Label: information for the user

Olmetec Plus 20 mg/12.5 mg film-coated tablets

Olmesartan medoxomil / Hydrochlorothiazide

Read this label carefully before starting to take this medicine, because it contains important information for you.

-Keep this label, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribedonlyto you, and you must not give it to others even if they have the same symptomsas you, as it may harm them.

-Ifyou experienceadverse effects, consult your doctor or pharmacist,even if they are not listed in this label. See section 4.

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

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

• Hydrochlorothiazide belongs to a group of medications called thiazide diuretics. It reduces blood pressure by contributing to the elimination of excess fluids, increasing urine production by the kidneys.

Olmetec Plus will only be given if treatment with Olmetec (olmesartan medoxomil) alone has not adequately controlled your blood pressure. The concurrent administration of both active substances in Olmetec Plus contributes to reducing blood pressure more than if each substance were administered alone.

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

High blood pressure can be controlled with medications like Olmetec Plus tablets. Your doctor has probably also recommended that you make some lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol consumption and reducing the amount of salt in your diet). Your doctor may also have recommended that you engage in regular exercise, such as walking or swimming. It is essential to follow your doctor's advice.

Do not take Olmetec Plus

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide, or to any of the other components of this medication (listed in section 6) or to substances similar to hydrochlorothiazide (sulfonamides).
• If you are more than 3 months pregnant. (It is also best to avoid Olmetec Plus at the beginning of pregnancy - see Pregnancy section).
• If you have severe kidney problems.
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains 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 severe liver problems, or yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, by gallstones).

If you think you have any of these conditions, or 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 medications used to treat high blood pressure (hypertension):

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

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels in the blood (such as 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 heart valves or heart muscle.
• Severe vomiting (feeling dizzy) or diarrhea, that is severe or lasts for several days.
• Treatment with high doses of medications that increase urine production (diuretics), or if you are on a low-salt diet.
• Problems with the adrenal glands (for example, 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, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from the sun and UV rays while taking Olmetec Plus.
• If you have had respiratory or pulmonary problems (such as 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.

Contact your doctor if you experienceany of the following symptoms:

• Severe, persistent diarrhea that causes significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your blood pressure treatment.
• Decreased vision or eye pain. These may be symptoms offluid accumulation in the vascular layer of the eye (choroidal effusion) orincreased pressure in the eye and may occur from a few hours to several weeks after taking Olmetec Plus. This can lead to permanent vision loss if not treated.

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

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

There may be a change in blood levels of certain chemical substances called electrolytes. Your doctor will probably want to perform blood tests 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 weak, slow, tired, drowsy, or restless, nausea, vomiting, decreased need to urinate, rapid heart rate.Tell your doctor if you notice any of these symptoms.

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

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

It is reported to athletes that this medication contains a component that may establish a positive analytical result for doping control.

Inform your doctor if you are pregnant or think you may be pregnant. Olmetec Plus is not recommended for use at the beginning of pregnancy, and it should 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 Pregnancy section).

Children and adolescents

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

Use of Olmetec Plus with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Particularly, inform your doctor or pharmacist about any of the following medications:

• Other blood pressure-lowering medications (anti-hypertensives), as they may increase 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 the information under the headings “Do not take Olmetec Plus” and “Warnings and precautions”).

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

-Potassium supplements (as well as salt substitutes that contain potassium).

-Medications that increase urine production (diuretics).

-Heparin (to thin the blood).

-Laxatives.

-Glucocorticoids.

-Adrenocorticotropic hormone (ACTH).

-Carbenoxolone (medication for the treatment of mouth and stomach ulcers).

-Penicillin G sodium (antibiotic also called benzylpenicillin sodium).

-Some analgesics such as aspirin or salicylates.

• Lithium (medication used to treat mood changes and some types of depression) if used at the same time as Olmetec Plus may increase its toxicity. If you need to take lithium, your doctor will measure your lithium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as Olmetec Plus may increase the risk of kidney failure and reduce the effect of Olmetec Plus.
• Sedatives, hypnotics, and antidepressants, used with Olmetec Plus may cause a sudden drop in blood pressure when standing up.
• Some medications such as baclofen and tubocurarine, used as muscle relaxants.
• Amifostine and other medications used to treat cancer, such as cyclophosphamide or methotrexate.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may reduce the effect of Olmetec Plus. Your doctor may advise you to take Olmetec Plus at least 4 hours before colesevelam hydrochloride.
• Colestiramine and colestipol, medications to lower blood fat levels.
• Anticholinergic medications, such as atropine and biperiden.
• Medications such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.
• Some medications such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digital, used to treat heart problems.
• Medications such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injectables, that may change heart rhythm.

• Oral antidiabetic medications, such as metformin, or insulin, used to lower blood sugar levels.
• Beta-blockers and diazoxide, medications used to treat high blood pressure or low blood sugar levels, respectively, as Olmetec Plus may intensify the effect of increasing blood sugar levels produced by these medications.
• Metildopa, a medication used to treat high blood pressure.
• Medications such as noradrenaline, used to increase blood pressure and decrease heart rate.
• Difemanil, used to treat slow heart rate or reduce sweating.
• Medications such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.
• Calcium supplements.
• Amantadine, an antiviral medication.
• Ciclosporin, a medication used to prevent organ transplant rejection.
• Antibiotics in the tetracycline group, or enoxacin.
• Amphotericin, a medication used to treat fungal infections.
• Some antacids, used to treat excess stomach acid, such as aluminum hydroxide and magnesium, as they may slightly reduce the effect of Olmetec Plus.
• Cisapride, used to increase stomach and intestinal movement.
• Halofantrine, used to treat malaria.

Taking Olmetec Plus with food and drinks

Olmetec Plus can be taken with or without food.

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

Black patients

Like other similar medications, the blood pressure-lowering effect of Olmetec Plus is somewhat less in black patients.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, (or if you suspect you may be). Your doctor will usually recommend that you stop taking Olmetec Plus before becoming pregnant or as soon as you know you are pregnant, and will recommend that you take another medication instead of Olmetec Plus. Olmetec Plus is not recommended for use during pregnancy, and in any case should not be administered after the third month of pregnancy, as it may cause serious harm to your baby if taken at this stage.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Olmetec Plus is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you want 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 medication.

Use in athletes

It is reported to athletes that this medication contains a component (hydrochlorothiazide) that may establish a positive analytical result for doping control.

Driving and operating machines

You may feel drowsy or dizzy while taking blood pressure medication. If this happens, do not drive or operate machines until the symptoms have disappeared. Consult your doctor.

Olmetec Plus contains lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended doseis 1 Olmetec Plus 20 mg/12.5 mg tablet per day. If blood pressure is not adequately controlled, your doctor may change the dose to 1 Olmetec Plus 20 mg/25 mg tablet per day.

Take the tablets with water. If possible, take your doseat the same time every day, for example, at breakfast time. It is essential to 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 take or if a child accidentally ingests one or more tablets, contact your doctor immediately or go to the nearest hospital emergency center and bring the medication packaging with you.

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

If you forget to take Olmetec Plus

If you forget to take a daily dose, take the usual dose the next day.Do nottake a double dose to compensate for the missed doses.

If you interrupt treatment with Olmetec Plus

It is essential to continue taking Olmetec Plus, unless your doctor tells you to stop.

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.

However, the following side effects can be serious:

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

• Olmetec Plus can cause a significant drop in blood pressure in susceptible patients or as a result of an allergic reaction. Less frequently, dizziness or fainting can occur.If this happens, 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 taking Olmetec Plus a long time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue with the treatment for high blood pressure.

Olmetec Plus is a combination of two active principles. The following information, first, describes the side effects reported so far with the combination Olmetec Plus (in addition to those already mentioned) and, second, the known side effects of the two active principles separately.

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

If these effects occur, they are often mild anddo not need to interrupt treatment.

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

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

Less frequent side effects (can affect up to 1 in 100 people):

Fast and intense heartbeat (palpitations), hives, eczema, dizziness, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps and muscle pain, joint pain, arm and leg pain, back pain, erectile dysfunction in men, blood in urine.

Also, some changes in blood tests have been observed, including:

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

Rare side effects (can affect up to 1 in 1,000 people):

Unpleasant sensation,altered consciousness, skin swelling (hives), acute kidney failure.

Also, some changes in blood test results have been observed, including:

Increased urea levels in the blood, decreased values of hemoglobin and hematocrit. Your doctor will monitor you through a blood test and tell you if you need to take any measures.

Additional side effects reported with the use of olmesartan medoxomil or hydrochlorothiazide alone, but not with Olmetec Plus or in a higher frequency:

Olmesartan medoxomil:

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

Bronchitis, cough, congestion and nasal 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.

Also, some changes in blood test results have been observed, including:

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

Less frequent side effects (can affect up to 1 in 100 people):

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

Also, some changes in blood test results have been observed, including:

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

Rare side effects (can affect up to 1 in 1,000 people):

Renal function deterioration, lack of energy.

Also, some changes in blood test results have been observed, including:

Increased potassium levels in the blood

Hydrochlorothiazide:

Very frequent side effects (can affect more than 1 in 10 people):

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

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

Confusion, abdominal pain, stomach discomfort, feeling of swelling, diarrhea, nausea, vomiting, constipation, glucose excretion in urine.

Also, some changes in blood test results have been observed, including:

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

Less frequent side effects (can affect up to 1 in 100 people):

Loss of appetite, severe difficulty breathing, skin allergic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, skin reactions to light sensitivity, itching, purple spots on the skin due to small hemorrhages (purpura), skin swelling (hives).

Rare side effects (can affect up to 1 in 1,000 people):

Salivary gland inflammation and pain, 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, gallbladder infection, symptoms of lupus erythematosus such as skin rash, joint pain and cold hands and fingers, skin allergic reactions, skin peeling and blistering, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which sometimes causes movement alteration).

Very rare side effects (can affect up to 1 in 10,000 people):

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

Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness and confusion).

Unknown side effects (the frequencycannot be estimated from the available data):

Decreased vision or eye pain (possible signs offluid accumulation in the vascular layer of the eye (choroidal hemorrhage) oracute angle-closure glaucoma).

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

Reporting of 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 leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products 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.

No special storage conditions are required.

Do not use this medication 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.

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 point of your 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 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*, hypromellose, low-substitution 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 contents of the package

Olmetec Plus 20 mg/12.5 mg is presented in the form of film-coated tablets, yellow-brown in color, round, 8.5 mm in diameter, 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 pre-cut single-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,

Building 14, Ground floor left

28223 Pozuelo de Alarcón – Madrid

Spain

Responsible for manufacturing

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 medicinal product is authorized in the member states of the European Economic Area with the following names:

Austria: Olmetec Plus

Belgium: Olmetec Plus

Denmark: Olmetec Plus

Germany: Olmetec Plus

Greece: Olmetec Plus

Finland: Olmetec Plus

France: CoOlmetec

Island: 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

Last review date of this leaflet:March 2022

Other sources of information

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