LORYTEC 10MG TABLETS

Land: Cypern

Sprog: græsk

Kilde: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Aktiv bestanddel:

LORATADINE

Tilgængelig fra:

DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629

ATC-kode:

R06AX13

INN (International Name):

LORATADINE

Dosering:

10MG

Lægemiddelform:

TABLETS

Sammensætning:

LORATADINE (0079794755) 10MG

Indgivelsesvej:

ORAL USE

Recept type:

Εθνική Διαδικασία

Terapeutisk område:

LORATADINE

Produkt oversigt:

Νομικό καθεστώς: Χωρίς Ιατρική Συνταγή; PACK WITH 10 TABS IN BLISTER(S) (980007001) 10 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 20 TABS IN BLISTER(S) (980007002) 20 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 30 TABS IN BLISTER(S) (980007004) 30 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή

Indlægsseddel

COMPARATIVE TABLE – ENGLISH PIL VS GREEK PIL
Package leaflet: Information for the user
Lorytec 10 mg tablets
loratadine
Read all of this leaflet carefully before you start taking this
medicine
because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as
your
doctor, pharmacist or nurse has told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This
includes any possible side effects not listed in this leaflet. See
section 4.

You must talk to a doctor if you do not feel better or if you feel
worse.
What is in this leaflet
1. What Lorytec is and what it is used for
2. What you need to know before you take Lorytec
3. How to take Lorytec
4. Possible side effects
5. How to store Lorytec
6. Contents of the pack and other information
1. What Lorytec is and what it is used for
Φύλλο οδηγιών χρήσης: Πληροφορίες για
το χρήστη
Lorytec 10 mg δισκία
λοραταδίνη
Διαβάστε προσεκτικά ολόκληρο το φύλλο
οδηγιών χρήσης πριν αρχίσετε
να
παίρνετε
αυτό
το
φάρμακο,
διότι
περιλαμβάνει
σημαντικές
πληροφορίες για σας.
Πρέπει πάντοτε να παίρνετε αυτό το
φάρμακο ακριβώς όπως περιγράφεται
στο παρόν φύλλο οδηγιών χρήσης ή
σύμφωνα με τις οδηγίες του γιατρού,
του
φαρμακοποιού ή του νοσοκόμου σας.

Φυλάξτε αυτό το φύλλο οδηγιών χρήσης.
Ίσως χρειαστεί να το διαβάσετε
ξανά.

Απευθυνθείτε στον φαρμακοποιό σας εάν
χρειαστείτε περισσότερες
πληροφορίες ή συμβουλές.

Εάν πα�

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Lorytec 10 mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg loratadine.
Excipients with known effect. The quantity of lactose in the
loratadine 10 mg tablet
composition is 60.00 mg.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablets.
White to off-white, round, flat tablets, 8mm diameter, scored on one
side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lorytec is indicated for the symptomatic treatment of allergic
rhinitis and chronic idiopathic
urticaria in adults and children over the age of 2 years with a body
weight more than 30 kg.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and children over 12 years of age:_
10 mg once daily (one tablet once daily).
Paediatric population
_Children 2 to 12 years of age are dosed by weight:_
Bodyweight more than 30 kg: 10 mg once daily (one tablet once daily).
Bodyweight 30 kg or less: The 10 mg strength tablet is not appropriate
in children with a
bodyweight less than 30 kg.
Safety and efficacy of Lorytec tablets in children under 2 years of
age has not been
established. No data are available.
_Patients with hepatic impairment_
Patients with severe liver impairment should be administered a lower
initial dose because they
may have reduced clearance of loratadine. An initial dose of 10 mg
every other day is
recommended for adults and children weighing more than 30 kg.
_Patients with renal impairment_
No dosage adjustments are required in patients with renal
insufficiency.
_Elderly_
No dosage adjustments are required in the elderly.
Method of administration
Oral use. The tablet may be taken without regard to mealtime.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Lorytec should be administered with caution in patients with severe
liver impairment (see
4.2).
This medicinal product contains lactose; thus patien