Calgel gum gel

Read this manual carefully, because it contains information that is important to you.

This medicine can be obtained without a prescription.
However, it is necessary to use the medicine Calgel® carefully, in order to achieve the best results with it.
If you have any further questions, ask your pharmacist.

If your symptoms worsen or you do not get better, you must contact your doctor.
If any side effect becomes serious or you notice any side effect that is not listed in this guide, please inform your doctor or pharmacist.

What is Calgel® and what is it for?
Calgel® gum gel relieves the pain in the gums that occurs in children during teething.

What should you know before taking Calgel®?
The drug Calgel®, gum gel contains two active substances, lidocaine hydrochloride and cetylpyridinium chloride. The lidocaine contained in the Calgel® gum gel acts to alleviate the pain in the gums that occurs during teething in children. Antiseptic (cetylpyridinium chloride) prevents infection of irritated surfaces and helps their healing. Apply a small amount of gel to the sensitive surface of the gums with the tip of a clean finger and gently rub it in.

Calgel® should not be used:

• Calgel® gum gel should not be used in children under 3 months of age.
• Calgel® gum gel should not be used if your child is allergic to any of its ingredients. Please inform your doctor or pharmacist if your child has ever had an allergy.
• If you think that your child has an allergic reaction, stop using Calgel® gum gel and immediately inform your doctor or pharmacist.

When taking Calgel®, take special care:

• Do not exceed the recommended dose of Calgel® gum gel. Do not apply Calgel® Gum Gel more than six times a day.
• If the symptoms are still present despite the use of the medicine, consult your doctor or pharmacist.
• If increased irritation occurs, stop using Calgel® gum gel.

Application of other drugs:
When applying Calgel® gum gel within the recommended dose, it is not known that Calgel® gum gel significantly affects the effect of other drugs.

Taking Calgel® with food or drink:
Not applicable.

Application of the drug Calgel® during pregnancy and breastfeeding:
Not applicable.

The effect of Calgel® on driving motor vehicles and using machines:
Not applicable.

Important information about some of the ingredients of Calgel®:

• Patients suffering from the rare hereditary disorder of fructose intolerance should not use this medicine.
• Xylitol can have a laxative effect.
• Castor oil can cause stomach upset and diarrhea.

How is Calgel® used?
Calgel® gum gel is suitable for use in babies older than 3 months. On the cheekbone of a clean finger, squeeze a small amount of Calgel® gum gel approximately 7.5 mm long and gently rub onto the painful surface of the gums. If necessary, the procedure can be repeated after 20 minutes. Calgel® gum gel can be applied up to six times a day.

If you have taken more Calgel® than you should:
Even in the case of improper or excessive application of Calgel® gum gel, it is unlikely that sufficient amounts of lidocaine hydrochloride or cetylpyridinium chloride would be used to produce clinically significant toxic effects. In case of overdose, it is necessary to stop using the drug and consult a doctor.

If you forget to take Calgel®:
Not applicable.

If you suddenly stop taking Calgel®:
Not applicable.

Possible side effects:
As with the use of other medicines, the use of Calgel® gum gel can lead to side effects, although they are rare and usually of moderate intensity.
If your child experiences any of the following side effects, stop using the medicine and seek medical help immediately:

• swelling of the mouth, gums or tongue
• hard breathing
• skin rash

Contact your doctor or pharmacist if your child experiences any side effects that are not listed in these instructions or if there is something you do not understand.

What Calgel® contains:

• The drug Calgel®, gum gel contains active substances:
• Lidocaine hydrochloride 0.33% m/m Cetylpyridinium chloride 0.10% m/m List of auxiliary substances
• Sorbitol, 70% solution (non-crystallizing)
• Xylitol
• Ethanol 96%
• Glycerol
• Hydroxyethylcellulose 5000 cps; Polyethylene glycol-40 hydrogenated castor oil (Cremophor RH 410); Hydroxypolyethoxydodecane
• Macrogol 300
• Saccharin-sodium
• Levomenthol
• Herbal aroma
• Color: Caramel (E150)
• Limic acid, monohydrate
• Sodium citrate
• Water, purified

What Calgel® looks like and contents of the pack:
Flexible aluminum tube of 10g, lacquered on the inside, with an opening covered with a protective membrane and a polypropylene closure.

Expiration date:
3 years old, unopened.
The medicine cannot be used after the expiration date indicated on the package.

Storage:
Keep out of the reach and sight of children. Store at a temperature of up to 25°C.

Packaging: 10 years

Manufacturer:
GlaxoSmithKline Pharmaceuticals SA

Before use, study the instructions in detail. Consult your doctor or pharmacist about indications, precautions and adverse drug reactions.