Twynsta 5 mg Tablets

TWYNSTA tablets contain two active substances called telmisartan and amlodipine. TWYNSTA is used to treat high blood pressure (also known as essential hypertension) in patients using the same components as individual components, or when treatment with amlodipine alone did not lower your blood pressure enough.

Do not take TWYNSTA if you are pregnant, are considering becoming pregnant or are breastfeeding. A switch to a suitable alternative treatment should be carried out in advance of planned pregnancy.

Do not take TWYNSTA

• if you are hypersensitive (allergic) to telmisartan, amlodipine or any of the other ingredients included in TWYNSTA tablets (listed in section 6)
• if you are allergic to other medicines of the dihydropyridine type (one type of calcium channel blocker)
• if you take any other products containing amlodipine
• if you suffer from a rare hereditary condition called fructose intolerance
• if you have developed swelling and giant wheals on your skin when having previously taken medicines called angiotensin converting enzyme inhibitors (ACE inhibitors) or angiotensin receptor blockers (ARBs)
• if you have a narrowing of the heart blood vessels
• if both blood vessels to the kidneys are narrowed or if you have a single kidney and the blood vessel to the kidney is narrowed
• if you suffer from severe liver problems
• if you suffer from biliary obstruction (a problem with the drainage of the bile from the liver and gall bladder)
• if you suffer from porphyria
• if you are currently taking lithium or potassium sparing water tablets containing spironolactone, triamterene or amiloride
• if you suffer from low heart output because of a serious heart problem
• if the blood circulation to your heart has not fully recovered following a recent heart attack
• if you suffer from severe renal impairment
• if you suffer from severe low blood pressure (hypotension)
• if you are currently taking aliskiren-containing products

Warnings and precautions

Please tell your health care provider if you are suffering or have ever suffered from any of the following conditions or illnesses:

• if you suffer from kidney disease or have ever had a kidney transplant
• if you suffer from liver problems
• if you have heart problems
• if you already take a medicine called an angiotensin converting enzyme inhibitor (ACE-I)
• if you have been told that you have raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals)
• if you have low blood pressure (hypotension), which is likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (“water tablets”), low-salt diet, diarrhoea, or vomiting
• if you have high potassium levels in your blood or use salt substitutes that contain potassium
• if you have diabetes

Talk to your health care provider:

• to re-evaluate your treatment if you are treated with ACE inhibitors/ Angiotensin receptor blockers together with a fluoroquinolone antibiotic.
• if you are elderly and your dose needs to be increased.

In case of surgery or anaesthesia, you should tell your health care provider that you are taking TWYNSTA.

Children and adolescents

The use of TWYNSTA in children and adolescents up to the age of 18 years is not recommended.

Other medicines and TWYNSTA

Always tell your health care provider if you are taking any other medicine. (This includes complementary or traditional medicines.) If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of TWYNSTA with these medicines may cause undesirable interactions. Please consult your health care provider for advice. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below when taken together with TWYNSTA:

• Digitalis glycosides (digoxin) which is a heart medication
• Lithium-containing medicines used to treat some types of depression
• Anticonvulsant agents (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone)
• Rifampicin
• St. John’s wort
• Medicines used for HIV/AIDS (e.g. ritonavir) or for treatment of fungal infections (e.g. ketoconazole, itraconazole)
• Erythromycin or clarithromycin (so-called macrolide antibiotics)
• Heart medicines called verapamil or diltiazem
• Simvastatin used to lower your cholesterol levels
• Dantrolene infusion used to treat an anaesthetic complication called malignant hyperthermia
• Ciclosporin, tacrolimus, sirolimus, temsirolimus or everolimus used to suppress your immune system or to treat certain types of cancer

The effect of TWYNSTA may be reduced when you take NSAIDs (non-steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids. TWYNSTA may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. antidepressants, barbiturates, narcotics) or alcohol. TWYNSTA can interfere with ACE-inhibitors (e.g. enalapril, lisinopril, perindopril, ramipril).

TWYNSTA with food and drink

You can take TWYNSTA with water or other non-alcoholic drink and with or without food.

Grapefruit and grapefruit juice

You should not eat grapefruit or drink grapefruit juice when you take TWYNSTA because this can increase the blood pressure lowering effect in some people.

