Flumitev Capsules

FLUMITEV contains oseltamivir, which belongs to a group of medicines named neuraminidase inhibitors. These medicines prevent the flu virus from spreading inside the body. They help to ease or prevent the symptoms of the flu virus infection.

Influenza, usually called flu, is an infection caused by a virus. The signs of flu often include a sudden fever (more than 37,8 °C), cough, runny or stuffy nose, headaches, muscle aches and extreme tiredness. These symptoms can also be caused by other infections. True influenza infection only occurs during annual outbreaks (epidemics) when flu viruses are spreading in the local community. Outside epidemic periods, flu-like symptoms are usually caused by a different type of illness.

• FLUMITEV is used for adults, adolescents and children above ≥ 1 year of age for treating flu (influenza).
• FLUMITEV may be prescribed for adults and children above ≥ 1 year of age as preventive treatment in exceptional circumstances – for example, if there is a global epidemic of flu (a flu pandemic) and the seasonal flu vaccine may not provide sufficient protection.
• FLUMITEV can also be prescribed for adults and children above ≥ 1 year of age for preventing flu, on a case-by-case basis – for instance, if you have been in contact with someone who has flu.

Do not take FLUMITEV:

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

Warnings and precautions:

Take special care with FLUMITEV:

• if you have problems with your kidneys. If so, your dose may need adjustment
• if you have a severe medical condition, which may require immediate hospitalisation
• if your immune system is not working
• if you have chronic heart disease or respiratory disease.

Children and adolescents:

During treatment with FLUMITEV, tell a doctor immediately:

• if you notice changes in behaviour or mood (neuropsychiatric events), especially in children and adolescents. These may be signs of rare but serious side effects.

FLUMITEV is not a flu vaccine: FLUMITEV is not a vaccine: it treats infection or prevents the flu virus spreading. A vaccine gives you antibodies against the virus. FLUMITEV will not change the effectiveness of a flu vaccine, and you might be prescribed both by your doctor.

Do not share medicines prescribed for you with any other person. Always take FLUMITEV exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Take FLUMITEV as soon as possible, ideally within two days of the flu symptoms starting. Swallow the capsules whole with water. Do not break or chew the capsules. People who find it hard to take capsules can use a liquid form of this medicine (oral suspension). If you need an oral suspension but it’s not available from your pharmacy, you can make a liquid form of FLUMITEV from these capsules. See Making Liquid FLUMITEV at home for instructions.

FLUMITEV can be taken with or without food, although taking it with food can reduce the chance of feeling or being sick (nausea or vomiting).

The usual dose is...

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

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

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

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

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

• Liver disorders (fulminant hepatitis, hepatic function disorder and jaundice): yellowing of the skin and white of the eyes, change in stool colour, changes in behaviour
• angioneurotic oedema: sudden onset of severe swelling of the skin mainly around the head and neck area, including eyes and tongue, with difficulties breathing
• convulsions and delirium, including altered level of consciousness Neuropsychiatric disorders, especially children and adolescents, should be closely monitored for the behavioural changes described above.
• gastrointestinal bleeding: prolonged bleeding from the large bowel or spitting up blood
• Stevens-Johnson syndrome and toxic epidermal necrolysis: complicated, possibly life-threatening allergic reaction, severe inflammation of the outer and possibly inner skin, initially with fever, sore throat, and fatigue, skin rashes, leading to blisters, peeling, shedding of larger areas of skin, possible breathing difficulties and low blood pressure

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
• cold sore virus
• upper respiratory tract infections (inflammation of the nose, throat and sinuses)
• flu
• headache
• sleeping difficulties
• cough
• runny nose, stuffy nose
• sore throat
• nausea
• vomiting
• indigestion
• stomach ache
• runny tummy
• back pain
• joint pain, muscle pain
• painful menstruation
• fever
• pain
• pain in limb
• tiredness
• dizziness
• fever or abrupt onset with one or more of: chills, headache, malaise, myalgia, cough, pharyngitis, other respiratory complaints, and presented for throat culture

Less frequent side effects

• Thrombocytopenia (low platelet count)
• delusions, hallucinations, agitation, anxiety, nightmares
• confusion, abnormal behaviour, self-injury
• convulsion, change in level of consciousness
• bleeding in the digestive system, disease in the gut called haemorrhagic colitis
• visual disturbances
• heart rhythm abnormalities
• mild to severe liver function disorders
• skin reactions (inflammation of the skin, red and itchy rash, scaling skin)
• hives, skin or mouth lesions that have a pink-red centre surrounded by a pale ring border and an outer pink-red ring

Children 1 to 12 years

Frequent side effects:

• Ear infection, ear inflammation and other ear disorders
• bronchitis, lung infection, inflammation of a nasal sinus
• a disease affecting the lymph nodes
• headache
• conjunctivitis (red eyes and discharge or pain in the eye)
• cough
• stuffy nose
• runny nose
• breathing difficulties (asthma)
• bleeding nose (epistaxis)
• vomiting
• nausea
• stomach ache, runny tummy
• indigestion

Less frequent side effects:

• Inflammation of the skin
• tympanic membrane (eardrum) disorder.

Post-Marketing Experience

Frequency unknown:

• fits
• abnormal and inappropriate behaviour, including abnormal motor behaviour
• disturbances in consciousness
• seeing or hearing things that aren’t real (hallucinations and delirium)
• allergy
• allergic skin reactions including dermatitis, rash, eczema, hives
• inflammation of the liver
• gastrointestinal bleedings, in particular, haemorrhagic colitis (characterized by abdominal cramping, bloody diarrhea).

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 Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of FLUMITEV.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from light. Keep original container until required for use. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).