TELMISARTAN/AMLODIPINE TEVA 80 mg/5 mg TABLETS

Introduction

Package Leaflet:information for the user

Telmisartan/Amlodipine Teva 80 mg/5 mg tablets EFG

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

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

Telmisartan/Amlodipine Teva tablets contain two active ingredients, telmisartan and amlodipine. Both active ingredients 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 ingredients work together to prevent blood vessels from becoming too narrow. As a result, blood vessels relax and blood pressure decreases.

Telmisartan/amlodipine is used to 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 Telmisartan/Amlodipine Teva

Do not take Telmisartan/Amlodipine Teva

• 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 recommended that you avoid taking telmisartan/amlodipine at the start of your 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 condition where 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 problems and are being treated with a blood pressure medicine that contains aliskiren.

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

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 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 a deficiency of salts 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 Telmisartan/Amlodipine:

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

• an angiotensin-converting enzyme inhibitor (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 Telmisartan/Amlodipine Teva”.

• 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 telmisartan/amlodipine. Your doctor will decide whether to continue treatment. Do not stop taking telmisartan/amlodipine.

In case of surgery or anesthesia, you should inform your doctor that you are taking this medicine.

Children and adolescents

Telmisartan/amlodipine is not recommended in children and adolescents up to 18 years.

Other medicines and Telmisartan/Amlodipine Teva

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 these 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 inhibitors (ACE inhibitors) or aliskiren (see also the information under the headings “Do not take Telmisartan/Amlodipine Teva” 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).
• St. John's Wort (hypericum).
• Dantrolene (infusion 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 treating high cholesterol levels.
• Digoxin.

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

Telmisartan/amlodipine 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 Telmisartan/Amlodipine Teva with food and drinks

The reduction in blood pressure can be enhanced by alcohol. You may notice this effect as dizziness when standing up.

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

Pregnancy and breast-feeding

Pregnancy

You should inform your doctor if you think you might be pregnant or are planning to become pregnant.

Usually, your doctor will advise you to stop taking telmisartan/amlodipine before you become pregnant or as soon as you know you are pregnant, and will recommend that you take another medicine instead of telmisartan/amlodipine. It is not recommended to use telmisartan/amlodipine at the start 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.

Breast-feeding

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

Inform your doctor if you are breast-feeding or plan to breast-feed. Telmisartan/amlodipine is not recommended for use during breast-feeding, and your doctor may decide to prescribe a different treatment if you want to breast-feed, 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 spinning when being treated for high blood pressure. If you experience any of these side effects, do not drive or use machines.

Telmisartan/Amlodipine Teva contains sodium

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

3. How to take Telmisartan/Amlodipine Teva

Always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.

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

You can take Telmisartan/Amlodipine 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 tablet of 40 mg/5 mg or one tablet of 40 mg/10 mg per day.

If you take more Telmisartan/Amlodipine 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 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 develop up to 24-48 hours after ingestion.

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

If you forget to take Telmisartan/Amlodipine Teva

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 nottake a double dose to make up for individual missed doses.

If you stop taking Telmisartan/Amlodipine Teva

It is important that you take Telmisartan/Amlodipine every day until your doctor tells you to stop. If you think that the effect of this medicine 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 telmisartan/amlodipine.

Common 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):

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 cramps, muscle pain, inability to have 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 tract infection, feeling of sadness (depression), anxiety, difficulty falling asleep, dizziness, nerve damage in the hands or feet, decreased sense of touch, taste disorders, 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 (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 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), red blood cell deficiency (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 (may affect up to 1 in 1,000 people):

Increased levels of certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), allergic reaction (e.g., exanthema, itching, difficulty breathing, wheezing, facial swelling or low blood pressure), low blood sugar levels (in diabetic patients), vision disorders, rapid heart rate, stomach discomfort, altered liver function, urticaria, drug exanthema, tendon inflammation, pseudo-influenza syndrome (e.g., muscle pain, general discomfort), 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.

Frequency Not Known(cannot be estimated from the available data):

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

Amlodipine

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

Common Adverse Effects (may affect up to 1 in 10 people):

Alteration of intestinal habits, diarrhea, constipation, visual disturbances, double vision, swelling in 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):

Decreased white blood cell count (leukopenia), low platelet count (thrombocytopenia), allergic reaction (e.g., exanthema, itching, difficulty breathing, wheezing, facial swelling or low blood pressure), high blood sugar, uncontrolled tics or jerky movements, heart attack, irregular heartbeat, blood vessel inflammation, pancreatitis, stomach lining inflammation (gastritis), liver inflammation, yellowing of the skin (jaundice), increased liver enzyme levels accompanied by jaundice, rapid swelling of the skin and mucous membranes (angioedema), severe skin reactions, urticaria, 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.

Frequency Not Known (cannot be estimated from the available data):

Severe allergic reactions with blistering skin and mucous membranes (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 does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the box and on the blister pack after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require any special storage temperature.

Keep it in the original packaging to protect it from light.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines that you no longer need in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Telmisartan/Amlodipine Teva

1. The active ingredients 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, corn starch, mannitol, meglumine, povidone K25, anhydrous colloidal silica, sodium hydroxide, pregelatinized starch (prepared from corn starch).

Appearance of the Product and Package Contents

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 slight speckling on the pink side, with dimensions of approximately 15 x 7 mm.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem

Netherlands

Manufacturer

Zaklady Farmaceutyczne POLPHARMA S.A.

(Pharmaceutical Works POLPHARMA S.A.)

ul.Pelplinska 19

83-200 Starogard Gdanski

Poland

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

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid (Spain)

Date of the Last Revision of this Prospectus:January 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (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 packaging 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