OLMESARTAN/HYDROCHLOROTHIAZIDE STADA 40 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Olmesartan/Hydrochlorothiazide Stada 40 mg/12.5 mg Film-Coated Tablets EFG

olmesartan medoxomil / hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Olmesartan/Hydrochlorothiazide Stada and what is it used for

Olmesartan/Hydrochlorothiazide Stada contains two active substances, olmesartan medoxomil and hydrochlorothiazide, which are used in the treatment of high blood pressure (hypertension):

• Olmesartan medoxomil belongs to a group of medicines called angiotensin II receptor antagonists. It lowers blood pressure by relaxing blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It lowers blood pressure by helping to remove excess fluid from the body, increasing urine production by the kidneys.

Olmesartan/hydrochlorothiazide will only be given to you if treatment with olmesartan medoxomil alone has not controlled your blood pressure sufficiently. The combination of the two active substances in olmesartan/hydrochlorothiazide reduces blood pressure more than either substance alone.

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

High blood pressure can be controlled with medicines such as olmesartan/hydrochlorothiazide tablets. Your doctor may also have recommended that you make some changes to your lifestyle, such as losing weight, stopping smoking, reducing the amount of alcohol you drink, and reducing 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 you take Olmesartan/Hydrochlorothiazide Stada

Do not take Olmesartan/Hydrochlorothiazide Stada:

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

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

Warnings and precautions

Talk to your doctor before you start 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 some 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 had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking olmesartan/hydrochlorothiazide, see a doctor immediately.

Before taking the tablets, tell your doctorif you are taking any of the following medicines used to treat high blood pressure (hypertension):

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

Your doctor may need to check your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Olmesartan/Hydrochlorothiazide Stada”.

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

• Kidney transplant.
• Liver disease.
• Heart failure or problems with the heart valves or heart muscle.
• Vomiting (feeling sick) or diarrhoea, which is severe or lasts for several days.
• Treatment with high doses of medicines that increase urine production (diuretics), or if you are on a low-salt diet.
• Problems with the adrenal glands (e.g. primary hyperaldosteronism).
• Diabetes.
• Systemic lupus erythematosus (an autoimmune disease).
• Allergy or asthma.

Contact your doctorif 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 proceed with your blood pressure treatment.
• Decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and may occur from a few hours to a few weeks after taking olmesartan/hydrochlorothiazide. This can lead to permanent vision loss if not treated. You may be at greater risk of developing this if you have previously been allergic to penicillin or sulphonamides.

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

Talk to your doctor if you experience 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 cause an increase in blood fat and uric acid levels (which can cause gout – painful swelling of the joints). Your doctor will probably want to perform a blood test from time to time to check for these possible changes.

A change in blood levels of certain chemicals called electrolytes may occur. Your doctor will probably want to perform 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 of weakness, slowness, tiredness, drowsiness or restlessness, nausea, vomiting, decreased need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

As with any other medicine that lowers blood pressure, excessively low blood pressure in patients with blood flow problems in the heart or brain may cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are going to have parathyroid function tests, you should stop taking olmesartan/hydrochlorothiazide before these tests are performed.

Athletes are informed that this medicine contains a component that may give a positive doping test result.

You should inform your doctor if you are pregnant, think you might be pregnant, or are planning to become pregnant. Your doctor will normally advise you to stop taking olmesartan/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of olmesartan/hydrochlorothiazide. It is not recommended to use olmesartan/hydrochlorothiazide during pregnancy, and it must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken after this time.

Children and adolescents

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

Other medicines and Olmesartan/Hydrochlorothiazide Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor or pharmacist about any of the following medicines:

• Other medicines used to treat high blood pressure (anti-hypertensives), as they may increase the effect of olmesartan/hydrochlorothiazide.

Your doctor may need to change 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 Olmesartan/Hydrochlorothiazide Stada” and “Warnings and precautions”).

• Medicines that may increase potassium levels in the blood if taken at the same time as olmesartan/hydrochlorothiazide. These include:

• Potassium supplements (as well as salt substitutes that contain potassium)
• Medicines that increase urine production (diuretics)
• Heparin (to thin the blood)
• Laxatives
• Steroids
• Adrenocorticotropic hormone (ACTH)
• Carbenoxolone (a medicine used to treat mouth and stomach ulcers)
• Sodium penicillin G (an antibiotic also called benzylpenicillin sodium)
• Certain painkillers such as aspirin or salicylates
• Lithium (a medicine used to treat mood changes and some types of depression) may increase lithium toxicity if taken at the same time as olmesartan/hydrochlorothiazide. If you have to take lithium, your doctor will monitor your lithium blood levels.
• Non-steroidal anti-inflammatory medicines (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as olmesartan/hydrochlorothiazide, may increase the risk of kidney problems and reduce the effect of olmesartan/hydrochlorothiazide.
• Sedatives, hypnotics, and antidepressants, used with olmesartan/hydrochlorothiazide, may cause a sudden drop in blood pressure when standing up.
• Certain muscle relaxants such as baclofen and tubocurarine.
• Medicines such as 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 olmesartan/hydrochlorothiazide at least 4 hours before colesevelam hydrochloride.
• Anticholinergic medicines, such as atropine and biperiden.
• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiaprida, droperidol, or haloperidol, used to treat certain psychiatric disorders.
• Certain medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis, used to treat heart problems.
• Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injection, which may change the heart rhythm.
• Oral anti-diabetic medicines, such as metformin, or insulin, used to lower blood sugar levels.
• Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood sugar levels, respectively, as olmesartan/hydrochlorothiazide may increase the blood sugar-raising effect of these medicines.
• Methyldopa, a medicine used to treat high blood pressure.
• Medicines such as noradrenaline, used to increase blood pressure and decrease 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.
• Cyclosporin, a medicine used to prevent organ transplant rejection.
• Antibiotics of the tetracycline group or sparfloxacin.
• Amphotericin, a medicine used to treat fungal infections.
• Certain antacids (indigestion remedies) used to treat stomach acid excess, such as aluminium and magnesium hydroxide, as they may slightly reduce the effect of olmesartan/hydrochlorothiazide.
• Cisapride, used to increase food movement in the stomach and intestines.
• Halofantrine, used to treat malaria.

