Olmesartan/amlodipine TAD 20 mg/5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

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

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

olmesartan medoxomil/amlodipine

Read this entire 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 and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Olmesartán/Amlodipino TAD contains two substances called olmesartan medoxomil and amlodipine (as amlodipine besilate). Both substances help control high blood pressure.

• Olmesartan medoxomil belongs to a group of medicines known as "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, thereby preventing blood vessels from narrowing, which also reduces blood pressure.

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

Olmesartán/Amlodipino TAD is used to treat high blood pressure in patients whose blood pressure is not adequately controlled with olmesartan medoxomil or amlodipine alone.

2. What you need to know before taking Olmesartan/Amlodipine TAD

Do not take Olmesartan/Amlodipine TAD

• if you are allergic to olmesartan medoxomil, amlodipine, or to a specific 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 olmesartan/amlodipine.
• if you are more than 3 months pregnant. It is best to avoid olmesartan/amlodipine in 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 shortness of breath or peripheral swelling) following a heart attack (acute myocardial infarction).

Warnings and precautions

Talk to your doctor or pharmacist before starting olmesartan/amlodipine.

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 Olmesartan/Amlodipine TAD”.

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, diarrhoea, 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 diarrhoea causing significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

Consult your doctor if you develop abdominal pain, nausea, vomiting, or diarrhoea after taking olmesartan/amlodipine. Your doctor will decide whether to continue treatment. Do not stop taking olmesartan/amlodipine on your own.

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 lead to 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. The use of olmesartan/amlodipine is not recommended in 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 during this period (see section “Pregnancy and breastfeeding”).

Children and adolescents

Olmesartan/amlodipine is not recommended for children and adolescents under 18 years of age.

Other medicines and Olmesartan/Amlodipine TAD

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 enhance the effect of olmesartan/amlodipine. 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 information under the headings “Do not take Olmesartan/Amlodipine TAD” and “Warnings and precautions”).
• Potassium supplements, salt substitutes containing potassium, diuretics (medicines that increase urine output), or heparin (used to thin the blood and prevent blood clots). Using these medicines together with olmesartan/amlodipine may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood disorders and certain types of depression) taken together with olmesartan/amlodipine 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 olmesartan/amlodipine may increase the risk of kidney failure. The effect of olmesartan/amlodipine may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of olmesartan/amlodipine. Your doctor may advise you to take olmesartan/amlodipine at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion and acidity), as they may slightly reduce the effect of olmesartan/amlodipine.
• 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 disorders and high blood pressure).
• Rifampicin, erythromycin, clarithromycin (antibiotics) used for tuberculosis or other infections.
• St. John’s wort (Hypericum perforatum), a herbal remedy.
• Dantrolene (administered intravenously for serious body temperature abnormalities).
• Simvastatin, a medicine used to lower cholesterol and fat (triglyceride) levels in the blood.
• Tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine, used to suppress the body’s immune response, making it possible for your body to accept a transplanted organ.

Taking Olmesartan/Amlodipine TAD with food and drinks

Olmesartan/amlodipine can be taken with or without food. Take the tablets with some liquid (such as a glass of water). If possible, take the daily dose at the same time each day, for example, with breakfast.

People taking olmesartan/amlodipine must not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could lead to an unpredictable increase in the blood pressure-lowering effect of olmesartan/amlodipine.

Elderly patients

If you are over 65 years of age, 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 olmesartan/amlodipine is somewhat reduced in black patients.

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 taking 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 olmesartan/amlodipine before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of olmesartan/amlodipine. The use of Olmesartan/Amlodipine TAD is not recommended in early pregnancy, and it must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onward.

If you become pregnant while being treated with olmesartan/amlodipine, contact your doctor immediately.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. It has been shown that amlodipine passes into breast milk in small amounts. Olmesartan/amlodipine 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.

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.

Driving and use of machines

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

Olmesartan/Amlodipine TAD contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

3. How to take Olmesartán/Amlodipino TAD

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

• The recommended dose of Olmesartán/Amlodipino TAD is one tablet daily.
• The tablets can 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 Olmesartán/Amlodipino TAD with grapefruit juice.
• If possible, take your daily dose at the same time each day, for example at breakfast time.

