OLMETEC PLUS 20 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olmetec Plus 20 mg/12.5 mg Film-Coated Tablets

Olmesartan Medoxomil / Hydrochlorothiazide

Read all of 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 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 Package Leaflet

1. What is Olmetec Plus and what is it used for
2. What you need to know before you take Olmetec Plus
3. How to take Olmetec Plus
4. Possible side effects
5. Storing Olmetec Plus
6. Package Contents and Additional Information

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

Olmetec Plus contains two active substances, olmesartan medoxomil and hydrochlorothiazide, which are used to treat 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 kidneys to remove excess fluid from the body, increasing urine production.

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

You may already be taking medicines to treat high blood pressure, but your doctor may think it is 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 has probably also advised you to make some changes to your lifestyle to help lower your blood pressure (e.g., losing weight, stopping smoking, reducing alcohol consumption, and reducing the amount of salt in your diet). Your doctor may have also advised you to take regular exercise, such as walking or swimming. It is important to follow your doctor's advice.

2. What you need to know before you take Olmetec Plus

Do not take Olmetec Plus

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6) or to sulphonamide-derived medicines.
• If you are more than 3 months pregnant. (It is also better to avoid Olmetec Plus at the start of pregnancy - see section Pregnancy).
• If you have severe kidney problems.
• If you have diabetes or kidney problems and are being treated with a blood pressure medicine containing aliskiren.
• If you have low potassium or sodium levels, high calcium or uric acid levels in your blood (with symptoms of gout or kidney stones), which do not improve with treatment.
• If you have severe liver problems, or yellowing of the skin and eyes (jaundice), or problems with the drainage of bile from the gallbladder (bile duct obstruction, e.g., due to gallstones).

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

Warnings and precautions

Consult your doctor before starting to use Olmetec Plus.

Before taking the tablets, 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 associated with diabetes.
• Aliskiren.

Your doctor may want to 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 Olmetec Plus”.

Before taking the tablets, tell your doctorif you have any of the following health problems:

• Mild to moderate kidney problems or if you have recently had a kidney transplant.
• Liver disease.
• Heart failure or problems with the heart valves or heart muscle.
• Vomiting (feeling sick) or diarrhea, which is severe or lasts for several days.
• Treatment with high doses of diuretics (water tablets) or if you are on a low-salt diet.
• Problems with the adrenal glands (e.g., primary hyperaldosteronism).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• If you have had skin cancer or if you 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 had respiratory or lung problems (e.g., inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Olmetec Plus, seek medical attention immediately.

Consult your doctorif you experience any of the following symptoms:

• Severe, persistent diarrhea that causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.
• Decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, and may occur from a few hours to a few weeks after taking Olmetec Plus. This can lead to permanent vision impairment if left untreated.

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

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea 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 an increase in blood fat and uric acid levels (which can cause gout - painful swelling of the joints). Your doctor will probably want to perform a blood test from time to time to monitor these possible changes.

A change in blood electrolyte levels may occur. Your doctor will probably want to perform a blood test from time to time to monitor this possible change. Some signs of electrolyte changes are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling of weakness, slowness, tiredness, drowsiness or restlessness, nausea, vomiting, decreased need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

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.

If you are going to have parathyroid function tests, you should stop taking Olmetec Plus before these tests are performed.

Athletes are informed that this medicine contains a component (hydrochlorothiazide) that may result in a positive doping test.

You must inform your doctor if you are pregnant or think you might be. Olmetec Plus is not recommended during pregnancy, and must not be taken 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).

Children and Adolescents

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

Using Olmetec Plus with Other Medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use 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 increase the effect of Olmetec Plus.

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 Olmetec Plus” and “Warnings and precautions”).

