Amlodipine/valsartan Tevagen 5 mg/160 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amlodipine/Valsartan Tevagen 5 mg/160 mg film-coated tablets EFG

Read the entire 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, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Amlodipine/Valsartan Tevagen is and what it is used for

Amlodipine/Valsartan Tevagen contains two substances called amlodipine and valsartan. Both substances help control high blood pressure.

• Amlodipine belongs to a group of substances known as "calcium channel blockers". Amlodipine prevents calcium from entering the blood vessel wall, thereby preventing the narrowing of blood vessels.

• Valsartan belongs to a group of substances known as "angiotensin II receptor antagonists". Angiotensin II is produced by the body and causes blood vessels to narrow, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II.

This means that both substances help prevent the narrowing of blood vessels. As a result, blood vessels relax and blood pressure decreases.

Amlodipine/Valsartan Tevagen is used to treat high blood pressure in adults whose blood pressure is not adequately controlled with amlodipine or valsartan alone.

2. What you need to know before taking Amlodipine/Valsartan Tevagen

Do not take Amlodipine/Valsartan Tevagen

• if you are allergic to amlodipine or any other calcium channel blocker. This may include itching, skin redness, or difficulty breathing.

• if you are allergic to valsartan or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, inform your doctor before taking amlodipine/valsartan.

• if you have severe liver problems or biliary disorders such as primary biliary cirrhosis or cholestasis.

• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also during early pregnancy; see Pregnancy section).

• if you have severely low blood pressure (hypotension).

• if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which your heart cannot supply enough blood to the body).

• if you have heart failure following a heart attack.

• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Do not take amlodipine/valsartan and inform your doctor if any of the above apply to you.

Warnings and precautions

Talk to your doctor before taking amlodipine/valsartan:

• if you have been ill (with vomiting or diarrhea).

• if you have liver or kidney problems.

• if you have had a kidney transplant or have been told you have narrowing of the arteries to your kidneys.

• if you have a disease affecting the adrenal glands called "primary hyperaldosteronism".

• if you have had heart failure or a heart attack. Follow your doctor's instructions carefully when starting treatment. Your doctor may also monitor your kidney function.

• if your doctor has told you that you have narrowing of the heart valves (called "aortic or mitral stenosis") or that the thickness of your heart muscle has abnormally increased (called "obstructive hypertrophic cardiomyopathy").

• if you have experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors). If you get these symptoms, stop taking amlodipine/valsartan and contact your doctor immediately. You must never take amlodipine/valsartan again.

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

• an angiotensin-converting enzyme inhibitor (ACEI) (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.

• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading “Do not take Amlodipine/Valsartan Tevagen”.

Tell your doctor before taking amlodipine/valsartan if any of the above conditions apply to you.

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Amlodipine/Valsartan Tevagen. Your doctor will decide whether to continue treatment. Do not stop taking Amlodipine/Valsartan Tevagen on your own.

Children and adolescents

The use of amlodipine/valsartan is not recommended in children and adolescents (under 18 years of age).

Taking Amlodipine/Valsartan Tevagen with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. Your doctor may need to adjust your dose and/or take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially important for the following medicines:

• an ACE inhibitor or aliskiren (see also information under the headings “Do not take Amlodipine/Valsartan Tevagen” and “Warnings and precautions”);

• diuretics (a type of medicine that increases urine production);

• lithium (a medicine used to treat certain types of depression);

• potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, and other substances that may increase potassium levels;

• certain types of pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 inhibitors (COX-2 inhibitors). Your doctor may also monitor your kidney function;

• anticonvulsants (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);

• St. John’s wort;

• nitroglycerin and other nitrates, or other substances called "vasodilators";

• medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);

• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole);

• medicines used to treat bacterial infections (such as rifampicin, erythromycin, clarithromycin, telithromycin);

• verapamil, diltiazem (heart medicines);

• simvastatin (a medicine used to control high cholesterol levels);

• dantrolene (given by infusion for serious body temperature abnormalities);

• medicines used to prevent transplant rejection (cyclosporine);

• rifampicin, erythromycin, clarithromycin (antibiotics);

• tacrolimus (used to control the body's immune response to allow acceptance of a transplanted organ).

