Active ingredients: Thiocolchicoside
Miotens contractures and pain 0.25% skin foam
Why is Miotens Contracture and Pain used? What is it for?
WHAT IS IT"
Miotens contractures and pain 0.25% cutaneous foam is a muscle relaxant drug for cutaneous use.
WHY IT IS USED
Myotens contractures and pain 0.25% cutaneous foam is used for the treatment of lumbo-sciatica (back pain), cervicobrachial neuralgia (pain and contracture affecting the neck, shoulder and upper limbs), stubborn stiff necks, post-traumatic pain syndromes and post-operative
Contraindications When Miotens should not be used Contracture and Pain
Hypersensitivity to the active substance or to any of the excipients.
The product should not be administered to patients with flaccid paralysis or muscle hypotonia.
Do not administer in known or suspected pregnancy and during lactation: (see What to do during pregnancy and lactation).
Precautions for use What you need to know before taking Miotens Contracture and Pain
The dosage should be suitably reduced in case of side effects.
Interactions Which drugs or foods can modify the effect of Miotens Contracture and Pain
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
At present, no interactions with other drugs have emerged.
Warnings It is important to know that:
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. If they occur, it is necessary to interrupt the treatment and institute a suitable therapy. Therefore, do not use for prolonged treatments. After a short period of treatment without appreciable results, consult your doctor.
When it can be used only after consulting your doctor
Patients who have suffered from flaccid paralysis or muscle hypotonia in the past should consult their doctor before using Miotens contractures and pain 0.25% skin foam
What to do during pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. Miotens contractures and pain 0.25% skin foam should not be used during pregnancy and lactation. Use should also be avoided if you suspect a pregnancy or wish to plan a maternity leave.
Effects on ability to drive and use machines
Although after administration of Miotens contractures and pain 0.25% skin foam the onset of drowsiness is to be considered a very rare occurrence, it is still necessary to take this possibility into account.
Important information about some of the ingredients
Miotens contractures and pain 0.25% skin foam contains propylene glycol which can cause skin irritation.
Doping warning
Not relevant
Dosage and method of use How to use Miotens Contracture and Pain: Dosage
HOW MUCH
Apply with light friction a quantity of foam according to the size of the affected area. Warning: do not exceed the indicated doses
WHEN AND FOR HOW LONG
Two to three times a day. Consult your doctor if the disorder occurs repeatedly or if you notice any recent change in its characteristics. Warning: use only for short periods of treatment.
LIKE
Shake before use and press the dispenser while holding the container upside down under pressure. The treatment can be associated with physical-rehabilitative therapies.
Overdose What to do if you have taken an overdose of Miotens Contracture and Pain
No cases of overdose have been reported.
In case of accidental ingestion / intake of an excessive dose of Miotens contractures and pain 0.25% skin foam, notify your doctor immediately or contact the nearest hospital.
IF YOU HAVE ANY DOUBT ABOUT THE USE OF MYOTENS CONTRACTURES AND PAIN 0.25% SKIN FOAM, CONTACT YOUR DOCTOR OR PHARMACIST
Side Effects What are the side effects of Miotens Contracture and Pain
Like all medicines, Miotens contractures and pain 0.25% skin foam can cause side effects, although not everybody gets them.
Cases of rash and skin rashes have been reported.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date printed 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 shown on the package.
Keep away from heat. Contains flammable propellant. Do not expose to temperatures exceeding 50 ° C.
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.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN.
It is important to always have the information on the medicine available, so keep both the box and the package leaflet.
Composition and pharmaceutical form
COMPOSITION
A pressurized container contains:
Active ingredient: thiocolchicoside 68.25 mg
1 ml of solution contains:
Active ingredient: thiocolchicoside 2.5 mg
Excipients: polysorbate 80, propylene glycol, ethyl alcohol, propylene glycol dipelargonate, benzyl alcohol, monobasic sodium phosphate monohydrate, disodium phosphate dodecahydrate, lavender Nerolene, purified water.
Each pressurized container contains 27.3 ml of solution and 2.7 ml of propellant gas.
HOW IT LOOKS
Skin foam
Pressurized container of 30 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
MIOTENS CONTRACTS AND PAIN 0.25% SKIN FOAM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml, as a solution, contain
active principle: thiocolchicoside 0.25 g
excipients: propylene glycol
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Skin foam
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Low back sciatica (back pain), cervicobrachial neuralgia (pain and contracture in the neck, shoulder and upper limbs), stubborn stiff necks, post-traumatic and post-operative pain syndromes.
