Viseltam

Leaflet accompanying the packaging: patient information

Viseltam, 75 mg, coated tablets

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

• Keep this leaflet, so you can read it again if you need to.
• If you have 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 side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Viseltam and what is it used for

• Viseltam is used in adults, adolescents, and children over 6 years of age, with a body weight of more than 40 kg, for the treatment of influenza. It can be used when influenza symptoms appear and when it is known that the influenza virus is circulating in the environment.
• Viseltam may also be prescribed to adults, adolescents, and children over 6 years of age, with a body weight of more than 40 kg, for the prevention of influenza. Each case is considered individually - for example, if the patient has had contact with a person with influenza.
• Viseltam may be prescribed to adults, adolescents, and children over 6 years of age, with a body weight of more than 40 kg, as a preventive treatmentin exceptional circumstances, such as during a global influenza epidemic (pandemic), when the seasonal influenza vaccine does not provide sufficient protection.

Viseltam 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 their occurrence in the case of influenza virus infection.
Influenza is an infectious disease caused by the influenza virus. Influenza symptoms include sudden onset of fever (above 37.8°C), cough, runny or stuffy nose, headache, muscle pain, and often extreme fatigue. Such symptoms can also be caused by infections other than influenza. 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, influenza-like symptoms are usually the result of developing another disease.

2. Important information before taking Viseltam

When not to take Viseltam

• if the patient is allergic to oseltamivir or any of the other ingredients of this medicine (listed in section 6). In such a case, contact a doctor. Do not take the medicine

Warnings and precautions

Before starting Viseltam, discuss with your doctor if

• the patient has an allergy to other medicines
• the patient has kidney disease. A dose change may be necessary.
• the patient has severe diseasesthat may require immediate hospital treatment
• the patient has an immune system disorder
• the patient has chronic heart diseaseor respiratory disease

During treatment with Viseltam, inform your doctor immediately:

• 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.

Viseltam does not replace influenza vaccination.

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

Viseltam and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Tell your doctor if you are pregnant or think you may be pregnant, so your doctor can decide if Viseltam is the right medicine for you.
The effect of Viseltam on breastfed infants is unknown. Tell your doctor if you are breastfeeding, so they can decide if Viseltam is the right medicine for you.

Driving and using machines

Viseltam does not affect the ability to drive and use machines.

Viseltam contains isomalt (E 953)

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Viseltam

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Viseltam 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 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 your condition improves quickly.
In patients with weakened immune systems, treatment will be continued for 10 days.
For the prevention of influenza or 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 the patient has a weakened immune system, treatment will 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 10 days.

Method of administration

Swallow the tablets with water. Viseltam tablets should not be divided or crushed.
Viseltam can be taken with food or between meals. Taking the medicine with food reduces the risk of nausea or vomiting.
For people with difficulty swallowing tablets, the availability of oseltamivir in other pharmaceutical forms should be checked.

Taking a higher dose of Viseltam than recommended

Stop taking Viseltam and contact your doctor or pharmacist immediately.
In most cases of overdose, no side effects were reported. If they were reported, they were similar to the 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.
Caution should be exercised when administering Viseltam tablets to children.

Missing a dose of Viseltam

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

Stopping Viseltam treatment

There are no side effects if Viseltam treatment is stopped. However, if the treatment is stopped earlier than recommended by the doctor, influenza symptoms may return. Always complete the treatment as recommended by the doctor.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Viseltam can cause side effects, although not everybody gets them.
The cause of many of the side effects listed below may also be influenza itself.
The following serious side effects have been reported rarely after oseltamivir was approved:

• anaphylactic and pseudoanaphylactic reactions: severe allergic reactions with facial and skin edema, itching rash, 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, significant skin edema, 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 skin layers, 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, indigestion, headache, and pain. These 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: consult a doctor immediately

(may occur in up to 1 in 1000 people)
The following rare cases have been reported during oseltamivir treatment:

• seizures and hallucinations, including changes in consciousness
• confusion, abnormal behavior
• delusions, hallucinations, agitation, restlessness, nightmares The above events, which often had a sudden onset and resolution, were observed mainly in children and adolescents. In sporadic cases, they were the cause of self-harm, sometimes resulting in death. Similar neuropsychiatric events have also been observed in people 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 any of these symptoms are noticed, especially in young people, consult a doctor 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 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 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 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 worse or if you notice any side effects not listed in the leaflet, tell your doctor or pharmacist.

• if the patient vomits repeatedly, or
• if influenza symptoms worsen or fever persists, tell your doctor as soon as possible.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Viseltam

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: Expiry Date (EXP). The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your 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 Viseltam contains

• The active substance is oseltamivir phosphate. One coated tablet contains 98.50 mg of oseltamivir phosphate, equivalent to 75 mg of oseltamivir.
• The other ingredients (excipients) are: calcium phosphate, potato starch, isomalt (E 953), talc, dibehenyl glycerol. The tablet coating Opadry QX: copolymer of macrogol and poly(vinyl alcohol), talc, titanium dioxide (E 171), mono- and dicaprylate glycerol, polyvinyl alcohol.

What Viseltam looks like and contents of the pack

Viseltam is a white or almost white, coated, round, biconvex tablet, 8 mm in diameter.
Viseltam 75 mg coated tablets are available in a PVC/PVDC/Aluminum blister pack containing 10 tablets, in a cardboard box.
Package sizes: 10, 20, and 30 tablets.

Marketing authorization holder:

Solinea Sp. z o.o
Szafranowa 6, Elizówka
21-003 Ciecierzyn
Phone: (+48) 81 463 48 82
Email: [email protected]

Manufacturer:

Medicofarma S.A.
Tarnobrzeska 13
26-613 Radom
Mako Pharma Sp. z o.o.
Kolejowa 231 A
05-092 Dziekanów Polski

Date of last revision of the leaflet: