Esidrex 25 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Esidrex 25 mg tablets

Hydrochlorothiazide

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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 Esidrex is and what it is used for
2. What you need to know before taking Esidrex
3. How to take Esidrex
4. Possible side effects
5. How to store Esidrex
6. Contents of the pack and other information

1. What Esidrex is and what it is used for

Esidrex 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:

• arterial hypertension (high blood pressure), either alone or in combination with other antihypertensive medicines,
• oedema (excessive fluid retention in the 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's small 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 Esidrex

Do not take Esidrex:

• if you are allergic to hydrochlorothiazide or 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 taking 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 have 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 may occur within hours to one week after taking Esidrex,
• if you have allergies or asthma,
• if you have had skin cancer or 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 Esidrex,
• 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 Esidrex, seek medical attention immediately.

Taking Esidrex with other medicines

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,
• antipsychotics, antidepressants, and antiepileptics,
• medicines used for the treatment of diabetes,
• digitalis (digoxin),
• anti-inflammatory medicines (salicylate derivatives, indomethacin),
• medicines for the treatment of gout, such as allopurinol,
• amantadine (antiviral medicine),
• medicines used for the treatment of cancer (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, sleeping pills (such as barbiturates and narcotics),
• pressor amines (such as noradrenaline).

Taking Esidrex 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 may 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 Esidrex, as Esidrex 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.

There are no human data 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.

Esidrex contains lactose

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

Esidrex contains wheat starch with gluten

This medicine contains very low levels of gluten (from wheat starch). It is considered "gluten-free," and it is very unlikely to cause problems if you have celiac disease.

One tablet contains no more than 0.49 micrograms of gluten.

If you have a wheat allergy (different from celiac disease), you should not take this medicine.

Use in athletes

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

3. How to take Esidrex

Follow exactly the instructions for use of this medicine provided 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 in one or two divided doses.
• Treatment of edema (excessive fluid retention under tissues): the dose should not exceed 50 mg/day.
• Prevention of kidney stone formation (urinary calculi): the recommended daily dose is 25 to 50 mg.
• Treatment of nephrogenic 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.

The tablet may be divided into two equal halves.

If you take more Esidrex than you should

If you have taken more Esidrex than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91 562 04 20, indicating the medication and the amount taken.

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 disturbances in the normal heart rhythm (cardiac arrhythmias) and muscle cramps.

If you forget to take Esidrex

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

If you stop taking Esidrex

Treatment of hypertension is long-term, and discontinuation of 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 people):

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

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

• 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 people):

• decrease in the number of platelets in the blood which may trigger 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,
• vision disorders,
• skin disorders due to photosensitivity reactions,
• abdominal pain, constipation, diarrhoea,
• yellowing of the skin,
• disturbances in heart rhythm.

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

• decrease in the number of white blood cells, 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 (symptoms 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 reports following 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 Esidrex

Keep this medicine out of sight and reach of children.

Store in the original packaging to protect it from moisture.

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 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 Esidrex

• The active substance is hydrochlorothiazide. Each tablet contains 25 mg of hydrochlorothiazide.
• The other components (excipients) are lactose, wheat starch (see section 2, contains gluten), talc, anhydrous colloidal silica and magnesium stearate.

Appearance of the product and contents of the pack

Esidrex 25 mg tablets are white, round, flat tablets with bevelled edges, one side having a score line and the other side without a score line.

Esidrex is packaged in blisters and is available in packs containing 20 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratoires Juvisé Pharmaceuticals
149 boulevard Stalingrad
69100 Villeurbanne
France

Manufacturer

Cenexi
52 Rue Marcel et Jacques Gaucher
94120 Fontenay-sous-Bois
France

Delpharm l’Aigle
Zone Industrielle N°1, Route de Crulai
61300 L’Aigle
France

Date of the most recent revision of this leaflet: January 2022

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