ALDACTAZIDE 25 mg/25 mg Tabletka Powlekana

Treść ulotki

1. ALDACTAZIDE 25 mg + 25 mg tablets
   1. What is ALDACTAZIDE and what is it used for
   2. What you need to know before taking ALDACTAZIDE
   3. How to take ALDACTAZIDE
   4. Possible side effects
   5. How to store ALDACTAZIDE
   6. Contents of the pack and other information

ALDACTAZIDE 25 mg + 25 mg tablets

Hydrochlorothiazide + Spironolactone

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What ALDACTAZIDE is and what it is used for
• 2. What you need to know before you take ALDACTAZIDE
• 3. How to take ALDACTAZIDE
• 4. Possible side effects
• 5. How to store ALDACTAZIDE
• 6. Contents of the pack and other information

1. What is ALDACTAZIDE and what is it used for

ALDACTAZIDE contains two active ingredients, hydrochlorothiazide and spironolactone in a fixed-dose combination.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics which increase the
production of urine, resulting in a decrease in blood pressure.
Spironolactone belongs to a group of medicines called potassium-sparing diuretics which
also increase urine production and prevent excessive potassium loss in the urine.
This medicine is indicated for the treatment of heart diseases (congestive heart failure), liver
(hepatic cirrhosis in the ascitic phase) and kidney (nephrotic syndrome), characterized by an accumulation of fluids
in the body due to an increase in the production of the hormone aldosterone (secondary hyperaldosteronism).

2. What you need to know before taking ALDACTAZIDE

Do not take ALDACTAZIDE

• if you are allergic to hydrochlorothiazide, spironolactone or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other thiazides or sulfonamide drugs;
• if you have difficulty urinating (anuria);
• if you have kidney problems (acute renal failure, worsening of renal excretory function);
• if you have high levels of potassium in your blood (hyperkalemia);
• if you suffer from a disease of the adrenal gland (Addison's disease) or other conditions associated with hyperkalemia;
• if you suffer from severe liver problems (severe hepatic insufficiency);
• if you have high levels of calcium in your blood (hypercalcemia);
• if you are breastfeeding;
• if you are taking other medicines to increase potassium levels in the blood or potassium supplements or salt substitutes containing potassium.

Warnings and precautions
Talk to your doctor or pharmacist before taking ALDACTAZIDE

• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of certain types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while using ALDACTAZIDE.
• if you have had breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking ALDACTAZIDE, consult a doctor immediately.

The concomitant administration of ALDACTAZIDE with certain medicines, potassium supplements and
potassium-rich foods may cause severe hyperkalemia (increased potassium levels
in the blood). Symptoms of severe hyperkalemia may include muscle cramps, irregular
heartbeat, diarrhea, nausea, dizziness or headache.
Take this medicine under the supervision of your doctor, with caution,if you are in any of the following
conditions:

• if you suffer from liver problems;
• if you suffer from kidney problems;
• if you suffer from diabetes;
• if you are taking other medicines that may promote increased potassium levels in the blood (hyperkalemia) (see section “Other medicines and ALDACTAZIDE”);
• if you have frequent episodes of vomiting (profuse emesis);
• if you have refractory edema (fluid accumulation in the body);
• if you suffer from or have suffered from allergic reactions or bronchial asthma;
• if you have an autoimmune disease called lupus erythematosus (also known as lupus or SLE).

Tell your doctor if you experience symptoms such as:

• excessive thirst, dry mouth, general weakness, drowsiness, agitation, muscle pain or cramps, nausea, vomiting, decreased blood pressure (hypotension), difficulty urinating, excessively fast heartbeat and stomach and intestinal disorders. These symptoms may indicate an imbalance of fluids and electrolytes (chemicals present in the blood and urine, e.g. sodium, potassium, calcium, magnesium, chlorine);
• decreased 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 (glaucoma) and may occur within hours or weeks of taking ALDACTAZIDE. If left untreated, they can lead to permanent vision damage.

During treatment with this medicine, especially in elderly patients and patients with reduced
liver and/or kidney function, your doctor will periodically check your kidney function, your
blood pressure, fluid intake, levels of certain chemicals present in the blood and urine, called electrolytes (e.g. sodium, potassium, calcium, magnesium, chlorine). It may also be necessary to
check glucose, cholesterol and triglyceride levels in the blood and uric acid levels in the
urine.
For athletes: the use of the drug without a therapeutic need constitutes doping and may
still result in a positive doping test.

Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age,
as safety and efficacy have not been established.

Other medicines and ALDACTAZIDE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Tell your doctor if you are using abiraterone for the treatment of prostate cancer.
Tell your doctor if you are taking mitotane for the treatment of malignant adrenal gland tumors.
This medicine should not be used in conjunction with mitotane.
Take this medicine with cautionand tell your doctor if you are taking:

• other medicines that may increase potassium levels in the blood, potassium supplements, salt substitutes containing potassium;
• trimethoprim and trimethoprim-sulfamethoxazole;
• medicines used to treat heart and/or blood vessel diseases, such as ACE inhibitorsand angiotensin II receptor antagonists;
• aldosterone antagonists,medicines used to control aldosterone levels in the blood;
• anti-inflammatory drugs such as indomethacinor other NSAIDs;
• if you are taking corticosteroids(e.g. cortisone) or if you are taking medicines based on adrenocorticotropic hormone(ACTH);
• medicines for controlling blood coagulation such as heparinand low molecular weight heparin;
• medicines used to treat heart problems (digoxin and digitalis);
• medicines for controlling blood sugar (oral antidiabeticsand insulin);
• tubocurarine, a medicine used to relax muscles;
• medicines containing lithium, used to treat mood disorders;
• medicines used for epilepsy (barbiturates).

If you are to undergo surgery, tell the anesthesiologist that you are taking this medicine, because
it may interact with the medicines used during surgical operations (anesthetics).

ALDACTAZIDE and alcohol
Drinking alcohol during treatment with this medicine may cause a feeling of dizziness
when getting up (orthostatic hypotension).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
The use of ALDACTAZIDE is not recommended during pregnancy as it may cause potentially
harmful effects on the fetus and newborn.
Hydrochlorothiazide should not be used during pregnancy for the treatment of symptoms such as
swelling and high blood pressure (edema and gestational hypertension, preeclampsia).

Do not useALDACTAZIDE if you are breastfeeding as hydrochlorothiazide and spironolactone may
be excreted in breast milk.
ALDACTAZIDE may reduce fertility in women.

Driving and operating machinery
ALDACTAZIDE may slightly or moderately impair the ability to drive or operate
machinery. If you experience drowsiness or dizziness, avoid driving or operating machinery.

3. How to take ALDACTAZIDE

Take this medicine following exactly the instructions of your doctor and pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The doctor will adjust the dosage based on your health conditions and your response to therapy.
The recommended doseis 2-4 tablets per day, to be taken divided into multiple administrations.

If you take more ALDACTAZIDE than you should
In case of ingestion of an excessive amount of this medicine, seek immediate medical attention or
go to the nearest hospital.
An excessive dosage of this medicine may manifest with an excessive reduction of
blood pressure (hypotension) and symptoms such as drowsiness, mental confusion, skin irritation (erythematous
or maculopapular rash), nausea, vomiting, dizziness or diarrhea, alteration of sodium and potassium levels in the blood
(hyponatremia, hyperkalemia/hypokalemia), depression of the nervous system and, in cases of people with liver
problems, even hepatic coma.
If you notice these symptoms, stop therapy and seek immediate medical attention.
In case of overdose, the doctor will induce vomiting or perform a gastric lavage, and will also establish a
supportive treatment to maintain hydration, the balance of electrolyte levels (chemical
substances present in the blood and urine, e.g. sodium, potassium, calcium, magnesium, chlorine) in the blood and monitor your
vital functions.

If you forget to take ALDACTAZIDE
Do not take a double dose to make up for the missed tablet.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Due to the presence of hydrochlorothiazide, the following side effects may occur:

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

• decreased levels of potassium in the blood (hypokalaemia);
• increased levels of cholesterol and triglycerides in the blood.

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

• increased levels of uric acid (hyperuricemia) in the blood;
• decreased levels of magnesium (hypomagnesaemia) and sodium (hyponatraemia) in the blood;
• feeling dizzy when getting up from a lying or sitting position (orthostatic hypotension);
• nausea, vomiting and loss of appetite;
• allergic skin reactions (urticaria);
• problems having sexual intercourse (impotence). Rare(may affect up to 1 in 1000):
• decreased number of platelets in the blood (thrombocytopenia);
• increased levels of calcium in the blood (hypercalcaemia);
• increased levels of sugar in the blood (hyperglycaemia) and worsening of diabetic metabolic status;
• depression and sleep disorders;
• dizziness, headache;
• altered sensation in the legs or arms (paraesthesia);
• vision changes;
• irregular heartbeats (arrhythmias);
• stomach problems (abdominal discomfort), constipation or diarrhoea;
• liver problems (intrahepatic cholestasis) and yellowish discoloration of the skin and whites of the eyes due to liver problems (jaundice);
• sensitivity to light (photosensitivity);
• presence of sugar in the urine (glycosuria). Very rare(may affect up to 1 in 10,000):
• decreased number of red blood cells and white blood cells in the blood (hemolytic anaemia, leucopenia), reduced production of new blood cells by the bone marrow;
• allergic reactions;
• reactivation or increase of the effects of an autoimmune disease that can affect different organs and tissues characterised by redness and lesions on the face (systemic lupus erythematosus);
• decreased levels of chlorine in the blood (hypochloraemic alkalosis);
• acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion);
• inflammation of the pancreas (pancreatitis);
• redness and lesions of the skin similar to those caused by a chronic disease (cutaneous lupus erythematosus);
• inflammation of superficial veins with resulting tissue death (necrotizing vasculitis) and severe skin reactions (toxic epidermal necrolysis).

Other side effects of unknown frequency(frequency cannot be estimated based on available data):

• skin and lip cancer (non-melanoma skin cancer);
• reduction in the number of blood cells (aplastic anaemia);
• rapid onset of distance vision impairment (acute myopia), decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma) and/or altered colour perception (xanthopsia);
• skin irritation (erythema multiforme);
• pemphigoid (a condition that manifests with the appearance of fluid-filled blisters on the skin);
• involuntary muscle contractions (muscle spasms);
• kidney problems (renal dysfunction, acute renal failure);
• muscle weakness (asthenia);
• fever.

Due to the presence of spironolactone, the following side effects of unknown frequencymay occur
(frequency cannot be estimated based on available data):

• generalised allergic reaction (anaphylactic reaction);
• inflammation of the small blood vessels in the skin (vasculitis);
• fever;
• urticaria, skin irritation with red spots, also raised (maculopapular or erythematous rashes);
• pemphigoid (a condition that manifests with the appearance of fluid-filled blisters on the skin);
• lesions in the stomach or intestine (stomach bleeding, ulcer), inflammation of the stomach (gastritis);
• diarrhoea, cramp-like abdominal pains, nausea and vomiting;
• alteration of the levels of electrolytes (chemical substances present in the blood and urine, e.g. sodium, potassium, calcium, magnesium, chlorine) in the blood (see section “Warnings and precautions”);
• reduced kidney function (renal insufficiency);
• enlargement of the breasts in men (gynaecomastia), erectile dysfunction;
• irregular menstrual cycle or complete absence of menstruation (amenorrhoea), post-menopausal bleeding, mild masculinising effects in women (hair growth, lowering of the voice);
• reduction in the number of white blood cells in the blood (agranulocytosis);
• mental confusion;
• loss of muscle coordination (ataxia);
• headache;
• drowsiness and lethargy;
• liver toxicity (hepatic toxicity).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store ALDACTAZIDE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Expiry”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ALDACTAZIDE contains

• The active ingredients are hydrochlorothiazide and spironolactone. Each tablet contains 25 mg of hydrochlorothiazide and 25 mg of spironolactone
• The other ingredients are starch, povidone, peppermint essence, magnesium stearate and calcium sulfate.

Description of the appearance of ALDACTAZIDE and contents of the pack
Pack of 20 white tablets in blisters.

Marketing Authorisation Holder
SPA - Società Prodotti Antibiotici S.p.A.
Via Biella, 8
20143 MILANO

Manufacturer
DOPPEL Farmaceutici S.r.l.
Workshop in Via Volturno, 48
20089 Quinto De' Stampi
Rozzano (MI).