ESIDREX 25 mg TABLETS

Introduction

Package Leaflet: Information for the User

Esidrex 25 mg Tablets

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

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

1. What is Esidrex and what is it used for

Esidrex 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 medicines,
• 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 urine,
• nephrogenic diabetes insipidus (a disorder in which a defect in the small tubes (tubules) of the kidney makes a person produce a large amount of urine) when treatment with antidiuretic hormone is not indicated.

2. What you need to know before you take 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 eliminating urine (anuria),
• if you are pregnant and have high blood pressure,

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

Be particularly 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 vision loss or eye pain, which 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 Esidrex,
• 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 cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Esidrex,
• 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 shortness of breath or severe difficulty breathing after taking Esidrex, seek medical attention immediately.

Taking Esidrex with other medicines

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,
• cyclosporine (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 Esidrex 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking 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.

No data are available in humans. Animal studies do not show effects on fertility.

Driving and using machines

Hydrochlorothiazide is unlikely to affect your ability to drive or use machines.

Esidrex contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them 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 is very unlikely to cause problems if you have celiac disease.

One tablet does not contain more than 0.49 micrograms of gluten.

If you have a wheat allergy (different from celiac disease), do not take 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 Esidrex

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, 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 daily 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 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 can be divided into two equal halves.

If you take more Esidrex than you should

If you have taken more Esidrex than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

The following signs and symptoms may occur in case of 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 Esidrex

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

If you stop taking Esidrex

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

If you have any further questions on 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 disorders 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, blistering of the skin, cutaneous lupus erythematosus reactions,
• pancreatitis,
• acute respiratory distress (symptoms include severe breathing difficulties, fever, weakness, and confusion).

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

• skin cancer and lip cancer (non-melanoma skin cancer).
• vision loss 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 renal failure, renal 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 through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Esidrex

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

Store in the original packaging to protect from moisture.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. 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 ingredients (excipients) are lactose, wheat starch (see section 2 contains gluten), talc, anhydrous colloidal silica, and magnesium stearate.

Appearance and packaging

Esidrex 25 mg tablets are white, round, flat tablets with beveled edges, one side with 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 authorization holder and manufacturer

Marketing authorization 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 last revision of this leaflet:January 2022

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