04.2 Posology and method of administration
Apply a quantity of foam according to the size of the area to be treated 2-3 times a day. The treatment can be associated with physical-rehabilitation therapies.
Method of administration: shake before use and press the dispenser while holding the container upside down.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Flaccid paralysis, muscle hypotonia. Pregnancy and lactation (see 4.6).
04.4 Special warnings and appropriate precautions for use
The dosage should be suitably reduced in case of side effects.
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. If they occur, it is necessary to interrupt the treatment and institute a suitable therapy.
MIOTENS CONTRACTS AND PAIN contains propylene glycol: it can cause skin irritation.
04.5 Interactions with other medicinal products and other forms of interaction
None known.
04.6 Pregnancy and lactation
Although a teratogenic effect was not observed in animal studies except when thiocolchicoside was administered at doses much higher than those recommended in human therapy (more than 10 times the therapeutic dose) as a precaution, the use of the product is contraindicated in the course of pregnancy. As the drug passes into breast milk, it is not recommended for use during breastfeeding.
04.7 Effects on ability to drive and use machines
Although after administration of MIOTENS CONTRACTS AND PAIN the onset of drowsiness is to be considered a very rare occurrence, it is still necessary to take this possibility into account.
04.8 Undesirable effects
Cases of rash and skin rashes have been reported. See also paragraph 4.4
04.9 Overdose
Cases of overdose are not known or have been reported in the literature.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other preparations for topical use for joint and muscle pain
ATC code: M02AX10
Thiocolchicoside is a semisynthetic sulfur derivative of colchicoside, a natural glycoside of colchicum, endowed with myorelaxant activity and devoid of curare-like effects. Some works have shown a selective agonist activity on GABA-ergic and glycinergic receptors. These actions can explain the effect of thiocolchicoside both in reflex, rheumatic and traumatic contractures, and in spastic ones of central origin. Thiocolchicoside does not alter voluntary motility, nor does it interfere with the respiratory muscles. Finally, it has no effect on the system. cardiovascular.
05.2 "Pharmacokinetic properties
The muscle relaxant effect appears on average after 1-2 hours after oral administration and 30-40 minutes after intramuscular administration. Bioavailability is 25% orally and 75% intramuscularly. The average plasma half-life is 4, 5 hours. No accumulation phenomena were observed after repeated administration of 8 mg / day for 7 days. Thiocolchicoside is extensively metabolised in plasma. On average, 8 and 20% of a single dose administered per os and i.m. respectively is excreted in the urine.
Skin foam: not relevant
05.3 Preclinical safety data
Chronic toxicity studies in the rat (per os and s.c.) and in the dog (per os) did not reveal any symptoms of toxicity affecting the individual organs or significant modifications of all the parameters examined. Subacute and chronic administration of thiocolchicoside in rats and rabbits via the epicutaneous route was equally well tolerated. Teratogenic studies were negative at doses ≤ 3 mg / kg / day. Mutagenicity studies are negative.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Polysorbate 80, propylene glycol, ethyl alcohol, propylene glycol dipelargonate, benzyl alcohol, monobasic sodium phosphate monohydrate, disodium phosphate dodecahydrate, lavender Nerolene, purified water
Propellant: propane-butane mixture (propane / n-butane / iso-butane).
06.2 Incompatibility
None known.
06.3 Period of validity
2 years.
The expiry date indicated refers to the product in intact and correctly stored packaging.
06.4 Special precautions for storage
MIOTENS CONTRACTURES AND PAIN 0.25% skin foam: keep away from heat. Contains flammable propellant. Do not expose to temperatures exceeding 50 ° C.
06.5 Nature of the immediate packaging and contents of the package
The medicine is contained in a pressurized aluminum container.
06.6 Instructions for use and handling
No special instructions
07.0 MARKETING AUTHORIZATION HOLDER
Dompé Pharmaceuticals S.p.A. - Via San Martino 12 - 20122 Milan
08.0 MARKETING AUTHORIZATION NUMBER
AIC n. 042045017
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Renewal date: February 27, 2007
10.0 DATE OF REVISION OF THE TEXT
January 2015
