Tamivil

Package leaflet: Information for the user

Tamivil, 45 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 a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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 45 mg hard capsules are 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 45 mg hard capsules may also be prescribed to 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 influenza.
• Tamivil 45 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 seasonal influenza vaccine does not provide adequate protection.

Tamivil 45 mg hard capsules contain oseltamivir, which belongs to a group of medicines called neuraminidase inhibitors. These medicines prevent the spread of the influenza virus in the body. They help to reduce symptoms or prevent their occurrence in case of infection with the influenza virus.
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 blocked 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 spreading in the local community. Outside epidemic periods, flu-like symptoms are usually due to other illnesses.

2. Important information before taking Tamivil

When not to take Tamivil 45 mg hard capsules

• if the patient is allergic ( hypersensitive ) to oseltamivir or any of the other
  components of this medicine listed in section 6.
  If this applies to the patient, please contact a doctor. Do not take Tamivil 45 mg
  hard capsules.
  Warnings and precautions
  Before taking Tamivil 45 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 45 mg hard capsules, the doctor should be informed 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 45 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. A vaccine provides antibodies against the virus. Tamivil does not affect
the effectiveness of influenza vaccination, and the doctor may prescribe both products.
Tamivil 45 mg hard capsules and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This also includes 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 he or she can decide whether Tamivil 45 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 he or she can decide whether Tamivil 45 mg hard capsules is
appropriate.
Before taking this medicine, consult a doctor or pharmacist.
Driving and operating machinery
Tamivil 45 mg hard capsules do not affect the ability to drive or operate machinery.
Tamivil 45 mg hard capsules contain sodium
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Tamivil

This medicine should always be taken according to the doctor's instructions. If in doubt, consult a
doctor or pharmacist.
Tamivil 45 mg hard capsules should be taken as soon as possible, preferably within the first two
days after flu symptoms appear.
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 quickly.
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 75 mg dose 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
The capsules should be swallowed whole with water. Capsules must not be broken or chewed.
Tamivil 45 mg hard capsules may be taken with food or independently of meals; however,
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 a liquid formulation of Tamivil 45 mg from the available capsules. See
instructions for Preparation of Tamivil 45 mg liquid at home.
Taking more than the recommended dose of Tamivil 45 mg hard capsules
Stop taking Tamivil 45 mg hard capsules immediately and contact your doctor or pharmacist without delay.
In most cases, no adverse effects were reported following overdose. When adverse effects occurred,
they were similar to those observed after recommended doses, as described in section 4.
Overdose has been reported more frequently after oseltamivir administration in children than in adults and adolescents.
Caution should be exercised when preparing the liquid formulation of Tamivil 45 mg for children and when administering Tamivil 45 mg in capsule or liquid form to children.
Missing a dose of Tamivil 45 mg hard capsules
Do not take a double dose to make up for a missed capsule.
Stopping treatment with Tamivil 45 mg hard capsules
There are no adverse effects associated with stopping treatment with Tamivil 45 mg hard capsules. However, if treatment is stopped earlier than recommended by the doctor, flu symptoms may return. Treatment should always be completed according to the doctor's instructions.
If you have any further 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 everyone will experience them.
Many of the side effects listed below may also be caused by influenza itself.
The following serious side effects have been reported rarely after oseltamivir was introduced into clinical use:

• 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 colour, changes in behaviour;

• Angioedema: sudden, 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 skin layers, beginning with fever, sore throat, and fatigue, progressing to skin rashes, blistering, peeling, and shedding of large areas of skin, which may be accompanied by
  breathing difficulties and low blood pressure;

• Gastrointestinal bleeding: prolonged bleeding from the large intestine or haemoptysis;

• Neuropsychiatric disorders, as described below.

If any of these symptoms occur, seek immediate medical help.
The most frequently (very common and common) reported side effects of oseltamivir are: nausea, vomiting, stomach pain, indigestion, headache, and pain. These symptoms usually occur only after the first dose and typically resolve during continued treatment.
The frequency of these side effects decreases if the medicine is taken with food.
Rare but serious side effects: consult a doctor immediately
(may occur in up to 1 in 1,000 patients)
Rare cases have been reported during oseltamivir treatment, including:

• seizures and delirium, including cases of altered consciousness;
• confusion, unusual behaviour;
• hallucinations, illusions, agitation, anxiety, nightmares. The above 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 receive oseltamivir.
• Patients, especially children and adolescents, should be closely monitored for the behavioural 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 side effects
(may affect more than 1 in 10 patients)

• headache;
• nausea.

