TWYNSTA 80 mg/10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Twynsta 80mg/10mg tablets

telmisartan/amlodipine

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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. Storage of Twynsta
6. Contents of the pack and other information

1. What Twynsta is and what it is used for

Twynsta tablets contain two active substances, telmisartan and amlodipine. Both active substances help to control your high blood pressure:

• Telmisartan belongs to a group of medicines 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 the action of angiotensin II.
• Amlodipine belongs to a group of medicines known as “calcium channel blockers”. Amlodipine prevents calcium from entering the wall of blood vessels, preventing them from becoming too narrow.

This means that both active substances work together to prevent blood vessels from becoming too narrow. As a result, blood vessels relax and blood pressure is lowered.

Twynsta is usedto treat high blood pressure

• in adult patients whose blood pressure is not sufficiently controlled with amlodipine alone.
• in adult patients who are already taking telmisartan and amlodipine in separate tablets and who would prefer to take the same doses in a single tablet for convenience.

High blood pressure, if left untreated, can damage blood vessels in various organs, putting patients at risk of serious complications such as heart attack, heart or kidney failure, stroke, or blindness. Usually, there are no symptoms of high blood pressure before damage occurs. Therefore, it is important to regularly check blood pressure to ensure it is within the normal range.

2. What you need to know before you take Twynsta

Do not take Twynsta

• if you are allergic to telmisartan or amlodipine or 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 blocker).
• if you are more than 3 months pregnant. (It is also better to avoid taking Twynsta at the start of 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 a narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a disorder in which the heart is unable to supply enough blood to the body).
• if you have heart failure after a heart attack.
• if you have diabetes or kidney impairment and are being treated with a blood pressure medicine containing aliskiren.

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

Warnings and precautions

Consult your doctor before starting to take Twynsta if you have or have had any of the following disorders or diseases:

• Kidney disease or kidney transplant.
• Narrowing of the blood vessels of one or both kidneys (renal artery stenosis).
• Liver disease.
• Heart problems.
• High levels of aldosterone (leading to water and salt retention in the body along with imbalance of various blood minerals).
• Low blood pressure (hypotension), which can occur if you are dehydrated (excessive loss of body water) or have low salt levels due to treatment with diuretics, a low-salt diet, diarrhea, or vomiting.
• High levels of potassium in the blood.
• Diabetes.
• Narrowing of the aorta (aortic stenosis).
• Chest pain associated with the heart at rest or with minimal exertion (unstable angina).
• A heart attack that occurred in the last four weeks.

Consult your doctor before starting to take Twynsta:

• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme (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 blood electrolyte levels (e.g., potassium) at regular intervals. See also “Do not take Twynsta”.

• if you are an elderly person and need to have your dose increased.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Twynsta. Your doctor will decide whether to continue treatment. Do not stop taking Twynsta on your own.

In case of surgery or anesthesia, you must inform your doctor that you are taking Twynsta.

Children and adolescents

Twynsta is not recommended for children and adolescents up to 18 years.

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 need to change the dose of those other medicines or take other precautions. In some cases, it may be necessary to stop using one of these medicines, especially if you are using any of the following medicines:

• Medicines containing lithium for the treatment of certain types of depression.
• Medicines that can increase potassium levels in the blood, such as potassium-containing salt substitutes or potassium-sparing diuretics (certain diuretics).
• Angiotensin II receptor blockers.
• Angiotensin-converting enzyme (ACE) inhibitors or aliskiren (see also the information under the headings “Do not take Twynsta” and “Warnings and precautions”).
• Non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen), heparin, immunosuppressants (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Rifampicin, erythromycin, clarithromycin (antibiotics).
• Hypericum.
• Dantrolene (infusion for severe body temperature disorders).
• Medicines used to alter the functioning of the immune system (e.g., sirolimus, temsirolimus, and everolimus).
• Medicines used for HIV/AIDS (e.g., ritonavir) or for the treatment of fungal infections (e.g., ketoconazole).
• Diltiazem (heart medicine).
• Simvastatin for treating high cholesterol levels.
• Digoxin.

