Oseltix

Package Leaflet: Information for the Patient

Oseltix, 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, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

• - Oseltix is used in adults, adolescents, and children over 6 years of age and weighing more than 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.
• Oseltix may also be prescribed for adults, adolescents, and children over 6 years of age and weighing more than 40 kg to prevent influenza. Each case is considered individually - for example, if the patient has been in contact with someone with the flu.
• Oseltix may be prescribed for adults, adolescents, and children over 6 years of age and weighing more than 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.

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 alleviate symptoms
or prevent their occurrence 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. True
influenza infection occurs only 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 Oseltix

When not to take Oseltix:

• if you are allergicto oseltamivir or any of the other ingredients of Oseltix listed in section 6.

In such a case, you should contact your doctor. Do not take the medicine

Oseltix.

Warnings and precautions

Before starting Oseltix, you should inform 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

During treatment with Oseltix, you should immediately inform 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

Oseltix is not an influenza vaccine

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

Oseltix and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, 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, breastfeeding

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 Oseltix is the right medicine for you.
The effect of Oseltix on breastfed infants is not known. If you are breastfeeding, tell your doctor, so they can decide if Oseltix is the right medicine for you.

Driving and using machines

Oseltix does not affect your ability to drive or use machines.

3. How to take Oseltix

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

Recommended dosage

To treat influenza, take two tablets (75 mg) per day, usually one in the morning and one in the evening. It is essential to complete the entire 5-day treatment cycle, even if you feel better quickly.
In patients with weakened immune systems, treatment will be continued for 10 days.
To prevent influenza after contact with an infected person, take one tablet (75 mg) per 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

*In patients with weakened immune systems, treatment lasts for 10 days.

Method of administration

Swallow the tablets with water. Do not divide or crush the tablets.
Oseltix can be taken with or without food. Taking the medicine with food reduces the risk of nausea or vomiting.
For people with swallowing difficulties, the availability of oseltamivir in other pharmaceutical forms should be checked.

Taking more Oseltix than prescribed

Stop taking Oseltix 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 after administration of Oseltix to children than to adults and adolescents.
Caution should be exercised when administering Oseltix in tablet form to children.

Missing a dose of Oseltix

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

Stopping Oseltix treatment

There are no side effects if Oseltix treatment is stopped, but if you stop taking the medicine earlier than your doctor recommended, flu symptoms may return. You should 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, Oseltix 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 facial and skin swelling, itchy rash, low blood pressure, and difficulty breathing
• liver disorders (fulminant hepatitis, liver dysfunction, 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 face 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, 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, indigestion, headache, and pain. These symptoms usually occur only after the first dose of the medicine and usually disappear during continued use. 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)
The following rare cases have been reported during the use of oseltamivir:

• seizures and hallucinations, including changes in consciousness
• confusion, abnormal behavior
• delusions, hallucinations, agitation, restlessness, nightmares The above events, which had a sudden onset and resolution, were mainly observed 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 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

Very common side effects

(may occur in more than 1 in 10 people)

• Headache
• Nausea

Common side effects

(may occur in up to 1 in 10 people)

• Bronchitis
• Herpes virus
• Cough
• Dizziness
• Fever
• Pain
• Limb pain
• Runny nose
• Sleep disturbances
• 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 people)

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

Rare side effects

(may occur in up to 1 in 1000 people)

• Thrombocytopenia (low platelet count)
• Visual disturbances

Children

Very common side effects

(may occur in more than 1 in 10 people)

• Cough
• Nasal congestion
• Vomiting

Common side effects

(may occur in up to 1 in 10 people)

• 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 people)

• Dermatitis
• Tympanic membrane disorders

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.

• if you vomit repeatedlyor
• if flu symptoms worsen or fever persists, you should inform your doctor as soon as possible.

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 Drug Safety 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
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 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 that month.
There are no special precautions for storage.
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 Oseltix 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 Oseltix looks like and contents of the pack

Oseltix tablets are white, round, and biconvex, with a diameter of 7.8 mm - 8.2 mm.
Oseltix tablets are packaged in OPA/Aluminum/PVC/Aluminum blisters, 10 tablets per blister, placed in a cardboard box.
Available packs: 10 tablets.

Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet: