Tamivil

Package Leaflet: Information for the User

Tamivil, 30 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What is Tamivil and what is it used for
• 2. Before you take 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, 30 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 relieve the symptoms of flu or prevent the symptoms from developing. Flu is an infectious disease caused by the flu virus. Flu symptoms often include sudden onset of high fever (above 37.8°C), cough, runny or stuffy nose, headache, muscle and joint pain, and extreme tiredness. Such symptoms can also be caused by other infections. True flu infection only occurs during annual outbreaks of the disease (epidemics), when flu viruses are circulating in the local community. Outside of epidemic periods, flu-like symptoms are usually caused by other illnesses.

• Tamivil, 30 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 have appeared and when it is known that the flu virus is circulating in the community.
• Tamivil, 30 mg, hard capsules can 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 had contact with someone with flu.
• Tamivil, 30 mg, hard capsules can be prescribed to adults, adolescents, children, and infants (including full-term newborns) as preventive treatmentin exceptional circumstances, such as during a global flu epidemic (flu pandemic), when the seasonal flu vaccine does not provide sufficient protection.

2. Before you take Tamivil

When not to take Tamivil, 30 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, 30 mg, hard capsules.

Warnings and precautions

Before taking Tamivil, 30 mg, hard capsules, tell your doctor if:

• you are allergic to other medicines
• you have kidney disease. Your dose may need to be changed.
• you have a severe medical conditionthat may require immediate hospital treatment
• your immune system is not working properly
• you have chronic heart or respiratory disease.

While taking Tamivil, 30 mg, hard capsules, tell your doctor immediatelyif:

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

Tamivil, 30 mg, hard capsules is not a flu vaccine

Tamivil is not a vaccine: it is used to treat 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, 30 mg, hard capsules and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, including those obtained without a prescription. This includes:

• 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, ask your doctor if Tamivil, 30 mg, hard capsules is suitable for you. The effect of oseltamivir on breastfed infants is not known. If you are breastfeeding, ask your doctor if Tamivil, 30 mg, hard capsules is suitable for you. Before taking this medicine, consult your doctor or pharmacist.

Driving and using machines

Tamivil, 30 mg, hard capsules does not affect the ability to drive or use machines.

Tamivil, 30 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, 30 mg, hard capsules should be taken as soon as possible, preferably within the first two days of flu symptoms appearing.

Recommended doses

To treat flu, take two doses a day. It is usually best to take one dose in the morning and one dose in the evening. It is important to complete the full 5-day treatment course, even if your symptoms improve quickly. For patients with weakened immune systems, treatment will be continued for 10 days. To prevent flu or after contact with someone with flu, take one dose a day for 10 days. It is best to take the medicine in the morning with breakfast. In special situations, such as during a flu outbreak or if the patient has a weakened immune system, treatment may last for 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

*For patients with weakened immune systems, treatment lasts for 10 days
**The 75 mg dose can consist of a 30 mg capsule and a 45 mg capsule

Children 1 to 12 years old

*For children with weakened immune systems, treatment lasts for 10 days
**The 75 mg dose can consist of a 30 mg capsule and a 45 mg capsule

Infants under 1 year old (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 evaluating the potential benefits and risks to the infant.

*For infants with weakened immune systems, treatment lasts for 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, 30 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 old

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

Taking more than the recommended dose of Tamivil, 30 mg, hard capsules

Stop taking Tamivil, 30 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, 30 mg, hard capsules

Do not take a double dose to make up for a missed capsule.

Stopping treatment with Tamivil, 30 mg, hard capsules

There are no adverse reactions if treatment with Tamivil, 30 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 on the use of this product, 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 marketing of oseltamivir:

• Anaphylactic and anaphylactoid reactions: severe allergic reactions with swelling of the face and skin, itching rash, 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 onset of significant skin swelling, mainly in the head and neck area, 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 skin layers, 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: feeling sick (nausea, vomiting), stomach pain, indigestion, headache, and pain. These symptoms usually occur only after the first dose of the medicine and usually disappear during continued treatment. The frequency of these adverse reactions decreases if the medicine is taken with food.

Rare but serious side effects: contact your doctorimmediately (may affect up to 1 in 1,000 people)

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-injury, 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 detect changes in behavior as described above. If any of these symptoms are noticed, especially in young people, seek medical help immediately.

Adults and adolescents 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;
• cough;
• dizziness;
• fever;
• pain;
• limb pain;
• runny nose;
• sleeping problems;
• sore throat;
• stomach pain;
• fatigue;
• feeling of fullness in the upper abdomen;
• upper respiratory tract infections (nasal, throat, and sinus infections);
• indigestion;
• vomiting.

Uncommon side effects

(may affect up to 1 in 100 people)

• allergic reactions;
• altered level of consciousness;
• seizures;
• heart rhythm disorders;
• 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);
• vision disorders.

Children 1 to 12 years old

Very common side effects

(may affect more than 1 in 10 people)

• cough;
• runny nose;
• vomiting.

Common side effects

(may affect up to 1 in 10 people)

• conjunctivitis (red eyes and discharge or pain in the eye)
• otitis media and other ear diseases;
• headache;
• nausea;
• runny nose;
• 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 old

Adverse reactions reported in infants under 1 year of age (0 to 12 months) are mostly similar to adverse reactions reported in older children (1 year and 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, tell your doctor or pharmacist. However,

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

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Drug Monitoring, 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. 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Tamivil contains

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

What Tamivil, 30 mg, hard capsules look like and contents of the pack

White, granular or slightly coarse powder in a hard capsule, size 4. The capsule consists of a dark yellow body and dark yellow cap. Tamivil, 30 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: [email protected]

Manufacturer

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

Date of last revision of the leaflet: