Package leaflet: Information for the user

Ipidacrine hydrochloride Grindeks, 20 mg, tablets
Ipidacrini hydrochloridum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same as yours.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

What Ipidacrine hydrochloride Grindeks is and what it is used for
Important information before taking Ipidacrine hydrochloride Grindeks
How to take Ipidacrine hydrochloride Grindeks
Possible side effects
How to store Ipidacrine hydrochloride Grindeks
Contents of the pack and other information

1. What Ipidacrine hydrochloride Grindeks is and what it is used for

The active substance in Ipidacrine hydrochloride Grindeks is ipidacrine hydrochloride (referred to hereinafter as ipidacrine), which is a reversible cholinesterase inhibitor. It is used in adults:

for the treatment of diseases of the peripheral nervous system (neuritis, polyneuritis, polyneuropathy, polyradiculoneuropathy, myasthenia and myasthenic syndromes of various etiologies);
for the treatment of certain types of paralysis and paresis;
in organic damage of the central nervous system (CNS) with motor disorders during the convalescence period;
in the treatment of demyelinating diseases, as part of complex therapy;
in the treatment of memory disorders of various origins (Alzheimer's disease and other types of senile dementia);
in the treatment of intestinal atony.

2. Important information before taking Ipidacrine hydrochloride Grindeks

When not to take Ipidacrine hydrochloride Grindeks

if the patient is allergic to ipidacrine or any of the other ingredients of this medicine (listed in section 6);
if the patient has epilepsy;
if the patient has extrapyramidal disorders with hyperkinesia (muscle spasms of the tongue, face, neck, and back);
if the patient has angina pectoris (acute episodes of pain in the area of the heart and/or behind the sternum);
if the patient has bradycardia (resting heart rate below 50 beats per minute before starting treatment);
if the patient has bronchial asthma;
if the patient has intestinal or urinary tract obstruction;
if the patient has experienced an exacerbation of peptic ulcer disease of the stomach or duodenum;
if the patient has vestibular disorders (sense and perception of balance);
if the patient is pregnant;
if the patient is breastfeeding.

Warnings and precautions
Before starting treatment with Ipidacrine hydrochloride Grindeks, consult a doctor if the patient currently has or has previously had:

gastric ulcers;
duodenal ulcers;
thyrotoxicosis;
cardiovascular disease;
respiratory disease.

Children and adolescents
The safety of this medicine in children and adolescents under 18 years of age has not been established.

Ipidacrine hydrochloride Grindeks and other medicines
Inform the doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Concomitant use of Ipidacrine hydrochloride Grindeks and drugs with depressant effects on the central nervous system (CNS) may enhance sedative effects.
The effect of ipidacrine and its adverse reactions may be intensified when used concomitantly with other cholinesterase inhibitors and M-cholinomimetic drugs.
Concomitant use of Ipidacrine hydrochloride Grindeks and other cholinergic drugs may increase the risk of cholinergic crisis in patients with myasthenia (a disease characterized by severe and generalized muscle weakness).
If beta-adrenolytics are administered before treatment with Ipidacrine hydrochloride Grindeks, the risk of bradycardia may increase.
This medicine may be used in combination with cerebrolysin.

Ipidacrine hydrochloride Grindeks and alcohol
Alcohol may intensify the adverse effects of this medicine.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before taking this medicine.

Pregnancy
Ipidacrine hydrochloride Grindeks increases uterine tone and contractions and may lead to premature delivery; therefore, it should not be taken during pregnancy (see: When not to take Ipidacrine hydrochloride Grindeks).

Breastfeeding
This medicine should not be taken if the patient is breastfeeding (see: When not to take Ipidacrine hydrochloride Grindeks).

Fertility
There is no data available on the effect of ipidacrine on fertility in humans.

Driving and operating machinery
Ipidacrine has a minor or moderate effect on the ability to drive and operate machinery. Ipidacrine hydrochloride Grindeks may cause post-medication sedation.
Therefore, caution should be exercised in patients experiencing this symptom.

Ipidacrine hydrochloride Grindeks contains lactose
If the doctor has previously diagnosed the patient with an intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

3. How to take Ipidacrine hydrochloride Grindeks

This medicine should always be taken as directed by the physician. If in doubt, consult your doctor.
The dosage and duration of treatment are determined by the physician, depending on the severity of the disease.
Oral administration. The tablet should be swallowed whole, preferably with water. This medicine may be taken with or without food.
Ipidacrine hydrochloride Grindeks is also available as an injection solution for intramuscular (into the muscle) or subcutaneous (under the skin) administration. The physician will decide which pharmaceutical form of Ipidacrine hydrochloride Grindeks is more suitable for the patient.

Peripheral nervous system disorders, myasthenia and myasthenic syndrome
The recommended dose is 20 mg of ipidacrine (1 tablet), 1-3 times daily.
Treatment lasts from 1 to 2 months. If necessary, treatment cycles may be repeated several times with intervals of 1-2 months between them.
15-30 mg (1-2 mL of Ipidacrine hydrochloride Grindeks, 15 mg/mL, injection solution) may be administered parenterally (intramuscularly or subcutaneously) for a short period to prevent myasthenic crisis with severe neuromuscular junction impairment. Treatment with Ipidacrine hydrochloride Grindeks should be continued using the tablet form, and the dose may be increased up to 20-40 mg (1-2 tablets) 5-6 times daily.
In the treatment of certain types of paralysis and paresis, during convalescence after organic CNS damage with motor disturbances, and in comprehensive treatment of demyelinating diseases
Dosage and duration of treatment should be individually adjusted depending on the severity of the disease and patient response. The daily dose is individually determined, usually 20 mg 2-3 times daily. The maximum daily dose may reach 200 mg. Treatment may be initiated with Ipidacrine hydrochloride Grindeks, 5 mg/mL, injection solution administered intramuscularly. Dosage recommendations are provided in the Package Leaflet for Ipidacrine hydrochloride Grindeks injection solution.
- Demyelinating diseases, as part of comprehensive therapy
  Dosage and duration of treatment should be individually adjusted depending on the severity of the disease and patient response. The daily dose is individually determined, usually 20-40 mg 2-3 times daily. The maximum daily dose may reach 200 mg. Treatment may be initiated with Ipidacrine hydrochloride Grindeks, 15 mg/mL, injection solution administered intramuscularly. Dosage recommendations are provided in the Package Leaflet for Ipidacrine hydrochloride Grindeks injection solution.
Memory disorders of various origins (Alzheimer's disease and other types of senile dementia)
Dosage and duration of treatment should be adjusted according to individual patient response. The daily dose is individually determined, usually 20 mg 2-3 times daily. The maximum daily dose may reach 200 mg. The duration of treatment ranges from 1 month to 1 year.
Intestinal atony
The recommended dose is 20 mg (1 tablet) 2-3 times daily for 1-2 weeks.

If you feel that the medicine's effect is too strong or too weak, consult your doctor.
If the patient is elderly or suffers from liver or kidney disease, the medicine should always be taken exactly as prescribed by the physician. In case of doubt, consult your doctor or pharmacist.

Taking more than the recommended dose of Ipidacrine hydrochloride Grindeks
If more than the recommended dose of Ipidacrine hydrochloride Grindeks has been taken, contact your doctor immediately.
Significant overdose may cause symptoms of "cholinergic crisis", including bronchospasm, eye tearing, excessive sweating, pupil constriction, nystagmus (involuntary, rapid, and repetitive eye movement), involuntary defecation and urination, vomiting, bradycardia (slow heart rate), heart block, irregular heartbeat, low blood pressure, motor restlessness, anxiety, agitation, fear sensation, impaired motor coordination and balance, slurred speech, drowsiness, weakness, seizures, and coma. Symptoms may be mild.

Missing a dose of Ipidacrine hydrochloride Grindeks
Take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Ipidacrine hydrochloride Grindeks
Discontinuing the medicine before the end of treatment may result in failure to achieve the desired therapeutic effect. In case of any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will get them.
Common (occurs in less than 1 out of 10 patients):

palpitations, slowed heart rate;
salivation, nausea;
excessive sweating.

Uncommon (occurs in no more than 1 out of 100 patients):

dizziness, headache, drowsiness (when using high doses);
increased bronchial secretion;
vomiting (when using high doses);
skin allergic reactions (itching, rash) (when using high doses);
muscle cramps (when using high doses);
weakness (when using high doses).

Rare (occurs in less than 1 out of 1000 patients):

diarrhoea, epigastric pain.

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

hypersensitivity reactions (including allergic dermatitis, anaphylactic shock, asthma, toxic epidermal necrolysis, erythema, urticaria, wheezing, laryngeal oedema).

If adverse effects occur, the doctor may reduce the dose or recommend temporarily discontinuing
the medicine for a short period (1–2 days). The doctor may prescribe additional medicines to prevent certain
adverse effects (such as salivation, slowed heart rate).
Reporting of adverse 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 of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ipidacrine hydrochloride Grindeks

Do not store above 25°C.
Keep the medicine in a place inaccessible to children and out of sight.
Do not use this medicine after the expiry date stated on the carton and blister pack following:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Ipidacrine hydrochloride Grindeks contains

The active substance in Ipidacrine hydrochloride Grindeks is ipidacrine hydrochloride. Each tablet contains 20 mg of ipidacrine hydrochloride (in monohydrate form).
The other ingredients are: monohydrate lactose, potato starch, calcium stearate.

What Ipidacrine hydrochloride Grindeks looks like and contents of the pack
White or almost white, round, flat tablets with bevelled edges. The tablet diameter is approximately 6 mm.
Ipidacrine hydrochloride Grindeks is available in packs of 50 or 100 tablets.
Marketing Authorisation Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53, Rīga, LV-1057, Latvia
Tel.: +371 67083205
Fax: +371 67083505
E-mail: [email protected]
This medicinal product is authorised in the European Economic Area countries under the following names:
Latvia Ipidacrine Grindeks 20 mg tablets
Bulgaria Ipigrix 20 mg tablets
Croatia Ipigriks 20 mg tablets
Hungary Ipidacrine Grindeks 20 mg tabletta
Lithuania Ipidacrine hydrochloride Grindeks 20 mg tabletės
Poland Ipidacrine hydrochloride Grindeks
Romania Ipigrix 20 mg comprimate
Slovakia Ipigrix 20 mg tablety
Slovenia Ipigrix 20 mg tablete