PATIENT INFORMATION LEAFLET

DIUZINE 5 mg/50 mg tablets

Hydrochlorothiazide and Amiloride Hydrochloride

Read this leaflet carefully before you start taking this medicine.

• 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. Do not give it to others, even if they have the same symptoms, as it may harm them.
• If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

DIUZINE acts by causing the kidneys to eliminate more water and salts and retain more potassium.

This helps to reduce hypertension and some forms of edema, while at the same time helping to maintain normal levels of potassium in the blood.

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

Do not take DIUZINE

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• if you are allergic (hypersensitive) to hydrochlorothiazide, amiloride hydrochloride, or any of the other components of DIUZINE.
• if you are allergic to any sulfonamide-derived medications (consult your doctor if you are not sure which medications are derived from sulfonamides).
• if you naturally have high levels of potassium in your blood.
• if you are taking other medications or supplements that increase the amount of potassium in your blood.
• if you have kidney disease.

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

Be especially careful with DIUZINE

• if you have any medical condition or allergy, inform your doctor.
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The use of hydrochlorothiazide, particularly long-term high-dose use, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV rays while taking DIUZINE.
• inform your doctor if you have high levels of potassium in plasma. Inform your doctor if you have any heart or lung disease, liver or kidney problems, gout, or lupus erythematosus (autoimmune disease), or if you are being treated with other diuretics. In such cases, your doctor may modify the dosage of your medications.
• if you have diabetes (high blood sugar levels), consult your doctor, as treatment with thiazides may require adjustment of the dosage of antidiabetic medications, including insulin.
• Before surgical procedures or anesthesia (including dental procedures) inform your doctor or dentist that you are taking DIUZINE, as a sudden drop in blood pressure may occur associated with anesthesia.
• The safety and efficacy of DIUZINE have not been established in children, therefore it is not recommended for use in minors.
• Consult your doctor, even if any of the previously mentioned circumstances have occurred at any time.
• If you experience a decrease in vision or eye pain, they may be symptoms offluid accumulation in the vascular layer of the eye (choroidal effusion)or an increase in eye pressure, which may 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 severe shortness of breath or difficulty breathing after taking DIUZINE, seek medical attention immediately.

Use of other medications

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

DIUZINE can generally be taken with other medications. However, it is essential to inform your doctor of any other medications you are taking, including those without a prescription, as some medications may interact with each other.

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

Also inform your doctor if you are taking other anti-hypertensive medications, other diuretics, cholesterol-lowering resins, antidiabetic medications, including insulin, muscle relaxants, pressor amines such as adrenaline (medications used in case of cardiac arrest or severe allergic reactions), steroids, certain analgesics and anti-inflammatory medications, medications that reduce the action of the body's defenses (ciclosporin, tacrolimus), or lithium (medication used in certain types of depression). The use of sedatives, narcotics, tranquilizers, alcohol, and analgesics may increase the anti-hypertensive effect of DIUZINE, so inform your doctor if you are taking any of them.

DIUZINE and food and beverages

Inform your doctor if you are taking potassium supplements or consuming a diet rich in potassium.

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 necessary, breastfeeding should be discontinued.

Driving and operating machinery

No data is available on the effects on the ability to drive and operate machinery.

Important information about some of the components of DIUZINE

It is informed to athletes that this medication contains a component that may result in a positive analytical test for doping control.

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.

Follow exactly the administration instructions for DIUZINE as indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

Your doctor will decide on the suitable dose, based on the patient's condition and whether they are taking other medications.

Most people take the tablets with a little water.

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

• Cardiac edema

The usual initial dose is one DIUZINE tablet per day.

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• 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 may be controlled with intermittent dosing regimens if your doctor indicates so.

Tablets may be divided to facilitate dose adjustment if your doctor indicates so.

Your doctor will inform you of the duration of your treatment with DIUZINE. Do not discontinue treatment prematurely, 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, contact your doctor immediately. The most likely symptoms will be dizziness or drowsiness, due to decreased blood pressure and/or excessive thirst, confusion, reduced urine output, or rapid heart palpitations.

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

If you forgot to take DIUZINE

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, DIUZINE can cause side effects, although not everyone will experience them.

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

Metabolism and nutrition disorders:more frequently: loss of appetite (anorexia); may cause changes in blood tests 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, feeling of sleepiness, agitation, reduced sexual desire.

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

Eye disorders:vision changes, increased intraocular pressure (high pressure inside the eye).

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

Ear and labyrinth disorders:ringing in the ears.

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

Vascular disorders:orthostatic hypotension (dizziness or lightheadedness due to a sudden drop in blood pressure when standing up) and other heart abnormalities.

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 inflammation, stomach pain and/or ulcer.

Hepatobiliary disorders:may cause changes in blood tests related to liver enzymes and bilirubin.

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

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

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

Reproductive and breast system 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)

If side effects occur, your doctor may reduce the dose of DIUZINE or discontinue treatment.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult 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 System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the reach and sight of children

No special storage conditions are required.

Do not use DIUZINE after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or in the trash. Dispose of packaging and unused medications at the pharmacy's Take-Back Point. If in doubt, ask your pharmacist how to dispose of unused packaging and medications.This will help protect the environment.

Composition of DIUZINE

• The active principles are hydrochlorothiazide and hydrochlorothiazide. Each scored tablet contains 5 mg of hydrochlorothiazide and 50 mg of hydrochlorothiazide.
• The other components are: lactose monohydrate, calcium phosphate dibasic, pregelatinized cornstarch, microcrystalline cellulose, and magnesium stearate.

Appearance of the product and contents of the package

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teofarma S.r.l.

Via F.lli Cervi 8

27010 VALLE SALIMBENE (Pavia) ITALIA

Responsible for manufacturing

BOHM, S.A.

Molinaseca, 23. Pol. Ind. Cobo Calleja.

28947 Fuenlabrada (Madrid) – España

or

TEOFARMA, S.r.L.

Viale Certosa, 8/a

27100 Pavia. Italia

This leaflet has been approved inDecember 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.agemed.es