Glucardiamid

Package Leaflet: Information for the Patient

GLUCARDIAMID,125 mg + 1500 mg, tablets
Nicethamide + Glucose

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

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is G and what is it used for
• 2. Important information before taking G
• 3. How to take G
• 4. Possible side effects
• 5. How to store G
• 6. Package contents and other information

1. What is G and what is it used for

G contains nicethamide and glucose as active substances.
Nicethamide has a stimulating effect on the central nervous system. It increases the sensitivity of the respiratory center to carbon dioxide, increases respiratory volume, and intensifies respiratory rate. By increasing heart rate, cardiac output, and pulmonary artery pressure, it raises blood pressure, especially in patients with hypotension.
The glucose contained in the medicine G serves as an energy source for the body.
G can be used as an auxiliary agent:

• in cases of significant and prolonged physical exertion;
• in cases of chronic weakness and fatigue.

2. Important information before taking G

When not to take G

• if the patient is allergic to nicethamide or glucose or any of the other ingredients of this medicine (listed in section 6);
• in patients with tachycardia (rapid heart action) and severe cardiac arrhythmias;
• in patients with unstable angina pectoris;
• in children under 12 years of age.

Warnings and precautions

Before starting to take G, the patient should discuss it with their doctor or pharmacist.
The following conditions require cautious use (only in consultation with a doctor):

• severe bronchial asthma, as the medicine may cause significant bronchospasm;
• hypertension;
• hyperthyroidism;
• epilepsy, as it may cause seizures;
• diabetes.

Nicethamide is on the list of doping substances in sports, prepared by the Anti-Doping Commission. It may cause positive results in some anti-doping tests.

Children and adolescents

Do not use in children under 12 years of age.

G and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interactions between G and other medicines have been observed at recommended doses.
The medicine should be used with caution in patients taking sympathomimetic drugs and monoamine oxidase inhibitors, as well as in combination with muscle relaxants.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The use of G is not recommended during pregnancy and breastfeeding due to the lack of safety confirmation.

Driving and operating machinery

The medicine does not affect psychophysical abilities, the ability to drive vehicles, or operate machinery.

G contains glucose and sucrose

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine. The medicine may have a harmful effect on teeth.

G contains quinoline yellow (E 104)

The medicine may cause allergic reactions.

G contains butylhydroxyanisole (E 320) and butylhydroxytoluene (E 321)

The medicine may cause local irritation of the mucous membranes.

3. How to take G

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Oral administration.
Recommended dose:
Suck 4 to 6 tablets per day.

Using a higher dose of G than recommended

Even if the patient swallows several tablets whole, G is released slowly, and a significant amount of the medicine is eliminated during this time.
In the event of significant overdose, the following symptoms may occur: accelerated breathing, nausea, vomiting, excessive sweating, itching, sneezing, anxiety, and seizures. Other symptoms include dizziness, headache, anxiety, disorientation, flushing, high fever, sweating, and paresthesia, as well as a feeling of heat. More severe overdose symptoms include increased blood pressure, muscle spasticity, sinus tachycardia, and other arrhythmias, as well as seizures.

Missing a dose of G

The patient should continue taking the medicine without increasing the next dose.
A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, G can cause side effects, although not everybody gets them.
Side effects may manifest as: lowered seizure threshold, persistent cough, bronchospasm, and headache.
More severe side effects include the exacerbation of porphyria symptoms, a disease characterized by episodic abdominal pain, neurological and psychiatric disorders.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store G

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the carton after the words "Expiry date". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What G contains

• The active substances of the medicine are nicethamide and glucose.
• The other ingredients are: liquid glucose, sucrose, solid fat, citric acid monohydrate, sorbitan monooleate, white wax, quinoline yellow (E 104), butylhydroxyanisole, and butylhydroxytoluene.

What G looks like and what the package contains

Tablets in the shape of flat cubes made of transparent, yellow mass, packaged separately in aluminum/paper/PE laminate, in a cardboard box.
The package contains 10 or 20 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warsaw
{logo Perrigo}
Manufacturer:
Przedsiębiorstwo Produkcyjno – Handlowe „EWA” S.A.
ul. Zamkowy Folwark 9
63-700 Krotoszyn

Date of last revision of the leaflet: August 2024