Vulante 300 mg/50 mg Film-Coated Tablets

VULANTE belongs to a group of medicines called antivirals, for treatment of HIV (human immunodeficiency virus) infection in adults aged 18 years and older.

Do not take VULANTE:

• if you are hypersensitive (allergic) to dolutegravir, lamivudine, tenofovir or any of the other ingredients of VULANTE (see section 6).
• if you are taking a medicine called metformin (to treat diabetes).
• if you are taking medicine called adefovir dipivoxil (used to treat Hepatitis B infection).
• if you are taking medicine called dofetilide or pilsicainide (to treat heart rhythm problems).
• if you are taking medicine called didanosine (to treat HIV).
• if you have liver or kidney disease.
• if you are a woman of child - bearing age not using effective contraception.
• if you are below the age of 18 years.
• if you are pregnant (in your first trimester) or breastfeeding your baby. VULANTE could seriously harm your unborn child if you fall pregnant while on treatment or if you start taking VULANTE in the first few weeks of your pregnancy (see Take Special care with VULANTE and Pregnancy and breastfeeding).

Warnings and precautions

LACTIC ACIDOSIS (EXCESS LACTIC ACID IN THE BLOOD) IS A RARE BUT SERIOUS POSSIBLE SIDE EFFECT THAT CAN BE FATAL. THE FOLLOWING SIDE EFFECTS MAY BE SIGNS OF LACTIC ACIDOSIS:

• DEEP, RAPID BREATHING
• WEIGHT LOSS, LOSS OF APPETITE
• GENERAL FEELING OF DISCOMFORT
• FEELING SICK (NAUSEA), BEING SICK (VOMITING) AND STOMACH PAIN

IF YOU THINK THAT YOU MAY HAVE LACTIC ACIDOSIS, CONTACT YOUR DOCTOR IMMEDIATELY.

AN ENLARGED LIVER WITH FATTY LIVER DISEASE HAVE BEEN REPORTED WITH THE USE OF VULANTE. IF YOU HAVE A LIVER DISEASE, TELL YOUR HEALTHCARE PROVIDER AS VULANTE CAN WORSEN OR CAUSE LIVER DISEASE. VULANTE IS NOT INDICATED TO TREAT HEPATITIS B (AN INFECTION OF YOUR LIVER THAT CAUSES INFLAMMATION AND SCARRING OF YOUR LIVER). IF YOU HAVE BEEN DIAGNOSED WITH HEPATITIS B, TELL YOUR HEALTHCARE PROVIDER AS VULANTE CAN WORSEN SYMPTOMS OF HEPATITIS B. YOUR DOCTOR WILL SEND YOU FOR REGULAR BLOOD TESTS TO MONITOR YOUR LIVER FUNCTION IF YOU HAVE HAD TO STOP VULANTE DUE TO HEPATITIS B INFECTION.

Do not share medicines prescribed for you with any other person. Always take VULANTE exactly as your doctor or pharmacist has instructed you. Check with your doctor or pharmacist if you are not sure. The usual dose of VULANTE is one tablet once a day. Your doctor will decide on the correct dose of VULANTE for you. Swallow the tablet with some liquid. VULANTE can be taken with or without food.

Your doctor will tell you how long your treatment with VULANTE will last. Do not stop treatment unless your doctor advises you to.

If you have the impression that the effect of VULANTE is too strong or too weak, tell your doctor or pharmacist.

If you take more VULANTE than you should

In the event of overdosage, consult your doctor or pharmacist. If your healthcare provider is not available, contact the nearest hospital or poison control centre.

If you forget to take VULANTE

Do not take a double dose to make up for forgotten individual doses. If you have missed a dose of VULANTE, take the dose that you have missed as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. If you have forgotten to take several doses, contact your doctor without delay.

If you stop taking VULANTE

Take VULANTE for as long as your doctor recommends. Do not stop taking VULANTE unless your doctor advises you to because stopping your treatment may cause resistance. Even if you decide to take VULANTE again at a later stage, VULANTE might not work. For these reasons, it is vital to take VULANTE exactly as your doctor or pharmacist has instructed you.

VULANTE can have side effects. Not all side effects reported for VULANTE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VULANTE, please consult your doctor or pharmacist for advice. 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 VULANTE. If you get any of these effects and if they are severe, your doctor may advise you to stop taking VULANTE.

