Patient Information Leaflet

Olmesartan Combix 20 mg Film-Coated Tablets

Olmesartan medoxomil

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 similar symptoms, 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 Olmesartan Combix and what it is used for

2.What you need to know before taking Olmesartan Combix

3.How to take Olmesartan Combix

4.Possible side effects

5.Storage of Olmesartan Combix

6.Contents of the pack and additional information

Olmesartán Combix belongs to a group of medicines known as angiotensin II receptor antagonists. It reduces 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 can lead to a heart attack, heart failure, or kidney failure, stroke, or blindness. High blood pressure usually does not present symptoms. It is essential to control blood pressure to prevent the occurrence of damage.

High blood pressure can be controlled with medicines like Olmesartán Combix tablets. Your doctor has probably also recommended that you make some lifestyle changes to help you lower your blood pressure (for example, losing weight, quitting smoking, reducing the amount of alcohol you drink, and reducing the amount of salt in your diet). Your doctor may also recommend that you exercise regularly, such as walking or swimming. It is essential to follow your doctor's advice.

Do not take Olmesartán Combix

• if you are allergic to olmesartán medoxomilo or any of the other components of this medication (listed in section 6).
• if you are more than 3 months pregnant. (It is also recommended to avoid taking olmesartán at the beginning of pregnancy – see section “Pregnancy and breastfeeding”).
• if you have yellow skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, due to gallstones).
• if you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olmesartán Combix.

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

• a converting enzyme inhibitor (ACEI) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskirén.

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

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

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

Tell your doctorif you have any of the following health problems:

• kidney problems.
• liver disease.
• heart failure or problems with heart valves or heart muscle.
• severe vomiting, diarrhea, treatment with high doses of medications that increase urine elimination (diuretics), or if you are on a low-sodium diet.
• elevated potassium levels in the blood.
• problems with the adrenal glands.

·

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

Inform your doctor if you are pregnant or think you may be pregnant. Olmesartán Combix 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).

Children and adolescents

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

Use of Olmesartán Combix with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any of the following medications:

• other blood pressure-lowering medications, 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 a converting enzyme inhibitor (ACEI) or aliskirén (see also the information under the headings “Do not take Olmesartán Combix” and “Warnings and precautions”).

• potassium supplements, salt substitutes containing potassium, medications that increase urine elimination (diuretics), or heparin (to thin the blood). The use of these medications at the same time as Olmesartán Combix may elevate potassium levels in the blood.
• lithium (a medication used to treat mood changes and certain types of depression), as used at the same time as Olmesartán Combix may increase its toxicity. If you need to take lithium, your doctor will measure lithium levels in the blood.
• nonsteroidal anti-inflammatory drugs (NSAIDs) (medications to relieve pain, swelling, and other symptoms of inflammation, including arthritis), as used at the same time as Olmesartán Combix may increase the risk of kidney insufficiency and reduce the effect of Olmesartán Combix.
• certain antacids (remedies for indigestion), as they may slightly reduce the effect of Olmesartán Combix.

Older patients

If you are over 65 years old and your doctor decides to increase the dose of olmesartán medoxomilo to 40 mg per day, your doctor will regularly monitor your blood pressure to ensure it does not decrease too much.

Black patients

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

Use of Olmesartán Combix with food and drinks

Olmesartán Combix can be taken with or without food.

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

Inform your doctor if you are pregnant, or if you think you may 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 advise you to take another medication instead of Olmesartán Combix. Olmesartán Combix 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.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Olmesartán Combix 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.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

You may feel drowsy or dizzy during hypertension treatment. If this happens, do not drive or operate machinery until the symptoms have disappeared. Consult your doctor.

Olmesartán Combix contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

The recommended initial dose is 1 Olmesartán Combix 10 mg tablet per day. 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 insufficiency, the maximum dose is 20 mg once a day.

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

If you take more Olmesartán Combix than you should

If you take a higher dose than necessary or if a child has accidentally ingested tablets, contact your doctor or the nearest hospital emergency center immediately and bring the medication packaging with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Olmesartán Combix

If you forget to take a dose, take the usual dose the next day. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Olmesartán Combix

It is essential to continue taking Olmesartán Combix, 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 may 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 may be serious, although not many people may experience them.

In rare cases (they may affect up to 1 in 1,000 people) the following allergic reactions have been reported, which can affect the entire body: inflammation of the face, mouth, and/or larynx, along with itching and skin rash.If this happens, stop taking Olmesartán Combix and consult your doctor immediately.

Very rarely (but slightly more often in elderly patients) Olmesartán Combix may cause a pronounced drop in blood pressure in susceptible patients or as a result of an allergic reaction. This can cause severe dizziness or fainting.If this happens, stop taking Olmesartán Combix, 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 a long time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue treatment for high blood pressure.

These are other side effects known so far with Olmesartán Combix:

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

Dizziness, headache, nausea, indigestion, diarrhea, stomach pain, gastroenteritis, fatigue, sore throat, congestion, and nasal secretion, 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 have also been observed in the results of certain blood tests:

Increased levels of fat (hypertriglyceridemia), increased levels of uric acid (hyperuricemia), increased urea in the blood, increased values in liver and muscle function tests.

Rare side effects (may affect up to 1 in 100 people):

Quick allergic reactions that can affect the entire body and may cause breathing problems, as well as a rapid decrease in blood pressure that can even cause fainting (anaphylactic reactions), dizziness, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, exanthema (skin rash), skin swelling (hives), chest pain (angina).

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

Rare side 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 that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

Reporting 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 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 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 and in the blister pack, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

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 OlmesartanCombix20 mg film-coated tablets

• The active ingredient is olmesartan medoxomil. Each film-coated tablet contains 20 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 (hipromelose (E464), macrogol 4000 (E1521), titanium dioxide (E171), talc).

Appearance of the product and content of the packaging

OlmesartanCombix 20 mg are white to off-white, round, beveled-edge, smooth-faced film-coated tablets.

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

The following pack sizes are available: 28 tablets.

Holder of the marketing authorization and Responsible for manufacturing

Holder of the marketing authorization

Combix Laboratories, S.L.U.

C/Badajoz, 2. Building 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

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

Last review date of this leaflet:February 2025.

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