Tamivil

Package leaflet: Information for the user

Tamivil, 30 mg, hard capsules
Oseltamivirum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Tamivil is and what it is used for
2. Important information 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 30 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 the influenza virus is circulating in the community.
• Tamivil 30 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 contact with someone suffering from influenza.
• Tamivil 30 mg hard capsules may be prescribed to adults, adolescents, children, and infants (including full-term newborns) as prophylactic treatment in exceptional circumstances, such as during a global influenza epidemic (pandemic), when the seasonal influenza vaccine does not provide sufficient protection.

Tamivil 30 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 relieve symptoms or prevent their occurrence in case of infection with the influenza virus.
Influenza is an infectious disease caused by a virus. Influenza symptoms often include sudden onset of
fever (above 37.8°C), cough, runny or stuffy nose, headache, muscle aches, and extreme fatigue.
Such 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 taking Tamivil

When not to take Tamivil 30 mg hard capsules

• if the patient is allergic ( hypersensitive ) to oseltamivir or to any of the other ingredients of this medicine listed in section 6. If this applies to the patient, consult a doctor. Do not take Tamivil 30 mg hard capsules.

Warnings and precautions
Before taking Tamivil 30 mg hard capsules, inform the doctor who prescribed the medicine

• if the patient has an allergy to other medicines
• if the patient has kidney disease. If so, a dose adjustment may be necessary.
• 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 30 mg hard capsules, the patient should immediately inform the doctor:

• if behavioral or mood changes ( neuropsychiatric events ) occur, especially in children and adolescents. These symptoms may be rare but serious adverse reactions.

Tamivil 30 mg hard capsules is not an influenza vaccine
Tamivil is not a vaccine: it is used to treat infection or prevent the spread of influenza virus. Vaccines provide antibodies against the virus. Tamivil does not alter the effectiveness of influenza vaccination, and the doctor may prescribe both products.

Tamivil 30 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 available 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 the doctor can decide whether Tamivil 30 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 the doctor can decide whether Tamivil 30 mg hard capsules is appropriate.
Consult a doctor or pharmacist before taking this medicine.

Driving and operating machinery
Tamivil 30 mg hard capsules has no influence on the ability to drive or operate machinery.

Tamivil 30 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 use Tamivil

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist.
Tamivil 30 mg hard capsules should be taken as soon as possible, preferably within the first two days of the onset of flu symptoms.
Recommended doses
For the 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 the 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 during an influenza outbreak or if the patient has a weakened immune system, 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 the amount of 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 a 30 mg capsule and a 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 assessing the potential benefits against the potential risks to 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 must be swallowed whole with water. Capsules must not be broken or chewed.
Tamivil 30 mg hard capsules may 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 the patient requires oral suspension and it is not available at the pharmacy, the patient may prepare a liquid formulation of Tamivil medicine from available capsules. See instructions on
Preparation of Tamivil 30 mg liquid at home.

Taking more Tamivil 30 mg hard capsules than recommended
Stop taking Tamivil 30 mg hard capsules and contact your doctor or pharmacist immediately.
In most cases, no adverse effects have been reported following overdose. When adverse effects have occurred, they were similar to those observed after recommended doses, as described in section 4.
Overdose has been reported more frequently in children than in adults and adolescents following oseltamivir administration.
Caution should be exercised when preparing the liquid formulation of Tamivil 30 mg for children and when administering Tamivil 30 mg in capsule or liquid form to children.

Missed dose of Tamivil 30 mg hard capsules
Do not take a double dose to make up for a missed capsule.

Stopping Tamivil 30 mg hard capsules
There are no adverse effects associated with stopping Tamivil 30 mg hard capsules. However, if treatment is stopped earlier than recommended by the doctor, influenza symptoms may return. Treatment should always be completed according to the doctor's instructions.

If you have any further questions concerning 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 adverse effects listed below may also be caused by influenza itself.
The following serious side effects have been reported rarely after 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 colour, changes in behaviour;
• Angioedema: sudden, significant swelling of the skin, mainly in 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, starting with fever, sore throat, and fatigue, progressing to skin rash, 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
(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 behaviour;
• 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 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 people)

• headache;
• nausea.

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

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

• 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 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;
• rhinitis;
• vomiting.

