Rowasip Cold and Flu with Decongestant 500 mg/12.2 mg powder for oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; Phenylephrine hydrochloride

Available from:

Rowex Ltd

ATC code:

N02BE; N02BE51

INN (International Name):

Paracetamol; Phenylephrine hydrochloride

Dosage:

500 mg/12.2 milligram(s)

Pharmaceutical form:

Powder for oral solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol, combinations excl. psycholeptics

Authorization status:

Not marketed

Authorization date:

2014-12-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROWASIP COLD AND FLU WITH DECONGESTANT 500 MG/12.2 MG POWDER FOR ORAL
SOLUTION
paracetamol/phenylephrine hydrochloride
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 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 3 days.
WHAT IS IN THIS LEAFLET
1.
What Rowasip is and what it is used for
2.
What you need to know before you take Rowasip
3.
How to take Rowasip
4.
Possible side effects
5.
How to store Rowasip
6.
Contents of the pack and other information
1.
WHAT ROWASIP IS AND WHAT IT IS USED FOR
Rowasip contains paracetamol, an analgesic which relieves aches and
reduces fever, and
phenylephrine, a decongestant to relieve a blocked up nose.
Rowasip is used for the relief of the symptoms of colds and influenza,
including the relief of pain,
headache, nasal congestion and lowering of temperature of adults and
adolescents over 16 years of
age.
Use Rowasip only if you have a cold or influenza accompanied by a
stuffy nose. If you do not have a
stuffy nose, monocomponent products containing only paracetamol should
be preferred.
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROWASIP
_ _
DO NOT TAKE ROWASIP:

if you are allergic to paracetamol and phenylephrine hydrochloride or
any of the other ingredients
of this medicine (listed in section 6)

if you have SEVERE CORONARY HEART DISEASE (a condition associated with
impaired function of the
heart)

if you have HIGH BLOOD PRESSURE

if you have GLAUCOMA (a dis

Summary of Product characteristics

Health Products Regulatory Authority
10 November 2019
CRN0098XP
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rowasip Cold and Flu with Decongestant 500 mg/12.2 mg powder for oral
solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 500 mg of paracetamol and 12.2 mg of
phenylephrine hydrochloride corresponding to 10.0 mg of
phenylephrine.
Excipients with known effect:
Each sachet contains 1.83 g of sucrose, 17.5 mg of aspartame (E 951)
and 1 mg of sorbitol (E 420).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder for oral solution
Free flowing white powder with lemon odour
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short term symptomatic treatment of colds and influenza (aches, fever)
when associated with nasal congestion.
Rowasip is indicated in adults and adolescents over 16 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adultsand adolescents over 16 years_
One sachet dissolved in a small cup (125 ml) by stirring in hot water.
The dose may be repeated in 4-6 hours.
No more than four doses should be taken in 24 hours.
_Paediatric Population_
Children under 16 years of age:
Rowasip is not recommended for use in children below the age of 16
years without medical advice.
_Hepatic impairment_
In patients with impaired hepatic function or Gilbert's syndrome, the
dose must be reduced or the dosing interval prolonged.
_Renal impairment_
In case of severe renal insufficiency (creatinine clearance < 10
ml/min) the dosing interval should be at least 8 hours.
_Elderly:_
There is no indication that dose needs to be modified in the elderly.
Medical supervision is recommended if symptoms are not relieved or
deteriorate within 3 days of therapy with Rowasip.
Method of Administration
Oral administration after dissolution in water.
4.3 CONTRAINDICATIONS
Health Products Regulatory Authority
10 November 2019
CRN0098XP
Page 2 of 7
• Hypersensitivity to the active substances or to any of the
excipients listed in section 6.1