DIUREX 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Diurex 20 mg Tablets

xipamide

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 experience 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 Diurex is and what it is used for

2. What you need to know before you take Diurex

3. How to take Diurex

4. Possible side effects

5. Storing Diurex

6. Contents of the pack and other information

1. What Diurex is and what it is used for

Diurex belongs to a group of medicines called diuretics. Diuretics increase your need to urinate, reducing the amount of water and salt in your body. Their use helps to decrease and control blood pressure.

Diurex is used to treat high blood pressure (hypertension) and to eliminate excess fluid accumulated in the body for various reasons (edema).

2. What you need to know before you take Diurex

Do not take Diurex

? if you are allergic to xipamide, other sulfonamide derivatives or thiazides, or any of the other ingredients of this medicine (listed in section 6).

? if you have severe liver disease.

? if you have severe kidney failure.

? if you have any of the following blood disorders: low potassium or sodium levels, as well as high calcium levels, even if you are being treated.

? if you have gout, a disease 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 medicine.

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

• Changes in blood pressure when standing up.
• Allergic reactions.
• Recurring stomach discomfort.
• Acute inflammation of the pancreas (pancreatitis) or gallbladder (cholecystitis).
• Worsening of pre-existing muscle disorders.
• Inflammation of blood vessels (vasculitis).
• Nervous system diseases.
• Blood disorders (anemia, leukopenia, thrombocytopenia).
• Addison's disease.

? If you are diabetic or have high uric acid levels in your blood, your doctor may need to monitor you more closely and you may need to undergo periodic check-ups.

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

? Inform your doctor if you have a parathyroid function disorder, such as hyperparathyroidism.

? 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 pressure in the eye, and 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, the use of Diurex is not recommended in children and adolescents (under 18 years old).

Using Diurex with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, homeopathic medicines, herbal remedies, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

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

? 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 medicines for the treatment of arrhythmias.

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

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

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

? Cyclosporine, tacrolimus (used in organ transplants).

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

? Cytostatics (medicines for the treatment of neoplasms).

? Muscle relaxants.

? Corticosteroids.

? Metformin and other oral antidiabetics.

? Iodinated contrast media.

? Calcium and its salts.

? Amphotericin (antibiotic for the treatment of fungal infections).

? Laxatives.

Taking Diurex with food, drinks, and alcohol

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

During treatment with this medicine, you should not drink alcohol, as it may cause a drop in blood pressure with dizziness and/or fainting.

Use in athletes

Athletes are informed that this medicine contains a component that can produce a positive result in doping tests.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Diurex should not be taken during pregnancy and breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, stop taking this medicine and inform your doctor as soon as possible.

Driving and using machines

At the start of treatment with this medicine, your ability to drive vehicles and use machines may be reduced due to a decrease in your reflexes, which may be increased if you also consume alcohol. Therefore, do not drive or use potentially hazardous machinery until you have checked how you tolerate the medicine.

Important information about some of the ingredients 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 medicine.

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

3. How to take Diurex

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The recommended dose is:

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

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

It is recommended to take the medicine 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 your doctor to explain the procedure to follow in these cases.

Instructions for the correct administration of the preparation

Swallow the tablets whole, without chewing, with the help of a sufficient amount of liquid (e.g., a glass of water). Remember to take your medicine.

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

If you think the effect of Diurex is too strong or too weak, tell 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 urine output).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine 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 then continue your usual dosing regimen. Do not take a double dose to make up for forgotten doses.

If you have any other questions about 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.

The following side effects have been reported for Diurex. In such cases, you should inform your doctor as soon as possible:

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

• decrease in potassium levels in the blood, which may manifest as nausea, vomiting, decreased muscle strength, changes in heart rhythm, and changes in the electrocardiogram.
• decrease in urinary excretion of magnesium.

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

• headache
• dizziness
• affective indifference (apathy)
• anxiety
• agitation
• palpitations
• decrease in blood pressure when standing up
• muscle cramps
• abdominal discomfort or pain
• diarrhea
• constipation
• dry mouth
• sweating
• fatigue
• increased uric acid with gout episodes
• decrease in 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 hives
• abnormal increase in sensitivity to sunlight
• vision changes and worsening of existing myopia

• severe allergic reactions
• hemorrhagic pancreatitis
• increase in blood fats
• inflammation of the gallbladder.

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

• yellowing of the skin and mucous membranes (jaundice)
• acute interstitial nephritis (inflammation of the renal tubules)
• blood test changes, such as reductions in red blood cells and/or white blood cells and platelets (thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia).

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

• decrease in 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

If you think any of the side effects you are suffering from is serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

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 Health Products Agency's website: www.notificaram.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Diurex

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging and blister 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 a pharmacy for proper disposal. 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 Diurex

The active substance is xipamide. Each tablet contains 20 mg of xipamide.

The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, povidone, talc, sodium starch glycolate, colloidal anhydrous silica, magnesium stearate, glycerol palmitostearate.

Appearance of the product and contents of the pack

Diurex are white, flat, round, and scored tablets. The score line is only to facilitate breaking the tablet if you have difficulty swallowing it whole, but not to divide the tablet into equal doses. There are packs of 30, 60, and 500 (clinical pack) tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Date of last revision of this leaflet:11/2020

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