Miotens muscle cramp and pain
Italy
Table of Contents
Package leaflet: Information for the patient
Miotens contratture e dolore 0.25% cutaneous foam
Tiocolchicoside
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any of the side effects listed in this leaflet, consult your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice any improvement or if your symptoms worsen after a short period of treatment.
Contents of this leaflet:
- What Miotens contratture e dolore is and what it is used for
- What you need to know before using Miotens contratture e dolore
- How to use Miotens contratture e dolore
- Possible side effects
- How to store Miotens contratture e dolore
- Contents of the pack and other information
1. What Miotens Muscle Spasms and Pain is and what it is used for
Miotens Muscle Spasms and Pain is a muscle relaxant containing the active substance tiocolchicoside.
This medicinal product is used topically on the skin for the treatment of back pain (lumbo-sciatica), pain and
muscle spasms affecting the neck, shoulder and upper limbs (cervico-brachial neuralgia), persistent torticollis, and painful conditions following trauma and surgical procedures.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.
2. What you should know before using Miotens muscle spasms and pain
Do not use Miotens muscle spasms and pain
- if you are allergic to tiocolchicoside or to any of the other ingredients of this medicine (listed in section 6);
- if you suffer from flaccid paralysis (progressive paralysis involving muscles) or muscular hypotonia (reduced muscle tone);
- if you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding (see subsection “Pregnancy and breastfeeding”).
Warnings and precautions
Talk to your doctor or pharmacist before using Miotens muscle spasms and pain.
If you have previously suffered from flaccid paralysis or muscular hypotonia (see subsection “Do not use Miotens muscle spasms and pain”), consult your doctor before using this medicine.
Prolonged use of topical products may lead to allergic reactions. If these occur, stop treatment and consult your doctor to establish appropriate therapy.
Therefore, do not use Miotens muscle spasms and pain for prolonged treatments. If, after a short period of treatment, no appreciable results are achieved, consult your doctor (see section 1 “What Miotens muscle spasms and pain is and what it is used for”).
If adverse effects occur, the dose of the medicine should be reduced (see section 4 “Possible side effects”).
Other medicines and Miotens muscle spasms and pain
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are currently reported.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
The use of Miotens muscle spasms and pain is contraindicated during pregnancy and breastfeeding (see subsection “Do not use Miotens muscle spasms and pain”). Avoid using the medicine also if you suspect you might be pregnant or if you are planning a pregnancy.
Driving and using machines
In rare cases, Miotens muscle spasms and pain may cause drowsiness.
Miotens muscle spasms and pain contains propylene glycol
Propylene glycol may cause skin irritation.
3. How to use Miotens contratture e dolore
Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Instructions for use of the topical foam:
- shake well before use and press the dispenser while holding the pressurized container upside down;
- apply 2–3 times daily a quantity of foam corresponding to the size of the affected area, with gentle friction.
Treatment may be combined with physical rehabilitation therapies.
Caution: Do not exceed the recommended doses. Use only for short treatment periods.
Consult your doctor if symptoms recur repeatedly or if you notice any recent changes in their characteristics.
If you use more Miotens contratture e dolore than you should
No cases of overdose have been reported.
In case of accidental ingestion or overdose of Miotens contratture e dolore, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Cases of rash and cutaneous erythema (skin irritations) have been reported (see subsection “Warnings and precautions”).
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
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.
5. How to store Miotens muscle strain and pain
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month. The expiry date applies to the product in its original, undamaged packaging, correctly stored.
Store protected from heat, as it contains flammable propellant. Do not expose to temperatures above 50°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Miotens muscle cramps and pain contains
- The active substance is tiocolchicoside. 1 ml of solution contains 2.5 mg of tiocolchicoside.
- The other components are: polysorbate 80, propylene glycol, ethyl alcohol, dipelargonic propylene glycol ester, benzyl alcohol, monobasic sodium phosphate monohydrate, dibasic sodium phosphate dodecahydrate, lavender Nerolene, purified water. Each pressurized container contains 27.3 ml of solution and 2.7 ml of propellant gas.
Description of the appearance of Miotens muscle cramps and pain and contents of the pack
Miotens muscle cramps and pain is a topical foam.
30 ml pressurized container.
Marketing Authorization Holder
Dompé farmaceutici S.p.A. - Via San Martino, 12 - 20122 Milan
Manufacturers
Zellaerosol GmbH - Wiesenstraße 13 - D - 79669 Zell i.W. (Germany)
Aerosol Service Italiana S.r.l. - Via del Maglio, 6 - 23868 Valmadrera (Lecco)