Tamivil

Package Leaflet: Information for the User

Tamivil, 75 mg, Hard Capsules

Oseltamivir

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

• 1. What is Tamivil and what is it 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 is Tamivil and what is it used for

Tamivil, 75 mg, hard capsules contain oseltamivir, which belongs to a group of medicines called neuraminidase inhibitors. These medicines prevent the spread of the flu virus in the body. They help to alleviate the symptoms or prevent them from occurring in case of flu virus infection. The 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 and extreme fatigue. Such symptoms can also be caused by other infections. True flu infection occurs only during annual outbreaks of the disease ( epidemic), when flu viruses spread in the local environment. Outside of epidemic periods, flu-like symptoms are usually the result of another disease.

• Tamivil, 75 mg, hard capsules are used in adults, adolescents, children, and infants (including full-term newborns) to treat flu. It can be used when flu symptoms appear and when it is known that the flu virus is circulating in the environment.
• Tamivil, 75 mg, hard capsules may also be prescribed to adults, adolescents, children, and infants over 1 year of age to prevent flu. Each case is considered individually, for example, if the patient has been in contact with a person with flu.
• Tamivil, 75 mg, hard capsules may be prescribed to adults, adolescents, children, and infants (including full-term newborns) as prophylactic treatmentin exceptional circumstances, such as during a global flu epidemic ( flu pandemic), when the seasonal flu vaccine does not provide sufficient protection.

2. Important information before taking Tamivil

When not to take Tamivil, 75 mg, hard capsules

• if you are allergic( hypersensitive) to oseltamivir or any of the other ingredients of this medicine listed in section 6.

If this applies to you, contact your doctor. Do not take Tamivil, 75 mg, hard capsules.

Warnings and precautions

Before taking Tamivil, 75 mg, hard capsules, tell your doctor

• if you are allergic to other medicines
• if you have kidney disease. If so, a dose change may be needed
• if you have a severe illnessthat may require immediate hospital treatment
• if your immune system is not working properly
• if you have chronic heart disease or respiratory disease.

While taking Tamivil, 75 mg, hard capsules, immediately tell your doctor

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

Tamivil, 75 mg, hard capsules is not a flu vaccine

Tamivil is not a vaccine: it is used to treat an infection or prevent the spread of the flu virus. The vaccine provides antibodies against the virus. Tamivil does not affect the effectiveness of the flu vaccine, and your doctor may prescribe both products to you.

Tamivil, 75 mg, hard capsules and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take. This includes medicines available 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

If you are pregnant, think you may be pregnant, or plan to have a baby, tell your doctor, so they can decide if Tamivil, 75 mg, hard capsules is suitable for you. The effect of oseltamivir on breastfed infants is not known. If you are breastfeeding, tell your doctor, so they can decide if Tamivil, 75 mg, hard capsules is suitable for you. Before taking this medicine, consult your doctor or pharmacist.

Driving and using machines

Tamivil, 75 mg, hard capsules does not affect the ability to drive and use machines.

Tamivil, 75 mg, hard capsules contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially 'sodium-free'.

3. How to take Tamivil

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Tamivil, 75 mg, hard capsules should be taken as soon as possible, preferably within the first two days of flu symptoms appearing.

Recommended doses

For the treatment of flu, take two doses a day. It is usually best to take one dose in the morning and one in the evening. It is essential to complete the entire 5-day treatment cycle, even if your condition improves quickly. In patients with weakened immune systems, treatment will be continued for 10 days. For the prevention of flu or after contact with an infected person, take one dose a day for 10 days. It is best to take the medicine in the morning during breakfast. In special situations, such as the spread of flu 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 oral suspension prescribed by your doctor.

Adults and adolescents 13 years and older

*In patients with weakened immunity, treatment lasts 10 days. **The 75 mg dose may consist of a 30 mg capsule and a 45 mg capsule.

Children 1 to 12 years of age

*In children with weakened immunity, treatment lasts 10 days. **The 75 mg dose 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 oseltamivir to infants under 1 year of age for prophylaxis during a flu pandemic should be made after assessing the potential benefits and risks to the infant.

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

Method of administration

Swallow the capsules whole with water. Do not break or chew the capsules. Tamivil, 75 mg, hard capsules can be taken with or without food, although taking the medicine with food reduces the risk of nausea or vomiting.

Patients who have difficulty swallowing capsules, as well as infants and children over 1 year of age

may use oseltamivir in the form of a powder for oral suspension, which may be available under a different trade name.

Taking a higher dose of Tamivil, 75 mg, hard capsules than recommended

Stop taking Tamivil, 75 mg, hard capsules and contact your doctor or pharmacist immediately. In most cases of overdose, no adverse reactions were reported. If they were reported, they were similar to adverse reactions after taking the recommended doses, as described in section 4. Overdose has been reported more frequently after administration of oseltamivir to children than to adults and adolescents.

