SPIROLANG 25 mg Capsule

Зміст інструкції

1. Spirolang 25 mg hard capsules, 50 mg hard capsules, 100 mg hard capsules
   1. What is Spirolang and what is it used for
   2. What you need to know before taking Spirolang
   3. How to take Spirolang
   4. Possible side effects
   5. How to store Spirolang
   6. Contents of the pack and other information

Spirolang 25 mg hard capsules, 50 mg hard capsules, 100 mg hard capsules

Spironolattone

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

1. What is Spirolang and what is it used for

This medicine contains spironolactone, a substance that belongs to a group of drugs
called “diuretics”, which help the body to lose excess water through urine.
Spirolang is used in particular, to reduce the accumulation of fluids in the body caused by one of the
following diseases:

• hyperaldosteronism(primary or secondary): a disease caused by excessive production of the hormone aldosterone, which manifests with potassium deficiency in the blood and high blood pressure and which may involve (in the secondary type) the onset of other diseases such as congestive heart failure(a condition characterized by the heart's inability to pump enough blood to meet the body's needs), nephrotic syndrome(a kidney disease that causes excess fluid in the body) or ascites(excess fluid in the abdomen, for example caused by cirrhosis of the liver);
• essential hypertension(high blood pressure caused by diseases of the circulatory system), when other therapeutic approaches have not been effective or well tolerated.

See your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Spirolang

Do not take Spirolang if:

• you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• you have a severe kidney disease (acute renal failure) or if your kidney function is impaired;
• you do not urinate enough (anuria);
• you have high levels of potassium in your blood (hyperkalaemia) and suffer from a disease called Addison's disease;
• you have very low levels of sodium in your blood (severe hyponatraemia);
• your blood volume is low (hypovolaemia) or if you are dehydrated;
• you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Spirolang.
Pay particular attention and talk to your doctor before taking Spirolang if:

• you suffer from very low blood pressure (severe hypotension);
• you do not have good kidney function, as the risk of increased potassium levels in the blood is greater (hyperkalaemia);
• your voice plays an important role in your life and work, as this medicine can cause changes in your voice.

During treatment with spironolactone, to keep your health under control and
monitor your response to the drug, your doctor will subject you to regular blood tests to
check your sodium, potassium, creatinine and glucose levels.
During treatment with this medicine, in fact, the normal balance between
water and mineral salts present in the blood may be altered (dystonies due to changes in
water and electrolyte homeostasis). In particular, it may happen that:

• the level of sodiumin your blood drops too low (hyponatraemia), which can lead to a feeling of dry mouth, thirst, fatigue (asthenia), drowsiness, agitation, muscle cramps, low blood pressure (hypotension), decreased urine production (oliguria), changes in heart rate (tachycardia) and stomach and intestinal disorders; this condition may occur more frequently if you are also taking other diuretics or if you suffer from edema (excess fluid accumulation in the body);
• heartbeat alterations, fatigue or weakness in the legs occur if the levels of potassiumin your blood increase too much (hyperkalaemia, sometimes associated with metabolic acidosis), especially in patients who suffer from liver problems (decompensated hepatic cirrhosis) even in the presence of normal kidney function;
• nitrogen levels in the blood increase, especially if you have kidney problems.

Frequent checks of potassium levels in your blood will therefore be necessary if:

• you are an elderly patient or have impaired kidney or liver function;
• you are taking other drugs that cause an increase in potassium levels (in this case your doctor will inform you and give you more information about the drugs you are taking).

Pain in the breasts and enlargement of the breasts (gynecomastia) may also appear
in both men and women, generally related to the dosage and duration of treatment, and of a
reversible nature (disappearance of the phenomenon after discontinuation of treatment).
Tell your doctor if you experience any of the conditions described above or if you do not
feel well during treatment with this medicine.
The concomitant administration of Spirolang with certain medicines, potassium supplements and foods
rich in potassium can cause severe hyperkalaemia (increased potassium levels in the blood). The
symptoms of severe hyperkalaemia can include muscle cramps, irregular heartbeat,
diarrhoea, nausea, dizziness and headache.
During therapy with Spirolang it is therefore important to avoid taking potassium, either with other
medicines (such as potassium-sparing diuretics, ACE inhibitors, angiotensin II antagonists,
aldosterone blockers, heparin, low molecular weight heparin, see paragraph Other

medicines and Spirolang), or with supplements such as salt substitutes containing potassium.
Spirolang can also cause changes in the voice. This requires attention in determining whether and
when to start therapy with this medicine in patients for whom the use of the voice plays an
important role in their work (e.g. actors, singers, teachers).

