid preparation but it is not available, you may use an oral suspension prepared in a pharmacy from Tamiflu capsules (see Information for healthcare professionals).
The pharmacy-prepared liquid formulation is the preferred option.
If even the pharmacy-prepared formulation is not available, you may prepare Tamiflu in liquid form at home from these capsules.
The dose is the same for treatment and prevention of influenza. The difference lies in the frequency of administration.

Preparing Tamiflu in liquid form at home

• If you have the correct capsules available for the required dosage (a 30 mg or 60 mg dose), open the capsule and mix its contents with a teaspoon (or less) of a sweetened food. This procedure is usually suitable for children older than 1 year. See top part of the instructions.
• If you need a lower dose, preparing Tamiflu in liquid form from capsules requires additional steps. This procedure is suitable for younger children and infants who usually require a Tamiflu dose lower than 30 mg. See bottom part of the instructions.

Children aged 1 to 12 years
To prepare a 30 mg or 60 mg dose,
you will need:

• One or two 30 mg Tamiflu capsules
• Sharp scissors
• A small bowl
• Teaspoon (5 mL)
• Water
• A sweet food to mask the bitter taste of the powder. For example: chocolate or cherry syrup, dessert toppings such as caramel or butterscotch sauce. Alternatively, you can prepare sweetened water by mixing a teaspoon (5 mL) of water with three quarters (3/4) of a teaspoon of sugar.

Step 1: Check that the dose is correct
To determine the correct amount of medicine to use, find the patient's weight in the left-hand column of the table.
Look in the right-hand column to find the number of capsules to administer to the patient per dose. The amount is the same for both treatment and prevention of influenza.

30 mg dose

60 mg dose
You should use the 30 mg capsules only for 30 mg and 60 mg doses. Do not attempt to prepare a 45 mg or 75 mg dose using the contents of 30 mg capsules. Instead, use capsules of the appropriate strength.

Step 2: Pour all the powder into a bowl
Hold the 30 mg capsule upright over a bowl and carefully cut off the rounded end with scissors.
Pour all the powder into the bowl.
Open a second capsule for a 60 mg dose. Pour all the powder into the bowl.
Be careful with the powder, as it may irritate the skin and eyes.

Step 3: Mix the powder and administer to the patient
Add a small amount – no more than one teaspoon (5 mL) – of sweetened food to the
powder in the bowl.
This will mask the bitter taste of Tamiflu powder.
Mix the mixture well.

Administer immediately the entire contents of the bowl to the patient.
If any of the mixture remains in the bowl, rinse the bowl with a small amount of water and give all the liquid to the patient to drink.
Repeat this procedure each time you need to administer the medicine.

Children under 1 year of age
To prepare a smaller single dose, you will need:

• One 30 mg Tamiflu capsule
• Sharp scissors
• Two small bowls (use a separate pair of bowls for each child)
• A large oral dosing device to measure water – a container with a capacity of 5 or 10 mL
• A small oral dosing device capable of measuring 0.1 mL, to administer the dose
• Teaspoon (5 mL)
• Water
• Sweet foods to mask the bitter taste of Tamiflu. For example: chocolate or cherry syrup, dessert toppings such as caramel or butterscotch sauce. Alternatively, you may prepare sweetened water by mixing one teaspoon (5 mL) of water with three quarters (3/4) of a teaspoon of sugar.

Step 1: Pour all the powder into a bowl
Hold one 30 mg capsule upright over one of the bowls and carefully cut off the rounded end with scissors. Be careful with the powder: it may irritate the skin and eyes.
Pour all the powder into the bowl, regardless of the dose being prepared.
The amount is the same whether treating or preventing influenza.

Step 2: Add water to dilute the medicine
Use the larger dosing device to measure 5 mL of water.
Add the water to the powder in the bowl.
Mix the mixture with a teaspoon (5 mL) for about 2 minutes.
Do not worry if not all the powder dissolves. The undissolved powder consists only of excipients.

Step 3: Select the correct amount based on the child's weight
Find the child's weight on the left side of the table.
The column on the right shows the amount of liquid suspension that should be drawn up with an oral syringe.
Infants under 1 year of age (including full-term newborns)

Step 4: Draw up the liquid suspension
Make sure you have the correct-sized dosing device (oral syringe).
Draw up the correct amount of liquid suspension from the first bowl.
Draw upwards slowly, taking care not to include air bubbles.
Gently dispense the correct dose into the second bowl.

Step 5: Mix with a sweetened food and administer to the child
Add a small amount – no more than one teaspoon – of sweetened food to the
second bowl.
This helps mask the bitter taste of the Tamiflu suspension.
Thoroughly mix the sweetened food and the liquid Tamiflu.

Give the child the entire contents of the second bowl immediately (sweetened food mixed with
liquid Tamiflu).
If any residue remains in the second bowl, rinse the bowl with a small amount
of water and give the child all of the rinse liquid to drink. For children unable to drink from a
bowl, use a spoon or feeding bottle to administer the remaining liquid mixture.
Give the child something to drink.
Discard any unused liquid left in the first bowl.
Repeat this procedure each time the medication is to be administered.

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Information intended exclusively for healthcare professionals
Patients unable to swallow capsules:
Tamiflu oral suspension (6 mg/mL), ready-to-use, is the preferred formulation for pediatric and adult
patients who have difficulty swallowing capsules or when lower doses are required. If Tamiflu oral
suspension powder is not available, the pharmacist may prepare a suspension (6 mg/mL) from Tamiflu
capsules. If even the pharmacy-prepared suspension is unavailable, patients may use capsules to
prepare the suspension at home.
Oral dosing devices (oral syringes) of appropriate volume and with graduations must be provided both
for administering the pharmacy-prepared suspension and for the home preparation procedures. In both
cases, the preferred formulation, the correct volume should preferably be marked on the dosing devices.
For home preparation, separate dosing devices must be provided to measure the correct volume of water
and to measure the Tamiflu-water mixture. To measure 5.0 mL of water, 5 mL or 10 mL dosing devices
should be used.
The appropriate dosing device size for drawing up the correct volume of Tamiflu suspension (6 mg/mL) is shown below.
Infants under 1 year of age (including term neonates):

Package leaflet: Information for the user

Tamiflu 45 mg hard capsules

oseltamivir
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to others. It could be harmful to other people, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:
1. What Tamiflu is and what it is used for
2. What you need to know before taking Tamiflu
3. How to take Tamiflu
4. Possible side effects
5. How to store Tamiflu
6. Contents of the pack and other information

1. What Tamiflu is and what it is used for

• Tamiflu is used in adults, adolescents, children and infants (including full-term newborns) for the treatment of influenza. It can be used when you have influenza symptoms and the influenza virus is circulating in the community.
• Tamiflu may also be prescribed on a case-by-case basis to adults, adolescents, children and infants over 1 year of age for the prevention of influenza, for example if you have been in close contact with someone who has influenza.
• Tamiflu may be prescribed to adults, adolescents, children and infants (including full-term newborns) as preventive treatment under exceptional circumstances, for example during a global influenza epidemic (influenza pandemic) when the seasonal influenza vaccine does not provide adequate protection.

Tamiflu contains oseltamivir, which belongs to a group of medicines called neuraminidase inhibitors. These medicines prevent the spread of the influenza virus in the body and thus help to relieve or prevent symptoms caused by infection with the influenza virus.
Influenza is a viral infection. Influenza symptoms often include sudden fever (above 37.8°C), cough, runny or stuffy nose, headache, muscle aches and extreme fatigue. These symptoms may also be caused by other infections. True influenza infection occurs only during annual epidemics when the influenza virus is spreading in the local community. Outside the epidemic period, influenza-like symptoms are generally caused by a different type of illness.

2. What you need to know before taking Tamiflu

Do not take Tamiflu

• if you are allergic ( hypersensitive ) to oseltamivir or to any of the excipients in Tamiflu listed in section 6. Consult your doctor if this applies to you. Do not take Tamiflu.

