Package Leaflet: Information for the user

amlodipino/valsartán cinfamed 5 mg/160 mg film-coated tablets

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

This medicationcontains two substances called amlodipino and valsartán. Both substances help control high blood pressure.

• Amlodipino belongs to a group of substances called «calcium channel antagonists». Amlodipino prevents calcium from entering the blood vessel wall, which prevents blood vessel constriction.
• Valsartán belongs to a group of substances called «angiotensin II receptor antagonists». Angiotensin II is produced by the body and causes blood vessels to constrict, thereby increasing blood pressure. Valsartán acts by blocking the effect of angiotensin II.

This means that both substances help prevent blood vessel constriction. As a result, blood vessels relax and blood pressure decreases.

Amlodipino/valsartán is used to treat high blood pressure in adults whose blood pressure is not adequately controlled with amlodipino or valsartán alone.

Do not take this medication

• if you are allergic to amlodipine or any other calcium channel blocker. This may include symptoms such as itching, skin redness, or difficulty breathing.
• if you are allergic to valsartan or any of the other components of this medication (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 bile duct problems such as biliary cirrhosis or cholestasis.
• if you are more than 3 months pregnant. (In any case, it is best to avoid taking this medication also at the beginning of your pregnancy, see Pregnancy section).
• if you have a severe decrease in blood pressure (hypotension).
• if you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a situation in which your heart cannot supply enough blood to your body).
• if you have heart failure after a heart attack.
• if you have diabetes or kidney failure and are being treated with a medication to reduce blood pressure that contains aliskiren.

Do not take amlodipine/valsartan and inform your doctor if you are affected by any of the above cases.

Warnings and precautions

Consult your doctor or pharmacist before starting to take amlodipine/valsartan cinfamed:

• if you have been sick (with vomiting or diarrhea).
• if you have liver or kidney problems.
• if you have undergone a kidney transplant or if you have been told that you have a narrowing of the kidney arteries.
• if you have a disease that affects the adrenal glands called "primary hyperaldosteronism".
• if you have had heart failure or have had a heart attack. Follow your doctor's instructions to start taking the medication carefully. Your doctor may also check your kidney function.
• if your doctor has told you that you have a narrowing of the heart valves (called "aortic or mitral stenosis") or that the thickness of your heart muscle has increased abnormally (called "hypertrophic obstructive cardiomyopathy").
• if you have experienced swelling, particularly in the face and throat, while taking other medications (including ACE inhibitors). If you have these symptoms, stop taking amlodipine/valsartan and contact your doctor immediately. Never take amlodipine/valsartan again.
• if you are taking any of the following medications used to treat high blood pressure:

• an ACE inhibitor (such as enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea 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 electrolyte levels (such as potassium) at regular intervals.

See also the information under the heading "Do not take this medication".

Inform your doctor before taking amlodipine/valsartan if you are affected by any of the cases mentioned.

Children and adolescents

Amlodipine/valsartan is not recommended for use in children or adolescents (under 18 years old).

Other medications and amlodipine/valsartan cinfamed

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. 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 medications. This applies especially to the medications listed below:

• an ACE inhibitor or aliskiren (see also the information under the headings "Do not take this medication" and "Warnings and precautions");
• diuretics (a type of medication that increases urine production);
• lithium (a medication used to treat certain types of depression);
• potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, and other substances that may increase potassium levels;
• a certain type of pain medication called nonsteroidal anti-inflammatory drugs (NSAIDs) or selective 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";
• medications used to treat HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);
• medications used to treat fungal infections (e.g. ketoconazole, itraconazole);
• medications used to treat bacterial infections (such as rifampicin, erythromycin, clarithromycin, telithromycin);
• verapamil, diltiazem (heart medications);
• simvastatin (a medication used to control high cholesterol levels);
• dantrolene (for severe temperature abnormalities);
• medications used to prevent rejection in a transplant (ciclosporin).

Taking amlodipine/valsartan cinfamed with food and drinks

People taking amlodipine/valsartan should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may cause an increase in the blood levels of the active ingredient amlodipine, which may lead to unpredictable reductions in blood pressure.

Pregnancy and breastfeeding

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

Pregnancy

You should inform your doctor if you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant. Your doctor will usually advise you to stop taking amlodipine/valsartan before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Amlodipine/valsartan is not recommended for use during the first 3 months of pregnancy and should not be administered after the third month of pregnancy as it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

Inform your doctor if you plan to start or are breastfeeding. Amlodipine has been shown to pass into breast milk in small amounts. Amlodipine/valsartan is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially in newborns or premature babies.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

This medication may make you feel dizzy, which may affect your ability to concentrate. Therefore, if you are unsure how this medication will affect you, do not drive, operate machinery, or perform other activities that require concentration.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. This will help you obtain the best results and reduce the risk of adverse effects.

The usual dose of amlodipino/valsartán is one tablet per day.

