Dolvidin 50 mg/600 mg/300 mg Film-Coated Tablets

    Dolvidin 50 mg/600 mg/300 mg Film-Coated Tablets

    S4


    1. What DOLVIDIN is and what it is used for

    DOLVIDIN is a medicine that contains three active ingredients used to treat HIV infection: abacavir, lamivudine and dolutegravir. Abacavir and lamivudine belong to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs), and dolutegravir belongs to a group of anti- retroviral medicines called integrase inhibitors (INIs).

    DOLVIDIN is used to treat HIV (human immunodeficiency virus) infection in adults and adolescents over 18 years old.

    DOLVIDIN does not cure HIV infection; it reduces the amount of virus in your body and keeps it at a low level. Not everyone responds to treatment with DOLVIDIN in the same way. Your doctor will monitor the effectiveness of your treatment.

    2. What you need to know before you take DOLVIDIN

    Do not take DOLVIDIN:

    • if you are hypersensitive (allergic) to dolutegravir, abacavir (or any other medicine containing abacavir), or lamivudine, or any of the other ingredients of DOLVIDIN listed in section 6
    • if you are taking a medicine called dofetilide (to treat heart conditions) or pilsicainide (to treat heart dysrhythmia)
    • if you have moderate or severe liver problems
    • if you are pregnant (three months before (preconception) to three months after conception and during the first trimester) or breastfeeding your baby
    • if you have severe kidney problems
    • if you are a diabetic, taking metformin and your doctor want to prescribe DOLVIDIN.

    Warnings and precautions

    Take special care with DOLVIDIN: IMPORTANT — Hypersensitivity reactions DOLVIDIN contains abacavir. About 5 in every 100 people who take abacavir develop a hypersensitivity reaction (a serious allergic reaction), which can be life-threatening if they continue to take abacavir.

    Who gets these reactions? Anyone taking DOLVIDIN could develop a hypersensitivity reaction to abacavir. You are more likely to develop such a reaction if you have a gene called HLA-B*5701 (but you can get a reaction even if you do not have this gene). If possible, you will have been tested for this gene before DOLVIDIN was prescribed for you. If you know you have this gene, tell your doctor before you take DOLVIDIN.

    What are the symptoms? The most common symptoms are:

    • fever (high temperature) and skin rash.

    Other common symptoms are:

    • nausea (feeling sick), vomiting (being sick), diarrhoea, abdominal (stomach) pain,
    • severe tiredness, shortness of breath, cough, headache, muscle pain and discomfort.

    Other less common symptoms can include:

    • pains in the joints, swelling of the neck, serious breathing problems, sore throat occasionally, inflammation of the eye (conjunctivitis), mouth ulcers, low blood pressure, tingling or numbness of the hands or feet.

    If you continue to take DOLVIDIN, the symptoms will get worse and may be life-threatening.

    3. How to take DOLVIDIN

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

    Adults and adolescents: The usual dose is one tablet once a day. Swallow the tablet with some liquid. DOLVIDIN can be taken with or without food.

    Children: DOLVIDIN should not be used in patients younger than 18 years.

    Do not take an antacid during the 6 hours before you take DOLVIDIN, or for at least 2 hours after you take it. Other acid-lowering medicines like ranitidine and omeprazole can be taken at the same time as DOLVIDIN. Talk to your doctor for further advice on taking antacid medicines with DOLVIDIN.

    Do not take a calcium or iron supplement during the 6 hours before you take DOLVIDIN, or for at least 2 hours after you take it. Talk to your doctor for further advice on taking calcium supplements, iron supplements or multivitamins with DOLVIDIN.

    Your doctor will tell you how long your treatment with DOLVIDIN will last. If you have the impression that the effect of DOLVIDIN is too strong or too weak, tell your doctor or pharmacist.

    If you take more DOLVIDIN than you should

    In the event of overdosage, consult your doctor or pharmacist without delay. If neither is available, contact the nearest hospital or poison centre.

    If you forget to take a dose of DOLVIDIN

    Do not take a double dose to make up for forgotten individual doses.

    If you stop taking DOLVIDIN

    Take DOLVIDIN for as long as your doctor recommends. Do not stop unless your doctor advises you to. If you have stopped taking DOLVIDIN for any reason, particularly because you think you are having side effects or for other illness, it is important that you contact your doctor before restarting. In some cases, your doctor will ask you to restart DOLVIDIN in a place where you will be able to get ready access to medical care if needed. If you have hepatitis B infection, do not stop DOLVIDIN without your doctor’s advice, as your hepatitis may come back.

    4. Possible side effects

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

    When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of DOLVIDIN or other medicines you are taking, or an effect of the HIV disease itself. So, it is very important to talk to your doctor about any changes in your health.

    Some side effects may only be seen in your blood tests and may not appear immediately after you start taking DOLVIDIN. If you get any of these effects, and if they are severe, your doctor may advise you to stop taking DOLVIDIN.

    Hypersensitivity to abacavir: About 5 in every 100 people who take abacavir develop a hypersensitivity reaction (a serious allergic reaction) which can be life-threatening. It is very important that you read and understand the information about this serious reaction. See ‘Take special care with DOLVIDIN’.

    If any of the following happens, stop taking / using DOLVIDIN 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 DOLVIDIN. 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:

    • symptoms of infection and inflammation such as muscle weakness and/or muscle pain joint pain or swelling, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations or tremor, hyperactivity (excessive restlessness and movement)
    • lactic acidosis with signs such as deep, rapid, difficult breathing, drowsiness, numbness or weakness in the limbs, feeling sick (nausea), vomiting and stomach pain
    • a 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 (toxic epidermal necrolysis)

    body shape changes such as fat may be lost from the legs, arms or face, extra fat may build up around the stomach, or on the breasts or internal organs, fatty lumps (sometimes called buffalo hump) may appear on the back of the neck

    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:

    • loss of appetite
    • difficulty in sleeping, abnormal dreams, depression, anxiety
    • nightmares, sleep disorder
    • headache, dizziness, sleepiness, lack of energy
    • cough, nasal symptoms
    • nausea, diarrhoea
    • vomiting, wind (flatulence), stomach pain, stomach discomfort, indigestion
    • reflux (heartburn)
    • hair loss
    • muscle pain and discomfort
    • joint pain
    • physical weakness, general feeling of being unwell, tiredness, fever
    • increased liver enzymes

    Less frequent side effects:

    • decreased number of cells involved in blood clotting (thrombocytopenia).
    • low red blood cell count (anaemia) or low white blood cell count (neutropenia)
    • a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
    • increase in sugar (glucose) in the blood
    • increase in triglycerides (type of fat) in the blood
    • suicidal thoughts and behaviours (particularly in patients who have had depression or mental health problems before)
    • numbness, tingly, pain feelings in the skin (pins and needles) of the hands and feet
    • inflammation of the pancreas
    • inflammation of the liver
    • skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
    • muscle weakness, pain and vomiting
    • increased liver enzymes especially amylase

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

    Reporting of side effects

    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/documents/adverse-drug-reactions-and-quality-problem-reporting-form. By reporting side effects, you can help provide more information on the safety of DOLVIDIN.

    5. How to store DOLVIDIN

    Store all medicines out of reach of children.

    Store at or below 30 °C.

    Do not use DOLVIDIN after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

    Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

    Important Disclaimer

    The Dolvidin 50 mg/600 mg/300 mg Film-Coated Tablets professional information leaflet below is the property of Novagen Pharma 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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