Common side effects
(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 (rhinitis, pharyngitis, sinusitis);
• indigestion;
• vomiting.

Uncommon side effects
(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 (dermatitis, red and itchy rash, skin peeling).

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

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

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

• cough;
• rhinitis;
• vomiting.

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

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

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

• dermatitis;
• disorders of the tympanic membrane.

Infants under 1 year of age
Adverse reactions reported in infants aged 0 to 12 months are most commonly similar to those reported in older children (aged 1 year or more). Additionally, diarrhoea and diaper rash have been reported.
If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist. However,

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

Reporting of adverse reactions
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301,
fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Tamivil

Keep this medicine out of 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 instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Tamivil contains

• Each hard capsule contains oseltamivir phosphate, equivalent to 45 mg of oseltamivir.
• Other ingredients: Contents of the capsule: pregelatinized starch (corn), povidone (K-29/32), sodium croscarmellose, talc, sodium stearyl fumarate.
  Capsule shell: titanium dioxide (E 171), gelatin.

What Tamivil looks like and contents of the pack
White, granular or slightly coarse powder in a size 4 hard capsule. The capsule consists of an opaque white body and an opaque white cap.
Tamivil 45 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

Information for users
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 solely 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 (45 mg dose), open the capsule and mix its contents with a teaspoon (or less) of a suitable sweetened food product. This dose is generally appropriate 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 suitable for younger, lighter children and infants who usually require a Tamivil dose lower than 45 mg. See the second part of the instructions.

Children aged 1 to 12 years
To prepare a 45 mg dose, the following are needed:

• One Tamivil 45 mg capsule
• Sharp scissors
• One small bowl
• 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 if the dose is correct
To determine the correct dose, find 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 45 mg dose, only 45 mg capsules should be used. A dose of 30 mg, 60 mg, or 75 mg should not be prepared using the contents of 45 mg capsules. In such cases, a capsule of the appropriate strength should be used.

Step 2: Empty the entire powder into a bowl
Hold the 45 mg capsule vertically over a bowl and carefully cut off the rounded end with scissors.
Empty the entire powder into the bowl.
Handle the powder carefully, 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 is to neutralize the bitter taste of Tamivil powder.
Mix well.

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

Infants under 1 year of age
To prepare a smaller single dose, the following will be needed:

• One 45 mg Tamivil capsule
• Sharp scissors
• Two small bowls (use a separate pair of bowls for each child)
• One large oral dosing syringe to measure water volume – either a 5 mL or 10 mL syringe
• One small oral dosing syringe marked in 0.1 mL increments for administering the dose
• One teaspoon (a 5 mL spoon)
• Water
• Sweet food to neutralize the bitter taste of Tamivil, such as chocolate or cherry syrup, or dessert toppings like caramel or nougat sauce. Alternatively, prepare sugar water: 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 45 mg capsule vertically over one of the bowls and carefully cut off the rounded end with scissors. Handle the powder carefully, as it may be irritating to the skin and eyes.
Empty 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 7.5 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 age and 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)

Step 4: Draw up the liquid mixture
Ensure that a dosing syringe of the correct volume is used.
Draw up the correct amount of liquid mixture from the first container.
Do this carefully to avoid introducing air bubbles.
Gently expel the correct dose into the second container.

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

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

Information intended exclusively for healthcare professionals

Patients unable to swallow capsules:
Patients unable to swallow capsules:
Manufactured oseltamivir in the form of a 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, a pharmacist may prepare an oral suspension (6 mg/mL) from Tamivil capsules. If pharmacy-prepared suspension is also unavailable, patients may prepare the suspension at home using the capsules.

Oral dosing devices (oral syringes) with appropriate volume and graduations must be provided both for administering the pharmacy-prepared suspension and for procedures related to home preparation of the product. In both cases, it is best if the dosing devices are 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 Tamivil mixture with water. To measure 5 mL of water, dosing devices with a capacity of 5 mL or 10 mL should be used.

The appropriate dosing device capacity to be used for measuring the correct amount of Tamivil suspension (6 mg/mL) is shown below.

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