Reydin Film-Coated Tablets

REYDIN is an antiviral medicine. REYDIN tablets are used to treat human immunodeficiency virus-1 (HIV-1) infected adults over 18 years of age.

WARNING TOO MUCH ACID IN THE BODY DUE TO LACTIC ACID AND SERIOUS ENLARGED, FATTY LIVER, INCLUDING CASES RESULTING IN DEATH, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES (MEDICINES USED FOR THE TREATMENT OF HIV) ALONE OR IN COMBINATION WITH OTHER ANTIRETROVIRALS (SEE WARNINGS AND PRECAUTIONS). REYDIN IS NOT INDICATED FOR TREATMENT OF CHRONIC HEPATITIS B VIRUS (HBV) INFECTION. THE SAFETY AND EFFICACY OF REYDIN HAS NOT BEEN ESTABLISHED IN PATIENTS INFECTED WITH BOTH HBV AND HIV. SEVERE ACUTE WORSENING OF HEPATITIS B HAS BEEN REPORTED IN PATIENTS WHO ARE INFECTED WITH BOTH HBV AND HIV AND HAVE STOPPED TAKING THE COMBINATION TABLET. LIVER FUNCTION SHOULD BE MONITORED CLOSELY BY A HEALTH CARE PRACTITIONER FOR AT LEAST SEVERAL MONTHS IN PATIENTS WHO ARE INFECTED WITH BOTH HIV AND HBV AND WHO STOPPED TAKING THE COMBINATION TABLET. IF APPROPRIATE, MEDICINE TO TREAT HEPATITIS B MAY NEED TO BE PRESCRIBED (SEE WARNINGS AND PRECAUTIONS).

Do not take REYDIN:

• If you are hypersensitive (allergic) to dolutegravir, lamivudine or tenofovir disoproxil fumarate, or any of the ingredients of REYDIN (listed in section 6).
• If you have kidney failure.
• If you have liver disease.
• If you are pregnant or breastfeeding your baby.
• If you plan on becoming pregnant.
• If you are a woman of childbearing age and not using effective contraceptives to prevent falling pregnant.
• If you are also taking heart medication for irregular heartbeat containing dofetilide and pilsicainide.
• If you are taking metformin, for the treatment of type 2 diabetes.
• If you are taking chronic medication for hepatitis B infection, containing adefovir dipivoxil.
• If you are taking other anti-retroviral medicines containing didanosine.
• If you are younger than 18 years of age.

Warnings and precautions

Take special care with REYDIN: Tell your doctor:

• If you develop a rash, or show any general signs of allergy (rash, accompanied by fever, general feeling of being ill, tiredness, muscle or joint aches, sores, oral scrapes, eye infection, facial swelling, a serious liver infection or swelling of the skin).
• If you develop changes in body fat, as changes have been seen in some patients taking REYDIN and other anti-HIV medicines. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen. The cause and long-term health effect of these conditions are not known at this time.
• If you show any symptoms of infection while you are taking REYDIN. People with advanced HIV infection (AIDS) have weak immune systems and are more likely to develop serious infections (opportunistic infections). When these people start with the treatment, they may find that old hidden infections (such as tuberculosis) flare up, causing signs and symptoms of inflammation (such as localised swelling, area appears red and hot, painful). These symptoms are probably caused by the body’s immune system becoming stronger, so that the body starts to fight these infections.
• If you have abnormal metabolic processes, such as, increased cholesterol, glucose or lactate in the blood or are resistant to insulin. Your healthcare professional may perform regular blood tests to confirm normal metabolic processes.
• If you have liver problems including hepatitis B virus (HBV) infection.
• If you show signs of liver injury.
• If you show symptoms such as nausea, vomiting, abdominal pain, non-specific general feeling of being ill, loss of appetite, weight loss, rapid and/or deep breathing, or muscle weakness.
• If you are female, very overweight (obese), or have been using medicines for the treatment of HIV for a long time as you may be more likely to get lactic acidosis (build-up of lactic acid in the body) (see Possible side effects).
• If you suffer from kidney disease.
• If you experience pain in the stomach, as this can be a symptom of pancreatitis (swelling of the pancreas) (see Possible side effects).
• If you suffer from liver disease including hepatitis B or C, as the use of antiviral medicine can cause fatal unfavourable liver symptoms. Your doctor will monitor your live enzymes as REYDIN can cause liver toxicity.
• If your child experiences symptoms of poor growth, loss of muscle coordination, muscle weakness, visual problems, hearing problems, learning disabilities, heart disease, liver disease, kidney disease, gastrointestinal disorders, respiratory disorders, nervous system problems (brain, spine and nerves), loss of voluntary body functions (such as breathing, bladder function, heartbeat and digestive processes) and dementia (loss of memory) can be a sign of mitochondrial (part of the cell that creates energy) disorder. These findings should be considered for any child exposed to treatment, before being born.
• If you have had bone problems in the past, your healthcare provider may need to do tests to check your bone mineral density or may prescribe medicines to help your bone mineral density.
• If you experience joint aches and pain, joint stiffness or difficulty in movement, you may suffer from osteonecrosis.
• If you are elderly and suffer from kidney or liver damage or failure.
• If you have a history of depression or mental illness as REYDIN may cause depression and suicidal thoughts.

REYDIN should be used with caution in the elderly (65 years and over), due to decreased liver and kidney function. REYDIN should not be taken with other medicines containing any of the active ingredients, namely: dolutegravir, lamivudine or tenofovir disoproxil fumarate (see Other medicines and REYDIN). REYDIN does not reduce the risk of passing HIV to others through sexual contact or blood contamination. Therefore, it is important to continue to take appropriate precautions to prevent passing HIV to others. Even if you are receiving treatment for HIV, you are still at risk of contracting other infections and other complications of the HIV infection. Therefore, you should remain under close observation by your doctor.

Do not share your medicines prescribed for you with any other person. REYDIN therapy should be initiated by a healthcare professional experienced in the management of HIV infections. Always take REYDIN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose for REYDIN is one tablet taken orally, once daily, with or without food. REYDIN can only be used by adults over the age of 18 years. Your doctor will tell you how long your treatment with REYDIN will last. Do not stop treatment early because this may worsen your condition and make your body resistant to the medicine. If you have an impression that the effect of REYDIN is too strong or too weak tell your doctor or pharmacist.

If you take medicine for tuberculosis containing rifampicin, please consult your healthcare professional (see Other medicines and REYDIN).

If you take more REYDIN 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.

If you forget to take REYDIN

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

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

If any of the following happens, stop taking REYDIN 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 REYDIN. 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:

• Pancreatitis (inflammation of the pancreas, which causes severe pain in the abdomen and back).
• Thrombocytopenia (bleeding into the skin, bruising and slow blood clotting after an injury).
• Hepatitis (swelling and inflammation of the liver, characterised by symptoms such as abdominal pain, dark urine and pale or clay-coloured stools, fatigue, fever, general itching, yellowing of the skin or eyes, loss of appetite, nausea and vomiting).
• 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 (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, 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.
• Increased liver enzyme levels.

Less frequent side effects:

• Anaemia (not having enough healthy red blood cells), neutropenia (changes in the white blood cell counts), thrombocytopenia (low platelet count in your blood which is required for blood to clot) and pure red cell aplasia (type of anaemia which affects red blood cells).
• 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).
• Dyspnoea (difficulty breathing).
• Increased digestive enzyme (amylase) levels.
• Joint pain, muscle pain.
• Kidney problems including kidney failure.
• Abnormal physical weakness or lack of energy.
• Redistribution of fat around your body.
• Decreased bone density, bone fractures.

Side effects with unknown frequency:

• Hypokalaemia (low blood potassium levels).
• Fatty liver disease (symptoms include weight loss, fatigue and abdominal pain).
• Bone pain, muscle weakness, experiencing a decrease in height, stooped posture, and easily fractured bone (loss of bone mass).
• Inflammation of the kidney, diabetes insipidus (frequent urination and often feeling thirsty).
• Immune reconstitution syndrome (condition in which the immune system begins to recover but then responds to a previously acquired opportunistic infection with an overwhelming inflammatory response making the symptoms of infection worse).

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 “Med Safety APP” (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website or to Cipla Medpro (Pty) Ltd. by e-mail: [email protected] or telephone: 080 222 6662 (toll free). By reporting side effects, you can help provide more information on the safety of REYDIN.

Store at or below 30 °C. Keep the container tightly closed. Store in the original container until required for use. Store all medicines out of reach of children. Do not store in a bathroom. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).