Warnings and precautions:
Before taking Tamiflu, make sure that your prescribing doctor knows

• if you are allergic to other medicines
• if you have any kidney disease. In this case, a dose adjustment may be necessary
• if you have a serious health condition that may require immediate hospitalization
• if your immune system is not functioning properly
• if you have chronic heart or respiratory diseases.

During treatment with Tamiflu, inform your doctor immediately

• if you notice changes in behaviour or mood ( neuropsychiatric events ), especially in children and adolescents. These may be symptoms of rare but serious side effects.

Tamiflu is not an influenza vaccine
Tamiflu is not a vaccine: it treats infection or prevents the spread of the influenza virus. A vaccine
provides antibodies against the virus. Tamiflu does not alter the effectiveness of an influenza vaccine, and
your doctor may prescribe both.
Other medicines and Tamiflu
Inform your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those without a prescription. The following medicines are particularly
important:

• chlorpropamide (used to treat diabetes)
• methotrexate (used to treat, for example, rheumatoid arthritis)
• phenylbutazone (used to treat pain and inflammation)
• probenecid (used to treat gout)

Pregnancy and breastfeeding
Inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant, so that
your doctor can decide whether Tamiflu is suitable for you.
The effects on breastfed infants are unknown. If you are breastfeeding, inform your doctor so that
he or she can decide whether Tamiflu is suitable for you.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Tamiflu does not affect your ability to drive or operate machinery.
Information about some excipients in Tamiflu
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially ‘sodium-free’.

3. How to take Tamiflu

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Take Tamiflu as soon as possible, ideally within two days of the onset of flu symptoms.
Recommended doses
For treatment of influenza, take two doses per day. It is usually convenient to take one dose
in the morning and one in the evening. It is important that you complete the full 5-day course,
even if you start to feel better quickly.
In patients with a weakened immune system, treatment will last for 10 days.
For prevention of influenza or after contact with an infected person, take one dose per day for
10 days. It is best to take this dose in the morning with breakfast.
In special situations, such as widespread influenza or for patients with a weakened immune system,
treatment may continue for up to 6 or 12 weeks.
The recommended dose depends on the patient's body weight. You must use the amount of capsules or
oral suspension prescribed by your doctor.
Adults and adolescents aged 13 years and older

*In patients with a weakened immune system, treatment lasts for 10 days.
**75 mg can be made up from one 30 mg capsule plus one 45 mg capsule.
Children from 1 to 12 years

*In children with weakened immune systems, treatment lasts for 10 days.
**75 mg may consist of one 30 mg capsule plus one 45 mg capsule.
Infants under 1 year of age (0 - 12 months)
The administration of Tamiflu to infants under 1 year of age for influenza prevention during an influenza pandemic should be based on the physician's judgment, following consideration of the potential benefits and potential risks to the child.

*In infants with a weakened immune system, treatment lasts for 10 days.
**mg per kg = mg per each kilogram of the child's body weight. For example:
If a 6-month-old infant weighs 8 kg, the dose is
8 kg x 3 mg per kg = 24 mg
Method of administration
Swallow the capsules whole with water. Do not break or chew the capsules.
Tamiflu may be taken with or without food, although taking it with food may reduce the likelihood
of feeling unwell (nausea or vomiting).
People who have difficulty swallowing capsules can use the liquid preparation,
Tamiflu oral suspension. If you need Tamiflu oral suspension but it is not available at
the pharmacy, it is possible to prepare Tamiflu solution from the capsules. For instructions,
see Preparing Tamiflu liquid at home, at the end of this page.
If you take more Tamiflu than you should
Stop taking Tamiflu and contact your doctor or pharmacist immediately.
In most cases of overdose, people did not report any adverse effects. When adverse effects were
reported, they were similar to those observed with normal doses as described in section 4.
Overdose cases have been reported more frequently when Tamiflu was administered to
children than to adults and adolescents. Be careful when preparing Tamiflu solution for children and when administering Tamiflu capsules or Tamiflu suspension to children.
If you forget to take Tamiflu
Do not take a double dose to make up for the forgotten capsule.
If you stop taking Tamiflu
There are no adverse effects when Tamiflu administration is stopped. However, if
Tamiflu is stopped before your doctor instructed, flu symptoms may return.
Always complete the course of treatment prescribed by your doctor.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Many of the side effects listed below may also be caused by influenza itself.
The following serious side effects have been rarely reported since oseltamivir has been marketed:

• Anaphylactic or anaphylactoid reactions: severe allergic reactions with swelling of the face and skin, itchy rash, low blood pressure, and breathing difficulties;
• Liver disorders (fulminant hepatitis, hepatic function disorders, and jaundice): yellowing of the skin and whites of the eyes, change in stool colour, changes in behaviour;
• Angioneurotic oedema: sudden onset of severe swelling of the skin, particularly around the head and neck, including eyes and tongue, with breathing difficulties;
• Stevens-Johnson syndrome and toxic epidermal necrolysis: a severe allergic reaction which may be fatal, characterised by severe inflammation of the skin and internal mucous membranes, initially accompanied by fever, sore throat, feeling of fatigue, skin rash, followed by blistering, skin peeling, extensive areas of dermo-epidermal detachment, possible breathing difficulties and low blood pressure;
• Gastrointestinal bleeding: prolonged bleeding from the large intestine or vomiting of blood;
• Neuropsychiatric disorders, as described below.

If you notice any of these symptoms, seek immediate medical help.
The most frequently reported side effects (very common and common) with Tamiflu are feeling unwell or malaise (nausea, vomiting), stomach ache, stomach disorders, headache, and pain. These side effects mostly occur after the first dose of the medicine and usually disappear with continued treatment. The frequency of these side effects is reduced if the medicine is taken with food.
Rare but serious side effects: consult a doctor immediately
( may affect up to 1 in 1,000 people )
During treatment with Tamiflu, rare events have been reported including:

• seizures and delirium including altered level of consciousness
• confusion, abnormal behaviour
• delirium, hallucinations, agitation, anxiety, nightmares
  These events have been reported mainly in children and adolescents and often occurred suddenly and resolved rapidly. A few cases progressed to self-injury (impulse to harm oneself), which in some cases led to death. Such neuropsychiatric events have also been reported in patients with influenza who had not taken Tamiflu.
• Patients, particularly children and adolescents, should be closely monitored for the behavioural changes described above.

If you notice any of these symptoms, especially in younger patients, seek immediate medical advice.
Adults and adolescents aged 13 years and older
Very common side effects
(may affect more than 1 in 10 people)

• Headache
• Nausea

Common side effects
(may affect up to 1 in 10 people)

• Bronchitis
• Cold sores (herpes labialis)
• Cough
• Dizziness
• Fever
• Pain
• Limb pain
• Runny nose
• Sleep disorders
• Sore throat
• Stomach ache
• Fatigue
• Feeling of fullness in the upper abdominal tract
• Upper respiratory tract infections (inflammation of the nose, throat, and nasal sinuses)
• Stomach disorders
• Vomiting

Uncommon side effects
(may affect up to 1 in 100 people)

• Allergic reactions
• Altered level of consciousness
• Seizures
• Abnormal heart rhythm
• Mild to severe liver function abnormalities
• Skin reactions (skin inflammation, red itchy rash, skin peeling)

Rare side effects
(may affect up to 1 in 1,000 people)

• Thrombocytopenia (low platelet count)
• Visual disturbances

Children aged 1 to 12 years
Very common side effects
(may affect more than 1 in 10 people)

• Cough
• Nasal congestion
• Vomiting

Common side effects
(may affect up to 1 in 10 people)

• Conjunctivitis (red eyes with discharge or eye pain)
• Ear inflammation and other ear disorders
• Headache
• Nausea
• Runny nose
• Stomach ache
• Feeling of fullness in the upper abdominal tract
• Stomach disorders

Uncommon side effects
(may affect up to 1 in 100 people)

• Skin inflammation
• Tympanic disorders

Infants under 1 year of age
The side effects reported in children from 0 to 12 months of age are mostly similar to those reported in older children (1 year and above). Diarrhoea and nappy rash (diaper rash) have also been reported.
If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist. In addition,

• if you or the child get sick often, or
• if flu symptoms worsen or fever persists,
  inform your doctor as soon as possible.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Tamiflu

Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp/EXP. The expiry date refers to the last day of the month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tamiflu contains

• Each hard capsule contains the equivalent of 45 mg of oseltamivir.
• The excipients are: capsule contents: pregelatinized starch, talc, povidone, sodium croscarmellose, and sodium stearate fumarate; capsule shell: gelatin, black iron oxide (E172), and titanium dioxide (E171); printing ink: shellac (E904), titanium dioxide (E171), and FD&C Blue No. 2 (indigotine E132).

Description of the appearance of Tamiflu and package contents
The 45 mg hard capsule consists of an opaque grey body marked with the word “ROCHE” and an opaque grey cap marked with “45 mg”. The inscriptions are in blue.
Tamiflu 45 mg hard capsules are available in blisters in packs of 10.

Marketing Authorization Holder and Manufacturer
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Roche Pharma AG
Emil-Barell-Str. 1,
D-79639 Grenzach-Wyhlen
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.

België/Belgique/Belgien Lietuva
N.V. Roche S.A. UAB “Roche Lietuva”
Tél/Tel: +32 (0) 2 525 82 11 Tel: +370 5 2546799

България Luxembourg/Luxemburg
Рош България ЕООД (Voir/siehe Belgique/Belgien)
Тел: +359 2 818 44 44

Česká republika Magyarország
Roche s. r. o. Roche (Magyarország) Kft.
Tel: +420 - 2 20382111 Tel: +36 - 23 446 800

Danmark Malta
Roche a/s (See Ireland)
Tlf: +45 - 36 39 99 99

Deutschland Nederland
Roche Pharma AG Roche Nederland B.V.
Tel: +49 (0) 7624 140 Tel: +31 (0) 348 438050

Eesti Norge
Roche Eesti OÜ Roche Norge AS
Tel: + 372 - 6 177 380 Tlf: +47 - 22 78 90 00

Ελλάδα Österreich
Roche (Hellas) A.E. Roche Austria GmbH
Τηλ: +30 210 61 66 100 Tel: +43 (0) 1 27739

España Polska
Roche Farma S.A. Roche Polska Sp.z o.o.
Tel: +34 - 91 324 81 00 Tel: +48 - 22 345 18 88

France Portugal
Roche Roche Farmacêutica Química, Lda
Tél: +33 (0) 1 47 61 40 00 Tel: +351 - 21 425 70 00

Hrvatska România
Roche d.o.o Roche România S.R.L.
Tel: +385 1 4722 333 Tel: +40 21 206 47 01

Ireland Slovenija
Roche Products (Ireland) Ltd. Roche farmacevtska družba d.o.o.
Tel: +353 (0) 1 469 0700 Tel: +386 - 1 360 26 00

Ísland Slovenská republika
Roche a/s Roche Slovensko, s.r.o.
c/o Icepharma hf Tel: +421 - 2 52638201
Sími: +354 540 8000

Italia Suomi/Finland
Roche S.p.A. Roche Oy
Tel: +39 - 039 2471 Puh/Tel: +358 (0) 10 554 500

Kύπρος Sverige
Γ.Α.Σταμάτης & Σια Λτδ. Roche AB
Τηλ: +357 - 22 76 62 76 Tel: +46 (0) 8 726 1200

Latvija United Kingdom
Roche Latvija SIA Roche Products Ltd.
Tel: +371 - 6 7039831 Tel: +44 (0) 1707 366000

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/ .

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Information for users
For people who have difficulty swallowing capsules, including very young children, a liquid preparation, Tamiflu oral suspension, is available.
If you need the liquid preparation but it is not available, you may use an oral suspension prepared in a pharmacy from Tamiflu capsules (see Information for healthcare professionals).
The pharmacy-prepared liquid formulation is the preferred option.
If even the pharmacy-prepared formulation is not available, you may prepare liquid Tamiflu at home from these capsules.
The dose is the same for treatment and prevention of influenza. The difference lies in the frequency of administration.

Preparing liquid Tamiflu at home

• If you have the correct capsules for the required dosage (a 45 mg dose), open the capsule and mix its contents with a teaspoon (or less) of a suitable sweetened food. This procedure is usually suitable for children over 1 year of age. See the top part of the instructions.
• If you need a lower dose, preparing liquid Tamiflu from capsules requires additional steps. This procedure is suitable for younger children, those with lower body weight, and infants, who usually require a Tamiflu dose lower than 45 mg. See the bottom part of the instructions.

Children aged 1 to 12 years
To prepare a 45 mg dose, you will need:

• One 45 mg Tamiflu capsule
• Sharp scissors
• A small bowl
• Teaspoon (5 mL)
• Water
• A sweet food to mask the bitter taste of the powder. For example: chocolate or cherry syrup, dessert toppings such as caramel or caramel sauce. Alternatively, you can prepare sweetened water by mixing a teaspoon (5 mL) of water with three quarters (3/4) of a teaspoon of sugar.

Step 1: Check that the dose is correct
To determine the correct amount of medicine to use, find the patient's weight in the left column of the table.
In the right column, find the number of capsules to administer to the patient per dose. The amount is the same for both treatment and prevention of influenza.

45 mg dose
Use 45 mg capsules only for 45 mg doses. Do not attempt to prepare a 30 mg, 60 mg, or 75 mg dose using the contents of 45 mg capsules. Instead, use capsules of the appropriate strength.

Step 2: Pour all the powder into a bowl
Hold the 45 mg capsule upright over a bowl and carefully cut off the rounded end with scissors.
Pour all the powder into the bowl.
Be careful with the powder, as it may irritate the skin and eyes.

Step 3: Mix the powder with food and administer to the patient
Add a small amount – no more than one teaspoon (5 mL) – of sweet food to the
powder in the bowl.
This will mask the bitter taste of Tamiflu powder.
Mix the mixture well.

Administer immediately the entire contents of the bowl to the patient.
If any of the mixture remains in the bowl, rinse the bowl with a small amount
of water and give all the rinse liquid to the patient to drink.
Repeat this procedure each time you need to administer the medicine.

Children under 1 year of age
To prepare a smaller single dose, you will need:

• One 45 mg Tamiflu capsule
• Sharp scissors
• Two small bowls (use a separate pair of bowls for each child)
• A large oral dosing device to measure water – a container with a capacity of 5 or 10 mL
• A small oral dosing device capable of measuring in 0.1 mL increments, to administer the dose (oral syringe)
• Teaspoon (5 mL)
• Water
• A sweet food to mask the bitter taste of Tamiflu. For example: chocolate or cherry syrup, dessert toppings such as caramel or butterscotch sauce. Alternatively, you may prepare sweetened water by mixing one teaspoon (5 mL) of water with three quarters (3/4) of a teaspoon of sugar.

Step 1: Pour all the powder into a bowl
Hold a 45 mg capsule upright over one of the bowls and carefully cut off
the rounded end with scissors. Be careful with the powder: it may irritate the skin and eyes.
Pour all the powder into the bowl, regardless of the dose you are preparing.
The amount is the same whether you are treating or preventing influenza.

Step 2: Add water to dilute the medicine
Use the larger dosing device
to measure 7.5 mL of
water.
Add the water to the
powder in the bowl.
Stir the mixture with a teaspoon
(5 mL) for about 2 minutes.
Do not worry if not all the powder dissolves. The undissolved powder consists only of
excipients.

Step 3: Select the correct amount based on the child's weight
Find the weight on the left side of the table.
The column on the right shows the amount of liquid suspension to be drawn up
using an oral syringe.

Infants under 1 year of age (including full-term newborns)

Step 4: Draw up the liquid suspension
Make sure you have the correct dosing device (oral syringe).
Draw up the correct amount of liquid suspension from the first bowl.
Draw upwards slowly, taking care not to include air bubbles.
Gently pour the correct dose into the second bowl.

