Olmesartan/amlodipine Macleods 40 mg/10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olmesartan/Amlodipine Macleods 20 mg/5 mg film-coated tablets EFG

Olmesartan/Amlodipine Macleods 40 mg/5 mg film-coated tablets EFG

Olmesartan/Amlodipine Macleods 40 mg/10 mg film-coated tablets EFG

olmesartan medoxomil / amlodipine

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if they have the same symptoms as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Olmesartán/Amlodipino Macleods is and what it is used for

This medicine contains two substances called olmesartán medoxomilo and amlodipino (as amlodipino besilato). Both substances help control high blood pressure.

• Olmesartán belongs to a group of medicines known as “angiotensin II receptor antagonists”, which lower blood pressure by relaxing blood vessels.
• Amlodipino belongs to a group of medicines called “calcium channel blockers”. Amlodipino prevents calcium from entering the blood vessel wall, thereby preventing blood vessels from narrowing, which also lowers blood pressure.

The combined action of both substances helps prevent the narrowing of blood vessels, allowing them to relax and reducing blood pressure.

This medicine is used to treat high blood pressure in patients whose blood pressure is not adequately controlled with olmesartán or amlodipino alone.

2. What you need to know before taking Olmesartán/Amlodipino Macleods

Do not take Olmesartán/Amlodipino Macleods

• If you are allergic to olmesartan, or to amlodipine, or to a special group of calcium channel blockers called dihydropyridines, 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 this medicine.

• If you are more than 3 months pregnant. It is best to avoid this medicine during early pregnancy (see section “Pregnancy and breastfeeding”).
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have severe liver problems, if bile secretion is impaired, or its release from the gallbladder is blocked (e.g., due to gallstones), or if you have jaundice (yellowing of the skin and eyes).
• If you have very low blood pressure.
• If you have inadequate blood supply to tissues, with symptoms such as low blood pressure, weak pulse, rapid heartbeat (shock, including cardiogenic shock). Cardiogenic shock means shock due to serious heart problems.
• If blood flow to your heart is blocked (e.g., due to narrowing of the aorta (aortic stenosis)).
• If you have low cardiac output (causing difficulty breathing or peripheral swelling) following a heart attack (acute myocardial infarction).

Warnings and precautions

Talk to your doctor or pharmacist before starting to use this medicine.

Tell your doctor if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• An angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskiren.

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

See also the information under the heading “Do not take Olmesartán/Amlodipino Macleods”.

Tell your doctor if you have any of the following health conditions:

• Kidney problems or a kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe vomiting, diarrhea, treatment with high doses of medicines that increase urine output (diuretics), or if you are on a low-salt diet.
• High levels of potassium in the blood.
• Problems with the adrenal glands (hormone-producing glands located above the kidneys).

Contact your doctor if you experience severe, persistent diarrhea causing significant weight loss. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

As with any other medicine that lowers blood pressure, excessive lowering of blood pressure in patients with impaired blood flow to the heart or brain may cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

You must inform your doctor if you are pregnant or think you might be pregnant. Use of this medicine is not recommended during early pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken at this stage (see section “Pregnancy and breastfeeding”).

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Olmesartán/Amlodipino Macleods. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartán/Amlodipino Macleods on your own.

Elderly patients

If you are over 65 years old, your doctor will regularly monitor your blood pressure each time your dose is increased, to ensure it does not drop too much.

Black patients

As with other similar medicines, the blood pressure-lowering effect of this medicine is somewhat less in black patients.

Children and adolescents (under 18 years of age)

This medicine is not recommended for children and adolescents under 18 years of age.

Taking Olmesartán/Amlodipino Macleods with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any of the following medicines:

• Other blood pressure-lowering medicines, as they may increase the effect of this medicine.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Olmesartán/Amlodipino Macleods” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, medicines that increase urine output (diuretics), or heparin (used to thin the blood and prevent blood clots). Taking these medicines together with this medicine may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood disorders and certain types of depression) taken together with this medicine may increase its toxicity. If you need to take lithium, your doctor will monitor lithium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) taken together with this medicine may increase the risk of kidney failure. The effect of this medicine may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may reduce the effect of this medicine. Your doctor may advise you to take this medicine at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion and heartburn), as they may slightly reduce the effect of this medicine.
• Medicines used for HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir) or for treating fungal infections (e.g., ketoconazole, itraconazole).
• Diltiazem, verapamil (medicines used for heart rhythm problems and high blood pressure).
• Rifampicin, erythromycin, clarithromycin (medicines used for tuberculosis or other infections).
• St. John’s wort (Hypericum perforatum), a herbal remedy.
• Dantrolene (administered intravenously for serious abnormalities in body temperature).
• Simvastatin, a medicine used to lower cholesterol and fat (triglyceride) levels in the blood.
• Tacrolimus, cyclosporine, used to control the body’s immune response, making it possible for your body to accept a transplanted organ.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Taking Olmesartán/Amlodipino Macleods with food and drinks

People taking this medicine should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could cause an unpredictable increase in the blood pressure-lowering effect of this medicine.

Pregnancy and breastfeeding

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.

Pregnancy

You must inform your doctor if you are pregnant or think you might be pregnant.

Your doctor will advise you to stop taking this medicine before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of this medicine is not recommended during early pregnancy, and it must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onwards.

If you become pregnant while taking this medicine, inform and see your doctor immediately.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. This medicine is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and using machines

During treatment for high blood pressure, you may feel drowsy, unwell, dizzy, or have a headache. If this happens, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

This medicine contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.

3. How to take/use Olmesartan/Amlodipine Macleods

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• The recommended dose of this medicine is one tablet daily.
• Tablets may be taken with or without food. Take the tablets with some liquid (such as a glass of water). Do not chew the tablet. Do not take this medicine with grapefruit juice.
• If possible, take your daily dose at the same time each day, for example at breakfast time.

If you take more Olmesartan/Amlodipine Macleods than you should

If you take more tablets than you should, you are likely to experience a drop in blood pressure, accompanied by symptoms such as dizziness, and fast or slow heartbeat.

If you take more tablets than prescribed or if a child accidentally ingests any tablets, contact your doctor immediately or go to the nearest emergency department, and bring the medicine package or this leaflet with you.

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 the Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to take Olmesartan/Amlodipine Macleods

If you forget to take a dose, take your usual dose the next day. Do not take a double dose to make up for forgotten doses.

If you stop taking Olmesartan/Amlodipine Macleods

It is important to continue taking this medicine unless your doctor tells you to stop.

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 may cause adverse effects, although not everyone will experience them. If they do occur, they are often mild and do not require discontinuation of treatment.

The following adverse effects may be serious, although they affect only a small number of people:

During treatment with this medicine, allergic reactions may occur, which can affect the whole body, with swelling of the face, mouth and/or larynx (vocal cords), together with itching and skin rash. If this happens to you, stop taking this medicine and consult your doctor immediately.

This medicine may cause a marked decrease in blood pressure in susceptible patients, or as a result of an allergic reaction. This may lead to fainting or severe dizziness. If this happens to you, stop taking this medicine, consult your doctor immediately, and remain lying down in a horizontal position.

Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you started treatment with Olmesartan/Amlodipine Macleods some time ago, contact your doctor immediately, who will assess your symptoms and decide how to proceed with your blood pressure treatment.

Other possible adverse effects with this medicine:

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

Dizziness; headache; swelling of the ankles, feet, legs, hands or arms; fatigue.

Uncommon (may affect up to 1 in 100 people):

Dizziness upon standing; lack of energy; tingling or numbness in the hands or feet; vertigo; awareness of heartbeat; rapid heartbeat; low blood pressure with symptoms such as dizziness, lightheadedness; difficulty breathing; cough; nausea; vomiting; indigestion; diarrhea; constipation; dry mouth; upper abdominal pain; skin rash; cramps; pain in arms and legs; back pain; feeling of urgency to urinate; sexual inactivity; inability to achieve or maintain an erection; weakness.

Some changes in the results of certain blood tests have also been observed:

Increase as well as decrease in blood potassium levels, increase in blood creatinine levels, increase in uric acid levels, increase in liver function test values (gamma-glutamyl transferase levels).

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

Hypersensitivity to the medicine; fainting; redness and sensation of warmth in the face; itchy red welts (urticaria); facial swelling.

Adverse effects reported with olmesartan medoxomil or amlodipine alone, but not with this combination medicine, or with higher frequency:

Olmesartan

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

Bronchitis; sore throat; nasal congestion and discharge; cough; abdominal pain; viral gastroenteritis; diarrhea; indigestion; nausea; joint and bone pain; back pain; blood in urine; urinary tract infection; chest pain; flu-like symptoms; pain. Changes in blood test results, such as increased levels of a type of fat (hypertriglyceridemia); increased uric acid and urea in blood, and increased values in liver and muscle function tests.

Uncommon (may affect up to 1 in 100 people):

Reduction in the number of a type of blood cells called platelets, which may lead to easy bruising or prolonged bleeding time; rapid allergic reactions affecting the whole body, which may cause breathing difficulties and a rapid drop in blood pressure, possibly leading to fainting (anaphylactic reactions); angina (chest pain or discomfort, known as angina pectoris); itching; skin rash; allergic skin rash; urticarial rash; facial swelling; muscle pain; malaise.

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

Swelling of the face, mouth and/or larynx (vocal cords); acute kidney failure and renal failure; lethargy.

Intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhea.

Amlodipine

Very frequent (may affect more than 1 in 10 people):

Edema (fluid retention).

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

Abdominal pain; nausea; swollen ankles; drowsiness; redness and sensation of warmth in the face; visual disturbances (including double vision and blurred vision); awareness of heartbeat; diarrhea; constipation; indigestion; cramps; weakness; difficulty breathing.

Uncommon (may affect up to 1 in 100 people):

Difficulty sleeping; sleep disorders; mood changes including anxiety; depression; irritability; tremor; taste disturbances; fainting; ringing in the ears (tinnitus); worsening of angina pectoris (chest pain or discomfort); irregular heartbeat; nasal discharge or congestion; hair loss; purple spots or skin lesions due to minor bleeding (purpura); skin discoloration; excessive sweating; skin rash; itching; itchy red welts (urticaria); joint or muscle pain; urinary problems; need to urinate during the night; increased need to urinate; breast enlargement in men; chest pain; pain; malaise; weight gain or loss.

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

Confusion.

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

Reduction in the number of white blood cells, which could increase the risk of infections; reduction in the number of blood cells known as platelets, which could lead to bruising and prolonged bleeding time; increased blood glucose; increased muscle tension or resistance to passive movement (hypertonia); tingling or numbness in the hands or feet; heart attack; inflammation of blood vessels; inflammation of the liver or pancreas; inflammation of the stomach wall; gum enlargement; elevated liver enzymes; yellowing of the skin and eyes; increased skin sensitivity to light; allergic reactions, itching, rash, swelling of the face, mouth and/or larynx (vocal cords), together with itching and rash, severe skin reactions including severe skin rash, urticaria, redness of the skin, severe itching, blisters, peeling and skin inflammation, mucous membrane inflammation, sometimes very severe.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 Olmesartan/Amlodipine 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 and blister (after "EXP"). The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, 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 Olmesartan/Amlodipine Macleods:

The active substances are olmesartan medoxomil and amlodipine (as besilate).

Olmesartan/Amlodipine Macleods 20 mg/5 mg film-coated tablets EFG

Each film-coated tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besilate).

Olmesartan/Amlodipine Macleods 40 mg/5 mg film-coated tablets EFG

Each film-coated tablet contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besilate).

Olmesartan/Amlodipine Macleods 40 mg/10 mg film-coated tablets EFG

Each film-coated tablet contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as amlodipine besilate).

Other components are:

Tablet core:

Silicified microcrystalline cellulose, anhydrous colloidal silica, pregelatinized maize starch, sodium croscarmellose, magnesium stearate

Film coating:

Olmesartan/Amlodipine 20 mg/5 mg

Polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171)

Olmesartan/Amlodipine 40 mg/5 mg

Polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), yellow iron oxide (E172)

Olmesartan/Amlodipine 40 mg/10 mg

Polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), red iron oxide, yellow iron oxide (E172)

Appearance of the product and pack contents

Olmesartan/Amlodipine Macleods 20 mg/5 mg film-coated tablets EFG

White, round, biconvex film-coated tablets with the imprint “L\ 75” on one side and smooth on the other side.

Olmesartan/Amlodipine Macleods 40 mg/5 mg film-coated tablets EFG

Cream-coloured, round, biconvex film-coated tablets with the imprint “L\ 77” on one side and smooth on the other side.

Olmesartan/Amlodipine Macleods 40 mg/10 mg film-coated tablets EFG

Reddish-brown, round, biconvex film-coated tablets with the imprint “L\ 78” on one side and smooth on the other side.

Blister pack made of OPA/Aluminium/PVC and aluminium foil.

Pack sizes of 28, 56 and 98 tablets.

Only some pack sizes may be marketed.

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 Nürnberg,

Germany

Date of latest revision of this leaflet: October 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/