Taking Amlodipine/Valsartan Tevagen with food and drink

People taking amlodipine/valsartan should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can increase blood levels of the active substance amlodipine, which may cause an unpredictable increase in the blood pressure-lowering effects of amlodipine/valsartan.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Generally, your doctor will advise you to stop taking amlodipine/valsartan before becoming pregnant or as soon as you become pregnant and will recommend another antihypertensive medicine instead. Amlodipine/valsartan is not recommended during early pregnancy (first 3 months) and must not be given from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that time.

Breastfeeding

Amlodipine has been shown to pass into breast milk in small amounts. Amlodipine/valsartan is not recommended for women who are breastfeeding. Your doctor may decide to prescribe a treatment more suitable for breastfeeding, especially if you are nursing a newborn or premature infant.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

This medicine may make you feel dizzy, which could affect your ability to concentrate. Therefore, if you are unsure how this medicine affects you, do not drive, operate machinery, or perform any activity requiring concentration.

Amlodipine/Valsartan Tevagen contains sodium

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

3. How to take Amlodipine/Valsartan Tevagen

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor again. This will help you achieve the best results and reduce the risk of adverse effects.

The usual dose of amlodipine/valsartan is one tablet per day.

• It is preferable to take the medicine at the same time each day.

• Swallow the tablets with a glass of water.

• You may take amlodipine/valsartan with or without food. Do not take amlodipine/valsartan with grapefruit or grapefruit juice.

Depending on your response to treatment, your doctor may suggest a higher or lower dose.

Do not exceed the prescribed dose.

Amlodipine/Valsartan Tevagen and elderly people (65 years of age or older)

Your doctor should exercise caution when increasing your dose.

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

If you take more Amlodipine/Valsartan Tevagen than you should

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

Excess fluid may accumulate in the lungs (pulmonary edema), causing breathing difficulties, which may develop within 24–48 hours after ingestion.

If you forget to take Amlodipine/Valsartan Tevagen

If you forget to take this medicine, take it as soon as you remember. Then take your next dose at the usual time. However, if it is almost time for your next dose, do not take the missed dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Amlodipine/Valsartan Tevagen

Stopping your treatment with amlodipine/valsartan may cause your condition to worsen. Do not stop taking your medicine unless your doctor tells you to.

4. Possible adverse effects

Like all medicines, amlodipine/valsartan may cause adverse effects, although not everyone experiences them.

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

A small number of patients have experienced these serious adverse effects (may affect up to 1 in 1,000 patients). If you notice any of the following, inform your doctor immediately:

Allergic reaction with symptoms such as rash, itching, swelling of the face, lips, or tongue, difficulty breathing, low blood pressure (feeling faint, dizziness).

Other possible adverse effects of amlodipine/valsartan:

Common (may affect up to 1 in 10 patients): Flu; stuffy nose, sore throat, and discomfort when swallowing; headache; swelling in the arms, hands, legs, ankles, or feet; fatigue; asthenia (weakness); flushing and warmth of the face and/or neck.

Uncommon (may affect up to 1 in 100 patients): Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling or numbness in the hands or feet; vertigo, rapid heartbeat including palpitations; dizziness upon standing; cough; diarrhea; constipation; skin rash, redness of the skin; joint swelling, back pain; joint pain.

Rare (may affect up to 1 in 1,000 patients): Feeling of anxiety; ringing in the ears (tinnitus); fainting; increased urine output or urgent need to urinate; inability to achieve or maintain an erection; feeling of heaviness; low blood pressure with symptoms such as dizziness, lightheadedness; excessive sweating; rash over the entire body, itching, muscle spasms.

