Patient Information Leaflet

Olmesartán/Hidroclorotiazida Stada 20 mg/25 mg Film-Coated Tablets

olmesartán medoxomilo / hidroclorotiazida

Read this leaflet carefully before you start taking this medicine, as 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isOlmesartán/Hidroclorotiazida Stadaand what is it used for

2. What you need to know before takingOlmesartán/Hidroclorotiazida Stada

3. How to takeOlmesartán/Hidroclorotiazida Stada

4. Possible side effects

5. Storage ofOlmesartán/Hidroclorotiazida Stada

6. Contents of the pack and additional information

Olmesartán/Hidroclorotiazida Stadacontains two active principles, olmesartán medoxomilo and hidroclorotiazida, which are used in the treatment of high blood pressure (hypertension):

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

Onlyolmesartán/hidroclorotiazidawill be givenif treatment with olmesartán medoxomilo alone has not adequately controlled your blood pressure. The concurrent administration of both active substances inolmesartán/hidroclorotiazidacontributes to reducing blood pressure more than if each substance were administered alone.

You may already be taking medications to treat high blood pressure, but your doctor may believe it necessary for you to takeolmesartán/hidroclorotiazidato lower it further.

High blood pressure can be controlled with medications likeolmesartán/hidroclorotiazidatablets. Your doctor has probably also recommended that you make some lifestyle changes to help lower your blood pressure (e.g., losing weight, quitting smoking, reducing alcohol consumption, and reducing the amount of salt in your diet). Your doctor has also probably recommended that you exercise regularly, such as walking or swimming. It is essential to follow your doctor's advice.

Do not take Olmesartán/Hidroclorotiazida Stada:

• If you are allergic to olmesartan medoxomil or to hydrochlorothiazide, or to any of the other components of this medication (listed in section 6) or to substances similar to hydrochlorothiazide (sulfonamides).
• If you are more than 3 months pregnant (it is also recommended to avoid olmesartan/hydrochlorothiazide at the beginning of pregnancy – see Pregnancy section).
• If you have severe kidney problems.
• If you have diabetes or kidney insufficiency and are being treated with a blood pressure medication that contains aliskiren.
• If you have low levels of potassium or sodium in the blood, high levels of calcium or uric acid in the blood (with symptoms of gout or kidney stones), that do not improve with treatment.
• If you have severe liver problems, or yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, due to gallstones).

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

Warnings and precautions

Consult your doctor before starting to take Olmesartan/Hidroclorotiazida Stada.

• 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 sun exposure and UV rays while taking olmesartan/hydrochlorothiazide.
• 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 shortness of breath or severe difficulty breathing after taking olmesartan/hydrochlorothiazide, seek medical attention immediately.

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

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

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels in the blood (e.g., potassium) at regular intervals.

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

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

• Mild to moderate kidney problems or if you have recently had a kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe vomiting (feeling dizzy) or diarrhea that is severe or lasts for several days.
• Treatment with high doses of medications that increase urine production (diuretics), or if you are on a low-sodium diet.
• Problems with the adrenal glands (e.g., primary aldosteronism).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.

Contact your doctorif you experience any of the following symptoms:

• Severe, persistent diarrhea that causes significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your blood pressure treatment.
• A decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or increased eye pressure, which can occur from a few hours to several weeks after taking olmesartan/hydrochlorothiazide. This can lead to permanent vision loss if not treated. You may be at higher risk of developing this 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 problems.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea 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 levels of fats and uric acid (which causes gout – painful swelling of the joints). Your doctor will likely want to perform blood tests from time to time to monitor these possible changes.

You may experience changes in blood levels of certain chemicals called electrolytes. Your doctor will likely want to perform blood tests from time to time to monitor this possible change. Some signs of electrolyte changes are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, slow, tired, drowsy, or restless, nausea, vomiting, decreased need to urinate, rapid heart rate.Tell your doctor if you notice any of these symptoms.

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

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

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

You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will usually recommend that you stop taking Olmesartan/Hidroclorotiazida Stada before becoming pregnant or as soon as you know you are pregnant, and recommend that you take another medication instead of olmesartan/hydrochlorothiazide. Olmesartan/hydrochlorothiazide is not recommended for use during pregnancy, and in any case, it should not be administered from the third month of pregnancy, as it may cause serious harm to your baby if administered from that time.

Children and adolescents

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

Other medications and Olmesartan/Hidroclorotiazida Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

• Other blood pressure-lowering medications (anti-hypertensives), as they may increase the effect of 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 the information under the headings “Do not take Olmesartan/Hidroclorotiazida Stada” and “Warnings and precautions”

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

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

-Diuretics

-Heparin (to thin the blood)

-Laxatives

-Glucocorticoids

-Adrenocorticotropic hormone (ACTH)

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

-Penicillin G sodium (antibiotic also called benzylpenicillin sodium)

