Label: information for the user

Olmetec Plus 40 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 questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

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

• Olmesartan medoxomilo 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 medoxomilo) alone has not adequately controlled your blood pressure. The concurrent administration of both active ingredients in Olmetec Plus contributes to reducing blood pressure more than if each active ingredient 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 may also have 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 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 best to avoid Olmetec Plus at the start of pregnancy - see Pregnancy section).
• If you have kidney problems.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• If you have low levels of potassium or sodium in your blood, high levels of calcium or uric acid in your blood (with symptoms of gout or kidney stones), that do not improve with treatment.
• If you have moderate or severe liver problems, or yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, due to gallstones).

If you think any of these apply to you, 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 medicines 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 check your kidney function, blood pressure, and levels of electrolytes in your 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:

• Transplant of the kidney.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Vomiting (feeling dizzy) or diarrhoea, that is severe or lasts for several days.
• Treatment with high doses of medicines that increase the elimination of urine (diuretics), or if you are on a low-salt diet.
• Problems with the adrenal glands (for example, primary aldosteronism).
• 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. The 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, see your doctor immediately.

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

• Severe, persistent diarrhoea that causes significant weight loss. Your doctor will assess your symptoms and decide how to continue your treatment for high blood pressure.
• Decreased vision or eye pain. These may 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 several weeks after taking Olmetec Plus. This may lead to permanent vision loss if not treated.

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

Olmetec Plus may cause an increase in levels of lipids and uric acid in the blood. Your doctor will probably want to do a blood test from time to time to check for these possible changes.

You may experience a change in the levels of certain substances in your blood called electrolytes. Your doctor will probably want to do a blood test from time to time to check for 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, vomiting, decreased need to urinate, rapid heart rate.Tell your doctor if you notice any of these symptoms.

As with any other medicine that lowers blood pressure, an excessive decrease in blood pressure in patients with impaired blood flow to the heart or brain may cause a heart attack or stroke. Your doctor will carefully monitor your blood pressure.

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

It is reported to athletes that this medicine 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 start 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 during this period (see Pregnancy section).

Children and adolescents

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

Use of Olmetec Plus with other medicines

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

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

• Other blood pressure-lowering medicines (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”).

• Medicines 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).

-Medicines that increase the elimination of urine (diuretics).

-Heparin (to thin the blood).

-Laxatives.

-Glucocorticoids.

-Adrenocorticotropic hormone (ACTH).

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

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

-Some analgesics such as aspirin or salicylates.

• Lithium (medicine 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 have to take lithium, your doctor will measure the levels of lithium in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines 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 and antidepressants, used with Olmetec Plus may cause a sudden drop in blood pressure when standing up.
• Some medicines such as baclofen and tubocurarine, used as muscle relaxants.
• Amifostine and other medicines used to treat cancer, such as cyclophosphamide or methotrexate.
• Colestiramine and colestipol, medicines to reduce levels of fat in the blood.
• Colesevelam hydrochloride, a medicine that reduces the level of cholesterol 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.
• Anticholinergic medicines, such as atropine and biperiden.
• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol or haloperidol, used to treat certain psychiatric disorders.
• Some medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol or digital, used to treat heart problems.
• Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide or erythromycin injectables, that may change heart rhythm.

• Oral anti-diabetic medicines, such as metformin, or insulin, used to reduce levels of sugar in the blood.
• Beta-blockers and diazoxide, medicines used to treat high blood pressure or low levels of sugar in the blood, respectively, as Olmetec Plus may intensify the effect of increasing sugar in the blood produced by these medicines.
• Metildopa, 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.
• Ciclosporin, a medicine used to prevent rejection of transplanted organs.
• Antibiotics of the tetracycline group or ciprofloxacin.
• Amphotericin, a medicine used to treat fungal infections.
• Some antacids, used to treat excess stomach acid, such as aluminium and magnesium hydroxide, as they may slightly reduce the effect of Olmetec Plus.
• Cisapride, used to increase movement of food in the stomach and intestine.
• 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 fizzy drinks with alcohol.

Black patients

As with other similar medicines, 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 think you may be 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 advise you to take another medicine instead of Olmetec Plus. Olmetec Plus is not recommended for use during 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 during this period.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to start breastfeeding. Olmetec Plus is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment if you wish to breastfeed.

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

Use in athletes

It is reported to athletes that this medicine 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 Olmetec Plus for high blood pressure. If this happens, do not drive or operate 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 certain sugars, consult with them before taking this medicine.

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 40 mg/12.5 mg tablet per day. If blood pressure is not adequately controlled, your doctor may change the dose to 1 Olmetec Plus 40 mg/25 mg tablet per day.

Take the tablets with water. If possible, take your dose at the same time each day, for example, with breakfast. 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 department and bring the medication packaging with you.

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

If you forget to take Olmetec Plus

If you forget to take a 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 may cause side effects, although not everyone will experience them.

However, the following side effects may be serious:

• In rare cases, an allergic reaction 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, stop taking Olmetec Plus and consult your doctor immediately.

• In sensitive individuals or as a result of an allergic reaction, Olmetec Plus may cause blood pressure to drop too low. Infrequently, dizziness or fainting may 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 some 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 (may affect up to 1 in 10 people):

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

Rare side effects (may 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, increased or decreased levels of potassium in the blood, increased levels of calcium in the blood, increased blood sugar, 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 (may affect up to 1 in 1,000 people):

Unpleasant sensation, alterations in consciousness, skin swelling (hives), acute renal insufficiency.

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

Increased urea 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 more frequently:

Olmesartan medoxomil:

Frequent side effects (may 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 levels of liver or muscle function.

Rare side effects (may affect up to 1 in 100 people):

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

Hydrochlorothiazide:

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

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

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

Rare side effects (may affect up to 1 in 100 people):

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

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

Salivary gland inflammation and pain, decreased white blood cell count, decreased platelet count in the blood, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures, yellow vision, 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 (may 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 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 Pharmacovigilance of Medicines 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 unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Olmetec Plus

The active principles 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-substitution hypromellose, hypromellose, magnesium stearate, titanium dioxide (E171), talc, hypromellose, and iron(III) oxides (E172).

* See previous section “Olmetec Plus contains lactose”“Olmetec Plus contains lactose”

Appearance of the product and contents of the package

Olmetec Plus 40 mg/12.5 mg film-coated tablets are yellow-orange, oval-shaped, 15 x 7 mm tablets with the inscription “C23” on one face.

Olmetec Plus film-coated tablets are available in packages of 14, 28, 30, 56, 84, 90, 98, 10 x 28, and 10 x 30 tablets, and in blister packs 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, 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,

12489 Berlin

Germany

This medicine 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 medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/