Rupatadine 10mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Rupatadine fumarate

Dostupné z:

Aspire Pharma Ltd

ATC kód:

R06AX28

INN (Medzinárodný Name):

Rupatadine fumarate

Dávkovanie:

10mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 03040100; GTIN: 5060209731629

Príbalový leták

Package Leaflet: Information for the user
RUPATADINE
10mg tablets
rupatadine
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, please ask your
doctor or your 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 Rupatadine is and what it is used for
2. What you need to know before you take
Rupatadine
3. How to take Rupatadine
4. Possible side effects
5. How to store Rupatadine
6. Contents of the pack and other information
1. WHAT RUPATADINE IS AND
WHAT IT IS USED FOR
Rupatadine is an antihistamine.
Rupatadine relieves the symptoms of allergic
rhinitis such as sneezing, runny nose, itching in the
eyes and nose.
Rupatadine is also used to relieve the symptoms
associated with urticaria (an allergic skin rash)
such as itching and hives (localised skin redness
and swelling).
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE RUPATADINE
Do not take Rupatadine
•
If you are allergic to rupatadine or any of the
other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Rupatadine.
If you suffer from kidney or liver insufficiency, ask
your doctor for advice. The use of Rupatadine 10mg
tablets is at present not recommended in patients
with impaired kidney or liver functions.
If you have low blood levels of potassium and/or if
you have a certain abnormal pattern to your
heartbeat (known prolongation of the QT interval on
the ECG) which can occur in some forms of heart
disease, ask your doctor for advice.
If you are older than 65, ask your doctor or your
pharmacist.
Children
This medicine is not for use in chil

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rupatadine 10 mg Tablets_ _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
10 mg of rupatadine (as fumarate)
Excipient with known effect lactose 57.57 mg as lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Round, light salmon coloured tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of allergic rhinitis and urticaria in adults and
adolescents
(over 12 years of age).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and adolescents (over 12 years of age)
The recommended dose is 10 mg (one tablet) once a day, with or without
food.
Elderly
Rupatadine should be used with caution in elderly people (see section
4.4).
_ _
Paediatric patients
Rupatadine 10 mg Tablets is not recommended for use in children below
age 12. In
children aged 2 to 11 years, the administration of rupatadine 1 mg/ml
oral solution is
recommended.
Patients with renal or hepatic insufficiency
As there is no clinical experience in patients with impaired kidney or
liver functions,
the use of rupatadine 10 mg Tablets is at present not recommended in
these patients.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The administration of rupatadine with grapefruit juice is not
recommended (see
section 4.5).
The combination of rupatadine with potent CYP3A4 inhibitors should be
avoided and
with moderate CYP3A4 inhibitors should be administered with caution
(see section
4.5).
Dose adjustment of sensitive CYP3A4 substrates (e.g. simvastatin,
lovastatin) and
CYP3A4 substrates with a narrow therapeutic index (e.g. ciclosporin,
tacrolimus,
sirolimus, everolimus, cisapride) could be required as rupatadine may
increase plasma
concentrations of these drugs (see section 4.5).
Cardiac safety of rupatadine was assessed in a Thorough QT/QTc study.
Rupatadine
up to 10 times therapeutic dose did not