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

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

amlodipine/valsartan cinfamed 5 mg/160 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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, since it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What amlodipine/valsartan cinfamed 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, thus 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 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 cinfamed

Do not take this medicine

• 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 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 section Pregnancy.)
• 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 apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking amlodipine/valsartan cinfamed:

• 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 kidney arteries.

• 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 for carefully starting treatment. Your doctor may also check 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 increased abnormally (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 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 (hypertension):

• 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 on your own.

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

See also the information under the heading “Do not take this medicine”.

Tell your doctor before taking amlodipine/valsartan if any of the above 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 amlodipine/valsartan cinfamed

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 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 this medicine” and “Warnings and precautions”);
• diuretics (a type of medicine that increases the amount of urine);
• 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, 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 (intravenous infusion for serious body temperature abnormalities);
• medicines used to prevent transplant rejection (cyclosporine).

Taking amlodipine/valsartan cinfamed 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

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

Pregnancy

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 pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Amlodipine/valsartan is not recommended during early pregnancy (first 3 months) 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 stage.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding. Amlodipine has been shown to pass into breast milk in small amounts. Amlodipine/valsartan is not recommended for use in women during this period. Your doctor may decide to prescribe a treatment more suitable if you wish to breastfeed, especially if the infant is a newborn or premature.

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.

3. How to take amlodipine/valsartan cinfamed

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist 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 cinfamed 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 cinfamed than you should

If you have taken too many amlodipine/valsartan tablets, or if someone else has taken your tablets, contact 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 amlodipine/valsartan cinfamed

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 cinfamed

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, tell 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 cinfamed:

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 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 amount of urine 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; generalized skin rash, itching, muscle spasms. Tell your doctor if any of these effects seriously affect you.

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

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, widespread redness of the skin, intense itching, blistering, peeling and inflammation 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 strong feeling of malaise.

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 (awareness of heartbeat); hot flushes, swelling of the ankles (edema); abdominal pain, feeling of discomfort (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, impaired vision, ringing in the ears; low blood pressure; sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis); indigestion, vomiting (nausea); 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, 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 the number of white blood cells, 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, photosensitivity; disorders combining stiffness, tremor and/or movement disorders.

Valsartan

Frequency not known (cannot be estimated from available data): Decrease in the number of red blood cells, fever, sore throat or mouth ulcers due to infection; spontaneous skin bleeding or bruising; increased potassium levels 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).

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.

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

Reporting of adverse effects

If you experience any type of 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 through 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 amlodipine/valsartan cinfamed

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

PVC/PVDC-Alu blisters: Do not store above 25°C.

OPA/Al/PVC-Alu blisters: This medicine does not require special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of amlodipine/valsartan cinfamed

• The active substances are amlodipine (as amlodipine besilate) and valsartan. Each tablet contains 5 mg of amlodipine and 160 mg of valsartan.
• The other components are:

Core: microcrystalline cellulose, crospovidone (type A), colloidal anhydrous silica and magnesium stearate.

Coating: Opadry beige 02F270003 (composed of hypromellose, yellow iron oxide (E-172), titanium dioxide (E-171), macrogol 4000 and talc).

Appearance of the medicinal product and contents of the pack

Film-coated, dark yellow, oblong tablets, 14.2 mm (length) x 5.7 mm (width).

amlodipine/valsartan cinfamed is available in packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra)
Spain

Manufacturer

Laboratorios Cinfa, S.A
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra)
Spain

or

ELPEN Pharmaceutical Co. Inc.
Marathonos Ave. 95, Pikermi Attiki, 19009
Greece

Date of the most recent revision of this leaflet: February 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) 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 in the package leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/86131/P_86131.html

QR code link: https://cima.aemps.es/cima/dochtml/p/86131/P_86131.html