• Medicines that may alter potassium levels in the blood when used at the same time as Olmetec Plus. These include:

• Potassium supplements (as well as salt substitutes containing potassium).
• Diuretics (water tablets).
• Heparin (to thin the blood).
• Laxatives.
• Corticosteroids.
• Adrenocorticotropic hormone (ACTH).
• Carbenoxolone (a medicine for treating mouth and stomach ulcers).
• Sodium penicillin G (an antibiotic also known as benzylpenicillin sodium).
• Certain painkillers such as aspirin or salicylates.
• Lithium (a medicine used to treat mood changes and some types of depression) may have its toxicity increased if taken at the same time as Olmetec Plus. If you have to take lithium, your doctor will measure lithium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) may increase the risk of kidney problems and reduce the effect of Olmetec Plus when used at the same time.
• Sedatives, hypnotics, and antidepressants used with Olmetec Plus may cause a sudden drop in blood pressure when standing up.
• Certain medicines such as baclofen and tubocurarine, used as muscle relaxants.
• Amifostine and other medicines used to treat cancer, such as cyclophosphamide or methotrexate.
• Colestyramine and colestipol, medicines used to lower blood fat levels.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of Olmetec Plus. Your doctor may advise you to take Olmetec Plus at least 4 hours before colestyramine.
• Anticholinergic medicines such as atropine and biperiden.
• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluperazine, cyanemazine, 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 erythromycin injections, which may change 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 levels, respectively, as Olmetec Plus may enhance the blood sugar-increasing 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.
• Difemanil, used to treat slow heart rate 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 of the tetracycline group or sparfloxacin.
• Amphotericin, a medicine used to treat fungal infections.
• Certain antacids, used to treat stomach acid excess, such as aluminum and magnesium hydroxide, as they may slightly reduce the effect of Olmetec Plus.
• Cisapride, used to increase food movement in the stomach and intestines.
• Halofantrine, used to treat malaria.

Taking Olmetec Plus with Food and Drink

Olmetec Plus can be taken with or without food.

Be careful when drinking alcohol while taking Olmetec Plus, as some people feel weak or dizzy. If this happens to you, do not drink any alcohol, including wine, beer, or alcoholic drinks.

Black Patients

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

Pregnancy and Breastfeeding

Pregnancy

You must inform your doctor if you are pregnant (or think you might be). Your doctor will generally advise you to stop taking Olmetec Plus before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Olmetec Plus. Olmetec Plus is not recommended during pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken after this time.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Olmetec Plus is not recommended during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed.

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Use in Athletes

Athletes are informed that this medicine contains a component (hydrochlorothiazide) that may result in a positive doping test.

Driving and Using Machines

You may feel drowsy or dizzy while being treated for high blood pressure. If this happens, do not drive or use machines until the symptoms have disappeared. Consult your doctor.

Olmetec Plus 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.

3. How to Take Olmetec Plus

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

Recommended Dose

The recommended dose is one Olmetec Plus 20 mg/12.5 mg tablet per day. If your blood pressure is not adequately controlled, your doctor may change the dose to one Olmetec Plus 20 mg/25 mg tablet per day.

Take the tablets with water. If possible, take your dose at the same time each day, e.g., at breakfast time. It is important that you continue to take 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 takes one or more 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, telephone 91 562 04 20, stating the medicine and the amount taken.

If You Forget to Take Olmetec Plus

If you forget to take a dose, take your normal dose the next day. Do nottake 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.

If you have any further questions on 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 all people suffer from them.

However, the following adverse effects can be serious:

• In rare cases, allergic reactions may occur that can affect the entire body, with inflammation of the face, mouth, and/or larynx, along with itching and skin rash. If this happens to you, stop taking Olmetec Plus and consult your doctor immediately.

• Olmetec Plus may cause a pronounced drop in blood pressure, in susceptible patients or as a result of an allergic reaction. Dizziness or fainting can occur infrequently. If this happens to you, stop taking Olmetec Plus, 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 Olmetec Plus a long time ago, contact your doctor immediatelywho will assess your symptoms and decide how to continue with blood pressure treatment.

Olmetec Plus is a combination of two active principles. 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 the two active principles separately.

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

If these effects occur, they are often mild and it is not necessary to interrupt treatment.

Common 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 intense heartbeat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps, and muscle pain, joint pain, arm and leg pain, back pain, erection problems in men, blood in urine.

Some changes in blood tests have also been observed infrequently, including:

Increased levels of fat in the blood, increased urea or uric acid in the blood, increased creatinine, increased or decreased potassium levels in the blood, increased calcium levels in the blood, increased blood sugar, increased liver function test values. Your doctor will monitor you with a blood test and tell you if you need to take any action.

Rare Adverse Effects (may affect up to 1 in 1,000 people):

Feeling of discomfort, alterations in consciousness, skin swelling (hives), acute kidney failure.

Some changes in blood test results have also been observed rarely, including:

Increased blood urea nitrogen, decreased hemoglobin and hematocrit values. Your doctor will monitor you with a blood test and tell you if you need to take any action.

Additional Adverse Effects Reported with the Use of Olmesartan Medoxomil or Hydrochlorothiazide Alone, but not with Olmetec Plus or at a Higher Frequency:

Olmesartan Medoxomil:

Common Adverse Effects (may affect up to 1 in 10 people):

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

Some changes in blood test results have also been observed frequently, including:

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

Uncommon Adverse Effects (may affect up to 1 in 100 people):

Rapid allergic reactions that can affect the entire body and cause breathing problems, as well as a rapid drop in blood pressure that can lead to fainting (anaphylactic reactions), facial inflammation, angina (chest pain or discomfort known as angina pectoris), feeling of discomfort, allergic skin rash, itching, exanthema (skin rash), skin swelling (hives).

Some changes in blood test results have also been observed infrequently, including:

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 that occurs with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Some changes in blood test results have also been observed rarely, including:

Increased potassium in the blood.

Hydrochlorothiazide:

Very Common Adverse Effects (may affect more than 1 in 10 people):

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

Common Adverse Effects (may affect up to 1 in 10 people):

Feeling of confusion, abdominal pain, stomach discomfort, feeling of bloating, diarrhea, nausea, vomiting, constipation, glucose excretion in urine.

Some changes in blood test results have also been observed, including:

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

Uncommon Adverse Effects (may affect up to 1 in 100 people):

Decreased or lost appetite, severe breathing difficulties, anaphylactic skin reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, skin reactions due to light sensitivity, itching, purple spots or patches on the skin due to small hemorrhages (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 platelets in the blood, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures (convulsions), 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, infection in the gallbladder, lupus erythematosus symptoms such as skin rash, joint pain, and cold hands and fingers, allergic skin reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which can sometimes cause movement disorders).

Very Rare Adverse Effects (may affect up to 1 in 10,000 people):

Electrolyte imbalance that can cause an abnormally reduced level of chloride in the blood (hypochloremic alkalosis), intestinal obstruction (paralytic ileus).

Acute respiratory distress (signs include severe breathing difficulties, fever, weakness, and confusion).

Unknown Adverse Effects (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 Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Olmetec Plus

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiration date that appears on the packaging and on the blister after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Olmetec Plus

The active ingredients are:

Olmetec Plus 20 mg/12.5 mg: each film-coated tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.

The other components (excipients) are: microcrystalline cellulose, lactose monohydrate*, low-substitution hypromellose, hypromellose, magnesium stearate, titanium dioxide (E 171), talc, hypromellose, and iron (III) oxides (E 172).

• See previous section "Olmetec Plus contains lactose"

Appearance of the Product and Package Contents

Olmetec Plus 20 mg/12.5 mg is presented in the form of film-coated tablets, yellow-red in color, round, 8.5 mm in size, with the inscription "C22" on one side.

Olmetec Plus film-coated tablets are presented in packages of 14, 28, 30, 56, 84, 90, 98, and 10 x 28 tablets, and in packages with precut unit-dose blisters of 10, 50, and 500 tablets.

Not all packages 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,

D-12489 Berlin

Germany

or

QUALIPHAR N.V.

Rijksweg 9, 2880 Bornem

Belgium

This medicine is authorized in the Member States of the European Economic Area 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 last revision of this prospectus: January 2025.

Other Sources of Information

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