Volutrip 50 mg/300 mg Film-Coated Tablets

VOLUTRIP contains three active ingredients, namely dolutegravir, tenofovir disoproxil and lamivudine and belongs to a group of medicines called antiviral medicines. VOLUTRIP is used is used to treat HIV (human immunodeficiency virus) infection in adults aged 18 years and older.

Do not take VOLUTRIP :

• If you are hypersensitive (allergic) to dolutegravir, lamivudine or tenofovir or any of the other ingredients of VOLUTRIP (listed in section 6).
• If you suffer from uncontrolled kidney failure.
• If you are taking anti-arrhythmic medicines called dofetilide or pilsicainide.
• If you are taking a medicine called metformin which is used for lowering of blood sugar levels.
• If you are taking the antiretroviral medicine called didanosine.
• If you are taking a medicine called adefovir dipivoxil which is used to treat hepatitis B.
• If you have any liver disease (moderate or severe).
• If you are younger than 18 years old.
• If you are pregnant or planning to become pregnant or breastfeeding (see Pregnancy breastfeeding and fertility).

Do not share medicines prescribed for you with any other person. VOLUTRIP therapy should be initiated by a medical practitioner experienced in the management of HIV infection. Always take VOLUTRIP exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

The usual dose of VOLUTRIP is one tablet daily and is only recommended for adults 18 years and older. Your doctor will tell you how long your treatment with VOLUTRIP will last. Do not stop treatment early because this may worsen your condition and make your body resistant to the medicine. If you have the impression that the effect of VOLUTRIP is too strong or too weak, tell your doctor or pharmacist.

If you take more VOLUTRIP then you should:

There is no specific treatment for VOLUTRIP overdose therefore if you have taken more VOLUTRIP than you should have your doctor will treat you for the symptoms that you have. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take VOLUTRIP:

If you forget to take a dose, take it as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for forgotten individual doses.

If you stop taking VOLUTRIP:

Consult your doctor if you stop or intend to stop taking VOLUTRIP.

VOLUTRIP can have side effects. Not all side effects reported for VOLUTRIP are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.

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

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching with blisters

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to VOLUTRIP. 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 which may occur frequently:

• Severe upper abdominal pain
• Yellowing of your skin, white of eyes, and nails

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

Tell your doctor if you notice any of the following which may occur frequently:

• Difficulty sleeping
• Headache
• Dizziness
• Abnormal dreams
• Diarrhoea
• Nausea
• Rash
• Itchy skin
• Tiredness
• Excess production of milk
• Increased blood sugar levels
• Feeling depressed
• Hair loss
• Painful muscles and joints
• Stomach cramps
• Kidney disorder in which the spaces between the kidney tubules become swollen (inflamed) - interstitial nephritis).
• excessive or an abnormally large production or passage of urine (polyuria)
• Fanconi syndrome (condition that affects how your kidneys reabsorb minerals and nutrients that you need to function).

Store at or below 30 °C. Keep the desiccant sachet in the container. Do not remove the desiccant sachet. Keep the tablets in the original container. Keep HDPE containers tightly closed. 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).