Package Leaflet: Information for the User

Twynsta 80mg/10mg tablets

telmisartán/amlodipino

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as 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 others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Twynsta and what it is used for

2.What you need to know before you start taking Twynsta

3.How to take Twynsta

4.Possible side effects

5.Storage of Twynsta

6.Contents of the pack and additional information

Twynsta tablets contain two active ingredients, telmisartan and amlodipine. Both active ingredients help 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 your blood vessels to constrict, increasing your blood pressure. Telmisartan blocks the effect of angiotensin II.
• Amlodipine belongs to a group of medicines known as “calcium channel blockers”. Amlodipine prevents calcium from passing into the walls of your blood vessels, preventing them from becoming rigid.

This means that both active ingredients work together to prevent your blood vessels from becoming rigid. As a result, your blood vessels relax and blood pressure decreases.

Twynsta is used forthe treatment of high blood pressure

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

High blood pressure, if left untreated, can damage the blood vessels of various organs, putting patients at risk of severe episodes such as heart attack, heart failure, or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Therefore, it is essential to monitor blood pressure periodically to ensure it is within the normal range.

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 dihydropyridine-type calcium channel blockers.
• if you are more than 3 months pregnant. (It is best to avoid taking Twynsta at the start of your pregnancy - see section “Pregnancy”).
• if you have severe liver problems or bile duct obstruction (problems with bile drainage from the liver and gallbladder).
• if you have aortic stenosis (narrowing of the aortic valve) or cardiogenic shock (a condition in which the heart cannot supply enough blood to the body).
• if you have heart failure after a heart attack.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains 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 conditions or diseases:

• kidney disease or kidney transplant.
• renal artery stenosis (narrowing of the blood vessels supplying the kidneys).
• liver disease.
• heart problems.
• high levels of aldosterone (leading to water and salt retention in the body and imbalance of various minerals in the blood).
• low blood pressure (hypotension), which may occur if you are dehydrated (excessive loss of body water) or have a salt deficiency due to diuretic treatment, a low-salt diet, diarrhea, or vomiting.
• high levels of potassium in the blood.
• diabetes.
• aortic stenosis (narrowing of the aortic valve).
• unstable angina (chest pain associated with the heart at rest or with minimal exertion).
• 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):

• a renin-angiotensin-aldosterone system (RAAS) 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 electrolyte levels (e.g., potassium) at regular intervals. See also “Do not take Twynsta”.

• if you are an elderly person and your dose needs to be 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.

Inform your doctor if you are undergoing surgery or anesthesia that you are taking Twynsta.

Children and adolescents

Twynsta is not recommended for children and adolescents under 18 years old.

Other medicines and Twynsta

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. Your doctor may need to change the dose of these other medicines or take other precautions. In some cases, you may need to stop using one of these medicines, especially if you are using any of the medicines listed below:

• 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, potassium-sparing diuretics (certain diuretics).
• angiotensin II receptor blockers.
• RAAS inhibitors or aliskiren (see also the information under the headings “Do not take Twynsta” and “Warnings and precautions”).
• NSAIDs (nonsteroidal anti-inflammatory drugs, e.g., aspirin or ibuprofen), heparin, immunosuppressants (e.g., cyclosporin or tacrolimus), and the antibiotic trimethoprim.
• erythromycin, clarithromycin (antibiotics).
• St. John's Wort.
• dantrolene (perfusion for severe body temperature abnormalities).
• 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 high cholesterol.
• digoxin.

Like other blood pressure-lowering medicines, the effect of Twynsta may be reduced when using NSAIDs (nonsteroidal anti-inflammatory drugs, e.g., aspirin or ibuprofen) or corticosteroids.

Twynsta may increase the effect of blood pressure-lowering medicines used to treat high blood pressure or medicines that may potentially lower blood pressure (e.g., baclofen, amifostine, neuroleptics, or antidepressants).

Twynsta with food and drinks

The decrease in blood pressure may be exacerbated 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 may lead to an increase in the blood levels of the active ingredient amlodipine in some patients and may increase the effect of blood pressure-lowering of Twynsta.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you may be pregnant or are planning to become pregnant. Your doctor will usually advise you to stop taking Twynsta before becoming pregnant or as soon as you know you are pregnant, and recommend taking another medicine instead of Twynsta. Twynsta is not recommended for use at the start of pregnancy and should not be administered from the third month of pregnancy, as it may cause serious harm to your baby when administered from that time.

Breastfeeding

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

Inform your doctor if you are planning to start breastfeeding or are breastfeeding. It is not recommended to administer Twynsta to women during this period, and your doctor may decide to administer 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 operating machinery

Some people may experience side effects such as dizziness, drowsiness, lightheadedness, or a sensation of vertigo when treated for high blood pressure. If you experience any of these side effects, do not drive or operate machinery.

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 a problem with certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient 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; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Remove your Twynsta tablet from the blister pack just before taking it.

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

If your liver does not function correctly, the usual dose should not exceed one40mg/5mg or one40mg/10mg tablet per day.

If you take moreTwynstathan you should

If you accidentally take too many tablets, contact your doctor or pharmacist or the nearest hospital emergency service immediately. You may experience a drop in blood pressure and rapid heartbeats. There have also been cases of slow heart rhythm, dizziness, decreased kidney function including kidney failure, marked and prolonged low blood pressure including shock and death.

A buildup of excess fluid in the lungs (pulmonary edema) that causes difficulty breathing may appear up to 24‑48hours after administration.

If you forget to takeTwynsta

If you forget to take a dose, take it as soon as you remember and continue as before. If you miss a tablet oneday, take your regular dose the next day.Do not takea double dose to make up for the missed doses.

If you interrupt treatment with Twynsta

It is essential 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, consult your doctor or pharmacist.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

Some side 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", is a severe infection of the whole body with high fever and feeling severely ill), rapid swelling of the skin and mucous membranes (angioedema); these side effects are rare (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 side effects are not treated, they can be fatal. An increased incidence of sepsis with telmisartan alone has been observed; however, it cannot be ruled out for Twynsta.

Frequent side effects (can affect up to 1in 10people)

Dizziness, swelling of the ankles (edema).

Rare side effects (can affect up to 1in 100people)

Drowsiness, migraine, headache, tingling or numbness of the hands or feet, feeling of dizziness, slow heart rate, palpitations (awareness of your heartbeat), low blood pressure (hypotension), dizziness when standing (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), elevated liver enzyme levels.

Rare side effects (can affect up to 1in 1,000people)

Urinary tract infection, feeling of sadness (depression), anxiety, difficulty falling asleep, drowsiness, nerve damage in the hands or feet, decreased sense of touch, taste alterations, tremors, vomiting, swollen gums, abdominal discomfort, dry mouth, eczema (a skin condition), redness of the skin, rash, back pain, leg pain, need to urinate at night, discomfort, elevated blood uric acid levels.

Very rare side effects (can affect up to 1in 10,000people)

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

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

Telmisartan

Additionally, the following side effects have been described in patients taking telmisartan alone:

Rare side effects (can affect up to 1in 100people)

Urinary tract infections, upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), anemia, elevated potassium levels, shortness of breath, abdominal distension, increased sweating, kidney damage including sudden inability of the kidney to function, elevated creatinine levels.

Rare side effects (can affect up to 1in 1,000people)

Eosinophilia (an increase in certain white blood cells), 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), vision disturbances, rapid heart rate, stomach discomfort, altered liver function, urticaria, drug-induced exanthema, tendon inflammation, pseudogripal disease (e.g., muscle pain, general discomfort), decreased hemoglobin levels, elevated creatine phosphokinase levels in blood, low sodium levels.

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

Unknown frequency

Intestinal angioedema: intestinal swelling has been reported with symptoms such as abdominal pain, nausea, vomiting, and diarrhea after use of similar products.

Amlodipino

Additionally, the following side effects have been described in patients taking amlodipine alone:

Frequent side effects (can affect up to 1in 10people)

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

Rare side effects (can affect up to 1in 100people)

Mood changes, visual disturbances, tinnitus, shortness of breath, runny nose/rhinitis, hair loss, bruising, and bleeding (damage to red blood cells), skin discoloration, increased sweating, difficulty urinating, increased need to urinate, especially at night, gynecomastia in men, pain, weight gain, weight loss.

Rare side effects (can affect up to 1in 1,000people)

Confusion.

Very rare side effects (can affect up to 1in 10,000people)

Leukopenia (decreased white blood cell count), thrombocytopenia (low platelet count), allergic reaction (e.g., rash, itching, difficulty breathing, wheezing, facial swelling or low blood pressure), hyperglycemia, uncontrolled tics or sudden movements, heart attack, irregular heartbeat, vascular inflammation, pancreatitis, gastric mucosal inflammation (gastritis), liver inflammation, jaundice, elevated liver enzyme levels accompanied by jaundice, rapid swelling of the skin and mucous membranes (angioedema), severe skin reactions, urticaria, severe allergic reactions with blistering of the skin and mucous membranes (dermatitis exfoliativa, Stevens-Johnson syndrome), increased skin sensitivity to the sun, increased muscle tension.

Unknown frequency (cannot be estimated from available data)

Severe allergic reactions with blistering of the skin and mucous membranes (toxic epidermal necrolysis).

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directlythrough thenational reporting system included in theAppendixV.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not usethis medicationafter the expiration date that appears on the box and on the blister pack after “CAD”. The expiration date is the last day of the month indicated.

This medication 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 pack just before taking it.

Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition ofTwynsta

• The active principles are telmisartan and amlodipine.

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

• The other components are anhydrous colloidal silica, Brilliant Blue FCF (E133), iron oxide black (E172), iron oxide yellow (E172), magnesium stearate, cornstarch, meglumine, microcrystalline cellulose, povidone K25, pregelatinized cornstarch, sodium hydroxide (see section 2), sorbitol (E420) (see section 2).

Appearance of the product and contents of the pack

Twynsta 80mg/10mg tablets are oval-shaped, two-layered, blue and white tablets, approximately 16 mm in length, with the code A4and the company logo engraved on the white layer.

Twynsta is available in a pack containing 14, 28, 56, 98tablets in aluminium/aluminium blisters or a pack containing 30x1, 90x1, 360 (4x90x1)tablets in pre-cut, single-dose aluminium/aluminium blisters.

Only some pack sizes may be marketed.

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of the summary of product characteristics:

Other sources of information

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