Glimbax

Package leaflet: Information for the patient

Glimbax, 0.74 mg/ml (0.074%), solution for oral and throat rinsing
Diclofenacum
Please read carefully the entire leaflet 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
recommended by the doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.

Table of contents of the leaflet:

1. What Glimbax is and what it is used for
2. Important information before using Glimbax
3. How to use Glimbax
4. Possible side effects
5. How to store Glimbax
6. Contents of the package and other information

1. What Glimbax is and what it is used for

Glimbax contains as the active substance diclofenac, which is a non-steroidal anti-inflammatory drug (NSAID).
When used locally in inflammatory conditions of the oral and pharyngeal mucosa, diclofenac exerts analgesic and anti-inflammatory effects.
Glimbax is indicated for the symptomatic treatment of inflammatory conditions of the oral and pharyngeal mucosa (e.g. symptoms of gingivitis, stomatitis, pharyngitis, post-dental procedure conditions, 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 to any of the other ingredients of this medicine (listed in section 6);
• if the patient has an allergy (hypersensitivity) to acetylsalicylic acid or to another non-steroidal anti-inflammatory drug (e.g. if asthma, urticaria, or allergic rhinitis occurred after taking ibuprofen, ketoprofen, or aspirin);
• in children under 14 years of age;
• during the last three months of pregnancy.

Warnings and precautions
Before starting treatment with Glimbax, consult your doctor or pharmacist.
When Glimbax is used locally, especially over a prolonged period, sensitization (hypersensitivity) may occur.
In such a case, treatment should be discontinued and the patient should contact a doctor, who will recommend appropriate treatment if necessary.
Contact of Glimbax with the eyes should be avoided.
There are no special dosage recommendations for patients with renal or hepatic impairment.
Theoretically, accumulation of the drug and its metabolites may occur in severe renal failure, but the clinical significance of this is unknown.
There is no need to modify the dosing regimen in elderly patients.

Glimbax with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No interactions are known between this medicine and other locally applied medicines in the oral cavity.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Glimbax must not be used during the last three months of pregnancy. During the first six months of pregnancy, Glimbax should not be used unless necessary and recommended by a doctor.
If use is necessary, the lowest possible dose for the shortest possible duration should be administered.
Adverse effects on the unborn child may occur after oral administration of diclofenac-containing medicines (e.g. tablets). It is not known whether the same risk applies to Glimbax when used in the oral cavity.
Glimbax must not be used in pregnant or breastfeeding women.

Driving and operating machinery
Glimbax has no influence on the ability to drive or operate machinery.

Glimbax contains sodium benzoate
The medicine contains 150 mg of sodium benzoate in each 15 ml, equivalent 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
physician or pharmacist. If in doubt, consult a physician 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
It is recommended to use the oral and throat rinse solution 2 to 3 times daily. Each time, use 15 ml of
the solution (1 measuring cup), undiluted or diluted with a small amount of water, and rinse the mouth
for approximately 30–60 seconds. After use, the solution should be spat out.
If symptoms worsen or do not improve within 7 days of using Glimbax, consult a physician.
Use of a higher than 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 potential swallowed dose would constitute one-fifth to one-sixth of the recommended
systemic dose.
No cases of Glimbax overdose have been reported.
In case of ingestion of a dose higher than recommended, seek immediate advice from a physician or
pharmacist.
Missed dose of Glimbax
If a dose is missed, do not take a double dose to make up for the missed dose. Instead, continue using
the medicine according to the recommended dosing schedule.
If there are any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
During use (especially prolonged use), symptoms of irritation of the oral mucosa and cough may occur.
Hypersensitivity reactions may also develop. In such a case, treatment should be discontinued and
medical advice sought for appropriate management.
Systemic adverse reactions cannot be ruled out in the event of swallowing or prolonged use of Glimbax.
Adverse reaction with unknown frequency (frequency cannot be estimated from the available data):

• burning sensation in the mouth.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to: Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Glimbax

Store below 25°C.
Shelf life after first opening: 12 months.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Glimbax contains
The active substance is diclofenac. One ml of solution contains 0.74 mg of diclofenac.
Other components are: choline chloride, sodium hydroxide, sorbitol, sodium benzoate, disodium edetate, acesulfame potassium, peach flavouring agent, mint flavouring agent, Allura Red AC (E129), purified water.

What Glimbax looks like and contents of the pack
Glimbax is a solution for mouth and throat rinsing.
The medicine is packaged in an amber glass bottle (type III) with a polyethylene child-resistant cap, together with a 15 ml dosing cup, all contained in a cardboard box.
1 bottle of 200 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
of the marketing authorisation holder.