Calgel gel

Země: Arménie

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivní složka:

lidocaine (lidocaine hydrochloride), cetylpyridinium (cetylpyridinium chloride)

Dostupné s:

GlaxoSmithKline Pharmaceuticals S.A.

ATC kód:

N01BB52

INN (Mezinárodní Name):

lidocaine (lidocaine hydrochloride), cetylpyridinium (cetylpyridinium chloride)

Dávkování:

3,3mg/g+ 1mg/g

Léková forma:

gel

Jednotky v balení:

10g aluminium tube

Druh předpisu:

Prescription

Stav Autorizace:

Registered

Datum autorizace:

2022-03-23

Informace pro uživatele

PACKAGE LEAFLET
CALGEL
gel 3.3mg/g / 1mg/g
Lidocaine Hydrochloride / Cetylpyridinium Chloride
■ This product can be used to help relieve pain and discomfort
associated with teething,
when other nonmedicinal methods such as massaging of the gums or use
of teething
rings do not provide necessary relief.
■ This medicine is suitable for most babies and children over 5
months. Do not give this
medicine, if your child is under 5 months old.
■ Do not give it to anyone on this list:

Not to anyone who has ever had a bad reaction to any of the
ingredients. See
section 6
■ Follow the dosage instructions carefully. These are shown in the
table. See section 3
NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE.
Keep the
leaflet: you might need it again.
1.
WHAT THE MEDICINE IS FOR
This product can be used to help relieve pain and discomfort
associated with teething,
in
children
from
5
months
of
age,
when
other
non-medicinal
methods
such
as
massaging of the gums or use of teething rings do not provide
necessary relief. It also
contains cetylpyridium chloride (a mild antiseptic) to help prevent
infection.
2.
BEFORE GIVING THE MEDICINE TO YOUR CHILD
This medicine is suitable for most children, but a few children should
not use it. If you
are in any doubt, talk to your doctor or pharmacist.
_DO NOT GIVE YOUR CHILD THIS MEDICINE… _
■ if your child is under 5 months old.
■ If your child has ever had an allergic reaction to the product,
chamomile, or any of the
ingredients.
If this applies, get advice from a doctor or pharmacist without using
CALGEL
■ Do not use at the same time as other products containing
lidocaine.
_TALK TO YOUR DOCTOR OR PHARMACIST… _
■ If your child has an intolerance to some sugars.
If this bullet point applies now or in the past, speak to a doctor or
pharmacist.
_IF YOUR CHILD IS USING ANY OTHER MEDICINES _
No interactions with other medicines are currently known.
_IF YOU ARE PREGNANT OR BREAST-FEEDING _
The following advice is included in case an older
child or adult is

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
CALGEL
Lidocaine Hydrochloride / Cetylpyridinium Chloride
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
CALGEL contains Lidocaine Hydrochloride 0.33% w/w and Cetylpyridinium
Chloride
0.10% w/w
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
The product is a yellowish-brown colored gel with characteristic odor.
Smooth and
free from grittiness, lumps and foreign matter.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For relief of pain and discomfort associated with teething in children
from 5 months
of age, where non-pharmacological treatments have failed to provide
sufficient relief.
It also has mild antiseptic properties.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
CALGEL is suitable for babies from the age of 5 months.
Apply a pea-sized amount (0.2 grams) of CALGEL with a clean finger to
the affected
area of gum.
The dose may be repeated if necessary after 3 hours, up to a maximum
of 6 doses
in 24 hours.
Treatment should be stopped once symptoms have resolved.
Not to be used for more than 7 days.
Parents or carers should seek medical attention if the child's
condition deteriorates
during treatment.
In case of vomiting, spitting or accidental ingestion, the dose should
not be repeated
immediately. The dose may be repeated if necessary after 3 hours.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section
6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not use more than one product containing lidocaine at the same
time.
The recommended dose should not be exceeded. Keep out of the sight and
reach of
children.
This medicine contains 29.4mg sorbitol in each 0.2g (pea sized blob).
The additive
effect of concomitantly administered products containing sorbitol (or
fructose) and
dietary intake of sorbitol (or fructose) should be taken into account.
The content of
sorbitol in
medicinal products for oral use may affect
the bioavailability of other
medicinal products for