Brand name Twynsta

Form tablets

Active substance / Dosage

AMLODIPINE

TELMISARTAN

Prescription type Prescription only

ATC code

C09DB04

Registration number 040332

Manufacturer BOEHRINGER INGELHEIM INTERNATIONAL GMBH

Table of Contents

Package leaflet: Information for the user
Twynsta 40 mg/5 mg tablets
1. What Twynsta is and what it is used for
2. What you need to know before taking Twynsta
3. How to take Twynsta
4. Possible side effects
5. How to store Twynsta
6. Package contents and other information
Package leaflet: information for the user
Twynsta 40 mg/10 mg tablets
1. What Twynsta is and what it is used for
2. What you need to know before taking Twynsta
3. How to take Twynsta
4. Possible side effects
5. How to store Twynsta
6. Package contents and other information
Package leaflet: Information for the user
Twynsta 80 mg/5 mg tablets
1. What Twynsta is and what it is used for
2. What you need to know before taking Twynsta
3. How to take Twynsta
4. Possible side effects
5. How to store Twynsta
6. Package contents and other information
Package leaflet: Information for the user
Twynsta 80 mg/10 mg tablets
1. What Twynsta is and what it is used for
2. What you should know before taking Twynsta
3. How to take Twynsta
4. Possible side effects
5. How to store Twynsta
6. Package contents and other information

Package leaflet: Information for the user

Twynsta 40 mg/5 mg tablets

telmisartan/amlodipine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Twynsta is and what it is used for
What you need to know before taking Twynsta
How to take Twynsta
Possible side effects
How to store Twynsta
Contents of the pack and other information

1. What Twynsta is and what it is used for

Twynsta tablets contain two active substances called telmisartan and amlodipine. Both of these substances help control high blood pressure:

Telmisartan belongs to a group of substances known as “angiotensin II receptor antagonists”. Angiotensin II is a substance produced in the body that causes blood vessels to narrow, thereby increasing blood pressure. Telmisartan blocks this effect of angiotensin II.
Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine prevents calcium from entering the walls of blood vessels and thereby stops the narrowing of blood vessels. This means that both active substances work together to help prevent the narrowing of blood vessels. As a result, blood vessels relax and blood pressure decreases.

Twynsta is used to treat high blood pressure

in adult patients whose blood pressure is not sufficiently controlled by amlodipine alone.
in adult patients who are already taking telmisartan and amlodipine separately and wish, for convenience, to take the same doses of both substances in a single tablet.

If left untreated, hypertension can damage blood vessels in many organs, putting patients at risk of serious events such as heart attack, heart or kidney failure, stroke, or blindness.
Hypertension usually does not cause symptoms until such damage occurs. Therefore, it is important to have regular blood pressure measurements to check whether it is within the normal range.

2. What you need to know before taking Twynsta

Do not take Twynsta

if you are allergic to telmisartan or amlodipine or to any of the other ingredients of this medicine (listed in section 6).
if you are allergic to other dihydropyridine-type medicines (a type of calcium channel blockers).
if you are more than 3 months pregnant. (It is also advisable to avoid taking Twynsta during early pregnancy - see Pregnancy section).
if you have severe liver problems or biliary obstruction (problems with bile drainage from the liver and gallbladder).
if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which your heart is unable to supply enough blood to the body).
if you have heart failure following a heart attack.
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are in any of these conditions, inform your doctor or pharmacist before taking Twynsta.
Warnings and precautions
Talk to your doctor before taking Twynsta if you have or have had any of the following conditions or diseases:

Kidney disease or kidney transplant.
Narrowing of the blood vessels to one or both kidneys (renal artery stenosis).
Liver disease.
Heart problems.
Increased levels of aldosterone (leading to water and salt retention in the body with imbalance of various minerals in the blood).
Low blood pressure (hypotension), which is more likely if you are dehydrated (excessive loss of water from the body) or have salt deficiency due to diuretic therapy ("diuretics"), low-salt diet, diarrhoea or vomiting.
High levels of potassium in the blood.
Diabetes.
Narrowing of the aorta (aortic stenosis).
Chest pain related to the heart, even at rest or with minimal exertion (unstable angina pectoris).
Heart attack within the last four weeks.

