Cipla Oseltamivir 75 mg Capsules

CIPLA OSELTAMIVIR contains oseltamivir which belongs to a group of medicines called antivirals. These medicines act by preventing the influenza virus from spreading inside the body, thereby helping ease or prevent symptoms of influenza virus infection.

CIPLA OSELTAMIVIR is indicated for:

• Treatment of influenza in adults and children ≥ 1 year of age.
• Pandemic use: CIPLA OSELTAMIVIR is indicated for the treatment of infants 6 to 12 months of age during a pandemic influenza outbreak only, and not for endemic (seasonal) influenza use.
• Prophylaxis (prevention) of influenza in adults and children ≥ 1 year of age.

Do not take CIPLA OSELTAMIVIR:

• If you are hypersensitive (allergic) to oseltamivir or any of the other ingredients of CIPLA OSELTAMIVIR (listed in section 6).

Warnings and precautions

Take special care with CIPLA OSELTAMIVIR:

• If you notice changes in your behaviour or mood (neuropsychiatric events) such as convulsions (seizures), hallucinations, delirium (disturbed state of mind) and disturbances in consciousness, within the first few days of taking CIPLA OSELTAMIVIR. You should inform your doctor as you should be carefully monitored for these adverse effects.
• If you have kidney problems as your dose of CIPLA OSELTAMIVIR may need to be adjusted.
• If you have a severe medical condition which may require immediate hospitilisation.
• If your immune system is weakened.
• If you any have chronic medical conditions which may affect your heart and lungs.

Other medicines and CIPLA OSELTAMIVIR

Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines. Tell your doctor if you are taking the following:

• Chlorpropamide (used to treat diabetes)
• Methotrexate (an immune suppressant)
• Phenylbutazone (used to treat pain and inflammation)
• Probenecid (used to treat gout).

CIPLA OSELTAMIVIR with food and drink

CIPLA OSELTAMIVIR may be taken with or without food.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding your baby, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking CIPLA OSELTAMIVIR. The safety and efficacy of CIPLA OSELTAMIVIR during pregnancy and lactation have not been established.

Do not share medicines prescribed for you with any other person. Always take CIPLA OSELTAMIVIR exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are unsure.

CIPLA OSELTAMIVIR should be taken within 2 days of influenza (flu) symptoms starting.

Treatment of influenza

In adults and adolescents ≥ 13 years of age, the recommended oral dose of CIPLA OSELTAMIVIR is one 75 mg capsule twice daily for 5 days.

Treatment with one 75 mg capsule twice daily for may also be administered to children > 40 kg who are able to swallow capsules. Children ≥ 1 year of age who are not able to swallow capsules (refer to Patients who are unable to swallow capsules below) Body weight Recommended dose for 5 days ≤ 15 kg 30 mg twice daily > 15 to 23 kg 45 mg twice daily > 23 to 40 kg 60 mg twice daily > 40 kg 75 mg twice daily.

The recommended oral dose of CIPLA OSELTAMIVIR for children 6 to 12 months of age who are not able to swallow capsules (refer to Patients who are unable to swallow capsules below) Dosage in children 6 to 12 months is 3mg/kg twice daily.

Prophylaxis (prevention) of influenza

For the prophylaxis of influenza following close contact with an infected individual the recommended oral dose of CIPLA OSELTAMIVIR is 75 mg once daily for at least 10 days. (Prophylactic therapy should be initiated within two days of exposure. During a community outbreak of influenza, the recommended dose for prophylaxis is 75 mg once daily. Safety and efficacy have been demonstrated for up to six weeks. Protection lasts for the duration of prophylactic treatment.

Children weighing > 40 kg, who are able to swallow capsules, may also receive prophylaxis with a 75 mg capsule once daily, for 10 days. The recommended prophylactic oral dose of CIPLA OSELTAMIVIR for children ≥ 1 year of age who are not able to swallow capsules (refer to Patients who are unable to swallow capsules below) Body weight Recommended dose for 5 days ≤ 15 kg 30 mg once daily > 15 to 23 kg 45 mg once daily > 23 to 40 kg 60 mg once daily > 40 kg 75 mg once daily.

Kidney impairment

Please inform your doctor if you suffer from kidney problems as your dose may need to be adjusted for treatment or prophylaxis of influenza with CIPLA OSELTAMIVIR.

