Cabrimiv 600 mg/300 mg Film-Coated Tablets

    Cabrimiv 600 mg/300 mg Film-Coated Tablets

    S4


    1. What CABRIMIV is and what it is used for

    What CABRIMIV is: CABRIMIV belongs to a group of antiviral medicines, also known as antiretrovirals, called nucleoside analogue reverse transcriptase inhibitors (NRTIs). These are used to treat Human Immunodeficiency Virus (HIV) infection.

    What it is used for: CABRIMIV is used in combination with other antiretroviral medicines for the treatment of HIV infection in adults and adolescents from 12 years of age. CABRIMIV is always used with other anti-HIV-1 medicines.

    2. What you need to know before you receive CABRIMIV

    Do not take CABRIMIV: • if you are allergic (hypersensitive) to any of the active ingredients abacavir, lamivudine or any of the other ingredients of CABRIMIV (listed in section 6); • if you have liver disease; • if you have kidney disease; • if you are taking emtricitabine (a medicine to treat HIV infection); • if you are a child below 12 years of age (weighing less than 40 kg) as the necessary dose adjustment cannot be made. If you are not sure whether you should be taking CABRIMIV, please discuss with your doctor before taking this medicine.

    Warnings and precautions

    Hypersensitivity reaction (serious allergic reaction): The most important symptoms of this reaction are high temperature (fever) and a skin rash. Other frequently seen signs or symptoms are nausea, vomiting, diarrhoea, abdominal pain, shortness of breath, cough, headache, and severe tiredness. Other symptoms may be joint or muscle pain, swelling of the neck and sore throat. Occasionally swelling of the eye, ulcers in the mouth or low blood pressure may occur. The symptoms of this allergic reaction can occur at any time during treatment with CABRIMIV. However, they usually occur in the first six weeks of treatment and get worse with continued treatment.

    3. How to take CABRIMIV

    Do not share medicines prescribed for you with any other person. Always take CABRIMIV exactly as your doctor has instructed. You should check with your doctor or pharmacist if you are unsure. The usual dose is: • The usual dose in adults and adolescents from 12 years of age, who weigh at least 40 kg, is one tablet daily. • Treatment should be prescribed and initiated by a medical practitioner experienced in the management of HIV infection. • Take CABRIMIV for as long as your doctor recommends. Don’t stop unless your doctor advises you to. Take great care not to miss any doses if at all possible. Swallow the tablet whole with water. • CABRIMIV Tablets can be taken with or without food. • Your doctor will tell you how long your treatment with CABRIMIV will last. • If you have the impression that the effect of CABRIMIV is too strong or too weak, tell your doctor or pharmacist.

    If you take more CABRIMIV than you should

    In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

    If you forget to take CABRIMIV

    It is important to take CABRIMIV as prescribed to ensure you get maximum benefit. If you forget to take a dose, take it as soon as you remember and then continue as before. Do not take a double dose to make up for forgotten individual doses.

    If you stop taking CABRIMIV

    • If you have stopped taking CABRIMIV for any reason, especially if you think you are having side effects, or for other illness, it is important that you contact your doctor before restarting. • In some cases, you doctor will ask you to restart CABRIMIV under direct medical supervision or where medical care can be easily accessed by yourself or others. If your doctor thinks that there is a possibility your symptoms were related to hypersensitivity reaction, you may be told never to take CABRIMIV or any other medicine containing abacavir again.

    4. Possible side effects

    CABRIMIV can have side effects. Not all side effects reported for CABRIMIV are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking CABRIMIV, please consult your doctor, pharmacist or other healthcare professional for advice. If any of the following happens, stop taking CABRIMIV and tell your doctor immediately or go to the casualty department at your nearest hospital: • Some patients treated with CABRIMIV and did not have a gene called HLA- B*5701 developed a serious allergic reaction. The hypersensitivity reaction can be life-threatening or fatal if treatment with CABRIMIV is continued. You should contact your doctor immediately for advice on whether you should stop taking CABRIMIV if: - you get a skin rash OR - you get one or more symptom from at least TWO of the following groups: - fever - shortness of breath, sore throat or cough - nausea or vomiting or diarrhoea or abdominal (stomach) pain - severe tiredness or aches and pains or generally feeling ill.

    • Lactic acidosis (is more likely to develop in people who have liver disease or in very overweight people, especially women). It can be life- threatening, causing failure of internal organs. • Liver disorders, such as jaundice, enlarged liver or fatty liver, hepatitis (inflammation of the liver). • Widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome ) and a more severe form causing skin peeling in more than 30 % of the body surface (toxic epidermal necrolysis), • Inflammation of the pancreas (pancreatitis). These are all very serious side effects. If you have them, you may have had a serious reaction to CABRIMIV. You may need urgent medical attention or hospitalisation.

    5. How to store CABRIMIV

    • Store all medicines out of reach of children. • Do not store above 30 °C. • Protect from light. • Store the tablets in the original container. • Keep the blisters in the outer carton until required for use. • Keep the container tightly closed. • Do not store in bathrooms. • Do not take the medicine after the expiry date stated on the bottle/blister/carton. • Return all unused medicine to your pharmacist. • Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

    Important Disclaimer

    The Cabrimiv 600 mg/300 mg Film-Coated Tablets professional information leaflet below is the property of Viatris Healthcare and is provided on Somayeza exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Somayeza serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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