MIOTENS 0.25 % Кожная пена

Содержание инструкции

1. Miotens contractures and pain 0.25% cutaneous foam
   1. What is Miotens contratture e dolore and what is it used for
   2. What you need to know before using Miotens contractions and pain
   3. How to use Miotens contratture e dolore
   4. Possible side effects
   5. How to store Miotens contratture e dolore
   6. Contents of the pack and other information

Miotens contractures and pain 0.25% cutaneous foam

Tiocolchicoside

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist
has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

• 1. What Miotens contractures and pain is and what it is used for
• 2. What you need to know before using Miotens contractures and pain
• 3. How to use Miotens contractures and pain
• 4. Possible side effects
• 5. How to store Miotens contractures and pain
• 6. Contents of the pack and other information

1. What is Miotens contratture e dolore and what is it used for

Miotens contratture e dolore is a muscle relaxant that contains the active ingredient tiocolchicoside.
This medicine is used on the skin for the treatment of back pain (lumbago-sciatic pain), pain and
contracture affecting the neck, shoulder and upper limbs (cervico-brachial neuralgia), stubborn torticollis, painful
syndromes following trauma and surgery.
See your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using Miotens contractions and pain

Do not use Miotens contractions and pain

• if you are allergic to tiocolchicoside or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from flaccid paralysis (progressive paralysis involving the muscles) or muscle hypotonia (reduced muscle tone);
• if you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before using Miotens contractions and pain.
If you have previously suffered from flaccid paralysis or muscle hypotonia (see section “Do not use Miotens
contractions and pain”) consult your doctor before using this medicine.
Prolonged use of topical products may cause allergic reactions. If these occur,
stop treatment and consult your doctor to establish appropriate therapy.
Do not therefore use Miotens contractions and pain for prolonged treatments. After a short period of
treatment without appreciable results, consult your doctor (see section 1 “What is Miotens
contractions and pain and what it is used for”).
If adverse effects occur, it is necessary to reduce the dose of the medicine (see section 4
“Possible side effects”).

Other medicines and Miotens contractions 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 have been reported.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
The use of Miotens contractions and pain is contraindicated during pregnancy and breastfeeding (see section
“Do not use Miotens contractions and pain”). Avoid using the medicine even if
you suspect you are pregnant or wish to plan a pregnancy.

Driving and operating machinery
In rare cases, Miotens contractions and pain can cause drowsiness.

Miotens contractions and pain contains propylene glycol
Propylene glycol can cause skin irritation.

3. How to use Miotens contratture e dolore

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Method of administration of the cutaneous foam:

• Shake before use and press the dispenser keeping the container upside down under pressure;
• Apply 2-3 times a day with light friction a quantity of foam based on the size of the affected area.

The treatment can be associated with physical-rehabilitation therapies.

Warning:do not exceed the indicated doses. Use only for short periods of treatment.
Consult your doctor if the disorder occurs repeatedly or if you notice any recent change
in its characteristics.

If you use more Miotens contratture e dolore than you should
No cases of overdose have been reported.
In case of ingestion/accidental intake of an excessive dose of Miotens contratture e dolore, immediately notify your doctor 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 skin erythema (skin irritation) have been reported (see the sub-paragraph
“Warnings and precautions”).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 contratture e dolore

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 packaging after “Scad”. The expiry date refers to the last day of that month. The expiry date refers to the product in
intact packaging, correctly stored.
Store away from heat as it contains flammable propellant. Do not expose it to temperatures
above 50°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Miotens contractures and pain contains

• The active ingredient is tiocolchicoside. 1 ml of solution contains 2.5 mg of tiocolchicoside.
• The other components are: polysorbate 80, propylene glycol, ethyl alcohol, propylene glycol dipelargonate, benzyl alcohol, monobasic sodium phosphate monohydrate, disodium phosphate dodecahydrate, Nerolene lavender, purified water. Each pressurized container contains 27.3 ml of solution and 2.7 ml of propellant gas.

Description of the appearance of Miotens contractures and painand contents of the pack
Miotens contractures and pain is presented as a cutaneous foam.
Pressurized container of 30 ml.

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)