Zirpine 10mg Tablets

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Cetirizine dihydrochloride

Доступно од:

Pinewood Laboratories Ltd,

АТЦ код:

R06AE; R06AE07

INN (Међународно име):

Cetirizine dihydrochloride

Дозирање:

10 milligram(s)

Фармацеутски облик:

Tablet

Тип рецептора:

Product subject to prescription which may be renewed (B)

Терапеутска област:

Piperazine derivatives; cetirizine

Статус ауторизације:

Not marketed

Датум одобрења:

2002-03-08

Информативни летак

PHARMACODE
PHARMACODE
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZIRPINE 10 mg TABLETS
Cetirizine dihydrochloride
24LF01683PD
Read all of this leaflet carefully before you start taking this
medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
What is in this leaflet:
1. What Zirpine 10 mg Tablets are and what they are used for
2. What you need to know before you take Zirpine 10 mg Tablets
3. How to take Zirpine 10 mg Tablets
4. Possible side effects
5. How to store Zirpine 10 mg Tablets
6. Contents of the pack and other information
1. What Zirpine 10 mg Tablets are and what they are used for
Zirpine 10 mg Tablets contain the active ingredient cetirizine
dihydrochloride. This is an antihistamine
used to treat seasonal allergic rhinitis (hay fever) and perennial
rhinitis, and urticaria (hives) in adults
and children over 6 years of age.
Antihistamines like Zirpine relieve the symptoms and discomfort
associated with these conditions,
such as sneezing, an itchy, runny and blocked nose, itchy, red and
watering eyes and itchy skin rashes.
2. What you need to know before you take Zirpine 10 mg Tablets
Do NOT take Zirpine 10 mg Tablets:
• if you have had an allergic reaction to cetirizine or hydroxyzine
or any of the other ingredients listed
in this medicine_ (see Section 6 and end of Section 2)._
• if you have severe kidney problems
Zirpine is not recommended for use in children under 6 years.
Warnings and Precautions
Talk to your doctor before taking Zirpine 10 mg Tablets:
• if you have kidney or liver problems which are not severe
• if you have a hereditary problem of galactose intolerance, Lapp
lactase deficiency or glucose-galactose
malabsorption _(see end

Карактеристике производа

Health Products Regulatory Authority
13 November 2019
CRN009G62
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zirpine 10mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg cetirizine dihydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
White, round, film-coated tablets embossed with AG on one side,
breakline on the reverse.
The tablets can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In adults and paediatric patients 6 year 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
Children aged from 6 to 12 years: 5 mg twice daily (a half tablet
twice daily).
Adults and adolescents over 12 years of age: 10 mg once daily (1
tablet).
The tablets need to be swallowed with a glass of liquid.
Elderly patients: Data do not suggest that the dose needs to be
reduced in elderly subjects provided that the renal function is
normal.
For patients with moderate to severe renal impairment: There are no
data to document efficacy/safety ratio in patients with
renal impairment. Since cetirizine is mainly excreted via the renal
route (see section 5.2), in cases where no alternative
treatment can be used, the dosing intervals must be individualised
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 (CLcr) in ml/min is
needed. The CLcr (ml/min) may be estimated from serum creatinine
(mg/dl) determination using the following formula:
CLcr = [140-age (years)] x weight (kg) (x 0.85 for women)
72 x serum creatinine (mg/dl)
Dosing adjustments for adult patients with impaired renal function GROUP CREATININE CLEARANCE (ML/MIN) POSOLOGY AND FREQUENCY
Normal
≥80
10 mg once daily
Mild
50