Rupatadine 10mg tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Rupatadine fumarate

から入手可能:

DE Pharmaceuticals

ATCコード:

R06AX28

INN（国際名）:

Rupatadine fumarate

投薬量:

10mg

医薬品形態:

Oral tablet

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 03040100

情報リーフレット

Package Leaflet: Information for the user
RUPATADINE
10mg Tablets
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 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 children under 12 y

製品の特徴

OBJECT 1
RUPATADINE 10MG TABLETS
Summary of Product Characteristics Updated 04-Jan-2019 | Aspire Pharma
Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, preganancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
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 childr