CAPTOPRIL/HYDROCHLOROTHIAZIDE TEVA-RATIOPHARM 50/25 mg TABLETS

Introduction

Package Leaflet: Information for the User

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

captopril and hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Captopril/Hydrochlorothiazide Teva-ratiopharm and what is it used for
2. What you need to know before you take Captopril/Hydrochlorothiazide Teva-ratiopharm
3. How to take Captopril/Hydrochlorothiazide Teva-ratiopharm
4. Possible side effects
5. Storage of Captopril/Hydrochlorothiazide Teva-ratiopharm

1. Contents of the pack and other information

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

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

Captopril/Hydrochlorothiazide Teva-ratiopharm is used in the treatment of hypertension when the desired result is not achieved by monotherapy alone.

2. What you need to know before you take 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 ingredients of this medicine (listed in section 6),
• if you have been treated with ACE inhibitors in the past and during this time you 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 pregnant for more than three months (it is best to avoid Captopril/Hydrochlorothiazide Teva-ratiopharm in the initial stages of pregnancy - see section pregnancy),
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren,
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in areas such as the throat) is high.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Captopril/Hydrochlorothiazide 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 suffering or suffer during treatment from severe diarrhea or vomiting,
• if you have heart failure,
• if you have coronary artery or cerebrovascular disease,
• if you have bilateral renal artery stenosis or stenosis of the artery of the only functioning kidney,
• if you have mitral valve stenosis or aortic stenosis,
• if you have kidney failure, renal artery stenosis, or are receiving dialysis,
• if you have gout or have affected urine excretion (urine output less than 100 ml in 24 hours),
• if you have diabetes or collagen vascular disease,
• if you have liver failure or other liver disorder,
• if you have hepatic encephalopathy (brain disorder associated with liver cirrhosis),

• if you are receiving desensitization therapy against insect toxins,

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

• if your potassium levels are high,
• if you experience a decrease in ocular vision, it could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure, and these can occur within a few hours to weeks after taking this medicine. If left untreated, this can lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamide, you may be at higher risk of developing it,
• 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, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is increased:
• sirolimus, everolimus, temsirolimus, and other mTOR inhibitor class medicines (used to prevent organ transplant rejection and for cancer)
• racecadotril, a medicine used to treat diarrhea
• vildagliptin, a medicine used to treat diabetes
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV ray exposure while taking Captopril/Hydrochlorothiazide 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/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 are warned that the 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.

Patients with kidney problems

If you have kidney failure, it is essential that you do not 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 using Captopril/Hydrochlorothiazide Teva-ratiopharm if you need to undergo surgery during treatment, as some anesthetics used during surgery may cause excessive blood pressure lowering in combination with Captopril/Hydrochlorothiazide Teva-ratiopharm.

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

Other medicines and Captopril/Hydrochlorothiazide Teva-ratiopharm

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

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

Remember to tell your doctor that you are taking Captopril/Hydrochlorothiazide Teva-ratiopharm if he prescribes another medicine for you during or after treatment.

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

• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase the amount of potassium 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 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 change 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/Hydrochlorothiazide Teva-ratiopharm” and “Warnings and precautions”).
• diuretics (medicines to control water retention, e.g., thiazides or loop diuretics),
• allopurinol (medicines for gout), procainamide (anti-arrhythmic medicine), oral corticosteroids, cytostatic agents (anticancer medicines), or medicines that affect the body's immune system,
• lithium (medicine used for bipolar affective disorder),
• antipsychotic and tricyclic antidepressant medicines,
• sympathomimetic medicines (used for hypertension, shock, heart failure, asthma, or allergies) such as ephedrine, noradrenaline, or adrenaline,
• non-steroidal anti-inflammatory medicines (NSAIDs),
• insulins or oral antidiabetic medicines,
• cholestyramine or colestipol resins (medicines that bind to cholesterol),
• muscle relaxants (e.g., tubocurarine chloride),
• amphotericin B (for antifungal treatment),
• carbenoxolone (for the treatment of duodenal and gastric ulcers),
• corticosteroids (including glucocorticoids, e.g., ACTH, prednisone),
• stimulant laxatives,
• medicines for heart problems, including thrombolytics, digoxin, beta-blockers, and/or nitrates,
• carbamazepine (for the treatment of epilepsy).
• medicines used more frequently to prevent organ transplant rejection and for cancer (sirolimus, everolimus, temsirolimus, and other mTOR inhibitor class medicines). See section “Warnings and precautions”.
• racecadotril (a medicine used to treat diarrhea),

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Inform your doctor if you think you are (or might be) pregnant. Your doctor will normally advise you to stop taking Captopril/Hydrochlorothiazide Teva-ratiopharm before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Captopril/Hydrochlorothiazide Teva-ratiopharm. Captopril/Hydrochlorothiazide Teva-ratiopharm is not recommended in the early stages of pregnancy and must not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if taken 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 using machines

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

Captopril/Hydrochlorothiazide Teva-ratiopharm contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Captopril/Hydrochlorothiazide Teva-ratiopharm

Follow exactly the administration instructions of this medicine as indicated by your doctor. Ask your doctor or pharmacist if you have any doubts.

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

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

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

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

Dose in renal impairment

Dosage depends on the degree of renal impairment. Follow the instructions indicated 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 a day, 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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 forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can have adverse effects, although not all people suffer from them.

Adverse Effects that Require Immediate Contact with Your Doctor or Emergency Services

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 the eyes/skin)
• unexplained and sudden skin reactions such as rash, burning, peeling, or redness of the skin.

Other Adverse Effects

Captopril

Frequent (may affect up to 1 in 10 people)

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

Uncommon (may 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 of discomfort
• paroxysmal local inflammation of the skin and mucous membranes of the face, limbs, lips, tongue, larynx, and/or vocal cords (angioedema), see section 2 "Warnings and Precautions",

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

• loss of appetite,
• sleepiness, headache
• mouth infection or mouth ulcers
• kidney function disorders, increased or decreased urine output, frequent increase in the need to urinate
• 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 that can cause decreased performance and fatigue), reduction in the number of certain types of white blood cells that can cause infection, sore throat, fever, or bleeding (neutropenia, agranulocytosis), reduction in the number of all blood cells (pancytopenia), increase in the number of a certain type of white blood cells (eosinophilia), enlargement of lymph nodes or development of autoimmune diseases (when the immune system attacks the body itself)
• decrease in platelet count (thrombocytopenia) that can cause a tendency to bruise or nosebleeds)
• confusion or depression
• circulatory disorders in the brain due to low blood pressure (fainting, paralysis)
• blurred vision
• constriction of the airways and shortness of breath, runny nose, allergic inflammation of the lung alveoli, or lung inflammation
• tongue inflammation, stomach ulcers, pancreatitis, pancreatic disorders (characterized by severe back and stomach pain)
• renal function impairment, cholestasis including jaundice (yellowing of the skin and eyes and itching), liver inflammation, or liver necrosis
• urticaria, swelling under the skin, sensitivity to light, or reactions in the mucous membranes that can cause skin problems, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, pemphigus)
• muscle and joint pain
• impotence or breast inflammation in men
• appearance of proteins in the urine
• laboratory value changes: increased potassium levels in serum or decreased sodium levels in serum (see section 2 "Warnings and Precautions"), increased creatinine, bilirubin, or liver enzyme values, decreased white blood cell count
• unusual test results for autoimmune diseases
• heart attack including stroke and fainting
• kidney disorders (nephrotic syndrome of the skin)

Hydrochlorothiazide

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 (cannot be estimated from available data)

• infections such as inflammation of the salivary glands (sialadenitis)
• anemia (reduction in red blood cell count that can cause decreased performance and fatigue), reduction in white blood cell count (leukopenia), 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 a tendency to bruise or nosebleeds
• bone marrow depression
• loss of appetite (anorexia); sugar in the urine; high sugar, uric acid (can lead to gout) levels in the blood
• electrolyte imbalance (decrease in 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 effusion or acute angle-closure glaucoma
• dizziness
• low blood pressure, heart problems such as irregular heartbeat
• inflammation of blood vessels
• pulmonary and respiratory problems such as respiratory distress
• gastric irritation, diarrhea, constipation, pancreatitis
• jaundice that causes the skin and eyes to turn yellow
• severe skin reactions: skin sensitivity to light, rash, reactions like lupus erythematosus, reactivation of lupus erythematosus, allergic reaction that causes itching and redness of the skin (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 that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date stated on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

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

The active ingredients are captopril and hydrochlorothiazide.

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

The other ingredients (excipients) are:

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

Product Appearance and Package Contents

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

Captopril/Hydrochlorothiazide Teva-ratiopharm 50/25 mg tablets are available in packages of 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 package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

c/ Anabel Segura 11, Edificio Albatros B 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle Strasse 3

89143 - Blaubeuren - Germany

Date of Last Revision of this Prospectus:November 2023

Detailed information on this medicine 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 updated information on this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63526/P_63526.html