NOTICE
ANSM - Updated: 29/05/2018
Name of the drug
VOLTARENACTIGO 1 PERCENT , gel
Diclofenac diethylamine
framed
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel worse after 4 days.
Do not let this medicine within the reach of children.
What does this booklet contain ?
1. What is VOLTARENACTIGO 1 PERCENT, gel and in what cases is it used?
2. What information do you need to know before using VOLTARENACTIGO 1 PERCENT, gel?
3. How to use VOLTARENACTIGO 1 PERCENT, gel?
4. What are the possible side effects?
5. How to store VOLTARENACTIGO 1 PERCENT, gel?
6. Contents of the package and other information.
1. WHAT IS VOLTARENACTIGO 1 PERCENT, FREEZE AND WHAT IT IS USED FOR?
Pharmacotherapeutic class - ATC code: M02AA15.
This drug is an anti-inflammatory and analgesic (it calms pain), in the form of gel for application on the skin, only in the area of pain.
Therapeutic indications
This drug is indicated in adults (from 15 years), as short-term local treatment in case of mild trauma: sprain (strain), contusion.
You should talk to your doctor if you do not feel better or feel worse after 4 days.
2. WHAT YOU SHOULD KNOW BEFORE USING VOLTARENACTIGO 1 PERCENT, FREEZE?
Never use VOLTARENACTIGO 1 PERCENT, freeze
· from the 25th week of gestation (early 6th month of pregnancy).
· in case of allergy to this drug or a related drug, including other nonsteroidal anti-inflammatory drugs, aspirin;
· in case of allergy to any of the excipients;
· on injured skin, whatever the lesion: oozing lesions, eczema, infected lesion, burn or wound;
· in children under 15 years old.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Warnings and precautions
Be careful with VOLTARENACTIGO 1 PERCENT, gel:
· Do not apply on the mucous membranes or on the eyes, only on the painful area.
· The appearance of a rash after application requires the immediate cessation of treatment.
· Do not apply to a large area of skin and for prolonged periods without medical advice.
· This medicine contains propylene glycol and may cause skin irritation.
· Due to the presence of benzyl benzoate, this drug may cause irritation to the skin, eyes and mucous membranes.
This medication should not be used under occlusive dressing.
IN THE ABSENCE OF IMPROVEMENT After 4 days of treatment, CONSULT your DOCTOR.
In adolescents aged 15 years and older, if symptoms worsen, it is recommended that you seek the advice of your doctor.
If you are pregnant or breastfeeding:
Do not use this medicine on your own. Ask your doctor or pharmacist for advice.
Children and adolescents (under 15 years old)
This medicine should not be used in children under 15 years (see section "Do not use VOLTARENACTIGO 1 PERCENT, gel in the following cases")
Other medicines and VOLTARENACTIGO 1 PERCENT, gel
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
This medicine contains Diclofenac. Other drugs contain some and especially some drugs taken orally. Do not combine them so as not to exceed the recommended maximum doses (see Dosage and Method of Administration). |
Pregnancy and lactation and fertility
Pregnancy
If you are pregnant or breastfeeding, or if you think you may be, or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
VoltarenActigo 1 PERCENT, should not be used from the 25th week of gestation (early 6 th month of pregnancy), as it could have adverse effects on the fetus or cause problems with childbirth. VOLTARENACTIGO 1 PERCENT, gel should be used only after medical advice until the 24 th week of amenorrhea (5 months of pregnancy completed) and the dose should be as low as possible and the duration of treatment as short as possible .
feeding
This medicine passes into breast milk in small amounts. During lactation, VOLTARENACTIGO 1 PERCENT, gel should be used only after medical opinion. However, VOLTARENACTIGO 1 PERCENT, gel should not be applied to the breasts in nursing mothers, nor on a large skin surface, or for an extended period of time.
If you are pregnant or breastfeeding, ask your doctor or pharmacist for more information.
Driving and using machines
Not applicable.
VOLTARENACTIGO 1 PERCENT, gel contains propylene glycol and benzyl benzoate.
3. HOW TO USE VOLTARENACTIGO 1 PERCENT, FREEZE?
Dosage and duration of treatment
Reserved for adults (from 15 years old)
The occurrence of adverse effects may be minimized by using the lowest possible dose for the shortest duration of treatment required to relieve symptoms.
1 local application, 2 to 3 times a day, for a maximum duration of 4 days. If the pain persists beyond, a doctor should be consulted.
The dose administered to each application should not exceed 2.5 g of gel. This maximum dose corresponds to a tape of 6 cm of gel (see diagram of the scale).
Administration mode
Local way.
EXTERNAL USE
To penetrate the gel by a gentle and prolonged massage on the painful or inflammatory area.
Wash your hands thoroughly after each use.
For the applicator tube (see Figure 1):
1. To remove tamper protection before first use, remove the clear protective cap and unscrew the applicator. Use the star port located on the side of the applicator to remove the tamper protection from the tube by rotating the applicator tip. Screw the applicator onto the tube before using the gel.
2. To open, pull the white part of the applicator using the 2 white side pastes. Apply, by firmly pressing the tube, a tape with a maximum length of 6 cm on the painful area then close the cap by pushing the white part of the applicator. Use the applicator tip of the tube instead of your fingers to gently and slowly massage the gel on the painful or inflammatory area.
3. After use, clean the applicator with a cotton towel or paper towel until it is dry and clean. Do not immerse or rinse under water. Do not use solvent or detergent to clean the surface of the applicator. After cleaning, replace the transparent protective cap on the tube before storing. Do not reuse the applicator with another tube. Discard the tube with its applicator according to the same procedure for the elimination of any medication (see section 5).
Figure 1
| Remove the transparent cap |
| Unscrew the applicator tip |
| Remove the tamper protection from the tube using the star-shaped hole on the side of the applicator tip by turning the applicator tip |
| Screw the applicator tip onto the tube |
| Pull the white part of the applicator using the 2 white side pastes to open the tube |
| Apply, by firmly pressing the tube, a tape of a maximum length of 6 cm on the painful area. |
| Close the tip by pressing on the white part of the applicator |
| Use the applicator tip of the tube instead of your fingers to gently and slowly massage the gel on the painful or inflammatory area |
| Clean the applicator with a cotton towel or paper towel until it is dry and clean |
If you have used more VOLTARENACTIGO 1 PERCENT, gel than you should have:
In case of overdose, or accidental poisoning, rinse thoroughly with water and consult your doctor or pharmacist immediately.
If you forget to use VOLTARENACTIGO 1 PERCENT, gel
If you accidentally miss a dose, wait for the next dose and continue your treatment normally. Do not take a double dose to make up for the dose you forgot to take.
If you stop using VOLTARENACTIGO 1 PERCENT, freeze
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Exceptionally can occur reactions that can be severe:
· allergic skin reactions: rash (pimples), urticaria, bubbles,
· respiratory problems like asthma attack (noisy and short breath, impression of diminished respiratory capacity),
· general manifestations of anaphylaxis type (swelling of the face, lips, tongue, throat).
Stop taking the medication immediately and tell your doctor or pharmacist.
More frequently, undesirable effects, usually mild and transient, can occur:
· local skin effects such as redness, itching, skin irritation, erosion or local ulceration,
· very exceptionally, an increase in the sensitivity to the sun,
· other general effects of nonsteroidal anti-inflammatory drugs, depending on the amount of gel applied, the area treated and its condition, the duration of treatment and whether or not a closed dressing is used.
Tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to <<> your pharmacist> . This also applies to any undesirable effect that is not mentioned 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: www.ansm.sante.fr
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE VOLTARENACTIGO 1 PERCENT, FREEZE?
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 carton after EXP. The expiry date refers to the last day of this month.
Store at a temperature not exceeding 25 ° C for the painted aluminum tube.
Store at a temperature not exceeding 30 ° C for the aluminum laminate tube. After opening, the maximum shelf life is 6 months.
Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment .
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What VOLTARENACTIGO contains 1 PERCENT, gel
· The active substance (s) is (are):
Diclofenac of diethylamine ............................................... .................................................. ........... 1.16 g
Quantity corresponding to diclofenac sodium ............................................. .................................. 1.00 g
For 100 g of gel.
· The other components are:
Diethylamine, 974P carbomer, cetomacrogol 1000, caprylic and capric acid ester with C12-C18 fatty alcohol, isopropyl alcohol, liquid paraffin, cream perfume 45 (containing benzyl benzoate), propylene glycol, purified water.
What VOLTARENACTIGO 1 PERCENT, gel and contents of the pack
This medicine comes in gel form. Box of 1 tube of 10 g, 50 g, 60 g, 75 g and 100 g.
Marketing Authorization Holder
GLAXOSMITHKLINE CONSUMER HEALTH
23 RUE FRANCOIS JACOB
92500 RUEIL-MALMAISON
LA FRANCE
Operator of the marketing authorization
GLAXOSMITHKLINE CONSUMER HEALTH
23 RUE FRANCOIS JACOB
92500 RUEIL-MALMAISON
LA FRANCE
Maker
NOVARTIS PHARMA SAS
26 CHAPEL STREET
68330 HUNINGUE
LA FRANCE
or
CENTER PHARMACEUTICAL SPECIALTIES
ZAC OF BAROGNE
77230 MOUSSY-LE-NEUF
LA FRANCE
or
GLAXOSMITHKLINE CONSUMER HEALTH
23 RUE FRANCOIS JACOB
92500 RUEIL-MALMAISON
LA FRANCE
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
[to be completed later by the holder]
<{MM / YYYY}> <{YYYY month}.>
Other
Detailed information on this medicine is available on the ANSM website (France).
Health Education Council:
Warning: if there is complete functional impotence, that is to say if you can not use the limb and in case of hematoma ("blue") important, you must consult without delay your doctor.
You have just had a trauma or bruise, you can use the gel for up to 4 days to relieve your pain. Do not resume a sporting activity or intense physical activity before the complete disappearance of pain.
Otherwise :
In case of sprained ankle
You should consult your doctor who will judge the need for an x-ray and orthopedic treatment:
· if you absolutely can not rest on your leg to take four steps,
· or if a hematoma (blue) appears within 24 to 48 hours
· or if there is deformity or edema (swelling) very important.
In case of knee injury
You should consult your doctor who will judge the need for an x-ray and orthopedic treatment:
· in case of significant swelling of the knee, with or without hematoma,
· and / or in case of impossibility of support.