Lypsyl Cold Sore gel

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Lidocaine hydrochloride; Zinc sulfate; Cetrimide

Inapatikana kutoka:

Alliance Pharmaceuticals Ltd

ATC kanuni:

D04AB

INN (Jina la Kimataifa):

Lidocaine hydrochloride; Zinc sulfate; Cetrimide

Kipimo:

20mg/1gram ; 10mg/1gram ; 5mg/1gram

Dawa fomu:

Cutaneous gel

Njia ya uendeshaji:

Cutaneous

Darasa:

No Controlled Drug Status

Dawa ya aina:

Never Valid To Prescribe As A VMP

Bidhaa muhtasari:

BNF: ; GTIN: 0000050487530

Taarifa za kipeperushi

COLD SORE GEL
LIDOCAINE HYDROCHLORIDE • ZINC SULFATE • CETRIMIDE
3g
MARKETING AUTHORISATION HOLDER: Alliance Pharmaceuticals
Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire,
SN15 2BB, UK. MANUFACTURER: Famar A.V.E. Avlon Plant, 49
th
km
National Road, Athens-Lamia, Avlona Attiki, 19011, Greece.
PL 16853/0146. Lypsyl, Alliance and associated devices are
registered trademarks of Alliance Pharmaceuticals Limited.
LYPSYL
® COLD SORE GEL
TRIPLE ACTION FORMULA
TRIPLE ACTION FORMULA TO RELIEVE THE
DISCOMFORT OF COLD SORES, CONTAINS:
•
Anaesthetic to relieve pain
•
Antiseptic to help prevent bacterial
infection
Astringent to dry up cold sores
•
DIRECTIONS FOR USE: Cutaneous use.
Apply a small amount of Lypsyl
with a clean finger tip at the first
sign of infection and then 3-4 times
a day. Wash hands after use. Do not
exceed stated dose. If symptoms
persist, consult your doctor.
NOT RECOMMENDED FOR CHILDREN
UNDER 12 YEARS.
use and talk to your doctor or
pharmacist. This includes any possible
side effects not listed on this carton.
You can also report side effects directly
via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help
provide more information on the
safety of this medicine.
ACTIVE INGREDIENTS:
Lidocaine Hydrochloride 2.0% w/w,
Zinc Sulfate 1.0% w/w, Cetrimide
0.5% w/w.
ALSO CONTAINS:
Hydroxyethylmethylcellulose 3000,
Polysorbate 20, Nonoxynol 9,
Propylene glycol, Menthol, Purified water.
KEEP OUT OF THE SIGHT AND REACH
OF CHILDREN
Store below 30°C
Date of information July 2016
Use this only on your skin
COLD SORE
GEL
TRIPLE ACTION
FORMULA
LIDOCAINE HYDROCHLORIDE
ZINC SULFATE • CETRIMIDE
RELIEVES THE DISCOMFORT OF COLD SORES
TRIPLE ACTION FORMULA
ANAESTHETIC TO
RELIEVE PAIN
ANTISEPTIC HELPS
PREVENT BACTERIAL INFECTION
ASTRINGENT TO
DRY UP COLD SORES
Alliance Pharmaceuticals Limited 2016.
•
•
•
•
•
DO NOT USE:
If you are allergic to any of the
ingredients or to other local
anaesthetics (of the amide-type).
CAUTION
This product contains pr

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lypsyl Cold Sore Gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lidocaine hydrochloride 2.0% w/w
Zinc sulfate 1.0% w/w
Cetrimide 0.5% w/w
Excipients with known effect:
Each tube contains 0.3g of propylene glycol
For the full list of excipients see section 6.1
3
PHARMACEUTICAL FORM
Gel
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic relief of cold sores.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children over 12 years: Apply a small amount to the
affected area
with your fingertips 3-4 times daily.
Paediatric population
Children under 12 years: Not recommended.
Method of administration: Cutaneous use
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances, anaesthetics of the
amide-type or to
any of the excipients listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only.
Contact with the eyes should be avoided.
Not recommended for children under 12 years.
The excipient propylene glycol may cause skin irritation.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
_ _
No known interactions with other drugs.
4.6
FERTILITY, PREGNANCY AND LACTATION
Pregnancy
The safety of this medicinal product for use in human pregnancy has
not been
established. The product is, therefore, not recommended during
pregnancy.
Breast-feeding
Lidocaine enters the mother’s milk, but in such small quantities
that there is
generally no risk of the child being affected at therapeutic dose
levels.
Fertility
No data on human fertility is available.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.
4.8
UNDESIRABLE EFFECTS
Undesirable effects are listed by MedDRA System Organ Classes.
Assessment of undesirable effects is based on the following frequency
groupings:
Very common:
≥
1/10
Common:
≥
1/100 to <1/10
Uncommon:
≥
1/1,000 to <1/100
Rare:
≥
1/10,000 to <1/1,000
Very rare: <1/10,000
Not known: cannot be estimated from the available data
SYSTEM ORGAN C