TWYNSTA 40 мг/5 мг Таблетки

Абдулла Альхасан

Абдулла Альхасан – врач-терапевт с международной клинической практикой в Великобритании и Италии. Проводит онлайн-консультации для взрослых пациентов, сочетая современный медицинский подход с вниманием к индивидуальным особенностям каждого случая.

Основные направления:

Общие симптомы: температура, слабость, боли в теле, кашель
Проблемы с давлением, утомляемость, головная боль
Интерпретация анализов, ЭКГ, результатов обследований
Сопровождение при хронических заболеваниях
Кардиологические жалобы: одышка, боль в груди, аритмии
Подбор терапии и рекомендации по дальнейшей диагностике

Доктор Альхасан помогает разобраться в причинах симптомов, предлагает чёткий план действий и поддерживает пациента на каждом этапе – в удобном онлайн-формате.

Записаться на онлайн-консультацию

zł318

Больше времени

Материал предназначен для общего ознакомления. Для индивидуальных рекомендаций обратитесь к врачу. При тяжелых или быстро ухудшающихся симптомах обратитесь за неотложной медицинской помощью.

Инструкция по применению TWYNSTA

Содержание инструкции

Twynsta 40 mg/5 mg tablets
Twynsta 40 mg/10 mg tablets
Twynsta 80 mg/5 mg tablets
Twynsta 80 mg/10 mg tablets

Twynsta 40 mg/5 mg tablets

telmisartan/amlodipine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Twynsta is and what it is used for
2. What you need to know before you take Twynsta
3. How to take Twynsta
4. Possible side effects
5. How to store Twynsta
6. Contents of the pack and other information

1. What is Twynsta and what is it used for

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

Telmisartan belongs to a group of substances called “angiotensin II receptor antagonists”. Angiotensin II is a substance produced in the body that causes the blood vessels to narrow, thus 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 the blood vessels and thus stops the narrowing of the blood vessels. This means that both of these active ingredients work together helping to prevent the narrowing of the blood vessels. As a result, the blood vessels relax and blood pressure decreases.

Twynsta is used totreat 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 would like to instead take the same doses of both substances in a single tablet for convenience.

Hypertension, if left untreated, can damage the blood vessels in many organs, which puts
patients at risk of serious events such as heart attack, heart or kidney failure, stroke or blindness.
Normally hypertension does not give symptoms before such damage occurs. Therefore, it is important
to have your blood pressure measured regularly to check if 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 medicines of the dihydropyridine type (a type of calcium channel blockers).
if you are pregnant for more than 3 months. (It is also better to avoid taking Twynsta even in the early stages of pregnancy - see the Pregnancy section).
if you have severe liver problems or bile drainage problems (problems with draining bile from the liver and gallbladder).
if you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which your heart is unable to pump enough blood to the body).
if you have heart failure following a heart attack.
if you have diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure containing aliskiren.

If you are in any of these conditions, tell your doctor or pharmacist before taking Twynsta.

Warnings and precautions
Talk to your doctor before taking Twynsta if you suffer from or have 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 problems.
Increased levels of aldosterone (which leads to water and salt retention in the body with an imbalance of various minerals in the blood).
Low blood pressure (hypotension), which is more likely to occur if you are dehydrated (excessive water loss from the body) or have a salt deficiency due to diuretic therapy (“diuretics”), a low-salt diet, diarrhea 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 in 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 check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also “Do not take Twynsta”.
if you are elderly and the dose needs to be increased.

In case of surgery or administration of anesthetics, you must inform the doctor that you are
taking Twynsta.

Children and adolescents
Twynsta is not recommended in children and adolescents up to 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 change the dose of these other medicines or to
take other precautions. In some cases it may be necessary to stop taking one of
these medicines. This applies especially to the medicines listed below:

Medicines containing lithium to treat some types of depression.
Medicines that can 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 “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 temperature abnormalities).
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 in the treatment of fungal infections (e.g. ketoconazole).
Diltiazem (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 you take NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or
ibuprofen) or corticosteroids.
Twynsta may increase the hypotensive effect of other medicines used to lower blood pressure
or of medicines that have the ability to lower blood pressure (e.g. baclofen, amifostine,
neuroleptics or antidepressants).

Twynsta with food and drink
The reduction in blood pressure may be increased by alcohol. You may feel it as
dizziness when getting up.
Grapefruit and grapefruit juice should not be consumed when taking Twynsta. This
is because in some patients grapefruit and grapefruit juice can cause an increase in the levels
of the active ingredient amlodipine in the blood, resulting in an increase in the effect of Twynsta on
lowering blood pressure.

Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you suspect or are planning a pregnancy. As a rule, your doctor will
advise you to stop taking Twynsta before starting a pregnancy or as soon as you
find out you are pregnant and will advise you to take another medicine instead of Twynsta. Twynsta is not recommended in the early stages of pregnancy and should not be taken
if you are pregnant for more than 3 months as it can cause serious harm to the baby if taken
after the third month of pregnancy.
Breastfeeding
Amlodipine has been shown to pass into breast milk in small amounts.
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Twynsta is not recommended
for women who are breastfeeding and your doctor may choose another treatment for you if you wish
to breastfeed, especially if the baby is newborn or premature.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Some patients may experience undesirable effects such as fainting, drowsiness, dizziness or
a feeling of spinning (vertigo) during treatment for hypertension. If you experience these
undesirable effects, do not drive or use machines.

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 following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose is one tablet a day. Try to take the tablet at the same time
each day.
Remove Twynsta tablets from the blister only immediately before taking them.
You can take Twynsta with or without food. The tablets must be swallowed with water or
another non-alcoholic beverage.
If your liver is not functioning properly, you must not exceed the usual dose of one
40 mg/5 mg or one 40 mg/10 mg tablet per day.

If you take more Twynsta than you should
If you have accidentally taken too many tablets, contact your doctor, pharmacist or
the emergency room of the nearest hospital immediately. You may experience low blood pressure and a rapid
heartbeat. Slowed heartbeat, dizziness, reduced kidney function including kidney failure, a marked and
prolonged decrease in blood pressure, including
shock and death have also been reported.
Excess fluid may accumulate in the lungs (pulmonary edema) causing shortness of breath that may
develop up to 24-48 hours after taking it.

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 skip a dose for one day, take your normal dose the next day. Do nottake a double
dose to make up for a forgotten dose.

If you stop taking Twynsta
It is important that you take Twynsta every day, until 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects may be serious and require immediate medical attention
You should immediately consult your doctor if you experience any of the following symptoms:
Sepsis (often called “blood infection”, is a serious 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 should stop taking the medicine and consult
their doctor immediately. If these effects are not treated, they can be fatal. An increase
in the incidence of sepsis has been observed with telmisartan alone, however, it 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)
Sleepiness, migraine, headache, tingling or numbness of the hands or feet, feeling of
spinning (vertigo), slow heartbeat, palpitations (awareness of your heartbeat),
low blood pressure (hypotension), dizziness when getting up (orthostatic hypotension), flushing,
cough, stomach discomfort (abdominal pain), diarrhea, feeling unwell (nausea), itching,
joint pain, muscle cramps, muscle pain, inability to achieve an erection,
weakness, chest pain, fatigue, swelling (edema), increased levels of liver enzymes.

Rare side effects (may affect up to 1 in 1,000 people)
Bladder infections, feeling sad (depression), feeling anxious, insomnia,
fainting, nerve damage in the legs or feet, reduced sense of touch, taste abnormalities,
tremor, vomiting, thickening of the gums, abdominal discomfort, dry mouth, eczema (skin disorder),
redness of the skin, 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 effects (may affect up to 1 in 10,000 people)
Progressive scarring of lung tissue (interstitial lung disease [mainly
interstitial pneumonitis and eosinophilic pneumonia]).
The following side effects have been observed with the individual components telmisartan or amlodipine and
may also occur with Twynsta:

Telmisartan
The following additional side effects have been found in patients treated with telmisartan alone:

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), low red blood cell count (anemia), high potassium levels in the blood, shortness of
breath, swelling, increased sweating, kidney damage including sudden inability of the kidneys to function,
increased levels of creatinine.

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. skin rash, itching, difficulty breathing, wheezing, swelling of the face
or low blood pressure), low blood sugar levels (in diabetic patients), blurred vision,
fast heartbeat, stomach upset, abnormal liver function, hives,
drug rash, tendon inflammation, flu-like illness (e.g. muscle pain, feeling generally unwell), decreased hemoglobin (a blood protein), increased levels of creatine phosphokinase in the blood, low sodium levels.
Most cases of abnormal liver function (liver) and hepatic disorders reported
with telmisartan during post-marketing occurred in Japanese patients. Japanese patients are
more likely to experience these adverse reactions.

