Tamivil

Leaflet accompanying the packaging: information for the user

Tamivil, 45 mg, hard capsules

Oseltamivir

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the 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 packaging and other information

1. What is Tamivil and what is it used for

Tamivil, 45 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 alleviate symptoms or prevent them from occurring in case of flu virus infection. The flu is an infectious disease caused by a virus. Flu 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 flu infection occurs only during annual outbreaks of the disease ( epidemic), when flu viruses spread in the local environment. Outside of epidemic periods, flu-like symptoms are usually the result of developing another disease.

• Tamivil, 45 mg, hard capsules are used in adults, adolescents, children, and infants (including full-term newborns) for the treatment of flu. It can be used when flu symptoms occur and when it is known that the flu virus is circulating in the environment.
• Tamivil, 45 mg, hard capsules may 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 a person with flu.
• Tamivil, 45 mg, hard capsules may be prescribed to adults, adolescents, children, and infants (including full-term newborns) as prophylactic treatmentin exceptional circumstances, such as during a global flu epidemic ( flu pandemic), when the seasonal flu vaccine does not provide sufficient protection.

2. Important information before taking Tamivil

When not to take Tamivil, 45 mg, hard capsules

• If the patient is allergic( hypersensitive) to oseltamivir or any of the other ingredients of this medicine listed in section 6.

If this applies to the patient, they should contact their doctor. Do not take Tamivil, 45 mg, hard capsules.

Warnings and precautions

Before taking Tamivil, 45 mg, hard capsules, the patient should 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 change may be necessary
• If the patient has a severe diseasethat may require immediate hospital treatment
• If the patient's immune systemis not working properly
• If the patient has chronic heart diseaseor respiratory disease.

During treatment with Tamivil, 45 mg, hard capsules, the patient should immediately inform their doctor:

• If the patient notices changes in behavior or mood( neuropsychiatric events), especially in children and adolescents. These symptoms can be rare but serious side effects.

Tamivil, 45 mg, hard capsules is not a flu vaccine

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

Tamivil, 45 mg, hard capsules and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they 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 and breastfeeding

If the patient is pregnant, thinks they may be pregnant, or plans to have a child, they should inform their doctor so that they can decide whether Tamivil, 45 mg, hard capsules is suitable. The effect of oseltamivir on breastfed infants is unknown. If the patient is breastfeeding, they should inform their doctor so that they can decide whether Tamivil, 45 mg, hard capsules is suitable. Before taking this medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Tamivil, 45 mg, hard capsules do not affect the ability to drive and use machines.

Tamivil, 45 mg, hard capsules contain sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Tamivil

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist. Tamivil, 45 mg, hard capsules should be taken as soon as possible, preferably within the first two days of flu symptoms.

Recommended doses

For the treatment of flu, the patient should take two doses a day. It is usually best to take one dose in the morning and one in the evening. It is essential to complete the entire 5-day treatment cycle, even if the patient's condition improves quickly. In patients with weakened immune systems, treatment will be continued for 10 days. For the prevention of flu or after contact with an infected person, the patient should take one dose a day for 10 days. It is best to take the medicine in the morning during breakfast. In special situations, such as the spread of flu or when the patient has a weakened immune system, treatment may last up to 6 or 12 weeks. The recommended dose is calculated based on the patient's body weight. The patient should take the number of capsules or oral suspension prescribed by their doctor.

Adults and adolescents over 13 years of age

*In patients with weakened immunity, treatment lasts 10 days. **The dose of 75 mg may consist of a 30 mg capsule and a 45 mg capsule.

Children from 1 year to 12 years of age

*In children with weakened immunity, treatment lasts 10 days. **The dose of 75 mg may consist of a 30 mg capsule and a 45 mg capsule.

Infants under 1 year of age (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 for the infant.

