Calgel
Poland
Table of Contents
Package leaflet: Information for the user
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
Lidocaini hydrochloridum + Cetylpyridinii chloridum
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
- If there is no improvement or if you feel worse, you should consult your doctor.
Contents of the leaflet:
- What Calgel is and what it is used for
- Important information before using Calgel
- How to use Calgel
- Possible side effects
- How to store Calgel
- Contents of the pack and other information
1. What Calgel is and what it is used for
Calgel is a combination medicine with local action. Lidocaine is a local anaesthetic. Cetylpyridinium chloride has mild antiseptic properties.
Calgel is indicated for inflammatory conditions associated with teething. Calgel acts quickly, reducing teething pain and soothing irritation of the infant's gums.
2. Important information before using Calgel
When not to use Calgel
Do not 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, discuss it with your doctor or pharmacist.
Do not use more than the recommended dose (see section 3).
If any adverse effects occur (see section 4) or if an overdose is suspected, the patient should stop using the medicine and seek medical advice.
If the patient has been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine (see below).
Calgel and other medicines
Tell your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Interactions have been reported between intravenous lidocaine and oral procainamide (an antiarrhythmic medicine), oral phenytoin (an antiepileptic medicine) administered separately or together with phenobarbital (a sedative and sleep aid), primidone (an antiepileptic medicine), carbamazepine (used in the treatment of epilepsy or certain psychiatric conditions), oral propranolol (a blood pressure-lowering medicine used in heart rhythm disorders, also a sedative), and diuretics (water pills) (bumetanide, furosemide, thiazides).
No interactions between Calgel and other medicines are known.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
This medicine is intended for use in children and infants.
Driving and operating machinery
Calgel has no effect on the ability to drive or operate machinery.
Calgel contains macrogol glycerol hydroxystearate
This medicine may cause skin reactions.
Calgel contains benzoic acid (E 210) (from herbal flavouring)
The medicine contains 0.004 mg of benzoic acid (E 210) per gram of gel.
Benzoic acid may cause local irritation.
Calgel contains Peru balsam (from herbal flavouring)
This medicine may cause allergic skin reactions.
Calgel contains benzyl alcohol (from herbal flavouring)
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 benzyl benzoate and linalool (from herbal flavouring)
Benzyl benzoate and linalool may cause allergic reactions.
Calgel contains propylene glycol (E 1520) (from herbal flavouring)
The medicine contains 0.04 mg of propylene glycol (E 1520) per dose, equivalent to 0.19 mg/g.
Important information in case of accidental ingestion
Calgel contains sorbitol (E 420)
The medicine contains 147 mg of sorbitol (E 420) per gram. Sorbitol is a source of fructose. If the patient (or the patient's child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance—a rare genetic disorder in which the body cannot break down fructose—the patient should consult a doctor before taking this medicine or giving it to a 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 cause noticeable effects.
Calgel contains macrogol glycerol hydroxystearate
This medicine may cause indigestion and diarrhoea.
Calgel contains benzyl alcohol (from herbal flavouring)
The medicine contains 0.00096 mg of benzyl alcohol per gram of gel.
Do not administer to young children (under 3 years of age) for longer than one week without medical advice from a doctor or pharmacist. Patients with liver or kidney disease should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Calgel contains sodium
Calgel contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".
Calgel contains glucose, sucrose, and invert sugar
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
3. How to use Calgel
This medicine should always be used exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is intended for local application to irritated gums.
Do not use Calgel in infants below 3 months of age.
Age | Dosage
---|---
Infants from 3 months of age | Squeeze a small amount of gel (7.5 mm) onto the tip of a clean finger and gently rub into the gums at the site where teeth are erupting.
If necessary, the procedure may be repeated. Wait at least 2 hours before reapplying the medicine. Do not use more than 6 times a day.
Do not exceed the recommended dose.
Use of more than the recommended dose of Calgel
If more than the recommended dose is used or if a large amount of Calgel is swallowed, stop using the medicine and consult a doctor immediately.
Missed dose of Calgel
Do not use a double dose to make up for a missed dose.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Very rarely (occurring in fewer than 1 in 10,000 patients), allergic reactions (including skin inflammation) and reactions at the application site (including redness) have been reported.
Chamomile, present in trace amounts as a component of the herbal flavouring, may cause allergic reactions. Hypersensitivity to chamomile usually manifests as difficulty in breathing or anaphylactic reactions occurring after drinking herbal infusions containing chamomile (herbal tea for asthma) or allergic skin reactions to products containing chamomile.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: +48 22 4921 301,
Fax: +48 22 4921 309, Website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of this medicine can be collected.
5. How to store Calgel
Store below 25°C.
Keep Calgel out of the sight and reach of children.
Shelf life after first opening of 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 indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the packaging and other information
What Calgel contains
- The active substances in this medicine are lidocaine hydrochloride and cetylpyridinium chloride. 1 gram of gel contains 3.3 mg of lidocaine hydrochloride and 1 mg of cetylpyridinium chloride.
- Other ingredients are: sorbitol solution 70% (E 420), xylitol (E 967), ethanol 96%, glycerol (E 422), hydroxyethylcellulose 5000, macrogol glycerol hydroxystearate, macrogol lauryl ether, macrogol 300, sodium saccharin (E 954), levomenthol, herbal flavour 17425490 (containing, among others, benzyl alcohol, benzoic acid (E 210), Peru balsam, propylene glycol (E 1520), ethanol, benzyl benzoate, linalool), caramel (E 150c), citric acid monohydrate, sodium citrate (E 331), purified water.
What Calgel looks like and contents of the pack
Calgel is a yellowish-brown gel with a characteristic odour.
The packaging consists of an aluminium tube with a PP cap containing 10 g of gel, packed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Latvia, 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation Number in Latvia, country of export: 00-0249
Parallel Import Authorisation Number: 68/16