Strepsils Strawberry lozenges sugar free

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
28-04-2023
Tabia za bidhaa Tabia za bidhaa (SPC)
28-04-2023

Viambatanisho vya kazi:

Amylmetacresol; Dichlorobenzyl alcohol

Inapatikana kutoka:

Reckitt Benckiser Healthcare (UK) Ltd

ATC kanuni:

R02AA03

INN (Jina la Kimataifa):

Amylmetacresol; Dichlorobenzyl alcohol

Kipimo:

600microgram ; 1.2mg

Dawa fomu:

Lozenge

Njia ya uendeshaji:

Oromucosal

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 12030300; GTIN: 5000158101364

Taarifa za kipeperushi

                                CUSTOMER INFO:
Minimum Point Size =
9.00pt
TR2252026
D
0000000
PACKAGE LEAFLET: INFORMATION FOR THE USER
STREPSILS STRAWBERRY SUGAR FREE LOZENGES
2,4-DICHLOROBENZYL ALCOHOL
AMYLMETACRESOL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
THIS MEDICINE IS AVAILABLE WITHOUT PRESCRIPTION. HOWEVER, YOU STILL
NEED TO TAKE STREPSILS
STRAWBERRY SUGAR FREE LOZENGES CAREFULLY TO GET THE BEST RESULTS FROM
IT. STREPSILS STRAWBERRY
SUGAR FREE LOZENGES WILL BE REFERRED TO AS THIS MEDICINE THROUGHOUT
THIS LEAFLET.
• 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 PHARMACIST. THIS
INCLUDES ANY POSSIBLE SIDE EFFECTS
NOT LISTED IN THE 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 THIS MEDICINE IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS MEDICINE
3. HOW TO TAKE THIS MEDICINE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE THIS MEDICINE
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
THIS MEDICINE CONTAINS TWO ANTISEPTIC INGREDIENTS FOR USE IN THROAT
MEDICATIONS. THESE ARE
USED FOR THE SYMPTOMATIC RELIEF OF MOUTH AND THROAT INFECTIONS. THESE
INGREDIENTS ARE BOTH
MILD ANTISEPTICS WHICH KILL THE BACTERIA ASSOCIATED WITH MOUTH AND
THROAT INFECTIONS. THE
ACTION OF SUCKING THE LOZENGE ALLOWS THE ACTIVE INGREDIENTS TO WORK IN
THE AREA OF THE
DISCOMFORT AND ALSO HELPS LUBRICATE AND SOOTHE THE PAINFUL AREA. THIS
HELPS RELIEVE THE
SORENESS AND DISCOMFORT OF MOUTH AND THROAT INFECTIONS.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS MEDICINE
THIS MEDICINE IS RECOMMENDED FOR ADULTS, CHILDREN (OVER 6 YEARS OLD)
AND THE ELDERLY.
CHILDREN UNDER 6 YEARS OLD SHOULD NOT USE THIS MEDICINE.
DO NOT TAKE THIS MEDICINE IF YOU:
• ARE ALLERGIC (HYPERSENSITIVE) TO 2,4-DICHLOROBENZYL ALCOHOL,
AMYLMETACRE
                                
                                Soma hati kamili
                                
                            

Tabia za bidhaa

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Strepsils Strawberry Sugar Free Lozenges
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients
Amylmetacresol 0.6mg/lozenge
2,4-Dichlorobenzyl alcohol 1.2mg/lozenge
Excipient(s) with known effect:
Propylene glycol (present in strawberry flavour)
Fragrance containing allergens – Benzyl Alcohol (present in
strawberry flavour)
Isomalt
Maltitol syrup
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Lozenge
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As an antiseptic for the relief of sore throat and its associated
pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Use the lowest dose for the shortest duration necessary to relieve
symptoms.
ADULTS:
One lozenge every 2-3 hours up to a maximum of
12 lozenges in 24 hours.
ELDERLY:
There is no need for dosage reduction in the elderly
CHILDREN OVER 6 YEARS OLD:
As above for adults.
CHILDREN UNDER 6 YEARS OLD:
Not suitable for children under 6 years (see section 4.4).
METHOD OF ADMINISTRATION
For oral administration. To be dissolved slowly in the mouth.
4.3
CONTRAINDICATIONS
Strepsils Strawberry Sugar Free Lozenges are contraindicated in
persons who
have previously shown hypersensitivity to any of the ingredients.
The product contains a small amount of butylated hydroxyanisole (BHA;
E320)
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Not to be given to children under 6 years.
If symptoms persist have not improved, or have worsened after 3 days,
or if
symptoms persist or are accompanied by a high fever or headache,
consult a doctor or
health care professional.
IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF THIS MEDICINE:
•
Contains isomalt and maltitol syrup, which may have a mild laxative
effect if
several are taken a day. Patients with rare hereditary problems of
fructose
intolerance should not take this medicine.
•
This medicine contains 7.30 mg propylene glycol (present in strawberry
flavour) in each lozenge.
•
This medicine contains fragrance Benzy
                                
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