Muntel 5 mg Film-coated Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
28-06-2019
Summary of Product characteristics
(SPC)
06-11-2019
Active ingredient:
Levocetirizine dihydrochloride
Available from:
UCB (Pharma) Ireland Limited
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:
Not marketed
Authorization date:
2004-07-02
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MUNTEL 5 MG FILM-COATED TABLETS
For adults and children aged 6 years and above
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 Muntel is and what it is used for
2.
What you need to know before you take Muntel
3.
How to take Muntel
4.
Possible side effects
5.
How to store Muntel
6.
Contents of the pack and other information
1.
WHAT MUNTEL IS AND WHAT IT IS USED FOR
Levocetirizine dihydrochloride is the active ingredient of Muntel.
Muntel is an antiallergic medication.
For the treatment of signs of illness (symptoms) associated with:
allergic rhinitis (including persistent allergic rhinitis);
nettle rash (urticaria).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MUNTEL
DO NOT TAKE MUNTEL
if you are allergic to levocetirizine dihydrochloride, to cetirizine,
to hydroxyzine or any of the other
ingredients of this medicine (listed in section 6)
if you have a severe impairment of kidney function (severe renal
failure with creatinine clearance
below 10 ml/min).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Muntel.
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.
CHILDREN
The use of Muntel is not recommended in children less than 6 years
since the film-coated tablets do
not allow for dose adaptation.
OTHER MEDICINES AND MUNTEL
Tell your doctor or pharmacist if you are taking, have recently taken
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
05 November 2019
CRN009FRG
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Muntel 5 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg levocetirizine dihydrochloride.
Excipient with known effect:
63.50 mg lactose monohydrate/tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, oval, film-coated tablet with a Y logo on one
side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Muntel is indicated in the symptomatic treatment of allergic rhinitis
(including persistent allergic rhinitis) and urticaria in adults
and children aged 6 years and above.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and adolescents 12 years and above:
The daily recommended dose is 5 mg (1 film-coated tablet).
_Elderly_
Adjustment of the dose is recommended in elderly patients with
moderate to severe renal impairment (see Renal impairment
below).
_Renal impairment_
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 patients with impaired renal function:
Group
Creatinine clearance (ml/min)
Dosage and frequency
Normal
≥ 80
1 tablet once daily
Mild
50 – 79
1 tablet once daily
Moderate
30 – 49
1 tablet once every 2 days
Severe
< 30
1 tablet once every 3 days
End-stage renal disease -
Patients undergoing dialysis
< 10
Contra-indicated
Health Products Regulatory Authority
05 November 2019
CRN009FRG
Page 2 of 9
In paediatric patients suffering from renal impairment, the dose will
have to be adjusted on an individual basis taking into
account the renal clearance of the patient and his body weight. There
are no specific data for chi
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