Rowasip Max Strength Cold and Flu with Decongestant 1000 mg/12.2 mg powder for oral solution

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Phenylephrine hydrochloride; Paracetamol

Sẵn có từ:

Rowex Ltd

Mã ATC:

N02BE; N02BE51

INN (Tên quốc tế):

Phenylephrine hydrochloride; Paracetamol

Liều dùng:

1000 mg/12.2 milligram(s)

Dạng dược phẩm:

Powder for oral solution

Loại thuốc theo toa:

Product not subject to medical prescription

Khu trị liệu:

Anilides; paracetamol, combinations excl. psycholeptics

Tình trạng ủy quyền:

Not marketed

Ngày ủy quyền:

2014-12-12

Tờ rơi thông tin

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROWASIP MAX STRENGTH COLD AND FLU WITH DECONGESTANT 1000 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 Max is and what it is used for
2.
What you need to know before you take Rowasip Max
3.
How to take Rowasip Max
4.
Possible side effects
5.
How to store Rowasip Max
6.
Contents of the pack and other information
1.
WHAT ROWASIP MAX IS AND WHAT IT IS USED FOR
Rowasip Max contains paracetamol, an analgesic which relieves aches
and reduces fever, and
phenylephrine, a decongestant to relieve a blocked up nose.
Rowasip Max 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 who weigh more than 50 kg.
Use Rowasip Max 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 MAX
_ _
DO NOT TAKE ROWASIP MAX:

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 o

Đặc tính sản phẩm

Health Products Regulatory Authority
10 November 2019
CRN0098XP
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rowasip Max Strength Cold and Flu with Decongestant 1000 mg/12.2 mg
powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 1000 mg of paracetamol and 12.2 mg of
phenylephrine hydrochloride corresponding to 10.0 mg of
phenylephrine.
_ _
Excipients with known effect:
Each sachet contains 3.8 g of sucrose, 35 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 Max is indicated in adults and adolescents over 16 years of
age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents over 16 years of age who weigh more than 50
kg_
One sachet dissolved in a mug (250 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 Max 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 Max.
Method of Administration
Oral administration after dissolution in water.
4.3 CONTRAINDICATIONS
• Hypersensitivity to the active substances or to any of the
excipients listed in section 6.1
• Severe coronary