Other medicines and Spirolang
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In addition, the simultaneous use of other medicines used to treat high blood pressure (antihypertensive drugs), can lead to a more pronounced drop in blood pressure. If you are taking these
medicines, your doctor will reduce the dose.
Non-steroidal anti-inflammatory drugs can instead reduce the effect of Spirolang.
The use of Spirolang is not recommended together with:

• other potassium-sparing diuretics or aldosterone blockers;
• medicines that can cause an increase in potassium levels in the blood (potassium supplements, potassium salts), or medicines that reduce potassium elimination;
• non-steroidal anti-inflammatory drugs (NSAIDs);
• medicines for high blood pressure (ACE inhibitors or angiotensin II receptor antagonistssuch as valsartanand losartan);
• medicines used to prevent blood clots (heparin, low molecular weight heparin);
• medicines to lower cholesterol levels (cholestyramine);
• medicines used to prevent organ rejection (tacrolimus, cyclosporine);
• trimethoprim and trimethoprim-sulfamethoxazole(medicines used for bacterial infections).

These medicines, if taken with spironolactone, could excessively increase
potassium levels in your blood (could cause hyperkalaemia, even severe).
Pay particular attention also to the simultaneous assumption of Spirolang with:

• lithium salts(used for the treatment of mental disorders): spironolactone reduces the elimination of this drug, increasing its toxicity;
• norepinephrine(used as a potent vasoconstrictor): you may not respond to the therapeutic action of this drug during surgery under local or general anesthesia if you are taking spironolactone;
• carbenoxolone(used for the treatment of stomach ulcers): the simultaneous assumption of this medicine and spironolactone compromises the pharmacological action of both drugs;
• digoxin(used in the treatment of heart function alterations): spironolactone can increase the levels of digoxin in the blood.

Spirolang with food and alcohol
The absorption of spironolactone increases significantly with food intake.
High amounts of licoricecan alter the action of Spirolang (in the same way as

carbenoxolone).
Following alcohol consumption, Spirolang may alter the ability to drive vehicles or operate
machinery (see paragraph Driving and using machines).

Pregnancy and breastfeeding
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.
Pregnancy
If you are pregnant, take this medicine only if your doctor has considered it strictly necessary and
under his/her strict supervision.
Breastfeeding
Do not take this medicine if you are breastfeeding.

Driving and using machines
This medicine can impair the ability to drive and operate machinery due to
side effects that may occur, especially at the beginning of therapy or after consumption
of alcohol (see paragraph Spirolang with food and alcohol).

For athletes:the use of the drug without therapeutic need constitutes doping
and may still result in positive doping tests.

3. How to take Spirolang

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 between 100 mg - 200 mg per day divided into several doses (fractionated doses). This dose may be varied based on your response to treatment with Spirolang.
The doctor will adjust the dose and duration of treatment according to your condition.

Use in children
The doctor will define a reduced dose, compared to that for adults, based on the body weight of your
child (approximately 3 mg for each kg of the child's weight).

Use in the elderly and patients with liver or kidney problems
It is recommended to start treatment with the lowest dose (25 mg).
If you suffer from severe liver or kidney problems, you should pay maximum attention to the use of
Spirolang. Consult your doctor if you have any doubts about using this medicine.

If you take more Spirolang than you should
Immediately inform your doctor or go to the nearest hospital if you have taken a dose of
Spirolang higher than the prescribed one.
An excessive dose of Spirolang can cause alterations in the levels of water and mineral salts present
in the blood (especially sodium and potassium), causing hyponatremia and hyperkalemia which
manifest with drowsiness and confusion.

If you forget to take Spirolang
Do not take a double dose to make up for a missed dose.
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 will experience them.
The following side effects may occur with frequency not known (frequency cannot be
defined based on available data):

• alteration of your heart rate, fatigue or muscle weakness (for example in the legs), caused by a possible increase in blood potassium levels (hyperkalaemia);
• dizziness and leg cramps which may depend on: increased blood potassium levels (hyperkalaemia), decreased blood sodium levels (hyponatraemia), reduced blood volume (hypovolaemia) or dehydration;
• alterations in the balance of mineral salts present in the blood (electrolyte imbalance);
• appearance or worsening of a state of “metabolic acidosis” caused by electrolyte imbalances;
• breast pain and breast enlargement (gynaecomastia) which may depend on the dose and also the duration of treatment. In rare cases this condition may persist even after discontinuation of treatment. Generally, breast enlargement

in men, correlated with the duration of therapy, is reversible, i.e. disappears after
stopping treatment;

• erectile dysfunction in men;
• irregularity of the menstrual cycle in women (amenorrhoea or post-menopausal bleeding with a dose-dependent effect);
• alteration of the voice manifested by difficulty in emitting vocal sounds (hoarseness), lowering of the tone of voice in women and increase in tone in men. In some patients, vocal alterations persist even after discontinuation of treatment;
• lesion of the stomach wall, sometimes with bleeding (gastric ulcer);
• inflammation of the stomach lining (gastritis);
• stomach cramps;
• nausea, vomiting and diarrhoea;
• alterations in normal kidney function up to severe kidney impairment (acute renal failure);
• appearance of benign tumours in the breast; isolated cases of malignant breast tumours have been reported, but no correlation with Spirolang has been established;
• increase or severe decrease in the number of white blood cells (eosinophilia and agranulocytosis);
• reduction in the number of platelets (thrombocytopenia);
• vertigo;
• drowsiness;
• loss of muscle coordination (ataxia);
• headache;
• confusional state;
• alteration of sexual desire;
• predisposition to continuous sleep (lethargy);
• increase in liver enzyme values and liver inflammation (hepatitis);
• pemphigoid (a condition characterized by blisters filled with fluid on the skin);
• hair loss (alopecia);
• abnormal hair growth (hypertrichosis);
• general malaise;
• skin disorders, such as itching, rash, urticaria. Rarely, red papules or widespread blisters with scaling of the skin, especially on legs, arms, hands and feet, may appear, which may also spread to the face and mouth, occasionally accompanied by fever. These may be symptoms of serious skin diseases such as Stevens-Johnson syndrome, toxic epidermal necrolysis and DRESS syndrome.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
consult your doctor or pharmacist. You can also report side effects directly through
the national reporting system at:
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of
this medicine.

5. How to store Spirolang

Keep this medicine out of the sight and reach of children.
Store in its original packaging and at a temperature not exceeding 30°C.
Do not use this medicine after the expiry date which is stated on the pack after “Expiry”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 Spirolang 25 mg hard capsules contain

• The active ingredient is spironolactone. One capsule contains 25 mg of spironolactone.
• The other ingredients are: capsule contents: corn starch, magnesium stearate;capsule: erythrosine (E127), indigotine (E132), titanium dioxide (E171) and gelatin.

What Spirolang 50 mg hard capsules contain

• The active ingredient is spironolactone. One capsule contains 50 mg of spironolactone.
• The other ingredients are: capsule contents: corn starch, magnesium stearate;capsule: iron oxide (E172), erythrosine (E127), titanium dioxide (E171) and gelatin.

What Spirolang 100 mg hard capsules contain

• The active ingredient is spironolactone. One capsule contains 100 mg of spironolactone.
• The other ingredients are: capsule contents: corn starch, magnesium stearate;capsule: iron oxide (E172), indigotine (E132), titanium dioxide (E171) and gelatin.

Description of the appearance of Spirolang and contents of the pack
Spirolang 25 mg is presented in a box of 16 hard capsules in a PVC-aluminium blister.
Spirolang 50 mg is presented in a box of 10 hard capsules in a PVC-aluminium blister.
Spirolang 100 mg is presented in a box of 10 hard capsules in a PVC-aluminium blister.

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