Step 5: Sweeten and administer to the child
Add a small amount – no more than one teaspoon – of sweetened food to the
second bowl.
This helps mask the bitter taste of the Tamiflu suspension.
Mix the sweetened food and liquid Tamiflu thoroughly.

Give the child the entire contents of the second bowl (the liquid mixture of
Tamiflu with added sweetened food) immediately.
If any residue remains in the second bowl, rinse the bowl with a small amount
of water and give the child all of the rinse water to drink. For children unable to drink from a
bowl, use a teaspoon or bottle to administer the remaining liquid mixture to the child.
Give the child something to drink afterwards.
Discard any unused liquid left in the first bowl.
Repeat this procedure each time the medicine needs to be administered.

Information intended exclusively for healthcare professionals
Patients unable to swallow capsules:
Tamiflu oral suspension (6 mg/mL), ready-to-use, is the preferred formulation for paediatric and adult patients who have difficulty swallowing capsules or when lower doses are required. If Tamiflu powder for oral suspension is not available, the pharmacist may prepare a suspension (6 mg/mL) from Tamiflu capsules. If even the pharmacy-prepared suspension is unavailable, patients may use capsules to prepare the suspension at home.
Oral dosing devices (oral syringes) of appropriate volume and calibration must be provided both for administering the pharmacy-prepared suspension and for the home preparation procedure. In both cases, the dosing devices should preferably be marked with the correct volume. For home preparation, separate dosing devices must be provided to measure the correct volume of water and to measure the Tamiflu-water mixture. To measure 5.0 mL of water, dosing devices of 5 mL or 10 mL capacity should be used.
The appropriate doser size for drawing up the correct volume of Tamiflu suspension (6 mg/mL) is shown below.
Infants under 1 year of age (including full-term neonates):

Package leaflet: information for the user

Tamiflu 75 mg hard capsules

oseltamivir
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:
1. What Tamiflu is and what it is used for
2. What you need to know before taking Tamiflu
3. How to take Tamiflu
4. Possible side effects
5. How to store Tamiflu
6. Contents of the pack and other information

1. What Tamiflu is and what it is used for

• Tamiflu is used in adults, adolescents, children and infants (including full-term newborns) for the treatment of influenza. It can be used when you have influenza symptoms and the influenza virus is circulating in the community.
• Tamiflu may also be prescribed to adults, adolescents, children and infants over 1 year of age, on a case-by-case basis, to prevent influenza, for example if you have been in contact with someone who has influenza.
• Tamiflu may be prescribed to adults, adolescents, children and infants (including full-term newborns) as preventive treatment under exceptional circumstances, for example during a global influenza epidemic (influenza pandemic) or when the seasonal influenza vaccine does not provide adequate protection.

Tamiflu contains oseltamivir, which belongs to a group of medicines called neuraminidase inhibitors. These medicines prevent the spread of the influenza virus in the body and thus help to relieve or prevent symptoms caused by influenza virus infection.
Influenza is a viral infection. Influenza symptoms often include sudden fever (above 37.8°C), cough, runny or stuffy nose, headache, muscle aches and extreme fatigue. These symptoms may also be caused by other infections. True influenza infection occurs only during annual outbreaks, when the influenza virus is spreading within the local community. Outside the epidemic period, influenza-like symptoms are generally caused by a different type of illness.

2. What you need to know before taking Tamiflu

Do not take Tamiflu:

• if you are allergic ( hypersensitive ) to oseltamivir or to any of the excipients of Tamiflu listed in section 6. Consult your doctor if this applies to you. Do not take Tamiflu.

Warnings and precautions
Before taking Tamiflu, make sure that your prescribing doctor knows

• if you are allergic to other medicines
• if you have any kidney disease. In this case, a dose adjustment may be necessary
• if you have a serious health condition that may require immediate hospitalization
• if your immune system is not functioning properly
• if you have heart or chronic respiratory diseases.

During treatment with Tamiflu, inform your doctor immediately

• if you notice changes in behaviour or mood (neuropsychiatric events), especially in children and adolescents. These may be symptoms of rare but serious side effects.

Tamiflu is not an influenza vaccine
Tamiflu is not a vaccine: it treats infection or prevents the spread of the influenza virus. A vaccine provides antibodies against the virus. Tamiflu does not alter the effectiveness of an influenza vaccine, and your doctor may prescribe both.
Other medicines and Tamiflu
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription. The following medicines are particularly important:

• chlorpropamide (used to treat diabetes)
• methotrexate (used to treat, for example, rheumatoid arthritis)
• phenylbutazone (used to treat pain and inflammation)
• probenecid (used to treat gout)

Pregnancy and breastfeeding
Inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant, so that your doctor can decide whether Tamiflu is suitable for you.
The effects on breastfed infants are unknown. If you are breastfeeding, inform your doctor so that they can decide whether Tamiflu is suitable for you.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Tamiflu does not affect your ability to drive or operate machinery.
Information on some excipients of Tamiflu
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially ‘sodium-free’.

3. How to take Tamiflu

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
Take Tamiflu as soon as possible, ideally within two days of the onset of flu symptoms.

Recommended doses
For treatment of influenza, take two doses per day. It is usually convenient to take one dose in the morning and one in the evening. It is important that you complete the full 5-day course, even if you start to feel better quickly.
In patients with a weakened immune system, treatment will continue for 10 days.

For prevention of influenza or after contact with an infected person, take one dose per day for 10 days. It is best to take this dose in the morning with breakfast.
In special situations, such as widespread influenza or for patients with a weakened immune system, treatment may continue for up to 6 or 12 weeks.

The recommended dose depends on the patient's body weight. You must use the amount of capsules or oral suspension prescribed by your doctor.

Adults and adolescents aged 13 years and older

In patients with a weakened immune system, the treatment lasts for 10 days.
** 75 mg can be composed of one 30 mg capsule plus one 45 mg capsule.*
Children from 1 to 12 years of age

*In children with weakened immune systems, treatment lasts for 10 days.
** 75 mg may consist of one 30 mg capsule plus one 45 mg capsule.
Infants under 1 year of age (0–12 months)
The administration of Tamiflu to infants under 1 year of age for the prevention of influenza during
an influenza pandemic should be based on the physician's judgment after considering the
potential benefits and potential risks for the child.

*In infants with weakened immune systems, treatment lasts for 10 days.
** mg/kg = mg per kilogram of the child's body weight. For example:
if a 6-month-old child weighs 8 kg, the dose is:
8 kg x 3 mg per kg = 24 mg
Instructions for use
Swallow the capsules whole with water. Do not break or chew the capsules.
Tamiflu may be taken with or without food, although taking it with food may reduce the likelihood
of feeling unwell (nausea or vomiting).
For people who have difficulty swallowing capsules, an oral liquid preparation,
Tamiflu oral suspension, can be used. If Tamiflu oral suspension is needed but not available
at the pharmacy, Tamiflu liquid can be prepared from the capsules. For instructions,
see the section Preparing Tamiflu liquid at home.
If you take more Tamiflu than you should
Stop taking Tamiflu and contact your doctor or pharmacist immediately.
In most overdose cases, people have not reported any adverse effects. When adverse effects
have been reported, they were similar to those observed with normal doses as described in
section 4.
Overdose cases have been reported more frequently when Tamiflu was administered to
children than to adults and adolescents. Be careful when preparing Tamiflu solution for children
and when administering Tamiflu capsules or Tamiflu suspension to children.
If you forget to take Tamiflu
Do not take a double dose to make up for the missed capsule.
If you stop taking Tamiflu
There are no adverse effects when Tamiflu administration is stopped. However, if
Tamiflu is stopped before the time instructed by your doctor, influenza symptoms may return.
Always complete the course of treatment prescribed by your doctor.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Many of the side effects listed below may also be caused by influenza.
The following serious side effects have been rarely reported since oseltamivir has been marketed:

• Anaphylactic or anaphylactoid reactions: severe allergic reactions with swelling of the face and skin, itchy rash, drop in blood pressure, and breathing difficulties;
• Liver disorders (fulminant hepatitis, disorders of liver function, and jaundice): yellowing of the skin and whites of the eyes, change in stool colour, changes in behaviour;
• Angioedema: sudden onset of severe swelling of the skin, particularly around the head and neck including eyes and tongue, with breathing difficulties;
• Stevens-Johnson syndrome and toxic epidermal necrolysis: a severe allergic reaction, which may be fatal, presenting with severe inflammation of the skin and internal mucous membranes, initially accompanied by fever, sore throat, feeling of fatigue, skin rash, followed by blistering, skin peeling and large areas of dermo-epidermal detachment, possible breathing difficulties and low blood pressure;
• Gastrointestinal bleeding: prolonged bleeding from the large intestine or vomiting of blood;
• Neuropsychiatric disorders, as described below.

