Leaflet:information for the user

Olmesartán Teva 40 mg film-coated tablets EFG

olmesartán medoxomilo

1. What is Olmesartán Teva and what it is used for

2. What you need to know before starting to take Olmesartán Teva

3. How to take Olmesartán Teva

4. Possible side effects

5. Storage of Olmesartán Teva

6. Contents of the pack and additional information

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

Olmesartán is used to treat high blood pressure (also known as hypertension) in adults, and in children and adolescents from 6 years 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 medicines like olmesartán. Your doctor 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 Olmesartán Teva:

• if you are allergic to olmesartán medoxomilo or any of the other ingredients of this medication (listed in section 6).

• if you are more than 3 months pregnant. (It is also best to avoid olmesartán at the beginning 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 olmesartán.

Inform your doctorif you are taking any of the following medications used to treat high blood pressure:

• a converting enzyme inhibitor (ACEI) (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 (such as potassium) at regular intervals.

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

Inform 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 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 takingOlmesartán Teva. Your doctor will decide on further treatment. Do not stop takingOlmesartán Tevaon your own.

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.

You should inform your doctor if you think you are (or may be) pregnant. Olmesartán 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 may cause serious harm to your baby if used from the third month of pregnancy (see Pregnancy section).

Patients of black race

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

Older patients

If you are 65 years or older and your doctor decides to increase the dose of olmesartán 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

Olmesartán has been studied in children and adolescents. For more information, consult your doctor. Olmesartán 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.

Other medications and Olmesartán Teva

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

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

• other blood pressure-lowering medications, as they may increase the effect of olmesartán.

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

if you are taking an ACEI or aliskirén (see also the information under the headings “Do not take Olmesartán Teva” 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 olmesartán 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 olmesartán 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 olmesartán may increase the risk of kidney failure and reduce the effect of olmesartán.
• colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may reduce the effect of olmesartán. Your doctor may advise you to take olmesartán at least 4 hours before colesevelam hydrochloride.
• certain antacids(remedies for indigestion), as they may slightly reduce the effect of olmesartán.

Taking Olmesartán Teva with food and drinks

Olmesartán can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant, or if you think you may be pregnant. Your doctor will advise you to stop taking olmesartán before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead of olmesartán. Olmesartán 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 may 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. Olmesartán is not recommended for mothers who are breastfeeding, 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 blood pressure treatment. If this happens, do not drive or operate machinery until the symptoms have disappeared. Consult your doctor.

Olmesartán Teva contains lactose

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. In case of doubt, consult your doctor or pharmacist again.

The recommended initial dose is one 10 mg tablet per day. 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 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.

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

If you take more Olmesartán Teva than you should

If you take more tablets than you should or if a child accidentally swallows any, go immediately to your doctor or the nearest hospital emergency center and bring the medication packaging with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forget to take Olmesartán Teva

If you forget to take a dose, take the usual dose the next day.Do nottake a double dose to make up for the missed doses.

If you interrupt treatment with Olmesartán Teva

It is essential to continue taking olmesartan, 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 they may not affect many people:

In rare cases (they may affect up to 1 in 1,000 people) the following allergic reactions that can affect the whole body have been reported:

Swelling of the face, mouth, and/or larynx, along with itching and skin rash may occur during treatment with olmesartan.They may occur during treatment with olmesartan.If this happens, 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 may cause severe dizziness or fainting.If this happens, stop taking olmesartan, consult your doctor immediately, and remain lying down in a horizontal position.

Frequency unknown: If you experience yellowing of the whites of the eyes, dark urine, skin itching, even if you started treatment with olmesartan 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 olmesartan:

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, or arms, blood in urine.

Some changes have also been observed in the results of certain blood tests: increased levels of fat (hypertriglyceridemia), increased levels of uric acid (hyperuricemia), increased urea in blood, increased values in liver and muscle function tests.

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

Quick allergic reactions that can affect the whole body and may cause breathing problems, as well as a rapid drop in blood pressure that may even cause fainting (anaphylactic reactions), facial inflammation, dizziness, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, exanthema (skin rash), 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: intestinal inflammation that manifests with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Some changes have been observed in the results of certain blood tests. These include 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 are similar to those reported in adults. However, dizziness and headache have been seen more often in children, and nosebleeds are a frequent side effect seen 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: https://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 on the blister pack after “CAD.” The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Olmesartán Teva

- The active ingredient is olmesartan medoxomil.

Cada comprimido recubierto contiene 40 mg de olmesartán medoxomilo.

- The other ingredients are:

Núcleo: lactosa monohidrato, hidroxipropilcelulosa de baja sustitución, hidroxipropilcelulosa, celulosa microcristalina y estearato de magnesio.

Recubrimiento: hipromelosa, dióxido de titanio (E171), lactosa monohidrato, macrogol y triacetina.

Appearance of Olmesartán Teva and content of the container

Olmesartán Teva 40 mg comprimidos recubiertos con película EFG are white, oval-shaped, marked with OL 40 on one face and smooth on the other.

Olmesartán Teva 40 mg comprimidos recubiertos con película EFG are presented in blisters of 28, 30, 56 and 98 comprimidos recubiertos con película and in calendar blisters of 28 comprimidos recubiertos con película.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva B.V.

Swensweg 5,

2031GA Haarlem

Netherlands

Responsible for manufacturing

Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Teva Pharma S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid (Spain)

Last review date of thisleaflet:April 2022

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