As well as the effects listed below for VULANTE, other conditions can develop during combination therapy for HIV (see section 2). If any of the following happens, stop taking VULANTE 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,
• skin rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to VULANTE. 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 in your liver or pancreas (hepatitis or pancreatitis) or liver problems that causes yellowing of the skin and eyes, (jaundice) dark coloured urine, light coloured stools, abdominal pain, nausea and vomiting,
• any unusual or unexplained bruising or bleeding due to a low blood platelet count (thrombocytopenia),
• fever, chills, swelling, sore throat, fatigue, which may be signs of an infection due to low white blood cell count (neutropenia),
• kidney problems, including kidney failure. Due to the build-up of waste products and excess fluid in the body, symptoms may include, but are not limited to, weakness, shortness of breath, tiredness, swelling in your legs, ankles, and feet, confusion, abnormal heart rhythm, reduction in how much and how often you urinate and pain or pressure in your chest,
• lactic acidosis. Patients who take VULANTE can develop a serious condition called lactic acidosis (build-up of an acid in the blood). Call your doctor right away if you get the following signs or symptoms of lactic acidosis:

- You feel very weak or tired,
- You suddenly lose weight and do not have an appetite,
- You have unusual (not normal) muscle pain,
- You have trouble breathing.

• rhabdomyolysis. The breakdown of muscle fibers that leads to the release of muscle fiber contents (myoglobin) into the bloodstream. Myoglobin is harmful to the kidney and often causes kidney damage. Call your doctor right away if you get the following signs or symptoms:

• Abnormal urine colour (dark, red, or cola coloured),
• Decreased urine production,
• General weakness,
• Muscle stiffness or aching (myalgia),
• Muscle tenderness,
• Weakness of the affected muscles.

• if you are also infected with the Hepatitis B Virus (HBV), you need close medical follow up for several months after stopping treatment with VULANTE. Follow-up includes medical exams and blood tests to check for HBV that could be getting worse. Patients with hepatitis B Virus who take VULANTE and then stop it, may get “flare-ups” of their hepatitis. A “flare-up” is when the disease suddenly returns in a worse way than before. VULANTE is not approved for the treatment of Hepatitis B Virus infection,

• suicidal thoughts or an attempt to take one’s own life,

• convulsions (fits),

• neural tube defects (a group of birth defects involving the brain, spine and spinal cord) in babies born to women taking VULANTE (see section 2),

• abnormal results when your blood is tested, decrease in red blood cells, white blood cells and platelets,

• an inflammatory condition which may develop as the immune system becomes stronger (immune reconstitution syndrome or ‘IRIS’). Symptoms can include fever, headache, stomach ache, difficulty breathing, rapid or irregular heartbeat or tremor, excessive restlessness and movement and weakness,

• blood in the urine (haematuria), protein in the urine (proteinuria), increased urine production (polyuria), frequently feeling thirsty,

• chest pain, inflammation of the lungs caused by a bacterial infection (pneumonia), difficulty breathing (dyspnoea),

• loss of blood flow to bone tissue, which causes the bone to die (osteonecrosis),

• painful joints and bones, bones that break more easily (osteomalacia),

• decreased levels of potassium in the blood (hypokalaemia).

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

Tell your doctor if you notice any of the following:

Frequent side effects:

• difficulty in sleeping (insomnia), abnormal dreams, depression,
• headache, dizziness,
• feeling sick (nausea) and being sick (vomiting), wind (flatulence), outward expansion of stomach (stomach distension), diarrhoea, stomach pain or cramps (upper abdominal pain, abdominal pain), stomach discomfort (abdominal discomfort), heartburn (dyspepsia), lack of appetite (anorexia),
• lack of energy (fatigue),
• increase in the level of liver enzymes when your blood is tested,
• cough, nasal symptoms,
• hair loss (alopecia),
• pain in the joints (arthralgia), muscle disorders,
• a general feeling of discomfort or illness (malaise), fever, abnormal physical weakness or lack of energy (asthenia),
• decreased phosphate levels (hypophosphataemia),
• feeling of unease, such as worry or fear (anxiety).

Less frequent side effects:

• pain in the muscles (myalgia), disease of the muscles (myopathy),
• “pins and needles” in the hands and feet (peripheral neuropathy),
• increased enzyme levels (serum amylase, AST, ALT),
• increased cholesterol levels in the blood (hypercholesterolaemia) or an increase in a certain type of fat in the blood (hypertriglyceridaemia),
• increased blood sugar levels (hyperglycaemia) or an inability of the body to lower blood sugar levels normally (insulin resistance),
• increased lactate levels in the blood (hyperlactatemia),
• fat redistribution,
• bone pain.

Side effects with unknown frequency:

• sensation of spinning (vertigo).

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. Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088

By reporting side effects, you can help provide more information on the safety of VULANTE.

Store all medicines out of reach of children

Store at or below 30 °C. Keep the bottle tightly closed. Protect from moisture. Keep the desiccant in the container. Do not remove the desiccant. Keep in original packaging until required for use. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).