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

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

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

Contents of this leaflet

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

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

Amlodipine/Valsartan Macleods 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 decreases.

Amlodipine/Valsartan Macleods 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/Valsartán Macleods

Do not take Amlodipine/Valsartán Macleods

• 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/Valsartán Macleods.
• If you have severe liver problems or biliary disorders such as primary biliary cirrhosis or cholestasis.

?? If you are more than 3 months pregnant. (It is better to avoid taking Amlodipine/Valsartán Macleods 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 pump 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/Valsartán Macleods and inform your doctor if any of the above apply to you.

Warnings and precautions

Talk to your doctor before starting Amlodipine/Valsartán Macleods:

• If you have been unwell (with vomiting or diarrhoea).

• If you have liver or kidney problems.

• If you have had a kidney transplant or 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 carefully when starting treatment. Your doctor may also monitor your kidney function.

• If your doctor has informed you that you have narrowing of the heart valves (called "aortic or mitral stenosis") or abnormal thickening of your heart muscle (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/Valsartán Macleods immediately and contact your doctor right away. You must never take Amlodipine/Valsartán Macleods again.

• If you are taking any of the following medicines used to treat 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.

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

See also the information under the heading “Do not take Amlodipine/Valsartán Macleods”.

Tell your doctor if any of the above conditions apply to you before taking Amlodipine/Valsartán Macleods.

Children and adolescents

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

Other medicines and Amlodipine/Valsartán Macleods

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 especially applies to the following medicines:

• an ACE inhibitor or aliskiren (see also information under the headings “Do not take Amlodipine/Valsartán Macleods” and “Warnings and precautions”);
• diuretics (medicines that increase 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 medicines used to treat pain 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 (intravenous infusion for serious body temperature abnormalities);
• tacrolimus (used to suppress the body’s immune response to allow acceptance of a transplanted organ);
• medicines used to prevent transplant rejection (cyclosporine).

Taking Amlodipine/Valsartán Macleods with food and drink

People taking Amlodipine/Valsartán Macleods 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 cause an unpredictable increase in the blood pressure-lowering effect of Amlodipine/Valsartán Macleods.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant or think you may be pregnant. Your doctor will usually advise you to stop taking Amlodipine/Valsartán Macleods before becoming pregnant or as soon as you become pregnant, and will recommend an alternative medicine. Amlodipine/Valsartán Macleods is not recommended during early pregnancy (first 3 months), and must not be used after the third month of pregnancy, as it may cause serious harm to your unborn baby when taken after the first trimester.

Breastfeeding

If you are breastfeeding or planning to breastfeed, inform your doctor. Amlodipine has been shown to pass into breast milk in small amounts.

Amlodipine/Valsartán Macleods is not recommended for breastfeeding mothers, and your doctor may decide to prescribe a different treatment that is more suitable if you wish to breastfeed, especially if you have 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. This could 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 Amlodipine/Valsartan Macleods

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 usual dose of Amlodipine/Valsartan Macleods 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 Macleods with or without food. Do not take Amlodipine/Valsartan Macleods 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 Macleods 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 Macleods than you should

If you have taken too many Amlodipine/Valsartan Macleods tablets, or if someone else has taken your tablets, contact a doctor immediately.

Excess fluid may accumulate in the lungs (pulmonary edema), causing breathing difficulties, 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 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Amlodipine/Valsartan Macleods

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 Macleods

Stopping your treatment with Amlodipine/Valsartan Macleods 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 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. If you notice any of the following, inform your doctor immediately:

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

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; diarrhoea; 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, dizziness; excessive sweating; rash all over the body, itching, muscle spasms. Inform your doctor if any of the mentioned cases affect you severely.

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

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 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 (feeling your heartbeat); hot flushes, swelling of the ankles (oedema); 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, 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 the breasts 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 cell count, decrease in blood platelets which may cause easy bleeding or unusual bruising (damage to red blood cells); high blood sugar (hyperglycaemia); 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 combining stiffness, tremor and/or movement disorders.

Valsartan

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 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).

Very rare (may affect up to 1 in 10,000 people): Intestinal angioedema: swelling in the intestine accompanied by symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 Macleods

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

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

Do not store above 30°C.

Do not use any pack of Amlodipine/Valsartan Macleods that is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater drains or household waste. Return unused packs and medicines to the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of packs and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amlodipino/Valsartán Macleods.

• 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.

• The other components are: microcrystalline cellulose, crospovidone, colloidal silicon dioxide, and magnesium stearate (tablet core); and hypromellose, polyethylene glycol, talc, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172) (film coating).

Appearance of the product and contents of the pack

Yellowish, oval-shaped, biconvex film-coated tablets, marked with “C95” on one side and smooth on the other.

Available pack sizes: boxes containing 14, 28, 30, 56, 90, and 98 film-coated tablets in blister packs.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Macleods Pharma España S.L.U.

World Trade Center Barcelona,

Moll de Barcelona, s/n,

08039 Barcelona,

Spain

Manufacturer

Synoptis Industrial Sp. z o.o.

ul. Rabowicka 15

62-020 Swarzedz, Poland

Or

Heumann Pharma GmbH & Co. Generica KG,

Südwestpark 50,

90449 Nuremberg, Germany

Or

Accord Healthcare B.V.,

Winthontlaan 200, 3526 KV Utrecht, The Netherlands

Or

Accord Healthcare Polska Sp. z o.o.,

ul. Lutomierska 50, 95-200 Pabianice, Poland

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

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