Talk to your doctor before taking Twynsta:

if you are taking any of the following medicines used to treat high blood pressure:
an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
aliskiren. Your doctor may monitor your kidney function, blood pressure and blood levels of electrolytes (e.g. potassium) at regular intervals. See also "Do not take Twynsta".
if you are elderly and the dose needs to be increased.

If you are undergoing surgery or receiving anaesthetics, you must inform your doctor that you are taking Twynsta.
Children and adolescents
Twynsta is not recommended for children and adolescents under 18 years of age.
Other medicines and Twynsta
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. Your doctor may decide to adjust the dose of these other medicines or take additional precautions. In some cases, it may be necessary to stop taking one of these medicines. This particularly applies to the following medicines:

Medicines containing lithium used to treat certain types of depression.
Medicines that may increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics (some "diuretics").
Angiotensin II receptor blockers.
ACE inhibitors or aliskiren (see also sections "Do not take Twynsta" and "Warnings and precautions").
NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen), heparin, immunosuppressants (e.g. cyclosporine or tacrolimus) and the antibiotic trimethoprim.
Rifampicin, erythromycin, clarithromycin (antibiotics).
St. John’s wort.
Dantrolene (infusion for severe abnormalities in body temperature).
Medicines used to modify the function of the immune system (e.g. sirolimus, temsirolimus and everolimus).
Medicines used for HIV/AIDS (e.g. ritonavir) or for treating fungal infections (e.g. ketoconazole).
Diltiazem (a heart medicine).
Simvastatin for the treatment of high cholesterol levels.
Digoxin.

As with other medicines that lower blood pressure, the effect of Twynsta may be reduced when taking NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen) or corticosteroids.
Twynsta may enhance the blood pressure-lowering effect of other medicines used to reduce blood pressure or of medicines that have the potential to lower blood pressure (e.g. baclofen, amifostine, neuroleptics or antidepressants).
Twynsta with food and drink
Alcohol may increase the blood pressure-lowering effect. You may experience this as dizziness when standing up.
Grapefruit and grapefruit juice must not be consumed when taking Twynsta. This is because in some patients, grapefruit and grapefruit juice can cause increased blood levels of the active ingredient amlodipine, thereby increasing the blood pressure-lowering effect of Twynsta.
Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you suspect you are pregnant or are planning a pregnancy. Your doctor will normally advise you to stop taking Twynsta before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Twynsta. Twynsta is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.
Breastfeeding
It has been shown that amlodipine passes into breast milk in small amounts.
Inform your doctor if you are breastfeeding or intend to breastfeed. Twynsta is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Some patients may experience side effects such as fainting, drowsiness, dizziness or spinning sensations (vertigo) during antihypertensive treatment. If these side effects occur, do not drive or operate machinery.
Twynsta contains sorbitol
This medicine contains 168.64 mg of sorbitol per tablet.
Twynsta contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Twynsta

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one tablet daily. Try to take the tablet at the same time each day.
Remove the Twynsta tablets from the blister pack only immediately before taking them.
You may take Twynsta with or without food. The tablets should be swallowed with water or another non-alcoholic drink.
If your liver is not functioning properly, the usual dose of one tablet of 40 mg/5 mg or one tablet of 40 mg/10 mg per day must not be exceeded.

If you take more Twynsta than you should
If you have taken too many tablets by mistake, contact your doctor, pharmacist, or the nearest hospital emergency department immediately. You may experience low blood pressure and a fast heartbeat. Slow heartbeat, dizziness, reduced kidney function including renal failure, marked and prolonged lowering of blood pressure, including shock and death, have also been reported.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may develop 24–48 hours after ingestion.

If you forget to take Twynsta
If you forget to take a dose, take it as soon as you remember, then continue as before. If you miss a day's dose, take your normal dose the next day. Do not take a double dose to make up for the forgotten dose.

If you stop taking Twynsta
It is important that you take Twynsta every day, unless your doctor tells you otherwise. If you feel that the effect of Twynsta is too strong or too weak, talk to your doctor or pharmacist.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious and require immediate medical attention
You must consult your doctor immediately if you experience any of the following symptoms:
Sepsis (often called "blood infection", a severe infection of the whole body with high fever and feeling severely unwell), rapid swelling of the skin and mucous membranes (angioedema); these side effects are rare (may affect up to 1 in 1,000 people), but extremely serious, and patients must stop taking the medicine and consult a doctor immediately. If these effects are not treated, they may be fatal. An increased incidence of sepsis has been observed with telmisartan alone; however, this cannot be excluded for Twynsta.

Common side effects (may affect up to 1 in 10 people)
Dizziness, swelling of the ankles (edema).

Uncommon side effects (may affect up to 1 in 100 people)
Drowsiness, headache, migraine, tingling or numbness in the hands or feet, dizziness (vertigo), slow heartbeat, palpitations (awareness of your heartbeat), low blood pressure (hypotension), dizziness upon standing (orthostatic hypotension), flushing, cough, stomach ache (abdominal pain), diarrhoea, feeling unwell (nausea), itching, joint pain, muscle cramps, muscle pain, inability to achieve an erection, weakness, chest pain, fatigue, swelling (edema), increased liver enzyme levels.

Rare side effects (may affect up to 1 in 1,000 people)
Bladder infections, feeling of sadness (depression), feeling anxious, insomnia, fainting, nerve damage in legs or feet, reduced sense of touch, taste disturbances, tremor, vomiting, gum overgrowth, abdominal discomfort, dry mouth, eczema (skin disorder), redness of the skin, skin rash, back pain, leg pain, urgency to urinate at night, feeling unwell (malaise), increased levels of uric acid in the blood.

Very rare side effects (may affect up to 1 in 10,000 people)
Progressive scarring of lung tissue (interstitial lung disease [mainly interstitial pneumonia and eosinophilic pneumonia]).

The following side effects have been observed with the individual components telmisartan or amlodipine and may also occur with Twynsta:

Telmisartan
In patients treated with 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, sinusitis, common cold), deficiency of red blood cells (anaemia), high potassium levels in the blood, shortness of breath, swelling, increased sweating, kidney damage including sudden inability of the kidneys to function, increased creatinine levels.

Rare side effects (may affect up to 1 in 1,000 people)
Increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, facial swelling or low blood pressure), low blood sugar levels (in diabetic patients), altered vision, rapid heartbeat, stomach upset, abnormal liver function, urticaria, drug rash, tendon inflammation, flu-like illness (e.g. muscle pain, general feeling of malaise), decreased haemoglobin (a blood protein), increased levels of creatine phosphokinase in the blood, low sodium levels.

Most cases of abnormal liver function and liver disorders reported with telmisartan during post-marketing experience occurred in Japanese patients. Japanese patients are more likely to experience these adverse reactions.

Amlodipine
In patients treated with amlodipine alone, the following additional side effects have been reported:

Common side effects (may affect up to 1 in 10 people)
Changes in bowel habits, diarrhoea, constipation, visual disturbances, double vision, swelling of the ankles.

Uncommon side effects (may affect up to 1 in 100 people)
Mood changes, altered vision, ringing in the ears, shortness of breath, sneezing/runny nose, hair loss, unusual bruising and bleeding (destruction of red blood cells), skin colour changes, increased sweating, difficulty urinating, increased need to urinate, especially at night, breast enlargement in men, pain, weight gain, weight loss.

Rare side effects (may affect up to 1 in 1,000 people)
Confusion.

Very rare side effects (may affect up to 1 in 10,000 people)
Decrease in white blood cell count (leucopenia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, facial swelling or low blood pressure), high blood sugar levels, uncontrollable contractions or jerky movements, heart attack, irregular heartbeat, inflammation of blood vessels, inflammation of the pancreas, inflammation of the stomach lining (gastritis), liver inflammation, yellowing of the skin (jaundice), increased liver enzyme levels with jaundice, rapid swelling of the skin and mucous membranes (angioedema), severe skin reactions, urticaria, severe allergic reactions with blistering rash of the skin and mucous membranes (exfoliative dermatitis, Stevens-Johnson syndrome), increased sensitivity of the skin to sunlight, increased muscle tension.

Not known (frequency cannot be estimated from the available data)
Severe allergic reactions with blistering rash of the skin and mucous membranes (toxic epidermal necrolysis).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Twynsta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature. Store in the original packaging to protect the medicine from light and moisture. Remove Twynsta tablets from the blister pack only immediately before taking them.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Twynsta contains

The active substances are telmisartan and amlodipine. Each tablet contains 40 mg of telmisartan and 5 mg of amlodipine (as amlodipine besilate).
The other components are anhydrous colloidal silica, brilliant blue FCF (E133), black iron oxide (E172), yellow iron oxide (E172), magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone K25, pregelatinized starch prepared from maize starch, sodium hydroxide (see section 2), sorbitol (E420) (see section 2).

