Leflunomide 10mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Leflunomide

Disponible des:

Aspire Pharma Ltd

Codi ATC:

L04AA13

Designació comuna internacional (DCI):

Leflunomide

Dosis:

10mg

formulario farmacéutico:

Tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 10010300; GTIN: 5060209730660

Informació per a l'usuari

Package leaflet: Information for the user
LEFLUNOMIDE 10, 20MG
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 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. It contains the active
substance leflunomide.
Leflunomide 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 LEFLUNOMIDE
Do not take Leflunomide

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),

if you have any liver problems,

if you have moderate to severe kidney problems,

if you have severely low n

Fitxa tècnica

OBJECT 1
LEFLUNOMIDE 10MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 12-Jun-2017 | Aspire Pharma
Ltd
1. Name of the medicinal product
Leflunomide 10mg film-coated tablets
2. Qualitative and quantitative composition
Leflunomide 10mg film-coated tablets:
Each tablet contains 10mg of leflunomide.
Excipients with known effect: each tablet contains 19.80 mg of lactose
monohydrate equivalent to 18.81
mg of lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
- Leflunomide 10mg film-coated tablets are white, round biconvex
tablets.
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 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 and psoriatic 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 started with a
loading dose of 100 mg once daily for 3
days. Omission of the loading dose may dec