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

• conjunctivitis (red eyes with discharge or eye pain);
• otitis media 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 people)

• dermatitis;
• tympanic membrane disorders.

Infants under 1 year of age
Adverse effects observed in infants aged 0 to 12 months are usually similar to those reported in older children (aged 1 year or more). In addition, 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 influenza symptoms worsen or fever persists,
  contact a doctor immediately.

Reporting of side effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this 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 after "EXP".
The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines should 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 package and other information

What Tamivil contains

• Each hard capsule contains oseltamivir phosphate, equivalent to 30 mg of oseltamivir.
• Other ingredients: Capsule contents: pregelatinized starch (corn), povidone (K-29/32), sodium croscarmellose, talc, sodium stearyl fumarate. Capsule shell: titanium dioxide (E 171), yellow iron oxide (E 172), gelatin.

What Tamivil looks like and contents of the pack
Tamivil 30 mg hard capsules contain white, granular or slightly coarse powder in a size 4 hard capsule. The capsule consists of a dark yellow body and a dark yellow cap.
Tamivil 30 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 Poznan
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, the liquid formulation of Tamivil can be prepared at home from capsules.
The doses are the same for both treatment and prevention of influenza. The difference lies in the frequency of administration.

Preparation of liquid formulation of Tamivil at home

• If the patient has appropriate capsules for the required dose (30 mg or 60 mg), 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 over 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 dose of Tamivil less than 30 mg. See the second part of the instructions.

Children aged 1 to 12 years
To prepare a 30 mg or 60 mg dose, the following will be needed:

• One or two Tamivil 30 mg capsules
• Sharp scissors
• One small bowl
• A teaspoon (5 mL spoon)
• Water
• A sweet food to mask the bitter taste of Tamivil powder, e.g., chocolate or cherry syrup, or 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 30 mg or 60 mg dose, only 30 mg capsules should be used. A 45 mg or 75 mg dose should not be prepared using the contents of a 30 mg capsule. In such cases, a capsule of the appropriate strength should be used.

Step 2: Empty the entire powder into a bowl
Hold the 30 mg capsule vertically over a bowl and carefully cut off the rounded end with scissors.
Pour the entire powder into the bowl.
Open a second capsule if a 60 mg dose is required.
Pour 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 helps neutralize 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 give the patient all of the rinse liquid to drink.
Repeat these steps each time the medicine is administered.

Infants under 1 year of age
To prepare a smaller dose, the following are required:

• One 30 mg Tamivil capsule
• Sharp scissors
• Two small bowls (use a separate pair of bowls for each child)
• One large oral syringe for measuring water – a 5 mL or 10 mL syringe
• One small oral syringe marked in 0.1 mL increments, for dosing
• One teaspoon (5 mL spoon)
• Water
• Sweet food to mask the bitter taste of Tamivil suspension, such as chocolate or cherry syrup, 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 30 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 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 particles are inactive ingredients.

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)

Step 4: Draw up the liquid mixture
Make sure to use the oral syringe of the correct volume.
Draw up the correct amount of liquid mixture from the first container.
Do this carefully to avoid 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 sweet food to the second container.
This helps neutralize the bitter taste of Tamivil medicine.
Mix the sweet food well with the liquid form of Tamivil medicine.

Immediately administer the entire contents of the second container (the liquid mixture of Tamivil medicine mixed with sweet food) to the child.
If any amount remains in the second container, rinse the container with a small amount of water and give the child all of it to drink. In 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 afterwards.
Discard any unused liquid Tamivil remaining in the first container.
Repeat these steps each time the medicine is administered.

Information intended exclusively for healthcare professionals

Patients who are unable to swallow capsules:
Manufactured oseltamivir oral suspension powder (6 mg/mL)
is the preferred product for children, adolescents, and adult patients who have difficulty
swallowing capsules or when lower doses are required. If oseltamivir oral suspension powder 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 capsules.
Oral dosing devices (oral syringes) with appropriate volume and graduations must be provided
for administering both pharmacy-prepared suspensions and for use in home preparation procedures.
In both cases, it is best if the dosing devices are clearly marked with the correct 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 5.0 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 indicated below.
Infants under 1 year of age (including full-term newborns):