Amlodipine
The following additional side effects have been found in patients treated with amlodipine alone:

Common side effects (may affect up to 1 in 10 people)
Altered bowel habits, diarrhea, 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), altered skin color,
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)
Decreased number of white blood cells (leukopenia), low platelet count (thrombocytopenia),
allergic reaction (e.g. skin rash, itching, difficulty breathing, wheezing, swelling of the face
or low blood pressure), excess sugar in the blood, uncontrolled muscle contractions or
jerky movements, heart attack, irregular heartbeat, inflammation of blood vessels,
inflammation of the pancreas, inflammation of the stomach lining (gastritis), inflammation
of the liver, yellowing of the skin (jaundice), increased levels of liver enzymes with jaundice,
rapid swelling of the skin and mucous membranes (angioedema), severe skin reactions, hives, severe
allergic reactions with blistering skin and mucous membranes (exfoliative dermatitis, Stevens-Johnson syndrome), increased sensitivity of the skin to the sun, increased muscle tension.

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system reported in
Appendix 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 which is stated on the package and on the blister after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature. Store in the
original package to protect the medicine from light and moisture. Remove the tablets of
Twynsta from the blister only immediately before taking them.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Twynsta contains

The active ingredients are telmisartan and amlodipine. Each tablet contains 40 mg of telmisartan and 5 mg of amlodipine (as amlodipine besilate).
The other ingredients 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 Twynsta and contents of the pack
Twynsta 40 mg/5 mg tablets are blue and white, oval-shaped, two-layer tablets approximately 14 mm in
length, imprinted with the product code A1 and the company logo on the white side.
Twynsta is available in packs of 14, 28, 56, 98 tablets in aluminium/aluminium blisters or
containing 30 x 1, 90 x 1, 360 (4 x 90 x 1) tablets in aluminium/aluminium divisible blisters for single dose
administration.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
Boehringer Ingelheim International GmbH
Binger Str. 173
55216 Ingelheim am Rhein
Germany
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Str. 173
55216 Ingelheim am Rhein
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 on this medicinal product, please contact the local representative of the
Marketing Authorisation Holder:

België/Belgique/Belgien
Boehringer Ingelheim SComm
Tél/Tel: +32 2 773 33 11

Lietuva
Boehringer Ingelheim RCV GmbH & Co KG
Lietuvos filialas
Tel.: +370 5 2595942

България
Бьорингер Ингелхайм РЦВ ГмбХ и Ко КГ -
клон България
Тел: +359 2 958 79 98

Luxembourg/Luxemburg
Boehringer Ingelheim SComm
Tél/Tel: +32 2 773 33 11

Česká republika
Boehringer Ingelheim spol. s r.o.
Tel: +420 234 655 111

Magyarország
Boehringer Ingelheim RCV GmbH & Co KG
Magyarországi Fióktelepe
Tel.: +36 1 299 89 00

Danmark
Boehringer Ingelheim Danmark A/S
Tlf: +45 39 15 88 88

Malta
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

Deutschland
Boehringer Ingelheim Pharma GmbH & Co. KG
Tel: +49 (0) 800 77 90 900

Nederland
Boehringer Ingelheim B.V.
Tel: +31 (0) 800 22 55 889

Eesti
Boehringer Ingelheim RCV GmbH & Co KG
Eesti Filiaal
Tel: +372 612 8000

Norge
Boehringer Ingelheim Norway KS
Tlf: +47 66 76 13 00

Ελλάδα
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.
Tηλ: +30 2 10 89 06 300

Österreich
Boehringer Ingelheim RCV GmbH & Co KG
Tel: +43 1 80 105-7870

España
Boehringer Ingelheim España, S.A.
Tel: +34 93 404 51 00

Polska
Boehringer Ingelheim Sp. z o.o.
Tel.: +48 22 699 0 699

France
Boehringer Ingelheim France S.A.S.
Tél: +33 3 26 50 45 33

Portugal
Boehringer Ingelheim Portugal, Lda.
Tel: +351 21 313 53 00

Hrvatska
Boehringer Ingelheim Zagreb d.o.o.
Tel: +385 1 2444 600

România
Boehringer Ingelheim RCV GmbH & Co KG
Viena - Sucursala Bucureşti
Tel: +40 21 302 28 00

Ireland
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

Slovenija
Boehringer Ingelheim RCV GmbH & Co KG
Podružnica Ljubljana
Tel: +386 1 586 40 00

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Boehringer Ingelheim RCV GmbH & Co KG
organizačná zložka
Tel: +421 2 5810 1211

Italia
Boehringer Ingelheim Italia S.p.A.
Tel: +39 02 5355 1

Suomi/Finland
Boehringer Ingelheim Finland Ky
Puh/Tel: +358 10 3102 800

Κύπρος
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.
Tηλ: +30 2 10 89 06 300

Sverige
Boehringer Ingelheim AB
Tel: +46 8 721 21 00

Latvija
Boehringer Ingelheim RCV GmbH & Co KG
Latvijas filiāle
Tel: +371 67 240 011

United Kingdom (Northern Ireland)
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

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 / .

