OLMESARTAN OPKO 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olmesartan OPKO 10 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 pack

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

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

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

Olmesartan OPKO is used to treat high blood pressure (also known as hypertension) in adults, and in 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 essential to control your blood pressure to avoid damage.

High blood pressure can be controlled with medications like Olmesartan OPKO tablets. Your doctor will probably also recommend that you make some lifestyle changes to help lower your blood pressure (e.g., lose weight, stop smoking, reduce the amount of alcohol you drink, and reduce 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 this advice from your doctor.

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

Do not take Olmesartan OPKO

• 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 OPKO 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, e.g., due to gallstones).
• If you have diabetes or kidney problems and are being treated with a blood pressure medicine containing aliskiren.

Warnings and precautions

Tell your doctor before you start taking Olmesartan OPKO.

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), especially 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 OPKO”.

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

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 OPKO is not recommended at the start of pregnancy, and you must not take it 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 OPKO 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 medoxomil has been studied in children and adolescents. For more information, consult your doctor. Olmesartan OPKO is not recommended in children between 1 year and less than 6 years of age, and it must not be used in children under 1 year of age as there is no experience available.

Using Olmesartán OPKO with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

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

• Potassium supplements, salt substitutes containing potassium, diuretics, or heparin (to thin the blood). Using these medicines at the same time as Olmesartan OPKO 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 OPKO. 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 reduce the effect of Olmesartan OPKO.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may reduce the effect of Olmesartan OPKO. Your doctor may advise you to take Olmesartan OPKO at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion), as they may slightly reduce the effect of Olmesartan OPKO.

Taking Olmesartán OPKO with food and drinks

Olmesartán OPKO can be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

You must inform your doctor if you are pregnant or think you might be. Your doctor will advise you to stop taking Olmesartan OPKO before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Olmesartan OPKO. It is not recommended to use this medicine 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.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Olmesartan OPKO is not recommended in breast-feeding mothers, and your doctor may choose another treatment if you want to breast-feed, especially if your baby is newborn or premature.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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.

Olmesartán OPKO contains lactose

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

Olmesartán OPKO contains sodium

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

3. How to take Olmesartán OPKO

Follow exactly the instructions of administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended initial dose is 1 tablet of Olmesartan OPKO 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, e.g., 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 Olmesartán OPKO than you should

In case of taking a larger number of tablets than necessary or if a child has accidentally ingested tablets, contact your doctor or the nearest hospital emergency department immediately and take the medicine pack with you.

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

If you forget to take Olmesartán OPKO

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

If you stop taking Olmesartán OPKO

It is essential to continue taking Olmesartan OPKO 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 not many people may have them:

Rarely (may affect 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 Olmesartan OPKO. If this happens to you, stop taking Olmesartan OPKO and consult your doctor immediately.

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

Common side effects (may 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 the 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 levels 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), swelling of the face, dizziness, vomiting, weakness, malaise, muscle pain, skin rash, allergic skin rash, itching, exanthem (skin rash), skin swelling (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 (may 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 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 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartán OPKO

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 is the last day of the month stated.

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 a pharmacy for proper disposal. This will help protect the environment.

6. Container Content and Additional Information

Composition of Olmesartán OPKO:

The active ingredient is olmesartán medoxomil.

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

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

Product Appearance and Container Content

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 are available in a blister pack consisting of a cold-formable foil made of 25µ OPA / 45µ aluminum foil / 60µ PVC as the formable material and 30µ flat aluminum foil / 6-8 gsm HSL as the covering material.

Olmesartán OPKO film-coated tablets EFG are 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

Marketing Authorization Holder

OPKO HEALTH SPAIN, S.L.U.

Pl. Europa 13-15, 08908

L'Hospitalet de Llobregat, (Barcelona)

Spain

Manufacturer

MacleodsPharma UK Limited

Wynyard Park House,

Wynyard Avenue,

Wynyard, Billingham,

TS22 5TB,

United Kingdom

Or

Synoptis Industrial Sp. z.o.o.

ul.Rabowicka 15, 62-020

Swarzedz,

Poland

Or

Laboratori Fundació Dau

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

08040, Barcelona,

Spain.

Date of the Last Revision of thisProspectus: January 2025

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