Strepsils Intensive 8.75 mg Lozenges

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Flurbiprofen

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

R02AX; R02AX01

INN (International Name):

Flurbiprofen

Dosage:

8.75 milligram(s)

Pharmaceutical form:

Lozenge

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other throat preparations; flurbiprofen

Authorization status:

Marketed

Authorization date:

2003-03-07

Patient Information leaflet

STREPSILS INTENSIVE 8.75MG LOZENGES
FLURBIPROFEN
PATIENT INFORMATION LEAFLET
Please read all of this leaflet carefully before you start using this
medicine because it contains
important information for you.
•
Always use this medicine exactly as described in this leaflet or as
your doctor or
pharmacist has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
•
You must talk to a doctor if you do not feel better, or if you feel
worse, after 3 days.
WHAT IS IN THIS LEAFLET:-
1.
What Strepsils Intensive Lozenges are and what they are used for
2.
What you need to know before you use Strepsils Intensive Lozenges
3.
How to use Strepsils Intensive Lozenges
4.
Possible side effects
5.
How to store Strepsils Intensive Lozenges
6.
Contents of the pack and other information
1.
WHAT STREPSILS INTENSIVE LOZENGES ARE AND WHAT THEY ARE USED
FOR?
The ingredient which makes this medicine work is called flurbiprofen.
Flurbiprofen belongs to a
group of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs), which help reduce
inflammation (swelling) and pain.
Strepsils Intensive Lozenges are for use in adults and children over
12 years of age to help
relieve the symptoms of sore throats, such as soreness, pain and
swelling.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE STREPSILS INTENSIVE
LOZENGES
DO NOT TAKE THESE LOZENGES IF YOU:
•
Have or have ever had a
STOMACH ULCER
•
Are
ALLERGIC
to flurbiprofen, aspirin or other NSAIDs or any of the other
ingredients (see
Section 6)
•
Have previously experienced
GASTROINTESTINAL BLEEDING OR PERFORATION
whilst taking
NSAIDS
•
Have ever had
BLOOD CLOTTING PROBLEMS OR BLEEDING PROBLEMS
after taking NSAIDs
•
Have ever had
WHEEZING, A RUNNY NOSE OR AN ITCHY RASH
(hives) after taking aspirin,
flurbiprofen or medicines containing NSAIDs
•
Are
UNDER 12 YEARS
ol

Summary of Product characteristics

Health Products Regulatory Authority
15 February 2021
CRN009Z4N
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Strepsils Intensive 8.75 mg Lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient flurbiprofen 8.75mg
Excipients with known effects:
Glucose 1.069 g / lozenge. Total maximum daily dose (MDD) is 5.345 g.
Sucrose 1.407 g / lozenge. Total MDD is 7.035 g.
Invert Sugar (Honey) 50.3 mg / lozenge. Total MDD is 0.2515 g.
Sulphites – Sulphur Dioxide (E220) 0.137 ppm / lozenge which is
present in liquid glucose.
Wheat Starch (containing gluten), one lozenge contains no more than
21.38 micrograms of gluten which is present in liquid
glucose.
Butylated hydroxyanisole (E320) present in Lemon flavour (0-1%).
Lemon flavour containing allergens (citral, citronellol, d-Limonene,
farnesol, geraniol and linalool).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lozenge
Clear, round lozenge
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of sore throats.
Strepsils Intensive Lozenges are indicated in adults and adolescents
over 12 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
Treatment should be administered for the shortest duration necessary
to control symptoms. It is recommended that this
product should be used for a maximum of three days.
ADULTS: One lozenge sucked/dissolved slowly in the mouth every 3 – 6
hours as required. Maximum 5 lozenges in any 24 hour
period.
PAEDIATRIC POPULATION:
ADOLESCENTS OVER THE AGE OF 12 YEARS: As above for adults
CHILDREN: Not indicated for children under 12 years. (see section
4.3).
ELDERLY: No dose modification is required.
The elderly are at increased risk of the serious consequences of
adverse reactions to NSAIDs (see section 4.4).
HEPATIC IMPAIRMENT: In patients with mild to moderate hepatic
impairment, no dose reduction is required. In patients with
severe hepatic insufficiency flurbiprofen is contraindicated (see
section 4.3).
RENAL IMPAIRMENT: In patients wit