Twynsta 40 mg/10 mg tablets

telmisartan/amlodipine

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Twynsta is and what it is used for
2. What you need to know before you take Twynsta
3. How to take Twynsta
4. Possible side effects
5. How to store Twynsta
6. Contents of the pack and other information

1. What is Twynsta and what is it used for

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

Telmisartan belongs to a group of substances called “angiotensin II receptor blockers”. Angiotensin II is a substance produced in the body that causes the blood vessels to narrow, thus 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 thus stops the narrowing of blood vessels. This means that both of these active ingredients work together helping to prevent the narrowing of blood vessels. As a result, the blood vessels relax and blood pressure decreases.

Twynsta is used totreat high blood pressure

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

Hypertension, if left untreated, can damage blood vessels in many organs, which puts patients at risk of serious events such as heart attack, heart or kidney failure, stroke or blindness.
Normally hypertension does not give symptoms before such damage occurs. Therefore, it is important to have your blood pressure measured regularly to check if 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 medicines of the dihydropyridine type (a type of calcium channel blockers).
if you are pregnant for more than 3 months. (It is also better to avoid taking Twynsta even in the early stages of pregnancy - see the Pregnancy section).
if you have severe liver problems or bile drainage problems (problems with draining bile from the liver and gallbladder).
if you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which your heart is unable to pump enough blood to the body).
if you have heart failure following a heart attack.
if you have diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure containing aliskiren.

If you are in any of these conditions, tell your doctor or pharmacist before taking Twynsta.

Warnings and precautions
Talk to your doctor before taking Twynsta if you suffer from or have 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 problems.
Increased levels of aldosterone (which leads to retention of water and salts in the body with an imbalance of various minerals in the blood).
Low blood pressure (hypotension), which is more likely to occur if you are dehydrated (excessive water loss from the body) or have a salt deficiency due to diuretic therapy (“diuretics”), a low-salt diet, diarrhea 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 in 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 check your kidney function, blood pressure and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also “Do not take Twynsta”.
if you are elderly and the dose needs to be increased.

In case of surgery or administration of anesthetics, you must inform the doctor that you are
taking Twynsta.

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

Medicines containing lithium for treating some types of depression.
Medicines that can increase the levels of potassium in the blood such as potassium-containing salt substitutes, potassium-sparing diuretics (some “diuretics”).
Angiotensin II receptor blockers.
ACE inhibitors or aliskiren (see also “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 of body temperature).
Medicines used to modify the functioning of the immune system (e.g. sirolimus, temsirolimus and everolimus).
Medicines used for HIV/AIDS (e.g. ritonavir) or in the treatment of fungal infections (e.g. ketoconazole).
Diltiazem (heart medicine).
Simvastatin for the treatment of high cholesterol levels.
Digoxin.

As with other medicines that reduce blood pressure, the effect of Twynsta may be reduced
when you take NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or
ibuprofen) or corticosteroids.
Twynsta may increase the hypotensive effect of other medicines used to reduce blood pressure
or of medicines that have the ability to lower blood pressure (e.g. baclofen, amifostine,
neuroleptics or antidepressants).

Twynsta with food and drink
The reduction in blood pressure may be increased by alcohol. You may feel it as a
dizziness when getting up.
Grapefruit and grapefruit juice should not be consumed when taking Twynsta. This
because in some patients grapefruit and grapefruit juice can cause an increase in the levels
of the active ingredient amlodipine in the blood with a consequent increase in the effect of Twynsta on
reducing blood pressure.

Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you suspect you are pregnant or are planning to become pregnant. As a rule your doctor will
advise you to stop taking Twynsta before starting pregnancy or as soon as you
find out you are pregnant and will advise you to take another medicine
instead of Twynsta. Twynsta is not recommended in the early stages of pregnancy and should not be taken
if you are pregnant for more than 3 months as it can cause serious harm to the baby if taken
after the third month of pregnancy.
Breastfeeding
Amlodipine has been shown to pass into breast milk in small amounts.
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Twynsta is not recommended
for women who are breastfeeding and your doctor may choose another treatment for you if you wish
to breastfeed, especially if the baby is newborn or premature.
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
feeling of spinning (vertigo) during treatment for hypertension. If you experience these
side effects, do not drive or use machines.