If you notice any of the following symptoms, seek immediate medical help.
The most frequently reported side effects (very common and common) with Tamiflu are feeling unwell or malaise (nausea, vomiting), stomach discomfort, stomach disorders, headache, and pain. These side effects mostly occur after the first dose of the medicine and usually disappear with continued treatment. The frequency of these side effects is reduced if the medicine is taken with food.
Rare but serious side effects: consult a doctor immediately
(may affect up to 1 in 1,000 people)
During treatment with Tamiflu, rare events have been reported including:

• seizures and delirium including altered level of consciousness
• confusion, abnormal behaviour
• delirium, hallucinations, agitation, anxiety, nightmares
  These events have been reported mainly in paediatric and adolescent patients and often occurred suddenly and resolved rapidly. A few cases progressed to self-injury (impulse to harm oneself), which in some cases led to death. Such neuropsychiatric events have also been reported in patients with influenza who had not taken Tamiflu.
• Patients, particularly children and adolescents, should be closely monitored for the behavioural changes described above. If you notice any of these symptoms, especially in younger patients, seek immediate medical advice.

Adults and adolescents aged 13 years and older
Very common side effects
(may affect more than 1 in 10 people)

• Headache
• Nausea

Common side effects
(may affect up to 1 in 10 people)

• Bronchitis
• Cold sores (herpes labialis)
• Cough
• Dizziness
• Fever
• Pain
• Limb pain
• Runny nose
• Sleep disorders
• Sore throat
• Stomach discomfort
• Fatigue
• Feeling of fullness in the upper abdomen
• Upper respiratory tract infections (inflammation of the nose, throat and nasal sinuses)
• Stomach disorders
• Vomiting

Uncommon side effects
(may affect up to 1 in 100 people)

• Allergic reactions
• Altered level of consciousness
• Seizures
• Abnormal heart rhythm
• Mild to severe abnormalities in liver function
• Skin reactions (skin inflammation, red itchy rash, skin peeling)

Rare side effects
(may affect up to 1 in 1,000 people)

• Thrombocytopenia (low platelet count)
• Visual disturbances

Children aged 1 to 12 years
Very common side effects
(may affect more than 1 in 10 people)

• Cough
• Nasal congestion
• Vomiting

Common side effects
(may affect up to 1 in 10 people)

• Conjunctivitis (red eyes, eye discharge or eye pain)
• Ear inflammation and other ear disorders
• Headache
• Nausea
• Runny nose
• Stomach discomfort
• Feeling of fullness in the upper abdomen
• Stomach disorders

Uncommon side effects
(may affect up to 1 in 100 people)

• Skin inflammation
• Tympanic membrane disorders

Infants under 1 year of age
The side effects reported in children aged 0 to 12 months are mostly similar to those reported in older children (1 year and above). Diarrhoea and nappy rash have also been reported.
If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist. In addition,

• if you or the child become unwell frequently, or
• if flu symptoms worsen or fever persists,
  inform your doctor as soon as possible.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Tamiflu

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp/EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tamiflu contains

• Each hard capsule contains the equivalent of 75 mg of oseltamivir.
• The excipients are: capsule contents: pregelatinized starch, talc, povidone, sodium croscarmellose, and sodium stearate fumarate; capsule shell: gelatin, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), and titanium dioxide (E171); printing ink: shellac (E904), titanium dioxide (E171), and FD&C Blue No. 2 (indigotine E132).

Description of the appearance of Tamiflu and package contents
The 75 mg hard capsule consists of an opaque grey body marked with the word "ROCHE" and a light yellow opaque cap marked with "75 mg". The markings are in blue.
Tamiflu 75 mg hard capsules are available in blisters in packs of 10.
Marketing Authorization Holder and Manufacturer
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Roche Pharma AG
Emil-Barell-Str. 1,
D-79639 Grenzach-Wyhlen
Germany
For further information on this medicinal product, please contact the local representative of the marketing authorization holder:
België/Belgique/Belgien Lietuva
N.V. Roche S.A. UAB “Roche Lietuva”
Tél/Tel: +32 (0) 2 525 82 11 Tel: +370 5 2546799
България Luxembourg/Luxemburg
Рош България ЕООД (Voir/siehe Belgique/Belgien)
Тел: +359 2 818 44 44
Česká republika Magyarország
Roche s. r. o. Roche (Magyarország) Kft.
Tel: +420 - 2 20382111 Tel: +36 - 23 446 800
Danmark Malta
Roche a/s (See Ireland)
Tlf: +45 - 36 39 99 99
Deutschland Nederland
Roche Pharma AG Roche Nederland B.V.
Tel: +49 (0) 7624 140 Tel: +31 (0) 348 438050
Eesti Norge
Roche Eesti OÜ Roche Norge AS
Tel: + 372 - 6 177 380 Tlf: +47 - 22 78 90 00
Ελλάδα Österreich
Roche (Hellas) A.E. Roche Austria GmbH
Τηλ: +30 210 61 66 100 Tel: +43 (0) 1 27739
España Polska
Roche Farma S.A. Roche Polska Sp.z o.o.
Tel: +34 - 91 324 81 00 Tel: +48 - 22 345 18 88
France Portugal
Roche Roche Farmacêutica Química, Lda
Tél: +33 (0) 1 47 61 40 00 Tel: +351 - 21 425 70 00
Hrvatska România
Roche d.o.o Roche România S.R.L.
Tel: +385 1 4722 333 Tel: +40 21 206 47 01
Ireland Slovenija
Roche Products (Ireland) Ltd. Roche farmacevtska družba d.o.o.
Tel: +353 (0) 1 469 0700 Tel: +386 - 1 360 26 00
Ísland Slovenská republika
Roche a/s Roche Slovensko, s.r.o.
c/o Icepharma hf Tel: +421 - 2 52638201
Sími: +354 540 8000
Italia Suomi/Finland
Roche S.p.A. Roche Oy
Tel: +39 - 039 2471 Puh/Tel: +358 (0) 10 554 500
Kύπρος Sverige
Γ.Α.Σταμάτης & Σια Λτδ. Roche AB
Τηλ: +357 - 22 76 62 76 Tel: +46 (0) 8 726 1200
Latvija United Kingdom
Roche Latvija SIA Roche Products Ltd.
Tel: +371 - 6 7039831 Tel: +44 (0) 1707 366000
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/ .

---

Patient Information Leaflet
For people who have difficulty swallowing capsules, including very young children, a liquid formulation is available: Tamiflu oral suspension.
If you need the liquid formulation but it is not available, a pharmacy-prepared oral suspension from Tamiflu capsules can be used (see Information for healthcare professionals). The pharmacy-prepared liquid formulation is the preferred option.
If even the pharmacy-prepared formulation is unavailable, you may prepare Tamiflu as a liquid at home from the capsules.
The dose is the same for treatment and prevention of influenza. The difference lies in the frequency of administration.
Preparing Tamiflu as a liquid at home

• If you have the correct capsules for the required dosage (a 75 mg dose), open the capsule and mix its contents with a teaspoon (or less) of a suitable sweetened food. This procedure is usually suitable for children over 1 year of age. See the top part of the instructions.
• If a lower dose is needed, preparing Tamiflu as a liquid from capsules requires additional steps. This procedure is suitable for younger children and infants who usually require a Tamiflu dose below 30 mg. See the bottom part of the instructions.

