Ipidacrine hidrohloride Grindeks

Package Leaflet: Information for the User

Ipidacrine Hydrochloride Grindeks, 20 mg, Tablets

Ipidacrine Hydrochloride

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

• Keep this 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 those not listed in this leaflet, please inform your 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 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, polyradiculoneuropathy, myasthenia and myasthenic syndrome of various etiologies);
• for the treatment of certain types of paralysis and paresis;
• for organic damage to the central nervous system (CNS) with movement disorders during the recovery period;
• for the treatment of demyelinating diseases, as part of complex therapy;
• for the treatment of memory disorders of various origins (Alzheimer's disease and other types of senile dementia);
• for 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 attacks of pain in the chest and/or behind the sternum);
• 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 had an exacerbation of 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, you should discuss it with your doctor if you 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 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 the medicines you plan to take.
Concomitant use of Ipidacrine Hydrochloride Grindeks and medicines that act depressively on the CNS may enhance sedative effects.
The action 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, it 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.

Ipidacrine Hydrochloride Grindeks contains lactose

If your doctor has previously determined that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Ipidacrine Hydrochloride Grindeks

Take this medicine always as directed by your doctor. If you are not sure, ask your doctor.
Depending on the severity of the disease, the dose and duration of treatment are determined by the doctor.
Oral administration. The tablet should be swallowed, preferably with water. This medicine can be taken with or without food.
Ipidacrine Hydrochloride Grindeks is also available as a solution for injection (intramuscular or subcutaneous). The 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 20 mg of ipidacrine (1 tablet), 1-3 times a day.

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 parenterally (intramuscularly or subcutaneously) for a short period to prevent myasthenic crisis with severe neuromuscular junction disorder. Treatment with Ipidacrine Hydrochloride Grindeks should be continued using this medicine in tablet form, and the dose can be increased to 20-40 mg (1-2 tablets) 5-6 times a day.

• Treatment of certain types of paralysis and paresis, during the recovery period after organic CNS damage with movement disorders, in complex treatment of demyelinating diseasesDoses and treatment duration should be adjusted individually depending on the severity of the disease and the patient's response. The daily dose is selected individually, usually 20 mg 2-3 times a day. The maximum daily dose may be 200 mg. Treatment can be started with Ipidacrine Hydrochloride Grindeks, 5 mg/mL, solution for injection as an intramuscular injection. Dosage recommendations are given in the Patient Leaflet Ipidacrine Hydrochloride Grindeks, solution for injection.
• Demyelinating diseases, as part of complex therapyDoses and treatment duration should be adjusted individually depending on the severity of the disease and the patient's response. The daily dose is selected individually, usually 20-40 mg 2-3 times a day. The maximum daily dose may be 200 mg. Treatment can be started with Ipidacrine Hydrochloride Grindeks, 15 mg/mL, solution for injection as an intramuscular injection. Dosage recommendations are given in the Patient Leaflet Ipidacrine Hydrochloride Grindeks, solution for injection.
• Memory disorders of various origins (Alzheimer's disease and other types of senile dementia)Doses and treatment duration should be adjusted according to the individual response of the patient. The daily dose is selected individually, usually 20 mg 2-3 times a day. The maximum daily dose may be 200 mg. Treatment duration is from 1 month to 1 year.
• Intestinal atonyThe recommended dose is 20 mg (1 tablet) 2-3 times a day for 1-2 weeks.

If you feel that the effect of the medicine is too strong or too weak, ask your doctor.
If you are elderly or have liver or kidney disease, you should always take this medicine exactly as directed by your doctor. If you are not sure, ask your doctor or pharmacist.

Taking a higher dose of Ipidacrine Hydrochloride Grindeks than recommended

If you have taken more than the recommended dose of Ipidacrine Hydrochloride Grindeks, 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, restlessness, anxiety, agitation, 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 less 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, throat swelling).

If you experience any 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 those not listed in this leaflet, please inform your 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ipidacrine Hydrochloride Grindeks

Do not store above 25°C.
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 blister 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 tablet contains 20 mg of ipidacrine hydrochloride (as a monohydrate).
• The other ingredients are: lactose monohydrate, potato starch, calcium stearate.

What Ipidacrine Hydrochloride Grindeks looks like and contents of the pack

White or almost white, round, flat tablets with beveled edges. The diameter of the tablet is approximately 6 mm.
Ipidacrine Hydrochloride Grindeks is available in packs of 50 or 100 tablets.

Marketing authorization holder and manufacturer

AS GRINDEKS
Krustpils iela 53, Rīga, LV-1057, Latvia
tel.: + 371 67083205
fax: + 371 67083505
e-mail: grindeks@grindeks.lv

This medicine is authorized in the Member States of the European Economic Area 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 tablets
Lithuania
Ipidacrine hydrochloride Grindeks 20 mg tablets
Poland
Ipidacrine hydrochloride Grindeks
Romania
Ipigrix 20 mg tablets
Slovakia
Ipigrix 20 mg tablets
Slovenia
Ipigrix 20 mg tablets

Date of last revision of the leaflet: