Altaeda 50 mg/200 mg/25 mg Film-Coated Tablets

ALTAEDA film coated tablets is an anti-viral medicine containing the following active substances: dolutegravir, emtricitabine and tenofovir alafenamide fumarate. ALTAEDA is indicated for use alone as a complete regimen for the treatment of human immunodeficiency virus - 1 (HIV-1) infection in adults and adolescents weighing at least 40 kg.

Do not take ALTAEDA:

• If you are allergic to dolutegravir, emtricitabine and/or tenofovir alafenamide fumarate or to any of the other ingredients of the ALTAEDA (see section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue;
• in combination with dofetilide;
• in combination with pilsicainide;
• in patients taking metformin;
• with other tenofovir-containing medicines, or with other emtricitabine-containing medicines;
• with lamivudine - containing medicines due to similarities between emtricitabine and lamivudine;
• in moderate and severe hepatic impairment;
• if creatinine clearance < 30 mL/min (renal impairment);
• Antiretroviral-experienced patients with HIV-1 harbouring the K65R mutation;
• if you pregnant or breastfeeding your baby (see “ Pregnancy and breastfeeding ”).

Warnings and precautions

ALTAEDA is not indicated for use as preexposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. Lactic acid build up in the body (causes nausea, vomiting, rapid deep breathing, and generalised weakness) and enlarged liver and fatty liver, have been reported with the use of some medicines for HIV alone or in combination with other antiretrovirals. Tenofovir alafenamide, one component of ALTAEDA film coated tablets, is approved for the treatment of chronic hepatitis B virus (HBV) infection. Severe acute worsening of hepatitis B has been reported in patients who are also infected with HIV-1 and HBV and have discontinued products containing tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of ALTAEDA film coated tablets.

Tell your doctor or health care provider before taking ALTAEDA:

• If you have liver disease;
• If you have kidney disease;
• If you have bone fractures or weak bones;
• If you are have hepatitis B or C or suspect that you might have these infections as treatment with ALTAEDA can increase your risk for severe and potentially fatal liver side effects.
• If you are currently taking any other medicine

Tell your doctor if any of the following happens while on treatment with ALTAEDA:

• Rash, or rash accompanied with fever, general feelings of discomfort, feeling tired, muscle or joint aches, blisters, sores in the mouth, infection or swelling of the eye, swelling of the face, tongue, throat, arms or legs and problems with breathing.
• Develop any infections and can be associated with the chest or eyes.
• Anxiety (feelings of nervousness or worrisome), hand tremors, weight loss, puffy eyes and an enlargement of the thyroid gland situated in the neck region.
• Muscle weakness and/or bone pain affecting both sides of the body, difficulty climbing stairs, rising from a seated position, lifting objects, or reaching overhead as this can be associated with an autoimmune disorder.
• Joint aches or stiffness and/or movement difficulties.
• Persistent or worsening bone pain, pain in arms and legs, fractures, and/or muscular pain or weakness.
• Weakness and tingling in the feet and legs, irregular beating of the heart (either fast or slow) as this can be associated with an autoimmune disorder.
• Kidney impairment, symptoms may include a reduce amount of urine, swelling of your legs, ankles, feet, excessive drowsiness and confusion, pain or pressure in the chest and seizures and may be associated with acute renal failure and Fanconi syndrome.
• Nausea, vomiting, abdominal pain, difficulty breathing, fatigue and weight loss.
• Liver impairment or worsening of liver disease, symptoms may include yellowing of the eyes or skin, itching, nausea or vomiting, pain and/or swelling of the tummy and loss of appetite.
• Redistribution of body fat, including central obesity, accumulation of fat that develops at the top of the back between the shoulders (buffalo hump), loss of fat on the arms, legs, and face with or without breast enlargement.

Do not share medicines prescribed for you with any other person. Always take ALTAEDA exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is one tablet once daily taken with or without food. Your doctor will tell you how long your treatment with ALTAEDA will last. Do not stop treatment early. If you have the impression that the effect of ALTAEDA is too strong or too weak, tell your doctor or pharmacist.

If you take more ALTAEDA you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take ALTAEDA Do not take a double dose to make up for forgotten individual doses. If you stop taking ALTAEDA Do not stop taking ALTAEDA unless your doctor tells you to.

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

If any of the following happens, stop taking ALTAEDA 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 (red skin, blistering of the lips, eyes or mouth, skin peeling), itching, high fever,
• Fainting

These are all very serious side effects. If you have them, you may have had a serious reaction to ALTAEDA. 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:

• changes in the way your heart beats, for example, if you notice it beating faster or slower
• chest pain
• difficulty breathing
• signs of recurrent infections such as fever and sore throat as well as infections, associated with the chest or eyes
• less urine than is normal for you, swelling of legs, ankles and feet
• yellowing of the skin and eyes, dark urine, and tiredness which may be symptoms of liver problems

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:

• Abnormal dreams
• Diarrhoea
• Difficulty breathing
• Difficulty sleeping
• Dizziness
• Fatigue (Abnormal physical weakness or lack of energy)
• Flatulence
• Generalised Pain
• Headache
• Increased amount of fat and glucose in the blood
• Increased amount of liver and digestive enzymes in the blood
• Increased bilirubin (broken down red blood cells) in the blood
• Increased in creatine kinase enzyme due to muscle breakdown
• Itching
• Low white blood cells
• Nausea
• Rash
• Skin discolouration
• Upper abdominal pain
• Vomiting

Less Frequent side effects:

• Aggravation of other infections after initiation of treatment with ALTAEDA
• Allergic reactions which may result in swelling of the face, tongue, throat (which may cause difficulty in swallowing or breathing), abdomen, or arms and legs often associated with severe itching and development of a skin rash which is raised and red in colour, also associated with sores in the mouth
• Anaemia (A condition in which the blood does not have enough healthy red blood cells)
• Depression (depressed mood and loss of interest in daily activities causing significant impairment in daily life
• Flatulence (increased gas in the digestive tract)
• Inflammation (swelling) of the liver
• Inflammation (swelling) of the muscles associated with pain
• Itchiness
• Kidneys not functioning properly
• Other psychiatric illness (A wide range of conditions that affect mood, thinking and behaviour)
• Pain and discomfort (bloating) in the tummy area and may be described as burning and nausea or vomiting
• Pain in the joints
• Trying to commit suicide or suicidal behaviour

Side effects of which frequency is unknown:

• Feelings of fear, worry and restlessness
• Liver failure which may manifest as yellowing of the skin and eyes balls, tummy pain and swelling, nausea, vomiting, disorientation, confusion, sleepiness and a general sense of feeling unwell
• Pain in the joints and muscle
• Increase amounts of lactic acid in the body which result in fast shallow breathing, unusual sleepiness, tiredness, or weakness and often associated with liver problems (sometimes kidney problems)
• Low potassium blood levels which can affect the way the heart beats
• Low levels of a phosphate in the blood which may result in muscle dysfunction and weakness associated with irritability and confusion
• Swelling of the pancreas often associated with tummy pain, nausea and vomiting
• Swelling of the liver and accumulation of fat in the liver
• Muscular pain and weakness of the muscle with or without muscle breakdown of muscle and /or softening of the bones which could result in fractures often associated with kidney impairment
• Renal and urinary disorders such as increase urination, increased amounts of protein in the urine which could be a sign of kidney disease or the kidney not functioning properly.

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

Store all medicines out of reach of children. Store at or below 25 °C. Keep the bottle tightly closed. Do not use after the expiry date stated on the container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).