Hydrochlorothiazide Normon 25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Hydrochlorothiazide Normon 25 mg tablets EFG

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

• Keep this leaflet, as 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, since 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.

Contents of the leaflet

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

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

Hidroclorotiazida Normon contains the active substance hydrochlorothiazide.

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), either 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 adult 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 Normon

Do not take Hidroclorotiazida Normon:

• 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 Hidroclorotiazida Normon.

Take special care in the following situations:

• If you have kidney problems.
• If you have liver problems.
• If you suffer from electrolyte imbalance, such as high levels of calcium in the blood.
• If you suffer from metabolic and endocrine disorders.
• If you have an autoimmune disease called systemic lupus erythematosus.
• If you experience a decrease in vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within a few hours to one week after taking Hidroclorotiazida Normon.
• 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 non-melanoma skin and lip cancer. Protect your skin from sun exposure and UV rays while taking Hidroclorotiazida Normon.
• If you have previously experienced respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop dyspnea or severe difficulty breathing after taking Hidroclorotiazida Normon, seek medical attention immediately.

Other medicines and Hidroclorotiazida Normon

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 reduce potassium levels.

• Antipsychotics, antidepressants, and antiepileptics.

• 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 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, sleep medications (such as barbiturates and narcotics).

• Pressor amines (such as noradrenaline).

Taking Hidroclorotiazida Normon with food, drinks, and alcohol

In combination with alcohol intake, 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 Hidroclorotiazida Normon, as Hidroclorotiazida Normon 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.

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

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 beginning of treatment, when changing doses, or if alcohol is consumed. If you experience dizziness or drowsiness, consult your doctor before performing such activities.

Use in athletes

This medicine contains hydrochlorothiazide, which may produce positive results in doping control tests.

Hidroclorotiazida Normon contains lactose

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

3. How to take Hydrochlorothiazide Normon

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

The recommended dose is:

• Treatment of hypertension (high blood pressure): initially a dose of 12.5 to 25 mg once daily is recommended; this dose 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) in adults: the recommended daily dose is 25 to 50 mg.
• Treatment of nephrogenic diabetes insipidus: initial doses of up to 100 mg/day are used.

Use in children and adolescents

Usual doses in children are:

• Treatment of hypertension (high blood pressure): 1 to 2 mg/kg body weight (which may be increased up to 3 mg/kg) once daily, given in one or two doses.
• Treatment of edema (excess fluid in the tissue beneath the skin): 2 mg/kg/day given in two divided doses.

Method and route of administration

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

The tablet may be divided into equal doses.

If you take more Hydrochlorothiazide Normon than you should

In case of overdose or accidental ingestion, contact 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, decreased circulating blood volume (hypovolemia), low blood pressure (hypotension), and electrolyte disturbances associated with irregular heart rhythms (cardiac arrhythmias) and muscle spasms.

If you forget to take Hydrochlorothiazide Normon

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

If you stop taking Hydrochlorothiazide Normon

Treatment for high blood pressure 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 may cause adverse effects, although not everyone experiences them.

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

• Decreased potassium levels in blood, increased blood lipid levels.

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

• Decreased levels of sodium and magnesium in blood, increased levels of uric acid.
• 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):

• Decreased number of platelets in blood, which may lead to a condition called purpura.
• Increased levels of calcium and blood sugar, 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.
• Yellow discoloration of the skin.
• Heart rhythm disturbances.

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

• Decreased number of white blood cells, haemolytic anaemia, disorders of bone marrow function.
• Allergic-type reactions, difficulty breathing.
• Decreased levels of chloride in blood.
• Inflammation of blood vessels, appearance of blisters on the skin, cutaneous lupus erythematosus-like reactions.
• Inflammation of the pancreas.
• Acute respiratory 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 reactions reported 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 kidney 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 Normon

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

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

Store below 30°C.

Medicines must not be disposed of via wastewater drains or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Hydrochlorothiazide Normon

• The active substance is hydrochlorothiazide. Each tablet contains 25 mg of hydrochlorothiazide.
• The other components (excipients) are lactose monohydrate, microcrystalline cellulose, corn starch, talc, magnesium stearate, colloidal anhydrous silica, and low-substituted hydroxypropylcellulose.

Appearance of the product and contents of the pack

Hydrochlorothiazide Normon 25 mg tablets are white or almost white, round, biconvex tablets, engraved with "H 25" on one side with a break line and smooth on the other, with a diameter of 7.1 mm ± 10%.

Hydrochlorothiazide Normon is packaged in aluminum-PVC-PVDC blisters (120) and is available in packs containing 20 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent review of this leaflet: December 2025

Detailed 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/

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/90833/P_90833.html