Spirolang

Package leaflet: Information for the patient

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

Spironolactone
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 they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 taking 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 Spirolang is and what it is used for

This medicinal product contains spironolactone, a substance that belongs to a group of medicines called "diuretics", which help the body eliminate excess water through urine.
Spirolang is specifically used to reduce fluid accumulation in the body caused by one of the following conditions:

• Hyperaldosteronism (primary or secondary): a disorder caused by excessive production of the hormone aldosterone, characterized by low potassium levels in the blood and high blood pressure, which may lead (in the case of secondary hyperaldosteronism) to other diseases such as congestive heart failure (a condition in which the heart is unable to pump sufficient blood to meet the body's needs), nephrotic syndrome (a kidney disease causing excess fluid in the body), or ascites (accumulation of fluid in the abdomen, for example due to liver cirrhosis);
• Essential arterial hypertension (elevated blood pressure due to circulatory system disorders), when other therapeutic approaches have not been effective or well tolerated.

Consult 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 substance or to any of the other ingredients of this medicine (listed in section 6);
• you have severe kidney disease (acute renal failure) or if your kidney function is impaired;
• you are not producing enough urine (anuria);
• you have high levels of potassium in your blood (hyperkalemia) and suffer from a condition called Addison's disease;
• you have very low levels of sodium in your blood (severe hyponatremia);
• your blood volume is low (hypovolemia) or if you are dehydrated;
• you are breastfeeding.

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

• you suffer from very low blood pressure (severe hypotension);
• you have poor kidney function, as the risk of increased potassium levels in the blood (hyperkalemia) is higher;
• your voice plays an important role in your life and work, as this medicine may cause voice changes.

During treatment with spironolactone, to monitor your health status and response to the drug, your doctor will perform regular blood tests to check your levels of sodium, potassium, creatinine, and glucose.
During treatment with this medicine, the normal balance of water and electrolytes in the blood may be altered (disturbances in water and electrolyte homeostasis). In particular, it may happen that:

• the level of sodium in your blood becomes too low (hyponatremia), which may cause dry mouth, thirst, fatigue (asthenia), drowsiness, restlessness, muscle cramps, low blood pressure (hypotension), reduced urine output (oliguria), changes in heart rhythm (tachycardia), and gastrointestinal disturbances; this condition may occur more frequently if you are also taking other diuretics or if you have edema (excess fluid accumulation in the body);
• changes in heart rhythm, fatigue, or weakness in the legs may occur if the levels of potassium in your blood become too high (hyperkalemia, sometimes associated with metabolic acidosis), especially in patients with liver problems (decompensated hepatic cirrhosis), even when kidney function is normal;
• blood levels of nitrogen may increase, particularly if you have kidney problems.

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

• you are elderly or have impaired kidney or liver function;
• you are taking other medicines that increase potassium levels (in this case, your doctor will inform and advise you about the medicines you are taking).

You may also experience breast pain and breast enlargement (gynecomastia) in both men and women, usually related to the dose and duration of treatment, and generally reversible (disappearance of the phenomenon after discontinuation of treatment).
Inform your doctor if you experience any of the conditions described above or if you do not feel well during treatment with this medicine.
Concomitant administration of Spirolang with certain medicines, potassium supplements, or 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, and headache.
During treatment with Spirolang, it is therefore important to avoid potassium intake, both from other medicines (such as potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, aldosterone blockers, heparin, low molecular weight heparin—see section Other medicines and Spirolang) and from supplements such as potassium-containing salt substitutes.
Spirolang may also cause voice changes. This requires careful consideration when deciding whether and when to start therapy with this drug in patients for whom voice use is important in their professional activities (e.g., actors, singers, teachers).

Other medicines and Spirolang
Inform 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) may lead to a more pronounced drop in blood pressure. If you are taking these medicines, your doctor may reduce their dose.
Non-steroidal anti-inflammatory drugs (NSAIDs) may reduce the effect of Spirolang.
The use of Spirolang is not recommended together with:

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

These medicines, when taken with spironolactone, could excessively increase potassium levels in your blood (they may cause hyperkalemia, even severe).
Pay particular attention also to the concomitant use of Spirolang with:

• lithium salts (used to treat mental disorders): spironolactone reduces the elimination of this medicine, increasing its toxicity;
• norepinephrine (used as a potent vasoconstrictor): you may not respond to the therapeutic action of this medicine during surgery under local or general anesthesia if you are being treated with spironolactone;
• carbenoxolone (used to treat stomach ulcers): concomitant use of this medicine and spironolactone impairs the pharmacological action of both drugs;
• digoxin (used to treat heart function disorders): spironolactone may increase digoxin levels in the blood.

Spirolang with food and alcohol
The absorption of spironolactone increases significantly when taken with food.
Large amounts of licorice may interfere with the action of Spirolang (similarly to carbenoxolone).
After consuming alcohol, Spirolang may impair your ability to drive or operate machinery (see section Driving and use of machinery).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you are pregnant, take this medicine only if your doctor considers it strictly necessary and under close medical supervision.
Breastfeeding
Do not take this medicine if you are breastfeeding.

Driving and use of machinery
This medicine may impair your ability to drive vehicles or operate machinery due to possible side effects, especially at the beginning of treatment or after alcohol consumption (see section Spirolang with food and alcohol).

For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

3. How to take Spirolang

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose ranges from 100 mg to 200 mg daily, divided into several doses (fractionated doses). This dose may be adjusted depending on your response to treatment with Spirolang.
Your doctor will adjust the dose and duration of treatment according to your condition.

Use in children
Your doctor will determine a reduced dose compared to adults, based on your child's body weight (approximately 3 mg per kg of the child's body 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 have severe liver or kidney problems, you must exercise maximum caution when using Spirolang. Consult your doctor if you have any doubts about using this medicine.

If you take more Spirolang than you should
Contact your doctor immediately or go to the nearest hospital if you have taken more Spirolang than prescribed.
An overdose of Spirolang may cause disturbances in the levels of water and electrolytes in the blood (especially sodium and potassium), leading to hyponatremia and hyperkalemia, which may manifest as drowsiness and confusion.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following adverse effects may occur with unknown frequency (the frequency cannot be determined from the available data):

• changes in your heart rhythm, fatigue or muscle weakness (e.g. in the legs), caused by possible increase in blood potassium levels (hyperkalemia);
• dizziness and leg cramps which may be due to: increased blood potassium levels (hyperkalemia), decreased blood sodium levels (hyponatremia), reduced blood volume (hypovolemia), or dehydration;
• disturbances in the balance of electrolytes in the blood (electrolyte imbalance);
• onset or worsening of a state of "metabolic acidosis" caused by electrolyte imbalances;
• breast tenderness and breast enlargement (gynecomastia), which may depend on the dose and duration of treatment. In rare cases, this condition may persist even after discontinuation of treatment. Generally, breast enlargement in men, related to the duration of therapy, is reversible, meaning it resolves after stopping the treatment;
• erectile dysfunction in males;
• menstrual irregularities in women (amenorrhea or post-menopausal bleeding, dose-dependent);
• voice changes manifesting as difficulty in producing vocal sounds (hoarseness), lowering of voice pitch in women and elevation of voice pitch in men. In some patients, voice changes may persist even after discontinuation of treatment;
• damage to the stomach lining, sometimes with bleeding (gastric ulcer);
• inflammation of the stomach mucosa (gastritis);
• stomach cramps;
• nausea, vomiting, and diarrhea;
• changes in normal kidney function up to severe kidney impairment (acute renal failure);
• development or worsening of benign breast tumors; isolated cases of malignant breast tumors have been reported, but no correlation with Spirolang has been established;
• marked increase or decrease in the number of white blood cells in the blood (eosinophilia and agranulocytosis);
• reduction in the number of platelets (thrombocytopenia);
• dizziness;
• somnolence;
• loss of muscle coordination (ataxia);
• headache;
• mental confusion;
• alteration of sexual desire;
• tendency toward prolonged drowsiness (lethargy);
• increased liver enzyme levels and inflammation of the liver (hepatitis);
• pemphigoid (a condition characterized by fluid-filled blisters 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 skin peeling may appear, particularly on the legs, arms, hands, and feet, and may extend to the face and mouth, occasionally accompanied by fever. These may be symptoms of severe skin diseases such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse 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 the original packaging and at a temperature not exceeding 30°C.
Do not use this medicine after the expiry date stated on the carton after "Expiry".
The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Spirolang 25 mg hard capsules contain

• The active substance is spironolactone. One capsule contains 25 mg of spironolactone.
• The other components are: capsule contents: maize starch, magnesium stearate; capsule shell: erythrosine (E127), indigo carmine (E132), titanium dioxide (E171) and gelatin.

What Spirolang 50 mg hard capsules contain

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

What Spirolang 100 mg hard capsules contain

• The active substance is spironolactone. One capsule contains 100 mg of spironolactone.
• The other components are: capsule contents: maize starch, magnesium stearate; capsule shell: iron oxide (E172), indigo carmine (E132), titanium dioxide (E171) and gelatin.

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

Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)