Cetirizine 10mg tablets

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Cetirizine hydrochloride

Mevcut itibaren:

Dexcel-Pharma Ltd

ATC kodu:

R06AE07

INN (International Adı):

Cetirizine hydrochloride

Doz:

10mg

Farmasötik formu:

Oral tablet

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 03040100; GTIN: 5033847000525

Bilgilendirme broşürü

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
This medicine is available without prescription. However, you
still need to use Cetirizine Hayfever and Allergy Relief 10 mg
Tablets carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- You must contact a doctor if your symptoms worsen or do not
improve after 3 days.
- 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 Cetirizine Hayfever and Allergy Relief 10 mg Tablets
are and what they are used for
2. What you need to know before you take Cetirizine Hayfever
and Allergy Relief 10 mg Tablets
3. How to take Cetirizine Hayfever and Allergy Relief 10 mg
Tablets
4. Possible side effects
5. How to store Cetirizine Hayfever and Allergy Relief 10 mg
Tablets
6. Content of the pack and other information
1. WHAT CETIRIZINE HAYFEVER AND ALLERGY RELIEF
10 MG TABLETS ARE AND WHAT THEY ARE USED FOR
Cetirizine hydrochloride is the active ingredient of Cetirizine
Hayfever and Allergy Relief 10 mg Tablets. Cetirizine Hayfever
and Allergy Relief 10 mg Tablets is an antiallergic medication.
In adults and children aged 6 years and above, Cetirizine
Hayfever and Allergy Relief 10 mg Tablets are indicated
- for the relief of symptoms of hay fever (seasonal allergic
rhinitis) and allergies such as dust or pet allergies (perennial
allergic rhinitis), such as sneezing, itchy, runny and blocked
nose, itchy, red and watery eyes.
- for the relief of swelling, redness and itchiness of the skin
(symptoms of chronic idiopathic urticaria, which is also
known as chronic nettle rash).
2. WHAT YOU
NEED TO
KNOW
BEFORE YOU TAKE
CETIRIZINE HAYFEVER AND ALLERGY RELIEF 10 MG
TABLETS
DO NOT TAKE CETIRIZINE HAYFEVER AND ALLERGY RELIEF 10 MG
TABLETS
- if you have a severe kidney disease (severe r

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cetirizine Hydrochloride 10 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Cetirizine hydrochloride 10 mg.
Excipient: This product contains 101.83 mg lactose per tablet
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet (tablets).
White circular biconvex film-coated tablets, embossed ‘A’ on one
side and a deep
score on the other.
The tablet can be divided into equal halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In adults and paediatric patients 6 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.
CLINICAL PARTICULARS
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).
Older people: 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
excreted 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 (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)
Dosage and frequency
Normal
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