If you take more Olmesartán/Amlodipino TAD 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.

Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop within 24–48 hours after ingestion.

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to take Olmesartán/Amlodipino TAD

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 Olmesartán/Amlodipino TAD

It is important to continue taking Olmesartán/Amlodipino TAD 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 can cause adverse effects, although not everyone experiences 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 olmesartan/amlodipine, 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 Olmesartán/Amlodipino TAD and consult your doctor immediately.

Olmesartan/amlodipine may cause a marked drop in blood pressure in susceptible patients, or as a result of an allergic reaction. This may cause fainting or severe dizziness. If this happens to you, stop taking olmesartan/amlodipine, 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 treatment with olmesartan/amlodipine was started 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 Olmesartán/Amlodipino TAD:

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

Dizziness; headache; swelling of 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 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; pain in the upper abdomen; skin rash; 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:

increases as well as decreases in blood potassium levels, increased blood creatinine levels, increased blood uric acid levels, and increases in liver function test values (levels of gamma-glutamyl transferase).

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

Hypersensitivity to the medicine; flushing and sensation of warmth in the face; red, itchy rash (urticaria); facial swelling.

Adverse effects reported with olmesartan medoxomil or amlodipine used alone, but not with Olmesartán/Amlodipino TAD, or with higher frequency:

Olmesartan medoxomil

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 increases in liver and muscle function test values.

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 causing 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; flushing 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; red, itchy rash (urticaria); joint or muscle pain; difficulty urinating; need to urinate at night; increased frequency of urination; 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 a type of blood cells known as platelets, which could lead to bruising and prolonged bleeding time; increased blood glucose; increased muscle tone or resistance to passive movement (hypertonia); tingling or numbness in 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 inflammation of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes very severe.

Adverse effects with unknown frequency (cannot be estimated from available data):

Tremor, rigid posture, mask-like facial expression, slow movements, and unsteady, unbalanced gait.

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 TAD

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 is the last day of the month indicated.

Store in the original packaging to protect it from light and moisture.

This medicine does not require special storage temperature conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at the pharmacy. 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 TAD

• The active substances are olmesartan medoxomilo and amlodipine.

Olmesartan/Amlodipine TAD 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).

Olmesartan/Amlodipine TAD 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).

Olmesartan/Amlodipine TAD 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 (excipients) are siliconized microcrystalline cellulose, pregelatinized maize starch, lactose monohydrate, sodium croscarmellose and magnesium stearate (E470b) in the tablet core; and polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172) – only for 40 mg/5 mg film-coated tablets and 40 mg/10 mg film-coated tablets – and red iron oxide (E172) – only for 40 mg/10 mg film-coated tablets – in the film coating. See section 2 “Olmesartan/Amlodipine TAD contains lactose and sodium”.

Presentation of the product and contents of the pack

Olmesartan/Amlodipine TAD 20 mg/5 mg film-coated tablets: white or almost white, round, biconvex film-coated tablet with bevelled edges. Tablet dimensions: diameter: 7 mm, thickness: 2.5–4.2 mm.

Olmesartan/Amlodipine TAD 40 mg/5 mg film-coated tablets: light brownish-yellow, round, biconvex film-coated tablet with bevelled edges, marked with a "5" on one side. Tablet dimensions: diameter: 9 mm, thickness: 3.6–5.3 mm.

Olmesartan/Amlodipine TAD 40 mg/10 mg film-coated tablets: reddish-brown, round, biconvex film-coated tablet with bevelled edges and a score line on one side. Tablet dimensions: diameter: 9 mm, thickness: 3.6–5.3 mm. The tablet may be divided into equal doses.

Olmesartan/Amlodipine TAD is available in packs containing 14, 28, 30, 56, 60, 84, 90, 98 and 100 film-coated tablets in blister packs.

Olmesartan/Amlodipine TAD is also supplied in calendar pack blister packs containing 14, 28, 56 or 98 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: May 2025

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/).