Olmesartan/hydrochlorothiazide Stada 40 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Olmesartán/Hidroclorotiazida Stada 40 mg/12.5 mg film-coated tablets EFG

olmesartán medoxomilo / hydrochlorothiazide

Read this entire 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 others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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 adverse effects
5. Storage of 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 either substance 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 may also have advised you to make certain lifestyle changes to help lower your blood pressure (e.g., lose weight, stop 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 Olmesartan/Hydrochlorothiazide Stada

DO NOT take Olmesartan/Hydrochlorothiazide Stada:

• 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 (sulphonamides).
• If you are more than 3 months pregnant (it is also best to avoid olmesartan/hydrochlorothiazide at the beginning of pregnancy – see Pregnancy section).
• If you have kidney problems.
• If you have diabetes or renal failure and are being treated with a blood pressure-lowering medicine containing 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, 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 taking Olmesartan/Hydrochlorothiazide 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 non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight 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, seek medical attention 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), especially 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 Olmesartan/Hydrochlorothiazide Stada”.

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

• Kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe or prolonged vomiting (with dizziness) or diarrhoea.
• Treatment with high doses of medicines that increase urine elimination (diuretics), or if you are on a low-salt diet.
• Problems with adrenal glands (e.g. primary hyperaldosteronism).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.

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 proceed with your blood pressure treatment.
• decreased vision or eye pain. These could be signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur from hours to weeks after taking olmesartan/hydrochlorothiazide. This may lead to permanent vision loss if untreated. Your risk may be higher if you have previously had an allergy to penicillin or sulphonamides.

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

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 levels of fats and uric acid (which causes gout – painful joint swelling) in the blood. Your doctor may want to 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 may want to perform blood tests periodically to monitor this possible change. Some signs of electrolyte imbalances include: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, sluggish, tired, drowsy 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, excessive lowering of blood pressure in patients with impaired blood flow to the heart or brain may lead to heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are scheduled for parathyroid function tests, you should stop taking olmesartan/hydrochlorothiazide before the tests are performed.

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

Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. The 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 during 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 Olmesartan/Hydrochlorothiazide Stada

Inform 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 Olmesartan/Hydrochlorothiazide Stada” and “Warnings and precautions”).

• Medicines that may increase potassium levels in blood when used together with olmesartan/hydrochlorothiazide. These include:

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

• Medicines that increase urine elimination (diuretics)

• Heparin (a blood thinner)

• Laxatives

• Steroids

• Adrenocorticotropic hormone (ACTH)

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

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

• Some painkillers such as aspirin or salicylates

  • Lithium (a medicine used to treat mood disorders and certain types of depression) may have increased toxicity when used with olmesartan/hydrochlorothiazide. If you need to take lithium, your doctor will monitor lithium levels in your blood.
  • 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 effectiveness of olmesartan/hydrochlorothiazide.
  • Sleeping pills, sedatives, and antidepressants, when used 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, which may reduce the effect of olmesartan/hydrochlorothiazide. Your doctor may advise you to take olmesartan/hydrochlorothiazide 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 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 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, which may slightly reduce the effect of olmesartan/hydrochlorothiazide.
  • Cisapride, used to increase movement of food through the stomach and intestine.
  • Halofantrine, used to treat malaria.

Taking Olmesartan/Hydrochlorothiazide 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 soft drinks.

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

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. The use of olmesartan/hydrochlorothiazide is not recommended during 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 stage.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. The use of olmesartan/hydrochlorothiazide is not recommended during breastfeeding, 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 undergoing treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

Olmesartan/Hydrochlorothiazide Stada contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him 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 40 mg/12.5 mg daily. If blood pressure is not adequately controlled, your doctor may increase the dose to one tablet of Olmesartán/Hidroclorotiazida Stada 40 mg/25 mg daily.

Swallow the tablets with water. The tablet's score mark must not be used to divide the tablet.

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 swallows 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 Poison Information Service immediately at telephone number 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 forgotten 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 can be serious and require urgent medical advice:

• Rarely, allergic reactions affecting the whole body may occur, 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 an excessive 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. Your doctor 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 combination olmesartan/hydrochlorothiazide (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 pounding 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:

Increased blood fat levels, increased blood urea or uric acid, increased creatinine, increased or decreased blood potassium levels, increased blood calcium levels, increased blood sugar levels, increased liver function test values.

Your doctor will monitor you with a blood test and advise you whether any action is needed.

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

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

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

Increased blood urea nitrogen, decreased hemoglobin and hematocrit values.

Your doctor will monitor you with a blood test and advise you whether any action is needed.

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

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:

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

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

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

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

Increased blood potassium levels.

Hydrochlorothiazide:

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

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

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

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

Changes in blood test results include:

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

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

Decreased or loss of appetite, severe difficulty breathing, skin anaphylactic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, photosensitivity skin reactions, itching, purple spots or 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 (sialoadenitis), decreased number of white blood cells, decreased number of platelets in blood, anemia, bone marrow depression, restlessness, depression, sleep disturbances, feeling of loss of interest (apathy), tingling and numbness (paresthesia), seizures, yellowish perception of objects when looking at them, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreas inflammation, jaundice, gallbladder infection, symptoms of systemic lupus erythematosus such as skin rash, joint pains, 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):

Decreased vision or eye pain due to elevated 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you 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 packaging at the SIGRE point located at your pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Olmesartan/Hydrochlorothiazide Stada

The active substances are olmesartan medoxomil and hydrochlorothiazide.

Each film-coated tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.

The other components are: monohydrate lactose, microcrystalline cellulose, crospovidone, colloidal anhydrous 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 container

Olmesartan/Hydrochlorothiazide Stada 40 mg/12.5 mg are film-coated, beige, oval, biconvex tablets, 16.3 mm long and 7.8 mm wide, with a score line on one side. The score line is not intended to divide the tablet.

Film-coated tablets are available in blister packs made of oPA-Al-PVC foil sealed with 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: Olmesartan/Hydrochlorothiazide Stada 40 mg/12.5 mg film-coated tablets EFG
Ireland: Olmesartan/Hydrochlorothiazide Clonmel 40 mg/12.5 mg film-coated tablets
Portugal: Olmesartan + Hydrochlorothiazide Ciclum

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

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