Description of the appearance of Twynsta and package contents
Twynsta 40 mg/5 mg tablets are blue and white, oval-shaped, two-layered tablets approximately 14 mm in length, with the product code A1 and the company logo imprinted on the white side.
Twynsta is available in packs of 14, 28, 56, and 98 tablets in aluminium/aluminium blisters, or packs containing 30 x 1, 90 x 1, and 360 (4 x 90 x 1) tablets in unit-dose divisible aluminium/aluminium blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder Manufacturer
Boehringer Ingelheim International GmbH Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Str. 173 Binger Str. 173
55216 Ingelheim am Rhein 55216 Ingelheim am Rhein
Germany Germany
Rottendorf Pharma GmbH
Ostenfelder Straße 51 - 61
59320 Ennigerloh
Germany
Boehringer Ingelheim France
100-104 Avenue de France
75013 Paris
France

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Boehringer Ingelheim SComm Boehringer Ingelheim RCV GmbH & Co KG
Tél/Tel: +32 2 773 33 11 Lietuvos filialas
Tel.: +370 5 2595942

България Luxembourg/Luxemburg
Бьорингер Ингелхайм РЦВ ГмбХ и Ко КГ - Boehringer Ingelheim SComm
клон България Tél/Tel: +32 2 773 33 11
Тел: +359 2 958 79 98

Česká republika Magyarország
Boehringer Ingelheim spol. s r.o. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +420 234 655 111 Magyarországi Fióktelepe
Tel.: +36 1 299 89 00

Danmark Malta
Boehringer Ingelheim Danmark A/S Boehringer Ingelheim Ireland Ltd.
Tlf: +45 39 15 88 88 Tel: +353 1 295 9620

Deutschland Nederland
Boehringer Ingelheim Pharma GmbH & Co. KG Boehringer Ingelheim B.V.
Tel: +49 (0) 800 77 90 900 Tel: +31 (0) 800 22 55 889

Eesti Norge
Boehringer Ingelheim RCV GmbH & Co KG Boehringer Ingelheim Norway KS
Eesti Filiaal Tlf: +47 66 76 13 00
Tel: +372 612 8000

Ελλάδα Österreich
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε. Boehringer Ingelheim RCV GmbH & Co KG
Tηλ: +30 2 10 89 06 300 Tel: +43 1 80 105-7870

España Polska
Boehringer Ingelheim España, S.A. Boehringer Ingelheim Sp. z o.o.
Tel: +34 93 404 51 00 Tel.: +48 22 699 0 699

France Portugal
Boehringer Ingelheim France S.A.S. Boehringer Ingelheim Portugal, Lda.
Tél: +33 3 26 50 45 33 Tel: +351 21 313 53 00

Hrvatska România
Boehringer Ingelheim Zagreb d.o.o. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +385 1 2444 600 Viena - Sucursala Bucureşti
Tel: +40 21 302 28 00

Ireland Slovenija
Boehringer Ingelheim Ireland Ltd. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +353 1 295 9620 Podružnica Ljubljana
Tel: +386 1 586 40 00

Ísland Slovenská republika
Vistor hf. Boehringer Ingelheim RCV GmbH & Co KG
Sími: +354 535 7000 organizačná zložka
Tel: +421 2 5810 1211

Italia Suomi/Finland
Boehringer Ingelheim Italia S.p.A. Boehringer Ingelheim Finland Ky
Tel: +39 02 5355 1 Puh/Tel: +358 10 3102 800

Κύπρος Sverige
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε. Boehringer Ingelheim AB
Tηλ: +30 2 10 89 06 300 Tel: +46 8 721 21 00

Latvija United Kingdom (Northern Ireland)
Boehringer Ingelheim RCV GmbH & Co KG Boehringer Ingelheim Ireland Ltd.
Latvijas filiāle Tel: +353 1 295 9620
Tel: +371 67 240 011

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/ .

