Olmesartan Pensapharma 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olmesartán pensa pharma 20 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 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.

Leaflet contents

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

1. What Olmesartán Pensa Pharma is and what it is used for

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

Olmesartán Pensa Pharma 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 produces no symptoms. It is important to monitor your blood pressure to prevent such complications.

High blood pressure can be controlled with medicines such as Olmesartán Pensa Pharma. 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 intake, and decreasing the amount of salt in your diet). Your doctor may also recommend regular physical exercise, such as walking or swimming. It is important to follow your doctor's advice.

2. What you need to know before taking Olmesartán Pensa Pharma

Do not take Olmesartán Pensa Pharma:

• If you are allergic to olmesartan medoxomil or to 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 olmesartan in early 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 a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions:

Talk to your doctor before starting Olmesartán Pensa Pharma.

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) (e.g., 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 (e.g., potassium) at regular intervals.

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

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.

Contact your doctor if you experience severe, persistent diarrhoea causing significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

Consult your doctor if you develop abdominal pain, nausea, vomiting, or diarrhoea 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 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. The use of olmesartan is not recommended in early pregnancy, and it must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if taken during this period (see Pregnancy section).

Children and adolescents:

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

Use of Olmesartán Pensa Pharma with other medicines:

Tell 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 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 Olmesartán Pensa Pharma” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, medicines that increase urine output (diuretics), or heparin (a blood thinner). Taking these medicines together with olmesartan may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood disorders and certain types of depression), as it may increase lithium toxicity when taken 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, which 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.

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 monitor your blood pressure regularly to ensure it does not drop too low.

Patients of black race:

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

Taking Olmesartán Pensa Pharma with food and drink:

Olmesartán Pensa Pharma can be taken with or without food.

Pregnancy and breastfeeding:

Pregnancy

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 an alternative medicine. The use of olmesartan is not recommended in early pregnancy, and it must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Olmesartan is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, 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.

Information about excipients:

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

3. How to take Olmesartán Pensa Pharma

Follow exactly the instructions for use of this medicine given by your doctor or

pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended starting dose is 1 tablet of olmesartan 10 mg once daily. If 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 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). If possible, take your dose at the same time each day, for example, with breakfast.

If you take more Olmesartán Pensa Pharma than you should:

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to take Olmesartán Pensa Pharma:

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 Pensa Pharma:

It is important to continue taking olmesartan 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, Olmesartán Pensa Pharma may cause adverse effects, although not everyone experiences 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.

Rare cases (may affect up to 1 in 1,000 people) of 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), Olmesartán Pensa Pharma 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 Olmesartán Pensa Pharma 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 known adverse effects reported so far with Olmesartán Pensa Pharma:

Frequent adverse 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:

increase in fat levels (hypertriglyceridemia), increase in uric acid levels (hyperuricemia), increase in 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), dizziness, vomiting, weakness, feeling unwell, 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 diarrhea.

Some changes in blood test results have been observed. These include increased levels of potassium in blood (hyperkalemia) 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, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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. Storage of Olmesartan Pensa Pharma

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

Do not use this medicine after the expiry date which is stated on the packaging/blister/label 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 medicines and their packaging 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 Pensa Pharma

The active substance is olmesartan. Each tablet contains 20 mg of olmesartan (as olmesartan medoxomil).

The other components are:

• tablet core: Microcrystalline cellulose, Lactose monohydrate, Povidone, Hydroxypropylcellulose and Magnesium stearate.
• tablet coating: Opadry Y-1-7000 (hypromellose, titanium dioxide and macrogol).

(see section 2, information about excipients)

Appearance of the product and contents of the pack

Olmesartán Pensa Pharma 20 mg are white, cylindrical, biconvex, film-coated tablets, scored on one side and marked OL2 on the other. The tablet can be divided into equal doses.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

Laboratorios Cinfa, S.A.

Olaz-Chipi, 10 - Polígono Industrial Areta 31620

Huarte-Pamplona. Spain

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

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products: http://www.aemps.gob.es