Calgel

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Calgel

(3.3 mg + 1 mg)/g, gel for application to the gums
Lidocaini hydrochloridum + Cetylpyridinii chloridum

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in this patient leaflet, or according to the
recommendations of a doctor or pharmacist.

• The 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 side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

1. WHAT IS CALGEL AND WHAT IS IT USED FOR

Calgel is a combination medicine with local action. Lidocaine is a local anesthetic. Cetylpyridinium chloride has slight antiseptic properties.
Calgel is indicated for inflammatory conditions during teething. Calgel acts quickly, reducing the pain caused by teething and soothing the irritation of the baby's gums.

2. IMPORTANT INFORMATION BEFORE USING CALGEL

When not to use Calgel

If the patient is allergic to lidocaine hydrochloride, cetylpyridinium chloride, or any of the other ingredients of this medicine (listed in section 6), including chamomile.

Warnings and precautions

Before starting to use Calgel, the patient should discuss it with their doctor or pharmacist.
A higher dose than recommended should not be used (see section 3).
In case of any side effects (see section 4) or overdose, the patient should stop using the medicine and seek medical advice.
If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine (see below).

Calgel and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Interactions have been reported between intravenously administered lidocaine and oral procainamide (an anti-arrhythmic medicine), oral phenytoin (an antiepileptic medicine) given separately or in combination with phenobarbital (a sedative and hypnotic medicine), primidone (an antiepileptic medicine), carbamazepine (used to treat epilepsy or certain mental illnesses), oral propranolol (a medicine that lowers blood pressure, used in arrhythmias, a sedative), and diuretics (drugs that increase urine production) (bumetanide, furosemide, thiazides).
No interactions with other medicines are known for Calgel.

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.
The medicine is intended for use in children and infants.

Driving and using machines

Calgel has no effect on the ability to drive vehicles or operate machines.

Calgel contains macrogol glycerol hydroxystearate

The medicine may cause skin reactions.

Calgel contains benzonic acid (derived from herbal flavoring)

The medicine contains 0.004 mg of benzonic acid per gram of gel.
Benzonic acid may cause local irritation.

Calgel contains Peruvian balsam (derived from herbal flavoring)

The medicine may cause allergic skin reactions.

Calgel contains benzyl benzoate (derived from herbal flavoring)

Benzyl benzoate may cause allergic reactions.
Important information in case of ingestion

Calgel contains sorbitol solution 70% (E 420)

The medicine contains 147 mg of sorbitol solution 70% (E 420) per gram. Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, they should consult their doctor before taking the medicine or giving it to their child.

Calgel contains ethanol 96%

The medicine contains 93.86 mg of alcohol (ethanol) per gram. The amount of alcohol in 1 gram of this medicine is equivalent to less than 3 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not have noticeable effects.

Calgel contains macrogol glycerol hydroxystearate

The medicine may cause gastrointestinal upset and diarrhea.
Calgel contains less than 1 mmol (23 mg) of sodium per dose,which means the medicine is considered "sodium-free".

Calgel contains glucose, sucrose, and inverted sugar

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. HOW TO USE CALGEL

This medicine should always be used exactly as described in this patient leaflet, or according to the
recommendations of a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The medicine is intended for local application to irritated gums.
Calgel should not be used in infants under 3 months of age.
A higher dose than recommended should not be used.

Using a higher dose of Calgel than recommended

In case of using a higher dose than recommended or ingesting a large amount of Calgel, the patient should stop using the medicine and consult their doctor.

Missing a dose of Calgel

A double dose should not be used to make up for a missed dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Calgel can cause side effects, although not everybody gets them.
Very rarely (occurring in less than 1 in 10,000 patients), hypersensitivity (including skin inflammation) and reactions at the site of application (including redness) have been reported.
Chamomile, present in negligible amounts as a component of the herbal flavoring, may cause allergic reactions. Hypersensitivity to chamomile usually manifests as difficulty breathing or anaphylactic reactions after drinking herbal tea containing chamomile (asthma tea) or skin allergic reactions to chamomile-containing preparations.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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
Reporting side effects will help to gather more information on the safety of the medicine.

5. HOW TO STORE CALGEL

Store in a temperature below 25°C.
Store in a place out of sight and reach of children.
Shelf life after first opening the tube: 1 month.
Do not use Calgel after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

What Calgel contains

• The active substances of Calgel are lidocaine hydrochloride and cetylpyridinium chloride.
• The other ingredients are: sorbitol solution 70% (E 420), xylitol (E 967), ethanol 96%, glycerol (E 422), hydroxyethylcellulose 5000, macrogol glycerol hydroxystearate, laureth-9, macrogol 300, sodium saccharin (E 954), levomenthol, herbal flavoring (Peruvian balsam, propylene glycol, benzyl benzoate, benzonic acid, chamomile), caramel (E 150c), citric acid monohydrate, sodium citrate (E 331), purified water.

What Calgel looks like and what the packaging contains

Calgel is a yellowish-brown gel with a characteristic odor.
The packaging is an aluminum tube containing 10 g of gel, placed in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Latvia, the country of export:

McNeil Healthcare (Ireland) Limited
Office 5, 6 & 7, Block 5
High Street, Tallaght
Dublin 24, D24 YK8N, Ireland

Manufacturer:

Delpharm Orléans
5, avenue de Concyr
45 071 Orléans Cedex 2
France

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Latvia, the country of export: 00-0249

Parallel import authorization number: 68/16

Date of leaflet approval:04.03.2025
[Information about the trademark]