Leflunomide 10mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Leflunomide

Verfügbar ab:

Mylan

ATC-Code:

L04AA13

INN (Internationale Bezeichnung):

Leflunomide

Dosierung:

10mg

Darreichungsform:

Tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 10010300; GTIN: 5016695004150

Gebrauchsinformation

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEFLUNOMIDE 10 MG FILM-COATED TABLETS
LEFLUNOMIDE 20 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 or 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 Leflunomide is and what it is used for
2.
What you need to know before you take Leflunomide
3.
How to take Leflunomide
4.
Possible side effects
5.
How to store Leflunomide
6.
Contents of the pack and other information
1. WHAT LEFLUNOMIDE IS AND WHAT IT IS USED FOR
Leflunomide belongs to a group of medicines called anti-rheumatic
medicines. Leflunomide is used
to treat adult patients with active rheumatoid 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 (reduction of red blood cells).
2.
W HAT YOU NEED TO KNOW BEFORE YOU TAKE LEFLUNOMIDE
DO NOT TAKE LEFLUNOMIDE
-
if you are allergic to leflunomide (especially a serious skin
reaction, often accompanied by
fever, joint pain, red skin stains, or blisters e.g. Stevens-Johnson
syndrome), to a medicine
called teriflunomide (which is related to leflunomide) or to any of
the other ingredients of
this medicine (listed in section 6)
-
if you have any
LIVER PROBLEMS
,
-
if you have moderate to severe
KIDNEY PROBLEMS
,
-
if you have severely low levels of
PROTEINS IN YOUR BLOOD
(hypoproteinaemia),
-
if you suffer from any problem which affects your
IMMUNE SYSTEM
(e.g. AIDS),
-
if you have any probl

Fachinformation

OBJECT 1
LEFLUNOMIDE MYLAN 10 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 23-Oct-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Leflunomide Mylan 10 mg film-coated tablets
2. Qualitative and quantitative composition
Leflunomide Mylan 10 mg film-coated tablets: Each tablet contains 10
mg of leflunomide.
Excipient with known effect: Each film-coated tablet contains 18.81 mg
of lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Leflunomide 10 mg film-coated tablets are white, round biconvex
tablets with a diameter of about 6.1
mm.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
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),
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 regarding these benefit/risk aspects.
Moreover, switching from leflunomide to another DMARD without
following the washout procedure (see
section 4.4) may also increase the risk of serious adverse reactions
even for a long time after the
switching.
4.2 Posology and method of administration
The treatment should be initiated and supervised by specialists
experienced in the treatment of
rheumatoid arthritis.
Alanine aminotransferase (ALT) or serum glutamopyruvate transferase
(SGPT) and a complete blood cell
count, including a differential white blood cell count and a platelet
count, must be checked
simultaneously and with the same frequency:
• before initiation of leflunomide,
• every two weeks during the first six months of treatment, and
• every 8 weeks thereafter (see section 4.4).
_Posology_
In rheumatoid arthritis: leflunomide therapy is usually started with a
lo