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 reactions if treatment with Tamivil, 75 mg, hard capsules is stopped. However, if treatment is stopped earlier than recommended by your doctor, flu symptoms may return. Always complete the treatment as recommended by your doctor. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The cause of many of the side effects listed below may also be the flu itself. The following serious side effects have been reported rarely after the introduction of oseltamivir to the market:

• Anaphylactic and pseudoanaphylactic reactions: severe allergic reactions with facial and skin edema, pruritus, low blood pressure, and difficulty breathing.
• Liver disorders (fulminant hepatitis, liver function disorders, and jaundice): yellowing of the skin and whites of the eyes, change in stool color, changes in behavior.
• Angioedema: sudden, significant skin edema, mainly localized to the head and neck, including the eyes and tongue, with difficulty breathing.
• Stevens-Johnson syndrome and toxic epidermal necrolysis: a complex, potentially life-threatening allergic reaction, severe inflammation of the outer and sometimes inner layers of the skin, starting with fever, sore throat, and fatigue, skin rash, progressing to blisters, peeling, and shedding of large areas of skin, which may be accompanied by difficulty breathing and low blood pressure.
• Gastrointestinal bleeding: prolonged bleeding from the colon or hematemesis.
• Neuropsychiatric disorders, as described below.

If you notice any of these symptoms, seek medical help immediately.

The most common (very common and common) adverse reactions of oseltamivir are: nausea (nausea, vomiting), stomach pain, indigestion, headache, and pain. Such symptoms usually occur only after the first dose of the medicine and usually disappear during further use of the medicine. The frequency of these adverse reactions decreases if the medicine is taken with food.

Rare but serious side effects: seek medical help immediately

(may occur in up to 1 in 1000 patients)
During treatment with oseltamivir, rare cases have been reported, including:

• seizures and hallucinations, including changes in consciousness;
• confusion, unusual behavior;
• delusions, hallucinations, agitation, anxiety, nightmares. These events, which had a sudden onset and resolution, were observed mainly in children and adolescents. In rare cases, they were the cause of self-harm, sometimes resulting in death. Similar neuropsychiatric events have also been observed in people with flu who did not take oseltamivir.
• Patient monitoring, especially children and adolescents, is necessary to check for changes in behavior as described above.

If you notice any of these symptoms, especially in young people, seek medical help immediately.

Adults and adolescents 13 years and older

Very common side effects

(may occur in more than 1 in 10 patients)

• headache;
• nausea.

Common side effects

(may occur in up to 1 in 10 patients)

• bronchitis;
• herpes virus;
• cough;
• dizziness;
• fever;
• pain;
• limb pain;
• runny nose;
• sleep disorders;
• sore throat;
• stomach pain;
• fatigue;
• feeling of fullness in the upper abdomen;
• upper respiratory tract infections (rhinitis, pharyngitis, and sinusitis);
• indigestion;
• vomiting.

Uncommon side effects

(may occur in up to 1 in 100 patients)

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

Rare side effects

(may occur in up to 1 in 1000 patients)

• thrombocytopenia (low platelet count);
• vision disorders.

Children 1 to 12 years of age

Very common side effects

(may occur in more than 1 in 10 patients)

• cough;
• runny nose;
• vomiting.

Common side effects

(may occur in up to 1 in 10 patients)

• conjunctivitis (red eyes and discharge or pain in the eye);
• otitis and other ear diseases;
• headache;
• nausea;
• runny nose;
• stomach pain;
• feeling of fullness in the upper abdomen;
• indigestion.

Uncommon side effects

(may occur in up to 1 in 100 patients)

• dermatitis;
• tympanic membrane disorders.

Infants under 1 year of age

The adverse reactions reported in infants from 0 to 12 months of age are mostly similar to the adverse reactions reported in older children (1 year of age or older). Additionally, diarrhea and diaper rash have been reported. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. However,

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this 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 which is stated on the carton and blister after 'EXP'. The expiry date refers to the last day of that month. There are no special storage instructions 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. 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 75 mg of oseltamivir.
• The other ingredients are: Capsule content: corn starch, maize starch, povidone, croscarmellose sodium, 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 hard capsule size 2. The capsule consists of an opaque white body and a dark yellow cap. Tamivil, 75 mg, hard capsules are available in a PVC/PVDC/PVC/Aluminum blister pack containing 10 capsules, in a cardboard box.

Marketing authorization holder

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500;
e-mail: biofarm@biofarm.pl

Manufacturer

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

Date of last revision of the leaflet: