Rarudine Film-Coated Tablets

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

Do not take RARUDINE:

• if you are hypersensitive (allergic) to dolutegravir, tenofovir disoproxil, lamivudine or any of the other ingredients of RARUDINE (see section 5)
• if you have kidney problems
• if you are pregnant or breastfeeding your baby
• if you are a women of child - bearing - age unless and are not using highly effective contraception
• if you are taking a medicine called adefovir dipivoxil (used to treat hepatitis B)
• if you are taking medicines called dofetilide or pilsicainide (to treat heart conditions)
• if you are taking medicine called didanosine (used in the treatment of HIV)
• if you are taking medicine called metformin (used to treat high blood sugar levels)
• if you are under the age of 18
• if you suffer from moderate to severe liver disease.

Warnings and precautions

WARNING If you take RARUDINE alone or with other medicine used for the treatment of HIV/AIDS (called antiretrovirals), you may develop a condition called lactic acidosis (build-up of lactate in the body which causes symptoms like stomach discomfort, lower appetite diarrhoea) or an enlarged liver with a condition called fatty liver disease (a build-up of fat in the liver and may include symptoms like fatigue, weight loss and abdominal pain) RARUDINE is not indicated for the treatment of chronic hepatitis B virus (HBV) infection (a serious liver infection). Your healthcare provide may advise you to discontinue the use of RARUDINE if you have both the HBV virus and HIV/AIDS, as you may experience worsening of the liver infection. Your healthcare provider will monitor your liver function, closely. Your healthcare provider may consider giving you anti-hepatitis B therapy.

Do not share medicines prescribed for you with any other person. Always use RARUDINE exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual dose is one tablet once daily. RARUDINE can be taken with food or between meals. Your doctor will tell you how long your treatment with RARUDINE 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 RARUDINE is too strong or too weak, tell your doctor or pharmacist.

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

If you forget to take RARUDINE: If you forget to take RARUDINE, take a dose as soon as you remember, then continue to take RARUDINE at the usual times. Do not take a double dose to make up for forgotten individual doses.

If you stop taking RARUDINE: If you have HIV and hepatitis B virus (HBV) and stop taking RARUDINE, your hepatitis infection may become worse than it was before starting treatment.

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

If any of the following happens, stop using RARUDINE 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 RARUDINE. 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:

• inflammation of the pancreas, which causes severe pain in the abdomen and back (pancreatitis)
• bleeding into the skin, bruising and slow blood clotting after an injury (thrombocytopenia)
• hepatitis (swelling and inflammation of the liver, characterised by symptoms such as, abdominal pain or distension, dark urine and pale or clay-coloured stools, fatigue, fever, general itching, yellowing of the skin or eyes, loss of appetite, nausea and vomiting), jaundice
• thoughts of killing or harming yourself, or attempting to commit suicide
• rhabdomyolysis (a condition affecting the muscles with symptoms such as dark urine and difficulty moving arms or legs)
• kidney failure
• lactic acidosis (excess lactic acid in the blood) with symptoms including deep, rapid breathing, drowsiness, nausea, vomiting and stomach pain. 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:

• Hypophosphataemia is an electrolyte disorder in which there is a low level of phosphate in the blood, with symptoms that may include weakness, trouble breathing, and loss of appetite
• Insomnia (difficulty sleeping), abnormal dreams (nightmares), depression, anxiety
• Headache, dizziness
• Cough, nasal discharge and congestion
• Nausea, diarrhoea, vomiting, flatulence, stomach pain or discomfort
• Skin rash, hair loss, severe itching of the skin
• Fatigue, general feeling of being unwell, fever
• Liver problems, increased enzyme levels
• Painful inflammation in the mouth
• Arthralgia
• Anorexia, indigestion.

Less frequent side effects:

• Anaemia, changes in the white blood cell counts (neutropenia), possibly resulting in an increased risk of infection
• Peripheral neuropathy (damage to nerves outside the spinal cord, affecting the normal functioning of the body’s organs and movement and/or feeling of sensation in the extremities, including your arms and legs)
• Tingling sensation in the hands, feet or lips (pins and needles)
• Difficulty in breathing (dyspnoea)
• Increased digestive enzyme levels
• Joint pain, muscle pain
• Changes to your urine and back pain caused by kidney problems, including kidney failure
• Abnormal physical weakness or lack of energy
• Redistribution of your body fat around your body
• Increased liver enzymes as determined by blood tests
• Decreased bone density, bone fractures

The following side effects have been reported but the frequency for them to occur is not known:

• Low blood potassium (with symptoms including muscle weakness, cramps, muscle twitches)
• Fatty liver disease (symptoms may include weight loss, fatigue and abdominal pain)
• Bone pain, muscle weakness
• Inflammation of the kidney, passing a lot of urine and feeling thirsty
• Recurrence of previous infections such as nose, throat or chest infections
• Abdominal pain and discomfort.

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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of RARUDINE.

Store all medicines out of reach of children. Store at or below 30 °C in original container. Discard 90 days after first opening. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).