OLMESARTAN HEC 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olmesartan HEC 40 mg Film-Coated Tablets EFG

Olmesartan Medoxomil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Olmesartan HEC and what is it used for
2. What you need to know before you take Olmesartan HEC
3. How to take Olmesartan HEC
4. Possible side effects
5. Storage of Olmesartan HEC
6. Contents of the pack and other information

1. What is Olmesartan HEC and what is it used for

Olmesartan belongs to a group of medicines called angiotensin II receptor antagonists. It lowers blood pressure by relaxing blood vessels.

Olmesartan is used to treat high blood pressure (also known as hypertension) in adults and children and adolescents from 6 to less than 18 years of age. 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. Usually, high blood pressure does not present symptoms. It is important to control your blood pressure to avoid damage.

High blood pressure can be controlled with medicines like olmesartan tablets. Your doctor has probably 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 essential to follow this advice from your doctor.

2. What you need to know before you take Olmesartan HEC

Do not take Olmesartan HEC

• If you are allergic to olmesartan medoxomil or any of the other ingredients of this medicine (listed in section 6).
• If you are more than 3 months pregnant. (It is also better to avoid olmesartan tablets 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 (bile obstruction, for example, due to gallstones).
• If you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Warnings and precautions

Tell your doctor before you start taking olmesartan

Tell your doctorif 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 check your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Olmesartan HEC”.

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 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 suffer from 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 HEC. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartan HEC on your own.

As with any other medicine that lowers blood pressure, excessive blood pressure reduction 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 might be. Olmesartan is not recommended at the start of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken at this stage (see section Pregnancy).

Black patients

As with other similar medicines, the blood pressure-lowering effect of olmesartan is somewhat smaller in black patients.

Elderly patients

If you are 65 years or older and your doctor decides to increase the dose of olmesartan medoxomil to 40 mg per day, you need your doctor to regularly check your blood pressure to ensure it does not decrease too much.

Children and adolescents

Olmesartan has been studied in children and adolescents. For more information, consult your doctor. Olmesartan is not recommended in children from 1 year to less than 6 years, and it must not be used in children under 1 year, as there is no experience available.

Using Olmesartan HEC with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, inform your doctor or pharmacist about any of the following medicines:

• Other blood pressure-lowering medicines, as they may increase the effect of olmesartan.

Your doctor may need to change 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 HEC” and “Warnings and precautions”).

• Potassium supplements, salt substitutes that contain potassium, diuretics, or heparin (to thin the blood). Using these medicines at the same time as olmesartan may increase potassium levels in the blood.
• Lithium (a medicine 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 have to take lithium, your doctor will measure lithium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines 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 medicine that lowers blood cholesterol levels, as it may decrease the effect of olmesartan. Your doctor may advise you to take olmesartan at least 4 hours before colesevelam hydrochloride.
• Certain antacids (indigestion remedies), as they may slightly reduce the effect of olmesartan.

Taking Olmesartan HEC with food and drinks

Olmesartan can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant or think you might be. Your doctor will advise you to stop taking olmesartan before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of olmesartan. Olmesartan is not recommended at the start of pregnancy, and it must not be taken when you are more than 3 months pregnant, 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. Olmesartan is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment if you want to breastfeed, especially if your baby is newborn or premature.

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

You may feel drowsy or dizzy during blood pressure treatment. If this happens, do not drive or use machines until the symptoms have disappeared. Consult your doctor.

Olmesartan HEC contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Olmesartan HEC

Follow exactly the instructions of administration of this medicine given by your doctor. In case of 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 problems, 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 (e.g., a glass). If possible, take your dose at the same time each day, for example, at breakfast time.

Children and adolescents from 6 to less than 18 years of age:

The recommended initial dose is 10 mg per day. If the patient's blood pressure is not adequately controlled, the doctor may decide to change the dose to 20 or 40 mg once daily. In children who weigh less than 35 kg, the dose will not exceed 20 mg once daily.

If you take more Olmesartan HEC than you should

In case of taking a larger amount 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 package leaflet with you.

In case of overdose, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Olmesartan HEC

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 HEC

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If they do occur, they are often mild and do not require treatment to be stopped.

The following side effects may be serious, although they are rare.

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: swelling of the face, mouth, and/or throat, 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 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 HEC 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:

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 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), swelling of the face, dizziness, 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.

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.

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

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 reported more frequently in children, and nosebleeds are a common side effect observed only in children.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartan HEC

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 carton and blister (after “EXP.”). The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartan HEC

The active substance is olmesartan medoxomil.

Each film-coated tablet contains 10 mg of olmesartan medoxomil.

The other ingredients are microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, magnesium stearate, titanium dioxide, Macrogol 400, and hypromellose (see section 2 “Olmesartan HEC contains lactose”).

Appearance of the product and pack contents

Olmesartan HEC 10 mg film-coated tablets are almost white, round, with the inscription L 19 on one side and smooth on the other.

Olmesartan HEC 10 mg film-coated tablets are available in packs of 28, 30, 56, 60, 98, and 100 tablets in PA/AL/PVC blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

HEC Pharm GmbH,

Gabriele-Tergit-Promenade 17,

10963 Berlin, Germany

Manufacturer

Formula Pharmazeutische und chemische Entwicklungs GmbH

Goerzallee 305b,

D-14167 Berlin, Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: March 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/