GLIMBAX mouthwash 200ml
Leaflet: information for the user
Glymbax 0.074% mouthwash
Glimbax 0.074% mouthwash
Diclofenac (Diclofenac)
Please read all of this leaflet carefully before you start using this medicine.
This medicine is available without a prescription. However, to get the best results from the treatment, you should carefully follow the instructions for use of the medicinal product.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, ask your doctor or pharmacist.
- If any of the side effects gets serious, or you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Glimbaks is and what it is used for
2. Before using Glimbaks
3. How to use Glimbaks
4. Possible side effects
5. How to store Glimbaks
6. Additional information
1. WHAT GLYMBAX IS AND WHAT IT IS USED FOR
Glimbaks is a nonsteroidal anti-inflammatory drug for oromucosal administration. Glimbaks contains Diclofenac, an active substance with strong analgesic and anti-inflammatory properties.
Glymbax is indicated for the symptomatic treatment of inflammations of the oral cavity accompanied by pain (for example: gingivitis, stomatitis, pharyngitis), as well as pain resulting from treatment or tooth extraction.
2. BEFORE YOU USE GLYMBAX
Do not use Glimbaks
- if you are allergic (hypersensitive) to diclofenac or any of the other ingredients of Glimbax.
- if you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory products.
Take special care when using Glimbax
Any unintentional ingestion of the rinsing or gargling solution does not cause harm to the patient, as it is equivalent to one fifth of the recommended dose for systemic administration.
The use of topical medicinal products, especially when prolonged, may cause hypersensitivity. If this occurs during use of the product, treatment should be discontinued and appropriate treatment should be initiated.
The product is intended for use by adults.
Do not use in children under 16 years of age.
Use of other medicines
There is no evidence of negative interactions with concomitant use with other medicinal products during treatment.
Pregnancy and breastfeeding
In pregnant or breastfeeding women, it should only be used when absolutely necessary and under medical supervision.
Driving and using machines
It does not affect concentration when driving or operating machinery.
3. HOW TO USE GLYMBAX
2 to 3 rinses or gargles daily of 15 ml (1 measuring cup) of the mouthwash, undiluted or diluted with a little water, are recommended.
If your symptoms do not improve or worsen, seek medical attention.
Overdose
There is no evidence of overdose with Glimbax.
4. POSSIBLE ADVERSE REACTIONS
Glymbax is generally well tolerated. The most common adverse drug reactions, especially with prolonged treatment, are: signs of mild inflammation in the oral cavity, numbness of the tongue, constipation, and cough.
Prolonged use of topical medicinal products may cause sensitization. If this occurs, treatment should be discontinued and appropriate therapy instituted if necessary.
Not known: burning sensation in the mouth
If you get any side effects, please tell 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: Bulgarian Medicines Agency, 8 Damyan Gruev Str., 1303 Sofia, Tel.: +359 2 8903417, website: www.bda.bg.
By reporting side effects, you can help provide more information about the safety of this medicine.
5. HOW TO STORE GLYMBAX
Store below 25ºС.
KEEP OUT OF THE REACH OF CHILDREN
Do not use Glimbaks after the expiry date which is stated on the carton and bottle label. The expiry date refers to the last day of that month.
Shelf life after opening the bottle: 7 days.
6. ADDITIONAL INFORMATION
What Glimbax contains
100 ml of mouthwash contains:
Active substance: 0.074 g diclofenac (diclofenac)
The other ingredients are: sorbitol, choline, sodium benzoate, sodium edetate, acesulfame potassium, natural mint flavor, natural peach flavor, colorant E124, purified water.
What Glimbaks looks like and contents of the pack
Glymbax is supplied in 200 ml bottles, placed in a cardboard box with a patient leaflet and a measuring cup.
Marketing Authorisation Holder
Angelini Pharma Bulgaria EOOD
10 Asen Yordanov Blvd.
Sofia 1592, Bulgaria
Tel.: + 359 2 975 13 95
Fax: + 359 2 971 57 45
Manufacturer
Doppel Srl, Via Martiri delle Foibe 1, Cortemaggiore (PC) – Italy
Vamfarma srl, Via Kennedy, 5, 26833 Comazzo (LO), Italy
Date of last approval of the leaflet 09 / 2019 .
