OSELTIX

Package leaflet: Information for the patient

Oseltix, 75 mg, tablets
Oseltamivir
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 consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Oseltix is and what it is used for
2. Important information before taking Oseltix
3. How to take Oseltix
4. Possible side effects
5. How to store Oseltix
6. Contents of the pack and other information

1. What Oseltix is and what it is used for

• • Oseltix 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 the influenza virus is circulating in the community.
• Oseltix may also be prescribed for adults, adolescents, and children over 6 years of age weighing more than 40 kg for the prevention of influenza. Each case is considered individually—for example, if the patient has been in contact with someone who has influenza.
• Oseltix may be prescribed for 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 epidemic (influenza pandemic), when the seasonal influenza vaccine does not provide adequate protection.

Oseltix 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 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 blocked 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 the influenza virus is spreading in the local community.
Outside epidemic periods, flu-like symptoms are usually due to other illnesses.

2. Information before using Oseltix

When not to use Oseltix:

• if the patient is allergic to oseltamivir or to any of the other ingredients of Oseltix listed in section 6.

In such a case, you should contact your doctor. Do not take
Oseltix.
Warnings and precautions
Before starting treatment with Oseltix, 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 Oseltix, you should inform your doctor immediately:

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

Oseltix is not an influenza vaccine
Oseltix is not a vaccine: it is used to treat infection or prevent the spread of
influenza virus. Vaccines provide antibodies against the virus. Oseltix does not affect
the effectiveness of influenza vaccination, and your doctor may prescribe both products.
Oseltix and other medicines
You must tell your doctor or pharmacist about all medicines currently taken or
recently taken, as well as medicines the patient plans to use. 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 or breastfeeding, suspects she may be pregnant, or is planning to become
pregnant, she should consult her doctor or pharmacist before using this medicine.
You should inform your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant, so that the doctor can decide whether Oseltix is the appropriate medicine.
The effect of Oseltix on breastfed infants is unknown. You should inform your doctor if you are breastfeeding, so that he or she can decide whether Oseltix is the appropriate medicine.
Driving and operating machinery
Oseltix has no effect on the ability to drive or operate machinery.

3. How to use Oseltix

This medicine should be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Oseltix should be taken as soon as possible, preferably within the first two days of the onset of
influenza symptoms.
Recommended dosage
For treatment of influenza: take two tablets (75 mg) daily, 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 quickly.
In patients with weakened immune systems, treatment will continue for 10 days.
For prevention of influenza after contact with an infected person: take one tablet (75 mg) daily
for 10 days, preferably in the morning with breakfast.
In special circumstances, such as during an influenza outbreak or if the patient has a weakened
immune system, treatment may last up to 6 weeks or 12 weeks.
Adults, adolescents, and children over 6 years of age

*In patients with weakened immune systems, treatment lasts for 10 days.
Method of administration
Tablets should be taken with water. Tablets must not be divided or chewed.
Oseltix can be taken with food or between meals. Taking the medicine with food
reduces the risk of nausea or vomiting.
For people who have difficulty swallowing tablets, availability of oseltamivir in
other pharmaceutical forms should be checked.
Overdose of Oseltix
Administration of Oseltix should be discontinued and immediate contact made with a doctor or
pharmacist.
In most cases of overdose, no adverse effects were reported. When adverse effects were reported,
they were similar to those occurring after recommended doses, as described in section 4.
Overdose has been reported more frequently in children than in adults and adolescents.
Caution should be exercised when administering Oseltix tablets to children.
Missed dose of Oseltix
Do not take a double dose to make up for a missed tablet.
Discontinuation of Oseltix treatment
There are no adverse effects associated with stopping Oseltix treatment; however, if treatment is discontinued earlier than advised by the doctor, flu symptoms may return. Treatment should always be completed according to the doctor's instructions.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, 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 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 affecting the head and neck area, including the 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 rash, blistering, 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 haemoptysis (coughing up blood)
• 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, indigestion, 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: seek immediate medical advice
(may occur in 1 out of 1,000 people)
Rare cases reported during oseltamivir use include:

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

The above events often had a sudden onset and resolution and were observed primarily in children and adolescents. In rare cases, they led to self-injury, sometimes resulting in death. Similar neuropsychiatric events have also been observed in influenza patients who did not receive oseltamivir.
Patients, especially children and adolescents, should be closely monitored for behavioural changes as described above. If any of these symptoms occur, especially in young individuals, seek immediate medical advice.

Adults and adolescents
Very common adverse reactions
(may occur in more than 1 out of 10 people)

• Headache
• Nausea

Common adverse reactions
(may occur in up to 1 out of 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)
• Indigestion
• Vomiting

Uncommon adverse reactions
(may occur in up to 1 out of 100 people)

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

Rare adverse reactions
(may occur in up to 1 out of 1,000 people)

• Thrombocytopenia (low platelet count)
• Vision disorders

Children
Very common adverse reactions
(may occur in more than 1 out of 10 people)

• Cough
• Nasal mucosal congestion
• Vomiting

Common adverse reactions
(may occur in up to 1 out of 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 adverse reactions
(may occur in up to 1 out of 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 vomits repeatedly or
• if flu symptoms worsen or fever persists, contact the doctor immediately.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Oseltix
Keep this medicine out of the sight and reach of children.
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.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

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

• The active substance is oseltamivir.

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

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

What Oseltix looks like and contents of the pack
Oseltix tablets are white, round, biconvex, with a diameter of 7.8 mm – 8.2 mm.
Oseltix tablets are packed in blisters made of OPA/Aluminium/PVC/Aluminium, with 10 tablets per blister, placed in a cardboard carton.
Available pack size: 10 tablets.

Marketing Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Tel. +48 61 66 51 500
e-mail: [email protected]