Package leaflet: information for the user

Twynsta 40 mg/10 mg tablets

telmisartan/amlodipine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

What Twynsta is and what it is used for
What you need to know before taking Twynsta
How to take Twynsta
Possible side effects
How to store Twynsta
Contents of the pack and other information

1. What Twynsta is and what it is used for

Twynsta tablets contain two active substances called telmisartan and amlodipine. Both of these substances help control high blood pressure:

Telmisartan belongs to a group of substances known as “angiotensin II receptor blockers”. Angiotensin II is a substance produced in the body that causes blood vessels to narrow, thereby increasing blood pressure. Telmisartan blocks this effect of angiotensin II.
Amlodipine belongs to a group of substances known as “calcium channel blockers”. Amlodipine prevents calcium from entering the walls of blood vessels, thereby stopping the narrowing of blood vessels. This means that both active substances work together to help prevent the narrowing of blood vessels. As a result, blood vessels relax and blood pressure decreases.

Twynsta is used to treat high blood pressure

in adult patients whose blood pressure is not sufficiently controlled by amlodipine alone.
in adult patients who are already taking telmisartan and amlodipine separately and wish, for convenience, to take the same doses of both substances in a single tablet.

If untreated, high blood pressure can damage blood vessels in many organs, putting patients at risk of serious events such as heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually does not cause symptoms until such damage occurs. Therefore, it is important to have regular blood pressure checks to ensure it remains within the normal range.

2. What you need to know before taking Twynsta

Do not take Twynsta

if you are allergic to telmisartan or amlodipine or to any of the other ingredients of this medicine (listed in section 6).
if you are allergic to other dihydropyridine-type medicines (a type of calcium channel blocker).
if you are more than 3 months pregnant. (It is also advisable to avoid taking Twynsta during early pregnancy - see section Pregnancy.)
if you have severe liver problems or biliary obstruction (problems with bile drainage from the liver and gallbladder).
if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which your heart is unable to supply enough blood to the body).
if you have heart failure following a heart attack.
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are in any of these conditions, inform your doctor or pharmacist before taking Twynsta.
Warnings and precautions
Talk to your doctor before taking Twynsta if you have or have had any of the following conditions
or diseases:

Kidney disease or kidney transplant.
Narrowing of the blood vessels to one or both kidneys (renal artery stenosis).
Liver disease.
Heart problems.
Increased levels of aldosterone (leading to fluid and salt retention in the body with imbalance of various minerals in the blood).
Low blood pressure (hypotension), which is more likely if you are dehydrated (excessive loss of water from the body) or have salt deficiency due to diuretic therapy ("diuretics"), low-salt diet, diarrhoea or vomiting.
High levels of potassium in the blood.
Diabetes.
Narrowing of the aorta (aortic stenosis).
Chest pain related to the heart even at rest or with minimal exertion (unstable angina pectoris).
Heart attack within the last four weeks.

Talk to your doctor before taking Twynsta:

if you are taking any of the following medicines used to treat high blood pressure:
an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
aliskiren. Your doctor may monitor your kidney function, blood pressure and blood electrolyte levels (e.g., potassium) at regular intervals. See also "Do not take Twynsta".
if you are elderly and your dose needs to be increased.

If you are undergoing surgery or receiving anaesthetics, you must inform your doctor that you are
taking Twynsta.
Children and adolescents
Twynsta is not recommended for children and adolescents under 18 years of age.
Other medicines and Twynsta
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. Your doctor may decide to adjust the dose of these other medicines or
take other precautions. In some cases, it may be necessary to stop taking one of
these medicines. This particularly applies to the following medicines:

Medicines containing lithium used to treat certain types of depression.
Medicines that may increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics (some "diuretics").
Angiotensin II receptor blockers.
ACE inhibitors or aliskiren (see also sections "Do not take Twynsta" and "Warnings and precautions").
NSAIDs (non-steroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or ibuprofen), heparin, immunosuppressants (e.g., cyclosporine or tacrolimus) and the antibiotic trimethoprim.
Rifampicin, erythromycin, clarithromycin (antibiotics).
St John’s wort.
Dantrolene (infusion for severe abnormalities in body temperature).
Medicines used to modify the function of the immune system (e.g., sirolimus, temsirolimus and everolimus).
Medicines used for HIV/AIDS (e.g., ritonavir) or for treating fungal infections (e.g., ketoconazole).
Diltiazem (a medicine for the heart).
Simvastatin for the treatment of high cholesterol levels.
Digoxin.

