TECARINI can have side effects. Not all side effects reported for TECARINI are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TECARINI, please consult your doctor, pharmacist, or other healthcare professional for advice.
If any of the following happens, stop taking TECARINI and tell your doctor immediately or go to the casualty department at your nearest hospital:
Frequency unknown:
- swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
- rash or itching.
These are all very serious side effects. If you have them, you may have had a serious reaction to TECARINI. 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:
Less frequent:
- Sepsis (often called "blood poisoning", is a severe infection of the whole-body with high fever and the feeling of being severely ill), rapid swelling of the skin and mucosa (angioedema). These side effects are extremely serious and you should stop taking TECARINI and see your doctor immediately. If these effects are not treated they could be fatal. Increased incidence of sepsis has been observed with telmisartan only, however can not be ruled out for TECARINI.
These are all serious side effects. You may need urgent medical attention.
Tell your doctor if you notice any of the following:
Frequent:
- dizziness,
- ankle swelling (oedema).
Less frequent:
- sleepiness, migraines, headaches, tingling or numbness of the hands or feet, feeling of spinning (vertigo), slow heart rate, palpitations (awareness of your heart beat), low blood pressure (hypotension), dizziness on standing up (orthostatic hypotension), flushing, coughing, stomach ache (abdominal pain), diarrhoea, feeling sick (nausea), itching, joint pain, muscle cramps, muscle pain, inability to obtain an erection, weakness, chest pain, tiredness, swelling (oedema), increased levels of hepatic enzymes;
- urinary bladder infection, feeling sad (depression), feeling anxious, sleeplessness, fainting, nerve damage in the hands or feet, reduced sense of touch, taste abnormalities, trembling, vomiting, enlarged gums, discomfort in the abdomen, dry mouth, eczema (a skin disorder), redness of skin, rash, back pain, leg pain, urge to urinate during the night, feeling unwell (malaise), increased levels of uric acid in the blood;
- progressive scarring of lung tissue (interstitial lung disease [mainly pneumonia of the interstitium and pneumonia with excess eosinophils]).
The following side effects have been observed with the components telmisartan or amlodipine and may occur also with TECARINI:
Telmisartan
In patients taking telmisartan alone the following additional side effects have been reported:
- Less frequent:
- urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels in the blood, shortness of breath, bloating, increased sweating, kidney damage including sudden inability of the kidneys to work, increased levels of creatinine;
- increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty in breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), impaired vision, fast heartbeat, upset stomach, abnormal liver function, hives (urticaria), medicine rash, inflammation of the tendons, flu-like illness (for example muscle pain, feeling generally unwell), decreased haemoglobin (a blood protein), increased levels of creatinine phosphokinase in the blood.
Most cases of abnormal liver function and liver disorder from post-marketing experience with telmisartan occurred in Japanese patients. Japanese patients are more likely to experience this side effect.
Amlodipine
In patients taking amlodipine alone the following additional side effects have been reported:
- Frequent:
- altered bowel habits, diarrhoea, constipation, visual disturbances, double vision, ankle swelling.
- Less frequent:
- mood changes, confusion, impaired vision, ringing in the ears, shortness of breath, sneezing/runny nose, hair loss, unusual bruising and bleeding (red blood cell damage), skin discolouration, increased sweating, difficulty passing urine, increased need to pass urine especially at night, enlarging of male breasts, pain, weight increased, weight decreased;
- reduced number of white blood cells (leucopenia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), excess sugar in blood, uncontrollable twitching or jerking movements, heart attack, irregular heartbeat, inflammation of the blood vessels, inflamed pancreas, inflammation of the stomach lining (gastritis), inflammation of the liver, yellowing of the skin (jaundice), increased levels of hepatic enzymes with jaundice, rapid swelling of skin and mucosa (angioedema), severe skin reactions, hives (urticaria), severe allergic reactions with blistering eruptions of the skin and mucous membranes (exfoliative dermatitis, Stevens-Johnson-Syndrome), increased sensitivity of the skin to sun, increased muscle tension.
Frequency unknown:
- severe allergic reactions with blistering eruptions of the skin and mucous membranes (toxic epidermal necrolysis).
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 “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/ By reporting side effects, you can help provide more information on the safety of TECARINI.
