Ipidacrine hidrohloride Grindeks

Leaflet accompanying the packaging: information for the user

Ipidacrine hydrochloride Grindeks, 5 mg/mL, solution for injection

Ipidacrine hydrochloride Grindeks, 15 mg/mL, solution for injection

Ipidacrine hydrochloride

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any 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 Ipidacrine hydrochloride Grindeks and what is it used for
• 2. Important information before taking Ipidacrine hydrochloride Grindeks
• 3. How to take Ipidacrine hydrochloride Grindeks
• 4. Possible side effects
• 5. How to store Ipidacrine hydrochloride Grindeks
• 6. Contents of the packaging and other information

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

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

• to treat diseases of the peripheral nervous system (neuritis, polyneuritis, polyneuropathy, polyradiculoneuropathy, myasthenia and myasthenic syndrome of various etiologies);
• to treat certain types of paralysis and paresis;
• for organic damage to the central nervous system (CNS) with movement disorders during the recovery period;
• to treat demyelinating diseases, as part of comprehensive 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 attacks of pain in the chest and/or behind the breastbone);
• if the patient has a slow heart rate (before starting treatment, the resting heart rate is less than 50 beats per minute);
• if the patient has bronchial asthma;
• if the patient has intestinal or urinary tract obstruction;
• if the patient has exacerbated gastric or duodenal ulcer disease;
• 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 to take Ipidacrine hydrochloride Grindeks, the patient should discuss this with their doctor or nurse if they have or have had in the past:

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

Children and adolescents

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

Ipidacrine hydrochloride Grindeks and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Concomitant use of Ipidacrine hydrochloride Grindeks and medicines that have a depressant effect on the CNS may enhance the sedative effect (calming).
The effect of ipidacrine and its side effects are enhanced during concomitant use with other cholinesterase inhibitors and M-cholinomimetic medicines.
Concomitant use of Ipidacrine hydrochloride Grindeks and other cholinergic medicines may increase the risk of cholinergic crisis in patients with myasthenia (a disease characterized by severe and generalized muscle weakness).
If beta-adrenolytics are used before treatment with Ipidacrine hydrochloride Grindeks, this may increase the risk of slowing the heart rate.
This medicine can be used in combination with cerebrolysin.

Ipidacrine hydrochloride Grindeks and alcohol

Alcohol may enhance the side effects of this medicine.

Pregnancy, breastfeeding, and fertility

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.
Pregnancy
Ipidacrine hydrochloride Grindeks increases uterine tone and contractions and may lead to premature labor, so 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 on the effect of ipidacrine on human fertility.

Driving and using machines

Ipidacrine has a minor or moderate effect on the ability to drive and use machines. Ipidacrine hydrochloride Grindeks may cause drug-induced sedation.
Therefore, patients who experience this symptom should be cautious.

3. How to take Ipidacrine hydrochloride Grindeks

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor. The dose and duration of treatment should be adjusted individually depending on the severity of the disease.
The solution for injection is administered intramuscularly or subcutaneously.
Ipidacrine hydrochloride Grindeks is also available in the form of tablets for oral administration.
The doctor will decide which pharmaceutical form of Ipidacrine hydrochloride Grindeks is more suitable for the patient.

• Diseases of the peripheral nervous system, myasthenia, and myasthenic syndromeThe recommended dose is 5-15 mg (1 mL of Ipidacrine hydrochloride Grindeks, 5 mg/mL, solution for injection or 1 mL of Ipidacrine hydrochloride Grindeks, 15 mg/mL, solution for injection) 1-2 times a day, administered as an intramuscular or subcutaneous injection. The treatment lasts from 1 to 2 months. If necessary, the treatment cycle can be repeated several times at intervals of 1-2 months between cycles.

15-30 mg (1-2 mL of Ipidacrine hydrochloride Grindeks, 15 mg/mL, solution for injection) may be administered as an intramuscular or subcutaneous injection for a short period to prevent the occurrence of myasthenic crisis with severe neuromuscular junction disorder. Treatment with Ipidacrine hydrochloride Grindeks should be continued using this medicine in the form of tablets, and the dose can be increased to 20-40 mg (1-2 tablets of Ipidacrine hydrochloride Grindeks, 20 mg), 5-6 times a day.

• Treatment of certain types of paralysis and paresis, during the recovery period after organic damage to the CNS with movement disordersThe dose and duration of treatment should be adjusted individually depending on the severity of the disease and the patient's response. Treatment begins with the administration of 1 mL of a 5 mg ipidacrine solution as an intramuscular injection twice a day for 10-14 days, and then treatment should be continued using the medicine in the form of tablets. Dosage recommendations can be found in the Patient Leaflet for the tablet form.
• Treatment of demyelinating diseases, as part of comprehensive therapyThe dose and duration of treatment should be adjusted individually depending on the severity of the disease and the patient's response. Treatment begins with the administration of 1 mL of a 15 mg ipidacrine solution as an intramuscular injection twice a day for 10-15 days, and then treatment should be continued using the medicine in the form of tablets. Dosage recommendations can be found in the Patient Leaflet for the tablet form.

In the case of elderly patients or those with liver or kidney disease, they should always take this medicine exactly as recommended by their doctor. In case of doubts, the patient should consult their doctor or pharmacist.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Taking a higher dose of Ipidacrine hydrochloride Grindeks than recommended

In case of taking a higher dose of Ipidacrine hydrochloride Grindeks than recommended, the patient should immediately contact their doctor.
Significant overdose may cause symptoms of "cholinergic crisis", including bronchospasm, lacrimation, excessive sweating, miosis, nystagmus (involuntary, rapid, and repetitive eye movements), involuntary defecation and urination, vomiting, bradycardia, heart block, abnormal heart rhythm, low blood pressure, agitation, anxiety, excitement, fear, coordination and balance disorders, slurred speech, drowsiness, weakness, seizures, and coma. Symptoms may be mild.

Missing a dose of Ipidacrine hydrochloride Grindeks

The next dose should be taken at the usual time. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Ipidacrine hydrochloride Grindeks

In case of stopping the use of the medicine before the end of treatment, there is a risk that the desired therapeutic effect will not be achieved. In case of any further doubts related to the use of this medicine, the patient should consult their doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common(occurring in less than 1 in 10 patients):

• palpitations, slow heart rate;
• salivation, nausea;
• excessive sweating.

Uncommon(occurring in no more than 1 in 100 patients):

• dizziness, headache, drowsiness (when taking high doses);
• increased bronchial secretion;
• vomiting (when taking high doses);
• symptoms of skin allergy (itching, rash) (when taking high doses);
• muscle spasms (when taking high doses);
• weakness (when taking high doses).

Rare(occurring in less than 1 in 1000 patients):

• diarrhea, abdominal pain.

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

• hypersensitivity reaction (including allergic dermatitis, anaphylactic shock, asthma, toxic epidermal necrolysis, erythema, urticaria, wheezing, laryngeal edema, rash at the injection site).

If side effects occur, the doctor may reduce the dose or recommend stopping the medicine for a short period (1-2 days). The doctor may prescribe medicines to prevent some side effects (such as salivation, slow heart rate).

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient 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, tel.: +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 to gather more information on the safety of the medicine.

5. How to store Ipidacrine hydrochloride Grindeks

There are no special recommendations for the storage temperature of the medicine.
Store in the original packaging to protect from light.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and ampoule label after: "Expiry date (EXP)". 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. Contents of the packaging and other information

What Ipidacrine hydrochloride Grindeks contains

• The active substance of Ipidacrine hydrochloride Grindeks is ipidacrine hydrochloride. Each ampoule (1 mL) contains 5 mg or 15 mg of ipidacrine hydrochloride (in the form of a monohydrate).
• The other ingredients are: hydrochloric acid (1M solution) (to adjust pH) and water for injections.

What Ipidacrine hydrochloride Grindeks looks like and what the pack contains

Clear, colorless 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 of solution in a colorless glass ampoule of type I hydrolytic class with a break line or point (OPC). The ampoules are marked with a colored ring - the lower ring is red and the upper ring is yellow.
5 ampoules with solution for injection packed in a PVC foil blister pack. Two PVC foil blister packs containing 5 ampoules are packed in a cardboard box.
Ipidacrine hydrochloride Grindeks, 15 mg/mL, solution for injection
1 mL of solution in a colorless glass ampoule of type I hydrolytic class with a break line or point (OPC). The ampoules are marked with a colored ring - the lower ring is red and the upper ring is green.
5 ampoules with solution for injection packed in a PVC foil blister pack. Two PVC foil blister packs containing 5 ampoules are packed in a cardboard box.

Marketing authorization holder and manufacturer

AS GRINDEKS
Krustpils iela 53, Rīga, LV-1057, Latvia
tel.: +371 67083205
fax: +371 67083505
e-mail: [email protected]

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

Latvia
Ipidacrine Grindeks 5 mg/ml šķīdums injekcijām
Ipidacrine Grindeks 15 mg/ml šķīdums injekcijām
Bulgaria
Ipigrix 5 mg/ml инжекционен разтвор
Ipigrix 15 mg/ml инжекционен разтвор
Croatia
Ipigriks 5 mg/ml otopina za injekciju
Ipigriks 15 mg/ml otopina za injekciju
Hungary
Ipidacrine Grindeks 5 mg/ml oldatos injekció
Ipidacrine Grindeks 15 mg/ml oldatos injekció
Lithuania
Ipidacrine hydrochloride Grindeks 5 mg/ml injekcinis tirpalas
Ipidacrine hydrochloride Grindeks 15 mg/ml injekcinis tirpalas
Poland
Ipidacrine hydrochloride Grindeks
Ipidacrine hydrochloride Grindeks
Romania
Ipigrix 5 mg/ml soluție injectabilă
Ipigrix 15 mg/ml soluție injectabilă
Slovakia
Ipigrix 5 mg/ml injekčný roztok
Ipigrix 15 mg/ml injekčný roztok
Slovenia
Ipigrix 5 mg/ml raztopina za injiciranje
Ipigrix 15 mg/ml raztopina za injiciranje

Date of last revision of the leaflet: