Antalcalm 140 Mg Patch

ANTALCALM plasters relieve pain. This patch medication provides short-term symptomatic local treatment of pain associated with sprains, strains, and acute bruises of the arms and legs resulting from trauma, such as a sports injury.

This medication belongs to a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Their active ingredient is diclofenac sodium (140 mg).

The other ingredients are: the backing layer: polyester non-woven fabric, the adhesive layer: basic butyl methacrylate copolymer, acrylates and vinyl acetate copolymer, macrogol 600 stearate, sorbitan oleate, and the protective film: paper coated with a single layer of silicone.

This medication is intended for adults and adolescents over 16 years of age.

Antacalm Pain Relief Patch Dosage
You are advised to apply one medicated plaster twice a day, morning and evening.

The maximum dosage is two plasters per day, even if there are multiple painful areas. Therefore, only treat one area at a time.

Pain treatment should last a maximum of one week. If symptoms persist or worsen, consult your doctor.

First, cut the sachet along the dotted lines and remove the Antacalm plaster. Remove one of the two protective films. Apply to the area to be treated and remove the other protective film. Then press lightly with the palm of your hand to ensure complete adhesion to the skin.
To remove it, moisten it with water, lift a corner, and then gently pull it away from the skin. To remove any product residue, gently wash the affected area with water, rubbing with your fingers in a circular motion.

If you find that the medicated plaster is not adherent enough, it can be held in place with a bandage. However, do not secure it with an occlusive dressing. Use only on intact, unbroken skin. Do not wear while bathing or showering. Do not cut the plaster if it is too large.

Precautions for use of Antacalm anti-inflammatory patch
Antacalm is contraindicated if you are allergic to diclofenac or any of the other ingredients, or if you are allergic to another nonsteroidal anti-inflammatory drug (NSAID, e.g., acetylsalicylic acid or ibuprofen). Do not use Antacalm if you have had an asthma attack, hives, or swelling and irritation inside the nose after taking acetylsalicylic acid or another NSAID.
This medicine should not be used if you currently have a stomach or intestinal ulcer or if you are in the last trimester of pregnancy.

Medical advice should be sought beforehand if you have kidney, heart, or liver problems, or if you have or have had a stomach or intestinal ulcer or inflammatory bowel disease, or if you are prone to bleeding.

Because older people are more prone to side effects, you should use Antacalm plasters with caution.

If applying this medicine triggers a rash, remove it immediately and discontinue treatment.

After removing the medicated plaster, avoid exposing the treated area to UV rays to prevent photosensitivity.

If you are using another medication, even if you obtained it without a prescription, you must inform your doctor. Antacalm should not be used at the same time as another medication containing diclofenac or another nonsteroidal anti-inflammatory analgesic medication, whether for topical use or taken orally.

If you are pregnant or breastfeeding, ask your doctor or pharmacist for advice before using Antacalm.

Please consult the package leaflet before use or ask your doctor or pharmacist for advice.

Packaging: 5 patches

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LEAFLET
ANSM - Updated on: 12/20/2024
Name of the medicinal product
ANTALCALM 140 mg medicated plaster
Diclofenac sodium
Box
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
You must always use this medicine exactly as provided in this leaflet or by your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
Ask your pharmacist for advice or information.
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
You must talk to your doctor if you do not feel better or if you feel worse after 7 days.
What is in this leaflet? 1. What is ANTALCALM 140 mg medicated plaster and what is it used for?
2. What you need to know before using ANTALCALM 140 mg medicated plaster?
3. How to use ANTALCALM 140 mg medicated plaster?
4. Possible side effects?
5. How to store ANTALCALM 140 mg medicated plaster?
6. Contents of the pack and other information.
1. WHAT IS ANTALCALM 140 mg medicated plaster AND WHAT IS IT USED FOR?
Pharmacotherapeutic group: Topicals for joint and muscle pain; nonsteroidal anti-inflammatory drugs for topical use - ATC code: M02AA15.
ANTALCALM is a pain-relieving medication. It belongs to a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs).
ANTALCALM is intended for the short-term symptomatic local treatment (maximum 7 days) of pain associated with acute sprains, strains, and bruises of the arms and legs resulting from trauma, such as a sports injury, in adults and adolescents aged 16 and over.
You should consult your doctor if you do not feel better or if you feel worse after 7 days.
2. BEFORE YOU USE ANTALCALM 140 mg, medicated plaster?
Do not use ANTALCALM:
· If you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);
· If you are allergic to another nonsteroidal anti-inflammatory drug (NSAID, e.g., acetylsalicylic acid or ibuprofen);
· If you have ever experienced an asthma attack, hives, or swelling and irritation inside the nose (rhinitis) after taking acetylsalicylic acid or another NSAID;
· If you currently have a stomach or duodenal ulcer;
· On any area of ??skin that has a break, scratch (abrasion), wound, burn, oozing, eczema, or infection;
· If you are in the last 3 months of pregnancy;
· If you are a child or adolescent under 16 years of age. Warnings and Precautions
Ask your doctor or pharmacist for advice before using ANTALCALM:
· If you suffer or have ever suffered from asthma or bronchial allergies; you may experience spasms of the bronchial muscle (bronchospasm) that make breathing difficult;
· If you notice a rash developing after applying the medicated plaster, remove it immediately and stop treatment;
· If you have kidney, heart, or liver problems, or if you have or have had a gastric or intestinal ulcer or inflammatory bowel disease, or if you are prone to bleeding.
Side effects can be limited by using the lowest effective dose for the shortest possible duration.
IMPORTANT Precautions
· The medicated plaster should not come into contact with the eyes or be applied to the eyes or mucous membranes;
· ANTALCALM should be used with caution in the elderly as they are more prone to adverse effects.
After removing the medicated plaster, avoid exposing the treated area to radiation (direct sunlight or UV cabins) to reduce the risk of photosensitivity.
Do not use ANTALCALM at the same time as any other medication containing diclofenac or any other nonsteroidal anti-inflammatory analgesic medication, whether for topical use or taken orally.
Children and adolescents
Not applicable.
Other medicines and ANTALCALM 140 mg medicated plaster
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. When ANTALCALM is used correctly (see section 3. HOW TO USE ANTALCALM 140 mg, medicated plaster?), only a small amount of diclofenac is absorbed by the body, so the interactions described for oral diclofenac-containing medicines are unlikely to occur.
ANTALCALM 140 mg, medicated plaster with food and drink
Not applicable.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
During the first and second trimesters of pregnancy, or if you are trying to become pregnant, ANTALCALM should only be used if clearly necessary and on the advice of your doctor or pharmacist, and in accordance with their instructions. If you need treatment during this period, you should use the lowest dose for the shortest possible time. During the last trimester of pregnancy, ANTALCALM should never be used. Oral forms (e.g., tablets) of diclofenac may cause complications for the mother and adverse effects in the unborn child (see section "Do not use ANTALCALM").
This risk is unknown when applied to the skin.
Breastfeeding
Small amounts of diclofenac pass into breast milk.
Consult your doctor before using ANTALCALM while breastfeeding. In any case, ANTALCALM should not be applied directly to the breast if you are breastfeeding.
Driving and using machines
ANTALCALM has no effect on the ability to drive or operate machinery.
ANTALCALM 140 mg medicated plaster contains
Not applicable.
3. HOW TO USE ANTALCALM 140 mg medicated plaster?
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
The recommended dose is one medicated plaster twice a day.
Apply one medicated plaster to the painful area twice a day, in the morning and evening. The maximum daily dose is two medicated plasters, even when treating more than one area. Only treat one painful area at a time.
Use in children and adolescents
ANTALCALM is contraindicated in children and adolescents under 16 years of age, due to the lack of data on safety and efficacy (see section 2).
In adolescents 16 years of age or older, if the medicine is used for pain relief for more than 7 days, or if symptoms worsen, it is advisable to consult a doctor. Method of administration
This medication is for skin application only (cutaneous use).
Instructions for use:
1. Cut the sachet along the dotted lines and remove the medicated plaster.
To apply the plaster:
2. Remove one of the two protective films.

3. Apply to the area to be treated and remove the other protective film.

4. Press gently with the palm of your hand to ensure complete adhesion to the skin.

To remove the plaster:
5. Moisten the plaster with water and lift a corner, then gently pull it away from the skin.

6. To remove any product residue, gently wash the affected area with water, rubbing with your fingers in a circular motion.
If necessary, the medicated plaster can be held in place with a bandage.
Use only on intact, unbroken skin. Do not use with an airtight dressing (occlusive dressing).
Do not wear while bathing or showering.
Do not cut the plaster.
Duration of treatment
Do not use ANTALCALM for more than 7 days.
If symptoms worsen or persist for more than 7 days, consult a doctor.
If you feel that the effect of ANTALCALM is too strong or too weak, talk to your doctor or pharmacist.
If you use more ANTALCALM 140 mg medicated plaster than you should
Inform your doctor or pharmacist of any significant adverse effects following incorrect use of this medicine or any accidental overdose (e.g., in a child). They will be able to advise you on the appropriate action to take, if necessary. If you forget to use ANTALCALM 140 mg medicated plaster
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
If you stop using ANTALCALM 140 mg medicated plaster
Not applicable.
4. POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately and stop taking this medicine if you notice any of the following:
· sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth, or throat, difficulty breathing, drop in blood pressure, or weakness. You may experience the following side effects:
Common side effects (may affect up to 1 in 10 people):
Local and/or application site skin reactions such as: eczema (dry, red, and itchy skin), redness, burning sensation, itching, inflammatory reddening of the skin (local allergic reactions and contact dermatitis), skin rashes, possibly with pustules or papules.
Rare side effects (may affect up to 1 in 1,000 people):
Onset of redness with blistering or bullae on the skin (bullous dermatitis),
Dry skin. Very rare side effects (may affect up to 1 in 10,000 people):
In patients using drugs in the same group as diclofenac for topical use, the following have been reported:
· Isolated cases of generalized skin rash with pustules and papules,
· Hypersensitivity reactions such as swelling of the skin and mucous membranes and anaphylactic-type reactions with acute circulatory disturbances,
· Photosensitive reactions,
· Asthma (respiratory discomfort, shortness of breath, wheezing, and/or chest tightness).
The absorption of diclofenac into the body through the skin is very low compared to the concentration of the drug in the blood after oral administration. The risk of developing adverse effects induced by oral treatment (such as gastrointestinal, liver, or kidney problems and breathing difficulties) while using the plaster therefore appears to be very low. However, in certain specific cases when the medicated plaster is applied to a relatively large area of ??skin and for an extended period, the possibility of systemic adverse effects (which may affect any organ) cannot be ruled out.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: https://signalement.social-sante.gouv.fr
By reporting side effects, you can help provide more information on the safety of this medicine. 5. HOW TO STORE ANTALCALM 140 mg, medicated plaster?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date printed on the outer carton and on the sachet after "EXP." The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original sachet to protect from light and moisture.
Do not use this medicine if you notice it is damaged.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION
What ANTALCALM 140 mg, medicated plaster contains
· The active ingredient is:
Diclofenac sodium
Each medicated plaster contains 140 mg of diclofenac sodium.
· The other ingredients are:
Backing layer:
Polyester non-woven
Adhesive layer:
Basic butyl methacrylate copolymer
Acrylates copolymer
Macrogol 600 (stearate)
Sorbitan oleate
Protective film:
Paper coated with a single layer of silicone
What ANTALCALM 140 mg, medicated plaster looks like and contents of the outer packaging
ANTALCALM comes in the form of 10x14 cm white self-adhesive plasters made of a non-woven backing on one side and paper on the other. ANTALCALM is available in packs of 2, 5, and 10 plasters, each plaster being packaged in an individual sachet.
Not all pack sizes may be marketed.
Marketing Authorization Holder
PIERRE FABRE MEDICAMENT
LES CAUQUILLOUS
81500 LAVAUR
Marketing Authorization Holder
PIERRE FABRE MEDICAMENT
PARC INDUSTRIEL DE LA CHARTREUSE
81100 CASTRES
FRANCE
Manufacturer
IBSA Farmaceutici Italia Srl
STRADA STATALE 11 PADANA SUPERIORE, KM 160
20051 CASSINA DE PECCHI (MI)
ITALY
Names of the medicinal product in the Member States of the European Economic Area
This medicinal product is authorized in the Member States of the European Economic Area under the following names: In accordance with current regulations. [To be completed later by the holder]
The last date this notice was revised is:
[To be completed later by the holder]
Other
Not applicable.