Arava 10mg tablets

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Leflunomide

Fáanlegur frá:

Sanofi

ATC númer:

L04AA13

INN (Alþjóðlegt nafn):

Leflunomide

Skammtar:

10mg

Lyfjaform:

Tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 10010300; GTIN: 5013841202224

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
ARAVA 10 MG FILM-COATED TABLETS
leflunomide
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, ask your doctor, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Arava is and what it is used for
2.
What you need to know before you take Arava
3.
How to take Arava
4.
Possible side effects
5.
How to store Arava
6.
Contents of the pack and other information
1.
WHAT ARAVA IS AND WHAT IT IS USED FOR
Arava belongs to a group of medicines called anti-rheumatic medicines.
It contains the active
substance leflunomide.
Arava is used to treat adult patients with active rheumatoid arthritis
or with active psoriatic arthritis.
Symptoms of rheumatoid arthritis include inflammation of joints,
swelling, difficulty moving and
pain. Other symptoms that affect the entire body include loss of
appetite, fever, loss of energy and
anaemia (lack of red blood cells).
Symptoms of active psoriatic arthritis include inflammation of joints,
swelling, difficulty moving,
pain and patches of red, scaly skin (skin lesions).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARAVA
DO NOT TAKE ARAVA
-
if you have ever had an
ALLERGIC
reaction to leflunomide (especially a serious skin reaction,
often accompanied by fever, joint pain, red skin stains, or blisters
e.g. Stevens-Johnson
syndrome) or to any of the other ingredients of this medicine (listed
in section 6), or if you are
allergic to teriflunomide (used to treat multiple sclerosis),
-
if you have any
LIVER PROBLEMS
,
-
if you have moderate to severe
KIDNEY PROBLEMS
,
-
if you have severely low num

Vara einkenni

OBJECT 1
ARAVA 10MG TABLETS
Summary of Product Characteristics Updated 09-Aug-2017 | SANOFI
•
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, pregnancy 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
Arava 10 mg film-coated tablets
2. Qualitative and quantitative composition
Each tablet contains 10 mg of leflunomide.
Excipients with known effect
Each tablet contains 78 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White to almost white, round film-coated tablet, imprinted with ZBN on
one side.
4. Clinical particulars
4.1 Therapeutic indications
Leflunomide is indicated for the treatment of adult patients with:
• active rheumatoid arthritis as a "disease-modifying antirheumatic
drug" (DMARD),
• active psoriatic arthritis.
Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs
(e.g. methotrexate) may
result in an increased risk of serious adverse reactions; therefore,
the initiation of leflunomide treatment
has to be carefully considered r