TWYNSTA 80 mg/5 mg tablets

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 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 stopscalcium 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.

TWYNSTAis used to treat high blood pressure

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

High blood pressure, if not treated, can damage blood vessels in several organs, which puts patients at risk of serious events such as heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal range.

Do not take TWYNSTA

• if you are allergic (hypersensitive) to telmisartan or amlodipine or any other ingredient included in TWYNSTA tablets (see section Further information for a list of other ingredients)
• 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 ? see Take special care with TWYNSTA and Pregnancy section.)
• if you have severe liver problems or biliary obstruction (problems with drainage of the bile from the liver and gall bladder)
• if you suffer from severe low blood pressure (including shock)
• if you suffer from low heart output because of a serious heart problem

If any of the above applies to you, tell your doctor or pharmacist before taking TWYNSTA.

Take special care with TWYNSTA

Please tell your doctor 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, diarrhoea, or vomiting
• Elevated potassium levels in your blood
• Diabetes
• Narrowing of the aorta (aortic stenosis)
• Heart-associated chest pain also at rest or with minimal effort (unstable angina pectoris)
• A heart attack within the last four weeks

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

Children

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

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 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 taken at the same time with TWYNSTA:

• Lithium-containing medicines to treat some types of depression
• Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain 'water tablets')
• NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim
• Rifampicin, St. John?s wort
• Medicines used for HIV/AIDS (e.g. ritonavir) or for treatment of fungal infections (e.g. ketoconazole)
• Erythromycin (antibiotic)
• Diltiazem (cardiac medicine)

As with other blood pressure lowering medicines, the effect of TWYNSTA may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid 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. baclofen, amifostine, neuroleptics or antidepressants). Further low blood pressure may be aggravated by alcohol. You may notice this as dizziness when standing up.

Taking TWYNSTA with food and drink

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

Pregnancy and breastfeeding

Pregnancy
You must tell your doctor if you think you are ( or might become) pregnant. Your doctor will normally advise you to stop taking TWYNSTA before you become pregnant or as soon as you know you are pregnant and will advise you to 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.

Breastfeeding
Tell your doctor if you are breastfeeding or about to start breastfeeding. TWYNSTA is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn, or was born prematurely.

Ask your doctor of pharmacist for advice before taking any medicine.

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.

Important information about some of the ingredients of TWYNSTA

TWYNSTA contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Always take TWYNSTA exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose of TWYNSTA 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 40 mg/5 mg tablet or one 40 mg/10 mg 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 heart beat, dizziness, reduced kidney function including kidney failure, marked and prolonged low blood pressure including shock and death have also been reported.

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 TWYNSTAevery day until your doctor tells you 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 product, ask your doctor or pharmacist.

Like all medicines, TWYNSTA can cause side effects, although not everybody gets them. These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the available data.

Common side effects are:
Dizziness, ankle swelling (oedema)

Uncommon side effects are:
Sleepiness, migraine, headache, 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, cough, 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.

Rare side effects are:
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.

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 are:
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.

Rare side effects are

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 of breathing, wheezing, swelling of the face or low blood pressure), impaired vision, fast heart beat, upset stomach, abnormal liver function, rapid swelling of skin and mucosa (angioedema), 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.

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

Uncommon side effects are:
Mood changes, tingling or numbness of skin (paraesthesia), impaired vision, ringing in the ears, shortness of breath, sneezing/running nose, change of bowel habit, 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 are: Confusion.

Very rare side effects are:
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 (diabetes), pain or numbness in hands and feet (peripheral neuropathy), uncontrollable twitching or jerking movements, heart attack, irregular heart beat, 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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use TWYNSTA after the expiry date which is stated on the carton after ?EXP?. The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions.
Store in the original package in order to protect from light and moisture.
Remove your TWYNSTA tablet from the blister only directly prior to intake.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What TWYNSTA contains

The active substances are telmisartan and amlodipine. Each tablet contains 80 mg telmisartan and 5 mg amlodipine.

The other ingredients are colloidal anhydrous silica, brilliant blue FCF (E 133), ferric oxide black (E172), ferric oxide yellow (E172), magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone K25, pregelatinized starch, sodium hydroxide, sorbitol (E420).

What TWYNSTA looks like and contents of the pack

TWYNSTA 80 mg/5 mg tablets are blue and white oval shaped two layer tablet engraved with the product code A3.

TWYNSTA is available in folding box containing 14, 28, 56, 98 tablets in aluminium/aluminium blisters and in folding box containing 30 x 1, 90 x 1, 360 (4 x 90) tablets in aluminium/aluminium perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder Boehringer Ingelheim International GmbH Binger Str. 173 D-55216 Ingelheim am Rhein Germany Manufacturer Boehringer Ingelheim Pharma GmbH Co. KG Binger Str. 173 D-55216 Ingelheim am Rhein Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien S.C.S. Boehringer Ingelheim Comm.V. TélTel 32 2 773 33 11 LuxembourgLuxemburg S.C.S. Boehringer Ingelheim Comm.V. TélTel 32 2 773 33 11

- 359 2 958 79 98 Magyarország Boehringer Ingelheim RCV GmbH Co KG Magyarországi Fióktelepe Tel. 36 1 299 89 00

eská republika Boehringer Ingelheim spol. s r.o. Tel 420 234 655 111 Malta Boehringer Ingelheim Ltd. Tel 44 1344 424 600

Danmark Boehringer Ingelheim Danmark AS Tlf 45 39 15 88 88 Nederland Boehringer Ingelheim b.v. Tel 31 0 800 22 55 889

Deutschland Boehringer Ingelheim Pharma GmbH Co. KG Tel 49 0 800 77 90 900 Norge Boehringer Ingelheim Norway KS Tlf 47 66 76 13 00

Österreich Boehringer Ingelheim RCV GmbH Co KG Tel 43 1 80 105-0 Eesti Boehringer Ingelheim RCV GmbH Co KG Eesti Filiaal Tel 372 60 80 940

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Tel.: +370 37 473922

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