Leaflet:information for the user

Telmisartán/Amlodipino Teva 80 mg/5 mg tablets EFG

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 yourdoctoror pharmacist.

-This medicine has been prescribedonlyfor you, and you must not give it to others even if they havethe same symptomsas 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 Telmisartán/Amlodipino Teva and what it is used for

2.What you need to knowbeforestarting totake Telmisartán/Amlodipino Teva

3.How to take Telmisartán/Amlodipino Teva

4.Possible side effects

5.Storage of Telmisartán/Amlodipino Teva

6.Contents of the pack and additional information

The Telmisartán/Amlodipino Teva tablets contain two active ingredients, telmisartán and amlodipino. Both active ingredients help control your high blood pressure:

• Telmisartán 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. Telmisartán blocks the effect of angiotensin II.
• Amlodipino belongs to a group of medicines known as “calcium channel blockers”. Amlodipino 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 your blood pressure decreases.

Telmisartán/amlodipino is used to treat high blood pressure:

• in adult patients whose blood pressure is not sufficiently controlled with amlodipino alone.
• in adult patients who are already receiving telmisartán and amlodipino 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, kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Therefore, it is essential to check your blood pressure periodically to ensure it is within the normal range.

Do not take Telmisartán/Amlodipino Teva

• if you are allergic to telmisartán or amlodipino 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 telmisartán/amlodipino 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 Telmisartán/Amlodipino.

Warnings and precautions

Consult your doctor before starting to take this medicine 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 (which can lead to water and salt retention in the body and imbalance of various minerals in the blood).
• low blood pressure (hypotension), which can 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 Telmisartán/Amlodipino:

• 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), particularly 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 Telmisartán/Amlodipino Teva”.

• 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 telmisartán/amlodipino. Your doctor will decide whether to continue treatment. Do not stop taking telmisartán/amlodipino.

Before surgery or anesthesia, you must inform your doctor that you are taking this medicine.

Children and adolescents

Telmisartán/amlodipino is not recommended for children and adolescents under 18 years.

Other medicines and Telmisartán/Amlodipino Teva

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 following medicines:

• medicines containing lithium for the treatment of certain types of depression.
• medicines that can increase blood potassium levels, such as potassium-containing salt substitutes, potassium-sparing diuretics (certain diuretics).
• angiotensin II receptor blockers.
• ACE inhibitors or aliskiren (see also the information under the headings “Do not take Telmisartán/Amlodipino Teva” and “Warnings and precautions”).
• NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen), heparin, immunosuppressants (e.g. ciclosporin or tacrolimus), and the antibiotic trimetoprim.
• erythromycin, clarithromycin (antibiotics).
• St. John's Wort (hypericum).
• 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 telmisartán/amlodipino may be reduced when using NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen) or corticosteroids.

Telmisartán/amlodipino 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).

Taking Telmisartán/Amlodipino Teva 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 telmisartán/amlodipino. This is because grapefruit and grapefruit juice may lead to an increase in blood levels of the active ingredient amlodipino in some patients and may increase the effect of blood pressure-lowering of telmisartán/amlodipino.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you may be pregnant or are planning to become pregnant.

Generally, your doctor will advise you to stop taking telmisartán/amlodipino before becoming pregnant or as soon as you know you are pregnant, and recommend taking another medicine instead of telmisartán/amlodipino. Telmisartán/amlodipino is not recommended for use from the third month of pregnancy, as it may cause serious harm to your baby when administered from that time.

Breastfeeding

It has been shown that amlodipino passes into breast milk in small amounts.

Inform your doctor if you are about to start breastfeeding or are breastfeeding. Telmisartán/amlodipino is not recommended for use 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 spinning when treated for high blood pressure. If you experience any of these side effects, do not drive or operate machinery.

Telmisartán/Amlodipino Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this 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 one tablet per day. Try to take the tablet every day at the same time.

You can take Telmisartán/Amlodipino 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 one tablet of 40 mg/5 mg or one tablet of 40 mg/10 mg per day.

If you take more Telmisartán/Amlodipino Teva than you should

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

Excess fluid may accumulate in the lungs (pulmonary edema) causing breathing difficulties that can develop up to 24-48 hours after ingestion.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount taken.

If you forgot to take Telmisartán/Amlodipino Teva

If you forget to take a dose, take it as soon as you remember and continue as before. If you miss a day, take your normal dose the next day.Do nottake a double dose to compensate for the missed doses.

If you interrupt treatment with Telmisartán/Amlodipino Teva

It is essential that you take Telmisartán/Amlodipino every day until your doctor tells you otherwise. If you feel that the effect of this medication 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," it 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 (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 side effects are not treated, they can be fatal. An increased incidence of sepsis has been observed with telmisartan alone; however, it cannot be ruled out for telmisartan/amlodipine.

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

Dizziness, swelling of the ankles (edema).

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

Feeling sleepy, migraine, headache, feeling of numbness or tingling in 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 cramps, muscle pain, inability to have an erection, weakness, chest pain, fatigue, swelling (edema), increased levels of liver enzymes.

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

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, increased levels of uric acid in the blood.

Very rare side 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 side effects have been observed with the components telmisartan or amlodipine and may also occur with telmisartan/amlodipine:

Telmisartan

The following additional side effects have been reported in patients taking telmisartan alone:

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

Urinary tract infections, upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), 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.

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

Eosinophilia (an increase in certain white blood cells), thrombocytopenia (low platelet count), 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 rash, tendon inflammation, pseudogripal disease (e.g., muscle pain, general discomfort), decreased hemoglobin levels, elevated creatine phosphokinase levels in the 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 (cannot be estimated from available data):

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

Amlodipino

The following additional side effects have been reported in patients taking amlodipine alone:

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

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

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

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

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

Confusion.

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

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, involuntary movements or tics, heart attack, irregular heartbeat, inflammation of blood vessels, pancreatitis, gastritis (inflammation of the stomach lining), hepatitis (inflammation of the liver), yellowing of the skin (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 sensitivity to sunlight, 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 experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es. 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 use this medication after the expiration date that appears on the box and on the blister 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.

Medicines should not be thrown down the drains or in the trash.Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy.If in doubt, ask your pharmacist how to dispose ofthe containers and themedications you no longerneed. In this way, you will help protect the environment.

Telmisartan/Amlodipine Teva Composition

1. The active principles are telmisartan and amlodipine.

Each tablet contains 80 mg of telmisartan and 5 mg of amlodipine (as amlodipine besylate).

1. The other components are microcrystalline cellulose, crospovidone, red iron oxide (E172), magnesium stearate, cornstarch, mannitol, meglumine, povidone K25, anhydrous colloidal silica, sodium hydroxide, pregelatinized cornstarch (prepared from cornstarch).

Appearance of the product and contents of the packaging

Telmisartan/Amlodipine Teva 80 mg/5 mg tablets EFG are oblong, biconvex, two-layer tablets, with one side white to off-white and the other side pink, with light speckles on the pink side, with approximate dimensions of 15 x 7 mm.

Aluminum/OPA/Al/PVC blisters in packaging of 14, 28, 30, 56, 90, and 98 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva B.V.

Swensweg 5,

2031GA Haarlem

Netherlands

Responsible manufacturer

Zaklady Farmaceutyczne POLPHARMA S.A.

(Pharmaceutical Works POLPHARMA S.A.)

ul.Pelplinska 19

83-200 Starogard Gdanski

Poland

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid (Spain)

Last review date of this prospectus:January 2024

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

QR code and URL

You can access detailed and updated information about this medicine by scanning the QR code included in the carton with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/87954/P_87954.html