Olmesartan/hydrochlorothiazide Stada 20 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Olmesartán/Hidroclorotiazida Stada 20 mg/12.5 mg film-coated tablets EFG

olmesartán medoxomilo / 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Olmesartán/Hidroclorotiazida Stada is and what it is used for

Olmesartán/Hidroclorotiazida Stada contains two active substances, olmesartán medoxomilo and hydrochlorothiazide, which are used in the treatment of high blood pressure (hypertension):

• Olmesartán medoxomilo 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.

You will only be given olmesartán/hydrochlorothiazide if treatment with olmesartán medoxomilo alone has not adequately controlled your blood pressure. The combined administration of both active substances in olmesartán/hydrochlorothiazide helps reduce blood pressure more than if each substance were given alone.

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

High blood pressure can be controlled with medicines such as olmesartán/hydrochlorothiazide tablets. Your doctor has likely also advised you to make certain lifestyle changes to help lower your blood pressure (e.g., lose weight, quit smoking, reduce alcohol consumption, and reduce 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 Olmesartán/Hidroclorotiazida Stada

DO NOT take Olmesartán/Hidroclorotiazida Stada:

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide, or to any of the other components of this medicine (listed in section 6), or to substances similar to hydrochlorothiazide (sulfonamides).
• If you are more than 3 months pregnant (olmesartan/hydrochlorothiazide is also best avoided at the beginning of pregnancy – see Pregnancy section).
• If you have severe kidney problems.
• If you have diabetes or kidney failure 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 severe liver problems, yellowing of the skin or 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 Olmesartán/Hidroclorotiazida Stada.

• 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 and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking olmesartan/hydrochlorothiazide.
• If you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking olmesartan/hydrochlorothiazide, see a doctor immediately.

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 Olmesartán/Hidroclorotiazida Stada”.

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

• 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.
• 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 the adrenal glands (e.g., primary hyperaldosteronism).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.

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.
• 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, which may occur from a few hours to several weeks after taking olmesartan/hydrochlorothiazide. This may lead to permanent vision loss if not treated. Your risk may be higher if you have previously had an allergy to penicillin or sulfonamides.

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

Consult your doctor if you develop abdominal pain, nausea, vomiting, or diarrhoea after taking olmesartan/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking olmesartan/hydrochlorothiazide on your own.

Olmesartan/hydrochlorothiazide may increase blood levels of fats and uric acid (which causes gout – painful swelling of the joints). 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 imbalance include: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, sluggish, tired, drowsy, or 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 should stop taking olmesartan/hydrochlorothiazide before these tests are performed.

Athletes should be aware that this medicine contains a component that may result in a positive doping test.

Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Use of olmesartan/hydrochlorothiazide is not recommended at the beginning of 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 Pregnancy section).

Children and adolescents

Olmesartan/hydrochlorothiazide is not recommended for children and adolescents under 18 years of age.

Other medicines and Olmesartán/Hidroclorotiazida Stada

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 olmesartan/hydrochlorothiazide.

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 Olmesartán/Hidroclorotiazida Stada” and “Warnings and precautions”).

• Medicines that may alter potassium levels in the blood when used together with olmesartan/hydrochlorothiazide. 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 together with olmesartan/hydrochlorothiazide. 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 olmesartan/hydrochlorothiazide, may increase the risk of kidney failure and reduce the effect of olmesartan/hydrochlorothiazide.
  • Sleeping pills, sedatives, and antidepressants, used together with olmesartan/hydrochlorothiazide, 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, as it may reduce the effect of olmesartan/hydrochlorothiazide. Your doctor may advise you to take Olmesartán/Hidroclorotiazida Stada 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 heart medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis.
  • 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, since olmesartan/hydrochlorothiazide may enhance their blood sugar-raising effect.
  • 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 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 (indigestion remedies) used to treat excess stomach acid, such as aluminium and magnesium hydroxide, as they may slightly reduce the effect of olmesartan/hydrochlorothiazide.
  • Cisapride, used to increase stomach and intestinal motility.
  • Halofantrine, used for malaria.

Taking Olmesartán/Hidroclorotiazida Stada with food, drinks, and alcohol

Olmesartan/hydrochlorothiazide can be taken with or without food.

Be cautious when drinking alcohol while taking olmesartan/hydrochlorothiazide, as some people may feel faint or dizzy. If this happens, avoid alcohol, including wine, beer, or alcoholic beverages.

Patients of Black race

As with other similar medicines, the blood pressure-lowering effect of olmesartan/hydrochlorothiazide is somewhat lower in patients of Black race.

Pregnancy and breastfeeding

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.

Pregnancy

Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking olmesartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Olmesartan/hydrochlorothiazide is not recommended at the beginning of pregnancy, and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby if taken from that point.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Use of olmesartan/hydrochlorothiazide during breastfeeding is not recommended, and your doctor may choose an alternative 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.

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.

Olmesartán/Hidroclorotiazida Stada 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 Olmesartán/Hidroclorotiazida Stada

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

The recommended dose is one tablet of Olmesartán/Hidroclorotiazida Stada 20 mg/12.5 mg daily. If blood pressure is not adequately controlled, your doctor may change the dose to one tablet of Olmesartán/Hidroclorotiazida Stada 20 mg/25 mg daily.

Swallow the tablets with water.

If possible, take your dose at the same time each day, e.g., with breakfast. It is important that you continue taking olmesartan/hydrochlorothiazide until your doctor tells you to stop.

If you take more Olmesartán/Hidroclorotiazida Stada than you should

If you take more tablets than prescribed, 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 medicine packaging with you.

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

If you forget to take Olmesartán/Hidroclorotiazida Stada

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

If you stop taking Olmesartán/Hidroclorotiazida Stada

It is important to continue taking olmesartan/hydrochlorothiazide unless your doctor tells you to stop.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

However, the following adverse effects may be serious and require urgent medical advice:

• In rare cases, allergic reactions may occur that can affect the entire body, with swelling of the face, mouth and/or larynx, together with itching and skin rash. If this happens to you, stop taking olmesartan/hydrochlorothiazide and consult your doctor immediately.
• Olmesartan/hydrochlorothiazide may cause too great a 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 olmesartan/hydrochlorothiazide, consult your doctor immediately, and remain lying down in a horizontal position.
• Very rare (may affect up to 1 in 10,000 people): Acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).
• Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you started treatment with olmesartan/hydrochlorothiazide some time ago, contact your doctor immediately, who will assess your symptoms and decide how to proceed with your blood pressure treatment.

Olmesartan/hydrochlorothiazide is a combination of two active substances. The following information first describes adverse effects reported so far with the olmesartan/hydrochlorothiazide 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 olmesartan/hydrochlorothiazide:

If these effects occur, they are often mild and you do not need to stop 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 or strong heartbeat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps, 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:

Increase in blood fat levels, increase in blood urea or uric acid, increase in creatinine, increase or decrease in blood potassium levels, increase in blood calcium levels, increase in blood glucose levels, increase in 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:

Increase in blood urea nitrogen, decrease in 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 in combination or at higher frequencies:

Olmesartan medoxomil:

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

Bronchitis, cough, nasal congestion or 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:

Increase in blood fat levels, increase in blood urea or uric acid, increase in liver or muscle function test values.

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 eruption), skin swelling (hives).

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

Reduction in the number of a type of blood cell 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 also been observed:

Increase in blood potassium levels.

Hydrochlorothiazide:

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

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

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

Feeling confused, abdominal pain, stomach discomfort, bloated feeling, diarrhea, nausea, vomiting, constipation, glucose excretion in urine (glucosuria).

Changes in blood test results include:

Increase in creatinine, urea, calcium, and blood glucose levels; decrease in blood chloride, potassium, magnesium, and sodium levels. Increase in serum amylase (hyperamylasemia).

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

Decreased or loss of appetite, severe difficulty breathing, anaphylactic skin reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, photosensitivity skin reactions, itching, purple spots or patches 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 (sialoadenitis), decrease in white blood cell count, decrease in platelet count, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness (paresthesia), seizures, yellowish 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 coldness in hands and fingers, skin allergic reactions, skin peeling and blistering, 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 blood chloride levels (hypochloremic alkalosis), intestinal obstruction (paralytic ileus).

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

Loss of vision or eye pain due to increased pressure (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 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 Olmesartan/Hydrochlorothiazide Stada

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 after “EXP”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartán/Hidroclorotiazida Stada

The active substances are olmesartan medoxomil and hydrochlorothiazide.

Each film-coated tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.

The other components are: monohydrate lactose, microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide (E 171) and yellow/red iron (III) oxides (E 172).

Appearance of the product and contents of the pack

Olmesartán/Hidroclorotiazida Stada 20 mg/12.5 mg are film-coated, beige-colored, round, biconvex tablets with a diameter of 8 mm.

The film-coated tablets are available in blister packs made of oPA-Al-PVC sealed with an aluminum foil, containing 10, 14, 28, 30, 56, 60, 84, 90, 98, 100, 112, 156 or 168 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona), Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain Olmesartán/Hidroclorotiazida Stada 20 mg /12.5 mg film-coated tablets EFG

Ireland Olmesartan/Hydrochlorothiazide Clonmel 20 mg/12.5 mg film-coated tablets

Portugal Olmesartan + Hydrochlorothiazide Ciclum

Date of the most recent review of this leaflet: January 2025

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