Spironolactone medreg

Package leaflet: Information for the patient

Spironolactone Medreg, 25 mg, coated tablets
Spironolactonum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Spironolactone Medreg is and what it is used for
2. Important information before taking Spironolactone Medreg
3. How to take Spironolactone Medreg
4. Possible side effects
5. How to store Spironolactone Medreg
6. Contents of the pack and other information

1. What Spironolactone Medreg is and what it is used for

Spironolactone Medreg belongs to a group of medicines called diuretics, which are also known as water pills.
You may have visited your doctor due to swelling around the ankles or shortness of breath. These symptoms may occur when the heart's ability to pump blood weakens due to excess fluid in the body. This is known as congestive heart failure. The need for the heart to pump excess fluid throughout the body means it must work harder. Your doctor has prescribed Spironolactone Medreg to help eliminate this excess fluid from your body. As a result, the heart will be able to work less intensively.
The excess fluid is removed in the form of urine, so during treatment with Spironolactone Medreg, you may need to urinate more frequently.
Your doctor may also prescribe Spironolactone Medreg if your blood pressure is higher than normal. This is called "hypertension." High blood pressure occurs when there is increased pressure of blood against the walls of blood vessels. By removing fluid from the blood vessels, Spironolactone Medreg reduces pressure on the vessel walls and thus lowers blood pressure.
Spironolactone Medreg may also be used in the following conditions:

• Nephrotic syndrome (a kidney disorder causing excess fluid in the body).
• Ascites (excess fluid in the abdominal cavity) and edema (fluid accumulation under the skin or in at least one body cavity, causing swelling, for example due to liver cirrhosis).
• Malignant ascites (excess fluid due to accumulation of cancer cells in the abdominal cavity).
• Primary hyperaldosteronism (excess fluid in the body caused by abnormally high levels of a hormone called aldosterone).

If you have any of these conditions, Spironolactone Medreg will help eliminate excess fluid from your body.
Please consult your doctor if you do not feel better or feel worse.
Children should only be treated under the supervision of a pediatrician.

2. Important information before using Spironolactone Medreg

When not to take Spironolactone Medreg:

• if the patient is allergic to spironolactone or any of the other ingredients of this medicine (listed in section 6);
• if the patient has Addison's disease (a deficiency of certain hormones, characterized by extreme weakness, weight loss, and low blood pressure);
• if the patient has hyperkalaemia (increased potassium levels in the blood) or any other symptoms related to hyperkalaemia;
• if the patient is unable to pass urine;
• if the patient has severe kidney disease;
• if the patient is taking eplerenone, a similarly acting medicine;
• if the patient is taking potassium-sparing diuretics (diuretic medicines that preserve potassium) or any other medicines to correct potassium deficiency;
• if the patient is a child or adolescent with moderate or severe kidney impairment.

Warnings and precautions
Before starting treatment with Spironolactone Medreg, discuss this with your doctor or
pharmacist:

• if the patient has kidney disease, especially children with hypertension, or liver disease;
• if the patient is elderly;
• if the patient has difficulty passing urine;
• if the patient has a condition associated with disturbances in blood electrolyte levels;
• if the patient has a condition associated with increased or decreased levels of electrolytes in the blood, such as potassium or sodium;
• if the patient has severe heart failure;
• if the patient has reduced kidney function or kidney failure, a significant increase in blood potassium levels may occur. This may affect heart function and, in extreme cases, may lead to death;
• if the patient is taking any other diuretic tablets (diuretics) in combination with Spironolactone Medreg, which may cause low sodium levels (hyponatraemia) in the blood;
• if the patient is pregnant or breastfeeding.

Concomitant use of Spironolactone Medreg with certain medicines, potassium supplements, or potassium-rich foods may lead to severe hyperkalaemia (increased blood potassium levels). Symptoms of severe hyperkalaemia may include muscle cramps, irregular heartbeat, diarrhoea, nausea, dizziness, or headache.
Children
Children should only be treated under the supervision of a paediatrician.
Spironolactone Medreg and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Your doctor may need to adjust the dose of Spironolactone Medreg if the patient is taking any of the following medicines:

• trimethoprim and trimethoprim with sulfamethoxazole (antibacterial medicines);
• lithium;
• carbenoxolone;
• cholestyramine;
• ammonium chloride;
• medicines used to treat high blood pressure, including ACE inhibitors;
• other diuretic medicines;
• cardiac glycosides, including digoxin (used in the treatment of heart failure);
• non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, indomethacin, mefenamic acid;
• noradrenaline;
• if the patient is to undergo a procedure involving local or general anaesthesia, the patient should inform the attending physician about the use of Spironolactone Medreg;
• antipyrine (used to reduce fever);
• heparin or low molecular weight heparin (medicines used to prevent blood clots);
• potassium supplements.

