Captopril/hydrochlorothiazide Teva-Ratiopharm 50/25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Captopril/Hydrochlorothiazide Teva-ratiopharm 50/25 mg tablets EFG

captopril and hydrochlorothiazide

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Captopril/Hydrochlorothiazide Teva-ratiopharm is and what it is used for

2. What you need to know before taking Captopril/Hydrochlorothiazide Teva-ratiopharm

3. How to take Captopril/Hydrochlorothiazide Teva-ratiopharm

4. Possible side effects

5. How to store Captopril/Hydrochlorothiazide Teva-ratiopharm

6. Contents of the pack and other information

1. What Captopril/Hydrochlorothiazide Teva-ratiopharm is and what it is used for

Captopril/Hydrochlorothiazide Teva-ratiopharm belongs to the group of antihypertensive medicines containing a combination of an ACE (angiotensin-converting enzyme) inhibitor. Captopril/Hydrochlorothiazide Teva-ratiopharm contains two active substances, captopril and hydrochlorothiazide, which reduce blood pressure through different mechanisms. Captopril prevents the formation of substances that raise blood pressure in the body, while hydrochlorothiazide lowers blood pressure by increasing the elimination of water and salts from the body.

Captopril/Hydrochlorothiazide Teva-ratiopharm is used for the treatment of hypertension when the desired effect cannot be achieved with monotherapy alone.

2. What you need to know before taking Captopril/Hydrochlorothiazide Teva-ratiopharm

Do not take Captopril/Hydrochlorothiazide Teva-ratiopharm

• if you are allergic to captopril, other ACE inhibitors, hydrochlorothiazide, sulfonamide derivatives, or any of the other components of this medicine (listed in section 6),
• if you have previously been treated with ACE inhibitors and during that time experienced hypersensitivity reactions manifesting, for example, as swelling of the face, lips, tongue, and/or larynx, 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 (Captopril/Hydrochlorothiazide Teva-ratiopharm is best avoided during early pregnancy—see pregnancy section),
• if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren,
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin, such as in the throat) is high.

Warnings and precautions

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

• if you are taking diuretics, your diet is low in salt or salt-free, or if you are currently experiencing or develop severe diarrhea or vomiting during treatment,
• if you have heart failure,
• if you have coronary or cerebrovascular disease,
• if you have bilateral renal artery stenosis or stenosis of the artery to the only functioning kidney,
• if you have mitral valve stenosis or aortic stenosis,
• if you have renal impairment, renal artery stenosis, or are undergoing dialysis,
• if you have gout or impaired urinary excretion (urine output less than 100 ml in 24 hours),
• if you have diabetes or collagen vascular disease,
• if you have hepatic insufficiency or other liver disorders,
• if you have hepatic encephalopathy (brain disorder associated with liver cirrhosis),
• if you are receiving desensitization therapy for insect venom,
• if you develop a persistent dry cough,
• if you have swelling due to a vascular nerve disorder (angioedema),
• if your potassium levels are high,
• if you experience a decrease in vision, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, occurring within hours to weeks after taking this medicine. If untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk,
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
• an angiotensin II receptor antagonist (ARA) (also known as “sartans”—e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes,
• aliskiren,
• if you are taking any of the following medicines, which increase the risk of angioedema (rapid swelling under the skin, such as in the throat):
• sirolimus, everolimus, temsirolimus, and other mTOR inhibitors (used to prevent organ transplant rejection and in cancer treatment),
• racecadotril, a medicine used to treat diarrhea,
• vildagliptin, a medicine used to treat diabetes,
• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from sun and UV exposure while taking Captopril/Hydrochlorothiazide Teva-ratiopharm.
• if you have previously had respiratory or lung problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop dyspnea or severe breathing difficulty after taking Captopril/Hydrochlorothiazide Teva-ratiopharm, seek medical attention immediately.

Your doctor may monitor 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 Captopril/Hydrochlorothiazide Teva-ratiopharm”.

Athletes should be aware that hydrochlorothiazide contained in this medicine may result in a positive doping test.

Children

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

Renal impairment

If you have renal impairment, it is important not to use potassium supplements or potassium-sparing diuretics during treatment with captopril/hydrochlorothiazide, as they may excessively increase potassium levels in your body.

Inform your doctor that you are taking Captopril/Hydrochlorothiazide Teva-ratiopharm if you require surgery during treatment, as certain anesthetic agents used during surgery may cause excessive lowering of blood pressure when combined with Captopril/Hydrochlorothiazide Teva-ratiopharm.

Inform your doctor if you think you are (or might be) pregnant. Captopril/Hydrochlorothiazide Teva-ratiopharm is not recommended during early stages of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby (see pregnancy section).

Other medicines and Captopril/Hydrochlorothiazide Teva-ratiopharm

Concomitant use of other medicines may affect the efficacy and safety of this medicine. Conversely, Captopril/Hydrochlorothiazide Teva-ratiopharm may affect the safety and efficacy of other medicines.

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

Remember to inform your doctor that you are taking Captopril/Hydrochlorothiazide Teva-ratiopharm if you are prescribed another medicine during or shortly after treatment.

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

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

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Inform your doctor if you think you are (or might be) pregnant. Your doctor will usually advise you to stop taking Captopril/Hydrochlorothiazide Teva-ratiopharm before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Captopril/Hydrochlorothiazide Teva-ratiopharm is not recommended during early pregnancy and must 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 about to start breastfeeding. Captopril/Hydrochlorothiazide Teva-ratiopharm is not recommended for breastfeeding mothers.

Driving and use of machines

During treatment with Captopril/Hydrochlorothiazide Teva-ratiopharm, you may occasionally experience dizziness or fatigue, which could affect your ability to drive or operate machinery requiring special attention.

Captopril/Hydrochlorothiazide Teva-ratiopharm contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Captopril/Hydrochlorothiazide Teva-ratiopharm

Follow exactly the instructions for use of this medicine as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

The dose of this medicine will depend on how you previously responded to treatment with captopril and/or hydrochlorothiazide taken individually.

The recommended dose is 25 mg of captopril and 12.5 mg of hydrochlorothiazide once daily.

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

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

Dosing in renal impairment

Dosage depends on the degree of renal impairment. Follow the instructions given by your doctor.

Elderly patients and diabetic patients

The recommended initial dose for elderly patients is 25 mg of captopril and 12.5 mg of hydrochlorothiazide once daily, taken in the morning, approximately 1 hour before breakfast.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Captopril/Hydrochlorothiazide Teva-ratiopharm

Do not take a double dose to make up for missed doses.

If you have any further questions about 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 everyone experiences them.

Adverse effects requiring immediate contact with your doctor or emergency care

If you experience any of the following effects, stop treatment with Captopril/Hydrochlorothiazide Teva-ratiopharm and seek immediate medical attention:

• swelling of the face or limbs, lips, tongue, mouth, or mucous membranes, which may be associated with shortness of breath or difficulty swallowing (angioedema),
• severe dizziness or fainting,
• severe abdominal pain,
• unusually fast or irregular heartbeat,
• jaundice (yellowing of eyes/skin),
• sudden, unexplained skin reactions such as rash, burning sensation, skin peeling, or redness.

Other adverse effects

Captopril

Common ( may affect up to 1 in 10 people)

• dry, persistent, and irritating cough; see section 2 "Warnings and precautions",
• sleep disturbances,
• taste disturbances or dry mouth,
• dizziness,
• nausea, vomiting, stomach irritation, abdominal pain, diarrhea, or constipation,
• itchy skin rash, burning skin without rash, or hair loss,
• dyspnea (shortness of breath).

Uncommon ( may affect up to 1 in 100 people)

• rapid heartbeat or other rhythm disturbances, palpitations, or chest pain,
• abnormally low blood pressure; see section 2 "Warnings and precautions"; worsening of Raynaud's syndrome (white fingers), flushing or pallor,
• fatigue, feeling unwell.

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

• loss of appetite,
• drowsiness, headache,
• mouth infection or mouth ulcers,
• kidney function disorders, increased or decreased urine output, increased frequency of urination,
• paresthesia,
• allergic reactions in the small intestine (intestinal angioedema).

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

• unexplained fever,
• anemia (reduction in red blood cell count which may cause reduced performance and fatigue), reduced number of certain types of white blood cells which may lead to infection, sore throat, fever, or bleeding (neutropenia, agranulocytosis), reduced number of all blood cells (pancytopenia), increased number of a certain type of white blood cells (eosinophilia), swollen lymph nodes, or development of autoimmune diseases (when the immune system attacks the body itself),
• reduced platelet count (thrombocytopenia), which may cause tendency to bruise or nosebleeds,
• confusion or depression,
• circulatory disorders in the brain due to low blood pressure (fainting, paralysis),
• blurred vision,
• narrowing of airways and difficulty breathing, runny nose, allergic inflammation of lung alveoli, or pulmonary inflammation,
• tongue swelling, stomach ulcers, pancreatitis, pancreatic disorders (characterized by severe back and stomach pain),
• impaired kidney function, cholestasis including jaundice (yellowing of the skin and whites of the eyes and itching), liver inflammation or hepatic necrosis,
• urticaria, swelling under the skin, photosensitivity, or mucosal reactions which may cause skin problems, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, pemphigus,
• muscle and joint pain,
• impotence or breast enlargement in men,
• appearance of protein in the urine,
• laboratory test abnormalities: increased serum potassium levels or decreased serum sodium levels (see section 2 "Warnings and precautions"), increased creatinine, bilirubin, or liver enzyme levels, decreased number or absence of white blood cells,
• unusual test results for autoimmune diseases,
• heart attack including stroke and fainting,
• kidney disorders (nephrotic skin syndrome).

Hydrochlorothiazide

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

• acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

Frequency not known (cannot be estimated from available data)

• infections such as inflammation of the salivary glands (sialadenitis),
• anemia (reduction in red blood cell count which may cause reduced performance and fatigue), reduced number of white blood cells (leukopenia), reduced number of certain types of white blood cells which may lead to infection, sore throat, fever, or bleeding (neutropenia, agranulocytosis), decreased blood clotting ability (thrombocytopenia) which may cause tendency to bruise or nosebleeds,
• bone marrow depression,
• loss of appetite (anorexia); sugar in urine; high levels of blood sugar, uric acid (which may lead to gout),
• electrolyte imbalance (decreased serum sodium and potassium levels), increased cholesterol and triglyceride levels,
• restlessness, depression, sleep disturbances,
• tingling, dizziness,
• yellow vision, blurred vision, vision loss, or eye pain due to elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion or acute angle-closure glaucoma)),
• dizziness,
• low blood pressure, heart problems such as irregular heartbeat,
• inflammation of blood vessels,
• lung and respiratory problems such as respiratory distress,
• gastric irritation, diarrhea, constipation, pancreatitis,
• jaundice causing yellowing of the skin and eyes,
• severe skin reactions: photosensitivity, rash, reactions such as cutaneous lupus erythematosus, reactivation of cutaneous lupus erythematosus, allergic reaction causing skin itching and redness (urticaria), anaphylactic reactions, toxic epidermal necrolysis,
• skin and lip cancer (non-melanoma skin cancer),
• muscle spasms,
• kidney problems,
• fever, weakness.

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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Captopril/Hydrochlorothiazide Teva-ratiopharm

Keep this medicine out of the sight and reach of children.

Do not use Captopril/Hydrochlorothiazide Teva-ratiopharm after the expiry date stated on the packaging after the abbreviation EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Captopril/Hydrochlorothiazide Teva-ratiopharm 50/25 mg tablets EFG

The active substances are captopril and hydrochlorothiazide.

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

The other components (excipients) are:

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

Appearance of the product and contents of the pack

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

Captopril/Hydrochlorothiazide Teva-ratiopharm 50/25 mg tablets are available in packs containing 10, 12, 20, 28, 30, 50, 60 or 100 tablets and in screw-cap containers containing 12, 20, 28, 30, 50, 60 or 100 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle Strasse 3

89143 - Blaubeuren - Germany

Date of the most recent revision of this package leaflet: November 2023

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63526/P_63526.html