TRIBUSS can have side effects. Not all side effects reported for TRIBUSS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TRIBUSS, please consult your healthcare provider for advice. If any of the following happens, stop taking TRIBUSS and tell your healthcare provider 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;
- blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens-Johnson Syndrome (SJS).
These are all very serious side effects. If you have them, you may have had a serious allergic reaction to TRIBUSS. You may need urgent medical attention or hospitalisation. Tell your healthcare provider immediately or go to the casualty department at your nearest hospital if you notice any of the following:
- Lactic acidosis (build-up of an acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital. Call your healthcare provider right away if you get any of the following signs of lactic acidosis:
- You feel weak and tired
- You have unusual muscle pain
- You have stomach pain with nausea and vomiting
- You feel cold, especially in your arms and legs
- You feel dizzy and lightheaded
- You have a fast and irregular heartbeat;
serious liver problems (hepatotoxicity), with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your healthcare provider right away if you get any of the following signs of liver problems:
- Yellow discolouration of your skin and the white part of your eyeballs known as jaundice
- Darkening of your urine
- Your bowel movements turn lighter in colour
- You feel sick to your stomach (nausea)
- You have stomach pain;
“flare-ups” of hepatitis B virus (HBV) infection, in which the disease suddenly returns in a worse way than before. Your healthcare provider will monitor your condition for several months after stopping TRIBUSS if you have both HIV and HBV infection and may recommend treatment for your HBV;
serious psychiatric problems. A small number of patients may experience severe depression, strange thoughts, thoughts of suicide or angry behaviour while taking TRIBUSS. Contact your healthcare provider right away if you think you are having these psychiatric symptoms;
a sudden, violent, irregular movement of the body (convulsions);
kidney problems. Should you notice blood in your urine, have difficult or painful urination and pain in the lower back, contact your healthcare provider immediately;
you have the feeling that your heart is beating too hard or too fast, skipping a beat, or fluttering and your heart rate increases (palpitations and tachycardia);
you have a persistent dry cough that often gets worse at night, fever, shortness of breath, fatigue or tiredness with chest pain that gets worse when you take a deep breath or cough (pneumonia); you have difficulty catching your breath or noisy breathing with very fast, shallow breaths and cold, clammy skin, difficulty breathing (dyspnoea). These are all serious side effects. You may need urgent medical attention.
Tell your healthcare provider if you notice any of the following:
The following side effects have been reported frequently:
- Dizziness, headache;
- vomiting, diarrhoea, winds (flatulence), indigestion (dyspepsia);
- obsessive desire to lose weight by refusing to eat (anorexia); weight loss;
- you have muscle weakness and cramps (elevation of creatinine kinase) or muscle dysfunction and weakness (hypophosphatemia);
- you experience pain below the ribs and above the pelvis (abdominal pain).
- extreme tiredness (fatigue);
The following side effects have been reported less frequently:
- you have trouble sleeping (insomnia), have a need to sleep all the time or sleeping for unusually long periods (somnolence);
- drowsiness, fainting due to drop in blood pressure (syncope) or you experience problems with your balance (vertigo);
- you have trouble concentrating and/or unusual dreams during treatment with TRIBUSS;
- you are confused, having trouble remembering familiar places, memory loss (amnesia);
- you have a loss of motivation or willingness to continue with daily activities (apathy);
- you have abnormal physical weakness or lack of energy (asthenia);
- you have a feeling of panic, fear, inability to stay calm (anxiety), you find yourself being annoyed at small things (agitation); have rapid changes in moods (emotional lability) or you have the feeling of discomfort, illness, or uneasiness (malaise);
- you have an increased feeling of excitement and happiness (euphoria), seeing things that are not real (hallucination);
- you have trouble moving different parts of your body together (abnormal coordination), the loss of full control of bodily movements (ataxia), reduced sense of touch or sensation (hypoaesthesia), abnormal sensation of the body, such as numbness, tingling, or burning (paraesthesia);
- you have pains in your joints (arthralgia), you have pain in your muscles or groups of muscles (myalgia);
- shaking of your arms, leg, hands (tremor) or you have the feeling that your muscles are weak (myopathy);
- shooting pains in your head or face (neuralgia) or your feet and hands tingle (peripheral neuropathy);
- problems speaking or pronouncing words (speech disorder);
- abnormal vision;
- noises or ringing in the ears (tinnitus);
- changes in your ability to taste for example the taste difference between sweet and salty (taste perversion);
- a sudden feeling of heat (hot flushes);
- tests may show that you have an increase of fatty deposits in your blood vessels (high cholesterol) or you have an increased level of natural fats and oil build up (raised triglyceride concentrations);
- you are coughing at night or wheezing with a tight chest (asthma);
- you have skin or mouth lesions that have a pink-red centre surrounded by a pale ring border and an outer pink-red ring (erythema multiforme); you have sores on your skin that are itchy, raised, red or skin-coloured (urticaria) or flaking/peeling of skin (skin exfoliation);
- partial or complete absence of hair from areas of the body where it normally grows; baldness (alopecia);
- you have abdominal pain that may radiate to the back, nausea and vomiting, worsening pain after eating, tenderness to touch of the abdomen, fever and chills, weakness and lethargy (pancreatitis).
It is possible that these symptoms may be more severe if TRIBUSS is used with alcohol or mood altering (street) medicines. The following side effects have been reported but the frequency is unknown:
- Changes in body fat. Changes in body fat develop in some patients taking TRIBUSS. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), in the breasts and around the trunk. Loss of fat from the legs, arms and face may also happen. The cause and long-term health effects of these fat changes or weight gain are not known;
- changes in bone mineral density (thinning bones). It is not known whether long-term use of TRIBUSS will cause damage to your bones. 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 (osteomalacia);
- you have the need to eat more than usual (increased appetite);
- you have a loss of appetite, upper stomach pain, nausea and vomiting, continuous upset stomach (gastritis); you have diarrhoea, cramps, nausea, vomiting and fever (gastroenteritis) or difficulty passing stool (constipation) or you have burning pain in the chest that usually occurs after eating and worsens when lying down (gastro-oesophageal reflux);
- your nose is blocked, you have trouble breathing through your nose, headaches, sore throat (sinusitis);
- discolouration (dark streaks, white streaks, or changes in nail colour), change in nail shape (nail disorders);
- you have small, white-headed pimples which appear around the hair follicles. They may itch or be painful (folliculosis); you have acne; you have rashes, dryness, flakiness, peeling, or redness of the skin (seborrhoea); you have swelling, difficulty breathing, a burning sensation, a red itchy rash sometimes resembling small blisters, and peeling of the skin (photoallergic dermatitis); you have a rash/patchy dry skin that appears on the arms and behind the knees (eczema); or you develop small spots or freckles on your skin (skin discolouration);
- inability in a man to achieve an erection or orgasm (impotence); increased or decreased in sexual desire (libido);
- decrease of white blood cells within your blood (neutropenia), decrease of red blood cells within your blood (anaemia);
- sweating; fever;
- you have an itchy or runny nose with sneezing, and a blocked nose (rhinitis); or you have a sore throat, phlegm on your chest, wheezing, coughing, tight chest (upper respiratory tract infections) influenza-like symptoms;
- enlargement of a man's breasts (gynaecomastia);
- you do not pass urine as often as usual or excess loss of glucose, bicarbonate, phosphates (phosphorus salts), uric acid, potassium, and certain amino acids in your urine (Fanconi syndrome);
- you are extremely thirsty as well as pass urine more often than usual (nephrogenic diabetes insipidus)(polyuria);
- you have back pain or any type of pain;
- change in colour of your palms and or soles (hyperpigmentation).
Contact your healthcare provider before stopping TRIBUSS because of side effects or for any other reason. If you notice any side effects not mentioned in this leaflet, please inform your healthcare provider.
