Boots Anaesthetic and Antibiotic throat lozenges

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

Compra'l ara

Fitxa tècnica Fitxa tècnica (SPC)
01-07-2016

ingredients actius:

Tyrothricin; Benzocaine

Disponible des:

The Boots Company Plc

Codi ATC:

n/a

Designació comuna internacional (DCI):

Tyrothricin; Benzocaine

Dosis:

1mg ; 5mg

formulario farmacéutico:

Lozenge

Vía de administración:

Oromucosal

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 12030300

Informació per a l'usuari

                                PATIENT INFORMATION LEAFLET
Anaesthetic & Antibiotic Throat Lozenges
(Tyrothricin, Benzocaine)
READ ALL OF THIS CARTON FOR FULL INSTRUCTIONS.
WHAT THIS MEDICINE IS FOR
This medicine contains an antibiotic and a local anaesthetic which act
to fight infection and
numb pain. It can be used to relieve sore throats.
BEFORE YOU TAKE THIS MEDICINE
X DO NOT TAKE:

IF YOU ARE ALLERGIC to any of the ingredients

IF YOU ARE ALLERGIC to other local anaesthetics

IF YOU HAVE METHAEMOGLOBINAEMIA (rare blood disorder)

IF YOU HAVE AN INTOLERANCE TO SOME SUGARS, unless your doctor tells
you to (this medicine
contains sucrose)

IF YOU ARE PREGNANT OR BREASTFEEDING
! TALK TO YOUR PHARMACIST OR DOCTOR:

If you have myasthenia gravis – a disease of the immune system which
causes muscle
weakness and tiredness

If you have low levels of an enzyme called cholinesterase in your
blood

If you take other medicines – sulphonamide antibiotics (e.g.
sulphadiazine),
anticholinesterases (e.g. neostigmine)
INFORMATION ABOUT SOME OF THE INGREDIENTS: Each lozenge contains 961
mg of sucrose.
This should be taken into account if you have diabetes.
 HOW TO TAKE THIS MEDICINE
Check the foil is not broken before use. If it is, do not take that
lozenge.
AGE
HOW MANY TO TAKE
HOW OFTEN TO TAKE
Adults and children of 12
years and over
One lozenge
When you need to. DON’T
TAKE MORE THAN 8 lozenges
in any 24 hours.
Suck each lozenge slowly until it dissolves.
Do not give to children under 12 years.
If symptoms do not go away talk to your doctor.
WARNING: Do not exceed the stated dose
! IF YOU TAKE TOO MANY LOZENGES: Talk to a doctor straight away. Take
your medicine with
you.
POSSIBLE SIDE EFFECTS
Most people will not have problems, but some may get some.
! IF YOU GET ANY OF THESE SERIOUS SIDE EFFECTS, STOP TAKING THE
LOZENGES. SEE A DOCTOR AT
ONCE:

Difficulty in breathing, swelling of the face, neck, tongue or throat
(severe allergic reactions)

Very rarely blue lips, greyish skin, difficulties breathing, dizziness
(m
                                
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Fitxa tècnica

                                OBJECT 1
BOOTS ANAESTHETIC AND ANTIBIOTIC
THROAT LOZENGES
Summary of Product Characteristics Updated 01-Aug-2016 | THE BOOTS
COMPANY PLC
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Boots Anaesthetic & Antibiotic Throat Lozenges
2. Qualitative and quantitative composition
Active ingredient
Tyrothricin
1.0 mg/lozenge
Benzocaine
5.0 mg/lozenge
3. Pharmaceutical form
Tablet
4. Clinical particulars
4.1 Therapeutic indications
For the relief of sore throats.
For oral administration.
4.2 Posology and method of administration
Adults and children over 12 years: one lozenge to be sucked slowly as
required. Not more than eight
lozenges to be taken in any one day.
Children under 12 years: not suitable for children under 12 years.
Elderly: The normal adult dose is still appropriate in the elderly.
4.3 Contraindications
Hypersensitivity to ester type local anaesthetics or the antibiotic
tyrothricin, or any of the other
ingredients.
Hereditary methaemoglobinaemia.
4.4 Special warnings and pre
                                
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