OLMESARTAN/HYDROCHLOROTHIAZIDE STADA 20 mg/12.5 mg FILM-COATED TABLETS

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 medication (listed in section 6) or to substances similar to hydrochlorothiazide (sulfonamides).
• If you are pregnant for more than 3 months (it is also best to avoid olmesartan/hydrochlorothiazide at the start of pregnancy – see section Pregnancy).
• If you have severe kidney problems.
• If you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren.
• If you have low potassium or sodium levels in the blood, high calcium or uric acid levels in the blood (with symptoms of gout or kidney stones), which 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 (bile duct obstruction, e.g., due to gallstones).

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

Warnings and precautions

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

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

• a converting enzyme inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking a converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Olmesartan/Hydrochlorothiazide Stada” and “Warnings and precautions”).

• Medications that can 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)
• Medications that increase urine production (diuretics)
• Heparin (to thin the blood)
• Laxatives
• Steroids
• Adrenocorticotropic hormone (ACTH)
• Carbenoxolone (medication for the treatment of mouth and stomach ulcers)
• Sodium penicillin G (antibiotic also called benzylpenicillin sodium)
• Certain pain relievers such as aspirin or salicylates
  • Lithium (medication used to treat mood changes and some types of depression) may increase lithium toxicity if used at the same time as olmesartan/hydrochlorothiazide. If you need to take lithium, your doctor will measure lithium levels in your blood.
  • Non-steroidal anti-inflammatory medications (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.
  • Certain medications such as baclofen and tubocurarine, used as muscle relaxants.
  • Amifostine and other medications used for cancer treatment, such as cyclophosphamide or methotrexate.
  • Colestyramine and colestipol, medications to lower blood fat levels.
  • Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may reduce the effect of olmesartan/hydrochlorothiazide. Your doctor may advise you to take Olmesartan/Hydrochlorothiazide Stada at least 4 hours before colestyramine hydrochloride.
  • Anticholinergic medications, such as atropine and biperiden.
  • Medications such as thioridazine, chlorpromazine, levomepromazine, trifluperazine, cyanemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.
  • Certain medications such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis, used to treat heart problems.
  • Medications such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injection, which can change heart rhythm.
  • Oral antidiabetic medications, such as metformin, or insulin, used to lower blood sugar levels.
  • Beta-blockers and diazoxide, medications used to treat high blood pressure or low blood sugar levels, respectively, as olmesartan/hydrochlorothiazide may enhance the effect of increasing blood sugar levels produced by these medications.
  • Methyldopa, a medication used to treat high blood pressure.
  • Medications such as norepinephrine, used to increase blood pressure and decrease 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.
  • Cyclosporine, a medication used to prevent organ transplant rejection.
  • Antibiotics from the tetracycline group or esparfloxacino.
  • Amphotericin, a medication used to treat fungal infections.
  • Certain antacids (indigestion remedies) used to treat stomach acid excess, such as aluminum hydroxide and magnesium, as they may slightly reduce the effect of olmesartan/hydrochlorothiazide.
  • Cisapride, used to increase food movement in the stomach and intestines.
  • Halofantrine, used for 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 dizzy or faint. If this happens, do not drink any alcohol, including wine, beer, or drinks with alcohol.

Black patients

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will generally advise you to stop taking olmesartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend that you take another medication instead of olmesartan/hydrochlorothiazide. It is not recommended to use olmesartan/hydrochlorothiazide at the start of pregnancy, and it should not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken after this time.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. It is not recommended to use olmesartan/hydrochlorothiazide 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 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 certain sugars, consult them before taking this medication.

3. How to take Olmesartan/Hydrochlorothiazide Stada

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

The recommended doseis one Olmesartan/Hydrochlorothiazide Stada 20 mg/12.5 mg tablet per day. If your blood pressure is not adequately controlled, your doctor may change the dose to one Olmesartan/Hydrochlorothiazide Stada 20 mg/25 mg tablet per day.

Swallow the tablets with water.

If possible, take your dose at the same time each day, e.g., at breakfast time. It is essential to continue taking 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 ingests one or more tablets, contact your doctor or go to the emergency department of the nearest hospital immediately and take the medication package with you.

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

If you forget to take Olmesartan/Hydrochlorothiazide Stada

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

If you stop taking Olmesartan/Hydrochlorothiazide Stada

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

If you have any further questions about the use of this medication, 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 may 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. Dizziness or fainting may occur infrequently. 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 secondly, 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)

Rapid 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.

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

Rapid allergic reactions that can affect the whole body and cause breathing problems, as well as a rapid drop 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 cell called platelets (thrombocytopenia).

Rare adverse 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 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 bloating, 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 lost 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 (sometimes causing 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 is not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: 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 disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This 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 20 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 20 mg/12.5 mg are film-coated tablets, beige in color, round, biconvex with a diameter of 8 mm.

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 20 mg /12.5 mg film-coated tablets EFG

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

Portugal Olmesartan + Hydrochlorothiazide Ciclum

Date of the 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/

.