GLIMBAX mouthwash 200ml
Leaflet: user information
Glimbax 0.074% mouthwash
Glimbax 0.074% mouth wash
Diclofenac (Diclofenac)
Please read the entire leaflet carefully before you start using this medicine.
This medicine is available without a prescription. However, in order to get the best results from the treatment, you must 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 become serious, or you notice other side effects not described in this leaflet, please inform your doctor or pharmacist.
In this leaflet:
1. What Glimbax is and what it is used for
2. Before using Glimbax
3. How to use Glimbax
4. Possible side effects
5. How to store Glimbax
6. Additional information
1. WHAT GLYMBAX IS AND WHAT IT IS USED FOR
Glimbax is a non-steroidal anti-inflammatory agent for oromucosal administration. Glimbax contains Diclofenac, an active substance with strong analgesic and anti-inflammatory properties.
Glimbax is indicated for the symptomatic treatment of inflammation of the oral cavity accompanied by pain (for example: gingivitis, stomatitis, pharyngitis), as well as pain due to treatment or extraction of a tooth.
2. BEFORE YOU USE GLYMBAX
Do not use Glimbax
- if you are allergic (hypersensitive) to diclofenac or any of the other ingredients of Glimbax.
- if you are allergic to acetylsalicylic acid or other NSAIDs.
Take special care when using Glimbax
A possible unwitting ingestion of the rinse or gargle 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 medicinal products for topical application, especially when prolonged, may cause hypersensitivity. If this occurs during use of the product, treatment should be discontinued and appropriate treatment instituted.
The product is intended for use by adults.
Do not apply to children under 16 years of age.
Use of other drugs
There are no data on negative interactions with simultaneous use with other medicinal products during treatment.
Pregnancy and breastfeeding
In pregnant or lactating women, it should be used only if absolutely necessary and under medical supervision.
Driving and using machines
Does not affect concentration when driving and 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 data on overdose with Glimbax.
4 . POSSIBLE ADVERSE REACTIONS
Glimbax is usually well tolerated. The most common adverse drug reactions, especially during long-term treatment, are: signs of mild inflammation in the oral cavity, numbness of the tongue, constipation and cough.
Prolonged use of medicinal products for local application may cause sensitization. If this occurs, treatment should be discontinued and appropriate therapy administered as necessary.
Not known: burning sensation in the mouth
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report adverse reactions directly through the national reporting system: Executive Agency for Medicines, 8 Damyan Gruev Street, 1303 Sofia, Tel.: +359 2 8903417, website: www.bda.bg.
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. HOW TO STORE GLYMBAX
To be stored below 25ºС.
KEEP OUT OF THE REACH OF CHILDREN
Do not use Glimbax after the expiry date which is stated on the carton and bottle label. The expiration date corresponds to the last day of the specified month.
Shelf life after opening the bottle: 7 days.
6. ADDITIONAL INFORMATION
What Glimbax contains
100 ml 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, color E124, purified water.
What Glimbax looks like and contents of the pack
Glimbax is supplied in 200 ml bottles placed in a cardboard box with a patient leaflet and a measuring cup.
License holder
Angelini Pharma Bulgaria Ltd
Bul. Asen Yordanov 10
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 leaflet 09/ 201 9 .