Do not share medicines prescribed for you with any other person. Always take TWYNSTA exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are unsure. The usual dose of TWYNSTA is one tablet per day. Try to take the tablet at the same time each day. Remove your TWYNSTA tablet from the blister only immediately prior to intake. You can take TWYNSTA with or without food. The tablets should be swallowed with some water or other non-alcoholic drink. Swallow the tablet whole - do not break, cut or crush it. It is important that you take TWYNSTA every day until your health care provider tells you otherwise.

If you have the impression that the effect of TWYNSTA is too strong or too weak, talk to your health care provider.

If your liver is not working properly, the usual dose should not exceed TWYNSTA 40/5 mg or TWYNSTA 40/10 mg once daily.

If you take more TWYNSTA than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Excess fluid may accumulate in your lungs (pulmonary oedema) causing shortness of breath that may develop up to 24-48 hours after intake.

If you forget to take TWYNSTA

If you forget to take a dose, do not worry. Take it as soon as you remember on the same day. If you do not take your tablet on that same day, take your normal dose on the next day. Do not take a double dose to make up for forgotten individual doses.

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

Frequent side effects may include:

• Dizziness, ankle swelling.

Less frequent side effects may include:

• Sleepiness, migraine, headache, tingling or numbness of the hands or feet, feeling of spinning (vertigo), slow heartbeat, palpitations (awareness of your heart beat), low blood pressure (hypotension), dizziness on standing up (orthostatic hypotension), flushing, cough, abdominal pain, diarrhoea, feeling sick (nausea), itching, joint pain, muscle cramps, muscle pain, back pain, inability to obtain an erection, weakness, chest pain, tiredness, swelling, increased levels of liver enzymes.

Rare side effects may include:

• Bladder infection, depression, feeling anxious, sleeplessness, fainting, taste abnormalities, trembling, vomiting, swollen gums, discomfort in the abdomen, dry mouth, eczema (a skin disorder), redness of skin, rash, painful limbs, urge to urinate during the night, feeling unwell, increased levels of uric acid in the blood.

Telmisartan

In patients taking telmisartan (one of the ingredients of TWYNSTA) alone the following additional side effects have been reported:

Less frequent side effects may include:

• Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, shortness of breath, bloating, increased sweating, kidney impairment including acute kidney injury, increased levels of creatinine in the blood.

Rare side effects may include:

• Sepsis (often called “blood poisoning” is a severe infection with whole body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), rapid swelling of skin and mucosa (angioedema) which may lead to death, low blood sugar (in diabetic patients), low levels of sodium in the blood, impaired vision, fast heart beat, stomach discomfort, abnormal liver function, hives (urticaria), a rash, inflammation of the tendons, flu-like illness, decreased haemoglobin (a blood protein), increased levels of creatine phosphokinase in the blood.

Amlodipine

In patients taking amlodipine (one of the ingredients of TWYNSTA) alone the following additional side effects have been reported:

Frequent side effects may include:

• Impaired vision, double vision, change of bowel habit, constipation, shortness of breath, joint swelling.

Less frequent side effects may include:

• Mood changes, ringing in the ears, irregular heartbeat, sneezing/running nose, hair loss, unusual bruising and bleeding (red blood cell damage), skin discolouration, increased sweating, rapid swelling of skin and mucosa (angioedema), hives (urticaria), difficulty passing urine, increased need to pass urine especially at night, enlarging of male breasts, pain, weight increased, weight decreased.

Rare side effects may include:

• Low number of white cells in the blood, 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 (diabetes), confusion, stiff muscles, heart attack, inflammation of the blood vessels, inflamed pancreas, abdominal bloating (gastritis), inflammation of the liver, yellowing of the skin (jaundice), increased levels of liver enzymes with jaundice, severe skin reactions, peeling of the skin, Stevens-Johnson syndrome (rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals), increased sensitivity of the skin to the sun.

Side effects where the frequency is not known may include:

• Abnormal muscle movements, severe skin reaction called toxic epidermal necrolysis.

If you notice any side effects not mentioned in this leaflet, please inform your health care provider.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to the South African Health Products Regulatory Authority (SAHPRA) via the Med Safety App (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on the SAHPRA website. Suspected adverse reactions can also be reported directly to the holder of the certificate of registration using the email address [email protected]. By reporting side effects, you can help provide more information on the safety of TWYNSTA.

Store at or below 30 °C in the original package in order to protect from light and moisture. Remove your TWYNSTA tablet from the blister only immediately prior to intake. Store all medicines out of reach of children. Do not take TWYNSTA after the expiry date stated on the blister strips and carton. The expiry date refers to the last day of that month. Return all unused or expired medicines to your health care provider for safe disposal. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).