Telmisartan/amlodipine Teva 80 mg/5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Telmisartan/Amlodipine Teva 80 mg/5 mg tablets EFG

Read the entire 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, because it may harm them.

  • If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Telmisartan/Amlodipine Teva is and what it is used for

Telmisartan/Amlodipine Teva tablets contain two active substances, telmisartan and amlodipine. Both active substances 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 narrow, thereby 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 entering the wall of your blood vessels, thus avoiding stiffening of your blood vessels.

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

Telmisartan/amlodipine is used to treat high blood pressure:

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

If left untreated, high blood pressure can damage the blood vessels of various organs, putting patients at risk of serious events such as heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Therefore, it is important to regularly monitor your blood pressure to ensure it remains within the normal range.

2. What you need to know before taking Telmisartán/Amlodipino Teva

Do not take Telmisartán/Amlodipino Teva

• 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 blocker).
• if you are more than 3 months pregnant. (It is best to avoid taking telmisartan/amlodipino also during early pregnancy – see section “Pregnancy”)
• if you have severe liver problems or biliary obstruction (problems with bile drainage from the liver and gallbladder).
• if you have narrowing of the aortic heart valve (aortic stenosis) 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 containing aliskiren.

If any of the above apply to you, tell your doctor or pharmacist before taking Telmisartán/Amlodipino.

Warnings and precautions

Talk to 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.

• Narrowing of the blood vessels to one or both kidneys (renal artery stenosis).

• Liver disease.

• Heart problems.

• High levels of aldosterone (leading to fluid and salt retention in the body along with imbalance of several blood minerals).

• Low blood pressure (hypotension), which may occur if you are dehydrated (excessive loss of body fluids) or have salt deficiency due to diuretic treatment, a low-salt diet, diarrhoea, or vomiting.

• High levels of potassium in the blood.

• Diabetes.

• Narrowing of the aorta (aortic stenupotassium levels in the blood (e.g., potassium) at regular intervals. See also “Do not take Telmisartán/Amlodipino Teva”.

• if you are elderly and a dose increase is needed.

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking telmisartan/amlodipino. Your doctor will decide whether to continue treatment. Do not stop taking telmisartan/amlodipino without medical advice.

If you are undergoing surgery or anaesthesia, 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 of age.

Other medicines and Telmisartán/Amlodipino Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Your doctor may need to adjust the dose of these other medicines or take other precautions. In some cases, you may need to stop taking one of these medicines, especially if you are using any of the following:

• Medicines containing lithium used to treat certain types of depression.
• Medicines that may increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics (certain diuretics).
• Angiotensin II receptor blockers.
• Angiotensin-converting enzyme (ACE) inhibitors or aliskiren (see also information under the headings “Do not take Telmisartán/Amlodipino Teva” 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 (Hypericum perforatum).
• Dantrolene (intravenous for severe disturbances in body temperature).
• Medicines used to alter the function of the immune system (e.g., sirolimus, temsirolimus, and everolimus).
• Medicines used for HIV/AIDS (e.g., ritonavir) or for treating fungal infections (e.g., ketoconazole).
• Diltiazem (a heart medicine).
• Simvastatin for treating high cholesterol levels.
• Digoxin.

As with other medicines that lower blood pressure, the effect of telmisartan/amlodipino may be reduced when used with NSAIDs (non-steroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or ibuprofen) or corticosteroids.

Telmisartán/amlodipino may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or of medicines that may potentially lower blood pressure (e.g., baclofen, amifostine, neuroleptics, or antidepressants).

Taking Telmisartán/Amlodipino Teva with food and drink

The blood pressure-lowering effect may be worsened by alcohol. You may notice this as dizziness when standing up.

You should not consume grapefruit or grapefruit juice while taking telmisartan/amlodipino. This is because grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine in some patients and may enhance the blood pressure-lowering effect of telmisartan/amlodipino.

Pregnancy and breastfeeding

Pregnancy

Tell your doctor if you think you may be pregnant or plan to become pregnant.

Generally, your doctor will advise you to stop taking telmisartan/amlodipino before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Telmisartan/amlodipino is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that time.

Breastfeeding

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

Inform your doctor if you are planning to breastfeed or are currently breastfeeding. The use of telmisartan/amlodipino is not recommended for women during this period, and your doctor may decide to prescribe another treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Some people may experience adverse effects such as fainting, drowsiness, dizziness, or vertigo when being treated for high blood pressure. If you experience any of these adverse 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; essentially “sodium-free”.

3. How to take Telmisartán/Amlodipino Teva

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

You may take Telmisartán/Amlodipino with or without food. Swallow the tablets with a little water or another non-alcoholic drink.

If your liver is not functioning properly, the usual dose should not exceed one 40 mg/5 mg tablet or one 40 mg/10 mg tablet 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 department immediately. You may experience a drop in blood pressure and rapid heartbeat. Cases of slow heart rate, dizziness, reduced 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, which may develop 24–48 hours after ingestion.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken.

If you forget 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 dose one day, take your normal dose the next day. Do not take a double dose to make up for the missed dose.

If you stop taking Telmisartán/Amlodipino Teva

It is important that you take Telmisartán/Amlodipino every day unless your doctor tells you otherwise. If you feel that the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.

If you have any further questions about 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 everyone will experience them.

Some adverse effects may be serious and require immediate medical attention:

If you experience any of the following symptoms, you must see your doctor immediately:

Sepsis (commonly called "blood poisoning", a severe systemic infection with high fever and feeling seriously unwell), rapid swelling of the skin and mucous membranes (angioedema); these adverse effects are rare (may affect up to 1 in 1,000 people) but are extremely serious, and patients must stop taking the medicine and see their doctor immediately. If these effects are not treated, they may be fatal. An increased incidence of sepsis has been observed with telmisartan alone; however, this cannot be ruled out for telmisartan/amlodipine.

Frequent adverse effects (may affect up to 1 in 10 people):

Dizziness, swelling of the ankles (edema).

Uncommon adverse effects (may affect up to 1 in 100 people):

Drowsiness, migraine, headache, tingling or numbness in the hands or feet, dizziness, slow heart rate, palpitations (awareness of heartbeat), low blood pressure (hypotension), dizziness upon standing (orthostatic hypotension), flushing, cough, stomach pain (abdominal pain), diarrhea, 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 adverse effects (may affect up to 1 in 1,000 people):

Urinary bladder infection, feeling of sadness (depression), anxiety, difficulty sleeping, dizziness, nerve damage in the hands or feet, reduced sense of touch, taste disturbances, 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, malaise, increased levels of uric acid in the blood.

Very rare adverse effects (may affect up to 1 in 10,000 people):

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

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

Telmisartan

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

Uncommon adverse effects (may affect up to 1 in 100 people):

Urinary tract infections, upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), deficiency of red blood cells (anemia), elevated blood potassium levels, shortness of breath, abdominal distension, increased sweating, kidney damage including sudden kidney failure, elevated creatinine levels.

Rare adverse effects (may affect up to 1 in 1,000 people):

Increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), allergic reaction (e.g., rash, itching, difficulty breathing, wheezing, facial swelling or low blood pressure), low blood sugar levels (in diabetic patients), visual disturbances, rapid heart rate, stomach discomfort, altered liver function, urticaria, drug rash, tendon inflammation, pseudoinfluenza illness (e.g., muscle pain, general malaise), decreased hemoglobin (a blood protein), increased levels of creatine phosphokinase in blood, low sodium levels.

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

Frequency not known (cannot be estimated from available data):

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

Amlodipine

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

Frequent adverse effects (may affect up to 1 in 10 people):

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

Uncommon adverse effects (may 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 (may affect up to 1 in 1,000 people):

Confusion.

Very rare adverse effects (may affect up to 1 in 10,000 people):

Decrease in white blood cell count (leucopenia), low platelet count (thrombocytopenia), allergic reaction (e.g., rash, itching, difficulty breathing, wheezing, facial swelling or low blood pressure), high blood sugar, uncontrollable tics or jerky movements, heart attack, irregular heartbeat, inflammation of blood vessels, inflammation of the pancreas, inflammation of the stomach lining (gastritis), liver inflammation, yellowing of the skin (jaundice), increased liver enzymes accompanied by jaundice, rapid swelling of the skin and mucous membranes (angioedema), serious skin reactions, urticaria, severe allergic reactions with blistering rash on the skin and mucous membranes (exfoliative dermatitis, Stevens-Johnson syndrome), increased skin sensitivity to sunlight, increased muscle tension.

Frequency not known (cannot be estimated from available data):

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Telmisartan/Amlodipine Teva

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

Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Telmisartan/Amlodipine Teva

1. The active substances are telmisartan and amlodipine.

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

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

Appearance of the medicine and contents of the pack

Telmisartan/Amlodipine Teva 80 mg/5 mg tablets EFG are oblong, biconvex, two-layer tablets, one side white to off-white and the other side pink, with slight speckling on the pink side, approximately 15 x 7 mm in size.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem

The Netherlands

Manufacturer

Zaklady Farmaceutyczne POLPHARMA S.A.

(Pharmaceutical Works POLPHARMA S.A.)

ul. Pelplinska 19

83-200 Starogard Gdanski

Poland

For further 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)

Date of the most recent revision of this leaflet: January 2024

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

QR Code and URL

You can access detailed and up-to-date information about this medicine by scanning the QR code included on the carton with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/87954/P_87954.html