SPIRIDAZIDE 25 mg/25 mg Hard Capsule

Зміст інструкції

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

Spiridazide 25 mg + 25 mg hard capsules

spironolactone + hydrochlorothiazide

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

1. What is Spiridazide and what is it used for

Spiridazide contains spironolactone and hydrochlorothiazide, two substances that belong to a group of
medicines called “diuretics”, which help the body to lose excess water through urine.
This medicine is prescribed to help lose fluids, which tend to accumulate when
the body produces a high amount of the hormone aldosterone. This condition, called
hyperaldosteronism, can manifest during the following diseases:

• congestive heart failure- a disease that as initial symptoms can present swelling in the ankles, legs and abdomen accompanied by fatigue and shortness of breath. This happens when the heart, having to pump a greater amount of fluids, has to work harder and weakens. By eliminating excess fluids, its heart will work less;
• nephrotic syndrome- a kidney disease that causes swelling around the eyes or in the abdomen, hands and legs due to excess fluid in the body;
• liver cirrhosis with ascites- a serious liver disease whose most frequent complication consists of the accumulation of fluid in the abdomen. If you have one of these diseases, Spiridazide will help your body get rid of excess fluids.

2. What you need to know before taking Spiridazide

Do not take Spiridazide

• if you are allergic to the active ingredients, to similar substances (other thiazides or sulfonamides) or to any of the other ingredients of this medicine (listed in section 6);
• if you do not urinate (anuria);
• if you have a severe kidney disease (acute renal failure) or suffer from conditions that involve damage to the normal filtering function of the kidneys;
• if you have an excess of potassium in the blood (which may be caused by the body's difficulty in eliminating potassium through the kidneys, as in Addison's disease);
• if you have a severe liver disease (severe hepatic insufficiency);
• if you have an excess of calcium in the blood;
• if you are following a therapy to supplement potassium deficient in the body, either through the assumption of drugs or as a potassium-rich diet.

Warnings and precautions
Consult your doctor or pharmacist before taking Spiridazide:

• 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 some types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Spiridazide.
• if you have had breathing or lung problems (including inflammation or fluid in the lungs) following the assumption of hydrochlorothiazide in the past. If after taking Spiridazide you experience shortness of breath or severe difficulty breathing, consult a doctor immediately. The concomitant administration of Spiridazide with some 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.

Consult your doctor and be careful:

• that your diet is not too rich in potassium and does not include potassium salt supplements, because this medicine can increase potassium levels in the blood;
• if you have dry mouth, thirst, deep feeling of weakness (asthenia), drowsiness, agitation, muscle cramps, low blood pressure, little urine (oliguria), have a fast heartbeat (tachycardia) or stomach and intestinal disorders. In these cases, consult your doctor because it is possible that the levels of some salts in your blood are altered (potassium, sodium, calcium, nitrogen, phosphate, iodine, ammonia, uric acid) and the assumption of this medicine can further modify the levels of these substances, called electrolytes, in your blood and urine (see also section “Possible side effects”). The doctor will regularly assess your health status and during therapy with Spiridazide will prescribe you blood and urine tests, especially if you are an elderly person or if during treatment with the medicine you should experience persistent vomiting;
• if you have an allergic disease called “Systemic Lupus Erythematosus” because the hydrochlorothiazide contained in this medicine may worsen the symptoms of the disease (see also section “Possible side effects”);
• if you are diabetic, because this medicine may increase the glucose level in the blood (see also section “Possible side effects”);
• if you are going to undergo surgery or a diagnostic examination that requires local or general anesthesia. Inform the anesthesiologist that you are taking this medicine;
• if you are allergic to the category of medicines called “sulfonamides”, of which hydrochlorothiazide is a part, or to penicillins (a type of antibiotics) because you may have a higher risk of developing serious eye problems during therapy with Spiridazide (e.g. acute myopia or acute angle-closure glaucoma);
• if you have decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and may occur within a period ranging from a few hours to weeks after taking Spiridazide. This can lead to permanent vision loss if left untreated. If you have previously had an allergy to penicillin or sulfonamide, you may have a higher risk of developing all of this.

Prolonged use of high doses of spironolactone (one of the active ingredients of Spiridazide), can
cause the development of breast gland in men (gynecomastia). This condition is
normally reversible when the treatment with Spiridazide is interrupted (see also
section “Possible side effects”).
In subjects undergoing sympathectomy (a surgical procedure aimed at interrupting the
stimuli of the peripheral nervous system in a specific arterial district improving blood
flow), it is possible that the blood pressure lowering effects exerted by Spiridazide are
increased.

Other medicines and Spiridazide
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Tell your doctor if you are using abiraterone for the treatment of prostate cancer.
In particular, ask your doctor for advice before taking:

• other diureticsor other aldosterone antagonists;
• ACE inhibitors, angiotensin II receptor antagonists:medicines that are mainly used in the therapy of high blood pressure;
• non-steroidal anti-inflammatory drugs (NSAIDs), for example indometacin;
• medicines used to prevent blood clots, such as heparin;
• potassium-based food supplements;
• salt substitutes containing potassium;
• any other drug that may cause an increase in potassium levels in the blood;
• trimethoprim and trimethoprim-sulfamethoxazole.

This medicine, if taken with the medicines or potassium sources listed above, may cause a
dangerous increase in potassium in the blood.
Other known interactions with Spiridazide are reported below:

• hormones mainly used as anti-inflammatory drugs (corticosteroids) and a hormone calledadrenocorticotropic hormone (ACTH):concomitant assumption with this medicine may cause a decrease in blood potassium content;
• insulin: this medicine may alter the response to medicines used to treat diabetes, including insulin. In these cases, your doctor may want to adjust the doses of the medicines you are taking;
• lithium-based drugs: this medicine may lead to an increase in lithium levels in the blood and therefore to potential toxic reactions, if taken simultaneously with lithium-based drugs (used to treat mood disorders such as depression);
• anesthetics:this medicine may alter the body's response to anesthetic drugs (used for local or general anesthesia). Concomitant use with anesthetics or with sedative drugs (barbiturates) may also increase the risk of sudden drops in blood pressure when suddenly moving from a sitting or lying position to an upright position;
• non-steroidal anti-inflammatory drugs (NSAIDs):the effectiveness of this medicine may be reduced by the simultaneous administration of non-steroidal anti-inflammatory drugs (NSAIDs), so in these cases the doctor should verify that the desired therapeutic effect is actually obtained;
• digoxin:concomitant assumption with this medicine may lead to an increase in digoxin levels in the blood and therefore to potential toxic reactions and may also alter its radioimmunoassay dosage;
• hypotensive or antihypertensive drugs: this medicine may potentiate the effect of drugs used to lower blood pressure. If you are taking these drugs, your doctor will reduce the dose.

Spiridazide and alcohol
The assumption of alcohol during treatment with the medicine should be avoided, because it may increase the risk
of sudden drops in blood pressure when suddenly moving from a sitting or lying position to an upright position.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist before taking this medicine.
Pregnancy
Spiridazide is not recommended during pregnancy and MUST NOT be taken if you are pregnant for more than 3 months, as it may cause serious harm to the baby if taken after the third
month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or if you are about to start breastfeeding. This medicine is not
recommended for women who are breastfeeding and your doctor may choose another treatment
if you wish to breastfeed.

Driving and operating machinery
Spiridazide moderately impairs the ability to drive vehicles or use machinery, because it
may cause drowsiness or dizziness.

For those who play sports:the use of the drug without therapeutic need constitutes doping and may

still determine positivity to doping tests.

3. How to take Spiridazide

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is:

Treatment of congestive heart failure
The recommended dose is 1 capsule 3 - 4 times a day.

Treatment of ascites and edema in patients with hepatic cirrhosis
The recommended dose is 1 capsule 4 times a day.
The doctor will adjust the dose and duration of treatment based on the evolution of your condition.

If you take more Spiridazide than you should
In case of taking a dose higher than that prescribed by the doctor immediately
inform your doctor or go to the nearest hospital.
In case of overdose, blood pressure may drop too low.
The most common symptoms caused by an overdose are drowsiness, mental confusion, rash,
nausea, vomiting, dizziness or diarrhea. An alteration in the levels of some
salts in your blood (for example, reduction of sodium levels, decrease or increase of
potassium levels or increase of nitrogen levels) may also occur, especially in patients with kidney problems.
In cases of high overdose, hepatic coma has been rarely observed in patients with severe
liver disease. Cases of lethargy or coma have also been reported.

If you forget to take Spiridazide
Do not take a double dose to make up for the missed capsule.
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 everybody gets them.
The following side effects are important and require immediate attention if they occur. Stop treatment with this medicineand seek immediate medical adviceif you experience the following symptoms:

• problems swallowing or breathing, shortness of breath, swelling of the lips, face, throat or tongue. These may be symptoms of a severe allergic reaction (anaphylactic reactions);
• skin changes, such as hives, formation of red papules or widespread blisters and scaling, particularly on the legs, arms, hands and feet, which may extend to the face and lips, sometimes accompanied by fever. These may be symptoms of serious diseases such as erythema multiforme, toxic epidermal necrolysis, necrotizing vasculitis and cutaneous lupus erythematosus, which can occur very rarely;
• worsening or reactivation of an autoimmune disease called systemic lupus erythematosus.

Other side effects may include the following:

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

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

Common (may affect up to 1 in 10 people)

• increased uric acid levels in the blood (hyperuricemia), decreased levels of magnesium or sodium in the blood (hypomagnesemia and hyponatremia);
• sudden drops in blood pressure when moving from a sitting or lying position to an upright position (orthostatic hypotension);
• decreased appetite, nausea, vomiting;
• difficulty achieving or maintaining an erection sufficient for sexual intercourse (impotence).

Rare (may affect up to 1 in 1,000 people)

• decreased number of blood cells called platelets (thrombocytopenia), sometimes associated with small skin hemorrhages, which appear as reddish-purple spots (purpura);
• increased levels of calcium or glucose in the blood (hypercalcemia and hyperglycemia), worsening of the condition in diabetics;
• depression, sleep disorders;
• dizziness, headache;
• altered sensitivity of the limbs or other parts of the body (paresthesia);
• vision problems;
• irregular heart rhythm (cardiac arrhythmias);
• abdominal discomfort, constipation, diarrhea;
• obstruction of the bile ducts of the liver (intrahepatic cholestasis), yellowing of the skin and whites of the eyes (jaundice);
• abnormal and exaggerated reaction of the skin, which becomes particularly sensitive, to exposure to sunlight (photosensitivity reactions);
• presence of sugar in the urine (glycosuria).

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

• severe reduction in the number of white blood cells in the blood (agranulocytosis), reduction in the number of other groups of blood cells (hemolytic anemia, leukopenia and general bone marrow depression);
• a condition characterized by an increase in the pH of the blood (hypochloremic alkalosis);
• respiratory failure caused by various types of damage (including pneumonia and pulmonary edema);
• inflammation of the pancreas (pancreatitis);
• acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).

Not known (frequency cannot be estimated from available data)

• insufficient production by the bone marrow of blood cells of all types (aplastic anemia);
• 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);
• eye problems (acute myopia, xanthopsia);
• skin disease characterized by lesions due to infection or allergic reaction (erythema multiforme);
• sudden and involuntary muscle contractions (muscle spasm);
• kidney problems (renal dysfunction, acute renal failure);
• decreased muscle strength (asthenia);
• fever;
• bleeding or inflammation of the stomach lining (ulcer, gastritis), diarrhea, stomach cramps, nausea and vomiting;
• alteration of the levels of some salts in the blood (electrolyte imbalance);
• alterations in kidney function;
• development of breast gland in men (gynecomastia), erectile dysfunction, irregularities in the menstrual cycle or absence of menstruation (amenorrhea), episodes of bleeding during menopause, mild masculinizing effects (so-called androgenic effects);
• breast cancer (in these cases, a definite correlation with the use of spironolactone has not been established);
• skin and lip cancer (non-melanoma skin cancer);
• mental confusion, loss of muscle coordination (ataxia), drowsiness, continuous predisposition to sleep (lethargy);
• liver poisoning (very rare cases);
• pemphigoid (a condition that manifests with the appearance of fluid-filled blisters on the skin).

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 Spiridazide

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the pack 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 Spiridazide contains

• The active ingredients are spironolactone and hydrochlorothiazide. Each hard capsule contains 25 mg of spironolactone and 25 mg of hydrochlorothiazide.
• The other ingredients are: Capsule contents: corn starch, magnesium stearate. Capsule:indigotine (E132), titanium dioxide (E171) and gelatin.

Description of the appearance of Spiridazide and contents of the pack
Spiridazide 25 mg + 25 mg hard capsules are presented in a box of 20 hard capsules in blisters of
transparent PVC/aluminium.

Marketing authorisation holder and manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 – 27035 Mede (PV)