Robitussin Plus Oral Solution;Guaifenesin 100mg/5ml;Pseudoephedrine HCI 30mg/5ml

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

العنصر النشط:

GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE

متاح من:

Pfizer Healthcare Ireland 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland

ATC رمز:

R05CA10

INN (الاسم الدولي):

GUAIFENESIN 20 mg/ml PSEUDOEPHEDRINE HYDROCHLORIDE 6 mg/ml

الشكل الصيدلاني:

ORAL SOLUTION

تركيب:

GUAIFENESIN 20 mg/ml PSEUDOEPHEDRINE HYDROCHLORIDE 6 mg/ml

نوع الوصفة الطبية :

OTC

المجال العلاجي:

COUGH AND COLD PREPARATIONS

الوضع إذن:

Withdrawn

تاريخ الترخيص:

2007-08-20

نشرة المعلومات

PLUS ORAL SOLUTION
GUAIFENESIN 100 MG/5ML
PSEUDOEPHEDRINE HYDROCHLORIDE 30 MG/5ML
PAA111359
Read all of this leaflet carefully because it contains important
information for you.
This medicine is available without prescription. However, you still
need to use Robitussin Plus
carefully to get the best results from it.
•
Keep this leaflet. You may need to read it again.
•
Ask your doctor or pharmacist if you need more information or advice.
•
If any of the side effects get serious, or if you notice any side
effect not listed in this
leaflet, please tell your doctor or pharmacist.
•
You must contact a doctor or pharmacist if symptoms persist.
In this leaflet:
1
What Robitussin Plus is and what it is used for
2
Before you take Robitussin Plus
3
How to take Robitussin Plus
4
Possible side effects
5
How to store Robitussin Plus
6
Further information
1
What Robitussin Plus is and what it is used for
Robitussin Plus contains the active ingredients guaifenesin and
pseudoephedrine
hydrochloride. Guaifenesin belongs to a group of medicines called
cough expectorants and
works by changing an unproductive cough to a cough that is more
productive and less frequent.
Pseudoephedrine hydrochloride belongs to a group of medicines called
nasal decongestants
and helps clear nasal congestion (a blocked or stuffy nose).
2
Before you take Robitussin Plus
•
Do not use in combination with any other medication unless your doctor
approves it.
Do not take this medicine if:
•
You are allergic (hypersensitive) to guaifenesin or pseudoephedrine
hydrochloride or any
of the other ingredients of Robitussin Plus.
•
You are taking a monoamine oxidase inhibitor (MAOI) or have done so in
the last 14 days.
•
You are taking other medicine for depression (e.g. tricyclic
antidepressants).
•
You are taking sympathomimetics (medicines used to treat nasal
congestion that also
contain for example pseudoephedrine, phenylephrine or
phenylpropanolamine).
•
You are taking cardiac glycosides (e.g. digoxin).
•
You are taking any medicine for hea

خصائص المنتج

RESTRICTED
Pfizer Consumer Healthcare
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Robitussin Plus Oral Solution
_Guaifenesin 100 mg/5ml _
_Pseudoephedrine HCl 30 mg/5ml _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of liquid contains:
Guaifenesin
100 mg
Pseudoephedrine HCl
30 mg
Excipients:
Each 5ml contains;
Ethanol (96%)
107 mg
Sodium
12.6 mg
Amaranth
0.033 mg
Liquid Maltitol
242 mg
Sorbitol Solution 70%
1.454 g
For a full list of excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
A clear, pale pink-coloured liquid with a cherry flavour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fixed combination of sympathomimetic and expectorant for use as a
nasal
decongestant and expectorant.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Taken orally.
ADULTS AND CHILDREN OVER 12 YEARS:
10 ml x 3 daily
CHILDREN UNDER 12:
Do not use
4.3.
CONTRAINDICATIONS
Use in children under 12 years of age.
Hypersensitivity to the active substance or to any of the excipients.
Persons with hypertension, acute ischaemic heart disease, glaucoma,
thyrotoxicosis or urinary retention, should use this product only as
directed by
a doctor
RESTRICTED
Pfizer Consumer Healthcare
Patients currently receiving, or who have received within two weeks,
monoamine oxidase inhibitors
Patients receiving other sympathominetic agents or tricyclic
antidepressants
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution should be exercised in patients with:
- High blood pressure, heart disease, diabetes, thyroid disease, or
trouble
urinating due to enlarged prostate gland.
-A chronic cough as occurs with smoking or chronic lung disease such
as
asthma or emphysema.
Severe Skin reactions
Severe skin reaction such as acute generalized exanthematous
pustulosis
(AGEP) may occur with pseudoephedrine-containing products. This acute
pustular eruption may occur within the first 2 days of treatment, with
fever,
and numerous, small, mostly non-follicular pustules arising on a
widespread
oedematous erythema and mainly localized on the skin folds, trunk, and
uppe