As with other medicines that lower blood pressure, the effect of Twynsta may be reduced when using NSAIDs (non-steroidal anti-inflammatory drugs, 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 medicines that may potentially lower blood pressure (e.g., baclofen, amifostine, neuroleptics, or antidepressants).

Taking Twynsta with food and drinks

The reduction in blood pressure caused by Twynsta may be increased by alcohol. You may notice this effect as dizziness when standing up.

Do not consume grapefruit or grapefruit juice when taking Twynsta. This is because grapefruit and grapefruit juice can lead to an increase in the levels of the active substance amlodipine in the blood in some patients and may increase the blood pressure-lowering effect of Twynsta.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you think you might be pregnant or are planning to become pregnant. In general, your doctor will advise you to stop taking Twynsta before you become pregnant or as soon as you know you are pregnant, and will recommend that you take another medicine instead of Twynsta. It is not recommended to use Twynsta during the first trimester of pregnancy and it must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken after that time.

Breastfeeding

Amlodipine has been shown to pass into breast milk in small amounts.

Tell your doctor if you are about to start breastfeeding or are already breastfeeding. It is not recommended to take Twynsta during breastfeeding, and your doctor may decide to prescribe another treatment if you want to breastfeed, especially if your baby is newborn or premature.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Some people may experience side effects such as fainting, drowsiness, dizziness, or a feeling of vertigo when being treated for high blood pressure. If you experience any of these side effects, do not drive or use machines.

Twynsta contains sorbitol

This medicine contains 337.28 mg of sorbitol in each tablet.

Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to some sugars, or you have been diagnosed with a rare genetic disorder called hereditary fructose intolerance (HFI), in which you cannot break down fructose, consult your doctor before taking this medicine.

Twynsta contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Twynsta

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose is one tablet per day. Try to take one tablet each day at the same time.

Take your Twynsta tablet out of the blister pack just before you take it.

You can take Twynsta with or without food. The tablets should be swallowed with a little water or other non-alcoholic drink.

If your liver is not working properly, the usual dose should not exceed one 40 mg/5 mg 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 or pharmacist or the nearest hospital emergency department immediately. You may experience a drop in blood pressure and a rapid heart rate. There have also been reports of slow heart rate, dizziness, decreased kidney function including kidney failure, marked and prolonged low blood pressure including shock, and death.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing, which can occur up to 24-48 hours after administration.

If you forget to take Twynsta

If you forget to take a dose, take it as soon as you remember and then continue as before. If you do not take your tablet one day, take your normal dose the next day. Do not takea double dose to make up for forgotten individual doses.

If you stop taking Twynsta

It is important that you take Twynsta every day until your doctor tells you to stop. If you think 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 Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Some adverse effects can be serious and require immediate medical attention

If you experience any of the following symptoms, you should visit your doctor immediately:

Sepsis (often called "blood poisoning", it is a serious infection of the entire body with high fever and a feeling of being seriously ill), rapid swelling of the skin and mucous membranes (angioedema); these adverse effects are rare (they can affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and visit 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 ruled out for Twynsta.

Frequent Adverse Effects (can affect up to 1 in 10 people)

Dizziness, swelling of the ankles (edema).

Infrequent Adverse Effects (can affect up to 1 in 100 people)

Feeling of sleepiness, migraine, headache, feeling of tingling or numbness in the hands or feet, feeling of vertigo, slow heart rate, palpitations (awareness of heartbeat), low blood pressure (hypotension), dizziness when standing up (orthostatic hypotension), flushing, cough, stomach pain (abdominal pain), diarrhea, nausea, itching, joint pain, muscle spasms, muscle pain, inability to have an erection, weakness, chest pain, fatigue, swelling (edema), increased levels of liver enzymes.

Rare Adverse Effects (can affect up to 1 in 1,000 people)

Urinary tract infection, feeling of sadness (depression), anxiety, difficulty falling asleep, dizziness, nerve damage in the hands or feet, decreased sense of touch, taste disturbances, tremors, vomiting, gum hypertrophy, abdominal discomfort, dry mouth, eczema (a skin disorder), redness of the skin, exanthema, back pain, leg pain, need to urinate at night, discomfort, increased levels of uric acid in the blood.

Very Rare Adverse Effects (can affect up to 1 in 10,000 people)

Progressive scarring of lung tissue (interstitial lung disease [mainly interstitial pneumonia and eosinophilic pneumonia]).

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

Telmisartan

The following additional adverse effects have been described in patients taking telmisartan alone:

Infrequent Adverse Effects (can 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 in the blood (anemia), elevated potassium levels in the blood, shortness of breath, abdominal distension, increased sweating, kidney damage including sudden inability of the kidney to function, elevated creatinine levels.

Rare Adverse Effects (can affect up to 1 in 1,000 people)

Increased levels of certain white blood cells in the blood (eosinophilia), low platelet count (thrombocytopenia), allergic reaction (e.g., exanthema, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), vision disturbances, rapid heart rate, stomach upset, liver function disorders, urticaria, drug exanthema, tendon inflammation, pseudogrippal illness (e.g., muscle pain, general malaise), decreased hemoglobin (a blood protein), increased levels of creatine phosphokinase in the blood, low sodium levels.

Most cases of abnormal liver function and liver disorder from post-marketing experience with telmisartan occurred in Japanese patients. Japanese patients are more likely to experience this adverse effect.

Unknown Frequency (cannot be estimated from available data)

Intestinal angioedema: swelling in the intestine has been reported, which occurs with symptoms such as abdominal pain, nausea, vomiting, and diarrhea after using similar products.

Amlodipine

The following additional adverse effects have been described in patients taking amlodipine alone:

Frequent Adverse Effects (can affect up to 1 in 10 people)

Alteration of intestinal habits, diarrhea, constipation, visual disturbances, double vision, swelling in the ankles.

Infrequent Adverse Effects (can affect up to 1 in 100 people)

Mood changes, visual disturbances, ringing in the ears, shortness of breath, sneezing/rhinitis, hair loss, unusual bruising and bleeding (damage to red blood cells), skin discoloration, increased sweating, difficulty urinating, increased need to urinate especially at night, breast enlargement in men, pain, weight gain, weight loss.

Rare Adverse Effects (can affect up to 1 in 1,000 people)

Confusion.

Very Rare Adverse Effects (can affect up to 1 in 10,000 people)

Decreased number of white blood cells in the blood (leukopenia), low platelet count (thrombocytopenia), allergic reaction (e.g., exanthema, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), high blood sugar, uncontrolled twitching or jerking movements, heart attack, irregular heartbeat, inflammation of blood vessels, pancreatitis, inflammation of the stomach lining (gastritis), liver inflammation, jaundice, increased levels of liver enzymes accompanied by jaundice, rapid swelling of the skin and mucous membranes (angioedema), severe skin reactions, urticaria, severe allergic reactions with blistering skin and mucous membrane reactions (exfoliative dermatitis, Stevens-Johnson syndrome), increased sensitivity of the skin to sunlight, increased muscle tension.

Unknown Frequency (cannot be estimated from available data)

Severe allergic reactions with blistering skin and mucous membrane reactions (toxic epidermal necrolysis).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Twynsta

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the carton and blister after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require any special storage temperature. Store in the original packaging to protect it from light and moisture. Remove your Twynsta tablet from the blister just before taking it.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Twynsta

• The active ingredients are telmisartan and amlodipine.

Each tablet contains 80 mg of telmisartan and 10 mg of amlodipine (as amlodipine besylate).

• 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 corn starch, sodium hydroxide (see section 2), sorbitol (E420) (see section 2).

Appearance and Package Contents

Twynsta 80 mg/10 mg tablets are oval, two-layer tablets, blue and white, approximately 16 mm in length, with the code A4 and the company logo engraved on the white layer.

Twynsta is available in a pack containing 14, 28, 56, 98 tablets in aluminum/aluminum blisters or in a pack containing 30 x 1, 90 x 1, 360 (4 x 90 x 1) tablets in pre-cut unit-dose aluminum/aluminum blisters.

Not all pack sizes may be marketed.

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.