Leaflet: information for the user

Olmesartán/Amlodipino Teva 20 mg/5 mg film-coated tablets EFG

Olmesartán/Amlodipino Teva 40 mg/5 mg film-coated tablets EFG

Olmesartán/Amlodipino Teva 40 mg/10 mg film-coated tablets EFG

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 Teva and what it is used for

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

3. How to take Olmesartán / Amlodipino Teva

4. Possible side effects

5. Storage of Olmesartán / Amlodipino Teva

6. Contents of the pack and additional information

Olmesartán/Amlodipino Teva contains two substances called olmesartan medoxomil and amlodipine (as amlodipine besylate). The two substances help control high blood pressure.

• Olmesartan belongs to a group of medicines called “angiotensin II receptor antagonists”, which decrease 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, preventing blood vessel constriction, which also decreases blood pressure.

The action of both substances contributes to preventing blood vessel constriction, so that they relax and blood pressure decreases.

Olmesartán /Amlodipino Teva is 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 Teva

• If you are allergic to olmesartán, or to amlodipino, or to a group of special calcium channel blockers called dihidropiridinas, or to any of the othercomponents of this medicine (including in the section 6).

Inform your doctor before taking Olmesartán /Amlodipino Teva if you think you may be allergic.

• If you are more than 3 months pregnant.(It is better to avoid Olmesartán /Amlodipino Teva 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 lowering medicine that contains aliskirén.
• If you have severe liver problems, if the secretion of bile is altered, or if the release of bile by the gallbladder 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 a poor 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 (for example, due to narrowing of the aorta (aortic stenosis)).
• If you have poor heart function (producing difficulty breathing, or peripheral swelling) after a heart attack (acute myocardial infarction).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olmesartán /Amlodipino Teva.

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

• A converting enzyme inhibitor (ACE inhibitor) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskirén.

Your doctor may check your kidney function, blood pressure, and electrolyte levels in the blood (for example, potassium) at regular intervals.

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

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.
• 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 (glands that produce hormones located above the kidneys).

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

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

Like any other medicine that lowers blood pressure, an excessive decrease in blood pressure in patients with heart or brain blood flow abnormalities can cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

Youmust inform your doctor if you are pregnant or think you may be pregnant. Do not take Olmesartán /Amlodipino Teva at the beginning of pregnancy, anddo not takeif you aremore than 3 months pregnant, as it can cause serious harm to your baby if taken at this stage (see section “Pregnancy and breastfeeding”).

Children and adolescents (under 18 years)

Olmesartán /Amlodipino Teva is not recommended for children and adolescents under 18 years.

Use of Olmesartán /Amlodipino Teva with other medicines

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

• Other blood pressure lowering medicines,as they may increase the effect of Olmesartán /Amlodipino Teva.

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

If you are taking an ACE inhibitor or aliskirén (see also the information under the headings “Do not take Olmesartán /Amlodipino Teva” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, medicines that increase urine production(diuretics), orheparin(to thin the blood and prevent blood clots). The use of these medicines at the same time as Olmesartán /Amlodipino Teva may increase potassium levels in the blood.
• Lithium(medicine used to treat mood changes and some types of depression) used at the same time as Olmesartán /Amlodipino Teva may increase lithium toxicity. If you need to take lithium, your doctor will measure lithium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) used at the same time as Olmesartán /Amlodipino Teva may increase the risk of kidney failure. The effect of Olmesartán /Amlodipino Teva may be reduced by NSAIDs.
• Colesevelam hydrochloride,a medicine that lowers cholesterol levels in the blood, as it may reduce the effect of Olmesartán /Amlodipino Teva. Your doctor may advise you to take Olmesartán /Amlodipino Teva at least 4 hours before colesevelam hydrochloride.
• Certain antacids(remedies for indigestion or heartburn), as they may slightly reduce the effect of Olmesartán Amlodipino Teva.
• Medicines used to treat HIV/AIDS(for example: ritonavir, indinavir, nelfinavir)or to treat fungal infections(for example: ketoconazole, itraconazole).
• Diltiazem,verapamil(medicines used to treat heart rhythm problems and high blood pressure).
• Rifampicin, erythromycin, clarithromycin(antibiotics).
• St. John's Wort(Hypericum perforatum), herbal remedy.
• Dantrolene(in infusion for severe body temperature abnormalities).
• Simvastatin, a medicine used to lower cholesterol and triglyceride levels in the blood.
• Tacrolimus, sirolimus, temsirolimus, everolimus, and ciclosporin,used to control the body's immune response, makingit possible for the 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 medicine.

Taking Olmesartán /Amlodipino Teva with food and drinks

Olmesartán /Amlodipino Teva can be taken with or without food. Take the tablets with a little liquid (such as a glass of water). If possible, take the daily dose at the same time each day, for example, at breakfast time (see section 3).

People taking Olmesartán /Amlodipino Teva 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 amlodipino, which may cause an unpredictable increase in the blood pressure lowering effect of Olmesartán /Amlodipino Teva.

Older patients

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

Black patients

Like other similar medicines, the blood pressure lowering effect of Olmesartán /Amlodipino Teva is somewhat less in black patients.

Pregnancy and breastfeeding

Pregnancy: You must inform your doctor if you are pregnant (or if you think you may be).

Your doctor will advise you to stop taking Olmesartán /Amlodipino Teva before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Olmesartán /Amlodipino Teva. Do not take Olmesartán /Amlodipino Teva at the beginning of pregnancy, anddo not takeif you aremore than 3 months pregnant, as it can cause serious harm to your baby if used from the third month of pregnancy.

If you become pregnant while taking Olmesartán /Amlodipino Teva, inform and visit your doctor immediately.

Breastfeeding:It has been shown that amlodipinopasses into breast milkin small amounts.Inform your doctor if you are breastfeeding or about to startbreastfeeding. Do notrecommend Olmesartán /Amlodipino Teva in mothers who are breastfeeding, and your doctor may choose another treatment if you want to breastfeed, especially if your baby is newborn or premature.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machines

During blood pressure treatment, you may feel drowsy, feel sick, or dizzy, or have a headache. If this happens,do notdrive or operate machines until the symptoms have disappeared. Consult your doctor for advice.

Olmesartán /AmlodipinoTeva contains lactose

This medicine contains lactose. If your doctor has told you that you have a problem with certain sugars, consult with him before taking this medicine.

Olmesartán /AmlodipinoTeva contains sodium

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

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

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 number of people:

During treatment with Olmesartán /Amlodipino Teva, allergic reactions can occur, which can affect the whole body, with inflammation of the face, mouth, and/or larynx (vocal cords), along with itching and skin rash.Allergic skin reactions that include intense skin rash, hives, redness of the skin all over the body, intense itching, blisters, peeling, and skin inflammation, mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis).If this happens, stop taking Olmesartán /Amlodipino Teva and consult your doctor immediately..

Olmesartán /Amlodipino Teva 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 Olmesartán /Amlodipino Teva, consult your doctor immediately, and remain lying down in a horizontal position.

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

Other possible side effects with Olmesartán /Amlodipino Teva:

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

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

Less frequent (can affect up to 1 in 100 people):

Dizziness when standing up; lack of energy; tingling or numbness of 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; abdominal pain; skin rash; muscle 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:increase, as well as decrease of potassium levels in the blood, increase of creatinine levels in the blood, increase of uric acid levels, increase in liver function test values (gamma-glutamyl transferase levels).

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

Drug hypersensitivity; fainting; redness and feeling of heat in the face; red, itchy rash (urticaria); facial inflammation.

Side effects reported with the use of olmesartán medoxomilo or amlodipino alone, but not with Olmesartán /Amlodipino Teva, or with a higher frequency:

Olmesartán medoxomilo

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 levels in the blood, and increased values of liver and muscle function tests.

Less frequent (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 whole 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, known as angina pectoris); itching; skin rash; allergic skin rash; skin rash with urticaria; facial swelling; muscle pain; discomfort.

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

Facial, mouth, and/or laryngeal inflammation (vocal cords); acute renal failure and renal insufficiency;lethargy.Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Amlodipino

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; feeling of sleepiness; redness and feeling of heat in the face, visual disturbances (including double vision and blurred vision), feeling the heartbeat, diarrhea, constipation, indigestion, muscle cramps, weakness, difficulty breathing.

