Ipidacrine hydrochloride grindeks

Package leaflet: Information for the user

Ipidacrine hydrochloride Grindeks, 5 mg/mL, solution for injection
Ipidacrine hydrochloride Grindeks, 15 mg/mL, solution for injection
Ipidacrini hydrochloridum
Please read this leaflet carefully before using this medicine, as 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. The medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Ipidacrine hydrochloride Grindeks is and what it is used for
2. Important information before using Ipidacrine hydrochloride Grindeks
3. How to use Ipidacrine hydrochloride Grindeks
4. Possible side effects
5. How to store Ipidacrine hydrochloride Grindeks
6. 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:

• in the treatment of diseases of the peripheral nervous system (neuritis, polyneuritis, polyradiculoneuropathy, myasthenia, and myasthenic syndromes of various etiologies);
• in 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.

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 chest 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 prior to 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 gastric or duodenal ulcer disease;
• if the patient has vestibular disorders (of the 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, discuss with a doctor or nurse if the patient currently has or has had in the past:

• 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 your doctor about all medicines the patient is currently taking, has recently taken, or plans to take.
Concomitant use of Ipidacrine hydrochloride Grindeks and central nervous system (CNS) depressants may enhance the sedative effect.
The effects 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 gravis (a disease characterized by severe and generalized muscle weakness).
If beta-blockers are administered before treatment with Ipidacrine hydrochloride Grindeks, this may increase the risk of bradycardia.
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 using this medicine.

Pregnancy
Ipidacrine hydrochloride Grindeks increases uterine tone and contractions and may lead to premature delivery; therefore, it should not be used 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 are no data available on the effect of ipidacrine on human fertility.

Driving and operating machinery
Ipidacrine has a minor or moderate influence 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.

3. How to take Ipidacrine hydrochloride Grindeks

This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor. Dosage and duration of treatment should be individually adjusted according to
the severity of the disease.
The injection solution is administered intramuscularly or subcutaneously.
Ipidacrine hydrochloride Grindeks is also available in the form of tablets for oral 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 5–15 mg (1 mL of Ipidacrine hydrochloride Grindeks, 5 mg/mL, injection solution or 1 mL of Ipidacrine hydrochloride Grindeks, 15 mg/mL, injection solution) 1–2 times daily, administered as an intramuscular or subcutaneous injection. Treatment lasts from 1 to 2 months. If necessary, the treatment course may be repeated several times with intervals of 1–2 months between courses.

15–30 mg (1–2 mL of Ipidacrine hydrochloride Grindeks, 15 mg/mL, injection solution) may be
administered as an intramuscular or subcutaneous injection 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 of the medicine, and the
dose may be increased to 20–40 mg (1–2 tablets of Ipidacrine hydrochloride Grindeks, 20 mg),
5–6 times daily.

• In the treatment of certain types of paralysis and paresis, during convalescence after organic CNS damage with motor disturbances
  Dosage and duration of treatment should be individually adjusted depending on the severity of the disease and the patient's response. Treatment is initiated with 1 mL of 5 mg ipidacrine solution administered intramuscularly twice daily for 10–14 days, followed by continuation of treatment with tablets. Dosage recommendations are provided in the Patient Information Leaflet for the tablet form.
  • In the treatment of demyelinating diseases, as part of comprehensive therapy
    Dosage and duration of treatment should be individually adjusted depending on the severity of the disease and the patient's response. Treatment is initiated with 1 mL of 15 mg ipidacrine solution administered intramuscularly twice daily for 10–15 days, followed by continuation of treatment with tablets. Dosage recommendations are provided in the Patient Information Leaflet for the tablet form.

In elderly patients or in patients with liver or kidney disease, this medicine should always be taken exactly as prescribed by the physician. In case of doubt, consult your doctor or pharmacist.
If you feel that the medicine's effect is too strong or too weak, consult your doctor.
Taking more Ipidacrine hydrochloride Grindeks than prescribed
If more than the prescribed 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, miosis (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, 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. If you have any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.

Common (occur in less than 1 in 10 patients):

• palpitations, slowed heart rate;
• hypersalivation, nausea;
• excessive sweating.

Uncommon (occur in no more than 1 in 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 (occur in less than 1 in 1000 patients):

• diarrhoea, abdominal 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, injection site rash).

If adverse reactions occur, the doctor may reduce the dose or recommend temporarily discontinuing
the medicine for a short period (1–2 days). The doctor may prescribe medications to prevent certain
adverse reactions (such as hypersalivation, slowed heart rate).

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ipidacrine hydrochloride Grindeks

No special storage temperature requirements.
Store in the original packaging to protect from light.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and the ampoule label
after: "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 required. Such measures 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 ampoule (1 mL) contains 5 mg or 15 mg of ipidacrine hydrochloride (as monohydrate).
• The other ingredients are: hydrochloric acid (1M solution) (for pH adjustment) and water for injections.

What Ipidacrine hydrochloride Grindeks looks like and contents of the pack
A clear, colourless liquid, practically free from visible particles.
The osmolality of the 15 mg/mL solution is approximately 90–100 mOsmol/kg.
The osmolality of the 5 mg/mL solution is approximately 35–45 mOsmol/kg.
Ipidacrine hydrochloride Grindeks, 5 mg/mL, solution for injection
1 mL solution in an ampoule made of colourless borosilicate glass of hydrolytic class I, with a break ring or point (OPC). The ampoules are marked with a coloured ring – the lower ring is red and the upper ring is yellow.
5 ampoules with solution for injection are packed in a PVC foil blister. Two PVC foil blisters, each containing 5 ampoules, are packed in a cardboard box.
Ipidacrine hydrochloride Grindeks, 15 mg/mL, solution for injection
1 mL solution in an ampoule made of colourless borosilicate glass of hydrolytic class I, with a break ring or point (OPC). The ampoules are marked with a coloured ring – the lower ring is red and the upper ring is green.
5 ampoules with solution for injection are packed in a PVC foil blister. Two PVC foil blisters, each containing 5 ampoules, are packed in a cardboard box.
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 Member States of the European Economic Area under the following names:
Latvia Ipidacrine Grindeks 5 mg/ml solution for injection
Ipidacrine Grindeks 15 mg/ml solution for injection
Bulgaria Ipigrix 5 mg/ml injection solution
Ipigrix 15 mg/ml injection solution
Croatia Ipigriks 5 mg/ml injection solution
Ipigriks 15 mg/ml injection solution
Hungary Ipidacrine Grindeks 5 mg/ml solution for injection
Ipidacrine Grindeks 15 mg/ml solution for injection
Lithuania Ipidacrine hydrochloride Grindeks 5 mg/ml injection solution
Ipidacrine hydrochloride Grindeks 15 mg/ml injection solution
Poland Ipidacrine hydrochloride Grindeks
Ipidacrine hydrochloride Grindeks
Romania Ipigrix 5 mg/ml solution for injection
Ipigrix 15 mg/ml solution for injection
Slovakia Ipigrix 5 mg/ml injection solution
Ipigrix 15 mg/ml injection solution
Slovenia Ipigrix 5 mg/ml solution for injection
Ipigrix 15 mg/ml solution for injection