Calgel

Package Leaflet: Information for the Patient

Calgel

(3.3 mg + 1 mg)/g, gel for gum application
Lidocaine hydrochloride + Cetylpyridinium chloride

Read the package leaflet carefully before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in this package leaflet for the patient, or as directed by a doctor or pharmacist.

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

Package Leaflet Contents:

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

1. What Calgel is and what it is used for

Calgel is a combination medicine for local use. 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).
If any side effects occur (see section 4) or in case of 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 contact 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), primidone (an antiepileptic), carbamazepine (used to treat epilepsy or certain mental disorders), oral propranolol (a medicine that lowers blood pressure, used in arrhythmias, a sedative) and diuretics (urinary medicines) (bumetanide, furosemide, thiazides).
No interactions are known between Calgel and other medicines.

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 does not affect the ability to drive or operate machines.

Calgel contains macrogolglycerol hydroxystearate (hydrogenated polyoxyethylene castor oil)

The medicine may cause skin reactions.

Calgel contains benzoe acid (derived from herbal flavoring)

The medicine contains 0.00384 mg of benzoe acid per gram of gel.
Benzoe acid may cause local irritation.

Calgel contains Peruvian balsam (derived from herbal flavoring)

The medicine may cause skin allergic reactions.

Calgel contains benzyl alcohol (derived from herbal flavoring)

The medicine contains 0.00096 mg of benzyl alcohol per gram of gel.
Benzyl alcohol may cause allergic reactions. The medicine may cause mild local irritation.

Calgel contains a flavoring substance with benzyl benzoate, benzyl cinnamate, cinnamaldehyde, d-limonene, and linalool

Benzyl benzoate, benzyl cinnamate, cinnamaldehyde, d-limonene, and linalool may cause allergic reactions.
Important information in case of ingestion

Calgel contains sorbitol

The medicine contains 210 mg of sorbitol 70% per gram. Sorbitol is a source of fructose. If the patient (or their child) has 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 contact their doctor before taking the medicine or giving it to their child.

Calgel contains ethanol

The medicine contains 93.35 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 macrogolglycerol hydroxystearate (hydrogenated polyoxyethylene castor oil)

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 benzyl alcohol (derived from herbal flavoring)

The medicine contains 0.00096 mg of benzyl alcohol per gram of gel.
Do not give to small children (under 3 years) for more than a week without the advice of a doctor or pharmacist. Patients with liver or kidney disease should consult their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).

3. How to use Calgel

This medicine should always be used exactly as described in this package leaflet for the patient, or as directed by a doctor or pharmacist.
In case of doubt, the patient should consult their doctor or pharmacist.
The medicine is intended for local use on 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 rare (occurs in less than 1 in 10,000 patients): hypersensitivity (including skin inflammation) and reactions at the site of application (including redness).
Chamomile, present in negligible amounts as a component of the herbal flavoring substance, may cause hypersensitivity reactions. Hypersensitivity to chamomile is usually manifested by difficulty breathing or anaphylactic reactions after drinking a herbal infusion containing chamomile (herbal tea for asthma) or skin allergic reactions to chamomile-containing preparations.

Reporting side effects

If the patient experiences any side effects, including any not listed in this package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw,
Phone: +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.

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.
The medicine should be stored 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 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 Calgel contains

• The active substances of Calgel are lidocaine hydrochloride and cetylpyridinium chloride.
• The other ingredients are: sorbitol solution 70%, xylitol, ethanol 96%, glycerol, hydroxyethylcellulose 5000, macrogolglycerol hydroxystearate, laureth-9, macrogol 300, sodium saccharin, levomenthol, herbal flavoring (AR Herbes 17425490; contains benzyl alcohol, benzoe acid (E 210), Peruvian balsam, propylene glycol (E 1520), ethanol, and benzyl benzoate, benzyl cinnamate, cinnamaldehyde, d-limonene, and linalool), caramel (E 150), citric acid monohydrate, sodium citrate dihydrate, purified water.

What Calgel looks like and contents of the package

Calgel is a yellowish-brown gel with a characteristic odor.
The package is an aluminum tube containing 10 g of gel, placed in a cardboard box.

Marketing authorization holder

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

Manufacturer

Delpharm Orleans
5, avenue de Concyr
45071 Orléans Cedex 2
France
To obtain more detailed information, please contact:
email: consumer-pl@kenvue.com

Date of last revision of the package leaflet: