Tesamolot Tm Tablets

The active substances are called telmisartan and amlodipine. TESAMOLOT™ is used to treat and control high blood pressure (also known as essential hypertension) in adult patients:

• who already receive telmisartan and amlodipine as separate tablets and who wish to take instead the same doses in one tablet for convenience.
• who are not adequately controlled with amlodipine alone.

Telmisartan belongs to a group of substances called “angiotensin-II receptor antagonists”. Angiotensin II is a substance produced in the body which causes blood vessels to narrow, thus increasing blood pressure. Telmisartan works by blocking the effect of angiotensin II. Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine stops calcium from moving into the blood vessel wall which stops the blood vessels from tightening. This means that both of these active substances work together to help stop your blood vessels tightening. As a result, the blood vessels relax and blood pressure is lowered.

Do not take TESAMOLOT™ if you:

• are allergic (hypersensitive) to telmisartan and/or amlodipine or any of the other ingredients of TESAMOLOT™ (See Section 6)
• if you are allergic to other medicines of the dihydropyridine type (one type of calcium channel blocker)
• if you have developed swelling and red swollen marks on your skin when you have previously taken medicines called angiotensin converting enzyme inhibitors (ACE inhibitors) or angiotensin receptor blockers (ARBs)
• if you are taking medicines called fluoroquinolones and have serious kidney problems
• if you have hereditary swelling problems or swelling that occurs without a known cause
• if you have a condition known as Hypertrophic Obstructive Cardiomyopathy (HOCM)
• if you have severe kidney problems
• if blood vessels to the kidneys are narrowed
• if you have a narrowing of the aortic blood vessel
• if you are currently taking lithium and potassium sparing water tablets containing spironolactone, triamterene or amiloride
• if you are currently taking aliskiren-containing medicines
• if you suffer from porphyria
• if you have problems with drainage of the bile from the liver and gall bladder
• if you have severe liver problems
• if you suffer from low heart output because of a serious heart problem
• if you are or may potentially be pregnant
• if you are breast-feeding or may breast feed

Your doctor will decide on the most suitable treatment for you including on:

• the correct dose
• how often and for how long you should be treated
• whether you should also receive other medicines with TESAMOLOT™ or not.

Your doctor will give you all the necessary information on your treatment plan. The recommended dose is one tablet a day. If your liver is not working properly, the usual dose should not exceed one 40 mg/5 mg tablet or one 40 mg/10 mg tablet per day. You can take TESAMOLOT™ with or without food. The tablets should be swallowed with some water or other non-alcoholic drink.

If you take more TESAMOLOT™ than you should

In the event of overdose, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. You might experience low blood pressure and rapid heartbeat. Slow heartbeat, dizziness, reduced kidney function including kidney failure, marked and prolonged low blood pressure including shock and death have also been reported. A type of oedema (a build-up of fluid in the body which causes swelling) called non-cardiogenic pulmonary oedema which manifests 24 to 48 hours later, has also been noted.

If you forget to take TESAMOLOT™ - If you forget to take a dose, take it as soon as you remember and then carry on as before. If you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for forgotten individual doses.

If you stop taking TESAMOLOT™ - Unless your doctor instructs you to stop treatment, it is important to continue taking TESAMOLOT™. If you stop and your original symptoms come back tell your doctor or pharmacist immediately. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

If any of the following happens, stop taking TESAMOLOT™ and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Allergic reactions include swelling of the hands, feet, ankles, face, mouth, lips, gums, tongue, throat and neck which may cause difficulty in swallowing or breathing
• throat tightness, shortness of breath and wheezing
• rash, “hives” (raised bumps), blisters or itching
• 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). If these effects are not treated they could be fatal
• Heart problems or heart attack. Heart problems may get worse in people that already have heart disease. This may happen when you start TESAMOLOT™ tablets or when there is an increase in your dose of TESAMOLOT™.

These are all very serious side effects. You may need urgent medical attention or hospitalisation. Other side effects include:

Frequent side effects:

• Dizziness
• Nos e, throat and urinary tract infections

Less frequent side effects:

• Bladder infection (cystitis)
• Low levels of iron in your blood (anaemia), high levels of a type of white blood cell called eosinophils (eosinophilia), low levels of platelets (thrombocytopenia), low levels of white blood cells called leukocytes (leukocytopenia)
• Swelling (angioedema), allergic reactions, hypersensitivity
• Feeling sad (depression), feeling anxious, problems sleeping (insomnia)
• Sleepiness (somnolence), migraine, headache, tingling or numbness of the hands or feet (paraesthesia), fainting (syncope), reduced sense of touch (hypoaesthesia), distortion of taste (dysgeusia), shaking (tremor)
• Feeling of spinning (vertigo)
• Slow heart rate (bradycardia), fast heart rate (tachycardia), feeling that your heart is beating too hard or too fast (palpitations)
• Low blood pressure (hypotension), low blood pressure on standing up (orthostatic hypotension), flushing
• Cough, shortness of breath (dyspnoea), runny nose (rhinitis)
• Stomach pain (abdominal pain), excessive gas in your stomach (flatulence), runny tummy/loose stools (diarrhoea), feeling sick (nausea), throwing up (vomiting), gum problems, indigestion (dyspepsia), dry mouth, change in bowel habits, inflammation of the pancreas (pancreatitis) and stomach (gastritis)
• Itching, dry, red, inflamed skin, rash, increased sweating (hyperhidrosis), hives (urticaria), hair loss (alopecia), skin sensitivity to light
• High levels of potassium in blood (hyperkalaemia), low levels of sugar in blood (hypoglycaemia) (in diabetic patients), high sugar levels (hyperglycaemia)
• Heart problems, increased heart rate
• Ringing in the ear (tinnitus)
• Eye problems
• Liver problems
• Joint pain (arthralgia), muscle cramps, muscle pain (myalgia), back pain, pain in your arms and legs, tendon pain
• Excessive urination at night (nocturia), kidney problems
• Inability to obtain an erection (erectile dysfunction), swelling of breasts in men (gynaecomastia)
• Swelling (oedema), weakness (asthenia), chest pain, tiredness (fatigue), flu-like sickness, weight increase or decrease
• Pain, increase or decrease in weight
• Increased levels of liver enzymes and uric acid in blood (picked up in blood tests)

If you notice any side effects not on 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/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of TESAMOLOT™.

Store at or below 25 °C. Keep blisters in original packaging until required for use. Keep all medicines out of reach and sight of children. Do not dispose medicines in drains or sewage systems (e.g., toilets).