OLMESARTAN COMBIX 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Olmesartán Combix 10 mg Film-Coated Tablets EFG

Olmesartan Medoxomil

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Olmesartán Combix and what is it used for
2. What you need to know before taking Olmesartán Combix
3. How to take Olmesartán Combix
4. Possible side effects
5. Storage of Olmesartán Combix
6. Package Contents and Additional Information

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

Olmesartán Combix belongs to a group of medications 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 can lead to a heart attack, heart or kidney failure, stroke, or blindness. Usually, high blood pressure does not present symptoms. It is essential to control your blood pressure to avoid damage.

High blood pressure can be controlled with medications like Olmesartán Combix tablets. Your doctor will likely also recommend making some lifestyle changes to help lower your blood pressure (e.g., 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 regular exercise, such as walking or swimming. It is crucial 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 medication (listed in section 6).
• if you are pregnant for more than 3 months. (It is also advisable to avoid taking olmesartan at the start of pregnancy – see section “Pregnancy and Breastfeeding”).
• if you have yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, e.g., due to gallstones).
• if you have diabetes or kidney failure and are being treated with a blood pressure medication containing aliskiren.

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):

• 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 need to monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

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

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

Like any other medication that lowers blood pressure, an excessive drop in blood pressure in patients with impaired blood flow to the heart or brain may cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

You should inform your doctor if you are pregnant or think you might be. Olmesartán Combix is not recommended at the start of pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if taken at this stage (see section Pregnancy).

Children and Adolescents

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

Using Olmesartán Combix with Other Medications

Tell your doctor or pharmacist if you are using, have recently used, or might 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 an ACE inhibitor or aliskiren (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 production (diuretics), or heparin (to thin the blood). Using these medications at the same time as Olmesartán Combix may increase potassium levels in the blood.
• Lithium (a medication used to treat mood changes and some types of depression), as it may increase toxicity when used with Olmesartán Combix. If you need to take lithium, your doctor will monitor your lithium blood levels.
• Non-steroidal anti-inflammatory medications (NSAIDs) (medications 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 Olmesartán Combix.
• Certain antacids (remedies 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 the dose of olmesartan medoxomil to 40 mg per day, your doctor will regularly monitor your blood pressure to ensure it does not drop too much.

Black Patients

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

Using Olmesartán Combix with Food and Drinks

Olmesartán Combix can be taken with or without food.

Pregnancy and Breastfeeding

If you are pregnant, breastfeeding, or think you might be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should inform your doctor if you are pregnant or think you might be. 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 medication. Olmesartán Combix is not recommended at the start of pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if used from the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Olmesartán Combix is not recommended for breastfeeding mothers, and your doctor may choose an alternative 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 Using Machines

You may feel drowsy or dizzy during treatment for high blood pressure. If this happens, do not drive or use machines 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 an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Olmesartán Combix

Follow the administration instructions for this medication exactly 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 your blood pressure is not adequately controlled, your doctor may increase the dose to 20 mg or 40 mg per day or prescribe additional treatment.

In patients with mild to moderate kidney failure, the maximum dose is 20 mg once a day.

The tablets can be taken with or without food. Take the tablets with a sufficient amount of water (e.g., 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

In case of taking a larger number of tablets than necessary or if a child has accidentally ingested tablets, contact your doctor or the nearest hospital emergency department immediately and bring the medication packaging with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology 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 forgotten doses.

If you stop taking Olmesartán Combix

It is essential to continue taking Olmesartán Combix unless your doctor tells you to stop.

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone may experience them. If they occur, they are usually mild and do not require stopping treatment.

The following side effects can be serious, although not many people may experience them.

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

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 fainting or severe dizziness. If this happens to you, stop taking Olmesartán Combix, consult your doctor immediately, and remain lying down.

Frequency not known: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 immediately, who will assess your symptoms and decide how to continue treatment for high blood pressure.

These are other known side effects of Olmesartán Combix:

Common Side Effects (may affect up to 1 in 10 people):

Dizziness, headache, nausea, indigestion, diarrhea, 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 fat levels (hypertriglyceridemia), increased uric acid levels (hyperuricemia), increased urea in blood, increases in liver and muscle function test values.

Uncommon Side Effects (may affect up to 1 in 100 people):

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

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 kidney function, kidney failure.

Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Olmesartán Combix

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

Do not use this medication after the expiration date stated on the packaging and blister, after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Olmesartán Combix 10 mg Film-Coated Tablets

• The active ingredient is olmesartan medoxomil. Each film-coated tablet contains 10 mg of olmesartan medoxomil.

• The other ingredients (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 and Package Contents

Olmesartán Combix 10 mg are white to off-white, round, film-coated tablets with beveled edges, smooth on both sides.

The tablets are available in Alu/Alu blister packs with a desiccant.

The following package 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 Last Revision of this Package Leaflet: February 2025

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