Valotensix 10 mg/160 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Valotensix 5 mg/160 mg film-coated tablets EFG

Valotensix 10 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, consult 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 could 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 Valotensix is and what it is used for
2. What you need to know before taking Valotensix
3. How to take Valotensix
4. Possible side effects
5. How to store Valotensix
6. Contents of the pack and other information

1. What Valotensix is and what it is used for

This medicine 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 blood vessels from narrowing.
• 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, thus 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 is used for the treatment of high blood pressure in adults whose blood pressure is not adequately controlled with amlodipine or valsartan alone.

2. What you need to know before starting to take Valotensix

Do not take Valotensix

• if you are allergic to amlodipine or any other calcium channel blocker,

to valsartan or to any of the other components of this medicine (listed in section 6). If you think you may be allergic, inform your doctor before taking amlodipine/valsartan. This may include itching, skin redness or difficulty breathing

• 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 severe 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 conditions apply to you.

Warnings and precautions

Talk to your doctor before starting to take amlodipine/valsartan:

• if you have been ill (with vomiting or diarrhoea),
• if you have liver or kidney problems,
• if you have had a kidney transplant or if you have been told you have narrowing of the arteries to the kidney,
• if you have a disease affecting the adrenal glands called "primary hyperaldosteronism",
• if you have experienced heart failure or have had a heart attack.

Follow your doctor's instructions for carefully starting the dosage. Your doctor may also check your kidney function,

• if your doctor has informed 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 in the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors).

If you have 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), particularly if you have kidney problems related to diabetes,
  • aliskiren

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

Your doctor may monitor your kidney function, blood pressure and levels of electrolytes (e.g.: potassium) through regular blood tests.

See also the information under the heading "Do not take Valotensix".

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

Children and adolescents

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

Other medicines and Valotensix

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 your dose and/or take other precautions. In some cases, you may have to stop taking one of the medicines. This especially applies to the medicines listed below:

• an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Valotensix” and “Warnings and precautions”);
• diuretics (a type of medicine that increases the amount of urine produced);
• 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;
• anticonvulsant agents (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, itraconazol);
• antibiotics (such as rifampicin, erythromycin, clarithromycin, telithromycin);
• verapamil, diltiazem (heart medicines);
• simvastatin (a medicine used to control high cholesterol levels);
• dantrolene (by infusion for serious body temperature abnormalities);
• medicines used to prevent transplant rejection (cyclosporine).

Taking Valotensix with food and drink

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

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will generally 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

Inform your doctor if you are breastfeeding or intend to breastfeed. Amlodipine has been shown to pass into breast milk in small amounts. Amlodipine/valsartan is not recommended for women during this period, and your doctor may decide to prescribe a treatment more suitable for breastfeeding, especially for newborns or premature infants.

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.

Driving and using machines

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

3. How to take Valotensix

Follow exactly the instructions for use of 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 recommended dose of amlodipine/valsartan is one tablet daily.

• 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.

Valotensix and advanced age (65 years 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 Valotensix than you should

If you have taken too many amlodipine/valsartan tablets, or if someone else has taken your tablets, consult a doctor immediately.

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

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.

If you forget to take Valotensix

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 a forgotten dose.

If you stop taking Valotensix

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, this medicine can 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,
• nasal congestion, 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 inflammation, 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 all over the body,
• itching,
• muscle spasms.

Tell your doctor if any of the above effects seriously affect you.

Adverse effects reported with amlodipine or valsartan alone, not observed with amlodipine/valsartan or observed with higher frequency than with amlodipine/valsartan:

Amlodipine

Seek immediate medical advice if you experience any of the following very rare, serious adverse effects 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, widespread redness of the skin, intense itching, blistering, peeling and inflammation of the skin, swelling 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 marked feeling of illness.

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

Common (may affect up to 1 in 10 patients)

Dizziness, drowsiness, palpitations (feeling your 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, taste disturbances, fainting, loss of pain sensation, visual disturbances, worsening of 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 the breasts in men, pain, malaise, 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), gum inflammation, 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, photosensitivity, disorders involving stiffness, tremor, and/or movement disorders.

Valsartan

Very rare (may affect up to 1 in 10,000 patients)

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 in blood, abnormal liver function test results, 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 adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Valotensix

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 after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice any visible signs of deterioration.

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

6. Contents of the pack and other information

Composition of Valotensix

• The active substances are amlodipine (as amlodipine besilate) and valsartan.

Each 5 mg/160 mg tablet contains 5 mg of amlodipine and 160 mg of valsartan. Each 10 mg/160 mg tablet contains 10 mg of amlodipine and 160 mg of valsartan.

• The other components are:

5 mg/160 mg tablets: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol, talc, titanium dioxide (E-171), yellow iron oxide (E-172).

10 mg/160 mg tablets: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol, talc, yellow iron oxide (E-172), red iron oxide (E-172).

Appearance of the product and contents of the pack

Valotensix 5 mg/160 mg are dark yellow, film-coated, oval, biconvex tablets, marked "C94" on one side and flat on the other.

Height: approximately 15.6 mm. Width: approximately 6.6 mm.

Valotensix 10 mg/160 mg are light yellow, film-coated, oval, biconvex tablets, marked "C95" on one side and flat on the other.

Height: approximately 15.6 mm. Width: approximately 6.6 mm.

Pack sizes: 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.
Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,
28108 Alcobendas (Madrid)
Spain

Manufacturer

Tecnimede - Sociedade Técnico-medicinal, S.a.
Quinta da Cerca, Caixaria
2565-187 Dois Portos, Lisboa
Portugal

Date of the most recent revision of this leaflet: February 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/