Twynsta (telmisartan/amlodipine)

Class: Angiotensin II receptor blockers (ARBs) and Calcium channel blockers.

Manufacturer: Rottendorf Pharma GmgH Ostenfelder StraBe 51-61 59320 Ennigerloh Germany, Cipla Limited Verna Industrial Estate, Goa – 403 722 India (for bulk)

Dosage Form: Tablet

Similar Brands:

Uses:

TWYNSTA tablets contain two active substances called telmisartan and amlodipine. Both of these substances help to control your high blood pressure.

Telmisartan belongs to a group of substances called “angiotensin-II receptor blockers”. 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 vessels wall which stops the blood vessels from tightening.

This means that both of these active substances work together to help stop your vesssels form tightening. As a result, the blood vessels relax and blood pressure is lowered.

TWYNSTA is used to treat high blood pressure

• In adult patients whose blood pressure is not controlled enough with amlodipine alone.
• In adult patients who already receive telmisartan and amlodipine from separate tablets and who wish to take instead the same doses in one tablet for convenience.

Dosage:

How to take twynsta

The recommended dose is one tablet a day. Try to take the tablet at the same time each day. Remove your twynsta tablet from the blister only directly prior to intake.

You can take twynsta with or without food. The tablets should be swallowed with some water or other non-alcoholic drink.

If your liver is not working properly, the usual dose should not exceed one 40mg/5mg tablet or one 40/10mg tablet per day.

If you take more twynsta than you should

If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately. You might experience low blood pressure and rapid heart beat, slow heartbeat, dizziness, reduced kidney function including kidney failure, marked and prolonged low blood pressure including shock and death have been reported.

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, 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 twynsta

It is important that you take twynsta every day until your doctor tells your otherwise. If you have the impression that the effect of twynsta is too strong or too weak, talk to your doctor or pharmacist. If you have any further questions on the use of this medicine, ask your doctor or pharmacist

Side Effects:

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and need immediate medical attention:

You should see your doctor immediately if you experience any of the following symptoms:

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 rare (may affect up to 1 in 1000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately. If these effects are not treated they could be fatal. Increased incidence of sepsis has been observed with telmisartan only, however can be ruled out for twynsta.

Common side effects (may affect up to 1 in 10 people): dizziness, ankle swelling (oedema).

Uncommon side effects (may affect up to 1 in 100 people): Sleepiness, migraine, headache, tingling or numbness or 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, cough, stomach ache (abdominal pain), diarrhea, 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.

Rare side effects (may affect up to 1 in 1000 people): 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.

Very rare side effect (may affect up to 1 in 10,000 people): progressive scarring of lung tissue (interstitial lung disease[mainly pneumonia of interstitium and pneumonia with excess eosinophils]).

The following side effects have been observed with the components telmisartan or amlodipine and may occur also with twynsta.

Telmisartan

In patients taking telmisartan alone the following additional side effects have been reported:

Uncommon side effects (may affect up to 1 in 100 people): 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 blood, shortness of breath, bloating, increased sweating, kidney damage including sudden inability to the kidneys work, increased levels of creatinine.

Rare side effects (may affect up to 1 in 1000 people): increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty of breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), impaired vision, fast heart beat, 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, low levels of sodium. 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:

Common side effects (may affect up to 1 in 10 people): altered bowel habits, diarrhea, constipation, visual disturbances, double vision, ankle swelling.

Uncommon side effects (may affect up to 1 in 100 people): mood changes, impaired vision, ringing in the ears, shortness of breath, sneezing/running 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.

Rare side effects (may affect 1 in 1000 people): confusion

Very rare effects (may affect 1 in 10,000 people): 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 heart beat, 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.

Warnings & Precautions:

Talk to your doctor before taking twynsta if you are suffering or have ever suffered from any of the following conditions or illnesses:

• Kidney disease or kidney transplant.
• Narrowing of the blood vessels to one or both kidneys (renal artery stenosis).
• Liver disease
• Heart trouble
• Raised aldosterone levels (which lead to water and salt retention in the body along with imbalance of various blood minerals).
• Low blood pressure (hypotension), 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, diarrhea, or vomiting.
• Elevated potassium levels in your blood.
• Diabetes
• Narrowing of the aorta (aortic stenosis).
• Hear-associated chest pain also at rest or with minimal effort (unstable angina pectoris).
• A heart attack within the last four weeks.

Children and adolescents

Twynsta is not recommended in children and adolescents up to the age of 18 years.

Driving and using machines

Some people may experience side effects such as fainting, sleepiness, dizziness or a feeling of spinning (vertigo) when they are treated for high blood pressure. If you experience these side effects, do not drive or use machines.

Pregnancy & Lactation:

Pregnancy

You must tell your doctor if you think you might be pregnant or are planning to have a baby. Your doctor will normally advise you to stop taking Twynsta before you become pregnant or as soon as you take another medicine instead of twynsta. Twynsta is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Amlodipine has been shown to pass into breast milk in small amounts. Tell your doctor if you are breast-feeding or about to start breast-feeding. Twynsta is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely

Drug Interactions:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may need to change the dose of these other medicines or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below;

• Lithium containing medicines to treat some type of depression.
• Medicines that may increase blood potassium levels such as salt substitute containing potassium, potassium sparing diuretics (certain ‘water tablets’).
• Angiotensin II receptor blockers.
• ACE-inhibitors or aliskiren.
• NSAIDs (non-steroidal anti-inflammatory medicines e.g. acetylsalicylic acid or ibuprofen), heparin, immunosuppressives (e.g. cyclosporine or tacrolimus), and the antibiotic trimethoprin.
• Rifampicin, erythromycin, clarithromycin (antibiotics).
• John’s wort.
• Dantrolene (infusion for severe body temperature abnormalities).
• Medicines used to alter the way your immune system works (e.g. sirolimus, temsirolimus and everolimus).
• Medicine used for HIV/AIDS (e.g. ritonavir) or for treatment of fungal infections (e.g. ketoconazole).
• Diltiazem (cardiac medicine).
• Simvastatin to treat elevated levels of cholesterol.
• Digoxin

Contraindications:

Do not take Twynsta

• If you are allergic to telmisartan or amlodipine or any of the other ingredients of this medicine.
• If you are allergic to other medicines of the dihydropyridine type (one type of calcium channel blocker)
• If you are more than 3 months pregnant. (it is also better to avoid TWYNSTA in early pregnancy)
• If you have severe liver problems or billiary obstruction (problems and drainage of the bile from the liver and gall bladder).
• If you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body).
• If you suffer from heart failure after a heart attack.
• If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Price: Ksh

Notes:

Leaflet last revised in: December 2022

Marketing Authorisation Holder:

Boehringer Ingelheim International GmbH Binger Str. 173

D-55216 Ingelheim am Rhein Germany

Manufacturer:

Rottendorf Pharma GmgH Ostenfelder StraBe 51-61 59320 Ennigerloh Germany

Bulk manufacturer:

Cipla Limited Verna Industrial Estate,

Goa – 403 722

India

Primary and secondary packaging

Rottendorf Pharma GmbH

Am Fleigendahl 3, 59320 Ennigerloh

Germany

Releasing Site

Rottendorf Pharma GmbH

Ostenfelder StraBe 51-61, 59320 Ennigerloh

Germany