Glimbax

Leaflet attached to the packaging: patient information

Glimbax, 0.74 mg/ml (0.074%), oral and throat rinse solution
Diclofenac

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 7 days, they should contact their doctor.

Table of contents of the leaflet:

• 1.What is Glimbax and what is it used for
• 2.Important information before using Glimbax
• 3.How to use Glimbax
• 4.Possible side effects
• 5.How to store Glimbax
• 6.Package contents and other information

1. What is Glimbax and what is it used for

Glimbax contains the active substance diclofenac, which is a non-steroidal anti-inflammatory drug (NSAID).
When used locally in inflammatory conditions of the oral and throat mucosa, diclofenac has analgesic and anti-inflammatory effects.
Glimbax is used for the symptomatic treatment of inflammatory conditions of the oral and throat mucosa (e.g., symptoms of gingivitis, oral inflammation, throat inflammation, post-dental procedures, symptoms of mechanical irritation).

2. Important information before using Glimbax

When not to use Glimbax:

• if the patient is allergic to the active substance (diclofenac) or any of the other ingredients of this medicine (listed in section 6);
• if the patient has an allergy (hypersensitivity) to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (e.g., ibuprofen, ketoprofen, aspirin caused an asthma attack, hives, or allergic rhinitis);
• in children under 14 years of age;
• during the last three months of pregnancy.

Warnings and precautions

Before starting to use Glimbax, the patient should discuss it with their doctor or pharmacist.
During local use of the medicine, especially long-term, an allergy (hypersensitivity) may develop. In such a case, the use of the medicine should be stopped and the patient should contact their doctor, who will prescribe appropriate treatment if necessary.
Contact between Glimbax and the eyes should be avoided.
There are no special dosage recommendations for patients with renal or hepatic impairment. However, there is a theoretical possibility of accumulation of the medicine and its metabolites in case of severe renal impairment, but its clinical significance is unknown.
No dose adjustment is necessary in elderly patients.

Glimbax and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interactions with other locally used oral medicines are known.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Glimbax should not be used during the last three months of pregnancy. During the first six months of pregnancy, Glimbax should not be used unless it is necessary and recommended by a doctor.
In case of use, the lowest possible dose should be administered for the shortest possible time.
After oral administration of diclofenac-containing medicines (e.g., tablets), side effects may occur in the unborn child. It is not known whether the same risk applies to Glimbax when used in the mouth.
Glimbax should not be used in pregnant or breastfeeding women.

Driving and using machines

Glimbax does not affect the ability to drive or operate machines.

Glimbax contains sodium benzoate

The medicine contains 150 mg of sodium benzoate in each 15 ml, which corresponds to 10 mg/ml. Sodium benzoate may cause local irritation.

3. How to use Glimbax

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Recommended dose

Children under 14 years of age

Glimbax should not be used in children under 14 years of age.

Adults and children over 14 years of age

The use of the oral and throat rinse solution is recommended 2 to 3 times a day. Each time, 15 ml of the solution (1 measuring cup) should be used undiluted or diluted with a small amount of water, and the mouth should be rinsed for about 30-60 seconds. After use, the solution should be spat out.
If symptoms worsen or do not improve after 7 days of using Glimbax, the patient should contact their doctor.

Using more than the recommended dose of Glimbax

Accidental, unintentional swallowing of a single dose of the oral rinse solution does not pose a risk to the patient, as the potentially swallowed dose of the medicine would be one-fifth to one-sixth of the recommended dose for general use.
No cases of Glimbax overdose have been reported.
In case of taking more than the recommended dose, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Glimbax

If a dose is missed, the patient should not take a double dose to make up for the missed dose but should take it at the time resulting from the recommended dosage regimen.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Glimbax can cause side effects, although not everybody gets them.
During use of the medicine (especially long-term), symptoms of irritation of the oral mucosa and cough may occur. An allergy may also develop. In such a case, the use of the medicine should be stopped and the patient should contact their doctor, who will prescribe appropriate treatment if necessary.
It cannot be excluded that systemic side effects may occur in case of swallowing or long-term use of Glimbax.
Side effect of unknown frequency(frequency cannot be estimated from the available data):

• burning sensation in the mouth.

Reporting side effects
If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to: Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Glimbax

Store at a temperature below 25°C.
Shelf life after first opening: 12 months.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the label and carton. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Glimbax contains

The active substance of the medicine is diclofenac. One ml of the solution contains 0.74 mg of diclofenac.
The other ingredients are: choline chloride, sodium hydroxide, sorbitol, sodium benzoate, disodium edetate, acesulfame potassium, peach flavor, mint flavor, Allura Red AC (E129), purified water.

What Glimbax looks like and what the package contains

Glimbax is an oral and throat rinse solution.
The packaging of the medicine is a transparent type III glass bottle with a brown color and a child-resistant polyethylene cap, and a 15 ml measuring cup in a cardboard box.
1 bottle of 200 ml

Marketing authorization holder and manufacturer

Marketing authorization holder:

Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B, 02-222 Warsaw
tel.: (22) 70 28 200
e-mail: [email protected]

Manufacturer:

ITC Production S.r.l
Via Pontina Km 29
00071 Pomezia (RM)
Italy
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (PC)
Italy
A patient leaflet in a format suitable for the blind and partially sighted is available at the marketing authorization holder's headquarters.

Date of last update of the leaflet: September 2024