Viseltam

Package leaflet: Information for the patient

Viseltam, 75 mg, film-coated tablets
Oseltamivir
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• 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 a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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

1. What Viseltam is and what it is used for

• Viseltam 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 appear and when it is known that the influenza virus is circulating in the community.
• Viseltam may also be prescribed for 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 who has the flu.
• Viseltam 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 epidemic (influenza pandemic), when the seasonal influenza vaccine does not provide adequate 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 reduce the severity of symptoms or prevent their occurrence if infection with the influenza virus occurs.
Influenza (flu) is an infectious disease caused by the influenza virus. Symptoms of influenza include sudden onset of fever (above 37.8°C), cough, runny or stuffy nose, headache, muscle aches, and often extreme fatigue. These symptoms may also be caused by infections other than influenza. 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. Important information before using Viseltam

When not to use Viseltam

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

Warnings and precautions
Before starting treatment with Viseltam, discuss with your doctor if:

• the patient has allergies to other medicines
• the patient has kidney disease. A dose adjustment may be necessary.
• the patient has severe illnesses that may require immediate hospital treatment
• the immune system is not functioning properly
• the patient has chronic heart disease or respiratory disease

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

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

Viseltam does not replace influenza vaccination.
Viseltam is not a vaccine: it is used to treat infection or to prevent the spread of influenza virus. Vaccines provide antibodies against the virus. Viseltam does not affect the efficacy of influenza vaccination, and the doctor may prescribe both products.

Viseltam and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, 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 and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Inform the doctor if the patient is pregnant or suspects pregnancy, so that the doctor can decide whether Viseltam is an appropriate medicine.
The effect of Viseltam on breastfed infants is unknown. Inform the doctor if the patient is breastfeeding, so that the doctor can decide whether Viseltam is appropriate.

Driving and operating machinery
Viseltam has no effect on the ability to drive or operate machinery.

Viseltam contains isomalt (E 953)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.

3. How to use Viseltam

This medicine should always be taken exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Viseltam 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 tablets (75 mg) 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.
In patients with weakened immune systems, treatment will continue for 10 days.
For prevention of influenza or after contact with an infected person, take one tablet (75 mg) per day
for 10 days, preferably in the morning with breakfast.
In special circumstances, such as widespread influenza outbreaks or in patients with weakened immune
systems, treatment may last up to 6 weeks or 12 weeks.
Adults, adolescents and children above 6 years of age

*In patients with weakened immune systems, treatment lasts for 10 days.
Method of administration
Tablets should be taken with water. Viseltam tablets must not be split or chewed.
Viseltam may be taken with or without food. Taking the medicine with food reduces the risk of nausea or vomiting.
For patients who have difficulty swallowing tablets, availability of oseltamivir in other pharmaceutical forms should be checked.
Overdose of Viseltam
Discontinue taking Viseltam and contact your doctor or pharmacist immediately.
In most cases of overdose, no adverse effects were reported. When adverse effects occurred, they were similar to those observed 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 Viseltam tablets to children.
Missed dose of Viseltam
Do not take a double dose to make up for a missed tablet.
Discontinuation of Viseltam
There are no adverse effects associated with stopping Viseltam. However, if treatment is discontinued earlier than recommended by the physician, flu symptoms may return. Treatment should always be completed according to the 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 will experience 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 has been 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 eyes and tongue, accompanied by breathing difficulties
• Stevens-Johnson syndrome and toxic epidermal necrolysis: complex, potentially life-threatening allergic reaction, severe inflammation of external and even internal skin layers, beginning with fever, sore throat and fatigue, skin rashes progressing to blisters, peeling, shedding of large areas of skin, which may be accompanied by breathing difficulties and low blood pressure
• gastrointestinal bleeding: prolonged bleeding from the large intestine or haemoptysis
• neuropsychiatric disorders, as described below.

If any of these symptoms occur, seek immediate medical help.
The most commonly (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 no more than 1 in 1,000 people)
Rare cases have been reported during oseltamivir use:

• seizures and delirium, including altered consciousness
• confusion, abnormal behaviour
• hallucinations, hallucinations, agitation, restlessness, nightmares
  The above events, which often had a sudden onset and resolution, were observed primarily in children and adolescents. In rare cases, these events led to self-injury, sometimes resulting in death. Similar neuropsychiatric events have also been observed in patients with influenza who were not taking oseltamivir.
  Patients, especially children and adolescents, should be closely monitored for behavioural changes as described above. If any of these symptoms occur, especially in younger individuals, seek immediate medical advice.

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

• Headache
• Nausea

Common adverse reactions
(may affect up to 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 (nasal, throat and sinus inflammation)
• Indigestion
• Vomiting

Uncommon adverse reactions
(may affect 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 adverse reactions
(may affect up to 1 in 1,000 people)

• Thrombocytopenia (low platelet count)
• Vision disorders

Children
Very common adverse reactions
(may affect more than 1 in 10 people)

• Cough
• Nasal mucosal congestion
• Vomiting

Common adverse reactions
(may affect up to 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
• Indigestion

Uncommon adverse reactions
(may affect up to 1 in 100 people)

• Dermatitis
• Tympanic membrane disorders

If any of the adverse reactions worsen, 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 your doctor as soon as possible.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 at 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Viseltam

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following: Expiry
date (EXP). The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What the medicine 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 hydrogen phosphate, potato starch, isomalt (E 953), talc, glyceryl dibehenate. The tablet coating Opadry QX: polyvinyl alcohol-polyethylene glycol grafted copolymer, talc, titanium dioxide (E 171), glyceryl mono- and dicaprylocaprinates, polyvinyl alcohol.

What Viseltam looks like and contents of the pack
Viseltam is a white or almost white, round, biconvex coated tablet with a diameter of 8 mm.
Viseltam 75 mg coated tablets are available in PVC/PVDC/Aluminium blisters containing
10 tablets per blister, packed in a cardboard box.
Pack sizes: 10, 20 and 30 tablets.
Marketing Authorisation Holder:
Solinea Sp. z o.o
ul. Szafranowa 6, Elizówka
21-003 Ciecierzyn
Telephone: (+48) 81 463 48 82
Email: [email protected]
Manufacturer:
Medicofarma S.A.
ul. Tarnobrzeska 13
26-613 Radom
Mako Pharma Sp. z o.o.
Kolejowa 231 A
05-092 Dziekanów Polski