Less frequent (can 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 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; nocturia; increased need to urinate, increased size of the breasts 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 levels in the blood; increased muscle tension or increased 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; yellow skin and eyes; increased sensitivity of the skin to light; allergic reactions, itching, rash, facial, mouth, and/or laryngeal inflammation (vocal cords), along with itching and rash, severe skin reactions, including intense skin rash, urticaria, redness of the skin all over the body, intense itching, blisters, peeling, and skin inflammation, mucous membrane inflammation sometimes very severe.

Unknown frequency:

The following side effects have been reported in patients taking Olmesartán/Amlodipino: movement disorders, tremor, and/or movement disorders, tremors, stiff posture, face with a mask-like appearance, slow movements and unsteady gait.

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 Vigilance 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 medicine.

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, the bottle, and the blister after “CAD.:”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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 ofOlmesartán/Amlodipino Teva

• The active ingredients are olmesartán medoxomilo and amlodipino (as amlodipino besilato).

Each tablet contains 20 mg of olmesartán medoxomilo and 5 mg of amlodipino (as amlodipino besilato).

Each tablet contains 40 mg of olmesartán medoxomilo and 5 mg of amlodipino (as amlodipino besilato).

Each tablet contains 40 mg of olmesartán medoxomilo and 10 mg of amlodipino (as amlodipino besilato).

• The other components are microcrystalline cellulose, lactose monohydrate, crospovidone, povidone, sodium starch glycolate (from potato), hydrated colloidal silica, magnesium stearate.

• The other components in the tablet coating are partially hydrolyzed polyvinyl alcohol (E1203), macrogol (E1521, polyethylene glycol), talc (E553b), red iron oxide (E172) (Olmesartán/Amlodipino Teva 40 mg/10 mg film-coated tablets only), titanium dioxide (E171) (Olmesartán/Amlodipino Teva 20 mg/5 mg film-coated tablets and Olmesartán/Amlodipino Teva 40 mg/5 mg film-coated tablets only), yellow iron oxide (E172) (Olmesartán/Amlodipino Teva 40 mg/5 mg film-coated tablets only)

Appearance of the product and contents of the package

Olmesartán/Amlodipino Teva 20 mg/5 mg film-coated tablets are white, round, convex tablets, coated with a film, marked with “5” on one face and the other face of the tablet is scored and marked with “2” on the left side of the score and “0” on the right side.

Olmesartán/Amlodipino Teva 40 mg/5 mg film-coated tablets are yellowish, round, convex tablets, coated with a film, marked with “5” on one face and the other face of the tablet is scored and marked with “4” on the left side of the score and “0” on the right side.

Olmesartán/Amlodipino Teva 40 mg/10 mg film-coated tablets are brownish, round, convex tablets, coated with a film, marked with “10” on one face and the other face of the tablet is scored and marked with “4” on the left side of the score and “0” on the right side.

The following package sizes are available:

OPA/Alu/ PE+ desiccant- aluminium blister

Blister 20/5 mg: sizes of 14, 28, 28 (28x1), 30, 30(30x1), 56, 90, 98 (98x1), 120 film-coated tablets

Blister 40/5 mg: sizes of 28, 28 (28x1), 30, 30(30x1), 56, 90, 98 (98x1), 120 film-coated tablets

Blister 40/10 mg: sizes of 28, 28 (28x1), 30, 30(30x1), 56, 90, 98 (98x1), 120 film-coated tablets

Container

100 film-coated tablets in a HPDE container. Each container contains a stopper with a desiccant to keep the tablets dry.

Not all package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Teva B.V.

Swensweg 5, 2031GA Haarlem,

Netherlands

Responsible manufacturer:

Merckle GmbH

Ludwig-Merckle-Strasse 3, Blaubeuren

Baden-Wuerttemberg

89143 Germany

or

Balkanpharma Dupnitsa AD,

3 Samokovsko Shosse Str.,

Dupnitsa 2600,

Bulgaria

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta

28108 - Alcobendas

Madrid (Spain)

Last revision date of thisleaflet:January 2025

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