Amlodipine/valsartan Stada 10 mg/160 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Amlodipine/Valsartan Stada 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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 Stada is and what it is used for
2. What you need to know before taking Amlodipine/Valsartan Stada
3. How to take Amlodipine/Valsartan Stada
4. Possible side effects
5. How to store Amlodipine/Valsartan Stada
6. Contents of the pack and other information

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

Amlodipine/Valsartan Stada tablets contain 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, 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 is lowered.

Amlodipine/Valsartan Stada 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 Stada

Do not take Amlodipine/Valsartan Stada

• 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 to 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 Stada.
• if you have severe liver problems or biliary disorders such as biliary cirrhosis or cholestasis.
• if you are more than 3 months pregnant. (It is also advisable to avoid taking Amlodipine/Valsartan Stada 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 Stada and inform your doctor if any of the above apply to you.

Warnings and precautions

Talk to your doctor before taking Amlodipine/Valsartan Stada:

• if you have been unwell (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 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 check your kidney function.

• if your doctor has told you that you have narrowing of the heart valves (“aortic or mitral stenosis”) or that the thickness of your heart muscle has increased abnormally (“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 Stada and contact your doctor immediately. You must never take Amlodipine/Valsartan Stada again.

• if you are taking any of the following medicines for high blood pressure:

• 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 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 Amlodipine/Valsartan Stada”.

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.

Tell your doctor before taking Amlodipine/Valsartan Stada if any of the above apply to you.

Children and adolescents

Amlodipine/Valsartan Stada is not recommended for use in children and adolescents (under 18 years of age).

Other medicines and Amlodipine/Valsartan Stada

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:

• ACE inhibitors or aliskiren (see also information under the headings “Do not take Amlodipine/Valsartan Stada” 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 (antibiotics 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 Stada with food and drink

People taking Amlodipine/Valsartan Stada must not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could lead to an unpredictable increase in the blood pressure-lowering effects of Amlodipine/Valsartan Stada.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, talk to your doctor before using this medicine.

Pregnancy

Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking Amlodipine/Valsartan Stada before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Amlodipine/Valsartan Stada 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 this stage.

Breast-feeding

It has been shown that amlodipine, one of the two active substances in Amlodipine/Valsartan Stada, passes into breast milk in small amounts. If you are breast-feeding or planning to breast-feed, inform your doctor before taking Amlodipine/Valsartan Stada. Amlodipine/Valsartan Stada is not recommended for women during this period. Your doctor may decide to prescribe a treatment more suitable for breast-feeding, especially if the infant is a newborn or premature.

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 Stada contains sodium

This medicine contains less than 23 mg of sodium (1 mmol), which is essentially “sodium-free”.

3. How to take Amlodipine/Valsartan Stada

Follow exactly the instructions for use of this medicine as 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 Stada 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 Stada with or without food. Do not take Amlodipine/Valsartan Stada 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 Stada and elderly patients (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 Stada than you should

If you have taken too many Amlodipine/Valsartan Stada 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, pharmacist, or call the Toxicology Information Service immediately at 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Amlodipine/Valsartan Stada

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 Stada

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

If you have any further questions about 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 everyone will experience 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 people). If you notice any of the following, contact 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 Stada:

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

• 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 people):

• 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 people):

• 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
• rash all over the body, itching, muscle spasms

Tell your doctor if any of the listed effects affect you severely.

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

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, severe 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 marked 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 people):

• 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 people):

• mood changes, anxiety, depression, drowsiness, tremor, altered taste, fainting, loss of pain sensation
• visual disturbances, blurred 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 breast enlargement in men, pain, discomfort, muscle pain, muscle cramps
• weight gain or weight loss

Rare (may affect up to 1 in 1,000 people):

• confusion

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

• decrease in white blood cells, 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, liver inflammation (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

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

• 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 cells, fever, sore throat or mouth ulcers due to infections
• spontaneous skin bleeding or bruising
• increased potassium levels in blood
• abnormal 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, contact your doctor immediately.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if they are possible adverse effects 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 Amlodipine/Valsartan Stada

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 refers to the last day of the month indicated.

Do not store above 30°C. Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Instead, return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amlodipine/Valsartan Stada

• The active substances are amlodipine (as amlodipine besilate) and valsartan. Each tablet contains 10 mg of amlodipine (as amlodipine besilate) and 160 mg of valsartan.
• Other components are:

Tablet core: microcrystalline cellulose, povidone, pregelatinized corn starch, colloidal anhydrous silica, crospovidone, sodium starch glycolate from potato, magnesium stearate.

Coating: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), talc, macrogol.

Appearance of the product and contents of the pack

Amlodipine/Valsartan Stada 10 mg/160 mg are film-coated tablets, light yellow in color, oval and biconvex.

Film-coated tablets are available in blister packs with a transparent PVC/TE/PVdC foil and an aluminum foil, containing 7, 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets.

Film-coated tablets are also available in unit dose blister packs with a transparent PVC/TE/PVdC foil and an aluminum foil, containing 7, 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona), Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

STADA M&D SRL

Str. Trascaului, nr 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria Amlodipine/Valsartan STADA 10 mg/160 mg Filmtabletten

Belgium Amlodipine/Valsartan EG 10 mg/160 mg filmomhulde tabletten

Germany Amlodipin/Valsartan AL 10 mg/160 mg Filmtabletten

Denmark Amlodipin/Valsartan STADA 10 mg/160 mg

Spain Amlodipino/Valsartán STADA 10 mg/160 mg comprimidos recubiertos con película EFG

Finland Amlodipin/Valsartan STADA 10/160 mg kalvopäällysteiset tabletit

France AMLODIPINE/VALSARTAN EG 10/160 mg, comprimé pelliculé

Ireland Amlodipine/Valsartan Clonmel 10 mg/160 mg film-coated tablets

Italy Amlodipina e Valsartan EG 10 mg/160 mg

Luxembourg Amlodipine/Valsartan EG 10 mg/160 mg comprimés pelliculés

Netherlands Amlodipine/Valsartan CF 10/160 mg, filmomhulde tabletten

Poland Amlodypina + Valsartan STADA

Portugal Amlodipina + Valsartan Ciclum 10/160 mg

Romania Amlodipina/Valsartan STADA 10/160 mg, comprimate filmate

Sweden Amlodipin/Valsartan STADA 10/160 mg, filmdragerad tablett

Slovenia Amlodipin/valsartan STADA 10 mg/160 mg filmsko obložene tablete

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 Health Products (AEMPS): http://www.aemps.gob.es/.