Tell your doctor if any of the above conditions affect you severely.

Adverse effects reported with amlodipine or valsartan alone, and not observed or observed with lower frequency with amlodipine/valsartan:

Amlodipine

Contact your doctor immediately if you experience any of the following serious adverse effects, which are very rare after taking this medicine:

• Sudden wheezing, chest pain, shortness of breath, or difficulty breathing.

• Swelling of the eyelids, face, or lips.

• Swelling of the tongue and throat causing severe difficulty breathing.

• Severe skin reactions including severe rash, hives, redness of the skin all over the body, intense itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions.

• Heart attack, irregular heartbeat.

• Inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by a general feeling of illness.

The following adverse effects have been reported. If any of these cause problems or persist for more than one week, consult your doctor.

Common (may affect up to 1 in 10 patients): Dizziness, drowsiness; palpitations (awareness of heartbeat); hot flushes, swelling of the ankles (edema); abdominal pain, feeling unwell (nausea).

Uncommon (may affect up to 1 in 100 patients): Mood changes, anxiety, depression, drowsiness, tremor, altered taste, fainting, loss of pain sensation; visual disturbances, impaired vision, ringing in the ears; low blood pressure; sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis); indigestion, vomiting (feeling unwell); hair loss, increased sweating, skin itching, skin discoloration; urinary disorders, increased need to urinate at night, increased frequency of urination; inability to achieve an erection, discomfort or enlargement of breasts in men, pain, discomfort, muscle pain, muscle cramps; weight gain or weight loss.

Rare (may affect up to 1 in 1,000 patients): Confusion.

Very rare (may affect up to 1 in 10,000 patients): Decrease in white blood cell count, decrease in blood platelets which may cause easy bleeding or unusual bruising (damage to red blood cells); high blood sugar (hyperglycemia); inflammation of the gums, abdominal swelling (gastritis); abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may affect certain medical tests; increased muscle tension; inflammation of blood vessels often with skin rashes, sensitivity to light; disorders combining stiffness, tremor, and/or movement disorders.

Valsartan

Very rare: Intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

Decrease in red blood cell count, fever, sore throat or mouth ulcers due to infection; spontaneous skin bleeding or bruising; increased potassium levels in blood; abnormal results in liver function tests; reduced kidney function and severely reduced kidney function; swelling, mainly of the face and throat; muscle pain; skin rash, purplish red spots; fever; itching; allergic reaction, blistering skin disease (sign of a condition called bullous dermatitis).

If you experience any of the above, consult your doctor immediately.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish System for Pharmacovigilance of 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 Amlodipine/Valsartan Tevagen

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

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

Do not store above 30°C.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of any containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amlodipine/Valsartan Tevagen

• The active substances of Amlodipine/Valsartan Tevagen are amlodipine (as amlodipine besilate) and valsartan. Each tablet contains 5 mg of amlodipine and 160 mg of valsartan.
• The other components are microcrystalline cellulose (types 101 and 102), povidone, sodium croscarmellose, talc and magnesium stearate (tablet core), and hypromellose; macrogol 400; titanium dioxide (E171); and yellow iron oxide (E172) (film coating).

Appearance of the product and contents of the pack

Amlodipine/Valsartan Tevagen 5 mg/160 mg tablets are yellow, oval-shaped, biconvex, film-coated tablets, with the imprint «2» on one side and «LD» on the other.

Amlodipine/Valsartan Tevagen is available in packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.,

Swensweg 5,

2031GA Haarlem,

The Netherlands

Manufacturer

Balkanpharma Dupnitza AD.

3 Samokovsko Shosse Street

Dupnitsa, 2600

Bulgaria

Actavis Ltd.

BLB016, Bulebel Industriale Estate

Zejtun ZTN 3000

Malta

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.U

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

Alcobendas, 28108, Madrid (Spain)

Date of the most recent review of this leaflet: June 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/82053/P_82053.html

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