Package Leaflet: Information for the Patient

Olmesartán/Hidroclorotiazida Stada 40 mg/12,5 mg Film-Coated Tablets

olmesartán medoxomilo / hidroclorotiazida

Read 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1. What isOlmesartán/Hidroclorotiazida Stadaand what it is 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 ingredients, olmesartán medoxomilo and hidroclorotiazida, 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 reduces blood pressure by relaxing blood vessels.
• Hidroclorotiazida belongs to a group of medicines called thiazide diuretics. It reduces blood pressure by contributing to the elimination of excess fluids, increasing urine production by the kidneys.

Onlyolmesartán/hidroclorotiazidawill be given to youif 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 medicines 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 medicines 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). Yourdoctor may also have 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 olmesartán/hidroclorotiazida at the beginning of pregnancy – see Pregnancy section).
• If you have kidney problems.
• If you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medication that contains aliskireno.
• 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 moderate or severe liver problems, or yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, due to gallstones).

If you think 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 Olmesartán/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 olmesartán/hidroclorotiazida.
• 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 olmesartán/hidroclorotiazida, 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.
• Aliskireno.

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

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

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

• Renal transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe or prolonged vomiting (feeling dizzy) or diarrhea.
• Treatment with high doses of medications that increase urine elimination (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, and 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 olmesartán/hidroclorotiazida. This can lead to permanent vision loss if not treated. You may be at higher risk of developing this if you have 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 olmesartán/hidroclorotiazida. Your doctor will decide whether to continue treatment. Do not stop taking olmesartán/hidroclorotiazida on your own.

Olmesartán/hidroclorotiazida may cause an increase in blood levels of fats and uric acid (which causes gout – painful swelling of the joints). Your doctor will probably want to perform blood tests from time to time to monitor these possible changes.

There may be a change in blood levels of certain chemical substances called electrolytes. Your doctor will probably 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 blood pressure reduction in patients with circulatory problems in the heart or brain can cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

If you are to undergo parathyroid function tests, you should stop taking olmesartán/hidroclorotiazida 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 olmesartán/hidroclorotiazida before becoming pregnant or as soon as you know you are pregnant, and will recommend that you take another medication instead of olmesartán/hidroclorotiazida. Olmesartán/hidroclorotiazida is not recommended 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 taken from that time.

Children and adolescents

Olmesartán/hidroclorotiazida is not recommended for children and adolescents under 18 years old.

Other medications and Olmesartán/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 olmesartán/hidroclorotiazida.

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 aliskireno (see also the information under the headings “Do not take Olmesartán/Hidroclorotiazida Stada” and “Warnings and precautions”).

• Medications that may increase blood potassium levels when used at the same time as olmesartán/hidroclorotiazida. These include:

-Potassium supplements (as well as salt substitutes containing 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) when used at the same time as olmesartán/hidroclorotiazida 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 olmesartán/hidroclorotiazida may increase the risk of kidney failure and reduce the effect of olmesartán/hidroclorotiazida.
• Sedatives, sleep-inducing medications, and antidepressants, used with olmesartán/hidroclorotiazida may cause a sudden drop in blood pressure when standing up.
• Baclofen and tubocurarine, 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 olmesartán/hidroclorotiazida. Your doctor may advise you to take olmesartán/hidroclorotiazida 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 olmesartán/hidroclorotiazida 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 olmesartán/hidroclorotiazida.
• Cisapride, used to increase stomach and intestinal movement.
• Halofantrine, used to treat malaria.

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

Olmesartán/hidroclorotiazidacan be taken with or without food.

Be careful when drinking alcohol while takingolmesartán/hidroclorotiazida, 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 ofolmesartán/hidroclorotiazidais somewhat lower 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 takingolmesartán/hidroclorotiazidabefore becoming pregnant or as soon as you know you are pregnant, and will recommend that you take another medication instead ofolmesartán/hidroclorotiazida. Olmesartán/hidroclorotiazida is not recommended 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 taken from that time.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Olmesartán/hidroclorotiazida is not recommended during breastfeeding, and your doctor may choose another treatment for you if you want 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 machines

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

Olmesartán/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. In case of doubt, consult your doctor or pharmacist again.

The recommended doseis one tablet ofOlmesartán/Hidroclorotiazida Stada40 mg/12.5 mg per day. If blood pressure is not adequately controlled, your doctor may change the dose to one tablet ofOlmesartán/Hidroclorotiazida Stada40 mg/25 mg per day.

Swallow the tablets with water. The groove should not be used to break the tablet.

Take your doseat the same time every day, for example, at breakfast time. 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 service 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 doses.

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 can 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 can occur, affecting 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/hydrochlorothiazidecan cause a too low 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 with blood pressure treatment.

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

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

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

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

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

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

Increased urea in the blood, decreased values of hemoglobin and hematocrit.

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

Additional side effects reported with the use of olmesartan medoxomil or hydrochlorothiazide alone, but not 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, some changes in blood test results have been observed, including:

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

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

Fast and intense allergic reactions that can affect the whole body and cause breathing problems, as well as a rapid decrease 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 rash, itching, hives, swelling of the skin (hives).

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

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

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

Renal function deterioration, lack of energy.

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, including:

Increased potassium in the blood

Hydrochlorothiazide:

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

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

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

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

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

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

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

Salivary gland inflammation and pain (sialoadenitis), decreased white blood cell count, decreased platelet count in the blood, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness (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, gallbladder infection, symptoms of lupus erythematosus such as skin rash, joint pain, and cold hands and fingers, skin allergic reactions, skin peeling and blistering, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which sometimes causes movement alteration).

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

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

Unknown side 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 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 Medicinal Products 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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Olmesartan/Hydrochlorothiazide Stada

The active principles 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: 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 40 mg/12.5 mg are film-coated tablets, beige in color, oval, biconvex, 16.3 mm in length and 7.8 mm in width, and with a notch on one of the faces. The notch should not be used to break the tablet.

The film-coated tablets are presented in sealed blister packs of laminated oPA-Al-PVC with an aluminum foil laminate 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 medicinal product is authorized in the member states of the European Economic Area with the following names:

SpainOlmesartan/Hydrochlorothiazide Stada 40 mg /12.5 mg film-coated tablets EFG

IrelandOlmesartan/Hydrochlorothiazide Clonmel 40 mg/12.5 mg film-coated tablets

PortugalOlmesartan + Hidroclorotiazida Ciclum

Date of the last review of this leaflet:January 2025

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.