Tamivil

Package leaflet: Information for the user

Tamivil 75 mg hard capsules
Oseltamivirum
Please read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Tamivil is and what it is used for

• Tamivil 75 mg hard capsules is used in adults, adolescents, children, and infants (including full-term newborns) for the treatment of influenza (flu). It may be used when flu symptoms are present and when it is known that influenza virus is circulating in the community.
• Tamivil 75 mg hard capsules may also be prescribed for adults, adolescents, children, and infants over 1 year of age for prevention of influenza (flu). Each case is considered individually, for example, if the patient has been in close contact with someone who has the flu.
• Tamivil 75 mg hard capsules may be prescribed to adults, adolescents, children, and infants (including full-term newborns) as preventive treatment in exceptional circumstances, such as during a global influenza epidemic (influenza pandemic), when the seasonal influenza vaccine does not provide adequate protection.

Tamivil 75 mg hard capsules contain oseltamivir, which belongs to a group of medicines called neuraminidase inhibitors. These medicines help prevent the spread of the influenza virus in the body. They help reduce the severity of symptoms or prevent their occurrence if infection with the influenza virus occurs.
Influenza (flu) is an infectious disease caused by a virus. Flu symptoms often include sudden onset of 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 seasonal outbreaks (epidemics), when influenza viruses are circulating in the local community. Outside epidemic periods, flu-like symptoms are usually due to other illnesses.

2. Important information before using Tamivil

When not to take Tamivil 75 mg hard capsules

• if the patient is allergic ( hypersensitive ) to oseltamivir or any of the other ingredients of this medicine listed in section 6. If this applies to the patient, contact a doctor. Do not take Tamivil 75 mg hard capsules.

Warnings and precautions
Before taking Tamivil 75 mg hard capsules, inform the doctor who prescribed the medicine

• if the patient is allergic to other medicines
• if the patient has kidney disease. If so, the dose may need to be adjusted
• if the patient has a serious illness that may require immediate hospital treatment
• if the patient's immune system is not functioning properly
• if the patient has chronic heart disease or respiratory disease.

During treatment with Tamivil 75 mg hard capsules, contact the doctor immediately if:

• the patient notices changes in behaviour or mood ( neuropsychiatric events ), especially in children and adolescents. These symptoms may be rare but serious adverse reactions.

Tamivil 75 mg hard capsules is not an influenza vaccine
Tamivil is not a vaccine: it is used to treat influenza infection or to prevent the spread of the influenza virus. Vaccines provide antibodies against the virus. Tamivil does not affect the effectiveness of influenza vaccination, and the doctor may prescribe both products.

Tamivil 75 mg hard capsules and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription. The following medicines are particularly important:

• chlorpropamide (used in the treatment of diabetes)
• methotrexate (used in the treatment of, for example, rheumatoid arthritis)
• phenylbutazone (used in the treatment of pain and inflammatory conditions)
• probenecid (used in the treatment of gout)

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should inform the doctor so that a decision can be made whether Tamivil 75 mg hard capsules is appropriate.
The effect of oseltamivir on breastfed infants is unknown. If the patient is breastfeeding, she should inform the doctor so that a decision can be made whether Tamivil 75 mg hard capsules is appropriate.
Consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Tamivil 75 mg hard capsules has no influence on the ability to drive or operate machinery.

Tamivil 75 mg hard capsules contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per capsule; therefore, the medicine is considered "sodium-free".

3. How to take Tamivil

This medicine should always be taken exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Tamivil 75 mg hard capsules should be taken as soon as possible, preferably within the first two
days after the onset of flu symptoms.
Recommended doses
For treatment of influenza, take two doses per day. It is usually best to take one
dose in the morning and one in the evening. It is important to complete the full 5-day treatment course, even
if the patient's condition improves rapidly.
In patients with weakened immune systems, 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 the medicine in the morning with breakfast.
In special situations, such as widespread influenza outbreaks or in patients with
weakened immune systems, treatment may last up to 6 or 12 weeks.
The recommended dose is calculated based on the patient's body weight. Take the number of
capsules or oral suspension prescribed by the doctor.
Adults and adolescents aged 13 years and older

*In patients with reduced immunity, treatment lasts 10 days
**The 75 mg dose may consist of a 30 mg capsule and a 45 mg capsule
Children aged 1 to 12 years

*In children with reduced immunity, treatment lasts 10 days
**The dose of 75 mg may consist of one 30 mg capsule and one 45 mg capsule
Infants under 1 year of age (0 to 12 months)
The decision to administer Tamivil to infants under 1 year of age for prophylaxis during an influenza pandemic should be made by a physician after evaluating the potential benefits against the potential risks for the infant.

*In infants with reduced immunity, treatment lasts 10 days.
**mg per kg = mg per each kilogram of infant's body weight. For example:
in a 6-month-old infant weighing 8 kg, the dose is
8 kg x 3 mg per kg = 24 mg

Method of administration
Capsules should be swallowed whole with water. Capsules must not be broken or chewed.
Tamivil 75 mg hard capsules can be taken with food or independently of meals,
although taking the medicine with food reduces the risk of nausea or vomiting.

Patients who have difficulty swallowing capsules may use liquid formulations of this medicine
(oral suspension). If a patient requires oral suspension and it is not available at the pharmacy,
the patient may prepare the liquid formulation of Tamivil medicine from available capsules. See the instructions
Preparing Tamivil liquid at home.

Taking more than the recommended dose of Tamivil 75 mg hard capsules
The use of Tamivil 75 mg capsules should be discontinued immediately and the patient should promptly contact
a physician or pharmacist.

In most cases, no adverse effects were reported following overdose. When they did occur,
they were similar to adverse effects observed after recommended doses, as described in section 4.
Overdose was reported more frequently after oseltamivir administration in children than in adults and adolescents.
Caution should be exercised when preparing the liquid formulation of Tamivil 75 mg for
children and when administering Tamivil 75 mg in capsule or liquid form to children.

Missing a dose of Tamivil 75 mg hard capsules
Do not take a double dose to make up for a missed capsule.

Stopping treatment with Tamivil 75 mg hard capsules
There are no adverse effects associated with stopping treatment with Tamivil 75 mg hard capsules.
However, if treatment is discontinued earlier than recommended by the physician,
influenza symptoms may recur. Treatment should always be completed according to the physician's instructions.

If you have any further questions concerning the use of this medicine, consult your
physician or pharmacist.

4. Possible adverse reactions

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

• Anaphylactic and anaphylactoid reactions: severe allergic reactions with facial and skin swelling, itchy rash, low blood pressure, and breathing difficulties.
• Liver disorders (fulminant hepatitis, hepatic dysfunction, and jaundice): yellowing of the skin and whites of the eyes, change in stool color, changes in behavior.
• Angioedema: sudden and significant swelling of the skin, mainly affecting the head and neck area, including eyes and tongue, accompanied by breathing difficulties.
• Stevens-Johnson syndrome and toxic epidermal necrolysis: complex, potentially life-threatening allergic reactions, severe inflammation of external and even internal layers of the skin, beginning with fever, sore throat, and fatigue, skin rashes progressing

into blisters, peeling, shedding of large areas of skin, possibly accompanied by
breathing difficulties and low blood pressure.

• Gastrointestinal bleeding: prolonged bleeding from the large intestine or hemoptysis.
• Neuropsychiatric disorders, as described below.

If any of these symptoms occur, seek immediate medical help.
The most frequently (very common and common) reported adverse reactions with oseltamivir are: nausea (feeling sick, vomiting), stomach pain, indigestion, headache, and pain. These symptoms usually occur only after the first dose of the medicine and typically resolve during continued treatment. The frequency of these adverse reactions decreases when the medicine is taken with food.
Rare but serious adverse reactions: seek immediate medical attention
(occurring in no more than 1 in 1,000 patients)
Rare cases have been reported during treatment with oseltamivir, including:

• seizures and delirium, including altered consciousness;
• confusion, unusual behavior;
• hallucinations, illusions, agitation, anxiety, nightmares. These events, which often had a sudden onset and resolution, were observed primarily in children and adolescents. In rare cases, they led to self-harm, sometimes resulting in death. Similar neuropsychiatric events have also been observed in patients with influenza who did not take oseltamivir.
• Patients, especially children and adolescents, should be closely monitored for the behavioral changes described above. If any of these symptoms occur, especially in young individuals, seek immediate medical advice.

Adults and adolescents aged 13 years and older
Very common adverse reactions
(may affect more than 1 in 10 patients)

• headache;
• nausea.

Common adverse reactions
(may affect up to 1 in 10 patients)

• bronchitis;
• herpes virus infection;
• cough;
• dizziness;
• fever;
• pain;
• limb pain;
• watery nasal discharge;
• sleep disturbances;
• sore throat;
• stomach pain;
• fatigue;
• feeling of fullness in the upper abdomen;
• upper respiratory tract infections (nasal, throat, and sinus inflammation);
• indigestion;
• vomiting.

