HYDROCHLOROTHIAZIDE CINFA 12.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Hidroclorotiazida Cinfa 12.5 mg Tablets

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 Package Leaflet

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

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

Hidroclorotiazida Cinfa is a medicine that contains hydrochlorothiazide as the active substance. Hydrochlorothiazide is a diuretic (a medicine that increases urine production) that belongs to the group of thiazides. Hydrochlorothiazide increases urine production (diuretic) helping to reduce blood pressure (antihypertensive).

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

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

2. What you need to know before you take Hidroclorotiazida Cinfa

Do not take Hidroclorotiazida Cinfa:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine. Be especially careful in the following situations:

• if you have kidney problems,
• if you have liver problems,
• if you have electrolyte imbalance, such as high calcium levels in the blood,
• if you have metabolic and endocrine disorders,
• if you have an autoimmune disease called systemic lupus erythematosus,
• if you experience decreased vision or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within a few hours to a 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 sun and UV radiation while taking hydrochlorothiazide,
• 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 hydrochlorothiazide, seek medical attention immediately.

Other medicines and Hidroclorotiazida Cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 decrease potassium levels,
• antipsychotic, antidepressant, and antiepileptic medicines,
• medicines used to treat diabetes,
• digitalis (digoxin),
• anti-inflammatory medicines (salicylic acid derivatives, indomethacin),
• medicines used to treat gout, such as allopurinol,
• amantadine (antiviral medicine),
• medicines used to treat cancer (such as methotrexate, cyclophosphamide),
• anticholinergic agents (such as atropine),
• resins used to decrease cholesterol levels (such as cholestyramine, colestipol),
• vitamin D,
• cyclosporin (medicine used in transplant patients),
• calcium salts,
• medicines used to treat hypoglycemia (diazoxide),
• methyldopa, used to treat hypertension,
• alcohol, sleep-inducing medicines (such as barbiturates and narcotics),
• pressor amines (such as noradrenaline).

Taking Hidroclorotiazida Cinfa with food, drinks, and alcohol

In combination with alcohol consumption, this medicine may cause dizziness, drowsiness, or headache.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 in breastfeeding mothers. No human data are 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 use machines. However, like other medicines used to treat high blood pressure, hydrochlorothiazide may cause dizziness or drowsiness in some people, especially at the start of treatment, when changing doses, or when consuming alcohol. If you experience dizziness or drowsiness, consult your doctor before performing these activities.

Hidroclorotiazida Cinfa contains lactose

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

Use in athletes

Athletes are informed that this medicine contains a component that may result in a positive doping test.

3. How to take Hidroclorotiazida Cinfa

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The usual doses are:

• Treatment of arterial hypertension (high blood pressure): initially, a dose of 12.5 to 25 mg once a day is recommended, which can be increased to 50 mg/day divided into one or two doses.
• Treatment of edema (excessive fluid retention in tissues): the dose should not exceed 50 mg/day.
• Prevention of urinary stone formation (kidney stones): 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 Hidroclorotiazida Cinfa 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 medicine and the amount ingested.

The following signs and symptoms may occur in poisoning caused by an overdose: dizziness, nausea, drowsiness, decreased blood volume (hypovolemia), low blood pressure (hypotension), and electrolyte disorders associated with cardiac arrhythmias and muscle spasms.

If you forget to take Hidroclorotiazida Cinfa

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

If you stop taking Hidroclorotiazida Cinfa

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects (may affect more than 1 in 10 people):

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

Common side effects (may affect up to 1 in 10 people):

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

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

• decrease in platelet count in the blood that can trigger a disease called purpura,
• increase in calcium and sugar levels in the blood, sugar in urine, worsening of diabetes,
• headache, dizziness, sleep disturbances, depression, tingling sensation,
• vision disorders,
• skin alterations due to photosensitivity reactions,
• abdominal pain, constipation, diarrhea,
• yellowing of the skin,
• heart rhythm disorders.

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

• decrease in white blood cell count, hemolytic anemia, bone marrow disorders,
• allergic reactions, breathing difficulties,
• decrease in chloride levels in the blood,
• inflammation of blood vessels, appearance of blisters on the skin, lupus erythematosus-like reactions,
• pancreatitis,
• acute respiratory distress (symptoms include severe shortness of breath, fever, weakness, and confusion).

Frequency not known (cannot be estimated from the available data):

• skin and lip cancer (non-melanoma skin cancer).
• decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

Post-marketing experience

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Health Products Agency (AEMPS) at https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Hidroclorotiazida 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 packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. 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 ingredients (excipients) are: lactose monohydrate, talc, corn starch, colloidal anhydrous silica, and magnesium stearate.

Appearance and packaging

White, round, and biconvex tablets, approximately 6 mm in diameter.

The tablets are packaged in single-dose PVC/AL blisters. 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 last revision of this leaflet: December 2024

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 about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. 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