Rinozal 5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levocetirizine dihydrochloride

Available from:

Clonmel Healthcare Ltd

ATC code:

R06AE; R06AE09

INN (International Name):

Levocetirizine dihydrochloride

Dosage:

5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Piperazine derivatives; levocetirizine

Authorization status:

Marketed

Authorization date:

2009-10-09

Patient Information leaflet

Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
RINOZAL 5MG FILM-COATED TABLETS
Levocetirizine dihydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

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 only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

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.
WHAT IS IN THIS LEAFLET
1. What Rinozal 5 mg is and what it is used for
2. What you need to know before you take Rinozal 5 mg
3. How to take Rinozal 5 mg
4. Possible side effects
5. How to store Rinozal 5 mg
6. Contents of the pack and other information
1. WHAT RINOZAL 5 MG IS AND WHAT IT IS USED FOR
The active substance of Rinozal 5 mg is levocetirizine
dihydrochloride, which is an anti allergic agent.
It is used to treat symptoms associated with allergic conditions, such
as:

chronic nettle rash
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RINOZAL 5 MG
DO NOT TAKE RINOZAL 5 MG

If you are allergic to levocetirizine, any other related substance, or
any of the other ingredients of
this medicine (listed in section 6).

If you suffer from severe kidney failure (less than 10 ml/min
creatinine clearance).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Rinozal 5 mg.

If you are likely to be unable to empty your bladder (with conditions
such as spinal cord injury or
enlarged prostate), please ask your doctor for advice.

If you suffer from epilepsy or are at risk of convulsions, please ask
your doctor for advice as use
of Levocetirizine dihydrochloride 5 mg may cause seizure aggravation.

If you are scheduled for allergy testing, ask your doctor if you
should stop taking Levocetirizine
dihydrochloride 5 mg for several days b

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rinozal 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg levocetirizine dihydrochloride
(equivalent to 4.2 mg of levocetirizine).
Excipient with known effect
Each film-coated tablet contains 64.0 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, oval, biconvex film-coated tablets, debossed with
‘L9CZ’ on one side and ‘5’ on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Levocetirizine is indicated for:
the relief of symptoms of chronic idiopathic urticaria.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents 12 years and above_
The daily recommended dose is 5 mg (one film-coated tablet) once
daily.
_Elderly_
For the time being, there is no data to suggest that the dose needs to
be reduced in elderly patients provided that the
renal function is normal.
_Renal impairment_
There are no data to document the efficacy/safety ratio in patients
with renal impairment. Since levocetirizine is mainly
excreted via renal route (see section 5.2), in cases 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:
Dosing adjustments for adult patients with impaired renal function:
Group
Creatinine clearance
(ml/min)
Dosage and frequency
Normal
80
One tablet daily
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