Leaflet: information for the user

Diurex 20 mg tablets

xipamide

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

?Keep this leaflet, as you may need to read it again.

?If you have any questions, consult your doctor or pharmacist.

?This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

?If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.- What Diurex is and for what it is used

2.- What you need to know before starting to take Diurex

3.- How to take Diurex

4.- Possible side effects

5.- Storage of Diurex

6.- Contents of the pack and additional information

Diurex belongs to a group of medications known as diuretics. Diuretics increase the need to urinate by reducing the amount of water and salt in the body. Its use helps to decrease and control blood pressure.

Diurex is used to treat high blood pressure (hypertension), as well as to eliminate excessive fluid accumulation in the body due to various causes (edemas).

Do not take Diurex

?If you are allergic to xipamide, other sulfonamide derivatives, or thiazide derivatives, or to any of the other components of this medication (listed in section 6).

?If you have a severe liver disease.

?If you have severe kidney insufficiency.

?If you suffer from any of the following blood disorders: potassium or sodium deficiency, as well as increased calcium levels, even if you are being treated.

?If you have gout, a condition characterized by an excess of uric acid in the blood.

?If you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions

?If you have liver or kidney disease, inform your doctor before taking this medication.

?If you have any of the following conditions, stop taking the medication and contact your doctor:

- Orthostatic hypotension.

- Allergic reactions.

- Repeated stomach discomfort.

- Acute pancreatitis or cholecystitis.

- Worsening of previous muscle disorders.

- Vasculitis.

- Neurological disorders.

- Blood disorders (anemia, leukopenia, thrombocytopenia).

- Addison's disease.

?If you are diabetic or have high uric acid levels in the blood, your doctor may require closer monitoring and possibly regular check-ups.

?Your doctor may ask you to have your sodium and potassium levels checked before and during treatment with this medication, especially if you are over 65 years old, have heart or liver disease, or are taking other medications.

?Inform your doctor if you have a parathyroid function disorder, for example, hyperparathyroidism.

?If you experience a decrease in vision or eye pain, it may be a symptom of fluid accumulation in the eye's vascular layer (choroidal effusion) or increased eye pressure, which can occur within a few hours to a week after taking Diurex.

Children and adolescents

The efficacy and safety of use in children have not been established. Therefore, Diurex is not recommended for use in children and adolescents (under 18 years old).

Use of Diurex with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription, homeopathic, herbal, or other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

It is especially important to inform your doctor if you are taking any of the following medications:

?Beta-blockers, ACE inhibitors, and other diuretics (used to treat high blood pressure).

?Lithium, for the treatment of manic-depressive disorder.

?Amiodarone, quinidine, and other antiarrhythmic medications.

?Cardiac glycosides, organic nitrates, and vasodilators (used in heart disease).

?Salicylates and nonsteroidal anti-inflammatory drugs, for pain relief and inflammation.

?Phenothiazines and tricyclic antidepressants for the treatment of personality disorders and depression.

?Ciclosporin, tacrolimus (used in organ transplants).

?Colestiramine and colestipol (used to reduce cholesterol and other fatty substances in the blood).

?Cytostatics (medications for cancer treatment).

?Muscle relaxants.

?Corticosteroids.

?Metformin and other oral antidiabetic medications.

?Iodinated contrast media.

?Calcium and its salts.

?Anfotericin (antibiotic for fungal infections).

?Laxatives.

Diurex with food, drinks, and alcohol

Diurex tablets are taken orally, swallowed whole, without chewing, with the help of a glass of water, and can be taken either on an empty stomach or with food (see also “Instructions for correct preparation administration”).

During treatment with this medication, do not consume alcohol, as it may cause a decrease in blood pressure with dizziness and/or fainting.

Use in athletes

Inform athletes that this medication contains a component that may produce a positive result in doping control tests.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Diurex should not be taken during pregnancy and breastfeeding. Therefore, if you are pregnant or breastfeeding, stop taking this medication and inform your doctor as soon as possible.

Driving and operating machinery

At the beginning of treatment with this medication, your ability to drive vehicles and operate machinery may be reduced due to decreased reflexes, which may be exacerbated if you consume alcohol at the same time. Therefore, do not drive or operate potentially hazardous machinery until you have checked how you tolerate the medication.

Important information about some components of Diurex

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

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. The recommended dose is:

?High blood pressure (hypertension): 1 tablet per day.

?Excessive fluid accumulation (edema): 2 tablets per day.

It is recommended to take the medication in the morning during or after breakfast.

In special situations (renal and/or hepatic insufficiency, congestive heart failure) it may be necessary to adjust the dose. Consult with your doctor to explain the course of action in these cases.

Instructions for Correct Administration of the Preparation

Swallow the tablets whole, without chewing, with a sufficient amount of liquid (for example, a glass of water). Remember to take your medication.

Your doctor will indicate the duration of your treatment with Diurex and may also adjust your dose if necessary. Do not change the dose indicated by your doctor, do not suspend treatment without consulting them first and never do it abruptly, as it may be harmful to your health.

If you estimate that the action of Diurex is too strong or weak, inform your doctor or pharmacist.

If You Take More Diurex Than You Should

If for any reason you took more Diurex tablets than you should, you may experience symptoms such as: nausea, vomiting, decreased blood pressure, cramps, dizziness, drowsiness, and urinary disorders (increased, decreased, or suppressed urination).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Diurex

If you forget to take a dose, do not worry; wait until the next dose to take your next tablet and continue with your usual dosing regimen. Do not take a double dose to compensate for the missed doses.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

The following side effects have been reported for Diurex. Inform your doctor as soon as possible in such cases:

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

- Decreased potassium levels in the blood that may manifest as nausea, vomiting, muscle weakness, heart rhythm disturbances, and changes in the electrocardiogram

- Decreased urinary excretion of magnesium.

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

- Headache

- Dizziness

- Affective indifference (apathy)

- Anxiety

- Restlessness

- Palpitations

- Decreased blood pressure upon standing

- Muscle cramps

- Abdominal discomfort or pain

- Diarrhea

- Constipation

- Dry mouth

- Sweating

- Fatigue

- Increased uric acid with episodes of gout

- Decreased sodium and magnesium levels in the blood

- Dehydration.

Rare side effects(may affect up to 1 in 1,000 people):

- Skin redness

- Itching and/or urticaria

- Abnormal increased sensitivity to sunlight

- Vision disturbances and worsening of existing myopia

- Severe allergic reactions

- Hemorrhagic pancreatitis

- Increased blood lipids

- Inflammation of the gallbladder.

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

- Yellow discoloration of the skin and mucous membranes (jaundice)

- Acute interstitial nephritis (inflammation of the renal tubules)

- Abnormalities in blood tests, such as reductions in red blood cells and/or white blood cells and platelets (thrombocytopenia, leucopenia, agranulocytosis, aplastic anemia).

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

- Decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, consult your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use. Website: www.notificaram.es

By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Diurex

The active ingredient is xipamida. Each tablet contains 20 mg of xipamida.

The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, povidone, talc, carboxymethylstarch sodium of potato, anhydrous colloidal silica, magnesium stearate, glycerin palmitoestearate.

Appearance of the product and contents of the packaging

Diurex are white, flat, round, and scored tablets. The score is only for breaking the tablet if it is difficult to swallow whole, but not for dividing the tablet into equal doses. There are packaging with 30, 60, and 500 (clinical packaging) tablets.

Not all packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Last review date of this leaflet: 11/2020

The detailed and updated information of this medicine is available on the website of

the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/