Olmesartan CINFA 40 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

olmesartán cinfa 40 mg film-coated tablets EFG

olmesartan medoxomil

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

Contents of the leaflet

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

1. What olmesartán cinfa is and what it is used for

olmesartán cinfa belongs to a group of medicines known as angiotensin II receptor antagonists. It lowers blood pressure by relaxing blood vessels.

olmesartán cinfa is used to treat high blood pressure (also known as hypertension) in adults, and in children and adolescents aged 6 to less than 18 years. High blood pressure can damage blood vessels in organs such as the heart, kidneys, brain and eyes. In some cases, this may lead to heart attack, heart or kidney failure, stroke or blindness. High blood pressure usually does not cause symptoms. It is important to monitor your blood pressure to prevent such complications.

High blood pressure can be controlled with medicines such as olmesartán cinfa. Your doctor has probably also advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol intake and reducing salt in your diet). Your doctor may also recommend regular physical activity, such as walking or swimming. It is important to follow your doctor's advice.

2. What you need to know before starting olmesartan cinfa

Do not take olmesartan cinfa

• If you are allergic to olmesartan medoxomil or any of the other ingredients of this medicine (listed in section 6).
• If you are more than 3 months pregnant. (Olmesartan should also be avoided at the beginning of pregnancy - see Pregnancy section).
• If you have yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, due to gallstones).
• If you have diabetes or renal impairment and are being treated with an antihypertensive medicine containing aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before starting to take olmesartán cinfa.

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) (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 blood levels of electrolytes (for example, potassium) at regular intervals.

See also the information under the heading “Do not take olmesartán cinfa”.

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

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

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

Contact your doctor if you develop severe, persistent diarrhoea 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 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. Use of olmesartán 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 stage (see section Pregnancy).

Black patients

As with other similar medications, the blood pressure-lowering effect of olmesartan is somewhat less in black patients.

Elderly Patients

If you are 65 years of age or older and your doctor decides to increase your olmesartan medoxomil dose to 40 mg daily, your doctor needs to regularly monitor your blood pressure to ensure it does not decrease too much.

Children and adolescents

Olmesartan has been studied in children and adolescents. For further information, consult your doctor. Olmesartan is not recommended for children from 1 year to less than 6 years of age, and must not be used in children under 1 year of age, as there is no experience available.

Taking olmesartan cinfa with other medicines

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

In particular, inform your doctor or pharmacist about any of the following medicines:

• Other blood pressure-lowering medicines, as they may increase the effect of olmesartan.
• 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 olmesartan cinfa” and “Warnings and precautions”).
• Potassium supplements, salt substitutes containing potassium, medicines that increase urine elimination (diuretics), or heparin (a blood thinner). Using these medicines together with olmesartan may raise blood potassium levels.
• Lithium (a medicine used to treat mood disorders and certain types of depression), as it may increase lithium toxicity when taken together with olmesartan. 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), as they may increase the risk of kidney failure and reduce the effect of olmesartan when taken together.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of olmesartan. Your doctor may advise you to take olmesartan at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion), as they may slightly reduce the effect of olmesartan.

Taking olmesartan cinfa with food and drink

Olmesartan can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 olmesartan before becoming pregnant or as soon as you know you are pregnant, and will recommend that you take another medicine instead of olmesartan. The use of olmesartan is not recommended at the beginning of pregnancy, and it must not be taken after the first 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onwards.

Breast-feeding

Inform your doctor if you are breast-feeding or planning to breast-feed. Olmesartan is not recommended for mothers who are breast-feeding, and your doctor may choose an alternative treatment if you wish to breast-feed, especially if your baby is newborn or premature.

Driving and using machines

You may feel drowsy or dizzy during treatment for high blood pressure. If this occurs, do not drive or operate machinery until these symptoms have resolved. Consult your doctor.

olmesartan cinfa contains lactose.

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take olmesartán cinfa

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

The recommended initial dose is 1 tablet of olmesartán 10 mg once daily. If blood pressure is not adequately controlled, your doctor may increase the dose up to 20 mg or 40 mg once daily or prescribe additional treatment.

In patients with mild to moderate renal impairment, the maximum dose is 20 mg once daily.

The tablets can be taken with or without food. Swallow the tablets with sufficient liquid (for example, a glass of water). If possible, take your dose at the same time each day, for example, with breakfast.

The tablet may be divided into equal doses.

Use in children and adolescents aged 6 to less than 18 years

The recommended initial dose is 10 mg once daily. If the patient's blood pressure is not adequately controlled, the doctor may decide to adjust the dose to 20 mg or 40 mg once daily. In children weighing less than 35 kg, the dose must not exceed 20 mg once daily.

If you take more olmesartán cinfa than you should

If you take more tablets than prescribed or if a child accidentally ingests the tablets.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take olmesartán cinfa

If you miss 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 cinfa

It is important to continue taking olmesartán unless your doctor tells you to stop treatment. 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 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 few people.

In rare cases (may affect up to 1 in 1,000 people), the following allergic reactions have been reported, which may affect the whole body: swelling of the face, mouth and/or larynx, together with itching and skin rash. If this happens to you, stop taking olmesartan and consult your doctor immediately.

Rarely (but slightly more frequently in elderly patients), olmesartan may cause a marked drop 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 olmesartan, 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 some time ago, contact your doctor immediately, who will assess your symptoms and decide how to proceed with your blood pressure treatment.

These are other adverse effects known so far with olmesartan:

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

Dizziness, headache, nausea, indigestion, diarrhoea, stomach pain, gastroenteritis, fatigue, sore throat, nasal congestion and discharge, bronchitis, flu-like symptoms, cough, pain, chest pain, back pain, bone pain, joint pain, urinary tract infection, swelling of ankles, feet, legs, hands, arms, blood in urine.

Some changes in the results of certain blood tests have also been observed: increased levels of fat (hypertriglyceridaemia), increased levels of uric acid (hyperuricaemia), increased blood urea, increases in liver and muscle function test values.

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

Rapid allergic reactions that may affect the whole body and may cause breathing difficulties, as well as a rapid drop in blood pressure that may even lead to fainting (anaphylactic reactions), facial swelling, vertigo, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, exanthema (skin eruption), skin swelling (hives), angina pectoris (chest pain or discomfort).

In blood tests, a decrease in the number of a type of blood cells called platelets (thrombocytopenia) has been observed.

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

Lack of energy, muscle cramps, worsening of kidney function, kidney failure.

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

Some changes in the results of certain blood tests have been observed. These include increased levels of potassium in the blood (hyperkalaemia) and increased levels of components related to kidney function.

Other adverse effects in children and adolescents:

Adverse effects observed in children are similar to those reported in adults. However, dizziness and headache have been observed more frequently in children, and nosebleeds are a frequent adverse effect observed only in children.

Reporting of adverse effects

If you experience any type of adverse effect, talk to 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of olmesartan cinfa

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging/blister label after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of olmesartán cinfa

• The active substance is olmesartan medoxomilo.

Each film-coated tablet contains 40 mg of olmesartan medoxomil.

• The other components are:

Tablet core: microcrystalline cellulose, monohydrate lactose, povidone, hydroxypropylcellulose, and magnesium stearate.

Tablet coating: Opadry Y-1-7000 (hypromellose, titanium dioxide, and macrogol).

Appearance of the medicinal product and contents of the pack

olmesartán cinfa 40 mg are film-coated tablets, oblong, white, biconvex, scored on one side and marked with the code OL4 on the other side.

It is available in blister packs containing 28 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

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

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

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/79898/P_79898.html

QR code to: https://cima.aemps.es/cima/dochtml/p/79898/P_79898.html