As with other medicines that lower blood pressure, the effect of Twynsta may be reduced
when taking NSAIDs (non-steroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or
ibuprofen) or corticosteroids.
Twynsta may enhance the blood pressure-lowering effect of other medicines used to reduce blood pressure or of medicines that are capable of lowering blood pressure (e.g., baclofen, amifostine, neuroleptics or antidepressants).
Twynsta with food and drinks
Alcohol may increase the blood pressure-lowering effect. You may experience this as dizziness when standing up.
Grapefruit and grapefruit juice must not be consumed when taking Twynsta. This is because in some patients, grapefruit and grapefruit juice may cause increased blood levels of the active ingredient amlodipine, thereby increasing Twynsta's blood pressure-lowering effect.
Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you suspect you are pregnant or are planning a pregnancy. Your doctor will normally advise you to stop taking Twynsta before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Twynsta. Twynsta is not recommended during early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to the unborn child if taken beyond the third month of pregnancy.
Breastfeeding
It has been shown that amlodipine passes into breast milk in small amounts.
Inform your doctor if you are breastfeeding or about to start breastfeeding. Twynsta is not recommended for breastfeeding women, and your doctor may choose an alternative treatment for you if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Some patients may experience side effects such as fainting, drowsiness, dizziness or spinning sensations (vertigo) during treatment for hypertension. If these side effects occur, do not drive or operate machinery.
Twynsta contains sorbitol
This medicine contains 168.64 mg of sorbitol per tablet.
Twynsta contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.

3. How to take Twynsta

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one tablet daily. Try to take the tablet at the same time each day.
Remove Twynsta tablets from the blister pack only immediately before taking them.
You may take Twynsta with or without food. Swallow the tablets with water or another non-alcoholic drink.
If your liver is not working properly, the usual dose of one tablet of 40 mg/5 mg or one tablet of 40 mg/10 mg daily must not be exceeded.

If you take more Twynsta than you should
If you have taken too many tablets by mistake, contact your doctor, pharmacist, or the nearest hospital emergency department immediately. You may experience low blood pressure and a fast heartbeat. There have also been reports of slow heartbeat, dizziness, reduced kidney function including kidney failure, marked and prolonged lowering of blood pressure, shock, and death.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may develop up to 24–48 hours after ingestion.

If you forget to take Twynsta
If you forget to take a dose, take it as soon as you remember, then continue as before. If you miss a day’s dose, take your normal dose the next day. Do not take a double dose to make up for the forgotten dose.

If you stop taking Twynsta
It is important that you take Twynsta every day, unless your doctor tells you otherwise. If you feel the effect of Twynsta is too strong or too weak, talk to your doctor or pharmacist.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious and require immediate medical attention.
You must contact your doctor immediately if you experience any of the following symptoms:
Sepsis (often called "blood infection", a severe infection of the whole body with high fever and feeling very unwell), rapid swelling of the skin and mucous membranes (angioedema). These side effects are rare (may affect up to 1 in 1,000 people), but extremely serious, and patients must stop taking the medicine and contact their doctor immediately. If these effects are not treated, they may be fatal. An increased incidence of sepsis has been observed with telmisartan alone; however, this cannot be excluded for Twynsta.

Common side effects (may affect up to 1 in 10 people)
Dizziness, swelling of the ankles (oedema).

Uncommon side effects (may affect up to 1 in 100 people)
Drowsiness, headache, migraine, tingling or numbness of the hands or feet, dizziness (vertigo), slow heart rate, palpitations (awareness of your heartbeat), low blood pressure (hypotension), dizziness upon standing (orthostatic hypotension), flushing, cough, stomach ache (abdominal pain), diarrhoea, feeling unwell (nausea), itching, joint pain, muscle cramps, muscle pain, inability to achieve an erection, weakness, chest pain, fatigue, swelling (oedema), increased liver enzyme levels.

Rare side effects (may affect up to 1 in 1,000 people)
Bladder infections, feeling of sadness (depression), feeling anxious, insomnia, fainting, nerve damage in the legs or feet, reduced sense of touch, taste disturbances, tremor, vomiting, gum overgrowth, abdominal discomfort, dry mouth, eczema (a skin disorder), skin redness, rash, back pain, leg pain, urgency to urinate during the night, feeling unwell (malaise), increased levels of uric acid in the blood.

