SPIROFUR 50 mg/20 mg Hard Capsule

Содержание инструкции

1. SPIROFUR 50 mg + 20 mg hard capsules
   1. What is SPIROFUR and what is it used for
   2. What you need to know before taking SPIROFUR
   3. How to take SPIROFUR
   4. Possible side effects
   5. How to store SPIROFUR
   6. Contents of the pack and other information

SPIROFUR 50 mg + 20 mg hard capsules

Spironolattone, Furosemide

Read this leaflet carefully before 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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is SPIROFUR and what is it used for

This medicine contains 2 active ingredients called spironolactone and furosemide, belonging to the class
of diuretics, drugs that increase urine production.
SPIROFUR is used to treat:

• fluid accumulation in the body(edematous states) due to problems with the heart (congestive heart failure) or liver (hepatic cirrhosis in the ascitic phase) or kidneys (nephrotic syndrome) and which can cause swelling of the ankles, shortness of breath and feeling of fatigue;
• high blood pressure(arterial hypertension), caused by excessive production of a hormone called aldosterone (primary or secondary hyperaldosteronism), or when other therapies are not effective or are not tolerated.

2. What you need to know before taking SPIROFUR

Do not take SPIROFUR:

• if you are allergic to the active ingredients or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to sulfonamides, antibiotic drugs used to treat infections;
• if you have severe liver problems that cause an alteration of consciousness (hepatic encephalopathy);
• if you have high (hyperkalemia) or very low (severe hypokalemia) potassium levels in your blood;
• if you have low (hyponatremia) sodium levels in your blood;
• if you have severe kidney problems;
• if you have reduced urine production (oliguria, anuria);
• if you have a high amount of nitrogen in your blood (hyperazotemia);
• if you have the following symptoms: dry and sticky mouth, thirst, scarcity of urine, absence or scarcity of tears and dry skin, signs of dehydration;
• if you have the following symptoms: low blood pressure, increased heartbeat, cold sweating and paleness of the skin, signs of hypovolemia;
• if you are pregnant or think you may be, or are breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor before taking SPIROFUR if:

• you have a condition that can increase potassium levels in your blood, for example, you are using preparations containing potassium (see “Other medicines and SPIROFUR”);
• you are elderly, as you are more likely to develop altered blood ions (electrolyte imbalances) and dehydration;
• you are at risk of having low blood pressure, for example, you have significant loss of mineral salts or fluids, you are taking other diuretic drugs or drugs for high blood pressure (see “Other medicines and SPIROFUR”);
• you have the following symptoms: fast heartbeat, dizziness, general weakness, which may indicate low blood pressure;
• you have dementia problems, especially if you are being treated with risperidone (see “Other medicines and SPIROFUR”);
• you have liver and kidney problems (hepatic cirrhosis with renal insufficiency);
• you have diabetes;
• you have gout;
• you have low protein levels in your blood (hypoproteinemia) and kidney function is impaired (nephrotic syndrome);
• you have difficulty urinating, for example, you have bladder obstruction or an enlarged prostate volume.

The concomitant administration of SPIROFUR with certain drugs, potassium supplements and potassium-rich foods
may lead to severe hyperkalemia (increased potassium levels in the blood). Symptoms of severe
hyperkalemia may include muscle cramps, irregular heartbeat, diarrhea, nausea, dizziness or headache.
As with all diuretics, especially during prolonged treatments, your doctor will advise you to have blood and
urine tests to assess blood parameters and kidney function.

Children and adolescents
SPIROFUR is not indicated for children and adolescents.

Other medicines and SPIROFUR
Tell your doctor if you are taking, have recently taken or might take any other medicines. This is
particularly important if you are taking:

• preparations containing potassium (see “Warnings and precautions”);
• other diuretic drugs or other drugs for high blood pressure, such as enalapril, losartan, candesartan, ACE-inhibitors (see “Warnings and precautions”);
• risperidone, a drug used for dementia (see “Warnings and precautions”);
• drugs against inflammation, for example, non-steroidal anti-inflammatory drugs (NSAIDs) and salicylates;
• drugs for diabetes, oral or insulin;
• corticosteroids or ACTH (adrenocorticotropic hormone);
• cyclosporine A, a drug that reduces the immune defenses;
• probenecid, a drug used for gout;
• carbenoxolone, a drug for ulcers;
• antibiotics (drugs against infections) such as cefaloridine, cephalosporins, trimethoprim and trimethoprim-sulfamethoxazole (cotrimoxazole);
• lithium salts (generally used for the treatment of manic-depressive disorders);
• barbiturates (drugs used for example for anxiety), narcotics (drugs used for severe pain) or tubocurarine (a drug used as an anesthetic);
• non-depolarizing neuromuscular blocking agents, drugs that reduce muscle contraction;
• drugs used for heart disease such as digitalis or digoxin;
• pressor amines, such as norepinephrine, drugs used in many heart, vascular or bronchial diseases;
• phenytoin, a drug used against epilepsy;
• clofibrate, a drug used to reduce fat levels in the blood;
• drugs that cause an alteration of the electrocardiogram called prolonged QT syndrome;
• drugs that cause damage to the ears (ototoxic) such as aminoglycosides (a type of antibiotics) or cisplatin (a drug against tumors);
• drugs that cause damage to the kidneys (nephrotoxic);
• abiraterone for the treatment of prostate cancer.

SPIROFUR with food and alcohol
The absorption of this medicine is favored if your stomach is full.
Do not take SPIROFUR with alcohol as this may increase the effect of this medicine, with
consequent severe lowering of blood pressure.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take SPIROFUR if you are pregnant or think you may be (see “Do not take SPIROFUR”).
Breastfeeding
Do not take SPIROFUR if you are breastfeeding (see “Do not take SPIROFUR”).

Driving and operating machinery
SPIROFUR can cause dizziness. Make sure you do not suffer from this side effect before driving
vehicles or operating machinery.

SPIROFUR contains:

• lactose.If your doctor has diagnosed you with intolerance to some sugars, contact him before taking this medicine;
• sodium. This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

Caution for those who practice sports: the active ingredient contained in this preparation is included in the
list of prohibited substances for doping.

3. How to take SPIROFUR

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose is 1-2 capsules per day.
If necessary, your doctor may increase this dose, up to a maximum of 8 capsules per day.

Method of administration
This medicine must be taken orally (by mouth). Take the capsules whole with a little
water.

If you take more SPIROFUR than you should,contact your doctor immediately or go to the nearest
hospital, as excessive doses of this medicine may cause an abnormal decrease in
blood pressure or an alteration of blood parameters.

If you forget to take SPIROFUR
Continue with therapy as usual. Do not take a double dose to make up for a missed
tablet.

If you stop taking SPIROFUR
This medicine must be used regularly, even if you feel well. Do not stop treatment
without consulting your doctor.
If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor if you notice any of the following while taking SPIROFUR:

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

• dizziness, headache;
• vomiting, diarrhoea;
• irregular menstrual cycle, breast discomfort, increased breast size;
• decreased heart rate (bradyarrhythmia).

Common side effects(may affect up to 1 in 10 people)

• high potassium levels in the blood (hyperkalaemia);
• increased breast size in men (gynaecomastia);
• fatigue.

Side effects with unknown frequency(frequency cannot be estimated from available data)

• decreased red blood cells (anaemia) also due to bone marrow problems (aplastic anaemia), decreased white blood cells (leucopenia), red spots on the skin due to bleeding caused by a decrease in the number of platelets (thrombocytopenic purpura);
• abnormal sensation in the extremities such as tingling or prickling (paresthesia), deep sleep (lethargy), loss of muscle coordination (ataxia), drowsiness, confusion;
• increased body temperature;
• nausea, disturbance of stomach and intestinal motility;
• blurred vision;
• deafness, hearing loss, ringing in the ears (tinnitus);
• absence of menstruation (amenorrhoea) or vaginal bleeding (metrorrhagia);
• erection problems;
• decreased ions (electrolytes), low magnesium levels (hypomagnesaemia) or sodium (hyponatraemia), high uric acid levels (hyperuricemia) or urea, high fat levels (triglycerides), cholesterol (low-density lipoproteins) or sugars (hyperglycaemia), decreased pH (acidosis), increased pH caused by decreased chlorine (hypochloremic alkalosis);
• decreased blood volume (hypovolaemia);
• low blood pressure (hypotension) even after suddenly moving from a sitting or lying position to an upright position (orthostatic hypotension);
• heart rhythm disturbance (arrhythmia);
• kidney dysfunction disorders also due to inflammation (interstitial nephritis);
• in women: increased number of hairs or appearance of hairs in areas where they are not normally present (hirsutism), voice alteration;
• more or less sudden appearance of skin lesions, for example changes in colour in patches or widespread, skin rash (erythema multiforme or polymorphum), itching, skin inflammation (dermatitis), skin rash characterized by the formation of blisters and vesicles (pemphigoid).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 SPIROFUR

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 30° C.
Do not use this medicine after the expiry date which is stated on the packaging. 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 SPIROFUR contains
The active ingredients are: spironolactone and furosemide.
Each hard capsule contains: 50 mg of spironolactone and 20 mg of furosemide.
The other ingredients are: lactose, talc, microgranular cellulose, magnesium stearate, sodium lauryl sulfate,
erythrosine (E-127), titanium dioxide, gelatin.

Description of the appearance of SPIROFUR and contents of the pack
SPIROFUR is available in packs of 10 or 20 hard capsules.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
BRUNO FARMACEUTICI S.p.A. – Via delle Ande, 15 – 00144, ROMA.
Manufacturer
Doppel Farmaceutici S.r.l., Via Volturno 48 - Quinto Dè Stampi - 20089 Rozzano (MI)
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo n.1 – 03012 Anagni (FR)