Tamivil

Package Leaflet: Information for the User

Tamivil, 75 mg, Tablets

Oseltamivir

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

• 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 experience any side effects, including any not listed in this leaflet, 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 is used in adults, adolescents, and children over 6 years of age and weighing over 40 kg for the treatment of influenza.

It can be used when flu symptoms appear and when it is known that the influenza virus is circulating in the environment.

• Tamivil may also be prescribed for adults, adolescents, and children over 6 years of age and weighing over 40 kg to prevent influenza. Each case is considered individually - for example, if the patient has been in contact with someone with influenza.
• Tamivil may be prescribed for adults, adolescents, and children over 6 years of age and weighing over 40 kg as preventive treatmentin exceptional circumstances, such as during a global influenza epidemic (pandemic), when the seasonal influenza vaccine does not provide sufficient protection.

Tamivil contains 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 alleviate symptoms or prevent them from occurring in case of influenza virus infection.
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 pain, and extreme fatigue. Such symptoms can also be caused by other infections. Actual influenza infection only occurs during annual outbreaks of the disease ( epidemics), when the influenza virus spreads in the local environment. Outside of epidemic periods, flu-like symptoms are usually the result of other diseases.

2. Important information before taking Tamivil

When not to take Tamivil:

• if you are allergic( hypersensitive) to oseltamivir or any of the other ingredients of Tamivil listed in section 6. In such a case, contact your doctor. Do not take Tamivil.

Warnings and precautions

Before taking Tamivil, tell your doctor who prescribed the medicine:

• if you are allergic to other medicines
• if you have kidney disease. If so, a dose change may be necessary.
• if you have severe diseasesthat may require immediate hospital treatment
• if your immune systemis not working properly
• if you have chronic heart diseaseor respiratory disease.

While taking Tamivil, 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 is not an influenza vaccine

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

Other medicines and Tamivil

Tell your doctor or pharmacist about all medicines you are taking or have recently taken. This includes medicines obtained 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, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant, so that your doctor can decide if Tamivil is suitable for you.
The effect of Tamivil on breastfed infants is not known. Tell your doctor if you are breastfeeding, so that your doctor can decide if Tamivil is suitable for you.

Driving and using machines

Tamivil does not affect the ability to drive or use machines.

3. How to take Tamivil

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Tamivil should be taken as soon as possible, preferably within the first two days of the onset of influenza symptoms.

Recommended dosage

For the treatment of influenza, take two doses a day, usually one in the morning and one in the evening. It is important to complete the entire 5-day treatment cycle, even if your condition improves quickly.
For the prevention of influenza or after contact with an infected person, take one dose a day for 10 days, preferably in the morning during breakfast.
In special situations, such as the spread of influenza or if you have a weakened immune system, treatment may last up to 6 weeks or 12 weeks.

Adults, adolescents, and children over 6 years of age

Method of administration

Swallow the tablets with water. Do not divide or crush the tablets.
Tamivil can be taken with or without food. Taking the medicine with food reduces the risk of nausea or vomiting.

Taking a higher dose of Tamivil than recommended

Stop taking Tamivil and contact your doctor or pharmacist immediately.
In most cases of overdose, no side effects have been reported. If they were reported, they were similar to side effects that occur after taking the recommended doses, as described in section 4.
Overdose has been reported more frequently in children than in adults and adolescents. Be cautious when giving Tamivil tablets to children.

Missing a dose of Tamivil

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

Stopping Tamivil treatment

There are no side effects if Tamivil treatment is stopped, but if you stop taking Tamivil earlier than your doctor recommended, influenza 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 following side effects may also be the flu itself.
The following serious side effects have been reported rarely after oseltamivir was approved:

• anaphylactic and pseudo-anaphylactic 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 severe swelling of the skin, mainly in the area of 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) side effects of oseltamivir are: nausea, vomiting, stomach pain, stomach upset, headache, and pain. These symptoms usually occur only after the first dose of the medicine and usually disappear during continued use of the medicine. The frequency of these side effects decreases if the medicine is taken with food.

Rare but serious side effects: seek medical help immediately

( may occur in 1 in 1000 people)
During the use of oseltamivir, rare cases of:

• seizures and hallucinations, including changes in consciousness
• confusion, abnormal behavior
• delusions, hallucinations, agitation, restlessness, nightmares

These events, which often 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 patients with influenza who did not take oseltamivir.

• Patient, especially children and adolescents, should be closely monitored 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 from 13 years and older

Very common side effects

(may occur in more than 1 in 10 people)

• Headache
• Nausea.

Common side effects

(may occur in 1 in 10 people)

• Bronchitis
• Herpes virus
• Cough
• Dizziness
• Fever
• Pain
• Limb pain
• Rhinorrhea
• Sleep disorders
• Sore throat
• Stomach pain
• Fatigue
• Feeling of fullness in the upper abdomen
• Upper respiratory tract infections (rhinitis, pharyngitis, and sinusitis)
• Stomach upset
• Vomiting.

Uncommon side effects

(may occur in 1 in 100 people)

• Allergic reactions
• Altered level of consciousness
• Seizures
• Arrhythmias
• Mild to severe liver function disorders
• Skin reactions (dermatitis, red and itchy rash, skin peeling).

Rare side effects

(may occur in 1 in 1000 people)

• Thrombocytopenia (low platelet count)
• Visual disturbances.

Children from 6 to 12 years of age

Very common side effects

(may occur in more than 1 in 10 people)

• Cough
• Nasal congestion
• Vomiting.

Common side effects

(may occur in 1 in 10 people)

• Conjunctivitis (red eyes and discharge or pain in the eye)
• Otitis and other ear diseases
• Headache
• Nausea
• Rhinorrhea
• Stomach pain
• Feeling of fullness in the upper abdomen
• Stomach upset.

Uncommon side effects

(may occur in 1 in 100 people)

• Dermatitis
• Tympanic membrane disorders.

If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

• if you or your child vomits repeatedlyor
• if influenza 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, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Tamivil

Keep this medicine out of the sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of that month.
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

• The active substance is oseltamivir.

One tablet contains 75 mg of oseltamivir (as oseltamivir phosphate).

• The other ingredients are: microcrystalline cellulose, anhydrous colloidal silica, povidone K30, crospovidone type A, magnesium stearate.

What Tamivil looks like and contents of the pack

Tamivil tablets are packaged in OPA/Aluminum/PVC/Aluminum blisters, placed in a cardboard box.
Available packs: 10, 20, and 30 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Phone: + 48 61 66 51 500
biofarm@biofarm.pl
Date of last revision of the leaflet:15.03.2021