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140 MG SODIUM ANTALCALM DICLOFENAC 5 plasters DRUG
Over-the-counter medication

140 MG SODIUM ANTALCALM DICLOFENAC 5 plasters DRUG

€10.44 EXCL. VAT €11.49 INCL. VAT
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Reference : 3400927620621
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140 MG SODIUM ANTALCALM DICLOFENAC 5 plasters DRUG is intended for symptomatic local treatment of acute pain associated with sprains, strains and bruises acute arms and legs resulting from trauma,

ANTALCALM DICLOFENAC SODIUM 140 MG 5 MEDICINAL PLANTS

Sprains - Foulures - Acute Contusions

Short-term local symptomatic treatment of pain.

Description of Antalcalm Diclofenac Sodium 140mg 5 medicated plasters  

Antalcalm Diclofenac Sodium 140mg 5 medicated plasters   is intended for the short-term local symptomatic treatment of pain associated with sprains, strains and acute bruises of the arms and legs resulting from a trauma, for example a sports injury in adults and adolescents from 16 years of age . You should talk to your doctor if you do not feel better or if you feel worse after 7 days.

Using advice from Antalcalm Diclofenac Sodium 140mg 5 medicated plasters

Always use this medication exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

The recommended dosage is one medicated plaster twice a day.

Apply a medicated plaster to the painful area twice a day, in the morning and in the evening. The maximum daily dosage is 2 medicated plasters, even when there is more than one region to be treated. Treat only one painful area at a time.

Use in children and adolescents

Antalcalm Diclofenac Sodium 140mg is not recommended for children and adolescents under 16 years of age, due to the lack of safety and efficacy data (see section 2).

In adolescents 16 years of age or older, if the product is used for more than 7 days to relieve pain, or if symptoms worsen, it is advisable to consult a doctor.

This medication is applied to the skin only (skin use). Do not take by mouth. Instructions

Do not use Antalcalm 140 mg for more than 7 days. Using this medication for a longer period requires the advice of a doctor.

If you have the impression that the effect of Antalcalm 140 mg is too strong or too weak, talk to your doctor or pharmacist.

Composition of Antalcalm Diclofenac Sodium 140mg 5 medicated plasters

  • Active ingredients

The active ingredient is diclofenac sodium.
Each medicated plaster contains 140 mg of diclofenac sodium.

  • Excipients

Backing layer : Polyester nonwoven

Adhesive layer : Basic butyl methacrylate copolymer Acrylates and vinyl acetate copolymer Macrogol 600 (stearate) Sorbitan oleate
Protective film : Paper coated with a monolayer of silicone

Presentation of Antalcalm Diclofenac Sodium 140mg 5 medicated plasters

Antalcalm 140 mg comes in the form of 10x14 cm white self-adhesive plasters consisting of a non-woven support on one side and paper on the other. Box of 5 medicated plasters.

advice

Proven home remedies
Pain relievers and bruises are not necessary. A refreshing serum wrap is enough to reduce swelling and reduce pain. Apply a generous layer of séré on the injured area, put a thin towel over it and wrap the joint with a plastic sheet. Arnica, aluminum acetate, chamomile extract or comfrey clay compresses are also suitable. Homeopathic or spagyric preparations with arnica, for internal use, accelerate the healing process from the inside. Consult your pharmacist.

Warnings on pain relievers

Attention, the drug is not a product like the others. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

  • Please inform your online pharmacist of the treatments in progress in order to identify any incompatibilities. The order validation form contains a personalized message field provided for this purpose.
  • Click here to find the leaflet for this medication on the website of the National Agency for the Safety of Medicines and Health Products.
  • Pharmacovigilance : Declare one or more undesirable effect (s) linked to the use of a drug.

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Last updated: 24/09/2014

Name of the medicinal product

ANTALCALM 140 mg, medicated plaster

Diclofenac sodium

framed

Please read this leaflet carefully before you start using this medicine because it contains important information for you.

You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.

· Keep this leaflet. You might need to read it again.

· Ask your pharmacist for advice or information.

· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.

· You should contact your doctor if you experience no improvement or feel less well after 7 days.

Review summary

What this leaflet contains:

1. What is ANTALCALM 140 mg, medicated plaster and in which cases it is used?

2. What should be known before using ANTALCALM 140 mg, medicated plaster ?

3. How to use ANTALCALM 140 mg, medicated plaster ?

4. What are the possible side effects?

5. How to store ANTALCALM 140 mg, medicated plaster ?

6. Additional information.

1. WHAT ANTALCALM 140 mg, medicated plaster AND WHAT IT IS USED FOR?

Pharmacotherapeutic group

ANTALCALM is a medication that relieves pain. It belongs to a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs).

Therapeutic indications

ANTALCALM is intended for the symptomatic local treatment of short duration of pain associated with sprains, strains and acute bruises of the arms and legs resulting from trauma, for example a sports injury in adults and adolescents from 16 years .

You should contact your doctor if you experience no improvement or feel less well after 7 days.

2. WHAT TO DO ABOUT BEFORE USING ANTALCALM 140 mg, medicated plaster?

List of information needed before taking the medication

Not applicable.

Cons-indications

Never use ANTALCALM 140 mg, medicated plaster:

· are allergic to diclofenac or to any of the other ingredients of this medication (mentioned in section 6);

· are allergic to another non-steroidal anti-inflammatory drug (NSAIDs, eg acetylsalicylic acid or ibuprofen);

· have ever had an attack of asthma , hives or swelling and irritation inside the nose after taking acetylsalicylic acid or other NSAIDs;

· are currently suffering from gastric or intestinal ulcers ;

· begin the last trimester of pregnancy;

ANTALCALM should not be used on injured skin (abrasions, cuts, burns), infected skin or skin with oozing dermatitis or eczema .

Precautions for use; special warnings

Warnings and Precautions

Ask your doctor or pharmacist for advice before using ANTALCALM:

· In case of a rash , immediately remove the medicated plaster and stop the 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 .

Consult a physician or pharmacist before using ANTALCALM if you are concerned with any of these problems.

Adverse effects may be limited by the use of the lowest effective dose for the shortest possible period of time.

IMPORTANT PRECAUTIONS

· If symptoms persist for more than 7 days, consult a physician.

· The medicated plaster must 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 surface to radiation (direct sunlight or UV cage) to reduce the risk of photosensitivity.

Do not use ANTALCALM together with any other medicinal product containing diclofenac or any other non-steroidal anti-inflammatory analgesic medicinal product, whether for external use or orally.

Children and Youth

ANTALCALM should not be used in children and adolescents under 16 years of age without sufficient experience in this age group.

Interaction with other medicines

Other medicines and ANTALCALM 140 mg, medicated plaster

Inform your doctor or pharmacist if you are taking, have recently taken or may be taking any other medicines.

When properly administered, only a small amount of diclofenac is absorbed by the body, so the interactions described for drugs containing diclofenac taken orally are unlikely to occur.

Interactions with food and beverages

Not applicable.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and breast feeding

If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

During the first and second trimester of pregnancy or if you wish to become pregnant, ANTALCALM should only be used on the advice of your doctor.

During the last trimester of pregnancy, ANTALCALM should not be used as the risk of complications for the mother and for the child can not be ruled out (see "Never use ANTALCALM ").

feeding

Small amounts of diclofenac pass into breast milk.

Consult your doctor before using ANTALCALM while breastfeeding. In all cases, ANTALCALM should not be applied directly to the chest if you are breast-feeding.

Sport

Not applicable.

Effects on ability to drive or use machines

Driving and using machines

ANTALCALM has no effect on the ability to drive and use machines.

List of excipients with known effect

Not applicable.

3. HOW TO USE ANTALCALM 140 mg medicated plaster?

Instructions for proper use

Not applicable.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Dosage

Always use this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dosage is one medication plaster twice daily.

Apply a medicated plaster to the painful area twice a day, in the morning and evening. The maximum daily dose is 2 medicated plasters even when there is more than one area to be treated. Treat only one painful region at a time.

Use in children and adolescents

ANTALCALM is not recommended for use in children and adolescents under 16 years of age due to a lack of safety and efficacy data (see section 2).

In adolescents 16 years of age or older , if the product is used for more than 7 days to relieve pain, or if symptoms worsen, it is advisable to consult a physician.

Administration mode

This medication is applied to the skin only (dermal use). Do not take orally.

Instructions:

1. Cut the sachet along the dotted lines and remove the medicated plaster.

image002.jpg 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 lightly with the palm of the hand to fully adhere to the skin.

To remove the plaster:

5. Moisten the plaster with water and lift a corner and then pull gently to peel off the skin.

6. To remove any residue of product, gently wash the affected area with water, rubbing with the fingers in a circular motion.

If necessary, the medicated plaster may be held in place by means of a bandage.

Use only on intact, non-injured skin.

Do not use with an air-tight 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. Use of this medication over a longer period requires the advice of a physician.

If you feel that the effect of ANTALCALM is too strong or too weak, talk to your doctor or pharmacist.

Symptoms and Instructions for Overdose

If you used more ANTALCALM 140 mg, medicated plaster than you should:

Tell your doctor or health care professional if your symptoms do not improve or if you notice any side effects not listed in this leaflet. He will be able to advise you on the measures to be taken, if necessary.

Instructions for omission of one or more doses

If you forget to use ANTALCALM 140 mg, medicated plaster:

Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, this medicine may cause side effects, although not everybody gets them.

Tell your doctor immediately and discontinue treatment if you notice any of the following:

· sudden onset of urticaria, swelling of the hands, feet, ankles, face, lips, mouth or throat, difficulty in breathing, drops in tension or weakness.

You may be suffering from the following side effects:

Common side effects (can affect up to 1 in 10 users):

· local skin reactions such as redness, burning sensation, itching, inflammatory redness of the skin, rash, possibly with pustules or papules.

Very rare side effects (can affect up to 1 user in 10 000):

· hypersensitivity reactions or local allergic reactions (contact dermatitis).

In patients using drugs in the same group as diclofenac for external use, isolated cases of generalized rash, hypersensitivity reactions such as swelling of the skin and mucous membranes and anaphylactic reactions with disorders of acute circulatory regulation and sensitivity reactions to light have been reported.

The absorption of diclofenac in the body through the skin is very low compared to the concentration of drug in the blood after an oral intake of the substance. The risk of developing adverse effects induced by oral treatment (such as gastrointestinal, respiratory and renal disorders) during use of the plaster appears to be very low.

Declaration of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr .

By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE ANTALCALM 140 mg medicated plaster?

Keep this medicine out of the reach and sight of children.

Expiration date

Do not use this medicine after the expiry date which is stated on the outer carton and on the pouch after "EXP". The expiry date refers to the last day of that month.

Storage conditions

Store at a temperature not exceeding 30 ° C.

Store in the original package in order to protect from light.

Keep the sachet tightly closed to protect from dryness and light.

If necessary, warnings against visible signs of deterioration

Do not use ANTALCALM if you notice that the product is damaged.

The plasters used must be folded in half, adhesive face inwards.

Do not throw any medication into drains or household waste. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

Full list of active substances and excipients

What ANTALCALM contains 140 mg medicated plaster

· The active ingredient is diclofenac sodium.

Each medicated plaster contains 140 mg of diclofenac sodium.

· The other components are:

Support layer :

Non woven polyester

Adhesive layer :

Basic copolymer of butyl methacrylate

Copolymer of acrylates and vinyl acetate

Macrogol 600 (stearate)

Oleate of sorbitan

Protective film :

Paper coated with a silicone monolayer

Pharmaceutical form and content

Aspect of ANTALCALM 140 mg medicated plaster and contents of the pack

ANTALCALM is in the form of white self-adhesive patches of 10x14 cm, consisting of a non-woven support on one side and paper on the other.

ANTALCALM is available in packs of 2, 5 and 10 plasters, each plaster being packaged individually.

Not all pack sizes may be marketed.

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Marketing Authorization Holder and Manufacturer

Holder

PIERRE FABRE MEDICAMENT

45 PLACE ABEL GANCE

92100 BOULOGNE

exploiting

PIERRE FABRE MEDICAMENT

45 PLACE ABEL GANCE

92100 BOULOGNE

Maker

SPA ITALIANA LABORATORI BOUTY

STRADA STATALE N ° 11 PADANA SUPERIORE KM 160

20060 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 the regulations in force.

[To be completed at a later date by the holder]

Date of approval of the notice

The last date on which this notice has been revised is

AMM under exceptional circumstances

Not applicable.

Internet Information

Detailed information on this medicine is available on the ANSM website (France).

Information for health professionals only

Not applicable.

Other

Not applicable.

VIDAL OF THE FAMILY

ANTALCALM

Anti-inflammatory local action

. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

ANTALCALM 1%: medicated plaster; box of 5 sachets.
-

Laboratory Pierre Fabre Medicine

COMPOSITION (summary)
p pllâtre
Diclofenac sodium 140 mg

INDICATIONS (summary)
This plaster is impregnated with a gel that contains a non- steroidal anti-inflammatory drug ( NSAID ). It locally fights against inflammation and pain.
It is used in the short-term treatment of pain following benign trauma (strain, sprain or contusion).
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
WARNING (Contents)
In case of sprains or bruises, this medication can be used on the advice of your pharmacist. Nevertheless, medical advice is preferable in cases of severe pain, severe edema or limb or joint mobility.
Precautions are necessary in cases of cardiac insufficiency, liver failure, renal insufficiency or a history of ulceration or repeated digestive hemorrhage .
In case of rash , do not repeat the applications until you have taken the advice of your doctor.
To avoid the risk of skin reaction when exposed to ultraviolet rays ( photosensitization ), it is recommended to cover the area of ​​application with a garment for 24 hours after removal of the patch.
PREGNANCY AND BREAST-FEEDING (summary)
Pregnancy :
NSAIDs taken orally may be toxic to the fetus; their use is contraindicated during the last 4 months of pregnancy. NSAIDs for local application may pass through the skin, pass through the blood, and expose the fetus to the same risk, when applied over a large area of ​​skin or under an occlusive dressing. Do not use this medication during pregnancy without medical advice.

Breastfeeding:
Do not use this medication while breastfeeding without medical advice.
DIRECTIONS FOR USE AND DOSAGE (summary)
Clean the skin and apply the plaster, without cutting it, over the painful area. An elastic net sold in pharmacies can help maintain it.

Usual dosage:

  • Adult and adolescent over 16 years: 1 plaster, 2 times a day, for a maximum of 7 days. If the symptoms persist beyond 3 days, a consultation is necessary to determine if the treatment is sufficient.
TIPS (summary)
This medication may be irritating to the eyes or mucous membranes : wash your hands after applying or removing the plaster. In case of accidental contact with eyes, rinse thoroughly with lukewarm water.
POSSIBLE ADVERSE EFFECTS (summary)
Common: redness, itching, rash, contact dermatitis.
Rarely: dry skin.
Very rare: asthma, photosensitivity, urticaria, generalized allergic reaction .


GLOSSARY (summary)


NSAIDs
Abbreviation for non-steroidal anti-inflammatory drug. Family of anti-inflammatory drugs that are not derived from cortisone (steroids), and the best known of which is aspirin.


allergy
Skin reaction (itching, pimples, swelling) or general discomfort occurring after contact with a particular substance, use of a medication, or ingestion of food. The main forms of allergy are eczema, urticaria, asthma, angioedema and allergic shock (anaphylactic shock). Food allergy can also result in digestive disorders.


antecedent
Affection healed or always in evolution. The antecedent may be personal or family. The background is the history of a person's health.


anti-inflammatory
Medicine that fights against inflammation. It can be either derived from cortisone (steroidal anti-inflammatory), or not derived from cortisone (nonsteroidal anti-inflammatory or NSAID).


duodenum
A part of the intestine into which food from the stomach penetrates.


eczema
Skin disease manifested by pimples and itching. Eczema may be due to contact with an allergic substance (contact eczema) or be linked to a genetic predisposition (atopic eczema).


skin rash
Appearance of pimples or plaques on the skin. These lesions can be due to a food, a drug, and translate an allergy or a toxic effect. Many viruses can also cause pimple eruptions: rubella, roseola and measles are the most common.


hemorrhage
Loss of blood from an artery or vein. Hemorrhage can be external, but also internal and go unnoticed.


inflammation
Natural reaction of the organism against an element recognized as foreign. It manifests itself locally by redness, heat, pain or swelling.


heart failure
Inability of the heart to fulfill its function as a pump. The main symptoms of heart failure are fatigue and shortness of breath during an effort.


Hepatic insufficiency
Inability of the liver to perform its function, which is essentially the elimination of some waste, but also the synthesis of many biological substances essential to the body: albumin, cholesterol and coagulation factors (vitamin K, etc.).


renal failure
Inability of the kidneys to eliminate waste or medicinal substances. Advanced renal insufficiency does not necessarily result in a decrease in the amount of urine excreted. Only a blood test and creatinine dosage may reveal this disease.


mucous
Tissue (membrane) that lines the cavities and ducts of the body communicating with the outside (digestive tract, respiratory tract, urinary tract, etc.).


photosensitivity
Abnormal sensitivity of the skin to light or ultraviolet rays due to a drug or a natural or chemical substance.


allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


ulcer
Injury of skin, mucous membranes or cornea.
  • Leg ulcer: chronic wound due to poor circulation of blood.
  • Gastroduodenal ulcer: a localized wound in the mucosa of the stomach or duodenum due to excess acidity and very often to the presence of a bacterium (Helicobacter pylori). The ulcer is favored by stress, alcohol, smoking and certain medications (aspirin, NSAIDs, etc.).

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