*In infants with weakened immunity, treatment lasts 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

Capsules should be swallowed whole, with a glass of water. Capsules should not be broken or chewed. Tamivil, 45 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 of age

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

Taking a higher dose of Tamivil, 45 mg, hard capsules than recommended

The patient should stop taking Tamivil, 45 mg, hard capsules and immediately contact their doctor or pharmacist. In most cases of overdose, no side effects have been reported. If they have been 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 oseltamivir to children than to adults and adolescents.

Missing a dose of Tamivil, 45 mg, hard capsules

The patient should not take a double dose to make up for a missed capsule.

Stopping treatment with Tamivil, 45 mg, hard capsules

There are no side effects if the patient stops taking Tamivil, 45 mg, hard capsules. However, if the patient stops taking the medicine earlier than recommended by their doctor, flu symptoms may return. The patient should always complete the treatment as recommended by their doctor. If the patient has any further doubts about taking this medicine, they should consult their 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 introduction of oseltamivir to the market:

• Anaphylactic and pseudoanaphylactic reactions: severe allergic reactions with facial and skin edema, pruritus, low blood pressure, and difficulty breathing;
• Liver disorders (fulminant hepatitis, liver function disorders, and jaundice): yellowing of the skin and eyes, change in stool color, changes in behavior;
• Angioedema: sudden, severe swelling of the skin, 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 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.

In case of any of these symptoms, the patient should immediately seek medical attention.

The most common (very common and common) side effects of oseltamivir are: feeling of nausea (nausea, vomiting), stomach pain, indigestion, headache, and pain. Such symptoms usually occur only after the first dose of the medicine and usually disappear during further treatment. The frequency of these side effects decreases if the medicine is taken with food.

Rare but serious side effects: the patient should immediately consult their doctor

(may occur in up to 1 in 1,000 patients)

• Seizures and hallucinations, including changes in consciousness;
• Confusion, unusual 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-injury, sometimes resulting in death. Similar neuropsychiatric events have also been observed in people with flu who did not take oseltamivir.
• Patient, especially children and adolescents, should be closely monitored for changes in behavior as described above.

In case of any of these symptoms, especially in young people, the patient should immediately consult their doctor.

Adults and adolescents over 13 years of age

Very common side effects

(may occur in more than 1 in 10 patients)

• Headache;
• Nausea.

Common side effects

(may occur in up to 1 in 10 patients)

• Bronchitis;
• Herpes virus;
• Cough;
• Dizziness;
• Fever;
• Pain;
• Limb pain;
• Runny nose;
• Sleep disorders;
• 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 patients)

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

Rare side effects

(may occur in up to 1 in 1,000 patients)

• Thrombocytopenia (low platelet count);
• Visual disturbances.

Children from 1 year to 12 years of age

Very common side effects

(may occur in more than 1 in 10 patients)

• Cough;
• Rhinitis;
• Vomiting.

Common side effects

(may occur in up to 1 in 10 patients)

• 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 patients)

• Dermatitis;
• Tympanic membrane disorders.

Infants under 1 year of age

The side effects reported in infants from 0 to 12 months of age are mostly similar to the side effects reported in older children (over 1 year of age). Additionally, diarrhea and diaper rash have been reported. If any of the side effects get worse or if the patient experiences any side effects not listed in this leaflet, they should tell their doctor or pharmacist. However,

• If the patient or their child vomits repeatedly or
• If flu symptoms worsen or fever persists, the patient should immediately inform their doctor.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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, more information can be collected on the safety of the medicine.

5. How to store Tamivil

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tamivil contains

• Each hard capsule contains oseltamivir phosphate, equivalent to 45 mg of oseltamivir.
• Other ingredients are: Capsule content: maize starch, cornstarch, povidone (K-29/32), croscarmellose sodium, talc, sodium stearyl fumarate.
• Capsule shell: titanium dioxide (E 171), gelatin.

What Tamivil, 45 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 an opaque white body and an opaque white cap. Tamivil, 45 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: