Anti-Hist Allergy 1mg/ml Oral Solution

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Cetrizine dihydrochloride

제공처:

Clonmel Healthcare Ltd

ATC 코드:

R06AE; R06AE07

INN (국제 이름):

Cetrizine dihydrochloride

복용량:

1 milligram(s)/millilitre

약제 형태:

Oral solution

처방전 유형:

Product not subject to medical prescription

치료 영역:

Piperazine derivatives; cetirizine

승인 상태:

Marketed

승인 날짜:

2015-05-29

환자 정보 전단

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ANTI-HIST ALLERGY 1MG/ML ORAL SOLUTION
Cetirizine dihydrochloride
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 after 3 days.
WHAT IS IN THIS LEAFLET:
1.
What Anti-Hist Allergy oral solution is and what it is used for
2.
What you need to know before you take Anti-Hist Allergy oral solution
3.
How to take Anti-Hist Allergy oral solution
4.
Possible side effects
5.
How to store Anti-Hist Allergy oral solution
6.
Contents of the pack and other information.
1.
WHAT ANTI-HIST ALLERGY ORAL SOLUTION IS AND WHAT IT IS USED FOR
Cetirizine, the active ingredient of the solution is an antihistamine.
It blocks the effects of a substance
called histamine which occurs naturally in the body. Histamine is
involved in allergic reactions.
Anti-Hist Allergy oral solution is used to treat adults and paediatric
patients aged 2 years and over who
have hay fever (seasonal allergic rhinitis), year round allergies such
as dust or pet allergies (perennial
allergic rhinitis) and urticaria (swelling, redness and itchiness of
the skin).
Antihistamines like Anti-Hist Allergy oral solution relieve the
unpleasant symptoms and discomfort
associated with these conditions, such as sneezing, irritated, runny
and blocked up nose, itchy, red and
watering eyes and skin rashes.
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 ANTI-HIST ALLERGY ORAL SOLUTION
DO NOT TAKE ANTI-HIST ALLERGY ORAL SOLUT

제품 특성 요약

Health Products Regulatory Authority
18 February 2020
CRN009GSY
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anti-Hist Allergy 1mg/ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution contains 1mg cetirizine dihydrochloride
Excipients with known effect:

one mL of solution contains 500 mg sorbitol (solution at 70 %, non
crystallizing)

one mL of solution contains 2 mg methyl parahydroxybenzoate

one mL of solution contains 0.20 mg propyl parahydroxybenzoate

one mL of solution contains 0.11 mg of sodium.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral solution.
Clear, colourless, flavoured solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In adults and paediatric patients 2 years and above:
- Cetirizine is indicated for the relief of nasal and ocular symptoms
of seasonal and perennial allergic rhinitis.
- Cetirizine is indicated for the relief of symptoms of chronic
idiopathic urticaria.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Children aged from 2 to 6 years: 2.5 mg twice daily (2.5 ml oral
solution twice daily (a half spoon twice daily)).
Children aged from 6 to 12 years: 5 mg twice daily (5 ml oral solution
bid (a full spoon twice daily)).
Adults and adolescents over 12 years of age: 10 mg once daily (10 ml
oral solution (2 full spoons)).
Elderly: data do not suggest that the dose needs to be reduced in
elderly subjects provided that the renal function is normal.
_Patients with moderate to severe renal impairment:_ There are no data
to document the efficacy/safety ratio in patients with
renal impairment. Since cetirizine is mainly eliminated via renal
route (see section 5.2), in cases no alternative treatment can be
used, the dosing intervals must be individualized according to renal
function. Refer to the following table and adjust the dose
as indicated. To use this dosing table, an estimate of the patient's
creatinine clearance (CL
cr
) in mL/min is needed. The
CL
cr
(mL/min) may be estima