Inform your doctor if the patient is taking abiraterone for the treatment of prostate cancer.
Tell your doctor if the patient is taking mitotane for the treatment of malignant adrenal tumours. This medicine should not be used concomitantly with mitotane.
Spironolactone Medreg with food and drink
This medicine should be taken with food.
Taking Spironolactone Medreg with a diet rich in potassium salts and salt substitutes containing potassium may lead to increased blood potassium levels.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
There is limited data on the use of Spironolactone Medreg in pregnant women. Your doctor will prescribe Spironolactone Medreg only if the potential benefits outweigh the potential risks.
Spironolactone Medreg should not be used in breastfeeding women. The patient should discuss the use of Spironolactone Medreg with her doctor, who will advise on an alternative method of feeding the infant during treatment with this medicine.
Driving and operating machinery
Exercise caution when driving or operating machinery.
Drowsiness and dizziness may occur with the use of Spironolactone Medreg, which may affect the ability to drive and operate machinery.
Spironolactone Medreg contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Spironolactone Medreg

This medicine should always be taken as prescribed by the doctor. In case of doubt, consult your
doctor or pharmacist.
The recommended dose for adults varies and ranges from 25 mg to 400 mg per day, depending on the severity of the disease.
This medicine should be taken once daily, during a meal.

Elderly patients
The doctor will start treatment with a low initial dose and then gradually increase the dose if necessary, until the desired effect is achieved.

Children
If Spironolactone Medreg is administered to children, the number of tablets depends on the child's body weight. The doctor determines individually the amount of tablets to be given.

Taking more Spironolactone Medreg than prescribed
If too many tablets are accidentally taken, contact a doctor immediately or go to the emergency department of the nearest hospital.
Symptoms of overdose include: drowsiness, dizziness, dehydration, and disorientation. The patient may also experience nausea or vomiting, diarrhea, and skin rash characterized by flat red areas of skin with small raised bumps. Changes in blood sodium and potassium levels may cause weakness, tingling, prickling, or numbness of the skin, and (or) muscle cramps, although it is unlikely that these symptoms are related to severe overdose.

Missed dose of Spironolactone Medreg
If a patient forgets to take a tablet of Spironolactone Medreg, they should take it as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.

Stopping treatment with Spironolactone Medreg
Spironolactone Medreg should be taken until the doctor decides to discontinue treatment, even if the patient feels better. Stopping treatment too early may cause the patient's condition to worsen.

If you have any further questions 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.
You must immediately inform your doctor if any of the following symptoms occur in the patient after taking the medicine. Although these symptoms are very rare, they may be serious:

• itching and blisters on the skin around the lips and other parts of the body, red or purple rash spreading and forming blisters (Stevens-Johnson syndrome),
• separation of the outer layer of skin from the underlying layers over the entire body surface (toxic epidermal necrolysis, Toxic Epidermal Necrolysis, TEN),
• skin rash, fever, and swelling (which may be signs of more serious conditions, drug reaction with eosinophilia and systemic symptoms, Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS),
• yellowing of the skin and eyes (jaundice; Spironolactone Medreg may cause liver function disorders),
• irregular heartbeat, which may lead to death, tingling sensation, paralysis (loss of muscle function), or difficulty breathing; these may be symptoms of increased potassium levels in the blood. Your doctor will recommend regular blood tests to monitor potassium and other electrolyte levels, and if necessary, may decide to discontinue treatment.

Other side effects:
Very common (may occur in more than 1 in 10 people):

• increased potassium levels in the blood.

Common (may occur in up to 1 in 10 people):

• disorientation
• dizziness
• nausea
• skin itching, rash
• muscle cramps
• kidney failure or kidney function disorders
• breast enlargement in men or breast pain in men
• general malaise.

Uncommon (may occur in up to 1 in 100 people):

• changes in the breasts, such as breast lumps
• disturbances in electrolyte levels
• liver function disorders
• urticaria
• menstrual disorders in women
• breast pain (in women).

Frequency not known (frequency cannot be estimated from available data):

• decreased number of white blood cells in the blood
• decreased number of infection-fighting cells – white blood cells, which makes it easier to contract infections
• decreased number of oxygen-carrying cells (anaemia)
• decreased number of blood clotting cells or increased number of eosinophils in the blood (eosinophilia), increasing the risk of bleeding or bruising or causing purplish spots on the skin (purpura)
• changes in sexual desire in both women and men
• headache, drowsiness, general weakness or lethargy, and problems with muscle coordination (ataxia)
• digestive disturbances
• a condition in which fluid-filled blisters appear on the skin (bullous pemphigoid)
• hair loss
• excessive hair growth
• temporary impotence in men
• fever.

Reporting of side effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to collect more information on the safety of the medicine.
Adverse effects can also be reported to the marketing authorization holder.

5. How to store Spironolactone Medreg

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after: EXP.
The expiry date refers to the last day of the stated month.
No special storage temperature requirements apply.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Spironolactone Medreg contains

• The active substance is spironolactone. Each coated tablet contains 25 mg of spironolactone.
• The other ingredients are:
  Tablet core: monohydrate lactose, pregelatinized maize starch, calcium hydrogen phosphate, povidone K 25, peppermint essential oil, talc, colloidal anhydrous silica, magnesium stearate.
  Tablet coating: hypromellose 2910, macrogol 400, titanium dioxide (E 171).

What Spironolactone Medreg looks like and contents of the pack
White or almost white, round, biconvex coated tablets (diameter approximately 8.1 mm), with the imprint “AD” on one side and smooth on the other, having a faint peppermint odour.
The tablets are packed in PVC/aluminium blisters placed in a cardboard box.
Pack sizes: 10, 20, 30, 50, 60, 90 or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
Tel.: (+420) 516 770 199

Manufacturer/Importer:
MEDIS INTERNATIONAL A.S.
Výrobní závod Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic

Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Spironolactone Medreg
Slovakia: Spironolactone Medreg
Poland: Spironolactone Medreg
Romania: Spironolactonă Gemax Pharma 25 mg comprimate filmate