Spironolactone Medreg

Package Leaflet: Information for the Patient

Spironolactone Medreg, 25 mg, Film-Coated Tablets

Spironolactone

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Contents of the Package Leaflet:

• 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, also known as water tablets.
The reason for the patient's visit to the doctor may be swelling of the ankles or shortness of breath. These symptoms may occur if the heart's pumping function weakens due to too much fluid in the body. This is called congestive heart failure.
The need to pump excess fluid throughout the body means that the heart has to work harder. The doctor prescribes Spironolactone Medreg to get rid of excess fluid from the body. As a result, the heart will be able to work less hard.
Excess fluid is removed in the form of urine, so it may be necessary to use the toilet more often while taking Spironolactone Medreg.
The doctor may also prescribe Spironolactone Medreg if the patient's blood pressure is higher than it should be. This is called hypertension. High blood pressure occurs when the blood pressure on the walls of the blood vessels increases. By removing fluid from the blood vessels, Spironolactone Medreg reduces the pressure on the blood vessel walls and thus lowers blood pressure.
Spironolactone Medreg may also be used in the following conditions:

• Nephrotic syndrome (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).
• Ascites caused by malignant tumors (excess fluid due to the accumulation of cancer cells in the abdominal cavity).
• Primary hyperaldosteronism (excess fluid in the body due to too high a concentration of a hormone called aldosterone).

If the patient has these conditions, Spironolactone Medreg will help get rid of excess fluid from the body.
Consult a doctor if the patient does not feel better or feels worse.
Children should only be treated under the supervision of a pediatrician.

2. Important information before taking 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 hyperkalemia (high potassium levels in the blood) or any other symptoms related to hyperkalemia;
• if the patient is unable to urinate;
• if the patient has severe kidney disease;
• if the patient is taking a similar-acting medicine, eplerenone;
• if the patient is taking potassium-sparing diuretics or any other medicines to supplement potassium;
• if the patient is a child or adolescent with moderate or severe kidney impairment.

Warnings and precautions

Before starting to take Spironolactone Medreg, the patient should discuss it with their doctor or pharmacist:

• if the patient has kidney disease, especially in children with hypertension, or liver disease;
• if the patient is elderly;
• if the patient has difficulty urinating;
• if the patient has a disease related to electrolyte imbalance in the blood;
• if the patient has a disease related to an increase or decrease in the concentration 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, the patient may experience a significant increase in potassium levels in the blood. This can affect heart function and, in severe cases, can lead to death;
• if the patient is taking other diuretic tablets (diuretics) in combination with Spironolactone Medreg, which can cause a decrease in sodium levels (hyponatremia) in the blood;
• if the patient is pregnant or breastfeeding.

Taking Spironolactone Medreg with certain other medicines, potassium supplements, or potassium-rich foods may lead to severe hyperkalemia (high potassium levels in the blood). Symptoms of severe hyperkalemia may include muscle cramps, heart rhythm disturbances, diarrhea, nausea, dizziness, or headache.

Children

Children should only be treated under the supervision of a pediatrician.

Spironolactone Medreg and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.

• 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;
• digitalis glycosides, such as digoxin (used to treat heart failure);
• non-steroidal anti-inflammatory medicines (NSAIDs), such as aspirin, indomethacin, mefenamic acid;
• noradrenaline;
• if the patient is to undergo surgery with local or general anesthesia, they should inform their doctor about taking Spironolactone Medreg;
• antipyretics (used to reduce fever);
• heparin or low molecular weight heparin (medicines used to prevent blood clots);
• potassium supplements.

The patient should inform their doctor if they are taking abiraterone for the treatment of prostate cancer.

Spironolactone Medreg with food and drink

This medicine should be taken with food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine.

Driving and using machines

The patient should be careful when driving or using machines.

Spironolactone Medreg contains lactose

If the patient has been told they have an intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Spironolactone Medreg

This medicine should always be taken exactly as the doctor has instructed. If the patient is unsure, they should ask their doctor or pharmacist.

Patients with kidney problems

The doctor will start treatment with a low initial dose and then gradually increase it as necessary until the desired effect is achieved.

Children

If Spironolactone Medreg is taken by children, the number of tablets depends on the child's body weight. The doctor will determine the number of tablets to be given individually.

What to do if the patient takes more Spironolactone Medreg than they should

If the patient has taken too many tablets, they should contact their doctor or go to the emergency department of the nearest hospital immediately.

What to do if the patient forgets to take Spironolactone Medreg

If the patient forgets to take a tablet, they should take it as soon as possible, unless it is almost time for their next dose. The patient should not take a double dose to make up for a forgotten dose.

What to do if the patient stops taking Spironolactone Medreg

Spironolactone Medreg should be taken for as long as the doctor recommends, even if the patient feels better. If the patient stops taking the medicine too quickly, their condition may worsen.

4. Possible side effects

Like all medicines, Spironolactone Medreg can cause side effects, although not everybody gets them.

• itching and blisters on the skin around the lips and on other parts of the body, red or purple rash spreading and forming blisters (Stevens-Johnson syndrome),
• the top layer of the skin peeling off from the lower layers of the skin all over the body (toxic epidermal necrolysis, TEN),
• rash, fever, and swelling (which may be symptoms of a more serious disorder, 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 can lead to death, feeling of tingling, paralysis (loss of muscle function), or difficulty breathing; these may be symptoms of high potassium levels in the blood.

Other side effects:

Very common (may affect up to 1 in 10 people):

• high potassium levels in the blood.

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

• disorientation
• dizziness
• nausea
• itching, rash
• muscle cramps
• kidney failure or kidney function disorders
• breast enlargement in men or breast pain in men
• general feeling of being unwell.

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

• breast changes, such as breast lumps
• electrolyte imbalance
• liver function disorders
• hives
• menstrual disorders in women
• breast pain (in women).

Rare (may affect up to 1 in 1,000 people):

• reduced white blood cell count
• reduced platelet count
• reduced red blood cell count (anemia)
• reduced blood clotting or increased eosinophil count in the blood (eosinophilia), which can increase the risk of bleeding or bruising or cause purple spots on the skin (purpura)
• changes in sex drive in both men and women
• headache, drowsiness, general weakness, or lethargy and coordination problems (ataxia)
• gastrointestinal disorders
• a condition in which blisters filled with fluid appear on the skin (pemphigoid)
• hair loss
• excessive hair growth
• temporary impotence in men
• fever.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist.

5. How to store Spironolactone Medreg

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP.

The expiry date refers to the last day of that month.

There are no special storage instructions for this medicine.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Spironolactone Medreg contains

• The active substance is spironolactone. Each film-coated tablet contains 25 mg of spironolactone.
• The other ingredients are: Tablet core: lactose monohydrate, maize starch, calcium hydrogen phosphate, povidone K 25, peppermint oil, talc, colloidal silica, anhydrous, 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 film-coated tablets (diameter approximately 8.1 mm) with the inscription "AD" on one side and smooth on the other, with a slight peppermint odor.

The tablets are packaged in PVC/Aluminum blisters placed in a cardboard box.

Available pack sizes: 10, 20, 30, 50, 60, 90, or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Medreg s.r.o.

Na Florenci 2116/15

Nové Město

110 00 Prague 1

Czech Republic

Phone: (+420) 516 770 199

Manufacturer/Importer:

MEDIS INTERNATIONAL A.S.

Výrobní závod Bolatice

Průmyslová 961/16

747 23 Bolatice

Czech Republic

Pharmazet Group s.r.o.

Třtinová 260/1

Čakovice

196 00 Prague 9

Czech Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:

Spironolactone Medreg

Slovakia:

Spironolactone Medreg

Poland:

Spironolactone Medreg

Romania:

Spironolactonă Gemax Pharma 25 mg film-coated tablets

Date of last revision of the leaflet: 04/2025