Tamivil

Package leaflet: Information for the user

Tamivil, 75 mg, tablets
Oseltamivir
Please read this leaflet carefully before using 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 consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any 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 is used in adults, adolescents, and children over 6 years of age weighing more than 40 kg 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 may also be prescribed to adults, adolescents, and children over 6 years of age weighing more than 40 kg for prevention of influenza (flu). Each case is considered individually—for example, if the patient has been in close contact with someone diagnosed with influenza.
• Tamivil may be prescribed to adults, adolescents, and children over 6 years of age weighing more than 40 kg as prophylactic treatment in exceptional circumstances, such as during a global influenza outbreak (influenza pandemic), when seasonal influenza vaccine does not provide adequate 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 reduce the severity of symptoms or prevent their occurrence if infection with the influenza virus occurs.
Influenza is an infectious disease caused by a virus. Symptoms of influenza often include sudden onset of fever (above 37.8°C), cough, runny or stuffy 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 the influenza virus is circulating in the local community. Outside epidemic periods, flu-like symptoms are usually due to other illnesses.

2. Important information before using Tamivil

When not to use Tamivil:

• if the patient is allergic ( hypersensitive ) to oseltamivir or to any of the other ingredients of Tamivil listed in section 6. In such a case, consult a doctor. Do not use Tamivil.

Warnings and precautions
Before taking Tamivil, inform the doctor who prescribed the medicine:

• if the patient is allergic to other medicines
• if the patient has kidney disease. If so, a dose adjustment may be necessary.
• if the patient has serious illnesses that may require immediate hospital treatment
• if the immune system is not functioning properly
• if the patient has chronic heart disease or respiratory disease.

During treatment with Tamivil, the patient should inform the doctor immediately:

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

Tamivil 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 efficacy of influenza vaccination, and the doctor may prescribe both products.

Other medicines and Tamivil
Tell the doctor or pharmacist about all medicines currently taken or taken recently, including 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, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Inform the doctor if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, so that the doctor can decide whether Tamivil is an appropriate medicine.
The effect of Tamivil on breastfed infants is unknown. Inform the doctor if the patient is breastfeeding, so that he or she can decide whether Tamivil is an appropriate medicine.

Driving and operating machinery
Tamivil does not affect the ability to drive or operate machinery.

3. How to use Tamivil

This medicine should be used as directed by a physician. If in doubt, consult a
physician or pharmacist.
Tamivil should be taken as soon as possible, preferably within the first two days after the onset of
influenza symptoms.
Recommended dosage
For treatment of influenza, take two doses per day, usually one 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.
For prevention of influenza or after contact with an infected person, take one dose per
day for 10 days, preferably in the morning with breakfast.
In special circumstances, such as widespread influenza outbreaks or if the patient has
a weakened immune system, treatment may last up to 6 weeks or 12 weeks.
Adults, adolescents and children above 6 years of age

Method of administration
The tablets should be taken with water. The tablets must not be divided or chewed.
Tamivil may be taken with or without food. Taking the medicine with food reduces the risk of nausea or vomiting.

Taking more Tamivil than recommended
You should stop taking Tamivil and contact your doctor or pharmacist immediately.
In most cases, no adverse effects were reported following overdose. When adverse effects were reported, they were similar to those occurring after recommended doses, as described in section 4.
Overdose was reported more frequently in children than in adults and adolescents. Caution should be exercised when administering Tamivil tablets to children.

If you miss a dose of Tamivil
Do not take a double dose to make up for the missed tablet.

Stopping Tamivil
There are no adverse effects associated with stopping Tamivil. However, if Tamivil is stopped earlier than advised by your doctor, flu symptoms may return. Treatment should always be completed according to your doctor's instructions.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Many of the adverse reactions listed below may also be caused by influenza itself.
The following serious adverse reactions have been reported rarely after oseltamivir was approved for marketing:

• anaphylactic and pseudoanaphylactic 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 color, changes in behavior
• 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, blisters, peeling, and shedding of large areas of skin, possibly accompanied by breathing difficulties and low blood pressure
• gastrointestinal bleeding: prolonged bleeding from the large intestine or hemoptysis
• neuropsychiatric disorders, as described below.

If any of these symptoms occur, seek immediate medical help.
The most frequently (very common and common) reported adverse reactions with oseltamivir are: nausea, vomiting, stomach pain, diarrhea, headache, and pain. These symptoms usually occur only after the first dose and typically resolve during continued treatment. The frequency of these adverse reactions decreases if the medicine is taken with food.
Rare but serious adverse reactions: consult a doctor immediately
(may occur in 1 out of 1000 people)
Rare cases have been reported during oseltamivir use:

• seizures and delirium, including altered consciousness
• confusion, abnormal behavior
• illusions, hallucinations, agitation, anxiety, nightmares

These events, often with sudden onset and resolution, have been observed primarily in children and adolescents. In rare cases, they have led to self-harm, sometimes resulting in death. Similar neuropsychiatric events have also been observed in influenza patients not taking oseltamivir.

• Patients, especially children and adolescents, should be closely monitored for behavioral changes as 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 adverse reactions
(may affect more than 1 in 10 people)

• Headache
• Nausea

Common adverse reactions
(may affect 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 (rhinitis, pharyngitis, sinusitis)
• Diarrhea
• Vomiting

Uncommon adverse reactions
(may affect 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 adverse reactions
(may affect 1 in 1000 people)

• Thrombocytopenia (low platelet count)
• Vision disorders

Children aged 6 to 12 years
Very common adverse reactions
(may affect more than 1 in 10 people)

• Cough
• Nasal mucosal congestion
• Vomiting

Common adverse reactions
(may affect 1 in 10 people)

• Conjunctivitis (red eyes with discharge or eye pain)
• Ear infections and other ear disorders
• Headache
• Nausea
• Watery nasal discharge
• Stomach pain
• Feeling of fullness in the upper abdomen
• Diarrhea

Uncommon adverse reactions
(may affect 1 in 100 people)

• Dermatitis
• Tympanic membrane disorders

If any adverse reaction worsens or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

• if the patient or their child vomits repeatedly or
• if flu symptoms worsen or fever persists, inform the doctor as soon as possible.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also 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
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tamivil
Keep the medicine out of the sight and reach of children.
No special storage conditions apply.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information
What Tamivil contains

• The active substance is oseltamivir.

Each tablet contains 75 mg oseltamivir (as oseltamivir phosphate).

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

What Tamivil looks like and contents of the pack
Tamivil tablets are packed in blisters made of OPA/Aluminum/PVC/Aluminum foil, placed in a cardboard box.
Available pack sizes: 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
Tel. +48 61 66 51 500
[email protected]