Package Insert: Information for the User

Esidrex 25 mg Tablets

Hidroclorotiazida

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Esidrex is a medication that contains hydrochlorothiazide as its active ingredient. Hydrochlorothiazide is a diuretic (a medication that increases the elimination of urine) that belongs to the group of thiazides. Hydrochlorothiazide increases the amount of urine (diuretic) helping to reduce blood pressure (antihypertensive).

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

• arterial hypertension (elevated blood pressure) alone or in combination with other antihypertensive medications,
• edema (excessive retention of fluid in tissues) due to heart, kidney, or liver disease,
• prevention of the formation of urinary stones (stones in the urinary tract) in patients with elevated levels of calcium in urine,
• renal insipid diabetes (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.

Do not take Esidrex:

• if you are allergic to hydrochlorothiazide or any of the other components of this medication (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 medication.

Be especially careful in the following situations:

• if you have kidney problems,
• if you have liver problems,
• if you have an electrolyte imbalance, such as high levels of calcium in the blood,
• if you have metabolic and endocrine problems,
• 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 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. The use of 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 exposure and UV rays 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 severe shortness of breath or difficulty breathing after taking Esidrex, seek medical attention immediately.

Taking Esidrex with other medications

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

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

• lithium (antidepressant),
• other antihypertensive medications,
• muscle relaxants,
• medications used to lower potassium levels,
• antipsychotic, antidepressant, and antiepileptic medications,
• medications used to treat diabetes,
• digitalis (digoxin),
• anti-inflammatory medications (salicylate derivatives, indomethacin),
• medications used to treat gout, such as allopurinol,
• amantadine (antiviral medication),
• medications used to treat cancer (such as methotrexate, cyclophosphamide),
• anticholinergic agents (such as atropine),
• resins used to lower cholesterol levels (such as cholestyramine, cholestipol),
• vitamin D,
• ciclosporin (medication used in transplant patients),
• calcium salts,
• medications used to treat hypoglycemia (diazoxide),
• metildopa, used to treat hypertension,
• alcohol, sleep-inducing medications (such as barbiturates and narcotics),
• aminergic pressors (such as noradrenaline).

Taking Esidrex with food, drinks, and alcohol

This medication may cause dizziness, vertigo, or headache when combined with alcohol consumption.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Generally, your doctor will advise you to take another medication 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 it is not recommended for lactating mothers.

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

Driving and operating machinery

It is unlikely that hydrochlorothiazide will affect your ability to drive or operate machinery.

Esidrex contains lactose

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

Esidrex contains wheat starch with gluten

This medication 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 0.49micrograms of gluten.

If you have a wheat allergy (other than celiac disease), do not take this medication.

Use in athletes

It is reported to athletes that this medication contains a component that may result in a positive analytical control for doping.

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

Usual doses are:

• Treatment of high blood pressure (high blood pressure): initially, a dose of 12.5 to 25 mg once a day is recommended, which can 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 system): the recommended daily dose is 25 to 50 mg.
• Treatment of diabetic nephrogenic diabetes insipidus: initial doses of up to 100 mg/day are used.

Administration Form

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

The tablet can be split into 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

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

If you forgot to take Esidrex

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Esidrex

High blood pressure treatment is a long-term treatment, and interrupting this treatment should be consulted with your doctor.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

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

• decrease in blood sodium and magnesium levels, 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 patients):

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

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

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

Side effects of unknown frequency (cannot be estimated from available data):

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

Post-marketing experience of adverse reactions

The following adverse reactions have been identified through post-marketing experiences. Since these reactions have been voluntarily reported by an uncertain population size, it is not possible to estimate the reliability of their frequency.

Unknown frequency: acute renal failure, renal disorder, aplastic anemia, erythema multiforme, fever, 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 that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Store in the original packaging to protect it from moisture.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Esidrex

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

Appearance of the product and contents of the packaging

Esidrex 25 mg tablets are white, round, flat tablets with beveled edges, with one face having a groove, and the other face without a groove.

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

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization

Laboratoires Juvisé Pharmaceuticals

149 boulevard Stalingrad

69100 Villeurbanne

France

Manufacturer responsible

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

Last review date of this leaflet:Januaryof 2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.