Liver impairment

Please inform your doctor if you suffer from liver problems. No dose adjustment is required for patients with mild or moderate hepatic dysfunction (liver problems). Safety has not been established in patients with severe hepatic impairment (liver problems).

Immuno-compromised patients

Seasonal prophylaxis (prevention) in immune-compromised patients 1 year of age and older is recommended for 12 weeks. No dose adjustment is necessary.

Elderly

Dose adjustment is not necessary for elderly patients who require treatment or prophylaxis (prevention) for influenza.

Children

Since the safety and efficacy of CIPLA OSELTAMIVIR in children under 1 year have not been established, CIPLA OSELTAMIVIR should not be used in children under 1 year of age, other than during a pandemic influenza outbreak.

Patients who are unable to swallow capsules

Adults, adolescents or children who are unable to swallow capsules may receive appropriate doses of CIPLA OSELTAMIVIR by opening capsules and pouring the contents of capsules into a suitable, small amount [1 teaspoon (5 mL) maximum] of sweetened food product such as regular or sugar-free chocolate syrup, honey (only for children two years or older), light brown or table sugar dissolved in water, dessert toppings, sweetened condensed milk, apple sauce or yoghurt to mask the bitter taste. The mixture should be stirred, and the entire contents taken. The mixture must be swallowed immediately after its preparation.

CIPLA OSELTAMIVIR can have side effects. Not all side effects reported for CIPLA OSELTAMIVIR are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking CIPLA OSELTAMIVIR, please consult your healthcare provider for advice.

If any of the following happens, stop taking CIPLA OSELTAMIVIR and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Hypersensitivity (allergic reaction, which includes swelling of the hands, feet, ankles, face, lips and mouth or throat which may cause difficulty in swallowing and breathing), anaphylactic/anaphylactoid reaction (body going into shock).
• Stevens-Johnson syndrome (severe skin reaction causing painful rash that spreads and blisters).
• Toxic epidermal necrolysis (life threatening skin condition which causes blistering and peeling of the skin).
• Erythema multiforme (skin disorder characterized by bull’s-eye shaped lesions).

These are all very serious side effects. If you have them, you may have had a serious reaction to CIPLA OSELTAMIVIR. You may need urgent medical attention.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Hepatic (liver) failure (symptoms may include yellowing of the skin and eyes along with stomach pain and swelling).
• Pneumonia (inflammation of the air sacs in the lung causing the lung to fill up with fluid).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Bronchitis (chest infection), upper respiratory tract infections.
• Herpes simplex (virus causing contagious sores, most often around the mouth or genitals).
• Nasopharyngitis (common cold).
• Sinusitis (swelling of the sinuses causing runny nose, headache, nasal congestion etc.).
• Otitis media (ear infection).
• Headache.
• Insomnia (difficulty sleeping or inability to sleep).
• Earache.
• Cough.
• Sore throat.
• Runny nose.
• Nasal congestion.
• Diarrhoea.
• Nausea.
• Vomiting.
• Abdominal (stomach) pain (including upper abdominal pain).
• Dyspepsia (indigestion).

Less frequent side effects:

• Thrombocytopenia (decreased number of blood cells called platelets which are required for blood clotting).
• Agitation.
• Abnormal behaviour.
• Anxiety.
• Confusion.
• Delusions.
• Delirium (confused thinking and lack of awareness).
• Hallucinations (seeing or hearing things that are not real).
• Nightmares.
• Self-injury.
• Altered level of consciousness.
• Convulsions (seizures).
• Conjunctivitis (pink eye).
• Visual disturbance (blurred vision).
• Ear disorder.
• Tympanic membrane disorder (inflamed eardrum).
• Cardiac arrhythmia (irregular heartbeat).
• Epistaxis (nose bleeds).
• Gastrointestinal bleeding.
• Hemorrhagic colitis (bloody stools).
• Elevated liver enzymes.
• Hepatitis (inflammation of the liver).
• Eczema (dry itchy skin).
• Dermatitis (skin irritation).
• Rash.
• Urticaria (hives).
• Swelling under the skin.

Side effects with unknown frequency:

• Lymphadenopathy (swelling of the lymph nodes).
• Asthma.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 or by e-mail: [email protected] or telephone: 080 222 6662 (toll free). By reporting side effects, you can help provide more information on the safety of CIPLA OSELTAMIVIR.

• Store at or below 25 °C.
• Store all medicines out of reach of children.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).