• It is preferable to take the medication at the same time every day.
• Swallow the tablets with a glass of water.
• You can take amlodipino/valsartán with or without food. Do not take amlodipino/valsartán with grapefruit or grapefruit juice.

Your doctor may suggest a higher or lower dose depending on your response to treatment. Do not exceed the prescribed dose.

amlodipino/valsartán cinfamed and older adults (65 years or older)

Your doctor should exercise caution when increasing the dose.

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

If you take more amlodipino/valsartán cinfamed than you should

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

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing that may develop up to 24-48 hours after ingestion.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take amlodipino/valsartán cinfamed

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

If you interrupt treatment with amlodipino/valsartán cinfamed

Stopping your treatment with amlodipino/valsartán may cause your condition to worsen. Do not stop taking your medication unless your doctor tells you to.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can be serious and require immediate medical attention:

A few patients have experienced these serious side effects(which can affect up to 1 in 1,000 patients).Notify your doctor immediately if you experience any of the following:allergic reaction with symptoms such as skin rash, itching, swelling of the face, lips, or tongue, difficulty breathing, low blood pressure (feeling faint, dizziness).

Other possible side effects of amlodipino/valsartán cinfamed:

Frequent (can 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 warming of the face and/or neck.

Infrequent (can affect up to 1 in 100 patients):dizziness; nausea and abdominal pain; dry mouth; somnolence, tingling, or numbness of the hands or feet; vertigo, rapid heartbeat including palpitations; dizziness when standing up; cough; diarrhea; constipation; skin rash, redness of the skin; joint inflammation, back pain; joint pain.

Rare (can affect up to 1 in 1,000 patients):anxiety sensation; ringing in the ears (tinnitus); fainting; increased urine production or urgent need to urinate; inability to achieve or maintain an erection; feeling of heaviness; low blood pressure with symptoms such as dizziness, fainting; excessive sweating; skin rash all over the body, itching, muscle spasms.Notify your doctor if any of the mentioned cases severely affect you.

Side effects reported with amlodipino or valsartán alone and not observed with amlodipino/valsartán cinfamed or observed with a higher frequency than with amlodipino/valsartán cinfamed:

Amlodipino

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

• Sudden hissing sounds when breathing (sudden sibilance), chest pain, shortness of breath, or difficulty breathing.
• Swelling of the eyelids, face, or lips.
• Swelling of the tongue and throat that causes severe difficulty breathing.
• Severe skin reactions that include intense skin rash, blisters, redness of the skin all over the body, intense itching, blister formation, peeling, and skin inflammation, mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Heart attack, abnormal heartbeat.
• Pancreatitis that can cause severe abdominal pain and back pain accompanied by severe discomfort.

The following side effects have been reported. If any of these cause problems or last more than a week, consult your doctor.

Frequent (can affect up to 1 in 10 patients):dizziness, somnolence; palpitations (feeling the heartbeat); hot flashes, swelling of the ankles (edema); abdominal pain, discomfort (nausea).

Infrequent (can affect up to 1 in 100 patients):mood changes, anxiety, depression, somnolence, tremor, altered taste, fainting; visual disturbances, visual deterioration, ringing in the ears; decreased blood pressure; nasal congestion/secreting caused by nasal mucosa inflammation (rhinitis); indigestion, vomiting (discomfort); hair loss, increased sweating, itching skin, skin discoloration; urinary disorders, increased need to urinate at night, increased frequency of urination; inability to achieve an erection, breast discomfort or enlargement in men, pain, discomfort, muscle pain, muscle cramps; weight gain or loss.

Rare (can affect up to 1 in 1,000 patients):confusion.

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

Valsartán

Frequency unknown (cannot be estimated from available data):decreased red blood cell count, fever, sore throat, or mouth ulcers due to infection; spontaneous skin bleeding or hematomas; increased potassium in the blood; abnormal liver function test results; decreased kidney function and severely decreased kidney function; swelling, mainly of the face and throat; muscle pain; skin rash, red purpura spots; fever; itching; allergic reaction, blistering skin disease (sign of a disease called dermatitis bullosa).

Very rare (can affect up to 1 in 10,000 patients):intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Notify your doctor immediately if you experience any of the mentioned cases.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

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

Do not use this medication after the expiration date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment

Composition of amlodipino/valsartán cinfamed

• The active principles are amlodipino (as amlodipino besilato) and valsartán. Each tablet contains 5 mg of amlodipino and 160 mg of valsartán.
• The other components are:

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

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

Appearance of the product and content of the packaging

Coated tablets with a dark yellow film and oblong shape, with 14.2 mm (length) x 5.7 mm (width).

amlodipino/valsartán cinfamed is available in packaging containing 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra)

Spain

Responsible for manufacturing

Cinfa Laboratories, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra)

Spain

or

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

Last review date of this leaflet: February 2025

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es

You can access detailed and updated information about this medication by scanning with your smartphone the QR code included in the 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 to:https://cima.aemps.es/cima/dochtml/p/86131/P_86131.html