Adults and adolescents aged 13 years and older, and children weighing 40 kg or more
To prepare a 75 mg dose, you will need:

• One 75 mg Tamiflu capsule
• Sharp scissors
• A small bowl
• Teaspoon (5 mL)
• Water
• A sweet food to mask the bitter taste of the powder. For example: chocolate or cherry syrup, dessert toppings such as caramel or butterscotch sauce. Alternatively, you can prepare sweetened water by mixing a teaspoon (5 mL) of water with three-quarters (3/4) of a teaspoon of sugar.

Step 1: Check that the dose is correct
To determine the correct amount of medicine to use, find the patient's weight in the left-hand column of the table.
Look in the right-hand column to find the number of capsules to administer to the patient for a single dose. The amount is the same for both treatment and prevention of influenza.

75 mg dose
You must use 75 mg capsules only for 75 mg doses. Do not attempt to prepare a 75 mg dose using the contents of 30 mg or 45 mg capsules.

Not suitable for children weighing less than 40 kg.
A dose lower than 75 mg must be prepared for children weighing less than 40 kg.
See below.
Step 2: Pour all the powder into a bowl
Hold a 75 mg capsule vertically over a bowl and carefully cut off the rounded end with scissors.
Pour all the powder into the bowl.
Be cautious with the powder, as it may irritate the skin and eyes.

Step 3: Mix the powder with food and administer to the patient
Add a small amount – no more than one teaspoon (5 mL) – of sweetened food to the powder in the bowl.
This helps mask the bitter taste of Tamiflu powder.
Mix the mixture thoroughly.

Give immediately to the patient all the contents of the bowl.
If any of the mixture remains in the bowl, rinse the bowl with a small amount of water and give all the rinse liquid to the patient to drink.
Repeat this procedure each time you need to administer the medicine.
Infants under 1 year of age and children with a body weight below 40 kg
To prepare a smaller single dose, you will need:

• One 75 mg Tamiflu capsule
• Sharp scissors
• Two small bowls
• A large oral dosing device to measure water – a container with a capacity of 5 or 10 mL
• A small oral dosing device capable of measuring 0.1 mL, to administer the dose (oral syringe)
• Teaspoon (5 mL)
• Water
• Sweet foods to mask the bitter taste of Tamiflu. For example: chocolate or cherry syrup, dessert toppings such as caramel or butterscotch sauce. Alternatively, you may prepare sweetened water by mixing one teaspoon (5 mL) of water with three quarters (3/4) of a teaspoon of sugar.

Step 1: Pour all the powder into a bowl
Hold a 75 mg capsule vertically over one of the bowls and carefully cut off the rounded end with scissors. Be cautious with the powder: it may irritate the skin and eyes.
Pour all the powder into the bowl, regardless of the dose being prepared. The amount is the same whether treating or preventing influenza.

Step 2: Add water to dilute the medicine
Use the larger dosing device to measure 12.5 mL of water.
Add the water to the powder in the bowl.
Stir the mixture with a teaspoon (5 mL) for about 2 minutes.
Do not worry if not all the powder dissolves. The undissolved powder consists only of excipients.
Step 3: Select the correct amount based on the child's weight
Find the weight on the left side of the table.
The column on the right side of the table shows the amount of liquid suspension that should be drawn up with an oral syringe.
Infants under 1 year of age (including full-term newborns)

Children aged 1 year and older and weighing less than 40 kg

Step 4: Draw up the liquid suspension
Make sure you have the correct size dosing device (oral syringe).
Draw up the correct amount of liquid suspension from the first bowl. Pull upwards,
taking care not to include air bubbles.
Gently pour the correct dose into the second bowl.

Step 5: Sweeten and administer to the child
Add a small amount – no more than one teaspoon – of sweetened food to the
second bowl.
This helps mask the bitter taste of the Tamiflu suspension.
Mix the sweetened food and liquid Tamiflu thoroughly.

Give the child the entire contents of the second bowl (the liquid mixture of
Tamiflu with added sweetened food) immediately.
If any residue remains in the second bowl, rinse the bowl with a small amount
of water and give the child all of the rinse liquid to drink. For children unable to drink
directly from the bowl, use a teaspoon or bottle to administer the remaining liquid mixture.
Give the child something to drink afterwards.
Dispose of any unused liquid remaining in the first bowl.
Repeat this procedure each time the medication is to be administered.

Information intended exclusively for healthcare professionals
Patients unable to swallow capsules:
Tamiflu oral suspension (6 mg/mL), ready-to-use, is the preferred formulation for
paediatric and adult patients who have difficulty swallowing capsules or when lower doses
are required. If Tamiflu oral suspension powder is not available, the pharmacist may
prepare a suspension (6 mg/mL) from Tamiflu capsules. If even the pharmacy-prepared
suspension is unavailable, patients may use the capsules to prepare the suspension at home.
Oral dosing devices (oral syringes) of appropriate volume and graduations must be provided for both
the administration of the pharmacy-prepared suspension and for the at-home preparation procedures.
In both cases, the dosing devices should preferably be marked with the correct volume. For at-home
preparation, separate dosing devices must be provided to measure the correct volume of water and to
measure the Tamiflu-water mixture. To measure 12.5 mL of water, 10 mL dosing devices should be used.
See below for the appropriate dosing device size to use for drawing up the correct volume of Tamiflu 6 mg/mL oral suspension.
Infants under 1 year of age (including full-term neonates):

Children over 1 year of age and weighing less than 40 kg

Package leaflet: information for the user

Tamiflu 6 mg/mL powder for oral suspension

oseltamivir
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to others. It could be harmful to them, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:
1. What Tamiflu is and what it is used for
2. What you should know before taking Tamiflu
3. How to take Tamiflu
4. Possible side effects
5. How to store Tamiflu
6. Contents of the pack and other information

1. What Tamiflu is and what it is used for

• Tamiflu is used in adults, adolescents, children and infants (including full-term newborns) for the treatment of influenza. It can be used when you have influenza-like symptoms and the influenza virus is circulating in the community.
• Tamiflu may also be prescribed to adults, adolescents, children and infants over 1 year of age, on a case-by-case basis, for the prevention of influenza, for example if you have been in contact with someone who has influenza.
• Tamiflu may be prescribed to adults, adolescents, children and infants (including full-term newborns) as preventive treatment under exceptional circumstances, for example during a global influenza epidemic (influenza pandemic) or when the seasonal influenza vaccine does not provide sufficient protection.

Tamiflu contains oseltamivir, which belongs to a group of medicines called neuraminidase inhibitors. These medicines prevent the spread of the influenza virus in the body and thus help relieve or prevent symptoms caused by influenza virus infection.
Influenza is a viral infection. Influenza symptoms often include sudden fever (above 37.8°C), cough, runny or stuffy nose, headache, muscle aches and extreme fatigue. These symptoms may also be caused by other infections. True influenza infection occurs only during annual epidemics when the influenza virus is spreading within the local community. Outside the epidemic period, influenza-like symptoms are generally caused by a different type of virus or illness.

2. What you should know before taking Tamiflu

Do not take Tamiflu

• if you are allergic ( hypersensitive ) to oseltamivir or to any of the excipients in Tamiflu listed in section 6. Consult your doctor if this applies to you. Do not take Tamiflu.

Warnings and precautions
Before taking Tamiflu, make sure your prescribing doctor knows

• if you are allergic to other medicines
• if you have any kidney disease. In this case, a dose adjustment may be necessary
• if you have a serious health condition that may require immediate hospitalization
• if your immune system is not functioning properly
• if you have chronic heart or respiratory diseases.

During treatment with Tamiflu, inform your doctor immediately:

• if you notice changes in behaviour or mood (neuropsychiatric events), especially in children and adolescents. These may be symptoms of rare but serious side effects.

