Ipidacrine hidrohloride 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

Ipidacrine Hydrochloride

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

• Keep this package 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 inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 pack 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:

• for the treatment of peripheral nervous system diseases (neuritis, polyneuritis, polyneuropathy, polyradiculoneuropathy, myasthenia and myasthenic syndrome of various etiologies);
• for the treatment of certain types of paralysis and paresis;
• for organic central nervous system (CNS) damage with movement disorders during the recovery period;
• for 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 you are allergic to ipidacrine or any of the other ingredients of this medicine (listed in section 6);
• if you have epilepsy;
• if you have extrapyramidal disorders with hyperkinesia (muscle spasms of the tongue, face, neck and back);
• if you have angina pectoris (acute attacks of pain in the chest and/or behind the breastbone);
• if you have a slow heart rate (before starting treatment, the resting heart rate is less than 50 beats per minute);
• if you have bronchial asthma;
• if you have intestinal or urinary tract obstruction;
• if you have had an exacerbation of gastric or duodenal ulcer disease;
• if you have vestibular disorders (sense and perception of balance);
• if you are pregnant;
• if you are breastfeeding.

Warnings and precautions

Before starting to take Ipidacrine Hydrochloride Grindeks, you should discuss this with your doctor or nurse if you have or have 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

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Concomitant use of Ipidacrine Hydrochloride Grindeks and medicines with a depressant effect on the CNS may enhance sedative effects.
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 with alcohol

Alcohol may enhance the side effects of this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice 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 you are breastfeeding (see: When not to take Ipidacrine Hydrochloride Grindeks).
Fertility
There are 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 drowsiness.
Therefore, caution should be exercised in patients who experience this symptom.

3. How to take Ipidacrine Hydrochloride Grindeks

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, ask your doctor.
Doses 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.
Your doctor will decide which pharmaceutical form of Ipidacrine Hydrochloride Grindeks is more suitable for you.

• Peripheral nervous system diseases, myasthenia, and myasthenic syndromeThe recommended dose is 5-15 mg (1 mL Ipidacrine Hydrochloride Grindeks, 5 mg/mL, solution for injection or 1 mL Ipidacrine Hydrochloride Grindeks, 15 mg/mL, solution for injection) 1-2 times a day, administered as an intramuscular or subcutaneous injection. 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 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 Ipidacrine Hydrochloride Grindeks, 20 mg), 5-6 times a day.

• For the treatment of certain types of paralysis and paresis, during the recovery period after organic CNS damage with movement disordersDoses and duration of treatment should be adjusted individually depending on the severity of the disease and the patient's response. Treatment starts 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 are given in the Patient Leaflet for the tablet form.
• For the treatment of demyelinating diseases, as part of complex therapyDoses and duration of treatment should be adjusted individually depending on the severity of the disease and the patient's response. Treatment starts 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 are given in the Patient Leaflet for the tablet form.

In the case of elderly patients or patients with liver or kidney disease, they should always take this medicine exactly as prescribed by their doctor. If you are unsure, ask your doctor or pharmacist.
If you feel that the effect of the medicine is too strong or too weak, ask your doctor.

Taking a higher dose of Ipidacrine Hydrochloride Grindeks than recommended

If you have taken a higher dose of Ipidacrine Hydrochloride Grindeks than recommended, contact your doctor immediately.
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

Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Ipidacrine Hydrochloride Grindeks

If you stop taking the medicine before the end of the treatment, there is a risk that the desired therapeutic effect will not be achieved. If you have any further questions about the use of this medicine, ask your 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);
• skin allergy symptoms (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, injection site rash).

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ipidacrine Hydrochloride Grindeks

There are no special recommendations for the storage temperature of the medicine.
Store in the original package to protect from light.
Keep the medicine out of the 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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 (as a monohydrate).
• The other ingredients are: hydrochloric acid (1M solution) (to adjust pH) and water for injections.

What Ipidacrine Hydrochloride Grindeks looks like and contents of the pack

Clear, colorless solution, 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 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. Two PVC foil blisters containing 5 ampoules are packed in a cardboard box.
Ipidacrine Hydrochloride Grindeks, 15 mg/mL, solution for injection
1 mL 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. Two PVC foil blisters 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 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: