Olmesartan Combix 40 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Olmesartán Combix 40 mg film-coated tablets EFG

Olmesartán medoxomilo

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

1. What Olmesartán Combix is and what it is used for

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

Olmesartán Combix is used to treat high blood pressure (also known as hypertension). 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 control your blood pressure to prevent organ damage.

High blood pressure can be controlled with medicines such as Olmesartán Combix tablets. Your doctor has likely also advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol consumption, and decreasing salt intake). 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 taking Olmesartán Combix

Do not take Olmesartán Combix

• 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. (It is also advisable to avoid taking olmesartan at the beginning of pregnancy – see section “Pregnancy and lactation”).
• 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 a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before starting Olmesartán Combix.

Talk to 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.

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking olmesartan. Your doctor will decide whether to continue treatment. Do not stop taking olmesartan monotherapy without medical advice.

See also the information under the heading “Do not take Olmesartán Combix”.

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

• 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 output (diuretics), or if you are on a low-salt diet.
• High levels of potassium in the blood.
• Problems with the adrenal glands.

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 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 Combix is not recommended at the beginning of 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).

Children and adolescents

Olmesartán Combix is not recommended for children and adolescents under 18 years of age.

Taking Olmesartán Combix with other medicines

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 increase the effect of Olmesartán Combix.

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 Olmesartán Combix” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, diuretics (medicines that increase urine output), or heparin (a blood thinner). Taking these medicines together with Olmesartán Combix may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood disorders and certain types of depression), as concomitant use with Olmesartán Combix 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), as their concomitant use with Olmesartán Combix may increase the risk of kidney failure and reduce the effectiveness of Olmesartán Combix.
• Certain antacids (medicines for indigestion), as they may slightly reduce the effect of Olmesartán Combix.

Elderly patients

If you are over 65 years old and your doctor decides to increase your dose of olmesartan medoxomil to 40 mg daily, your doctor will regularly monitor your blood pressure to ensure it does not drop too much.

Patients of black origin

As with other similar medicines, the blood pressure-lowering effect of Olmesartán Combix is somewhat reduced in patients of black origin.

Taking Olmesartán Combix with food and drink

Olmesartán Combix can be taken with or without food.

Pregnancy and lactation

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 Olmesartán Combix before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of Olmesartán Combix is not recommended at the beginning of 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 onwards.

Breast-feeding

Inform your doctor if you are breast-feeding or about to start breast-feeding. Olmesartán Combix is not recommended for breast-feeding mothers, and your doctor may choose an alternative treatment if you wish to breast-feed, especially if your baby is a newborn or premature.

Consult your doctor or pharmacist before using any medicine.

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 symptoms have resolved. Consult your doctor.

Olmesartán Combix contains lactose

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

3. How to take Olmesartán Combix

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

The recommended initial dose is 1 tablet of Olmesartán Combix 10 mg once daily. If blood pressure is not adequately controlled, your doctor may increase the dose up to 20 mg or 40 mg per day 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. Take the tablets with a sufficient amount of water (for example, a glass of water). If possible, take your dose at the same time each day, for example, with breakfast.

If you take more Olmesartán Combix than you should

If you take more tablets than prescribed or if a child has accidentally ingested tablets, contact your doctor or the nearest hospital emergency department immediately and bring the medicine package with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist 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 Combix

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 Combix

It is important to continue taking Olmesartán Combix 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 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 small number of people.

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

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

The following are other known adverse effects of Olmesartán Combix so far:

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, influenza-like symptoms, cough, pain, chest pain, back pain, bone pain, joint pain, urinary tract infection, swelling of ankles, feet, legs, hands or arms, blood in urine.

Some changes in the results of certain blood tests have also been observed:

Increase in fat levels (hypertriglyceridaemia), increase in uric acid levels (hyperuricaemia), increased blood urea, elevations 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), vertigo, vomiting, weakness, malaise, muscle pain, skin rash, allergic skin rash, itching, exanthema (skin eruption), skin swelling (hives), angina (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.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects 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. Olmesartán Combix Storage

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

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

No special storage conditions are required.

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

6. Contents of the pack and other information

Composition of Olmesartán Combix 40 mg film-coated tablets

The active substance is olmesartan medoxomil. Each film-coated tablet contains 40 mg of olmesartan medoxomil.

The other components (excipients) are:

• Tablet core: lactose monohydrate, microcrystalline cellulose (E460i), low-substituted hydroxypropylcellulose, hydroxypropylcellulose (E463), magnesium stearate (E470b), stearic acid.
• Tablet coating: Opadry white (hypromellose (E464), macrogol 4000 (E1521), titanium dioxide (E171), talc).

Appearance of the medicinal product and contents of the pack

Olmesartán Combix 40 mg are white to off-white, oval, biconvex film-coated tablets, smooth on both sides.

The tablets are presented in Alu/Alu blister packs with desiccant.

The following pack sizes are available: 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Netpharmalab Consulting Services

Crta. De Fuencarral, 22

28108 Alcobendas (Madrid)

Spain

Date of the most recent revision 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 Health Products (AEMPS) http://www.aemps.gob.es/