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 following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
The recommended dose is one tablet a day. Try to take the tablet at the same time each day.
Remove Twynsta tablets from the blister only immediately before taking them.
You can take Twynsta with or without food. The tablets must be swallowed with water or
another non-alcoholic beverage.
If your liver is not functioning properly, you must not exceed the usual dose of one
40 mg/5 mg or one 40 mg/10 mg tablet per day.

If you take more Twynsta than you should
If you have accidentally taken too many tablets, contact your doctor, pharmacist or
the emergency room of the nearest hospital immediately. You may experience low blood pressure and a
rapid heartbeat. Slow heartbeat, dizziness, reduced kidney function including kidney failure, a
marked and prolonged decrease in 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 up to 24-48 hours after taking it.

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 dose for one day, take your normal dose the next day. Do nottake a double dose
to make up for a forgotten dose.

If you stop taking Twynsta
It is important that you take Twynsta every day, until 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 the use of 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 should immediately consult a doctor if you experience any of the following symptoms:
Sepsis (often called “blood infection”, is a serious 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 should stop taking the medicine and consult
a doctor immediately. If these effects are not treated they can be fatal. An increase
in the incidence of sepsis has been observed with telmisartan alone, however it 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)
Sleepiness, migraine, headache, tingling or numbness of the hands or feet, feeling of
spinning (vertigo), slow heartbeat, palpitations (awareness of your heartbeat),
low blood pressure (hypotension), dizziness when getting up (orthostatic hypotension), flushing,
cough, stomach discomfort (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 levels of liver enzymes.

Telmisartan
The following additional side effects have been found in patients treated with telmisartan alone:

Rare side effects (may affect up to 1 in 1,000 people)
Increase in some white blood cells (eosinophilia), low platelet count (thrombocytopenia), allergic
reaction (e.g. skin rash, itching, difficulty breathing, wheezing, swelling of the face
or low blood pressure), low blood sugar levels (in diabetic patients), altered vision,
fast heartbeat, stomach upset, abnormal liver function, hives,
drug rash, tendon inflammation, flu-like illness (e.g. muscle pain, feeling generally unwell), decreased hemoglobin (a blood protein), increased levels of creatine phosphokinase in the blood, low sodium levels.
Most cases of abnormal liver function (liver) and liver disorders reported
with telmisartan during post-marketing occurred in Japanese patients. Japanese patients are more likely to experience these adverse reactions.

Amlodipine
The following additional side effects have been found in patients treated with amlodipine alone:

Common side effects (may affect up to 1 in 10 people)
Altered 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), altered skin colour, 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 the number of white blood cells (leukopenia), low platelet count (thrombocytopenia),
allergic reaction (e.g. skin rash, itching, difficulty breathing, wheezing, swelling of the face
or low blood pressure), excess sugar in the blood, uncontrollable or
jerky movements, heart attack, irregular heartbeat, inflammation of blood vessels,
inflammation of the pancreas, inflammation of the stomach lining (gastritis), inflammation
of the liver, yellowing of the skin (jaundice), increased levels of liver enzymes with jaundice,
rapid swelling of the skin and mucous membranes (angioedema), severe skin reactions, hives, severe
allergic reactions with blistering 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 available data)
Severe allergic reactions with blistering skin and mucous membranes (toxic epidermal necrolysis).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system reported 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 which is stated on the package and on the blister after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature. Store in the
original packaging to protect the medicine from light and moisture. Remove the tablets of
Twynsta from the blister only immediately before taking them.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Twynsta contains

The active ingredients are telmisartan and amlodipine. Each tablet contains 40 mg of telmisartan and 10 mg of amlodipine (as amlodipine besilate).
The other ingredients 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 Twynsta and contents of the pack
Twynsta 40 mg/10 mg tablets are blue and white, oval-shaped, two-layer tablets approximately 14 mm
in length imprinted with the product code A2 and the company logo on the white side.
Twynsta is available in packs of 14, 28, 56, 98 tablets in aluminium/aluminium blisters or
containing 30 x 1, 90 x 1, 360 (4 x 90 x 1) tablets in aluminium/aluminium divisible blisters for single
dose.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
Boehringer Ingelheim International GmbH
Binger Str. 173
55216 Ingelheim am Rhein
Germany
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Str. 173
55216 Ingelheim am Rhein
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 on this medicinal product, contact the local representative of the marketing
authorisation holder: