DIUZINE 5 mg/50 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

DIUZINE 5 mg/50 mg tablets

Amiloride hydrochloride and hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine.

• 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, do not pass it on to others. It may harm them, even if their symptoms 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.

Contents of the pack:

1. What DIUZINE is and what it is used for
2. Before taking DIUZINE
3. How to take DIUZINE
4. Possible side effects
5. Storage of DIUZINE
6. Further information

1. What DIUZINE is and what it is used for

The amiloride component of DIUZINE belongs to a group of medicines called potassium-sparing diuretics (potassium-saving): amiloride is also a weak diuretic. The hydrochlorothiazide component of DIUZINE belongs to a group of medicines called diuretics (thiazides).

DIUZINE works by making the kidneys remove more water and salts and retain more potassium.

This helps to reduce high blood pressure and some forms of swelling, while also helping to maintain normal potassium levels in the blood.

DIUZINE is indicated for the treatment of high blood pressure (high blood pressure), especially in patients with low potassium levels; cardiac edema (swelling of the ankles, feet, or legs due to fluid retention); or ascites (fluid accumulation in the abdomen) due to cirrhosis (liver disease).

2. Before taking DIUZINE

Do not take DIUZINE

• if you are allergic (hypersensitive) to amiloride hydrochloride, hydrochlorothiazide, or any of the other components of DIUZINE.
• if you are allergic to any sulfonamide-derived medication (consult your doctor if you are unsure what medications are derived from sulfonamides).
• if you naturally have high potassium levels in your blood.
• if you are taking other medications or supplements that increase potassium levels in your blood.
• if you have kidney disease.

Consult your doctor if you are unsure whether you should start taking DIUZINE.

Be careful with DIUZINE

• if you have or have had any medical problems or allergies, inform your doctor.
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking DIUZINE.
• Tell your doctor if you have high potassium levels in your blood. Inform your doctor if you have any heart or lung problems, liver or kidney problems, gout, or lupus (an autoimmune disease), or if you are being treated with other diuretics. In such cases, your doctor may adjust the dose of your medications.
• if you have diabetes (high blood sugar levels), consult your doctor, as treatment with thiazides may require an adjustment of the dose of antidiabetic medications, including insulin.
• Before surgical interventions or anesthesia (even at the dentist), inform your doctor or dentist that you are taking DIUZINE, as a sudden drop in blood pressure associated with anesthesia may occur.
• The safety and efficacy in children have not been established, therefore, administration in minors is not recommended.
• Consult your doctor, even if any of the above circumstances have occurred to you in the past.
• If you experience a decrease in vision or eye pain, they 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 DIUZINE.
• 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 shortness of breath or severe difficulty breathing after taking DIUZINE, go to the doctor immediately.

Using other medications

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

In general, DIUZINE can be taken with other medications. However, it is essential to inform your doctor about any other medication you are taking, including those without a prescription, as some medications can compromise the action of others.

It is especially important that your doctor knows if you are taking any ACE inhibitors (used to treat high blood pressure), other potassium-sparing medications, or potassium supplements.

Also, inform your doctor if you are taking other antihypertensive medications, other diuretics, resins that reduce high cholesterol levels, antidiabetic medications, including insulin, muscle relaxants, pressor amines such as adrenaline (medications used in case of cardiac arrest or severe allergic reactions), steroids, certain painkillers, and anti-inflammatory medications, medications that decrease the body's defenses (cyclosporine, tacrolimus), or lithium (a medication used in some types of depression). The use of sedatives, narcotics, tranquilizers, alcohol, and painkillers can increase the antihypertensive effect of DIUZINE, so you should inform your doctor if you take any of them.

Taking DIUZINE with food and drinks

Tell your doctor if you take potassium supplements or eat a potassium-rich diet.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

The use of DIUZINE is not recommended during pregnancy.

The hydrochlorothiazide component of DIUZINE passes into breast milk. If treatment with this medication is essential, breastfeeding should be interrupted.

Driving and using machines

No data are available on the effects on the ability to drive and use machines.

Important information about some of the components of DIUZINE

Athletes are informed that this medication contains a component that can result in a positive doping test.

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

3. How to take DIUZINE

Follow the administration instructions of DIUZINE indicated by your doctor exactly.

Consult your doctor or pharmacist if you have any doubts.

Your doctor will decide the suitable dose, according to your condition and whether you are taking other medications.

Most people take the tablets with a little water.

Take DIUZINE daily. Do not take more tablets than the prescribed dose.

• Cardiac edema

The usual initial dose is one DIUZINE tablet per day.

