Diuzine 5 mg/50 mg tablets
SpainTable of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIUZINE 5 mg/50 mg tablets
Amiloride hydrochloride and hydrochlorothiazide
Read the entire 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 and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you think any of the side effects you experience is serious or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What DIUZINE is and what it is used for
- Before you take DIUZINE
- How to take DIUZINE
- Possible side effects
- How to store DIUZINE
- Further information
1. What DIUZINE is and what it is used for
The amiloride component of DIUZINE belongs to a group of medicines called antikaliuretic (potassium-sparing) agents: 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 eliminate more water and salts while retaining more potassium.
This helps reduce hypertension and certain types of edema, while simultaneously helping to maintain normal potassium levels in the blood.
DIUZINE is indicated for the treatment of hypertension (high blood pressure), particularly in patients who have low potassium levels; edema of cardiac origin (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
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- if you are allergic (hypersensitive) to amiloride hydrochloride, hydrochlorothiazide, or to any of the other components of DIUZINE.
- if you are allergic to any medicine derived from sulfonamides (consult your doctor if you are unsure which medicines are derived from sulfonamides).
- if you naturally have high levels of potassium in your blood.
- if you are taking other medicines or supplements that increase the amount of potassium in your blood.
- if you have kidney disease.
Consult your doctor if you are unsure whether you should start taking DIUZINE.
Take special care with DIUZINE
- if you suffer or have suffered from any medical condition or any allergy, inform your doctor.
- 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 exposure to sunlight and UV rays while taking DIUZINE.
- Inform your doctor if you have elevated levels of potassium in plasma. Inform your doctor if you have any heart or lung disease, liver or kidney problems, gout, or systemic lupus erythematosus (an autoimmune disease), or if you are being treated with other diuretics. In such cases, your doctor may need to adjust the dose of your medications.
- if you have diabetes (high blood sugar levels), consult your doctor, as treatment with thiazides may require adjustment of the dose of antidiabetic medicines, including insulin.
- Before undergoing surgery or anesthesia (including at the dentist), inform the doctor or dentist that you are taking DIUZINE, as a sudden drop in blood pressure associated with anesthesia may occur.
- Safety and efficacy have not been established in children; therefore, administration in pediatric patients is not recommended.
- Consult your doctor, even if any of the above conditions occurred in the past.
- 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 eye pressure, which may occur within hours to a week after taking DIUZINE.
- if you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop dyspnea or severe difficulty breathing after taking DIUZINE, seek medical attention immediately.
Use of other medicines
Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines, including those obtained without a prescription.
In general, DIUZINE can be taken with other medicines. However, it is important to inform your doctor about any other medicines you are taking, including those without a prescription, as some medicines may interfere with 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 medicines, or potassium supplements.
Also inform your doctor if you are taking other antihypertensive medicines, other diuretics, cholesterol-lowering resins, antidiabetic medicines including insulin, muscle relaxants, pressor amines such as adrenaline (medicines used in cardiac arrest or severe allergic reactions), steroids, certain analgesics and anti-inflammatory drugs, medicines that reduce immune defenses (cyclosporine, tacrolimus), or lithium (a medicine used in some types of depression). The use of sedatives, narcotics, tranquilizers, alcohol, and analgesics may enhance the antihypertensive effect of DIUZINE, so you should inform your doctor if you are taking any of these.
Taking DIUZINE with food and drinks
Inform your doctor if you take potassium supplements or follow a potassium-rich diet.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before using any medicine.
The use of DIUZINE is not recommended during pregnancy.
The hydrochlorothiazide component of DIUZINE passes into breast milk. If treatment with this medicine is essential, breastfeeding should be discontinued.
Driving and using machines
There are no data available on the effects on the ability to drive and use machines.
Important information about some of the components of DIUZINE
Athletes are advised that this medicine contains a component that may result in a positive doping test.
This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take DIUZINE
Follow exactly the administration instructions for DIUZINE as indicated by your doctor.
Consult your doctor or pharmacist if you have any doubts.
The appropriate dose will be determined by your doctor, depending on the patient's condition and whether or not they 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.
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- Hypertension
The usual initial dose is one DIUZINE tablet taken once daily or divided into two doses.
- Cirrhosis with ascites
The usual dose is one DIUZINE tablet taken once daily.
This dose may be increased by your doctor if necessary, without exceeding two tablets per day. In some patients, maintenance treatment may be managed with intermittent dosing schedules, as directed by your doctor.
The tablets may be divided to facilitate dose adjustment, as directed by your doctor.
Your doctor will indicate the duration of your treatment with DIUZINE. Do not stop treatment earlier, as only your doctor knows what is appropriate for you.
Use in children
Safety and efficacy have not been established in children; therefore, administration in pediatric patients is not recommended.
If you take more DIUZINE than you should
In case of overdose, call your doctor immediately. The most likely symptoms are dizziness or lightheadedness due to a drop in blood pressure and/or excessive thirst, confusion, reduced urine volume, or rapid palpitations (strong and fast heartbeats).
In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 915620420.
If you forget to take DIUZINE
Do not take a double dose to make up for missed doses.
If you have any other questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, DIUZINE may produce adverse effects, although not everyone experiences them.
Blood and lymphatic system disorders: changes in blood cell counts, red spots on the skin.
Metabolism and nutrition disorders: most frequently: anorexia (loss of appetite); may cause changes in blood test results regarding 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: most frequently: headache, dizziness; fainting, vertigo, tingling sensation, stupor, tremors, encephalopathy (brain disease).
Eye disorders: visual disturbances, ocular hypertension (increased pressure inside the eye).
Decreased vision or eye pain due to elevated pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].
Ear and labyrinth disorders: tinnitus (ringing in the ears).
Cardiac disorders: arrhythmia (irregular heart rate), tachycardia (increased heart rate), chest pain, palpitations (strong and rapid heartbeats).
Vascular disorders: orthostatic hypotension (dizziness or lightheadedness due to a drop in blood pressure upon standing suddenly), and other heart abnormalities.
Respiratory, thoracic and mediastinal disorders: cough, breathing difficulties, chest pain, shortness of breath, nasal congestion, and very rarely, acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion).
Gastrointestinal disorders: most frequently: nausea; vomiting, diarrhea, constipation, abdominal pain, gastrointestinal bleeding, appetite disturbances, abdominal heaviness, flatulence (gas), thirst, hiccups, bad taste in mouth, dry mouth, cramps, indigestion, pancreatitis (inflammation of the pancreas), stomach pain and/or ulcer.
Hepatobiliary disorders: may cause changes in blood tests related to liver enzymes and bilirubin.
Skin and subcutaneous tissue disorders: most frequently: skin rash; itching, redness, sweating, hair loss, photosensitivity, salivary gland inflammation, blistering, toxic epidermal necrolysis (a severe skin reaction characterized by blister formation).
Musculoskeletal and connective tissue disorders: limb pain, muscle cramps, joint pain, back pain, neck and shoulder pain.
Renal and urinary disorders: urinary disturbances, renal dysfunction including kidney failure, kidney inflammation.
Reproductive system and breast disorders: impotence.
General disorders and administration site conditions: fatigue, malaise, weakness, allergic reaction, fever.
Benign and malignant neoplasms (including cysts and polyps):
Frequency unknown: Skin and lip cancer (non-melanoma skin cancer)
When adverse effects occur, your doctor may reduce your DIUZINE dose or discontinue treatment.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of DIUZINE
Keep out of the reach and sight of children.
No special storage conditions required.
Do not use DIUZINE after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the Punto Sigre collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. ADDITIONAL INFORMATION
Composition of DIUZINE
- The active substances are amiloride hydrochloride and hydrochlorothiazide. Each scored tablet contains 5 mg of amiloride hydrochloride and 50 mg of hydrochlorothiazide.
- The other components are: monohydrate lactose, dibasic calcium phosphate, pregelatinized corn starch, microcrystalline cellulose, and magnesium stearate.
Appearance of the product and contents of the pack
DIUZINE is available as round, white or almost white tablets, in blisters, in pack sizes 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 in December 2021
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.agemed.es