Hydrochlorothiazide Cinfa 12.5 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Hydrochlorothiazide cinfa 12.5 mg tablets

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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 could 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.

Leaflet contents

1. What Hydrochlorothiazide cinfa is and what it is used for
2. What you need to know before taking Hydrochlorothiazide cinfa
3. How to take Hydrochlorothiazide cinfa
4. Possible side effects
5. How to store Hydrochlorothiazide cinfa
6. Contents of the pack and other information

1. What Hidroclorotiazida cinfa is and what it is used for

Hidroclorotiazida cinfa is a medicine containing hydrochlorothiazide as the active substance. Hydrochlorothiazide is a diuretic (a medicine that increases urine elimination) belonging to the thiazide group. Hydrochlorothiazide increases urine output (diuretic effect), helping to reduce blood pressure (antihypertensive effect).

This medicine is indicated for the treatment of the following conditions:

• hypertension (high blood pressure), alone or in combination with other antihypertensive medicines,
• edema (excessive fluid retention in tissues) due to heart, kidney, or liver disease,
• prevention of urinary stone formation (stones in the urinary tract) in patients with high levels of calcium in the urine,
• nephrogenic diabetes insipidus (a disorder in which a defect in the kidney tubules causes a person to excrete large amounts of urine), when treatment with antidiuretic hormone is not indicated.

2. What you need to know before taking Hidroclorotiazida cinfa

Do not take Hidroclorotiazida cinfa:

• if you are allergic to hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6),
• if you have problems passing urine (anuria),
• if you are pregnant and have high blood pressure.

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine. Take special care in the following situations:

• if you have kidney problems,
• if you have liver problems,
• if you have electrolyte imbalances, such as high levels of calcium in the blood,
• if you have metabolic or endocrine disorders,
• if you suffer from an autoimmune disease called systemic lupus erythematosus,
• if you experience a decrease in vision or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, and which may occur within hours to one week after taking hydrochlorothiazide,
• if you have allergies or asthma,
• 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 exposure to sunlight and UV rays while taking hydrochlorothiazide,
• if you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking hydrochlorothiazide, seek medical attention immediately.

Other medicines and Hidroclorotiazida cinfa

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

The following medicines may interact with hydrochlorothiazide when used at the same time:

• lithium (antidepressant),
• other antihypertensives,
• muscle relaxants,
• medicines used to lower potassium levels,
• antipsychotic, antidepressant, and antiepileptic medicines,
• medicines used for the treatment of diabetes,
• digitalis (digoxin),
• anti-inflammatory medicines (salicylic acid derivatives, indomethacin),
• medicines for the treatment of gout, such as allopurinol,
• amantadine (antiviral medicine),
• medicines used for cancer treatment (such as methotrexate, cyclophosphamide),
• anticholinergic agents (such as atropine),
• resins used to lower cholesterol levels (such as cholestyramine, colestipol),
• vitamin D,
• cyclosporine (a medicine used in transplant patients),
• calcium salts,
• medicines used for the treatment of hypoglycemia (diazoxide),
• methyldopa, used for the treatment of hypertension,
• alcohol, sleep-inducing medicines (such as barbiturates and narcotics),
• pressor amines (such as noradrenaline).

Taking Hidroclorotiazida cinfa with food, drinks, and alcohol

When taken together with alcohol, this medicine may cause dizziness, lightheadedness, or headache.

Pregnancy, breastfeeding, and fertility

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

Generally, your doctor will advise you to take another medicine instead of hydrochlorothiazide, as hydrochlorothiazide is not recommended during pregnancy. This is because hydrochlorothiazide crosses the placenta and its use after the first trimester of pregnancy may cause potentially harmful effects on the fetus and newborn.

Hydrochlorothiazide is excreted in breast milk, so its use is not recommended for breastfeeding mothers. Human data are not available. Animal studies do not show effects on fertility.

Driving and using machines

It is unlikely that hydrochlorothiazide will affect your ability to drive or operate machinery. However, like other medicines used to treat high blood pressure, hydrochlorothiazide may cause dizziness or drowsiness in some people, especially at the beginning of treatment, when changing doses, or if alcohol is consumed. If you experience dizziness or drowsiness, consult your doctor before engaging in such activities.

