OLMESARTAN PENSA PHARMA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olmesartan Pensa Pharma 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 questions, 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 side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

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

Olmesartan 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 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 Olmesartan Pensa Pharma. Your doctor has likely also recommended that you make some lifestyle changes to help lower your blood pressure (such as 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 crucial to follow your doctor's advice.

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

Do not take Olmesartan Pensa Pharma:

• 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 best to avoid olmesartan at the start of pregnancy - see section Pregnancy).
• 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 kidney failure and are being treated with a blood pressure medication that contains aliskiren.

Warnings and Precautions:

Consult your doctor before starting to take Olmesartan 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) (such as enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• Aliskiren.

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

See also the information under the heading "Do not take Olmesartan 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-salt diet.

• High levels of potassium in the blood.
• Problems with the adrenal glands.

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

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

As with 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 must inform your doctor if you are pregnant or think you may be pregnant. Olmesartan 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:

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

Using Olmesartan Pensa Pharma with other medications:

Tell your doctor or pharmacist if you are taking, have recently taken, or may 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 Olmesartan Pensa Pharma" and "Warnings and Precautions").

• Potassium supplements, salt substitutes that contain potassium, medications that increase urine production (diuretics), or heparin (to thin the blood). Using these medications at the same time as olmesartan may increase potassium levels in the blood.
• Lithium (a medication used to treat mood changes and some types of depression), as it may increase lithium toxicity when used at the same time as olmesartan. 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 decrease the effect of olmesartan.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may decrease the effect of Olmesartan Pensa Pharma. Your doctor may advise you to take Olmesartan 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 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 Olmesartan Pensa Pharma is slightly less in black patients.

Taking Olmesartan Pensa Pharma with Food and Drinks:

Olmesartan Pensa Pharma can be taken with or without food.

Pregnancy and Breastfeeding:

Pregnancy

You must 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 an alternative medication. Olmesartan 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 onwards.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Olmesartan is not recommended in 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.

Information on Excipients:

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 Olmesartan Pensa Pharma

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 tablet of olmesartan 10 mg 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 Olmesartan Pensa Pharma than you should:

In case of taking 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 medication packaging with you.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: 91 562 04 20.

If you forget to take Olmesartan Pensa Pharma:

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 Olmesartan Pensa Pharma:

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

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

4. Possible Side Effects

Like all medications, Olmesartan Pensa Pharma 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 olmesartan and consult your doctor immediately.

Rarely (but slightly more often in elderly patients), Olmesartan Pensa Pharma 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 olmesartan, consult your doctor immediately, and remain lying down.

Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started treatment with Olmesartan Pensa Pharma a long 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 side effects of Olmesartan Pensa Pharma:

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 levels of fat (hypertriglyceridemia), increased levels of uric acid (hyperuricemia), increased urea in the 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 of 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 levels of potassium in the blood (hyperkalemia) and increased levels of components related to kidney function.

Other side effects in children and adolescents

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring 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 Olmesartan Pensa Pharma

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

Do not use this medication after the expiration date stated on the packaging/blister/label 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 via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. 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 Olmesartan Pensa Pharma

The active ingredient is olmesartan. Each tablet contains 10 mg of olmesartan (in the form of olmesartan medoxomil).

The other ingredients 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 on excipients)

Appearance of the Product and Package Contents

Olmesartan Pensa Pharma 10 mg are white, cylindrical, biconvex, scored film-coated tablets with "OL1" on one side.

They are 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 last revision of this package leaflet:February 2025

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