Tamiflu is not an influenza vaccine
Tamiflu is not a vaccine: it treats the infection or prevents the spread of the influenza virus. A vaccine
provides antibodies against the virus. Tamiflu does not interfere with the effectiveness of an influenza vaccine, and your
doctor may prescribe both.
Other medicines and Tamiflu
Inform your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those without a prescription. The following medicines are particularly
important:

• chlorpropamide (used to treat diabetes)
• methotrexate (used to treat, for example, rheumatoid arthritis)
• phenylbutazone (used to treat pain and inflammation)
• probenecid (used to treat gout).

Pregnancy and breastfeeding
Inform your doctor if you are pregnant, think you may be pregnant, or are trying to become pregnant, so that
your doctor can decide whether Tamiflu is suitable for you.
The effects on breastfed infants are unknown. If you are breastfeeding, inform your doctor so that
they can decide whether Tamiflu is suitable for you.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and use of machines
Tamiflu does not affect your ability to drive or operate machinery.
Important information about some excipients in Tamiflu
Tamiflu contains sorbitol.
Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars, or
if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before taking this
medicine.
Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.
5 mL of oseltamivir suspension contains 0.9 g of sorbitol.
7.5 mL of oseltamivir suspension contains 1.3 g of sorbitol.
10 mL of oseltamivir suspension contains 1.7 g of sorbitol.
12.5 mL of oseltamivir suspension contains 2.1 g of sorbitol.
Tamiflu contains sodium benzoate.
Sodium benzoate (E211) may increase jaundice (yellowing of the skin and eyes) in newborns (up to
4 weeks of age).
5 mL of oseltamivir suspension contains 2.5 mg of sodium benzoate.
7.5 mL of oseltamivir suspension contains 3.75 mg of sodium benzoate.
10 mL of oseltamivir suspension contains 5.0 mg of sodium benzoate.
12.5 mL of oseltamivir suspension contains 6.25 mg of sodium benzoate.
This medicine contains less than 1 mmol of sodium (23 mg) per single dose (based on a maximum dose of 75 mg), i.e., essentially ‘sodium-free’.

3. How to take Tamiflu

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
Always use the oral dosing device (syringe) provided in the package, which is graduated to indicate
the dose in millilitres (mL).
Take Tamiflu as soon as possible, preferably within two days of the onset of flu symptoms.
Recommended doses
For treatment of influenza: Take two doses per day. It is usually convenient to take one dose
in the morning and one in the evening. It is important that you complete the full 5-day course,
even if you start to feel better quickly.
In patients with a weakened immune system, treatment will last for 10 days.
For prevention of influenza or after contact with an infected person, take one dose per
day for 10 days. It is best to take this dose in the morning with breakfast.
In special situations, such as widespread influenza or for patients with a weakened immune system,
treatment may continue for up to 6 or 12 weeks.
The recommended dose depends on the patient's body weight. You must take the amount of
Tamiflu prescribed by your doctor. People who have difficulty swallowing capsules may use
Tamiflu oral suspension. See instructions on the following page for preparing and administering a dose.
Adults and adolescents aged 13 years and older

*In patients with a weakened immune system, treatment lasts for 10 days.
**12.5 mL consist of one 5 mL dose plus one 7.5 mL dose.
Children from 1 to 12 years of age

*In children with weakened immune systems, treatment lasts for 10 days.
**12.5 mL consists of one 5 mL dose plus one 7.5 mL dose.
Infants under 1 year of age (0 to 12 months)
The administration of Tamiflu in infants under 1 year of age for the prevention of influenza during an influenza pandemic should be based on the physician's judgment following consideration of the potential benefit and any possible risks for the child. An oral dosing dispenser (syringe) of 3 mL (graduated in 0.1 mL increments) must be used to administer Tamiflu oral suspension to children under 1 year of age who require 1 to 3 mL.

*In patients with a weakened immune system, the treatment lasts for 10 days.
If you take more Tamiflu than you should
Stop taking Tamiflu and contact your doctor or pharmacist immediately.
In most cases of overdose, people did not report any adverse effects. When adverse effects were reported, they were similar to those observed with normal doses as described in section 4.
Cases of overdose have been reported more frequently when Tamiflu was administered to children than to adults and adolescents. Exercise caution when preparing the Tamiflu solution for children and when administering Tamiflu capsules or Tamiflu oral suspension to children.
If you forget to take Tamiflu
Do not take a double dose to make up for the missed dose.
If you stop taking Tamiflu
There are no adverse effects when Tamiflu administration is stopped. However, if Tamiflu is stopped before the time instructed by your doctor, influenza symptoms may return. Always complete the course of treatment prescribed by your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Many of the side effects listed below may also be caused by influenza.
The following serious side effects have been rarely reported since oseltamivir has been marketed:

• Anaphylactic or anaphylactoid reactions: severe allergic reactions with swelling of the face and skin, itchy rash, drop in blood pressure, and breathing difficulties;
• Liver disorders (fulminant hepatitis, liver function disorders, and jaundice): yellowing of the skin and whites of the eyes, change in stool colour, changes in behaviour;
• Angioneurotic oedema: sudden onset of severe swelling of the skin, especially around the head and neck, including eyes and tongue, with breathing difficulties;
• Stevens-Johnson syndrome and toxic epidermal necrolysis: a severe allergic reaction, which may be fatal, characterised by severe inflammation of the skin and internal mucous membranes, initially accompanied by fever, sore throat, feeling of fatigue, skin rash, followed by blisters, skin peeling with extensive areas of dermo-epidermal detachment, possible breathing difficulties and low blood pressure;
• Gastrointestinal bleeding: prolonged bleeding from the large intestine or vomiting of blood.

If you notice any of these symptoms, seek medical help immediately.
The most frequently reported side effects (very common and common) with Tamiflu are feeling unwell or malaise (nausea, vomiting), stomach ache, stomach disorders, headache and pain. These side effects mostly occur after the first dose of the medicine and usually disappear with continued treatment. The frequency of these side effects is reduced if the medicine is taken with food.
Rare but serious side effects: consult a doctor immediately
(may affect up to 1 in 1,000 patients)
During treatment with Tamiflu, rare events have been reported, including:

• seizures and delirium, including altered level of consciousness
• confusion, abnormal behaviour
• delirium, hallucinations, agitation, anxiety, nightmares.

These events have been reported mainly in children and adolescents and often occurred suddenly and resolved rapidly. In a few cases, these progressed to self-injury (impulse to harm oneself), which in some cases led to death. Such neuropsychiatric events have also been reported in patients with influenza who had not taken Tamiflu.

• Patients, particularly children and adolescents, should be closely monitored for the behavioural changes described above. If you notice any of these symptoms, especially in younger patients, seek medical advice immediately.

Adults and adolescents aged 13 years and older
Very common side effects
(may affect more than 1 in 10 people)

• Headache
• Nausea.

Common side effects
(may affect up to 1 in 10 people)

• Bronchitis
• Cold sores
• Cough
• Dizziness
• Fever
• Pain
• Limb pain
• Runny nose
• Sleep disorders
• Sore throat
• Stomach ache
• Feeling of fullness in the upper abdomen
• Upper respiratory tract infections (inflammation of the nose, throat and nasal sinuses)
• Stomach disorders
• Vomiting.

Uncommon side effects
(may affect up to 1 in 100 people)

• Allergic reactions
• Altered level of consciousness
• Seizures
• Abnormal heart rhythm
• Mild to severe liver function abnormalities
• Skin reactions (skin inflammation, red itchy rash, skin peeling).

Rare side effects
(may affect up to 1 in 1,000 people)

• Thrombocytopenia (low platelet count)
• Visual disturbances.

Children aged 1 to 12 years
Very common side effects
(may affect more than 1 in 10 people)

• Cough
• Nasal congestion
• Vomiting.

Common side effects
(may affect up to 1 in 10 people)

• Conjunctivitis (red eyes, eye discharge or eye pain)
• Ear inflammation and other ear disorders
• Headache
• Nausea
• Runny nose
• Stomach ache
• Feeling of fullness in the upper abdomen
• Stomach disorders.

