Leaflet: information for the user

Olmesartan OPKO 40 mg film-coated tablets EFG

Olmesartan medoxomil

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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 leaflet. See section 4.

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

2. What you need to know before starting to take Olmesartan OPKO

3. How to take Olmesartan OPKO

4. Possible side effects

5. Storage of Olmesartan OPKO

6. Contents of the pack and additional information

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

Olmesartán OPKO 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 medicines like Olmesartán OPKO 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 Olmesartán OPKO

• 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 recommended to avoid Olmesartán OPKO tablets at the beginning of pregnancy - see Pregnancy section).
• If you have a yellowish 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 insufficiency 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 OPKO.

Tell your doctorif you are taking any of the following medications used to treat high blood pressure (hypertension):

• An angiotensin-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 in your blood (such as potassium) at regular intervals.

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

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

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 elimination (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 evaluate your symptoms and decide how to continue your treatment for high blood pressure.

Like any other medication that lowers blood pressure, excessive lowering of blood pressure in patients with alterations in blood flow to the heart or brain can cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

You should inform your doctor if you are pregnant or think you may be pregnant. Olmesartán OPKO is not recommended at the beginning 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 Olmesartán OPKO 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 decrease too much.

Children and adolescents

Olmesartan medoxomilo has been studied in children and adolescents. For more information, consult your doctor. Olmesartan OPKO is not recommended for children between 1 year and under 6 years, and it should not be used in children under 1 year as there is no experience.

Use of Olmesartán OPKO with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any of the following medications:

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 OPKO. 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 OPKO” and “Warnings and precautions”).

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

Taking Olmesartán OPKO with food and drinks

Olmesartán OPKO can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant or think you may be pregnant. Your doctor will advise you to stop taking Olmesartán OPKO as soon as you know you are pregnant, and will recommend another medication in its place. Olmesartán OPKO is not recommended at the beginning 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).

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Olmesartán OPKO is not recommended for 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.

Olmesartán OPKO 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.

Olmesartán OPKO contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet, which is essentially “sodium-free”.

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 1 Olmesartán OPKO 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 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 every 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 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 Olmesartán OPKO 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 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 forgot to take Olmesartán OPKO:

If you forgot 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 OPKO:

It is essential to continue taking Olmesartán OPKO, 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 can 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 can be serious, although not many people may experience them:

In rare cases (affecting up to 1 in 1,000 people), the following allergic reactions, which 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 Olmesartán OPKO.If this happens, stop taking Olmesartán OPKO and consult your doctor immediately.

Rarely (but slightly more often in elderly patients), Olmesartán OPKO 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 Olmesartán OPKO, 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 Olmesartán OPKO some 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 Olmesartán OPKO:

Frequent side effects (can affect up to 1 in 10 people):

Dizziness, headache, nausea, indigestion, diarrhea, stomach pain, gastroenteritis, fatigue, sore throat, runny or stuffy nose, bronchitis, flu-like symptoms, cough, pain, chest pain, back pain, bone pain, joint pain, urinary tract infection, swelling in 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 the blood, increased values in liver and muscle function tests.

Rare side effects (can 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 can even lead to fainting (anaphylactic reactions), facial inflammation, dizziness, vomiting, weakness, indisposition, muscle pain, skin rash, allergic skin rash, itching, hives, angina (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 (can affect up to 1 in 1,000 people):

Lack of energy, muscle cramps, altered kidney function, kidney failure.

Intestinal angioedema: swelling in the intestine that presents 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

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 prospectus. 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 in the blister (after “CAD”). The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

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 OPKO:

The active ingredient is olmesartan medoxomil.

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

The other components are lactose monohydrate, microcrystalline cellulose (PH 101), sodium carboxymethyl starch from potato (type B), hydroxypropyl cellulose, colloidal anhydrous silica, magnesium stearate and Instacoat universal White (A05G10022) [HPMC 2910 / hypromellose 6cPs, hydroxypropyl cellulose, talc and titanium dioxide]. (See section 2 “Olmesartán OPKO contains lactose”).

Appearance of the product and contents of the packaging

Olmesartán OPKO 10 mg film-coated tablets EFG are white, round, biconvex tablets with the inscription “C 52” on one face and smooth on the other face.

Olmesartán OPKO film-coated tablets EFG is available in a blister pack consisting of a cold-formable sheet that consists of 25µ OPA / 45µ aluminum / 60µ PVC as the moldable material and 30µ aluminum flat sheet / 6-8 gsm HSL as the covering material.

Olmesartán OPKO film-coated tablets EFG is presented in packs of 14, 28, 30, 56, 90, 98 and 280 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

OPKO HEALTH SPAIN, S.L.U.

Pl. Europa 13-15, 08908

L'Hospitalet de Llobregat, (Barcelona)

Spain

Manufacturer responsible

MacleodsPharma UK Limited

Wynyard Park House,

Wynyard Avenue,

Wynyard, Billingham,

TS22 5TB,

United Kingdom

Ó

Synoptis Industrial Sp. z.o.o.

ul.Rabowicka 15, 62-020

Swarzedz,

Poland

Ó

Fundació Dau Laboratories

C/ C, 12-14 Pol. Ind. Zona Franca,

08040, Barcelona,

Spain.

Last revision date of thisleaflet: January 2025

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