Olmesartan OPKO 40 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olmesartan OPKO 40 mg film-coated tablets EFG

Olmesartan medoxomil

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Olmesartán OPKO belongs to a group of medicines known as angiotensin II receptor antagonists. It lowers 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 aged 6 to less than 18 years. High blood pressure can damage blood vessels in organs such as the heart, kidneys, brain, and eyes. In some cases, this may lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually does not cause symptoms. It is important to monitor your blood pressure regularly to help prevent such damage.

High blood pressure can be controlled with medicines such as Olmesartán OPKO tablets. Your doctor has likely also advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol intake, 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 important to follow your doctor's advice.

2. What you need to know before taking Olmesartán OPKO

Do not take Olmesartán OPKO

• If you are allergic to olmesartan medoxomil or to any of the other ingredients of this medicine (listed in section 6).
• If you are more than 3 months pregnant. (It is also advisable to avoid Olmesartán OPKO tablets at the beginning of pregnancy – see Pregnancy section.)
• If you have yellowing of the 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 blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor before starting to take Olmesartán OPKO.

Tell your doctor if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• An angiotensin-converting enzyme (ACE) inhibitor (for example enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• Aliskiren.

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

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

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

Tell your doctor if you have any of the following health conditions:

• Kidney problems.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe vomiting, diarrhoea, treatment with high doses of medicines that increase urine elimination (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 develop severe, persistent diarrhoea 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 lowering of blood pressure in patients with impaired blood flow to the heart or brain may lead to 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 pregnant. Use of Olmesartán OPKO is not recommended at the beginning 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 during this stage (see Pregnancy section).

Patients of Black race

As with other similar medicines, the blood pressure-lowering effect of Olmesartán OPKO is somewhat reduced in patients of Black race.

Elderly patients

If you are 65 years of age or older and your doctor decides to increase your dose of olmesartan medoxomil to 40 mg daily, you will need regular monitoring of your blood pressure by your doctor to ensure it does not drop too low.

Children and adolescents

Olmesartan medoxomil has been studied in children and adolescents. For further information, consult your doctor. Olmesartán OPKO is not recommended for children between 1 year and under 6 years of age, and must not be used in children under 1 year of age due to lack of experience.

Taking Olmesartán OPKO with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any of the following 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 Olmesartán OPKO. Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Olmesartán OPKO” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, medicines that increase urine elimination (diuretics), or heparin (to thin the blood). Taking these medicines together with Olmesartán OPKO may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood disorders and certain types of depression), as taking it together with Olmesartán OPKO may increase its toxicity. If you need to take lithium, your doctor will monitor lithium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines to relieve pain, swelling, and other symptoms of inflammation, including arthritis), as taking them together with Olmesartán OPKO may increase the risk of kidney failure and reduce the effect of Olmesartán OPKO.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may reduce 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 drink

Olmesartán OPKO can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant or think you might be pregnant. Your doctor will advise you to stop taking Olmesartán OPKO before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Olmesartán OPKO. Use of this medicine is not recommended at the beginning of pregnancy, and it must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Olmesartán OPKO is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a 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 medicine.

Driving and using machines

You may feel drowsy or dizzy during treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

Olmesartán OPKO contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him 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 for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended starting dose is 1 tablet of Olmesartán OPKO 10 mg once daily. 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 impairment, 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 (for example, a glass). If possible, take your dose at the same time each day, for example, with breakfast.

Children and adolescents aged 6 to less than 18 years:

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

If you take more Olmesartán OPKO than you should

If you take more tablets than prescribed or if a child has accidentally ingested tablets, contact your doctor or the nearest hospital emergency department immediately and bring the medicine packaging with you.

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

If you forget to take Olmesartán OPKO

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

If you stop taking Olmesartán OPKO

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. If they occur, they are often mild and do not require discontinuation of treatment.

The following adverse effects may be serious, although they affect only a few people:

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

Swelling of the face, mouth and/or larynx together with itching and skin rash may occur during treatment with Olmesartán OPKO. If this happens to you, stop taking Olmesartán OPKO and consult your doctor immediately.

Rarely (but slightly more often in elderly patients), Olmesartán OPKO may cause a marked drop in blood pressure in susceptible patients or as a result of an allergic reaction. This may lead to fainting or severe dizziness. If this happens to you, stop taking Olmesartán OPKO, consult your doctor immediately, and remain lying down in a horizontal position.

Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you started treatment with Olmesartán OPKO some time ago, contact your doctor immediately, who will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

The following are other known adverse effects reported so far with Olmesartán OPKO:

Frequent adverse 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 urine.

Some changes in certain blood test results have also been observed:

Increase in fat levels (hypertriglyceridemia), increase in uric acid levels (hyperuricemia), increase in blood urea, elevations in liver and muscle function test values.

Uncommon adverse effects (may affect up to 1 in 100 people):

Rapid allergic reactions that may affect the whole body and may cause breathing difficulties, as well as a rapid drop in blood pressure that may even lead to collapse (anaphylactic reactions), facial swelling, dizziness, vomiting, weakness, malaise, muscle pain, skin rash, allergic skin rash, itching, exanthema (skin eruption), skin swelling (hives), angina (chest pain or discomfort).

In blood tests, a decrease in the number of a type of blood cells called platelets (thrombocytopenia) has been observed.

Rare adverse 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 presenting symptoms such as abdominal pain, nausea, vomiting and diarrhea.

Some changes in certain blood test results have been observed. These include increased levels of potassium in the blood (hyperkalemia) and increased levels of components related to kidney function.

Other adverse effects in children and adolescents

Adverse effects observed in children are similar to those reported in adults. However, dizziness and headache have been observed more frequently in children, and nosebleeds are a frequent adverse effect observed only in children.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartan OPKO

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

Do not use this medicine after the expiry date stated on the packaging and blister (after "EXP"). The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE point located in pharmacies. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartan OPKO:

The active substance is olmesartan medoxomil.

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

The other components are monohydrate lactose, microcrystalline cellulose (PH 101), sodium carboxymethyl starch from potato (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 “Olmesartan OPKO contains lactose”).

Nature of the product and pack contents

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

Olmesartan OPKO film-coated tablets EFG are available in cold-forming blister packs consisting of a forming layer made of 25µ OPA / 45µ aluminium foil / 60µ PVC and a sealing layer made of 30µ aluminium foil / 6-8 gsm HSL.

Olmesartan OPKO film-coated tablets EFG are supplied in pack sizes 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

Macleods Pharma 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 most recent review of this leaflet: January 2025

Detailed and up-to-date 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/