Iglu Rapid Relief oromucosal gel

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Aminoacridine hydrochloride; Lidocaine hydrochloride

Dostopno od:

Dendron Ltd

INN (mednarodno ime):

Aminoacridine hydrochloride; Lidocaine hydrochloride

Odmerek:

500microgram/1gram ; 6.6mg/1gram

Farmacevtska oblika:

Oromucosal gel

Pot uporabe:

Oromucosal; Gingival

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: ; GTIN: 5016379296505

Navodilo za uporabo

PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE USING THIS PRODUCT.
Keep this leaflet. You may need to read it again. Ask your doctor,
dentist or pharmacist
if you need more information or advice. You must contact a doctor or
dentist if your symptoms
worsen or do not improve. If any of the side effects gets serious, or
if you notice any side effect
not listed in this leaflet, please tell your doctor, dentist or
pharmacist.
IN THIS LEAFLET:
1. What Iglü Rapid Relief Gel is and
what it is used for
2. Before you use Iglü Rapid Relief Gel
3. How to use Iglü Rapid Relief Gel
4. Possible side effects
5. How to store Iglü Rapid Relief Gel
6. Further information
1. WHAT IGLÜ RAPID RELIEF GEL IS
AND WHAT IT IS USED FOR
• Iglü Rapid Relief Gel is a treatment for fast,
effective relief of pain from common mouth
ulcers, sore gums and denture rubbing.
• The product, which at first looks like a pale
yellow paste, forms a smooth, flexible and
adhesive protective gel coating when it
becomes wet on contact with saliva inside
the mouth.
• Iglü Rapid Relief Gel is suitable for use by
ADULTS, THE ELDERLY AND CHILDREN OVER
7 YEARS OF AGE.
• The product works in three ways:
• by forming a gel coating to protect the
sensitive and delicate area of the mouth
lining as it heals, and
• by the actions of its two ACTIVE
INGREDIENTS, lidocaine hydrochloride
and aminoacridine hydrochloride,
which work by:
•
stopping pain (lidocaine hydrochloride
is a local anaesthetic), and
•
preventing infection (aminoacridine
hydrochloride is an antiseptic).
2. BEFORE YOU USE IGLÜ RAPID
RELIEF GEL
DO NOT USE Iglü Rapid Relief Gel if you are
ALLERGIC (HYPERSENSITIVE) to lidocaine
hydrochloride, aminoacridine hydrochloride
or any of the other ingredients of Iglü Rapid
Relief Gel listed in Section 6.
TAKE SPECIAL CARE when using this product:
• Apply it sparingly.
• Keep the product away from your eyes.
USING OTHER MEDICINES
Iglü Rapid Relief Gel is not known to affect,
or to be affected by, any other medicines.
PREGNANCY AND BRE

Lastnosti izdelka

OBJECT 1
IGLU RAPID RELIEF GEL
Summary of Product Characteristics Updated 06-May-2015 | Diomed
Developments Limited
1. Name of the medicinal product
IGLÜ
®
RAPID RELIEF GEL
2. Qualitative and quantitative composition
Lidocaine Hydrochloride 0.66% w/w; Aminoacridine Hydrochloride 0.05%
w/w.
For full list of excipients, see section List of Excipients.
3. Pharmaceutical form
Soft, pale yellow, slightly opalescent oromucosal gel.
4. Clinical particulars
4.1 Therapeutic indications
For fast, effective relief from the pain of common mouth ulcers,
soreness of gums and denture rubbing.
4.2 Posology and method of administration
For use in the mouth.
For adults, the elderly and children over 7 years old.
Apply sparingly, directly to the affected area(s) with a clean finger
tip or a cotton wool bud. Re-apply as
necessary – the aim being to keep the affected area(s) protected with
a thin layer of gel. As a guide, each
application should normally last for an hour or more, although eating
and/or drinking may necessitate
more frequent re-application. In some cases, applications may remain
in place for several hours.
4.3 Contraindications
Do not use in cases of known sensitivity to lidocaine hydrochloride
(or other local anaesthetics of the
amide-type), aminoacridine hydrochloride or any of the other
ingredients.
4.4 Special warnings and precautions for use
Keep the product away from the eyes. In case of accidental contact,
wash eye immediately with water:
keep rinsing for 10 to 15 minutes, holding the eyelids well apart and
avoid getting the rinse liquid into the
other eye. Consult a doctor if irritation persists.
If symptoms persist consult your doctor or dentist.
4.5 Interaction with other medicinal products and other forms of
interaction
None known.
4.6 Pregnancy and lactation
Animal studies are insufficient with respect to effects on pregnancy
and lactation (see section Preclinical
Safety Data). The potential risk for humans is unknown.
Caution should therefore be exercised before recommending this
treatment for use duri