Rulide D

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Roxithromycin 50mg

Dostupné z:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Medzinárodný Name):

Roxithromycin 50 mg

Dávkovanie:

50 mg

Forma lieku:

Dispersible tablet

Zloženie:

Active: Roxithromycin 50mg Excipient: Colloidal silicon dioxide Crospovidone Fumaric acid Glycyrrhiza glabra Macrogol 6000 Magnesium stearate Methacrylic acid copolymer Microcrystalline cellulose Purified talc Saccharin sodium Sodium hydroxide Sodium laureth sulfate Strawberry Flavour Triethyl citrate

Typ predpisu:

Prescription

Výrobca:

Sanofi Chimie

Terapeutické indikácie:

Rulide D 50mg tablets are indicated for the treatment of the following mild to moderately severe infections in children caused by, or likely to be caused by susceptible micro-organisms: - Acute pharyngitis - Acute tonsillitis - Impetigo

Prehľad produktov:

Package - Contents - Shelf Life: Blister pack, polyamide/aluminium/PVC laminate blister sheet in carton - 2 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, polyamide/aluminium/PVC laminate blister sheet in carton - 4 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, polyamide/aluminium/PVC laminate blister sheet in carton - 10 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, polyamide/aluminium/PVC laminate blister sheet in carton - 20 tablets - 36 months from date of manufacture stored at or below 30°C

Dátum Autorizácia:

2014-07-09

Príbalový leták

Rulide
® D Tablets
1
RULIDE® D TABLETS
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING RULIDE D?
Rulide D contains the active ingredient roxithromycin. Rulide D is
mainly used to treat respiratory tract infections, and skin and
soft tissue infections. For more information, see Section 1. Why am I
using Rulide D? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE RULIDE D?
Do not use if you have ever had an allergic reaction to roxithromycin
or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become
pregnant or are breastfeeding. For more information, see Section 2.
What should I know before I use Rulide D?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Rulide D and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I USE RULIDE D?
•
For children weighing less than 40 kg, the dosage can range from one
half a tablet, one tablet or two tablets twice a day.
•
Your doctor will tell you the correct number of tablets to give your
child
More instructions can be found in Section 4. How do I use Rulide D? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING RULIDE D?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that your child is taking
Rulide D.
•
If symptoms of your child's infection do not improve with a few days,
or if they become worse, tell
your doctor.
•
If your child is about to start taking any new medicine, tell your
doctor or pharmacist that they are
taking Rulide D
THINGS YOU
SHOULD NOT DO
•
Rulide D has been prescribed for your child. Do not give to anyone
else, even if they have the same
condition as your child.
•
Do not use Rulide D to treat any other complaints unless your doctor
tells you to
LOOKIN

Súhrn charakteristických

rulide-d-ccdsv8-dsv7-14nov22
Page 1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Rulide D 50 mg dispersible tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rulide D tablets contain 50 mg of roxithromycin.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Rulide D tablets are practically white, scored, cylindrical tablets,
8mm in diameter.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CHILDREN
Rulide D 50mg tablets are indicated for the treatment of the following
mild to moderately severe
infections in children caused by or likely to be caused by susceptible
micro-organisms:
•
acute pharyngitis
•
acute tonsillitis
•
impetigo
Appropriate culture and sensitivity tests should be performed when
necessary to determine an
organism’s susceptibility and thus treatment suitability. Therapy
with roxithromycin may be
initiated before results of these tests are known; once results become
available, appropriate
therapy should be continued.
4.2
DOSE AND METHOD OF ADMINISTRATION
Children
rulide-d-ccdsv8-dsv7-14nov22
Page 2
The recommended dose and duration of treatment should NOT be exceeded
in children (see
Section 4.4 Special Warnings and Precautions for Use).
Rulide D should be taken at least 15 minutes before food or on an
empty stomach (
_i.e._
more than
3 hours after a meal).
Rulide D is administered twice daily at a dose of 5 to 8 mg/kg per
day. Recommended dosage
regimens are presented in the following table:
BODYWEIGHT
RULIDE D 50MG TABLETS
6 - 11 KG
Half a tablet morning and evening
12 - 23 KG
One tablet morning and evening
24 - 40 KG
Two tablets morning and evening
> 40 KG
Three tablets morning and evening
Rulide D 50mg tablets are administered to children as an aqueous
suspension that is made by
adding either a half, one, two or three tablets to a spoonful of
water. After waiting for 30 to 40
seconds for the tablet(s) to disintegrate into fine granules, the
suspension is given to the child. A
drink of water should follow the dose.
Note: Rulide D 50mg tablets are desig