Uncommon adverse reactions
(may affect up to 1 in 100 patients)

• allergic reactions;
• altered level of consciousness;
• seizures;
• cardiac arrhythmias;
• mild to severe liver function disorders;
• skin reactions (skin inflammation, red and itchy rash, skin peeling).

Rare adverse reactions
(may affect up to 1 in 1,000 patients)

• thrombocytopenia (low platelet count);
• visual disturbances.

Children aged 1 to 12 years
Very common adverse reactions
(may affect more than 1 in 10 patients)

• cough;
• rhinitis;
• vomiting.

Common adverse reactions
(may affect up to 1 in 10 patients)

• conjunctivitis (red eyes, eye discharge or eye pain);
• ear infections and other ear disorders;
• headache;
• nausea;
• watery nasal discharge;
• stomach pain;
• feeling of fullness in the upper abdomen;
• indigestion.

Uncommon adverse reactions
(may affect up to 1 in 100 patients)

• skin inflammation;
• tympanic membrane disorders.

Infants under 1 year of age
Adverse reactions reported in infants aged 0 to 12 months are usually similar to those reported in older children (aged 1 year or more). In addition, diarrhea and diaper rash have been reported.
If any adverse reaction worsens or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

• if the patient or their child vomits repeatedly, or
• if flu symptoms worsen or fever persists,
  contact your doctor immediately.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tamivil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP".
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Doing so helps protect the environment.

6. Contents of the package and other information

What Tamivil contains

• Each hard capsule contains oseltamivir phosphate, corresponding to 75 mg of oseltamivir.
• Other ingredients: Capsule contents: pregelatinized starch (maize), povidone (K-29/32), sodium croscarmellose, talc, sodium stearyl fumarate.
  Capsule shell: Body: titanium dioxide (E 171), gelatin; Cap: titanium dioxide (E 171), yellow iron oxide (E 172), gelatin.

What Tamivil 75 mg hard capsules look like and contents of the pack
White, granular or slightly coarse powder in a size 2 hard capsule. The capsule consists of an opaque white body and a dark yellow cap.
Tamivil 75 mg hard capsules are available in PVC/PVDC/PVC/Aluminium blisters containing 10 capsules, packed in a cardboard box.

Marketing Authorisation Holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500;
e-mail: [email protected]

Manufacturer
Balkanpharma-Razgrad AD
68 “Aprilsko vastanie” Blvd.
7200 Razgrad, Bulgaria

Patient information
For patients who have difficulty swallowing capsules, including young children, an oral liquid formulation may be available.
If the patient requires the medicine in liquid form and this is not commercially available, an oral suspension can be prepared from Tamivil capsules (see Information intended exclusively for healthcare professionals).
A pharmacy-prepared product is preferred.
If a pharmacy-prepared product is also unavailable, a liquid formulation of Tamivil can be prepared at home from the capsules.
The doses are the same for both treatment and prevention of influenza. The difference lies in the frequency of administration.

Preparing liquid Tamivil at home

• If the patient has the appropriate capsules for the required dose (75 mg dose), open the capsule and mix its contents with a teaspoon (or less) of a suitable sweetened food product. This dose is generally suitable for children above 1 year of age. See the first part of the instructions.
• If the patient requires a lower dose, preparing a liquid formulation from Tamivil capsules involves additional steps. These are appropriate for younger children and infants who usually require a Tamivil dose lower than 30 mg. See the second part of the instructions.

Adults, children aged 13 years and older, and children weighing 40 kg or more
To prepare a 75 mg dose, the following are needed:

• One Tamivil 75 mg capsule
• Sharp scissors
• One small bowl
• One teaspoon (spoon with 5 mL capacity)
• Water
• Sweet food to mask the bitter taste of Tamivil powder, e.g., chocolate or cherry syrup, dessert toppings such as caramel or nougat sauce. Alternatively, sugar water can be prepared: mix one teaspoon of water with three quarters (3/4) of a teaspoon of sugar.

Step 1: Check whether the dose is correct
To determine the correct dose, locate the patient's body weight in the left column of the table. Then check the number of capsules required for a single dose in the right column. The amount is the same for both treatment and prevention of influenza.

To prepare a 75 mg dose, only 75 mg capsules should be used. A 75 mg dose must not be prepared using the contents of a 30 mg or 45 mg capsule.

