LORDYNO TABLET

Երկիր: Հարավաֆրիկյան Հանրապետություն

Լեզու: անգլերեն

Աղբյուրը: South African Health Products Regulatory Authority (SAHPRA)

Հասանելի է:

Biotech Laboratories (Pty) Ltd

Դոզան:

See ingredients

Դեղագործական ձեւ:

TABLET

Կազմը:

EACH TABLET CONTAINS LORATADINE 10,0 mg

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

2003-03-11

Տեղեկատվական թերթիկ

Biotech Laboratories (Pty) Ltd_ _
10 mg Loratadine
Tablets
1.3.2 – Approved PIL
Page 1 of 7
CLEAN PROPOSED PATIENT INFORMATION LEAFLET FOR LORDYNO
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S2
LORDYNO, 10 MG, TABLETS
LORATADINE
CONTAINS SUGAR (69,175 MG LACTOSE MONOHYDRATE PER TABLET)
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
LORDYNO is available without a doctor’s prescription, for you to
treat a mild illness.
Nevertheless, you still need to take LORDYNO carefully to get the best
results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share LORDYNO with any other person.
•
Ask your health care provider or pharmacist if you need more
information or advice.
•
You must see a doctor if your symptoms worsen or do not improve.
WHAT IS IN THIS LEAFLET
1.
What LORDYNO is and what it is used for
2.
What you need to know before you take
LORDYNO
3.
How to take LORDYNO
4.
Possible side effects
5.
How to store LORDYNO
6.
Contents of the pack and other information.
Biotech Laboratories (Pty) Ltd_ _
10 mg Loratadine
Tablets
1.3.2 – Approved PIL
Page 2 of 7
1.
WHAT LORDYNO IS AND WHAT IT IS USED FOR
LORDYNO contains loratadine which belongs to a class of medicines
called antihistamines.
LORDYNO is indicated for the relief of the symptoms of
•
perennial (symptoms are present throughout the year) and/or seasonal
(symptoms are
present during the spring and summer months) allergic rhinitis
(inflammation of the nose),
such as sneezing, runny or itchy nose and burning or itchy eyes
•
chronic urticaria, such as itchy, raised, red or skin-coloured welts
on your skin
•
allergic skin disorders, such as itching, redness and swelling of
areas on your skin.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORDYNO
DO NOT TAKE LORDYNO:
If you are hypersensitive (allergic) to loratadine or any of the other
ingredients of LORDYNO
(listed in section 6).
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE WITH LORDYNO:
•
if you are elderly, as the safety of LORDYNO in elderl

Ապրանքի հատկությունները

Biotech Laboratories (Pty) Ltd_ _
10 mg Loratadine
Tablets
_ _
1.3.1.1 Approved PI
Page 1 of 9
CLEAN AMENDED PROPOSED PROFESSIONAL INFORMATION FOR LORDYNO
SCHEDULING STATUS
1.
NAME OF THE MEDICINE
LORDYNO tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg loratadine.
Excipient with known effect:
Contains sugar (69,175 mg lactose monohydrate per tablet).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM_ _
Tablets.
White, oval tablets, notched and coded LT/10 on one side (length: 7,5
to 7,9 mm and width: 4,9 to
5,3 mm).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LORDYNO is indicated for the relief of the symptoms associated with
perennial and/or seasonal
allergic rhinitis, chronic urticaria and other allergic skin
disorders.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
S2
Biotech Laboratories (Pty) Ltd_ _
10 mg Loratadine
Tablets
_ _
1.3.1.1 Approved PI
Page 2 of 9
Take one tablet once daily.
METHOD OF ADMINISTRATION
Oral administration.
LORDYNO can be taken with or without food.
4.3
CONTRAINDICATIONS
•
LORDYNO is contraindicated in patients who have shown hypersensitivity
or idiosyncrasy to
loratadine or to any of the excipients listed in section 6.1.
•
Safety of LORDYNO in the elderly has not been established.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients with severe liver impairment should be administered a lower
initial dose because they
may have reduced clearance of loratadine, the active ingredient in
LORDYNO; an initial dose of 5
mg once daily or 10 mg every second day is recommended.
Increase in body mass has been reported with the use of LORDYNO (see
section 4.8).
LORDYNO contains lactose monohydrate. Patients with rare hereditary
problems of galactose
intolerance, total lactase deficiency or glucose-galactose
malabsorption, should not take
LORDYNO.
4.5
INTERACTION WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTION
When administered concomitantly with alcohol, LORDYNO has no
potentiating effects as
measured by psychomotor perfo