Calgel

Leaflet attached to the packaging: information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Calgel

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

You should 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 as directed by
your doctor or pharmacist.

• You should keep this leaflet, so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If there is no improvement or you feel worse, you should contact your 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 for local use. Lidocaine is a local anesthetic. Cetylpyridinium chloride has slight disinfectant 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 you are 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, you should discuss it with your doctor or pharmacist.
You must not use a larger dose than recommended (see section 3).
If you experience any side effects (see section 4) or overdose, you should stop using the medicine and consult a doctor.
If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine (see below).

Calgel and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you 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 heart rhythm disorders, a sedative) and diuretics (urinary medicines) (bumetanide, furosemide, thiazides).
No interactions with other medicines are known for Calgel.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice 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 or use machines.

Calgel contains macrogolglycerol hydroxystearate (hydrogenated polyoxyethylene castor oil)

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 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.
Important information in case of ingestion

Calgel contains sorbitol (E 420)

The medicine contains 147 mg of sorbitol 70% per gram. Sorbitol is a source of fructose. If you or your child have been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the body does not break down fructose, you should consult your doctor before taking the medicine or giving it to your child.

Calgel contains ethanol

The medicine contains 91.46 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 patient leaflet, or as directed by
your doctor or pharmacist. If you are unsure, you should consult your 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.

You must not use a larger dose than recommended.

Using a larger dose of Calgel than recommended

If you use a larger dose than recommended or swallow a large amount of Calgel, you should stop using the medicine and consult a doctor.

Missing a dose of Calgel

You should not use a double dose 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 is usually characterized by difficulty breathing or anaphylactic reactions after drinking a herbal infusion containing chamomile (herbal tea for asthma) or skin allergic reactions to chamomile-containing products.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of 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.
By reporting side effects, you can help provide more information on the safety of this 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 stated month.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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. 1 gram of gel contains 3.3 mg of lidocaine hydrochloride and 1 mg of cetylpyridinium chloride.
• The other ingredients are: sorbitol solution 70% (E 420), xylitol (E 967), ethanol 96%, glycerol (E 422), hydroxyethylcellulose 5000, macrogolglycerol hydroxystearate, laureth-9, macrogol 300, sodium saccharin (E 954), levomenthol, herbal flavoring, caramel (E 150c), citric acid monohydrate, sodium citrate dihydrate (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 with a PP cap containing 10 g of gel, placed in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the 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, Ireland

Manufacturer:

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

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Latvia, the country of export:00-0249
Parallel import authorization number:296/16

Date of approval of the leaflet: 04.03.2025

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