Non-Drowsy Sudafed Decongestant 30mg/5ml Syrup

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PSEUDOEPHEDRINE HYDROCHLORIDE

Available from:

Johnson & Johnson (Ireland) Limited

ATC code:

R01BA; R01BA02

INN (International Name):

PSEUDOEPHEDRINE HYDROCHLORIDE

Dosage:

30 mg/5ml

Pharmaceutical form:

Syrup

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Sympathomimetics; pseudoephedrine

Authorization status:

Marketed

Authorization date:

1994-04-01

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or
as your doctor or pharmacist have 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 after 5 days.
WHAT IS IN THIS LEAFLET
1. What Non-Drowsy Sudafed Decongestant Syrup is and
what it is used for
2. What you need to know before you use Non-Drowsy
Sudafed Decongestant Syrup
3. How to use Non-Drowsy Sudafed Decongestant Syrup
4. Possible side-effects
5. How to store Non-Drowsy Sudafed Decongestant Syrup
6. Contents of the pack and other information
1 WHAT NON-DROWSY SUDAFED DECONGESTANT SYRUP
IS AND WHAT IT IS USED FOR
Non-Drowsy Sudafed Decongestant Syrup is used to provide
relief from the symptoms of colds and flus including nasal
congestion and blocked sinuses. It can also provide relief from
nasal congestion when this is due to hay fever and similar
allergic conditions. The syrup contains pseudoephedrine
hydrochloride, which is a decongestant that relieves nasal and
sinus congestion.
This medicine is for use in adults and children aged 6 years
and over.
2 WHAT YOU NEED TO KNOW BEFORE YOU USE NON-
DROWSY SUDAFED DECONGESTANT SYRUP
This medicine is suitable for most people but a few people
should not use it. If you are in any doubt, talk to your doctor
or pharmacist.
X DO NOT USE NON-DROWSY SUDAFED DECONGESTANT SYRUP…
■ If you have ever had a
BAD REACTION (ALLERGIC REACTION)
to any of the ingredients
_(listed in section 6_
).
■ If you have
SEVERE KIDNEY PROBLEMS
.
■ If you have
DIABETES
.
■ If you have a
PHEOCHROMOCYTOMA
(rare tumour which
affects your heart rate and blood pressure).
■ If you have an
OVERACTIVE THYROID GLA

Summary of Product characteristics

Health Products Regulatory Authority
24 February 2021
CRN009ZKD
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Non-Drowsy Sudafed Decongestant 30mg/5ml Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of this medicine contains 30.0 mg Pseudoephedrine
Hydrochloride
Excipient(s) with known effect: Each 5 ml contains:
Sucrose 3.5g
Methyl parahydroxybenzoate (E218) 5mg
Ponceau 4 R (E124) 1.5mg
Propylene glycol (E1520) 3.73mg
Sodium Benzoate 5mg
Benzyl alcohol 0.00007mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Syrup.
A clear, red liquid with a characteristic raspberry odour and taste.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicine is a decongestant of the mucous membranes of the upper
respiratory tract, especially the nasal mucosa and
sinuses and is indicated for the symptomatic relief of nasal
congestion in conditions such as allergic rhinitis, vasomotor
rhinitis,
the common cold and influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
ADULTS AND CHILDREN AGED 12 YEARS AND OVER
10 ml syrup every 4-6 hours, up to four times a day.
Maximum daily dose: 40 ml (240 mg pseudoephedrine).
CHILDREN 6-12 YEARS
5 ml syrup every 4-6 hours, up to four times a day.
Maximum daily dose: 20ml. (120 mg pseudoephedrine).
A pharmacist or other healthcare professional should be consulted
before use in children aged 6 to 12 years.
Use only when simple measures have failed to provide adequate relief.
CHILDREN UNDER 6 YEARS
This medicine is contraindicated in children under the age of 6 years
[See Section 4.3].
USE IN THE ELDERLY
There have been no specific studies of this medicine in the elderly.
Experience has indicated that normal adult dosage is
appropriate.
HEPATIC DYSFUNCTION
Caution should be exercised when administering this medicine to
patients with severe hepatic impairment.
Health Products Regulatory Authority
24 February 2021
CRN009ZKD
Page 2 of 8
RENAL DYSFUNCTION
Caution should be exercised when administering this medicine to
patie