-Some analgesics such as aspirin or salicylates

• Lithium (medication used to treat mood changes and certain types of depression) if used at the same time as olmesartan/hydrochlorothiazide may increase lithium toxicity. If you need to take lithium, your doctor will measure your lithium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as olmesartan/hydrochlorothiazide may increase the risk of kidney failure 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.
• Baclofen and tubocurarine, medications used as muscle relaxants.
• Amifostine and other medications used to treat cancer, such as cyclophosphamide or methotrexate.
• Colestiramine and colestipol, medications to reduce blood fat levels.
• Colesevelam hydrochloride, a medication that reduces 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 medications, such as atropine and biperiden.
• Medications such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.
• Some medications such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digital, used to treat heart problems.
• Medications such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injection, that may change heart rhythm.
• Oral diabetes medications, such as metformin, or insulin, used to reduce blood sugar levels.
• Beta-blockers and diazoxide, medications used to treat high blood pressure or low blood sugar, respectively, as olmesartan/hydrochlorothiazide may intensify the effect of increasing blood sugar that these medications produce.
• Metildopa, a medication used to treat high blood pressure.
• Medications such as noradrenaline, used to increase blood pressure and reduce heart rate.
• Difemanil, used to treat slow heart rate or reduce sweating.
• Medications such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.
• Calcium supplements.
• Amantadine, an antiviral medication.
• Ciclosporin, a medication used to prevent organ transplant rejection.
• Antibiotics in the tetracycline group, or enoxacin.
• Amphotericin, a medication used to treat fungal infections.
• Some antacids (remedies for indigestion) used to treat excess stomach acid, such as aluminum hydroxide and magnesium, as they may slightly reduce the effect of olmesartan/hydrochlorothiazide.
• Cisapride, used to increase stomach and intestinal movement.
• Halofantrine, used to treat malaria.

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

Olmesartan/hydrochlorothiazidecan be taken with or without food.

Be careful when drinking alcohol while takingolmesartan/hydrochlorothiazide, as some people may feel dizzy or lightheaded. If this happens, do not drink any alcohol, including wine, beer, or fizzy drinks with alcohol.

Black patients

Like other similar medications, the blood pressure-lowering effect ofOlmesartan/Hidroclorotiazida Stadais somewhat less in black patients.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will usually recommend that you stop takingOlmesartan/Hidroclorotiazida Stadabefore becoming pregnant or as soon as you know you are pregnant, and recommend that you take another medication instead of olmesartan/hydrochlorothiazide. Olmesartan/hydrochlorothiazide is not recommended for use during pregnancy, and in any case, it should not be administered from the third month of pregnancy, as it may cause serious harm to your baby if administered from that time.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Olmesartan/hydrochlorothiazide is not recommended for use during breastfeeding, and your doctor may choose another treatment for you 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 medication.

Driving and operating machinery

You may feel drowsy or lightheaded while taking treatment for high blood pressure. If this happens, do not drive or operate machinery until the symptoms have disappeared. Consult your doctor.

Olmesartan/Hidroclorotiazida Stada contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

The recommended doseis one tablet ofOlmesartán/Hidroclorotiazida Stada20 mg/12.5 mg per day. If blood pressure is not adequately controlled, your doctor may change the dose to one tablet ofOlmesartán/Hidroclorotiazida Stada20 mg/25 mg per day.

Swallow the tablets with water.

Take your doseat the same time every day, for example, with breakfast. It is essential that you continue takingolmesartán/hidroclorotiazidauntil your doctor tells you to stop.

If you take more Olmesartán/Hidroclorotiazida Stada than you should

If you take more tablets than you should 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, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Olmesartán/Hidroclorotiazida Stada

If you forget to take a dose, take the usual dose the next day.Do nottake a double dose to make up for the missed dose.

If you interrupt treatment with Olmesartán/Hidroclorotiazida Stada

It is essential to continue takingolmesartán/hidroclorotiazida, unless your doctor tells you to stop treatment.

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 and require urgent medical advice:

• In rare cases, an allergic reaction may occur, which can affect the whole body, with inflammation of the face, mouth, and/or larynx, along with itching and skin rash.If this happens, stop taking olmesartan/hydrochlorothiazide and consult your doctor immediately..
• Olmesartan/hydrochlorothiazide may cause a too pronounced drop in blood pressure in susceptible patients or as a result of an allergic reaction. Rarely, dizziness or fainting may occur.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 respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).
• Unknown frequency: If you experience yellowing of the whites of the eyes, dark urine, skin itching, even if you started treatment with olmesartan/hydrochlorothiazide some time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue treatment for high blood pressure.

Olmesartan/hydrochlorothiazideis a combination of two active principles. The following information, first, describes the side effects reported so far with the combinationolmesartan/hydrochlorothiazide(in addition to those already mentioned) and, secondly, the known side effects of the two active principles separately.

These are other side effects known so far with olmesartan/hydrochlorothiazide:

If these effects occur, they are often mild andyou do 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, rarely, some changes in blood tests have been observed that include:

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, rarely, some changes in blood test results have been observed that include:

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 in combination or in a higher frequency:

Olmesartan medoxomil:

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

Bronchitis, cough, congestion or 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, frequently, some changes in blood test results have been observed that include:

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)

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

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

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.

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

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

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 levels of uric acid.

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 (glucosuria).

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

Increased levels of creatinine, urea, calcium, and sugar in the blood, 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)

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

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

Salivary gland inflammation and pain (sialoadenitis), 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, biliary tract infection, symptoms of lupus erythematosus such as skin rash, joint pain, and cold hands and fingers, skin allergic reactions, skin peeling and blisters, 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 an abnormally low level of chloride in the blood (hypochloremic alkalosis), intestinal obstruction (paralytic ileus).

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

Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma).

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of 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 after “CAD”. The expiration date is the last day of the month indicated.

Medicines 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. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

Composition of Olmesartan/Hydrochlorothiazide Stada

The active principles are olmesartan medoxomil and hydrochlorothiazide.

Each film-coated tablet contains 20 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.

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

Appearance of the product and contents of the package

Olmesartan/Hydrochlorothiazide Stada 20 mg/25 mg are film-coated tablets, salmon-colored, round, biconvex with a diameter of 8 mm.

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Responsible for manufacturing

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 with the following names:

SpainOlmesartan/Hydrochlorothiazide Stada 20 mg /25 mg film-coated tablets EFG

IrelandOlmesartan/Hydrochlorothiazide Clonmel 20 mg/25 mg film-coated tablets

PortugalOlmesartan + Hidroclorotiazida Ciclum

Date of the last review of this leaflet:January 2025

The 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/.