• Hypertension

The usual initial dose is one DIUZINE tablet taken once a day or divided into two doses.

• Cirrhosis with ascites

The usual dose is one DIUZINE tablet taken once a day.

This dose may be increased by your doctor if necessary, without exceeding two tablets per day. In some patients, maintenance treatment can be controlled with intermittent dosing if your doctor indicates so.

The tablets can be divided to facilitate dose adjustment if your doctor indicates so.

Your doctor will indicate the duration of your treatment with DIUZINE. Do not stop treatment before, as only your doctor knows what is best for you.

Use in children

The safety and efficacy in children have not been established, therefore, administration in minors is not recommended.

If you take more DIUZINE than you should

In case of overdose, call your doctor immediately. The most likely symptoms will be dizziness or drowsiness, due to low blood pressure and/or excessive thirst, confusion, reduced urine volume, or rapid heartbeats.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: 915620420.

If you forget to take DIUZINE

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

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

4. Possible side effects

Like all medicines, DIUZINE can cause side effects, although not everybody gets them.

Blood and lymphatic system disorders: changes in blood cell count, red spots on the skin.

Metabolism and nutrition disorders: more frequently: anorexia (loss of appetite); may cause changes in your blood test results related to sodium, potassium, glucose, and uric acid levels. It may also increase glucose levels in urine. Gout, dehydration.

Psychiatric disorders: insomnia, nervousness, mental confusion, depression, drowsiness, agitation, reduced sexual desire.

Nervous system disorders: more frequently: headache, dizziness; fainting, vertigo, tingling sensation, stupor, tremors, encephalopathy (brain disease).

Eye disorders: vision changes, ocular hypertension (increased pressure inside the eye).

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].

Ear and labyrinth disorders: ringing in the ears.

Cardiac disorders: arrhythmia (change in heart rate), tachycardia (increased heart rate), chest pain, and palpitations (strong and rapid heartbeats).

Vascular disorders: orthostatic hypotension (dizziness or drowsiness due to low blood pressure when standing up suddenly) and other heart anomalies.

Respiratory, thoracic, and mediastinal disorders: cough, respiratory disorders, chest pain, difficulty breathing, nasal congestion, and very rarely, acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion.

Gastrointestinal disorders: more frequently: nausea; vomiting, diarrhea, constipation, abdominal pain, gastrointestinal bleeding, changes in appetite, abdominal heaviness, flatulence (gas), thirst, hiccups, bad taste in the mouth, dry mouth, cramps, difficult digestion, pancreatitis, stomach pain and/or ulcers.

Hepatobiliary disorders: may cause changes in your blood test results related to liver enzymes and bilirubin.

Skin and subcutaneous tissue disorders: more frequently: skin rash; itching, redness, sweating, hair loss, sensitivity to light, inflammation of the salivary glands, blistering, toxic epidermal necrolysis (a severe skin reaction characterized by blistering).

Musculoskeletal and connective tissue disorders: limb pain, muscle cramps, joint pain, back pain, neck and shoulder pain.

Renal and urinary disorders: changes in urination, renal dysfunction including kidney failure, kidney inflammation.

Reproductive system and breast disorders: impotence.

General disorders and administration site conditions: fatigue, discomfort, weakness, allergic reaction, fever.

Benign, malignant, and unspecified neoplasms (including cysts and polyps):

Frequencyunknown: Skin and lip cancer (non-melanoma skin cancer)

When side effects appear, your doctor may reduce the dose of DIUZINE or interrupt treatment.

If you experience any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of DIUZINE

Keep out of the reach and sight of children

No special storage conditions are required.

Do not use DIUZINE after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. FURTHER INFORMATION

Composition of DIUZINE

• The active ingredients are amiloride hydrochloride and hydrochlorothiazide. Each scored tablet contains 5 mg of amiloride hydrochloride and 50 mg of hydrochlorothiazide.
• The other ingredients are: lactose monohydrate, calcium phosphate dibasic, pregelatinized corn starch, microcrystalline cellulose, and magnesium stearate.

Appearance of the product and packaging contents

DIUZINE is presented in the form of white or almost white round tablets, in blisters, in packs of 20 and 60 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teofarma S.r.l.

Via F.lli Cervi 8

27010 VALLE SALIMBENE (Pavia) ITALY

Manufacturer

BOHM, S.A.

Molinaseca, 23. Pol. Ind. Cobo Calleja.

28947 Fuenlabrada (Madrid) – Spain

or

TEOFARMA, S.r.L.

Viale Certosa, 8/a

27100 Pavia. Italy

This leaflet was approved inDecember 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.agemed.es