Instructions for use Miopridin tablets 4 mg No. 20
Composition
active ingredient: pridinol mesylate;
1 tablet contains 4 mg of pridinol mesylate (corresponding to 3.02 mg of pridinol);
excipients: povidone K 30, lactose monohydrate, talc, colloidal anhydrous silicon dioxide, microcrystalline cellulose, hydrogenated castor oil, magnesium stearate (from vegetable raw materials).
Dosage form
Pills.
Main physicochemical properties: white, flat tablets on both sides with a score on one side. The tablet can be divided into equal doses.
Pharmacotherapeutic group
Medicines for the treatment of diseases of the musculoskeletal system. Muscle relaxants, centrally acting drugs. Other centrally acting drugs.
ATX code M03B X03.
Pharmacological properties
Pharmacodynamics.
The active ingredient of the drug Miopridin® is pridinol in the form of pridinol mesylate, which is a derivative of piperidine-polymeric alcohol with the chemical formula: 1,1-diphenyl-1-ol-3-piperidine-propane-methanolsulfonate.
Its pharmacological action is manifested through an atropine-like effect on smooth and striated muscles. This effect is used to treat states of tension in both central and peripheral skeletal muscles.
The earlier myotonic treatment is started, the more effective pridinol is in relieving muscle tension. In the presence of muscle spasms for a longer period of time, in which anatomical changes in muscle fibers, ligaments and joint capsules have additionally occurred, pridinol may achieve only a partial effect.
Pharmacokinetics.
The results of pharmacokinetic studies of pridinol mesylate in humans have shown that, when administered orally, the maximum concentration in the blood is reached after approximately 1 hour and is evenly distributed throughout the body. The active substance, pridinol, is excreted mainly within 24 hours. Pridinol is excreted by the kidneys, partly in unchanged form, partly in the form of glucuronate and sulfoconjugate.
Indication
Central and peripheral muscle spasms, lumbago, torticollis, general muscle pain in adults.
Contraindication
Hypersensitivity to the active substances or to any of the excipients of the medicinal product.
Glaucoma.
Prostate hypertrophy.
Urinary retention syndromes.
Obstructions in the gastrointestinal tract.
Heart rhythm disturbances.
First trimester of pregnancy.
Interaction with other medicinal products and other types of interactions
Miopridin® enhances the effect of anticholinergics, such as atropine (see section "Adverse reactions").
Application features
This medicine should be used with caution in patients with renal and/or hepatic insufficiency, as higher levels of the active substance in the blood and/or for a longer period of time should be expected.
Miopridin® contains lactose. One Miopridin® tablet contains 143.5 mg of lactose (as monohydrate). Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Miopridin®.
Use during pregnancy or breastfeeding
Pregnancy
The drug is contraindicated in the first trimester of pregnancy.
During the later course of pregnancy, the drug should be taken only after a thorough examination by a doctor, under medical supervision, and only in case of urgent need.
Breastfeeding period
There is no data on whether pridinol passes into human breast milk. The use of the drug should be avoided during breastfeeding.
Fertility
There are no data on the effect of pridinol on human fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
Due to the possible anticholinergic effect on vision (see section "Adverse reactions"), it is recommended to exercise extreme caution when driving or using other mechanisms.
Method of administration and doses
Doses
The recommended dose is 1.5 - 3 mg of pridinol 3 times a day (½ - 1 tablet).
For nocturnal leg cramps, take 3-6 mg of pridinol (1-2 tablets) before bedtime.
The duration of treatment is determined by the doctor.
The tablets are taken regardless of food intake, with the effect occurring faster if the drug is taken before meals.
For some patients (suspected circulatory disorders, angioedema) it may be advisable to take the tablets after meals, as the risk of a hypotensive circulatory reaction may be increased. The drug should be taken with particular caution on the first day of treatment.
Method of application
For oral use.
Take the tablets without chewing, with a sufficient amount of liquid (for example, 1 glass of water).
Children.
There are no data on the use of the drug in children.
Overdose
In case of overdose or accidental poisoning, symptoms typical of an overdose of anticholinergics occur.
Depending on the severity of symptoms, physostigmine salicylate should be administered slowly intravenously.
Adverse reactions
The following classification was used to determine the frequency of adverse reactions:
Very common (≥1/10)
Common (≥1/100, <1/10)
Uncommon (≥1/1,000, <1/100)
Rare (≥1/10,000, <1/1,000)
Very rare (<1/10,000)
Frequency not known (frequency cannot be estimated from the available data).
The frequency of adverse reactions was estimated from a prospective, uncontrolled clinical study involving 1369 patients. For adverse reactions reported from spontaneous reporting, the frequency cannot be determined due to the lack of a real control value. Therefore, they are classified as “Frequency unknown” (see table below).
When using the indicated dosages, adverse reactions occur rarely or infrequently and generally disappear after dose reduction or drug withdrawal.
In case of simultaneous use with other anticholinergics, the following side effects may occur: dry mouth, thirst, temporary visual disturbances (mydriasis, accommodation disorders, photosensitivity, slight increase in intraocular pressure), redness and dryness of the skin, bradycardia followed by tachycardia, urination disorders, constipation, in very rare cases - vomiting, dizziness and unsteadiness when walking.
| Organ system class | Infrequently | Rarely | Frequency unknown |
| On the part of the immune system | hypersensitivity reaction (e.g. itching, skin redness, swelling or shortness of breath) | | |
| Mental disorders | trouble | feeling of fear, depression | hallucinations |
| From the nervous system | dizziness, headache, speech disorders | impaired attention, coordination, taste | hand tremor, paresthesia |
| From the organs of vision | accommodation disorders, visual impairment | acute glaucoma attack in angle-closure glaucoma | |
| From the heart | tachycardia | heart rhythm disturbances, bradycardia | |
| From the vascular side | circulatory reaction, hypotension | | |
| Gastrointestinal tract | nausea, abdominal pain, dry mouth | diarrhea, vomiting | |
| Musculoskeletal and connective tissue disorders | muscle weakness | | |
| Renal and urinary disorders | Urination disorders, acute urinary retention in BPH | | |
| General diseases and local reactions | fatigue, asthenia | increased body temperature | |
Reporting of suspected adverse reactions
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Pharmacovigilance Information System at https//aisf.dec.gov.ua.
Expiration date
5 years.
Storage conditions
Store at a temperature not exceeding 25 C. Keep out of the reach of children.
Packaging
10 tablets in a blister; 2 or 5 blisters in a pack.
Vacation category
According to the recipe.
Producer
Mibe GmbH Arcnaymittel.
Location of the manufacturer and address of its place of business.
Münchenerstrasse 15, Brena, Saxony-Anhalt, 06796, Germany.
