OLMESARTAN/AMLODIPINE MACLEODS 40 mg/5 mg FILM-COATED TABLETS

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 their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What Olmesartan/Amlodipine Macleods is and what it is used for
2. What you need to know before you take Olmesartan/Amlodipine Macleods
3. How to take Olmesartan/Amlodipine Macleods
4. Possible side effects
5. Storage of Olmesartan/Amlodipine Macleods
6. Pack contents and further information

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

This medicine contains two active substances called olmesartan medoxomil and amlodipine (as amlodipine besylate). Both substances help to control high blood pressure.

• Olmesartan belongs to a group of medicines called “angiotensin II receptor antagonists”, which lower blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of medicines called “calcium channel blockers”. Amlodipine prevents calcium from entering the blood vessel wall, which prevents the blood vessels from narrowing, and thus lowers blood pressure.

The action of both substances contributes to preventing the narrowing of blood vessels, so that they relax and blood pressure is lowered.

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

2. What you need to know before you take Olmesartan/Amlodipine Macleods

Do not take Olmesartan/Amlodipine Macleods

• If you are allergic to olmesartan, or amlodipine, or 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 better to avoid this medicine at the start of pregnancy (see section “Pregnancy and breast-feeding”).
• If you have diabetes or kidney problems and are being treated with a blood pressure medicine that contains aliskiren.
• If you have severe liver problems, if bile secretion is altered, or its release by the gallbladder is blocked (e.g. by gallstones), or if you have jaundice (yellowing of the skin and eyes).
• If you have very low blood pressure.
• If you have insufficient blood supply to the tissues, with symptoms such as low blood pressure, weak pulse, rapid heart rate (shock, including cardiogenic shock). Cardiogenic shock means shock due to severe heart problems.
• If the blood flow to your heart is blocked (e.g. due to narrowing of the aorta (aortic stenosis)).
• If you have poor heart performance (causing difficulty breathing, or peripheral swelling) after a heart attack (acute myocardial infarction).

Warnings and precautions

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

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

• a medicine called 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 check 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 Olmesartan/Amlodipine Macleods”.

Tell your doctorif you have any of the following health problems:

• Kidney problems or a kidney transplant.
• Liver disease.
• Heart failure or problems with the heart valves or heart muscle.
• Severe vomiting, diarrhea, treatment with high doses of medicines that increase urine production (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 that causes significant weight loss. Your doctor will assess 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 should inform your doctor if you are pregnant or think you might be pregnant. This medicine is not recommended during the first trimester of pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken after the third month of pregnancy.

Elderly patients

If you are over 65 years old, your doctor will regularly check your blood pressure whenever your dose is increased, to make sure it does not drop too much.

Black patients

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

Children and adolescents (under 18 years)

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

Using Olmesartan/Amlodipine Macleods with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

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

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

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Olmesartan/Amlodipine Macleods” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, medicines that increase urine production(diuretics), or heparin(to thin the blood and prevent blood clots). Taking these medicines at the same time as this medicine may increase potassium levels in the blood.
• Lithium(a medicine used to treat mood changes and some types of depression) used at the same time as this medicine may increase its toxicity. If you have to take lithium, your doctor will measure lithium levels in your blood.
• Non-steroidal anti-inflammatory medicines(NSAIDs, medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) used at the same time as this medicine may increase the risk of kidney problems. 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 to treat HIV/AIDS(e.g. ritonavir, indinavir, nelfinavir) or to treat fungal infections(e.g. ketoconazole, itraconazole).
• Diltiazem, verapamil (medicines used to treat heart rhythm problems and high blood pressure).
• Rifampicin, erythromycin, clarithromycin (medicines used to treat tuberculosis or other infections).
• St. John's Wort(Hypericum perforatum), a herbal remedy.
• Dantrolene(in infusion for severe body temperature abnormalities).
• Simvastatin, a medicine used to lower cholesterol and fat (triglyceride) levels in the blood.
• Tacrolimus, cyclosporin, used to control the body's immune response, making it possible for your body to accept a transplanted organ.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking Olmesartan/Amlodipine Macleods with food and drinks

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Your doctor will advise you to stop taking this medicine before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of this one. This medicine is not recommended during the first trimester of pregnancy, and must not be taken when you are more than 3 months pregnant, as it may cause serious harm to your baby if taken after the third month of pregnancy.

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

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. This medicine is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment if you wish to breast-feed, especially if your baby is newborn or premature.

Driving and using machines

During treatment for high blood pressure, you may feel drowsy, feel sick, or have headaches, or dizziness. If this happens, do not drive or use machines until the symptoms have gone away. Consult your doctor.

This medicine contains sodium

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

3. How to take/use Olmesartan/Amlodipine Macleods

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

• The recommended dose of this medicine is one tablet per day.
• The tablets can be taken with or without food. Take the tablets with a little 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 will probably experience a drop in blood pressure, accompanied by symptoms such as dizziness, and rapid or slow heart rate.

If you take more tablets than you should, or a child accidentally takes some tablets, contact your doctor or go to the nearest hospital casualty department immediately and take this leaflet and the medicine pack with you.

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 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 normal dose the next day. Do nottake 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 on 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 all people suffer from them. If they 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 group of people:

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

This medicine may cause a pronounced decrease in blood pressure, in susceptible patients, or as a result of an allergic reaction. This can cause 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, itching of the skin, even if you started treatment with Olmesartan/Amlodipine Macleods a long time ago, contact your doctor immediatelywho will evaluate your symptoms and decide how to continue with 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 when standing up; lack of energy; tingling or numbness of the hands or feet; vertigo; noticing heartbeats; rapid heartbeat; low blood pressure with symptoms such as dizziness, dizziness; difficulty breathing; cough; nausea; vomiting; indigestion; diarrhea; constipation; dry mouth; pain in the upper abdomen; skin rash; cramps; pain in arms and legs; back pain; urge to urinate; sexual inactivity; inability to have or maintain an erection; weakness.

Also, some changes in the results of certain blood tests have been observed:

Increased, as well as decreased levels of potassium in the blood, increased levels of creatinine in the blood, increased levels of uric acid, increased values of liver function tests (gamma glutamyl transferase levels).

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

Hypersensitivity to the medicine; fainting; flushing and feeling of heat in the face; red hives with itching (urticaria); inflammation of the face.

Adverse effects reported with the use of olmesartan medoxomil or amlodipine alone, but not with this medicine, or with a higher frequency:

Olmesartan

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

Bronchitis; sore throat; nasal congestion and secretion; cough; abdominal pain; viral gastroenteritis; diarrhea; indigestion; nausea; pain in the joints and bones; back pain; blood in the urine; urinary tract infection; chest pain; flu-like symptoms; pain. Changes in the results of blood tests, such as increased levels of a type of fat (hypertriglyceridemia); increased uric acid and urea in the blood and increased values of 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 can cause easy bruising or prolonged bleeding time; rapid allergic reactions, which can affect the whole body and cause respiratory problems, as well as a rapid drop in blood pressure, which can even cause fainting (anaphylactic reactions); angina (chest pain or discomfort known as angina pectoris); itching; skin rash; allergic skin rash; urticaria; facial swelling; muscle pain; malaise.

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

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

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; swelling of the ankles; feeling of sleep; flushing and feeling of heat in the face, visual disturbances (including double vision and blurred vision), noticing heartbeats, 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 secretion or congestion; hair loss; purple spots or spots on the skin due to small hemorrhages (purpura); skin discoloration; excessive sweating; skin rash; itching; red hives with itching (urticaria); pain in the joints or muscles; urination problems; need to urinate at night; increased need to urinate, increased breast size in men, chest pain; pain; feeling of discomfort; 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):

Decrease in the number of white blood cells, which could increase the risk of infections; decrease in the number of a type of blood cells called platelets, which could lead to bruising and prolonged bleeding time; increased blood glucose; increased muscle tension or greater resistance to passive movement (hypertonia); tingling or numbness of the hands or feet; heart attack; inflammation of blood vessels; inflammation of the liver or pancreas; inflammation of the stomach wall; gum thickening; elevated liver enzymes; yellowing of the skin and eyes; increased sensitivity of the skin to light; allergic reactions, itching, rash, inflammation of the face, mouth, and/or larynx (vocal cords), along with itching and rash, severe skin reactions, including intense skin rash, urticaria, redness of the skin of the body, severe itching, blisters, peeling, and inflammation of the skin, inflammation of the mucous membranes, 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 that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Olmesartan/Amlodipine Macleods

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

Do not use this medicine after the expiration date that appears on the packaging and on the blister pack (after "CAD"). The expiration date is the last day of the month indicated.

Do not store above 30°C

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Olmesartan/Amlodipine Macleods:

The active ingredients are olmesartan medoxomil and amlodipine (as besylate).

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 besylate).

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 besylate).

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 besylate).

The other components are:

Core of the tablet:

Silified microcrystalline cellulose, anhydrous colloidal silica, pregelatinized corn starch, sodium croscarmellose, magnesium stearate

Coating film:

Olmesartan/Amlodipine 20 mg/5 mg

Polyvinyl alcohol, polyethylene glycol, talc, and 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 package contents

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

White, round, biconvex film-coated tablets with the inscription "L 75" on one side and smooth on the other side.

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

Cream-colored, round, biconvex film-coated tablets with the inscription "L 77" on one side and smooth on the other side.

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

Brown-red, round, biconvex film-coated tablets with the inscription "L 78" on one side and smooth on the other side.

Blister pack OPA/Aluminum/PVC and aluminum 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

O

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50,

90449 Nürnberg,

Germany

Date of the last revision of this prospectus: October 2024

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