Leaflet: information for the user

Olmesartan pensa pharma 40 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 yourdoctor or pharmacist.

-This medicine has been prescribed for youonlyand should not be given to others even if they havethe same symptomsas you,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 isOlmesartan Pensa Pharmaand what it is used for

2. What you need to know before takingOlmesartan Pensa Pharma

3. How to takeOlmesartan Pensa Pharma

4. Possible side effects

5. Storage ofOlmesartan Pensa Pharma

6. Contents of the pack and additional information

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

Olmesartán Pensa Pharma is used in the treatment of 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. Normally, high blood pressure does not present symptoms. It is essential to control blood pressure to prevent damage.

High blood pressure can be controlled with medicines like Olmesartán Pensa Pharma. 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 takeOlmesartán Pensa Pharma:

• If you are allergic to olmesartan medoxomil or any of the other components of this medication (listed in section 6).
• If you are more than 3 months pregnant. (It is also best to avoid olmesartan at the beginning of pregnancy - see Pregnancy section).
• If you have a yellowish skin and eye discoloration (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, due to gallstones).
• If you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskiren.

Warnings and precautions:

Consult your doctor before starting to take Olmesartán Pensa Pharma.

Tell your doctorif you are taking any of the following medications 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 electrolyte levels in your blood (such as potassium) at regular intervals.

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

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-sodium diet.

• Elevated potassium levels in the blood.
• Problems with the adrenal glands.

Contact your doctor if you experience severe, persistent diarrhea, and significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your blood pressure treatment.

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

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. Olmesartan 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 can cause serious harm to your baby if used from the third month of pregnancy (see Pregnancy section).

Children and adolescents:

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

Use of Olmesartán Pensa Pharma with other medications:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any of the following medications:

• Other blood pressure-lowering medications, 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 ACE inhibitor or aliskiren

(see also the information under the headings “Do not take Olmesartán Pensa Pharma” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, diuretics, or heparin (to thin the blood). The use of these medications at the same time as olmesartan 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 olmesartan may increase its toxicity. If you need to take lithium, your doctor will measure lithium levels in your 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 olmesartan may increase the risk of kidney failure and reduce the effect of olmesartan.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may reduce the effect of Olmesartán Pensa Pharma. Your doctor may advise you to take Olmesartán Pensa Pharma at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion), as they may slightly reduce the effect of olmesartan.

Older patients:

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

Black patients:

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

Taking Olmesartán Pensa Pharma with food and drinks:

Olmesartán Pensa Pharma can be taken with or without food.

Pregnancy and breastfeeding:

Pregnancy

Inform your doctor if you are pregnant or think you may 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 another medication in place of olmesartan. Olmesartan 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 can cause serious harm to your baby if used from the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to start breastfeeding. Olmesartan is not recommended for use in breastfeeding mothers, 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 high blood pressure treatment. If this happens, do not drive or operate machinery until the symptoms have disappeared. Consult your doctor.

Information on excipients:

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 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 moreOlmesartán Pensa Pharmathan 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 the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to take Olmesartán Pensa Pharma:

If you forgot 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 Pensa Pharma:

It is essential to continue taking olmesartán unless your doctor tells you to stop treatment.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, Olmesartán Pensa Pharma 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 (affecting 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 and consult your doctor immediately.

Rarely (but slightly more often in elderly patients) Olmesartán Pensa Pharma 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, 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 withOlmesartán Pensa Pharmasome 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 Pensa Pharma:

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

increase in triglyceride levels (hypertriglyceridemia), increase in uric acid levels (hyperuricemia), increase in urea levels in blood, increases in liver and muscle function test values.

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

Severe allergic reactions that can affect the entire body and may cause breathing problems, as well as a rapid drop in blood pressure that can even cause fainting (anaphylactic reactions), vertigo, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, exanthema (skin eruption), 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 an increase in potassium levels in the blood (hyperkalemia) and an increase in levels related to kidney function.

Other side effects in children and adolescents

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

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 the 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.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging/container/label 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 trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofOlmesartán Pensa Pharma

The active ingredient is olmesartan. Each tablet contains 40 mg of olmesartan (in the form of olmesartan medoxomilo).

The other components are:

- tablet core: Microcrystalline cellulose, Lactose monohydrate, Povidone, Hydroxypropyl cellulose and Magnesium stearate.

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

(see section 2 information on excipients)

Appearance of the product and contents of the packaging

Olmesartán Pensa Pharma 40 mg are film-coated tablets,white, oblong,biconvex, scored on one face and OL4 on the other face. The tablet can be divided into equal doses.

It is presented in blister packs with 28 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

Laboratorios Cinfa, S.A.

Olaz-Chipi, 10 - Industrial Estate Areta 31620

Huarte-Pamplona. Spain

Date of the last review of this leaflet:February 2025

The detailed information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices.http://www.aemps.gob.es