Label: Information for the User

Captopril/Hidroclorotiazida Teva-ratiopharm 50 /25 mg Tablets EFG

captopril and hydrochlorothiazide

Read this label carefully before starting to take the medication, as it contains important information for you

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

6. Contents of the pack and additional information

Captopril/HidroclorotiazidaTeva-ratiopharmbelongs to the group of anti-hypertensive medications that contain a combination of an ACE (angiotensin-converting enzyme) inhibitor. Captopril/ HidroclorotiazidaTeva-ratiopharmcontains two active substances, captopril and hidroclorotiazida, which lower blood pressure through different mechanisms. Captopril prevents the formation of hypertensive agents in the body, and hidroclorotiazida lowers blood pressure by increasing the elimination of water and salts from the body.

Captopril/ HidroclorotiazidaTeva-ratiopharmis used in the treatment of hypertension when the desired result is not achieved by itself in monotherapy.

Do not take Captopril/Hidroclorotiazida Teva-ratiopharm

• if you are allergic to captopril, other ACE inhibitors, hydrochlorothiazide, sulfonamide derivatives, or any of the other components of this medication (listed in section 6),
• if you have been treated with ACE inhibitors in the past and have experienced hypersensitivity reactions that manifest, for example, as swelling of the face, lips, tongue, and/or larynx and are accompanied by difficulty swallowing or breathing (angioedema) or if you have experienced similar reactions for any other reason,
• if you have severe liver or kidney problems,
• if you are more than three months pregnant (it is better to avoid Captopril/Hidroclorotiazida Teva-ratiopharm in the early stages of pregnancy - see pregnancy section),
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medication containing aliskiren,
• if you have taken or are currently taking sacubitril/valsartan, a medication used to treat a type of chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Captopril/Hidroclorotiazida Teva-ratiopharm and if any of the following apply to you:

• if you are using diuretics, your diet contains little or no salt, or if you are currently experiencing or suffer from severe diarrhea or vomiting,
• if you have heart failure,
• if you have coronary or cerebrovascular disease,
• if you have bilateral renal artery stenosis or stenosis of the renal artery of the only functioning kidney,
• if you have mitral or aortic stenosis,
• if you have kidney insufficiency, renal artery stenosis, or are receiving dialysis,
• if you have gout or impaired urine excretion (urine output less than 100 ml in 24 hours),
• if you have diabetes or vascular collagen disease,
• if you have liver insufficiency or other liver disorders,
• if you have hepatic encephalopathy (a brain disorder associated with liver cirrhosis),

• if you are receiving insect venom desensitization therapy,

• if you have persistent dry cough,
• if you have swelling caused by a nervous vascular disorder (angioedema),

• if your potassium levels are elevated,
• if you experience a decrease in visual acuity, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which can occur within a few hours to weeks after taking this medication. If left untreated, this can lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamide, you may be at a higher risk of developing it,
• if you are taking any of the following medications used to treat high blood pressure (hypertension):
• an angiotensin II receptor antagonist (ARA) (also known as "sartanes" - for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes
• aliskiren
• if you are taking any of the following medications, which increases the risk of angioedema (rapid swelling under the skin in areas such as the throat):
• sirolimus, everolimus, temsirolimus, and other mTOR inhibitors (used to prevent organ transplant rejection and for cancer)
• racecadotrilo, a medication used to treat diarrhea
• vildagliptina, a medication used to treat diabetes
• if you have had skin cancer or if a skin lesion appears unexpectedly 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 Captopril/Hidroclorotiazida Teva-ratiopharm.
• 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 severe shortness of breath or difficulty breathing after taking Captopril/Hidroclorotiazida Teva-ratiopharm, seek medical attention immediately.

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

See also the information under the heading "Do not take Captopril/Hidroclorotiazida Teva-ratiopharm."

Warning to athletes: The hydrochlorothiazide contained in this medication may result in a positive test result in a doping control.

Children

Do not administer Captopril/Hidroclorotiazida Teva-ratiopharm to children. There is no relevant indication for the use of Captopril/Hidroclorotiazida Teva-ratiopharm in children.

Renal patients

If you have kidney insufficiency, it is essential that you do not use potassium supplements or potassium-sparing diuretics during treatment with captopril/hydrochlorothiazide, as they may increase your potassium levels excessively.

Inform your doctor that you are using Captopril/Hidroclorotiazida Teva-ratiopharm if you need to undergo surgery during treatment, as some anesthetic agents used during surgery may cause excessive blood pressure lowering in combination with Captopril/Hidroclorotiazida Teva-ratiopharm.

Inform your doctor if you think you are (or may be) pregnant. Captopril/Hidroclorotiazida Teva-ratiopharm is not recommended for use in the early stages of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy (see pregnancy section).

Other medications and Captopril/Hidroclorotiazida Teva-ratiopharm

The concomitant use of other medications may affect the efficacy and safety of this medication. Conversely, Captopril/Hidroclorotiazida Teva-ratiopharm may affect the safety and efficacy of other medications.

