Package leaflet: Information for the patient

SPIROFUR 50 mg + 20 mg hard capsules

Spironolactone, Furosemide
Please read all of 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful to them.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What SPIROFUR is and what it is used for
What you need to know before taking SPIROFUR
How to take SPIROFUR
Possible side effects
How to store SPIROFUR
Contents of the pack and other information

1. What SPIROFUR is and what it is used for

This medicinal product contains two active substances called spironolactone and furosemide, belonging to the class of diuretics, medicines that increase urine production.
SPIROFUR is used to treat:

Fluid accumulation in the body (edematous states) due to heart problems (congestive heart failure), liver (hepatic cirrhosis with ascites), or kidney (nephrotic syndrome), which may cause swollen ankles, shortness of breath, and a feeling of fatigue;
High blood pressure (arterial hypertension), caused by excessive production of a hormone called aldosterone (primary or secondary hyperaldosteronism), or when other treatments are ineffective or not tolerated.

2. What you should know before taking SPIROFUR

Do not take SPIROFUR:

if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
if you are allergic to sulfonamides, antibiotic medicines used to treat infections;
if you have severe liver problems causing altered consciousness (hepatic encephalopathy);
if you have high levels of potassium in the blood (hyperkalemia) or very low levels (severe hypokalemia);
if you have low levels of sodium in the blood (hyponatremia);
if you have severe kidney problems;
if you have reduced urine production (oliguria, anuria);
if you have high levels of nitrogen in the blood (hyperazotemia);
if you have the following symptoms: dry and sticky mouth, thirst, reduced urination, absence or lack of tears, dry skin—signs of dehydration;
if you have the following symptoms: low blood pressure, increased heart rate, cold sweating, and pale skin—signs of hypovolemia;
if you are pregnant or think you might be, or if you are breastfeeding (see “Pregnancy and breastfeeding”).

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

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

Concomitant administration of SPIROFUR with certain medicines, 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 treatment, your doctor will advise regular blood and urine tests to monitor blood parameters and kidney function.
Children and adolescents
SPIROFUR is not indicated for use in children and adolescents.
Other medicines and SPIROFUR
Inform your doctor if you are taking, have recently taken, or might take any other medicine. This is particularly important if you are taking:

potassium-containing preparations (see “Warnings and precautions”);
other diuretic medicines or other medicines for high blood pressure, such as enalapril, losartan, candesartan, ACE inhibitors (see “Warnings and precautions”);
risperidone, a medicine used for dementia (see “Warnings and precautions”);
anti-inflammatory medicines, for example non-steroidal anti-inflammatory drugs (NSAIDs) and salicylates;
medicines for diabetes, either oral or insulin;
corticosteroids or ACTH (adrenocorticotropic hormone);
cyclosporine A, a medicine that suppresses the immune system;
probenecid, a medicine used for gout;
carbenoxolone, a medicine for ulcers;
antibiotics (medicines for infections) such as cephaloridine, cephalosporins, trimethoprim, and trimethoprim-sulfamethoxazole (co-trimoxazole);
lithium salts (commonly used to treat bipolar disorder);
barbiturates (medicines used, for example, for anxiety), narcotics (medicines used for severe pain), or tubocurarine (a medicine used as an anesthetic);
non-depolarizing neuromuscular blockers, medicines that reduce muscle contraction;
medicines used for heart conditions such as digitalis or digoxin;
pressor amines, such as noradrenaline, medicines used in various heart, vascular, or bronchial diseases;
phenytoin, a medicine used for epilepsy;
clofibrate, a medicine used to reduce blood lipid levels;
medicines that cause an electrocardiogram abnormality known as long QT syndrome;
medicines that cause ear damage (ototoxic), such as aminoglycosides (a type of antibiotic) or cisplatin (a medicine for cancer);
medicines that cause kidney damage (nephrotoxic);
abiraterone for the treatment of prostate cancer.

Your doctor may need to adjust the dose and/or take other precautions if you are taking any of the following medicines:

Aliskiren – used for the treatment of high blood pressure.

SPIROFUR with food and alcohol
Absorption of this medicine is enhanced when taken with food.
Do not take SPIROFUR with alcohol, as this may increase the effect of the medicine, leading to a significant drop in blood pressure.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take SPIROFUR if you are pregnant or think you might be (see “Do not take SPIROFUR”).
Breastfeeding
Do not take SPIROFUR if you are breastfeeding (see “Do not take SPIROFUR”).
Driving and using machines
SPIROFUR may cause dizziness. Make sure you do not experience this side effect before driving or operating machinery.
SPIROFUR contains:

lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine;
sodium. This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially “sodium-free”.

Attention for those engaged in sports activities: The active substance contained in this preparation is included in the list of prohibited substances for doping.

3. How to take SPIROFUR

Take this medicine exactly as your doctor has told you. If you are unsure, consult 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 is for oral use. 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 abnormally low blood pressure or changes in blood parameters.
If you forget to take SPIROFUR
Continue your treatment as usual. Do not take a double dose to make up for the missed dose.
If you stop taking SPIROFUR
This medicine must be taken regularly, even if you feel well. Do not stop treatment without consulting your doctor.
If you have any doubts about how to use this medicine, consult your doctor.

4. Possible side effects

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

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

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

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

high blood potassium levels (hyperkalaemia);
breast enlargement in men (gynaecomastia);
fatigue.

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

decrease in red blood cells (anaemia), including due to bone marrow problems (aplastic anaemia); decrease in white blood cells (leucopenia); appearance of red spots on the skin due to bleeding caused by a reduced number of platelets (thrombocytopenic purpura);
abnormal sensations in the extremities such as tingling or prickling (paraesthesia), deep drowsiness (lethargy), loss of muscle coordination (ataxia), somnolence, confusion;
increased body temperature;
nausea, gastrointestinal motility disorders;
blurred vision;
deafness, hearing loss, ringing in the ears (tinnitus);
absence of menstruation (amenorrhoea) or vaginal bleeding (metrorrhagia);
erectile problems;
low blood calcium levels (hypocalcaemia);
reduction in ions (electrolytes), low magnesium levels (hypomagnesaemia) or low sodium levels (hyponatraemia), high uric acid levels (hyperuricaemia) or high urea levels, high levels of fats (triglycerides), cholesterol (low-density lipoproteins) or blood sugar (hyperglycaemia), decreased pH (acidosis), increased pH due to decreased chloride (hypochloraemic alkalosis);
decreased blood volume (hypovolaemia);
low blood pressure (hypotension), including upon sudden change from sitting or lying position to standing (orthostatic hypotension);
changes in heart rhythm (arrhythmia);
kidney function disorders, including due to inflammation (interstitial nephritis);
in women: increased hair growth or appearance of hair in areas where it is not normally present (hirsutism), voice changes;
sudden or gradual appearance of skin lesions, for example patchy or widespread changes in skin colour, skin rash (skin eruption, erythema multiforme or polymorphous), itching, skin inflammation (dermatitis), skin eruption characterised by formation of blisters and vesicles (bullous eruption, pemphigoid).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via 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 below 30°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SPIROFUR contains
The active substances are: spironolactone and furosemide.
Each hard capsule contains: 50 mg spironolactone and 20 mg furosemide.
The other components are: lactose, talc, microcrystalline cellulose, magnesium stearate, sodium lauryl sulfate,
erythrosine (E-127), titanium dioxide, gelatin.
Description of the appearance of SPIROFUR and package contents
SPIROFUR is available in packages containing 10 or 20 hard capsules.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
BRUNO FARMACEUTICI S.p.A. – Via delle Ande, 15 – 00144 ROME.
Manufacturer
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo n.1 – 03012 Anagni (FR)