Hydrochlorothiazide Normon 50 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

HidroclorotiazidaNormon 50 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Hidroclorotiazida Normon is and what it is used for
2. What you need to know before taking Hidroclorotiazida Normon
3. How to take Hidroclorotiazida Normon
4. Possible side effects
5. How to store Hidroclorotiazida 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 (kidney stones) 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 have an electrolyte imbalance, such as high levels of calcium in the blood.
• If you have metabolic or endocrine disorders.
• If you suffer from 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 one week after taking Hidroclorotiazida Normon.
• If you suffer from 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 cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking hydrochlorothiazide.
• If you have previously experienced respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking hydrochlorothiazide, seek medical attention immediately.

Other medicines and Hidroclorotiazida Normon

Tell 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 antiepileptic medicines.
• Medicines used for the treatment of diabetes.
• Digitalis (digoxin).
• Anti-inflammatory medicines (salicylic acid derivatives, indomethacin).
• Medicines used for the treatment of gout, such as allopurinol.
• Amantadine (antiviral medicine).
• Medicines used for cancer treatment (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-inducing medicines (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, therefore 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 operate machinery. 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 engaging in such activities.

Use in athletes

This medicine contains hydrochlorothiazide, which may lead to a positive result in doping control tests.

Hidroclorotiazida Normon contains lactose

If your doctor has informed you that you have 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 prescribed by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended doses are:

• Treatment of hypertension (high blood pressure): the initial recommended dose is 12.5 to 25 mg once daily, which 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 (kidney stones 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

The 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 tissues beneath the skin): 2 mg/kg/day administered 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, sleepiness (somnolence), reduced 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 forgotten doses.

If you stop taking Hydrochlorothiazide Normon

Treatment of hypertension is a long-term therapy, 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 patients):

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

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

• 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 patients):

• Decrease in the number of platelets in the blood, which may trigger a disease 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, diarrhea.
• Yellowing of the skin.
• Heart rhythm disturbances.

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

• 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 (signs include severe shortness of breath, fever, weakness, and confusion).

Adverse effects with frequency not known (cannot be estimated from 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].

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 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 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 refers to the last day of the month indicated.

Store below 30 °C.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Hydrochlorothiazide Normon

• The active substance is hydrochlorothiazide. Each tablet contains 50 mg of hydrochlorothiazide.
• The other components (excipients) are monohydrate lactose, microcrystalline cellulose, corn starch, talc, magnesium stearate, anhydrous colloidal silica, and low-substituted hydroxypropylcellulose.

Appearance of the medicinal product and contents of the pack

Hydrochlorothiazide Normon 50 mg tablets are white or almost white, round, biconvex tablets, engraved with "H 50" on one side with a break line, and smooth on the other side, with a diameter of 9.1 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 can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/90834/P_90834.html