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

Remember to inform your doctor that you are taking Captopril/Hidroclorotiazida Teva-ratiopharm if they prescribe another medication during treatment or shortly after.

It is especially important to inform your doctor if you are using any of the following:

• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medications that may increase the amount of potassium in your blood (for example, trimethoprim and co-trimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medication used to thin the blood to prevent clots),
• calcium supplements, or dietary supplements containing calcium,
• other antihypertensive agents (for example, beta-blockers or long-acting calcium channel blockers),
• angiotensin II receptor antagonists (ARA) or aliskiren (blood pressure-lowering medications): your doctor may need to adjust your dose and/or take other precautions if you are taking angiotensin II receptor antagonists (ARA) or aliskiren (see also the information under the headings "Do not take Captopril/Hidroclorotiazida Teva-ratiopharm" and "Warnings and precautions").
• diuretics (medications to control water retention, for example, thiazides or loop diuretics),
• allopurinol (medications for gout), procainamide (antiarrhythmic medication), oral corticosteroids, cytostatic agents (anticancer medications), or medications that affect the body's immune system,
• lithium (medication used for bipolar affective disorder),
• tricyclic antidepressants,
• sympathomimetic medications (used to treat hypertension, shock, heart failure, asthma, or allergies) such as ephedrine, noradrenaline, or adrenaline,
• nonsteroidal anti-inflammatory drugs (NSAIDs),
• insulins or oral antidiabetic medications,
• cholestyramine or colestipol (medications that bind to cholesterol),
• muscle relaxants (for example, tubocurarine chloride),
• amphotericin B (for antifungal treatment),
• carbenoxolone (for the treatment of duodenal and gastric ulcers),
• corticosteroids (including glucocorticoids, for example, ACTH, prednisone),
• laxatives,
• medications for heart problems, including thrombolytics, digoxin, beta-blockers, and/or nitrates,
• carbamazepine (for the treatment of epilepsy).
• medications used more frequently to prevent organ transplant rejection and for cancer (sirolimus, everolimus, temsirolimus, and other mTOR inhibitors). See the section "Warnings and precautions."
• racecadotrilo (a medication used to treat diarrhea),

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Inform your doctor if you think you are (or may be) pregnant. Your doctor will usually advise you to stop taking Captopril/Hidroclorotiazida Teva-ratiopharm before becoming pregnant or as soon as you know you are pregnant and will advise you to take another medication instead of Captopril/Hidroclorotiazida Teva-ratiopharm. Captopril/Hidroclorotiazida Teva-ratiopharm is not recommended for use in the early stages of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Captopril/Hidroclorotiazida Teva-ratiopharm is not recommended for use in breastfeeding mothers.

Driving and operating machinery

During treatment with Captopril/Hidroclorotiazida Teva-ratiopharm, you may occasionally experience dizziness or fatigue that may affect your ability to drive or operate machinery that requires special attention.

Captopril/Hidroclorotiazida Teva-ratiopharm contains lactose

If your doctor has indicated 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. Consult your doctor or pharmacist if you have any doubts.

The dosage of this medication will depend on how you have responded previously to the intake of captopril and/or hidroclorotiazida individually.

The recommended dosage is 25 mg of captopril and 12.5 mg of hidroclorotiazida once a day.

The tablets should be taken in the morning, approximately 1 hour before breakfast. This dosage may be increased by your doctor up to 1 tablet of Captopril/Hidroclorotiazida Teva-ratiopharm 50/25 mg once a day.

The maximum daily dosage is 1 tablet of Captopril/Hidroclorotiazida Teva-ratiopharm 50/25 mg.

Dosage in renal insufficiency

The dosage depends on the degree of renal insufficiency. Follow the instructions indicated by your doctor.

Elderly patients and diabetic patients

The initial recommended dosage for elderly patients is 25 mg of captopril and 12.5 mg of hidroclorotiazida once a day, taken in the morning, approximately 1 hour before breakfast.

If you take more Captopril/Hidroclorotiazida Teva-ratiopharm than you should

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

If you forgot to take Captopril/Hidroclorotiazida Teva-ratiopharm

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can have side effects, although not everyone will experience them.

Side effects that require immediate contact with your doctor or first aid

If you experience any of the following side effects, stop taking Captopril/Hidroclorotiazida ratiopharm and seek medical attention immediately:

• swelling of the face or extremities, lips, tongue, mouth, or mucous membranes, which may be associated with shortness of breath or difficulty swallowing (angioedema),
• intense dizziness or fainting,

• severe abdominal pain
• unusually fast or irregular heartbeat,
• jaundice (yellowing of the eyes/skin)
• unexplained and sudden skin reactions such as rash, burning, peeling, or redness.

Other side effects

Captopril

Frequent (can affect up to 1 in 10 people)

• dry, persistent, and irritating cough, see section 2 "Warnings and precautions",
• sleep disturbances
• alterations in taste or dry mouth
• dizziness
• nausea, vomiting, stomach irritation, abdominal pain, diarrhea, or constipation
• skin rash with itching, skin irritation without rash, or hair loss
• shortness of breath

Rare (can affect up to 1 in 100 people)

• rapid heartbeat or other rhythm disorders, palpitations, or chest pain
• abnormally low blood pressure, see section 2 "Warnings and precautions", worsening of Raynaud's syndrome (white fingers), redness, or paleness
• fatigue, feeling unwell
• paroxysmal local inflammation of the skin and mucous membranes of the face, extremities, lips, tongue, larynx, and/or vocal cords (angioedema), see section 2 "Warnings and precautions",

Very rare (can affect up to 1 in 1,000 people)

• loss of appetite,
• drowsiness, headache
• mouth or lip ulcers
• renal function disorders, increased or decreased urine output, frequent need to urinate
• paresthesia
• allergic reactions in the small intestine (intestinal angioedema)

Very rare (can affect up to 1 in 10,000 people)

• unexplained fever
• anemia,(reduction in red blood cell count that can cause decreased performance and fatigue), reduction in white blood cell count that can cause infection, sore throat, fever, or bleeding (neutropenia, agranulocytosis), reduction in all blood cell types (pancytopenia), increase in eosinophil count,enlargement of lymph nodes or development of autoimmune diseases (when the immune system attacks the body itself)
• decreased platelet count (thrombocytopenia) that can cause bruising or nasal bleeding)
• confusion or depression
• brain circulation disorders due to low blood pressure (fainting, paralysis)
• blurred vision
• airway constriction and shortness of breath, nasal discharge, allergic inflammation of the alveoli or lung inflammation
• inflammation of the tongue, stomach ulcers, pancreatitis, or pancreatic disorders (characterized by severe back and stomach pain)
• renal insufficiency, cholestasis including jaundice (yellowing of the skin and white of the eyes and skin itching), liver inflammation, or liver necrosis
• urticaria, swelling under the skin, sensitivity to light, or reactions on mucous membranes that can cause skin problems, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, pemphigus
• muscle and joint pain
• impotence or chest inflammation in men
• protein appearance in urine
• laboratory value alterations: increased potassium levels in serum or decreased sodium levels in serum (see section 2 "Warnings and precautions"), increased creatinine, bilirubin, or liver enzyme levels, decreased white blood cell count
• unusual results in medical tests for autoimmune diseases
• heart attack, including strokes and fainting
• renal disorders (nephrotic syndrome of the skin)

Hidroclorotiazida

Very rare (can affect up to 1 in 10,000 people)

• acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Frequency unknown (cannot be estimated from available data)

• infections such as salivary gland inflammation (sialoadenitis)
• anemia (reduction in red blood cell count that can cause decreased performance and fatigue), reduction in white blood cell count (leucopenia), reduction in certain types of white blood cells that can cause infection, sore throat, fever, or bleeding (neutropenia, agranulocytosis), a decrease in the blood's ability to clot (thrombocytopenia) that can cause bruising or nasal bleeding
• bone marrow depression
• loss of appetite (anorexia); sugar in urine; high levels of sugar, uric acid (can lead to gout) in the blood
• electrolyte imbalance (decreased serum sodium and potassium levels), increased cholesterol and triglycerides
• restlessness, depression, sleep disturbances
• tingling, dizziness
• yellow vision,blurred vision, loss of 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
• dizziness
• low blood pressure, heart problems such as irregular heartbeat
• blood vessel inflammation
• respiratory and lung problems such as respiratory distress
• gastrointestinal irritation, diarrhea, constipation, pancreatitis
• jaundice that causes the skin and eyes to turn yellow
• severe skin reactions: skin sensitivity to light, rash,lupus erythematosus-like reactions,reactivation of lupus erythematosus-like reactions, allergic reactions that cause itching and skin redness (urticaria),anaphylactic reactions, toxic epidermal necrolysis
• skin cancer and lip cancer (non-melanoma skin cancer)
• muscle spasms
• renal problems
• fever, weakness

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.

Do not use Captopril/Hydrochlorothiazide Teva-ratiopharm after the expiration date that appears on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medicines should not be thrown down the drains or in the trash.Deposit the packaging and medicines that you no longer need at the SIGRE collection point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

Composition ofCaptopril/Hidroclorotiazida Teva-ratiopharm50/ 25 mg tablets EFG

The active principles are captopril and hidroclorotiazida.

Each tablet contains 50 mg of captopril and 25 mg of hidroclorotiazida.

The other components (excipients) are:

lactose monohydrate, magnesium stearate, pregelatinized cornstarch, microcrystalline cellulose and stearic acid.

Appearance of the product and contents of the packaging

White, round, convex, scored tablets on one side.

Captopril/HidroclorotiazidaTeva-ratiopharm50/ 25 mg tablets is available in packaging with 10, 12, 20, 28, 30, 50 60 or 100 tablets and in screw-top packaging containing 12, 20, 28, 30, 50, 60 or 100 tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

c/ Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible for manufacturing

Merckle GmbH

Ludwig-Merckle Strasse 3

89143 - Blaubeuren - Germany

Last review date of this leaflet: November 2023