Leaflet: information for the user

Olmesartán/ Amlodipino Macleods 20 mg/5 mg film-coated tablets

Olmesartán/ Amlodipino Macleods 40 mg/5 mg film-coated tablets

Olmesartán/ Amlodipino Macleods 40 mg/10 mg film-coated tablets

olmesartán medoxomilo / amlodipino

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.

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

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

3. How to take Olmesartán/ Amlodipino Macleods

4. Possible side effects

5. Storage of Olmesartán/ Amlodipino Macleods

6. Contents of the pack and additional information

This medication contains two substances called olmesartan medoxomil and amlodipine (as amlodipine besilate). The two substances help control high blood pressure.

• Olmesartan belongs to a group of medications called “angiotensin II receptor antagonists”, which decrease blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of medications called “calcium channel blockers”. Amlodipine prevents calcium from entering the blood vessel wall, preventing blood vessel constriction, which also decreases blood pressure.

The action of both substances contributes to preventing blood vessel constriction, allowing blood vessels to relax and blood pressure to decrease.

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

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 othercomponents of this medication (including in the section 6).

Inform your doctor before taking this medication if you think you may be allergic.

• If you are more than 3 months pregnant. It is best to avoid this medication at the beginning of pregnancy (see section “Pregnancy and breastfeeding”).
• If you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren.
• If you have severe liver problems, if your bile secretion is altered, or if your bile release is blocked (for example, by gallstones), or if you have jaundice (yellow skin and eyes).
• If you have very low blood pressure.
• If you have inadequate blood flow to your 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 (for example, due to aortic stenosis).
• If you have poor heart function (producing difficulty breathing, or peripheral edema) after a heart attack (acute myocardial infarction).

Warnings and precautions

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

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

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

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

See also the information under the heading “Do not take Olmesartán/ Amlodipino 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 heart valves or heart muscle.
• Intense vomiting, diarrhea, treatment with high doses of medications that increase urine production (diuretics), or if you are on a low-sodium diet.
• Elevated potassium levels in your blood.
• Problems with the adrenal glands (glands that produce hormones located above the kidneys).

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

Like any other medication that lowers blood pressure, excessive lowering of blood pressure in patients with altered blood flow to the heart or brain can cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

You should inform your doctor if you are pregnant or think you may be pregnant. This medication is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this period (see section “Pregnancy and breastfeeding”).

Older patients

If you are over 65 years old, your doctor will regularly monitor your blood pressure each time you increase the dose, to ensure that it does not decrease too much.

Black patients

Like with other similar medications, the blood pressure-lowering effect of this medication is somewhat less in black patients.

Children and adolescents (under 18 years)

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

Use of Olmesartán/ Amlodipino Macleods with other medications

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

• Other blood pressure medications,as they may increase the effect of this medication.

Your doctor may need to modify 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 Olmesartán/ Amlodipino Macleods” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, medications that increase urine production(diuretics), orheparin(to thin the blood and prevent blood clots). The use of these medications at the same time as this medication may elevate potassium levels in your blood.
• Thelithium(medication used to treat mood changes and some types of depression) used at the same time as this medication may increase its toxicity. If you need to take lithium, your doctor will measure your lithium levels in your blood.
• Thenonsteroidal anti-inflammatory drugs(NSAIDs, medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) used at the same time as this medication may increase the risk of kidney failure. The effect of this medication may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may reduce the effect of this medication. Your doctor may advise you to take this medication at least 4 hours before colesevelam hydrochloride.
• Certain antacids(remedies for indigestion and heartburn), as they may slightly reduce the effect of this medication.
• Medications used to treat HIV/AIDS(e.g. ritonavir, indinavir, nelfinavir)or fungal infections(e.g. ketoconazole, itraconazole).
• Diltiazem, verapamil (medications used to treat heart rhythm problems and high blood pressure).
• Rifampicin, erythromycin, clarithromycin (medications used to treat tuberculosis or other infections).
• St. John's Wort(Hypericum perforatum), herbal remedy.
• Dantrolene(in infusion for severe body temperature abnormalities).
• Simvastatin, a medication used to lower cholesterol and triglyceride levels in the blood.
• Tacrolimus, cyclosporine,used to control the body's immune response, making itpossible for your body to accept the transplanted organ.

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

Taking Olmesartán/ Amlodipino Macleods with food and drinks

People taking this medication 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 cause an unpredictable increase in the blood pressure-lowering effect of this medication.

Pregnancy and breastfeeding

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

Pregnancy

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

Your doctor will advise you to stop taking this medication before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead of this medication. This medication is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this period.

If you become pregnant while taking this medication, inform and visit your doctor immediately.

Breastfeeding

Inform your doctor if you are breastfeeding or about to startbreastfeeding. Thismedication is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and operating machines

During blood pressure treatment, you may experience drowsiness, feel sick or dizzy, or have a headache. If this occurs, do not drive or operate machines until the symptoms have disappeared. Consult your doctor.

This medication contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• The recommended dose of this medication is one tablet per day.
• 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 medication with grapefruit juice.
• Try to take your daily dose at the same time each day, for example at breakfast time.

If you take more Olmesartán/ Amlodipino 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 a rapid or slow heart rate.

If you take more tablets than you should or a child accidentally ingests some tablets, contact your doctor immediately or go to the nearest emergency center and bring with you the packaging of the medication or this leaflet.

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 Toxicological Information Service. Phone 91 562 04 20.

If you forgot to take Olmesartán/ Amlodipino Macleods

If you forgot to take a dose, take the usual dose the next day.Do nottake a double dose to make up for the missed doses.

If you interrupt treatment with Olmesartán/ Amlodipino Macleods

It is essential to continue taking this medication unless your doctor tells you to stop treatment.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If they occur, they are often mild and do not require interrupting treatment.

The following side effects can be serious, although they may affect only a small group of people:

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

This medicine can cause a pronounced drop in blood pressure in susceptible patients, or as a result of an allergic reaction. This can cause dizziness or severe drowsiness.If this happens, stop taking this medication, consult your doctor immediately, and remain lying down in a horizontal position.

Unknown frequency: If you experience yellowing of the whites of the eyes, dark urine, skin itching, even if you started treatment with Olmesartán/Amlodipino Macleods some time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue with the treatment for high blood pressure.

Other possible side effects with this medication:

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

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

Rare (can affect up to 1 in 100 people):

Dizziness when standing up; lack of energy; numbness or tingling in the hands or feet; vertigo; feeling the heartbeat; rapid heartbeat; low blood pressure with symptoms such as dizziness, drowsiness; difficulty breathing; cough; nausea; vomiting; indigestion; diarrhea; constipation; dry mouth; upper abdominal pain; skin rash; cramps; arm and leg pain; back pain; sensation of urgency to urinate; sexual inactivity; inability to achieve 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 (can affect up to 1 in 1,000 people):

Medication hypersensitivity; fainting; flushing and sensation of heat in the face; red itchy rash (urticaria); facial inflammation.

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

Olmesartan

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

Bronchitis; sore throat; congestion and nasal secretion; cough; abdominal pain; viral gastroenteritis; diarrhea; indigestion; nausea; joint and bone pain; 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.

Rare (can affect up to 1 in 100 people):

Reduction in the number of a type of blood cell, called platelets, which can cause easy bruising or prolong bleeding time; rapid allergic reactions, which can affect the entire body and cause respiratory problems, as well as rapid drop in blood pressure, which can even cause fainting (anaphylactic reactions); angina (chest pain or discomfort); itching; skin rash; allergic skin rash; rash with urticaria; facial swelling; muscle pain; discomfort.

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

Facial, mouth, and/or laryngeal (vocal cord) inflammation; acute renal failure and renal insufficiency;lethargy.

Amlodipine

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

Edema (fluid retention).

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

Abdominal pain; nausea; swelling of the ankles; drowsiness; flushing and sensation of heat in the face, visual disturbances (including double vision and blurred vision), feeling the heartbeat, diarrhea, constipation, indigestion, cramps, weakness, difficulty breathing.

Rare (can affect up to 1 in 100 people):

Difficulty sleeping; sleep disorders; mood changes, including anxiety; depression; irritability; tremor; taste disturbances; fainting; tinnitus (ringing in the ears); worsening of angina (chest pain or discomfort); irregular heartbeat; nasal secretion or congestion; hair loss; purple spots or patches on the skin due to small hemorrhages (purpura); skin discoloration; excessive sweating; skin rash; itching; red itchy rash (urticaria); joint or muscle pain; urinary 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 (can affect up to 1 in 1,000 people):

Confusion.

Very rare (can 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 a type of blood cell called platelets, which could cause the appearance of bruises and prolong bleeding time; increased glucose in the blood; increased muscle tension or increased resistance to passive movement (hypertonia); numbness or tingling in 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; yellow skin and eyes; increased skin sensitivity to light; allergic reactions, itching, rash, facial, mouth, and/or laryngeal (vocal cord) inflammation, along with itching and rash, severe skin reactions, including intense skin rash, urticaria, red skin flushing, severe itching, blisters, peeling, and skin inflammation, severe membrane mucosal inflammation sometimes very severe.

Reporting of 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 leaflet. 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 medication.

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

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

Do not store at a temperature above 30°C

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Olmesartán/Amlodipino Macleods:

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

Olmesartán/Amlodipino Macleods 20 mg/5 mg film-coated tablets

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

Olmesartán/Amlodipino Macleods 40 mg/5 mg film-coated tablets

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

Olmesartán/Amlodipino Macleods 40 mg/10 mg film-coated tablets

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

The other components are:

Core tablet::

Microcrystalline cellulose silicified, anhydrous colloidal silica, pregelatinized maize starch, sodium croscarmellose, magnesium stearate

Coating:

Olmesartán/Amlodipino 20 mg/5 mg

Polvinyl alcohol, polyethylene glycol, talc, and titanium dioxide (E171)

Olmesartán/Amlodipino 40 mg/5 mg

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

Olmesartán/Amlodipino 40 mg/10 mg

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

Appearance of the product and contents of the package

Olmesartán/Amlodipino Macleods 20 mg/5 mg film-coated tablets

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

Olmesartán/Amlodipino Macleods 40 mg/5 mg film-coated tablets

Crema film-coated, round, biconvex tablets with the inscription “L 77” on one face and smooth on the other face.

Olmesartán/Amlodipino Macleods 40 mg/10 mg film-coated tablets

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

Blister pack 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 responsible person for manufacturing

Marketing authorization holder

Macleods Pharma España S.L.U.

World Trade Center Barcelona

Moll de Barcelona, s/n,

08039 Barcelona

Spain

Responsible person for manufacturing

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

Last review date of this leaflet: October 2024

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