Olmetec Plus 40 mg/12.5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olmetec Plus 40 mg/12.5 mg film-coated tablets

Olmesartan medoxomil / Hydrochlorothiazide

Read the entire 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 questions, ask 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, 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.

Leaflet contents

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

1. What Olmetec Plus is and what it is used for

Olmetec Plus contains two active substances, olmesartan medoxomil and hydrochlorothiazide, which are used in the treatment of high blood pressure (hypertension):

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

• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It lowers blood pressure by helping the body get rid of excess fluid, increasing urine production by the kidneys.

Olmetec Plus will only be prescribed if treatment with Olmetec (olmesartan medoxomil) alone has not adequately controlled your blood pressure. The combined administration of both active substances in Olmetec Plus contributes to a greater reduction in blood pressure than when either substance is given alone.

You may already be taking medicines to treat high blood pressure, but your doctor may consider it necessary for you to take Olmetec Plus to lower it further.

High blood pressure can be controlled with medicines such as Olmetec Plus tablets. Your doctor may also have advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol consumption, and decreasing the amount of salt in your diet). Your doctor may also have recommended 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 Olmetec Plus

Do not take Olmetec Plus

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide, or to any of the other ingredients of this medicine (listed in section 6), or to substances similar to hydrochlorothiazide (sulfonamides).
• If you are more than 3 months pregnant. (It is also advisable to avoid Olmetec Plus in early pregnancy – see Pregnancy section).
• If you have kidney problems.
• If you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have low levels of potassium or sodium in the blood, high levels of calcium or uric acid in the blood (with symptoms of gout or kidney stones) that do not improve with treatment.
• If you have moderate or severe liver problems, yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, e.g., due to gallstones).

If you think any of these apply to you, or you are unsure, do not take the tablets. Speak to your doctor and follow their advice.

Warnings and precautions

Talk to your doctor before starting to use Olmetec Plus.

Before taking the tablets, tell your doctor if 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), particularly if you have kidney problems related to diabetes.
• Aliskiren.

Your doctor may monitor 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 Olmetex Plus”.

Before taking the tablets, tell your doctor if you have any of the following health conditions:

• Kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Vomiting (with dizziness) or diarrhoea that is severe or lasts for several days.
• Treatment with high doses of medicines that increase urine output (diuretics), or if you are on a low-salt diet.
• Problems with adrenal glands (e.g., primary hyperaldosteronism).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Olmetec Plus.
• If you have previously experienced respiratory or lung problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Olmetec Plus, seek medical attention immediately.

Contact your doctor if you experience any of the following symptoms:

• Severe, persistent diarrhoea causing significant weight loss. Your doctor will assess your symptoms and decide how to continue your blood pressure treatment.
• Vision changes or eye pain. These could be signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur from hours to weeks after taking Olmetec Plus. This may lead to permanent vision loss if not treated.

Your doctor may want to see you more frequently and perform some tests if you have any of these conditions.

Talk to your doctor if you develop abdominal pain, nausea, vomiting, or diarrhoea after taking Olmetec Plus. Your doctor will decide whether to continue treatment. Do not stop taking Olmetec Plus on your own.

Olmetec Plus may cause increased levels of fats and uric acid (which causes gout – painful joint swelling) in the blood. Your doctor will likely perform blood tests from time to time to monitor these possible changes.

Changes in blood levels of certain chemicals called electrolytes may occur. Your doctor will likely perform blood tests periodically to monitor this possible change. Some signs of electrolyte imbalances include: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, sluggish, tired, drowsy, restless, nausea, vomiting, reduced need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

As with any other medicine that lowers blood pressure, an excessive drop in 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.

If you are scheduled for tests of parathyroid function, you must stop taking Olmetec Plus before the tests are performed.

Athletes should be aware that this medicine contains a component (hydrochlorothiazide) that may result in a positive analytical finding in doping controls.

Tell your doctor if you are pregnant or think you might be pregnant. Use of Olmetec Plus is not recommended in early 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).

Children and adolescents

Olmetec Plus is not recommended for children and adolescents under 18 years of age.

Use of Olmetec Plus with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• Other blood pressure-lowering medicines (antihypertensives), as they may enhance the effect of Olmetec Plus.

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

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

• Medicines that may alter potassium levels in the blood when used together with Olmetec Plus. These include:

• Potassium supplements (as well as salt substitutes containing potassium).

• Medicines that increase urine output (diuretics).

• Heparin (a blood thinner).

• Laxatives.

• Steroids.

• Adrenocorticotropic hormone (ACTH).

• Carbenoxolone (a medicine used to treat mouth and stomach ulcers).

• Sodium penicillin G (an antibiotic also known as sodium benzylpenicillin).

• Some painkillers such as aspirin or salicylates.

  • Lithium (a medicine used to treat mood disorders and certain types of depression) may have increased toxicity when used with Olmetec Plus. If you need to take lithium, your doctor will monitor lithium blood levels.
  • Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), when used together with Olmetec Plus, may increase the risk of kidney failure and reduce the effect of Olmetec Plus.
  • Sleeping pills, sedatives, and antidepressants used with Olmetec Plus may cause a sudden drop in blood pressure upon standing.
  • Certain muscle relaxants such as baclofen and tubocurarine.
  • Amifostine and other cancer treatments such as cyclophosphamide or methotrexate.
  • Cholestyramine and colestipol, medicines used to lower blood fat levels.
  • Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, which may reduce the effect of Olmetec Plus. Your doctor may advise you to take Olmetec Plus at least 4 hours before colesevelam hydrochloride.
  • Anticholinergic medicines such as atropine and biperiden.
  • Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.
  • Certain medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis, used to treat heart problems.
  • Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or injectable erythromycin, which may alter heart rhythm.

• Oral antidiabetic medicines such as metformin, or insulin, used to lower blood sugar levels.

• Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood sugar, respectively, as Olmetec Plus may intensify the blood sugar-raising effect of these medicines.

• Methyldopa, a medicine used to treat high blood pressure.

• Medicines such as noradrenaline, used to increase blood pressure and reduce heart rate.

• Difemethane, used to treat slow heartbeat or reduce sweating.

• Medicines such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.

• Calcium supplements.

• Amantadine, an antiviral medicine.

• Cyclosporine, a medicine used to prevent organ transplant rejection.

• Antibiotics from the tetracycline group or sparfloxacin.

• Amphotericin, a medicine used to treat fungal infections.

• Some antacids used to treat excess stomach acid, such as aluminium and magnesium hydroxide, which may slightly reduce the effect of Olmetec Plus.

• Cisapride, used to increase stomach and intestinal motility.

• Halofantrine, used to treat malaria.

Taking Olmetec Plus with food and drink

Olmetec Plus can be taken with or without food.

Be cautious when drinking alcohol while taking Olmetec Plus, as some people may feel weak or dizzy. If this happens, avoid alcohol, including wine, beer, or alcoholic soft drinks.

Patients of Black race

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

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, think you might be pregnant, or are planning to become pregnant. Your doctor will advise you to stop taking Olmetec Plus before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of Olmetec Plus is not recommended during pregnancy, and must not be taken after the first 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 planning to breastfeed. Olmetec Plus is not recommended for breastfeeding mothers, and your doctor may choose a different treatment if you wish to breastfeed.

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.

Use in athletes

Athletes should be aware that this medicine contains a component (hydrochlorothiazide) that may result in a positive analytical finding in doping controls.

Driving and using machines

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

Olmetec Plus contains lactose

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

3. How to take Olmetec Plus

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

Recommended dose: The recommended dose is 1 tablet of Olmetec Plus 40 mg/12.5 mg once daily. If blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet of Olmetec Plus 40 mg/25 mg once daily.

Take the tablets with water. If possible, take your dose at the same time each day, for example, with breakfast. It is important that you continue taking Olmetec Plus until your doctor tells you to stop.

If you take more Olmetec Plus than you should

If you take more tablets than you should, or if a child accidentally ingests one or more tablets, contact your doctor immediately or go to the nearest hospital emergency department, and take the medicine package with you.

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

If you forget to take Olmetec Plus

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

If you stop taking Olmetec Plus

It is important to continue taking Olmetec Plus unless your doctor tells you to stop treatment.

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.

However, the following adverse effects may be serious:

• Rarely, allergic reactions may occur that can affect the whole body, with swelling of the face, mouth and/or larynx, together with itching and skin rash. If this happens to you, stop taking Olmetec Plus and consult your doctor immediately.

• Olmetec Plus may cause a marked drop in blood pressure in susceptible patients or as a result of an allergic reaction. Fainting or dizziness may occur infrequently. If this happens, stop taking Olmetec Plus, 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 Olmetec Plus some time ago—contact your doctor immediately. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

Olmetec Plus is a combination of two active substances. The following information first describes the adverse effects reported so far with the Olmetec Plus combination (in addition to those already mentioned), and secondly, the known adverse effects of each of the two active substances when used separately.

These are other known adverse effects reported so far with Olmetec Plus:

If these effects occur, they are often mild and you do not need to stop treatment.

Frequent adverse effects (may affect up to 1 in 10 people):

Dizziness, weakness, headache, fatigue, chest pain, swelling of ankles, feet, legs, hands or arms.

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

Rapid and strong heartbeat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps and muscle pain, joint pain, pain in arms and legs, back pain, erectile dysfunction in men, blood in urine.

Uncommonly, the following changes in blood test results have also been observed:

Increased levels of fat in the blood, increased blood urea or uric acid, increased creatinine, increased or decreased blood potassium levels, increased blood calcium levels, increased blood sugar levels, increased liver function test values. Your doctor will monitor you with a blood test and advise you whether any action is needed.

Rare adverse effects (may affect up to 1 in 1,000 people):

Feeling unwell, disturbances in consciousness, skin swelling (hives), acute kidney failure.

Rarely, the following changes in blood test results have also been observed:

Increased blood urea nitrogen, decreased hemoglobin and hematocrit values. Your doctor will monitor you with a blood test and advise you whether any action is needed.

Additional adverse effects reported with olmesartan medoxomil or hydrochlorothiazide used alone, but not with Olmetec Plus or at a higher frequency:

Olmesartan medoxomil:

Frequent adverse effects (may affect up to 1 in 10 people):

Bronchitis, cough, nasal congestion and discharge, sore throat, abdominal pain, indigestion, diarrhea, nausea, gastroenteritis, joint or bone pain, back pain, blood in urine, urinary tract infection, flu-like symptoms, pain.

Frequently observed changes in blood test results include:

Increased levels of fat in the blood, increased blood urea or uric acid, increased liver or muscle enzyme levels.

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

Rapid allergic reactions affecting the whole body, which may cause breathing difficulties and a rapid drop in blood pressure that may even lead to fainting (anaphylactic reactions), facial swelling, angina (chest pain or discomfort, known as angina pectoris), feeling unwell, allergic skin rash, itching, exanthema (skin rash), skin swelling (hives).

Uncommonly, the following changes in blood test results have been observed:

Reduction in the number of a type of blood cells called platelets (thrombocytopenia).

Rare adverse effects (may affect up to 1 in 1,000 people):

Worsening of kidney function, lack of energy, intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Rarely, the following changes in blood test results have been observed:

Increased potassium levels in blood.

Hydrochlorothiazide:

Very frequent adverse effects (may affect more than 1 in 10 people):

Changes in blood tests including: increased blood fat levels and increased uric acid levels.

Frequent adverse effects (may affect up to 1 in 10 people):

Confusion, abdominal pain, stomach discomfort, bloating sensation, diarrhea, nausea, vomiting, constipation, glucose excretion in urine.

Changes in blood test results include:

Increased levels of creatinine, urea, calcium, and blood sugar, decreased levels of chloride, potassium, magnesium, and sodium in blood. Increased serum amylase (hyperamylasemia).

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

Decreased or loss of appetite, severe difficulty breathing, skin anaphylactic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, photosensitivity skin reactions, itching, purple spots or dots on the skin due to minor bleeding (purpura), skin swelling (hives).

Rare adverse effects (may affect up to 1 in 1,000 people):

Inflammation and pain of the salivary glands, decreased number of white blood cells, decreased number of blood platelets, anaemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures, yellowish perception of objects when looking at them, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, gallbladder infection, symptoms of systemic lupus erythematosus such as skin rash, joint pain, and coldness in hands and fingers, skin allergic reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes causing movement disturbances).

Very rare adverse effects (may affect up to 1 in 10,000 people):

Electrolyte imbalance that may cause abnormally low chloride levels in blood (hypochloremic alkalosis), intestinal obstruction (paralytic ileus).

Acute breathing difficulty (signs include severe breathing difficulty, fever, weakness, and confusion).

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

Decreased vision or eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

Skin and lip cancer (non-melanoma skin cancer).

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 can 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 Olmetec Plus

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

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmetec Plus

The active substances are:

Olmetec Plus 40 mg/12.5 mg: each film-coated tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.

The other components are: microcrystalline cellulose, lactose monohydrate*, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, titanium dioxide (E171), talc, hypromellose and iron (III) oxides (E172).

• See previous section “Olmetec Plus contains lactose”

Appearance of the product and contents of the pack

Olmetec Plus 40 mg/12.5 mg film-coated tablets are yellowish-red, oval tablets, 15 x 7 mm, with the imprint “C23” on one side.

Olmetec Plus film-coated tablets are available in packs of 14, 28, 30, 56, 84, 90, 98, 10 x 28 and 10 x 30 tablets, and in packs with single-dose perforated blisters containing 10, 50 and 500 tablets.

Not all pack sizes are marketed.

Marketing Authorization Holder

DAIICHI SANKYO ESPAÑA, S.A.

Paseo del Club Deportivo nº1,

Edificio 14, Planta baja izquierda

28223 Pozuelo de Alarcón – Madrid

Spain

Manufacturer

DAIICHI SANKYO EUROPE GmbH

Luitpoldstrasse 1

85276 Pfaffenhofen

Germany

or

BERLIN-CHEMIE AG

Glienicker Weg 125,

12489 Berlin

Germany

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

Austria: Olmetec Plus
Belgium: Olmetec Plus
Denmark: Olmetec Plus
Germany: Olmetec Plus
Greece: Olmetec Plus
Finland: Olmetec Plus
France: CoOlmetec
Iceland: Olmetec Plus
Ireland: Benetor Plus
Italy: Olmegan
Luxembourg: Olmetec Plus
Netherlands: Olmetec HCTZ
Norway: Olmetec Comp
Portugal: Olmetec Plus
Spain: Olmetec Plus
United Kingdom: Olmetec Plus

Date of the most recent review of this summary: January 2025.

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es/.