Sudafed Chesty Coughs with Decongestant liquid

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Pseudoephedrine hydrochloride; Guaifenesin

Disponível em:

McNeil Products Ltd

Código ATC:

R01BA52

DCI (Denominação Comum Internacional):

Pseudoephedrine hydrochloride; Guaifenesin

Dosagem:

6mg/1ml ; 20mg/1ml

Forma farmacêutica:

Oral solution

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 03090200; GTIN: 5010123667559

Folheto informativo - Bula

■
_Sympathomimetic drugs _(_stimulants _or_ _
_appetite suppressants _and drugs used to
treat CONGESTION and ASTHMA).
■
_Tricyclic antidepressants (_used to treat MOOD
DISORDERS).
If you are not sure about any of the medicines
you are taking, show the bottle or pack to your
pharmacist.
If any of these bullet points apply to you now or in
the past, TALK TO A DOCTOR OR PHARMACIST.
IF YOU ARE PREGNANT OR
BREAST-FEEDING
■
Ask your doctor or pharmacist for advice
before taking this medicine if you are
pregnant or breast-feeding.
SOME OF THE INGREDIENTS CAN CAUSE
PROBLEMS
■
Each 5 ml of this medicine contains 3 g of
sucrose. This may be harmful to your teeth.
This should be taken into account in patients
with diabetes mellitus. If you have been told
by your doctor that you have an intolerance
to some sugars, contact your doctor before
taking this medicine.
■
This medicine contains 5% v/v ethanol
(alcohol), which is up to 190 mg per 5 ml,
equal to 5 ml beer or 2 ml wine per 5 ml.
This can be harmful for those suffering from
alcoholism. The ethanol content should be
taken into account in pregnant or breast-
feeding women, children and high-risk
groups such as patients with
liver disease or epilepsy.
■
Methyl hydroxybenzoate and propyl
hydroxybenzoate may cause allergic
reactions such as skin rash; this may happen
after a few days.
■
The colourings Ponceau 4R (E124) and
Sunset Yellow (E110) in this medicine may
cause allergic reactions.
_Guaifenesin & Pseudoephedrine_
■
This medicine is used to relieve chesty coughs and
help clear the stuffy, blocked up feeling in your
nose and sinuses and reduce catarrh.
■
This medicine is for use by adults and children aged
12 years and over.
■
DO NOT TAKE THIS MEDICINE:
■
There are some people who should not take this
medicine. _To find out if you are one of them_ _see _
_section 2_
c
■
If you have ever had a BAD REACTION to any of the
ingredients. _For the list of ingredients see section 6_
c
■
SPEAK TO YOUR DOCTOR:
■
If you suffer from any of the condition

Características técnicas

OBJECT 1
SUDAFED CHESTY COUGHS WITH
DECONGESTANT LIQUID
Summary of Product Characteristics Updated 11-Jun-2020 | McNeil
Products Ltd
•
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 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
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5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
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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
Sudafed Chesty Coughs with Decongestant Liquid
Benylin MUCUS Cough plus Decongestant Syrup
2. Qualitative and quantitative composition
This product contains 30 mg pseudoephedrine hydrochloride and 100 mg
guaifenesin in each 5 ml.
Each 5ml also contains:
Sucrose
Methyl Hydroxybenzoate (E 218)
Propyl Hydroxybenzoate (E 216)
Ethanol 96 %v/v
Ponceau 4R (E 124)
Sunset Yellow (E110)
For the full list of excipients see section 6.1.
3. Pharmaceutical form
A clear orange-red syrup.
4. Clinical particulars
4.1 Therapeutic indications
This product is indicated for the symptomatic relief of upper
respiratory tract disorders accompanied by
productive cough, which are benefited by the combination of a
decongestant of the mucous membranes of
the upper respiratory tract, especially the nasal mucosa and sinuse