Active ingredients: Pridinol (pridinol mesylate)
Lyseen 4 mg tablets
Lyseen 2 mg / ml solution for injection
Why is Lyseen used? What is it for?
Lyseen contains the active substance pridinol mesylate, a substance that works by relaxing the muscles.
Lyseen is indicated for the treatment of muscle contractures associated with:
- neurological disorders such as diseases of the vessels of the brain, tremors due to Parkinson's, diseases or injuries of the spinal cord, etc.
- musculoskeletal disorders such as lumbo-sacral arthrosis, disc herniation, back pain due to exertion (low back pain due to exertion), flat foot pain, low back pain (lumbago), stiff neck, muscle pain in general, night cramps, etc.
Contraindications When Lyseen should not be used
Do not use Lyseen
- if you are allergic to pridinol mesylate or any of the other ingredients of this medicine (listed in section 6).
- if you have increased pressure in the eye (glaucoma)
- if you have an enlarged prostate
- if you suffer from urinary retention or bowel obstruction
- if you suffer from heart rhythm disturbances (tachyarrhythmia)
- if you are in the first trimester of pregnancy (see section "Pregnancy and Breastfeeding).
Precautions for use What you need to know before taking Lyseen
Talk to your doctor or pharmacist before using Lyseen.
Pay particular attention:
- the first day you take the medicine
- if you have low blood pressure or if you are an emotionally sensitive person, take the tablets on a full stomach
- if you have low blood pressure or if you are an emotionally sensitive person, rest for 10 minutes in a horizontal position after injecting Lyseen into the muscle
- if you have severe kidney or liver failure because the medicine may be more effective than in other patients.
The injection into a vein will be given to you in serious and urgent cases and only by your doctor.
Interactions Which drugs or foods can modify the effect of Lyseen
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Do not use Lyseen with anticholinergic medicines (which work by counteracting the physiological effects of acetylcholine) such as atropine.
Lyseen solution for injection must not be mixed with other preparations in the same syringe.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Do not use Lyseen during the first trimester of pregnancy. In the following months, use the medicine only if absolutely necessary and follow what your doctor tells you.
Driving and using machines
Lyseen can cause temporary visual disturbances so take special care if you have to drive and use machines.
Lyseen 4 mg tablets contain lactose
This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Lyseen 2 mg / ml solution for injection contains sodium
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, ie it is essentially "sodium-free".
Dose, Method and Time of Administration How to use Lyseen: Posology
Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Attack therapy
The recommended dose is 1 to 3 ampoules a day by injection into the muscle (intramuscularly). In severe cases, your doctor may also give you Lyseen into a vein.
Maintenance therapy
Unless otherwise directed by your doctor, the recommended dose is half - 1 tablet 3 times a day.
Treatment of nocturnal cramps
For the treatment of nocturnal leg cramps take 1-2 tablets a day before going to sleep.
Physiotherapy
To facilitate physiotherapy and improve results, you can inject 1-2 ampoules of Lyseen into the muscle half an hour before or one hour before treatment.
The individual pharmaceutical forms (ampoules and tablets) must be administered one at a time and at regular intervals of time between each other.
Duration of treatment
The duration of the treatment varies according to the type and intensity of the muscle contracture to be treated.
If you start treatment with Lyseen early, you will be able to resolve the muscle contracture more easily.
Switch to maintenance therapy as soon as possible, do not stop therapy abruptly.
Consult your doctor if you do not notice any improvement.
How to open the vials
Take the vial as indicated in the drawing with the colored dot facing up and break it with a sharp movement
Overdose What to do if you have taken too much Lyseen
If you use more Lyseen than you should
In case of accidental ingestion or use of an excessive dose of Lyseen, notify your doctor immediately or go to the nearest hospital. Your doctor will treat the use of too much Lyseen based on your condition.
If you forget to use Lyseen
Do not use a double dose to make up for a forgotten dose.
If you stop taking Lyseen
Do not stop taking Lyseen abruptly. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Lyseen
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Lyseen is generally well tolerated.
Side effects that may occur rarely:
- slight feeling of weakness dry mouth
These side effects generally disappear following dose reduction or discontinuation of treatment.
The following side effects have been reported with medicines similar to Lyseen:
- dry mouth
- thirst
- temporary visual disturbances
- redness and dryness of the skin,
- reduction in heart rate followed by an increase in heart rate
- trouble urinating
- constipation
- vomiting, dizziness and uncertainty when walking (very rarely)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What Lyseen contains
Lyseen 4 mg tablets
- The active ingredient is pridinol mesylate. Each tablet contains 4 mg of pridinol mesylate.
- The other ingredients are lactose, starch, talc, glycerol dibeenate.
Lyseen 2 mg / ml solution for injection
- The active ingredient is pridinol mesylate. 1 ml of solution for injection contains 2 mg of pridinol mesylate.
- The other ingredients are glacial acetic acid, sodium hydroxide, water for injections.
What Lyseen looks like and contents of the pack
Lyseen 4 mg tablets
Each pack of Lyseen 4 mg tablets contains 30 tablets in blisters.
Lyseen 2 mg / ml solution for injection
Each pack of Lyseen 2 mg / ml solution for injection contains 5 ampoules.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
LYSEEN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets
One tablet contains - Active ingredient: 4 mg of pridinol mesylate.
Excipient (s) with known effect: lactose.
For the full list of excipients, see section 6.1.
Injectable solution
One ampoule of 1 ml of solution for injection contains - Active ingredient: 2 mg of pridinol mesylate.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Tablets.
Injectable solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Contractures of central and peripheral origin. Lumbago, stiff neck, myalgia in general.
04.2 Posology and method of administration
In general, the average dosage recommended for attack therapy is 1-3 ampoules per day intramuscularly, or in the case of emergency therapy, intravenously.
Maintenance therapy
Unless otherwise judged by the doctor, in general the average recommended daily dose is 0.2 mg per kg per day. This is achieved by administering ½ - 1 tablet 3 times a day.
Night cramps
For nocturnal leg cramps, prescribe 1-2 tablets before bedtime.
Physiotherapy
To facilitate physiotherapy measures and improve results, inject 1-2 ampoules intramuscularly half "hour or one" hour before treatment.
Except in special cases, the single pharmaceutical forms (solution for injection and tablets) must be administered one at a time and at regular intervals of time one from the other.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Glaucoma, prostatic hypertrophy, urinary retention and intestinal obstruction syndromes, tachyarrhythmia.
Contraindicated in the first trimester of pregnancy. In the further period it is to be reserved for the judgment of the doctor, only in cases of absolute necessity.
04.4 Special warnings and appropriate precautions for use
Lyseen has never given rise to addiction and / or addiction phenomena.
Keep the preparation out of the reach of children.
Administer with caution in patients with severe renal and / or hepatic insufficiency due to the resulting higher and / or longer lasting blood rates.
In some subjects (slightly hypotensive, vaso-neuro-labile) it may be appropriate to administer the tablets on a full stomach and keep the patient at rest in a horizontal position for some time (10 ") after the intramuscular injection.
The intravenous injection can be given in urgent cases (severe generalized contractural states); in this case the contents of 1 ampoule must be diluted with 3-5 ml of glucose solution and the injection must be made slowly with the patient in a horizontal position.
Particular caution should be taken on the first day of therapy.
04.5 Interactions with other medicinal products and other forms of interaction
Lyseen enhances the activity of anticholinergics, for example of atropine.
Lyseen vials should not be combined in the same syringe with other preparations.
04.6 Pregnancy and lactation
Do not administer in the first trimester of pregnancy. In the further period use only in case of real need and under the direct supervision of the doctor.
04.7 Effects on ability to drive and use machines
In relation to the potential anticholinergic effects of the visual type (see undesirable effects), greater caution is recommended when driving vehicles or using machines.
04.8 Undesirable effects
Lyseen is generally well tolerated. At the indicated doses, undesirable effects are rare and generally disappear following a reduction in the dosage or discontinuation of treatment; they consist of a slight feeling of asthenia and dry mouth.
With anticholinergic drugs, in particular with atropine, the following undesirable effects may occur: dry mouth, thirst, transient visual disturbances (mydriasis, altered accommodation, photophobia, slight increase in intra-ocular pressure), redness and dry skin, bradycardia followed by tachycardia, disturbed urination, constipation, and very rarely vomiting, dizziness and uncertainty in walking.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address: www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
In case of overdose or accidental intoxication, the symptomatological picture is that common to anticholinergics.
If the severity of the symptoms requires it, administer physostigmine salicylate i.v. slowly at doses of 0.5 mg repeatable up to a total of 2 mg.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: other centrally acting muscle relaxants.
ATC code: M03BX03.
The active ingredient of Lyseen is pridinol mesylate, a derivative of piperidinpropyl alcohol, whose chemical formula is the following: 1,1-diphenyl-1-ol-3-piperidino-propane methanesulfonate.
Its pharmacological action is expressed with an atropine-like mechanism both at the level of smooth and striated muscles.
This activity is appropriately exploited in practice in the treatment of contractures of the skeletal muscles, whether they are of central or peripheral origin.
Lyseen resolves muscle contractures all the more easily the earlier the decontracting treatment is started. In inveterate contractures, which are superimposed on anatomical alterations of muscle fibers, ligaments and joint capsules, the effect of Lyseen can only be partial.
05.2 Pharmacokinetic properties
The kinetics of pridinol mesylate in humans showed that the maximum blood concentration is reached within the first hour and that the distribution in the organism is uniform. The elimination of the active principle, partly unchanged and partly in the glucuronic and sulfo-conjugated form, takes place via the kidney in about 24 hours.
05.3 Preclinical safety data
Acute toxicity has been studied in some animal species: the LD50 in the oral mouse is 250 mg / kg, in the rat subcutaneously it is equal to 446 mg / kg. Chronic toxicity in rats treated for 6 months with doses of 5 to 20 mg / kg / day did not show any toxic effects.
No teratogenic effects were observed in mice treated with doses up to 25 mg / kg / day of pridinol mesylate.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Tablets
Lactose; starch; talc; glycerol dibeenate.
Injectable solution
Glacial acetic acid; sodium hydroxide; water for injections.
06.2 Incompatibility
Lyseen vials should not be combined in the same syringe or injected simultaneously with other preparations.
06.3 Period of validity
5 years.
06.4 Special precautions for storage
This medicine does not require any special storage conditions
06.5 Nature of the immediate packaging and contents of the package
Box of 30 tablets of 4 mg.
Box of 5 ampoules of 2 mg / ml solution for injection.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations
07.0 MARKETING AUTHORIZATION HOLDER
Novartis Consumer Health S.p.A., Origgio (Varese).
08.0 MARKETING AUTHORIZATION NUMBER
Tablets: A.I.C. n. 011987017
Solution for injection: A.I.C. n. 011987029
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of most recent renewal: 01.06.2010
10.0 DATE OF REVISION OF THE TEXT
06/2015
