Package Insert: Information for the User

Olmetec 20 mg Coated Tablets

Olmesartan medoxomil

Read this package insert carefully before you start taking this medicine, as it contains important information for you.

-Keep this package insert, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Olmetec belongs to a group of medications known as angiotensin II receptor antagonists. It reduces blood pressure by relaxing blood vessels.

Olmetec is used to treat high blood pressure (also known as hypertension) in adults, and in children and adolescents from 6 years of age 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. High blood pressure usually does not present symptoms. It is essential to control blood pressure to prevent damage.

High blood pressure can be controlled with medications such as Olmetec tablets. 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 take Olmetec

• If you are allergic to olmesartan medoxomilo 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 taking Olmetec tablets at the start of pregnancy - see Pregnancy section).
• If you have yellow 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 medication to lower blood pressure that contains aliskirén.

Warnings and precautions

Consult your doctor before starting to take Olmetec.

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.
• Aliskirén.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels in your blood (for example, potassium) at regular intervals.

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

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 that causes significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your blood pressure treatment.

Like 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. Olmetec is not recommended for use at the start 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 during this period (see Pregnancy section).

Black patients

Like other similar medications, the blood pressure-lowering effect of Olmetec is somewhat less in black patients.

Older patients

If you are 65 years or older and your doctor decides to increase the dose of olmesartan medoxomilo to 40 mg per day, your doctor will regularly monitor your blood pressure to ensure it does not drop too low.

Children and adolescents

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

Use of Olmetec with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

• Other blood pressure-lowering medications, as they may increase the effect of Olmetec.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskirén (see also the information under the headings “Do not take Olmetec” and “Warnings and precautions”).

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

Taking Olmetec with food and drinks

Olmetec 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 Olmetec before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead of Olmetec. Olmetec is not recommended for use at the start 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 during this period.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Olmetec 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.

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

Olmetec 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.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended initial dose is 1 Olmetec 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 per 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.

Children and adolescents aged 6 to under 18 years:

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 up to 20 or 40 mg per day. In children weighing less than 35 kg, the dose will not exceed 20 mg per day.

If you take more Olmetec than you should

In case you take a higher number of tablets 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 forget to take Olmetec

If you forget to take a dose, take the usual dose the next day. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Olmetec

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

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

Like all medicines, this medicine 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 Olmetec and consult your doctor immediately.

Rarely (but slightly more often in elderly patients) Olmetec 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 Olmetec, 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 with Olmetec a long 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 Olmetec:

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 secretion, 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):

Quick allergic reactions that can affect the entire body and may cause breathing problems, as well as a rapid decrease in blood pressure that can even lead to fainting (anaphylactic reactions), inflammation of the face, dizziness, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, exanthema (skin rash), skin swelling (hives), chest pain (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 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 Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and blister after“CAD”.The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not dispose of medications 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 of Olmetec

The active ingredient is olmesartan medoxomil.

Each film-coated tablet contains 20 mg of olmesartan medoxomil.

The other components are microcrystalline cellulose, lactose monohydrate, hydroxypropyl cellulose, low-substitution hydroxypropyl cellulose, magnesium stearate, titanium dioxide (E171), talc, and hypromellose (see section 2 "Olmetec contains lactose").

Appearance of the product and contents of the packaging

Olmetec 20 mg film-coated tablets are white, round tablets with the inscription C14 on one side.

Olmetec film-coated tablets are available in packaging of 14, 28, 30, 56, 84, 90, 98, and 10 x 28 tablets, and in blister packs of 10, 50, and 500 tablets.

Not all packaging is marketed.

Marketing authorization holder

Daiichi Sankyo España, S.A.

Paseo del Club Deportivo nº1,

Edificio 14, Ground floor left

28223 Pozuelo de Alarcón – Madrid

Spain

Responsible for manufacturing

Daiichi Sankyo Europe GmbH

Luitpoldstrasse 1

85276 Pfaffenhofen

Germany

or

Qualiphar N.V.

Rijksweg, 9

2880 Bornem

Belgium

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Austria: Olmetec

Belgium: Olmetec

Denmark: Olmetec

Germany: Olmetec

Greece: Olmetec

Finland: Olmetec

France: Olmetec

Iceland: Olmetec

Ireland: Benetor

Italy: Olmetec

Luxembourg: Olmetec

Netherlands: Olmetec

Norway: Olmetec

Portugal: Olmetec

Spain: Olmetec

United Kingdom: Olmetec

Last review date of this leaflet:March 2022

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/