Uncommon side effects
(may affect up to 1 in 100 people)

• Skin inflammation
• Tympanic disorders.

Infants under 1 year of age
The side effects reported in infants from 0 to 12 months of age are mostly similar to those reported in older children (1 year and above). Diarrhoea and nappy rash have also been reported.
If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist. In addition,

• if you or the child become unwell frequently, or
• if influenza symptoms worsen or fever persists

inform your doctor as soon as possible.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tamiflu

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle after
Exp. The expiry date refers to the last day of the month.
Powder: store below 30°C.
After reconstitution, store below 25°C and use within 10 days.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Tamiflu contains

• The active substance is oseltamivir (6 mg/mL of oseltamivir after reconstitution).
• The excipients are sorbitol (E420), sodium citrate dihydrate (E331[a]), xanthan gum (E415), sodium benzoate (E211), sodium saccharin (E954), titanium dioxide (E171), and tutti-frutti flavour (containing maltodextrins [maize], propylene glycol, gum arabic E414, and natural-identical flavouring substances [mainly consisting of banana, pineapple, and peach flavours]).

Description of the appearance of Tamiflu and contents of the pack
Oral suspension powder
The powder is a granular or blocky granulate ranging in colour from white to pale yellow.
Tamiflu 6 mg/mL powder for oral suspension is supplied in a bottle containing 13 g of powder to be mixed with 55 mL of water.
The pack also contains 1 plastic graduated glass (55 mL), 1 bottle adapter in plastic (to assist pouring the medicine into the dosing device), 1 plastic oral dosing syringe of 3 mL, and 1 plastic oral dosing syringe of 10 mL (to administer the correct amount of medicine orally). The oral dosing syringes are marked with graduations in millilitres (mL) of medicine (see figures in the Instructions for the User).
For details on how to prepare the oral suspension and how to measure and take the medicine, please read the Instructions for the User at the end of this page.

Marketing Authorisation Holder and Manufacturer
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Roche Pharma AG
Emil-Barell-Str. 1,
D-79639 Grenzach-Wyhlen
Germany

For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
N.V. Roche S.A. UAB “Roche Lietuva”
Tél/Tel: +32 (0) 2 525 82 11 Tel: +370 5 2546799

България Luxembourg/Luxemburg
Рош България ЕООД (Voir/siehe Belgique/Belgien)
Тел: +359 2 818 44 44

Česká republika Magyarország
Roche s. r. o. Roche (Magyarország) Kft.
Tel: +420 - 2 20382111 Tel: +36 - 23 446 800

Danmark Malta
Roche a/s (See Ireland)
Tlf: +45 - 36 39 99 99

Deutschland Nederland
Roche Pharma AG Roche Nederland B.V.
Tel: +49 (0) 7624 140 Tel: +31 (0) 348 438050

Eesti Norge
Roche Eesti OÜ Roche Norge AS
Tel: + 372 - 6 177 380 Tlf: +47 - 22 78 90 00

Ελλάδα Österreich
Roche (Hellas) A.E. Roche Austria GmbH
Τηλ: +30 210 61 66 100 Tel: +43 (0) 1 27739

España Polska
Roche Farma S.A. Roche Polska Sp.z o.o.
Tel: +34 - 91 324 81 00 Tel: +48 - 22 345 18 88

France Portugal
Roche Roche Farmacêutica Química, Lda
Tél: +33 (0) 1 47 61 40 00 Tel: +351 - 21 425 70 00

Hrvatska România
Roche d.o.o Roche România S.R.L.
Tel: +385 1 4722 333 Tel: +40 21 206 47 01

Ireland Slovenija
Roche Products (Ireland) Ltd. Roche farmacevtska družba d.o.o.
Tel: +353 (0) 1 469 0700 Tel: +386 - 1 360 26 00

Ísland Slovenská republika
Roche a/s Roche Slovensko, s.r.o.
c/o Icepharma hf Tel: +421 - 2 52638201
Sími: +354 540 8000

Italia Suomi/Finland
Roche S.p.A. Roche Oy
Tel: +39 - 039 2471 Puh/Tel: +358 (0) 10 554 500

Kύπρος Sverige
Γ.Α.Σταμάτης & Σια Λτδ. Roche AB
Τηλ: +357 - 22 76 62 76 Tel: +46 (0) 8 726 1200

Latvija United Kingdom
Roche Latvija SIA Roche Products Ltd.
Tel: +371 - 6 7039831 Tel: +44 (0) 1707 366000

More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/ .

Instructions for the User

There are two steps in preparing Tamiflu oral suspension.

Step 1: Prepare a new bottle of medicine
The pharmacist may have already prepared the medicine for you when you collected your prescription. If not, you can easily prepare it yourself. See the first part of these instructions. You need to prepare the bottle only once, at the beginning of treatment.

Step 2: Measure and administer the correct dose
Shake the suspension well, draw up the recommended dose, and place it into the dosing syringe. See the second part of these instructions. You will need to repeat this step each time a dose is required.

Step 1: Prepare a new bottle of medicine
You will need:

• Bottle containing Tamiflu powder (supplied in the medicine pack)
• Bottle cap (supplied in the medicine pack)
• A plastic graduated measuring glass (supplied in the medicine pack)
• Plastic bottle adapter (supplied in the medicine pack)
• Water

Cup – cap
Bottle adapter – bottle adapter
Measuring jug – measuring glass
Fill line – fill line

• Tap the bottle to disperse the powder Gently tap the closed bottle several times to loosen the powder.
• Using the measuring glass, measure 55 mL of water: The measuring glass supplied in the pack has a mark indicating the exact volume. Fill it with water up to the indicated level.
• Add water, close and shake Pour all the water from the measuring glass into the bottle containing the powder. Always use 55 mL of water, regardless of the dose required. Put the cap on the bottle. Shake the bottle well for 15 seconds.
• Press in the bottle adapter Open the bottle and press the adapter into the neck of the bottle.
• Close the bottle again Screw the cap tightly onto the bottle, now including the adapter. This will ensure the adapter fits securely in the correct position.

You now have a ready-to-use bottle of Tamiflu oral suspension from which you can measure doses. You do not need to repeat this preparation unless you start a new bottle.

Step 2: Measure and administer the correct dose

You will need

• A pre-prepared bottle of Tamiflu oral suspension
• Depending on the required dose, you will need either the 3 mL oral dosing syringe (orange plunger, graduations every 0.1 mL) or the 10 mL oral dosing syringe (transparent plunger, graduations every 0.5 mL) supplied in the medicine pack.
• For doses between 1.0 mL and 3.0 mL, use the 3 mL oral dosing syringe. For doses greater than 3 mL, use the 10 mL oral dosing syringe. Always use the oral dosing syringe supplied with the medicine to measure the correct dose.

• Shake the bottle Ensure the cap is securely closed, then shake the bottle of Tamiflu oral suspension well. Shake well before each use.
• Prepare the oral dosing syringe Depending on the required dose, use either the 3 mL oral dosing syringe (orange plunger) or the 10 mL oral dosing syringe (transparent plunger) supplied in the pack. Push the plunger down to the tip of the dosing syringe.

• Fill the dosing syringe with the correct dose Unscrew the cap from the bottle. Insert the tip of the dosing syringe into the bottle adapter. Invert the entire assembly (bottle and dosing syringe together).

Slowly draw up the medicine by pulling back the plunger of the dosing syringe.
Stop when the plunger reaches the mark corresponding to the required dose.
Turn the assembly upright.
Remove the dosing syringe from the bottle.

• Administer the medicine into the mouth Administer the suspension directly into the mouth by pushing the plunger of the dosing syringe. Ensure the medicine is swallowed. You may drink or eat something after taking the medicine.
• Close the bottle and store carefully Replace the cap on the bottle. Keep the medicine out of sight and reach of children.

Store the medicine below 25°C for up to 10 days. See section 5 How to store Tamiflu.
Immediately after administration, disassemble the dosing syringe into its two parts and rinse both under running water.