Not intended for children weighing less than 40 kg.
Doses smaller than 75 mg should be prepared for children weighing less than 40 kg.
See below.

Step 2: Empty the entire powder into a bowl
Hold the 75 mg capsule vertically over a bowl and carefully cut off the rounded end with scissors.
Pour the entire powder into the bowl.
Handle the powder with care, as it may be irritating to the skin and eyes.

Step 3: Sweeten the suspension and administer the dose
Add a small amount – no more than one teaspoon – of sweet food to the powder in the bowl.
This helps mask the bitter taste of Tamivil powder.
Mix thoroughly.

Immediately administer the entire contents of the bowl to the patient.
If any residue remains in the bowl, rinse the bowl with a small amount of water and have the patient drink all of it.
Repeat these steps each time the medicine is administered.

Infants under 1 year of age and children weighing less than 40 kg
To prepare a smaller single dose, the following items are required:

• One Tamivil 75 mg capsule
• Sharp scissors
• Two small bowls
• One large oral dosing syringe for measuring water volume – 5 mL or 10 mL syringe
• One small oral dosing syringe with 0.1 mL graduations for administering the dose
• One teaspoon (5 mL capacity)
• Water
• Sweet food to mask the bitter taste of Tamivil, such as chocolate or cherry syrup, dessert toppings like caramel or nougat sauce. Alternatively, prepare a sugar-water solution: mix one teaspoon of water with three quarters (3/4) of a teaspoon of sugar.

Step 1: Empty the entire powder into a bowl
Hold the 75 mg capsule vertically over one bowl and carefully cut off the rounded end with scissors. Handle the powder with care, as it may be irritating to the skin and eyes.
Pour the entire powder into the bowl, regardless of the dose being prepared.
The amount is the same for both treatment and prevention of influenza.

Step 2: Add water to dissolve the medicine

Using the larger syringe,
draw up 12.5 mL of water.
Add the water to the powder in
the bowl.
Mix the contents with a
spoon for about 2
minutes.
Do not be concerned if some of the powder does not dissolve. The undissolved powder is inactive substance.

Step 3: Select the volume appropriate for the child's body weight
Find the child's body weight in the left column of the table. The right column indicates the volume of the liquid mixture to be drawn up.

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

Children aged 1 year or older, weighing less than 40 kg

Step 4: Draw up the liquid mixture
Ensure that the correct volume dispenser is used.
Draw up the appropriate amount of liquid mixture from the first cup.
Do so carefully to avoid introducing air bubbles.
Gently dispense the correct dose into the second cup.

Step 5: Sweeten and administer to the child
Add a small amount – no more than one teaspoon – of sweet food to the second cup. This helps
neutralize the bitter taste of the medicine Tamivil.
Mix the sweet food well with the liquid form of Tamivil.

Immediately administer the entire contents of the second cup (the liquid mixture of Tamivil with the
sweet food) to the child.
If any amount remains in the second cup, rinse the cup with a small amount of water and give it
to the child to drink. For children unable to drink from a cup, use a spoon or a baby feeding bottle
to administer the remaining liquid.
Give the child something to drink.
Discard any unused liquid form remaining in the first cup.
Repeat the above steps each time the medicine is administered.

Information intended exclusively for healthcare professionals

Patients unable to swallow capsules:
Commercially manufactured oseltamivir powder for oral suspension (6 mg/mL)
is the preferred product for children and adolescents, as well as adult patients, who have difficulty
swallowing capsules or when lower doses are required. When oseltamivir powder for oral suspension is not available on the
market, the pharmacist may compound an oral suspension (6 mg/mL) from Tamivil capsules. If pharmacy-compounded suspension is also
unavailable, patients may prepare the suspension at home using Tamivil capsules.
Oral dosing devices (oral syringes) of appropriate volume and graduations should be provided both for administering the pharmacy-prepared suspension and for procedures related to home preparation of the product.
In both cases, dosing devices should ideally be clearly marked with the appropriate volumes. When preparing the suspension at home, separate dosing devices should be used to measure the correct amount of water and to measure the mixture of Tamivil with water. To measure 12.5 mL of water, a 10 mL dosing device should be used.
The appropriate dosing device capacity to be used for measuring the correct volume of Tamivil oral suspension (6 mg/mL) is indicated below.
Infants under 1 year of age (including full-term newborns):

Children aged one year or older weighing less than 40 kg: