Active ingredients: Thiocolchicoside
MuscoRil 4 mg hard capsules
MuscoRil 8 mg hard capsules
MuscoRil 8 mg orodispersible tablets
MuscoRil 4 mg / 2 ml solution for injection for intramuscular use
Why is Muscoril used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Other centrally acting muscle relaxants.
THERAPEUTIC INDICATIONS
Adjuvant treatment of painful muscle contractures in acute spinal disorders in adults and adolescents aged 16 years and over.
Medicinal product subject to additional monitoring. This will allow the rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of the "Side Effects" section for information on how to report side effects.
Contraindications When Muscoril should not be used
Thiocolchicoside should not be used:
- in patients with hypersensitivity to the active substance or to any of the excipients listed in the "Composition" section
- in patients with flaccid paralysis, muscle hypotonia.
- throughout the pregnancy period, in case of suspected pregnancy and if pregnancy is planned
- while breastfeeding
- in women of childbearing potential who are not using contraceptives
Precautions for use What you need to know before taking Muscoril
The dosage should be suitably reduced in case of diarrhea following oral administration.
Episodes of vasovagal syncope have been observed following intramuscular administration, therefore the patient should be monitored after injection (see Undesirable Effects).
The maximum daily oral dose of 16 mg should not be exceeded and should be divided into two administrations at 12 hour intervals.
If you forget to take one dose, move on to the next one and avoid taking close doses
Interactions Which drugs or foods can modify the effect of Muscoril
No interaction studies have been performed.
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Warnings It is important to know that:
Post-marketing cases of cytolytic and cholestatic hepatitis have been reported with thiocolchicoside.
Severe cases (eg fulminant hepatitis) have been observed in patients who had taken NSAIDs or acetaminophen at the same time. Patients should be advised to report any signs of liver toxicity (see Undesirable Effects)
Thiocolchicoside can precipitate seizures especially in patients with epilepsy or in those at risk of seizures (see Undesirable effects).
Preclinical studies have shown that one of the metabolites of thiocolchicoside (SL59.0955) induced aneuploidy (alteration in the number of chromosomes in dividing cells) at concentrations close to the human exposure observed with doses of 8 mg twice daily per os. L "aneuploidy is considered to be a risk factor for teratogenicity, embryo / fetal toxicity, spontaneous abortion, impaired male fertility and a potential risk factor for cancer. As a precautionary measure, the use of the drug at doses higher than the dose recommended or long-term use should be avoided (see "Dose, method and time of administration").
Patients should be carefully informed about the potential risk of a possible pregnancy and about effective contraceptive measures to be followed.
Muscoril should not be used in children and adolescents under 16 years of age due to safety concerns
Fertility, pregnancy and lactation
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
There are limited data on the use of thiocolchicoside in pregnant women. Therefore, the potential risks to the embryo and fetus are unknown. Animal studies have shown teratogenic effects. Muscoril is contraindicated during pregnancy, in women of childbearing potential who are not using contraceptives, if pregnancy is suspected and if pregnancy is planned (see "Contraindications").
Feeding time
The use of thiocolchicoside is contraindicated during breastfeeding as it is secreted in breast milk (see "Contraindications").
Fertility
In a fertility study conducted in rats, no impairment of fertility was observed at doses up to 12 mg / kg, i.e. at dose levels inducing no clinical effect. Thiocolchicoside and its metabolites exert aneugenic activity at different concentration levels, which is a risk factor for impaired human fertility.
Effects on ability to drive and use machines
No studies on the ability to drive or use machines have been performed. As drowsiness is a common occurrence, this should be taken into account when driving or operating machinery.
Important information about some of the ingredients
MuscoRil 4 mg hard capsules and MuscoRil 8 mg hard capsules contain 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.
MuscoRil 8mg orodispersible tablets contain aspartame. This medicine contains a source of phenylalanine. It can be harmful to you if you have phenylketonuria. MuscoRil 4 mg / 2 ml solution for injection for intramuscular use contains less than 1 mmol (23 mg) sodium per dose, ie it is essentially "sodium-free"
Dosage and method of use How to use Muscoril: Dosage
Dosage
- For the oral form of 4 mg and 8 mg: The recommended and maximum dose is 8 mg every 12 hours (16 mg per day). The duration of the treatment is limited to 7 consecutive days.
- For the intramuscular form: The recommended and maximum dose is 4 mg every 12 hours (8 mg per day). The duration of the treatment is limited to 5 consecutive days.
- For both oral and intramuscular forms: Higher than recommended doses or long-term use should be avoided (see "Precautions for use").
Pediatric population
Muscoril should not be used in children and adolescents under 16 years of age due to safety concerns.
Method of administration
MuscoRil 8mg orodispersible tablets: Dissolve the orodispersible tablet in the mouth with or without water
Overdose What to do if you have taken too much Muscoril
OVERDOSE
Cases of overdose are not known or have been reported in the literature. In case of ingestion / intake of an excessive dose of MuscoRil notify your doctor immediately or go to the nearest hospital. If you have any questions about the use of MuscoRil, ask your doctor or pharmacist.
WHAT TO DO IF YOU HAVE FORGOTTEN TO TAKE ONE OR MORE DOSES
Do not take a double dose to make up for a forgotten dose. If you have any questions about the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Muscoril
As with all medicines, MuscoRil can have side effects, although not everybody gets them.
Disorders of the immune system
Anaphylactic reactions such as:
Uncommon: itching,
Rare: hives
Very rare: hypotension
not known: angioedema and anaphylactic shock after intramuscular administration.
Nervous system disorders
Common: somnolence (see Effects on ability to drive and use machines)
Rare: passenger agitation and drowsiness,
not known: malaise with or without vasovagal syncope in the minutes following intramuscular administration, convulsions (see Undesirable effects).
Gastrointestinal disorders
Common: diarrhea (see Side Effects), gastralgia
Uncommon: nausea, vomiting
Rare: heartburn after oral administration
Hepatobiliary disorders
Not known: cytolytic and cholestatic hepatitis (see Undesirable effects)
Skin and subcutaneous tissue disorders
Uncommon: allergic skin reactions
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
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. Undesirable effects can also be reported directly through the national reporting system at "https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse". By reporting side effects you can help provide more information on the safety of this medicine. "
Expiry and Retention
Expiry: see the expiry date indicated on the package. The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date indicated on the package.
Hard capsules:
Store at a temperature not exceeding 30 ° C.
Orodispersible tablets and 4 mg / 2 ml solution for injection:
This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
COMPOSITION
MuscoRil 4 mg hard capsules
Each capsule contains:
Active ingredient: thiocolchicoside 4 mg
Excipients: lactose monohydrate, corn starch, magnesium stearate,
excipient of the shell: gelatin (transparent capsule).
MuscoRil 8 mg hard capsules
Each capsule contains:
Active ingredient: thiocolchicoside 8 mg
Excipients: lactose monohydrate, corn starch, magnesium stearate,
excipients of the shell: gelatin, titanium dioxide, yellow iron oxide (white-yellow capsule # 2).
MuscoRil 8 mg orodispersible tablets
Each tablet contains:
Active ingredient: thiocolchicoside 8 mg
Excipients: crospovidone, aspartame, mannitol, magnesium stearate
MuscoRil 4 mg / 2 ml solution for injection for intramuscular use
Each vial contains:
Active ingredient: thiocolchicoside 4 mg
Excipients: sodium chloride, hydrochloric acid, water for injections
PHARMACEUTICAL FORM AND CONTENT
Hard capsules: box of 20 capsules of 4 mg; box of 10 capsules of 8 mg
Orodispersible tablets: box of 10 tablets of 8 mg
Solution for injection for intramuscular use: box of 6 ampoules of 2 ml
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
MUSCORIL
▼ Medicinal product subject to additional monitoring. This will allow the rapid identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for information on how to report adverse reactions.
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
MuscoRil 4 mg hard capsules
Each capsule contains:
Active principle: thiocolchicoside 4 mg.
Excipients with known effects: lactose 218.3 mg.
MuscoRil 8 mg hard capsules
Each capsule contains:
Active principle: thiocolchicoside 8 mg.
Excipients with known effects: lactose 214.3 mg.
MuscoRil 8mg orodispersible tablets
Each tablet contains:
Active principle: thiocolchicoside 8mg.
Excipients with known effects: aspartame 7.6 mg.
MuscoRil 4 mg / 2ml solution for injection for intramuscular use
Each vial contains:
Active principle: thiocolchicoside 4 mg.
Excipients with known effects: sodium chloride 16.8 mg equal to 6.66 mg of sodium (0.3 mmol).
For the full list of excipients see section 6.1.
03.0 PHARMACEUTICAL FORM
Hard capsules:
Transparent capsules containing 4 mg granules
White-yellow capsules containing the 8 mg granules
Orodispersible tablets:
Flat, round, beveled, slightly yellow tablets.
Solution for injection for intramuscular use.
2 ml glass ampoules containing a clear, yellow solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Adjuvant treatment of painful muscle contractures in acute spinal disorders in adults and adolescents aged 16 years and over.
04.2 Posology and method of administration
Dosage
• For the oral form of 4 mg and 8 mg:
The recommended and maximum dose is 8 mg every 12 hours (16 mg per day). The duration of the treatment is limited to 7 consecutive days.
• For the intramuscular form:
The recommended and maximum dose is 4 mg every 12 hours (8 mg per day). The duration of the treatment is limited to 5 consecutive days.
• For both oral and intramuscular forms:
Higher than recommended doses or long-term use should be avoided (see section 4.4).
Pediatric population
Muscoril should not be used in children and adolescents under 16 years of age due to safety concerns (see section 5.3).
Method of administration
MuscoRil 8mg orodispersible tablets:
Dissolve the orodispersible tablet in the mouth with or without water.
04.3 Contraindications
Thiocolchicoside should not be used
- in patients with hypersensitivity to the active substance or to any of the excipients listed in section 6.1
- in patients with flaccid paralysis, muscular hypotonia.
- throughout the pregnancy period
- during breastfeeding
- in women of childbearing age who are not using contraceptives.
04.4 Special warnings and appropriate precautions for use
The dosage should be suitably reduced in case of diarrhea following oral administration.
Episodes of vasovagal syncope have been observed after intramuscular administration, therefore the patient should be monitored after injection (see section 4.8).
Post-marketing cases of cytolytic and cholestatic hepatitis have been reported with thiocolchicoside.
Severe cases (eg fulminant hepatitis) have been observed in patients who had taken NSAIDs or acetaminophen at the same time. Patients should be advised to report any signs of hepatic toxicity (see section 4.8).
Thiocolchicoside can precipitate seizures especially in patients with epilepsy or in those at risk of seizures (see section 4.8).
The maximum daily oral dose of 16 mg should not be exceeded and should be divided into two administrations at 12 hour intervals.
If you forget to take one dose, move on to the next one and avoid taking close doses.
Preclinical studies have shown that one of the metabolites of thiocolchicoside (SL59.0955) induced aneuploidy (alteration in the number of chromosomes in dividing cells) at concentrations close to the human exposure observed with doses of 8 mg twice daily orally (see section 5.3). Aneuploidy is considered to be a risk factor for teratogenicity, embryo / fetal toxicity, spontaneous abortion, impaired male fertility and a potential risk factor for cancer. at doses higher than the recommended dose or long-term use should be avoided (see section 4.2).
Patients should be carefully informed about the potential risk of a possible pregnancy and about effective contraceptive measures to be followed.
Important information about some of the ingredients
MuscoRil 4 mg hard capsules and MuscoRil 8 mg hard capsules contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose / galactose malabsorption should not take this medicine.
MuscoRil 8mg orodispersible tablets contain aspartame. This medicine contains a source of phenylalanine. It can be harmful in patients with phenylketonuria.
MuscoRil 4 mg / 2 ml solution for injection for intramuscular use contains less than 1 mmol (23 mg) sodium per dose, ie it is essentially "sodium-free"
04.5 Interactions with other medicinal products and other forms of interaction
No interaction studies have been performed.
04.6 Pregnancy and lactation
Pregnancy
There are limited data on the use of thiocolchicoside in pregnant women. Therefore, the potential risks to the embryo and fetus are unknown.
Animal studies have shown teratogenic effects (see section 5.3).
Muscoril is contraindicated during pregnancy and in women of childbearing potential who are not using contraceptives (see section 4.3).
Feeding time
The use of thiocolchicoside is contraindicated during lactation as it is secreted in breast milk (see section 4.3).
Fertility
In a fertility study conducted in rats, no impairment of fertility was observed at doses up to 12 mg / kg, i.e. at dose levels inducing no clinical effect. Thiocolchicoside and its metabolites exert aneugenic activity at different concentration levels, which is a risk factor for impaired human fertility (see section 5.3).
04.7 Effects on ability to drive and use machines
No studies on the ability to drive or use machines have been performed.
As drowsiness is a common occurrence, this should be taken into account when driving vehicles or using machines.
04.8 Undesirable effects
Disorders of the immune system
Anaphylactic reactions such as:
Uncommon: itching,
Rare: hives,
Very rare: hypotension,
not known: angioedema and anaphylactic shock after intramuscular administration.
Nervous system disorders
Common: somnolence (see section 4.7).
Rare: passenger agitation and drowsiness,
not known: malaise with or without vasovagal syncope in the minutes following intramuscular administration, convulsions (see section 4.4).
Gastrointestinal disorders
Common: diarrhea (see section 4.4), gastralgia
Uncommon: nausea, vomiting
Rare: heartburn after oral administration
Hepatobiliary disorders
not known: cytolytic and cholestatic hepatitis (see section 4.4)
Skin and subcutaneous tissue disorders
Uncommon: allergic skin reactions.
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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse".
04.9 Overdose
Cases of overdose are not known or have been reported in the literature.
In the event of overdose, however, careful medical surveillance and the implementation of symptomatic measures are recommended (see section 5.3).
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: other centrally acting muscle relaxants.
ATC code: M03BX05.
Thiocolchicoside is a semisynthetic sulfur derivative of colchicoside, endowed with myorelaxant pharmacological activity.
In vitro, thiocolchicoside only binds to strychnine-sensitive gabaergic and glycinergic receptors. Since thiocolchicoside acts as an antagonist of the gabaergic receptor, its muscle relaxant effect could be exerted at the supraspinal level, through a complex regulatory mechanism, even if the glycinergic mechanism of action cannot be excluded. The characteristics of the interaction with the gabaergic receptors they are qualitatively and quantitatively shared between thiocolchicoside and its major circulating metabolite, the glucuronidated derivative (see section 5.2).
In vivo the muscle relaxant properties of thiocolchicoside and its main metabolite have been demonstrated in various predictive models in rats and rabbits. The lack of thiocolchicoside muscle relaxant effect in the spinalized rat suggests a predominant supraspinal activity.
Furthermore, electroencephalographic studies have shown that thiocolchicoside and its main metabolite are devoid of any sedative effect.
05.2 Pharmacokinetic properties
Absorption
- After intramuscular administration, Thiocolchicoside Cmax occurs in 30 minutes and reaches values of 113 ng / ml after a 4 mg dose, and 175 ng / ml after an 8 mg dose. The corresponding AUC values are 283 and 417 ng.h / mL, respectively.
The pharmacologically active metabolite SL18.0740 is also observed at lower concentrations, with a Cmax of 11.7 ng / ml occurring 5 hours post dose and an AUC of 83 ng.h / ml.
No data are available for the inactive metabolite SL59.0955.
- After oral administration, thiocolchicoside is not detected in plasma. Only two metabolites are observed: the pharmacologically active metabolite SL18.0740 and an inactive metabolite SL59.0955. For both metabolites, maximum plasma concentrations occur 1 hour after thiocolchicoside administration. After a single oral dose of 8 mg of thiocolchicoside the Cmax and AUC of SL18.0740 are respectively about 60 ng / ml and 130 ng.h / ml. For SL59.0955 these values are much lower: Cmax about 13 ng / ml and AUC values are between 15.5 ng.h / ml (up to 3h) and 39.7 ng.h / ml (up to 24h).
Distribution
The apparent volume of distribution of thiocolchicoside is estimated to be around 42.7 L after intramuscular administration of 8 mg. No data are available for both metabolites.
Biotransformation
After oral administration, thiocolchicoside is first metabolised to 3-demethylthiocolchicine aglycone or SL59.0955. This transformation occurs mainly by intestinal metabolism and explains the lack of unchanged circulating thiocolchicoside with this route of administration.
The metabolite SL59.0955 is then glucuroconjugated to SL18.0740 which has an equipotent pharmacological activity to thiocolchicoside and therefore supports the pharmacological activity after oral administration of thiocolchicoside.
The metabolite SL59.0955 is also demethylated to didemethyl-thiocolchicine.
Elimination
- After intramuscular administration the apparent t½ of thiocolchicoside is 1.5 hours and the plasma clearance 19.2 l / h.
- After oral administration, the total radioactivity is excreted mainly in the faeces (79%), while the urinary excretion accounts for only 20%. Unchanged thiocolchicoside is excreted neither in the urine nor in the faeces. The metabolites SL18.0740 and SL59.0955 they are found in urine and faeces, while didemethyl-thiocolchicine is recovered only in faeces.
After oral administration of thiocolchicoside, the metabolite SL18.0740 is cleared with an apparent t½ of 3.2 to 7 hours and the metabolite SL59.0955 has a mean t½ of 0.8 hours.
05.3 Preclinical safety data
The thiocolchicoside profile was evaluated in vitro and in vivo after parenteral and oral administration.
Thiocolchicoside was well tolerated after oral administration for up to 6 months in both the rat and the non-human primate when administered at repeated doses of less than or equal to 2 mg / kg / day in the rat and less than or equal to 2.5 mg / kg. / day in the non-human primate, and intramuscularly in the primate at repeated doses up to 0.5 mg / kg / day for 4 weeks.
At high doses, after acute oral administration, thiocolchicoside induced emesis in dogs, diarrhea in rats and convulsions in both rodents and non-rodents.
After repeated administration, thiocolchicoside induced oral gastrointestinal disturbances (enteritis, emesis) and intramuscular emesis.
Thiocolchicoside itself did not induce gene mutation in bacteria (Ames test), chromosomal damage in vitro (chromosomal aberration test in human lymphocytes) and chromosomal damage in vivo (micronucleus test in mouse bone marrow after intraperitoneal administration).
The major glucuroconjugate metabolite SL18.0740 did not induce gene mutation in bacteria (Ames test), however it did induce chromosomal damage in vitro (human lymphocyte micronucleus test) and in vivo chromosomal damage (mouse bone marrow micronucleus test after oral administration). Micronuclei were predominantly from chromosomal loss (centromere-positive micronuclei after centromere FISH staining), suggesting aneugenic properties. The aneugenic effect of the metabolite SL18.0740 was observed at concentrations in the in vitro test and plasma exposures (AUC) in the in vivo test, higher (greater than 10-fold based on AUC) than those observed in human plasma at doses therapeutic.
The aglycone metabolite (3-desmethylthiocolchicine-SL59.0955), which is formed mainly after oral administration, induced chromosomal damage in vitro (human lymphocyte micronucleus test) and in vivo chromosomal damage (bone marrow micronucleus test). rat after oral administration). Micronuclei were predominantly from chromosomal loss (centromere micronuclei positive after FISH or CREST staining of the centromere), suggesting aneugenic properties. The aneugenic effect of SL59.0955 was observed at concentrations in the in vitro test and at exposures in the in vivo test close to those observed in human plasma at therapeutic doses of 8 mg twice daily per os. The aneugenic effect in cells dividing can cause aneuploid cells. Aneuploidy is an alteration in the number of chromosomes and loss of heterozygosity, which is recognized as a risk factor for teratogenicity, embryo toxicity / spontaneous abortion, impaired male fertility, when it affects germ cells, and a potential risk factor for cancer when it concerns somatic cells. The presence of the aglycone metabolite (3-demethylthiocolchicine-SL59.0955) after intramuscular administration has never been evaluated, therefore its formation via this route of administration cannot be excluded.
In the rat, an oral dose of 12 mg / kg / day of thiocolchicoside resulted in major malformations along with fetal toxicity (growth retardation, embryo death, altered rate of sex distribution). The no-toxic effect dose was 3 mg / kg / day.
In rabbits, thiocolchicoside showed maternal toxicity starting at 24 mg / kg / day. In addition, minor anomalies (supernumerary ribs, delayed ossification) were observed.
In a fertility study in rats, no impairment of fertility was observed at doses up to 12 mg / kg / day, i.e. dose levels inducing no clinical effect. Thiocolchicoside and its metabolites exert aneugenic activity at different concentration levels, this is recognized as a risk factor for impaired human fertility.
Carcinogenic potential has not been evaluated.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
MuscoRil 4 mg hard capsules
lactose monohydrate, maize starch, magnesium stearate, carrier excipient: gelatin (clear capsule).
MuscoRil 8 mg hard capsules
lactose monohydrate, corn starch, magnesium stearate, shell excipients: gelatin, titanium dioxide, yellow iron oxide (white-yellow capsule # 2).
MuscoRil 8 mg orodispersible tablets:
Crospovidone, aspartame, mannitol, magnesium stearate.
MuscoRil 4 mg / 2 ml solution for injection for intramuscular use
sodium chloride, 1M hydrochloric acid, water for injections
06.2 Incompatibility
Not relevant.
It is possible the extemporaneous association in syringe of MuscoRil with specialty vials for parenteral administration containing: tenoxicam, piroxicam, ketoprofen, ketorolac trometamine, diclofenac sodium, lysine acetylsalicylate, betamethasone disodium phosphate, cyanocobalamin (vitamin B121) and vitamin B6 complexes B12.
06.3 Period of validity
MuscoRil 4 mg hard capsules: 5 years.
MuscoRil 8 mg hard capsules: 2 years.
MuscoRil 8 mg orodispersible tablets: 3 years
MuscoRil 4 mg / 2ml solution for injection: 3 years.
06.4 Special precautions for storage
MuscoRil 4 mg hard capsules and MuscoRil 8mg hard capsules:
Store at a temperature not exceeding 30 ° C.
MuscoRil 8 mg orodispersible tablets and MuscoRil 4mg / 2ml solution for injection:
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
MuscoRil 4 mg hard capsules:
Cardboard box containing 2 PVC / Aluminum blisters of 10 capsules each.
MuscoRil 8mg hard capsules:
Cardboard box containing 1 PVC / Aluminum blister of 10 capsules.
MuscoRil 8 mg orodispersible tablets:
Cardboard box containing 1 polyamide, aluminum, PVC / Aluminum blister of 10 tablets
MuscoRil 4 mg / 2ml solution for injection for intramuscular use:
Cardboard box containing 6 type I 2 ml white glass ampoules.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Sanofi S.p.A. - Viale L. Bodio, 37 / B - Milan
08.0 MARKETING AUTHORIZATION NUMBER
MuscoRil 4 mg hard capsules - 20 capsules .......................................... .................................. AIC n. 015896020
MuscoRil 8 mg hard capsules - 10 capsules .......................................... .................................. AIC n. 015896083
MuscoRil 8 mg orodispersible tablets - 10 tablets .......................................... ...... AIC n.015896095
MuscoRil 4 mg / 2 ml solution for injection for intramuscular use - 6 ampoules of 2 ml ....... AIC n. 015896018
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
MuscoRil 4 mg hard capsules -20 hard capsules: Authorization: 23.01.1960. Renewal 01.06.2005
MuscoRil 4 mg / 2 ml solution for injection for intramuscular use - 6 ampoules of 2 ml: Authorization: 12.03.1959. Renewal: 01.06.2005
Muscoril 8 mg hard capsules - 10 hard capsules: Authorization: 27.02.2008
Muscoril 8 mg orodispersible tablets - 10 tablets: Authorization: 05.05.2010
10.0 DATE OF REVISION OF THE TEXT
October 2014