Hidroclorotiazida cinfa contains lactose

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

Use in athletes

Athletes are advised that this medicine contains a component that may lead to a positive analytical finding in doping control tests.

3. How to take Hydrochlorothiazide cinfa

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The usual doses are:

• Treatment of hypertension (high blood pressure): initially, a dose of 12.5 to 25 mg once daily is recommended, which may be increased up to 50 mg/day divided into one or two doses.
• Treatment of edema (excessive fluid retention under the tissues): the dose should not exceed 50 mg/day.
• Prevention of urinary stone formation (stones in the urinary tract): the recommended daily dose is 25 to 50 mg.
• Treatment of renal diabetes insipidus: initial doses of up to 100 mg/day are used.

Method of administration

The tablets should be taken orally, with or without food.

If you take more Hydrochlorothiazide cinfa than you should

In case of overdose or accidental ingestion, consult 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.

The following signs and symptoms may occur in poisoning due to overdose: dizziness, nausea, somnolence, reduced circulating blood volume (hypovolemia), low blood pressure (hypotension), and electrolyte disturbances associated with irregular heart rhythm (cardiac arrhythmias) and muscle spasms.

If you forget to take Hydrochlorothiazide cinfa

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

If you stop taking Hydrochlorothiazide cinfa

Treatment of hypertension is long-term, and discontinuation of this treatment should be discussed with your doctor.

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.

Very common adverse effects (may affect more than 1 in 10 patients):

• decrease in blood potassium levels, increase in blood lipids.

Common adverse effects (may affect up to 1 in 10 patients):

• decrease in blood sodium and magnesium levels, increase in uric acid levels,
• urticaria, skin rash,
• loss of appetite, nausea, vomiting,
• orthostatic hypotension (sudden drop in blood pressure),
• impotence.

Uncommon adverse effects (may affect up to 1 in 1,000 patients):

• decrease in platelet count which may lead to a condition called purpura,
• increase in blood calcium and blood sugar levels, sugar in urine, worsening of diabetes,
• headache, dizziness, sleep disturbances, depression, tingling sensation,
• visual disturbances,
• skin disorders due to photosensitivity reactions,
• abdominal pain, constipation, diarrhoea,
• yellowing of the skin,
• disturbances in heart rhythm.

Rare adverse effects (may affect up to 1 in 10,000 patients):

• decrease in white blood cell count, haemolytic anaemia, disorders of bone marrow function,
• allergic-type reactions, difficulty breathing,
• decrease in blood chloride levels,
• inflammation of blood vessels, appearance of blisters on the skin, cutaneous lupus erythematosus-like reactions,
• inflammation of the pancreas,
• acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

Adverse effects with unknown frequency (cannot be estimated from available data):

• skin and lip cancer (non-melanoma skin cancer).
• decreased vision 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].

Adverse reaction experiences after marketing

The following adverse reactions have been identified from post-marketing experience. Because these reactions have been reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.

Unknown frequency: acute renal failure, renal disorder, aplastic anaemia, erythema multiforme, pyrexia, muscle spasms, asthenia, angle-closure glaucoma.

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 Hydrochlorothiazide cinfa

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

This medicine does not require any special storage temperature. Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hidroclorotiazida cinfa

• The active substance is hydrochlorothiazide.

Each tablet contains 12.5 mg of hydrochlorothiazide.

• The other components (excipients) are: monohydrate lactose, talc, corn starch, anhydrous colloidal silica and magnesium stearate.

Appearance of the product and contents of the pack

White, round, biconvex tablets with an approximate diameter of 6 mm.

The tablets are packaged in single-dose AL/PVC blister packs. Each pack contains 20 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Pharmaceutical Works Polpharma S.A.

Pelplinska 19

83-200 Starogard Gdanski

Poland

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the most recent review of this leaflet: December 2024

Detailed information on this medicine is available on the website of the Spanish Agency of 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 in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/90051/P_90051.html

QR code to: https://cima.aemps.es/cima/dochtml/p/90051/P_90051.html