Salonpas flexible
Italy
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
Salonpas Flexible
105 mg / 31.5 mg medicated patch
Methyl salicylate / levomenthol
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 to do.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
- Consult your doctor if you do not feel better or if you feel worse after 3 days.
Contents of this leaflet:
- What Salonpas Flexible is and what it is used for
- What you need to know before using Salonpas Flexible
- How to use Salonpas Flexible
- Possible side effects
- How to store Salonpas Flexible
- Contents of the pack and other information
1. What Salonpas Flexible is and what it is used for
The medicine is used for the symptomatic treatment of muscle and joint pain associated with muscle strains and sprains.
2. What you need to know before using Salonpas Flexible
Do not use Salonpas Flexible:
if you are allergic (hypersensitive) to any of the components of this medicine
if you suffer from allergies, have a history of allergies, or have experienced asthma attacks, particularly
in connection with taking other painkillers, fever-reducing drugs, or other non-steroidal anti-inflammatory drugs (NSAIDs)
if you are currently taking painkillers similar to this one, as their combination may cause additional adverse effects; if in doubt, consult your pharmacist
if you have had a serious heart condition
if you have severe kidney or liver problems
if you have a bleeding ulcer or a coagulation disorder
if you are in the third trimester (last 3 months) of pregnancy
in children and adolescents under 18 years of age
The patch must not be used on open wounds, irritated skin, eyes, or mucous membranes.
Warnings and precautions
if you currently suffer from or have previously suffered from gastrointestinal ulcer/bleeding, or if you have a history of gastrointestinal ulcer, chronic dyspepsia (discomfort after meals or heartburn)
if you currently suffer from or have previously suffered from asthma
if you are elderly, as you are generally more prone to developing adverse effects.
Prolonged or repeated use of the medicine may lead to sensitization (hypersensitivity). Treatment must be discontinued if allergic reactions (hypersensitivity) occur.
Other medicines and Salonpas Flexible
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.
If you are being treated with anticoagulants (blood-thinning medicines) such as warfarin, consult your doctor before using Salonpas Flexible.
Pregnancy and breastfeeding
Salonpas Flexible must not be used during the third trimester (last 3 months) of pregnancy.
During the first and second trimesters (first 6 months) of pregnancy, the use of Salonpas Flexible should be avoided.
If you are breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
3. How to use Salonpas Flexible
Clean and dry the affected area before applying the patch. Remove the protective film
and apply the adhesive side directly to the skin.
Apply 1 patch to the affected area and leave in place for up to 8–12 hours. If pain returns after 8–12
hours from application of the first patch, a second patch may be applied.
Use only 1 patch at a time. Do not use more than 2 patches per day. Do not use for more than 3
consecutive days.
Use in children
Not recommended for use in children or adolescents under 18 years of age.
Do not chew or swallow the patch.
Duration of treatment
Do not exceed 3 days. If symptoms persist, consult a doctor or pharmacist.
If you use more Salonpas Flexible than you should
Contact your doctor or pharmacist immediately.
No cases of overdose have been reported.
If you forget to use Salonpas Flexible
Apply the medicine as soon as you remember, and then continue with your normal dosing schedule.
Do not apply a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them. The following side effects may occur with this medicine:
Very common (may affect more than 1 in 10 people)
- Erythema at the application site
Common (may affect up to 1 in 10 people)
- Itching, pain, and warmth at the application site
- Headache
Uncommon (may affect up to 1 in 100 people)
- Skin rash and change in skin colour at the application site
- Itching and skin rash
- Tinnitus
Not known (frequency cannot be estimated from the available data)
- Burns at the application site
Reporting of side effects
If you experience any side effect, 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 the website http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Salonpas Flexible
Keep this medicine out of the sight and reach of children.
Store this medicine at a temperature not exceeding 25°C and in the original packaging to
protect it from light.
Each time a patch is removed from the packaging, carefully fold the open end of the sachet twice to protect the remaining patches from light.
Do not use Salonpas Flexible after the expiry date stated on the box or more than 3
months after opening the packaging.
6. Pack contents and other information
What Salonpas Flexible contains
The active substances are 105 mg of methyl salicylate and 31.5 mg of levomenthol in each patch.
The other components are saturated aliphatic hydrocarbon resin, liquid paraffin, polyisobutylene,
styrene-isoprene-styrene block copolymer, synthetic aluminium silicate, support matrix and
plastic film.
Description of the appearance of Salonpas Flexible and pack contents
This medicine is a beige medicinal plaster, 70 cm, with a flexible support layer.
The adhesive side is protected by a plastic film.
1 pack contains a sachet with 3 or 5 patches.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Hisamitsu Italia S.r.l., Via Paolo da Cannobio 9, 20122 Milano, Italy
Manufacturer
Hisamitsu Pharmaceutical Co., Inc., 408 Tashirodaikan-machi, Tosu, Saga, 841-0017, Japan
Batch release site
Millmount Healthcare Ltd
Block-7, City North Business Campus, Stamullen, Co. Meath, K32 YD60, Ireland
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