Taking Olmesartan/Hydrochlorothiazide Stada with food, drinks, and alcohol

Olmesartan/hydrochlorothiazide can be taken with or without food.

Be careful when drinking alcohol while taking olmesartan/hydrochlorothiazide, as some people may feel faint or dizzy. If this happens, do not drink any alcohol, including wine, beer, or alcohol-containing refreshments.

Black patients

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

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant, think you might be pregnant, or are planning to become pregnant. Your doctor will normally advise you to stop taking olmesartan/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of olmesartan/hydrochlorothiazide. It is not recommended to use olmesartan/hydrochlorothiazide during pregnancy, and it must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken after this time.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. It is not recommended to use olmesartan/hydrochlorothiazide during breastfeeding, and your doctor may choose another treatment for you if you want to breastfeed.

If you are pregnant, think you might be pregnant, or are planning 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 happens, do not drive or use machines until the symptoms have disappeared. Consult your doctor.

Olmesartan/Hydrochlorothiazide Stada contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Olmesartan/Hydrochlorothiazide Stada

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, consult your doctor or pharmacist again.

The recommended doseis one Olmesartan/Hydrochlorothiazide Stada 40 mg/12.5 mg tablet per day. If your blood pressure is not controlled sufficiently, your doctor may change the dose to one Olmesartan/Hydrochlorothiazide Stada 40 mg/25 mg tablet per day.

Swallow the tablets with water. The score line is not intended for breaking the tablet.

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

If you take more Olmesartan/Hydrochlorothiazide Stada than you should

If you take more tablets than you should or if a child accidentally takes one or more tablets, contact your doctor or go to the nearest hospital emergency department immediately and take the medicine pack with you.

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

If you forget to take Olmesartan/Hydrochlorothiazide Stada

If you forget to take a dose, take your normal dose the next day. Do nottake a double dose to make up for forgotten doses.

If you stop taking Olmesartan/Hydrochlorothiazide Stada

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

• In rare cases, allergic reactions 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 to you, stop taking olmesartan/hydrochlorothiazide and consult your doctor immediately.
• Olmesartan/hydrochlorothiazide may cause a pronounced drop in blood pressure in susceptible patients or as a result of an allergic reaction. Infrequently, fainting or dizziness may occur. If this happens to you, 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 respiratory distress (symptoms include severe respiratory distress, fever, weakness, and confusion).
• Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, skin itching, even if you started treatment with olmesartan/hydrochlorothiazide a long time ago, contact your doctor immediatelywho will assess your symptoms and decide how to continue with blood pressure treatment.

Olmesartan/hydrochlorothiazide is a combination of two active ingredients. The following information, first, describes the adverse effects reported so far with the olmesartan/hydrochlorothiazide combination (in addition to those already mentioned) and, second, the known adverse effects of the two active ingredients separately.

These are other known adverse effects of olmesartan/hydrochlorothiazide so far:

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

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

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

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

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

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

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

Your doctor will monitor you with a blood test and tell you if you need to take any action.

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

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

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

Increased blood urea nitrogen, decreased hemoglobin and hematocrit values.

Your doctor will monitor you with a blood test and tell you if you need to take any action.

Additional adverse effects reported with the use of olmesartan medoxomil or hydrochlorothiazide alone, but not 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 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 frequently, including:

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

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

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

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

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

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

Worsening of kidney function, lack of energy.

Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

Increased potassium in the blood.

Hydrochlorothiazide:

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

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

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

Feeling of confusion, abdominal pain, stomach discomfort, feeling of swelling, diarrhea, nausea, vomiting, constipation, glucose in urine (glucosuria).

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

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

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

Decreased or loss of appetite, severe breathing difficulties, anaphylactic skin reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, skin reactions due to light sensitivity, itching, purple spots or patches on the skin due to small hemorrhages (purpura), skin swelling (hives).

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

Inflammation and pain of the salivary glands (sialadenitis), 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 (paresthesia), convulsions, yellowish perception of objects when looking at them, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, infection in the gallbladder, symptoms of lupus erythematosus such as skin rash, joint pain, and cold hands and fingers, allergic skin reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which can sometimes cause movement disorders).

Very rare adverse effects (may affect up to 1 in 10,000 people):

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

Unknown adverse effects (frequency cannot be estimated from available data):

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

5. Storage of Olmesartan/Hydrochlorothiazide Stada

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Olmesartan/Hydrochlorothiazide Stada

The active ingredients are olmesartan medoxomil and hydrochlorothiazide.

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

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

Appearance of the product and package contents

Olmesartan/Hydrochlorothiazide Stada 40 mg/12.5 mg are film-coated tablets, beige in color, oval, biconvex, 16.3 mm long and 7.8 mm wide, with a score line on one side. The score line should not be used to split the tablet.

The film-coated tablets are presented in blister packs 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.

Not all 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 medicine is authorized in the Member States of the European Economic Area under the following names:

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

Ireland Olmesartan/Hydrochlorothiazide Clonmel 40 mg/12.5 mg film-coated tablets

Portugal Olmesartan + Hidroclorotiazida Ciclum

Date of the last revision of this leaflet:January 2025

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