Very rare side effects (may affect up to 1 in 10,000 people)
Progressive scarring of lung tissue (interstitial lung disease [mainly interstitial pneumonia and eosinophilic pneumonia]).

The following side effects have been observed with the individual components telmisartan or amlodipine and may also occur with Twynsta:

Telmisartan
In patients treated with 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, sinusitis, common cold), red blood cell deficiency (anaemia), high blood potassium levels, shortness of breath, swelling, increased sweating, kidney damage including sudden inability of the kidneys to function, increased creatinine levels.

Rare side effects (may affect up to 1 in 1,000 people)
Increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, facial swelling or low blood pressure), low blood sugar levels (in diabetic patients), blurred vision, rapid heartbeat, stomach upset, abnormal liver function, hives, drug rash, tendon inflammation, flu-like illness (e.g. muscle pain, generalised feeling of being unwell), decreased haemoglobin (a blood protein), increased blood creatine phosphokinase levels, low sodium levels.

Most cases of abnormal liver function and liver disorders reported with telmisartan during post-marketing experience occurred in Japanese patients. Japanese patients are more likely to experience these adverse reactions.

Amlodipine
In patients treated with amlodipine alone, the following additional side effects have been reported:

Common side effects (may affect up to 1 in 10 people)
Changes in bowel habits, diarrhoea, constipation, visual disturbances, double vision, swelling of the ankles.

Uncommon side effects (may affect up to 1 in 100 people)
Mood changes, blurred vision, ringing in the ears, shortness of breath, sneezing/runny nose, hair loss, unusual bruising and bleeding (destruction of red blood cells), skin colour changes, increased sweating, difficulty urinating, increased need to urinate, especially at night, breast enlargement in men, pain, weight gain, weight loss.

Rare side effects (may affect up to 1 in 1,000 people)
Confusion.

Very rare side effects (may affect up to 1 in 10,000 people)
Decrease in white blood cell count (leucopenia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, facial swelling or low blood pressure), high blood sugar levels, uncontrollable muscle contractions or jerky movements, heart attack, irregular heartbeat, inflammation of blood vessels, pancreatitis, inflammation of the stomach lining (gastritis), liver inflammation, yellowing of the skin (jaundice), increased liver enzyme levels with jaundice, rapid swelling of the skin and mucous membranes (angioedema), severe skin reactions, hives, severe allergic reactions with blistering rash of the skin and mucous membranes (exfoliative dermatitis, Stevens-Johnson syndrome), increased skin sensitivity to sunlight, increased muscle tone.

Not known (frequency cannot be estimated from the available data)
Severe allergic reactions with blistering rash of the skin and mucous membranes (toxic epidermal necrolysis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Twynsta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature. Store in the original packaging to protect the medicine from light and moisture. Remove Twynsta tablets from the blister pack only immediately before taking them.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Twynsta contains

The active substances are telmisartan and amlodipine. Each tablet contains 40 mg of telmisartan and 10 mg of amlodipine (as amlodipine besilate).
The other components are anhydrous colloidal silica, brilliant blue FCF (E133), black iron oxide (E172), yellow iron oxide (E172), magnesium stearate, corn starch, meglumine, microcrystalline cellulose, povidone K25, pregelatinized starch prepared from corn starch, sodium hydroxide (see section 2), sorbitol (E420) (see section 2).

Description of the appearance of Twynsta and package contents
Twynsta 40 mg/10 mg tablets are blue and white, oval-shaped, two-layered tablets approximately 14 mm in length, with the product code A2 and the company logo imprinted on the white side.
Twynsta is available in packs of 14, 28, 56, and 98 tablets in aluminum/aluminum blisters, or packs containing 30 x 1, 90 x 1, and 360 (4 x 90 x 1) tablets in aluminum/aluminum blisters divided into single doses.
Not all pack sizes may be marketed.

Marketing Authorization Holder Manufacturer
Boehringer Ingelheim International GmbH Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Str. 173 Binger Str. 173
55216 Ingelheim am Rhein 55216 Ingelheim am Rhein
Germany Germany
Rottendorf Pharma GmbH
Ostenfelder Straße 51 - 61
59320 Ennigerloh
Germany
Boehringer Ingelheim France
100-104 Avenue de France
75013 Paris
France