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

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Guaiphenesin; PSEUDOEPHEDRINE HYDROCHLORIDE

Sẵn có từ:

Haleon Ireland Limited

Mã ATC:

R01BA; R01BA52

INN (Tên quốc tế):

Guaiphenesin; PSEUDOEPHEDRINE HYDROCHLORIDE

Liều dùng:

100 mg/5ml/30 mg/5ml

Dạng dược phẩm:

Oral solution

Khu trị liệu:

Sympathomimetics; pseudoephedrine, combinations

Tình trạng ủy quyền:

Marketed

Ngày ủy quyền:

1985-07-29

Tờ rơi thông tin

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROBITUSSIN PLUS ORAL SOLUTION
guaifenesin 100mg/5ml pseudoephedrine
hydrochloride 30mg/5ml
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take 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 5 days.
IN THIS LEAFLET:
1. What ROBITUSSIN PLUS is and what it is used for
2. What you need to know before you take
ROBITUSSIN PLUS
3. How to take ROBITUSSIN PLUS
4. Possible side effects
5. How to store ROBITUSSIN PLUS
6. Contents of the pack and other 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROBITUSSIN PLUS
Do not use in combination with any other medication unless your
pharmacist 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 medicines for the relief of colds and flu,
congestion or blocked nose,
stimulant drugs called amphetamines (sometimes used to treat attention
deficit disorders),
appetite su

Đặc tính sản phẩm

Health Products Regulatory Authority
15 February 2024
CRN00DJ04
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 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 with known effect
Each 5ml contains;
Ethanol (96%)
114.9 mg
Sodium
13.76 mg
Amaranth (E123)
0.033 mg
Liquid Maltitol (E965)
242 mg
Sorbitol Solution 70% (E420)
1.454 g
Propylene glycol (E1520)
7.59 mg
Sodium benzoate (E211)
6.0 mg
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
Posology
ADULTS (INCLUDINGELDERLY) AND CHILDRENOVER12YEARS:
10 ml x 3 daily (this dose is not to be exceeded)
At least 4 hours should elapse between two doses.
This medicine is not to be used with other nasal decongestants or
expectorants. The treatment duration should not exceed 5
days without medical advice.
The maximum daily dose is 30 ml in any 24 hours (pseudoephedrine
hydrochloride 240 mg, guaifenesin 800 mg).
_PAEDIATRIC POPULATION_
Health Products Regulatory Authority
15 February 2024
CRN00DJ04
Page 2 of 8
This medicine should not be used in children under 12 years.
_ELDERLY_
Caution is advised in patients over the age of 60 years. Patients in
this age group are at greater risk of adverse reactions due to
decreased renal function (see Section 4.4).
_RENAL IMPAIRMENT_
Do not use in patients with severe renal impairment (GFR <30 ml/min)
(see Section
4.3 and 4.4).
_HEPATIC IMPAIRMENT_
Pseudoephedrine should be used cautiously in patients with severe
hepatic impairment.
Method of administration
Take orally.
4.3 CONTRAINDICATIONS
This medicine should not be given to children below 12 years of age
(see
Section 4.2)