Puri-Nethol 50mg Tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Mercaptopurine

Disponible depuis:

LTT Pharma Limited

Code ATC:

L01BB; L01BB02

DCI (Dénomination commune internationale):

Mercaptopurine

Dosage:

50 milligram(s)

forme pharmaceutique:

Tablet

Type d'ordonnance:

Product subject to prescription which may not be renewed (A)

Domaine thérapeutique:

Purine analogues; mercaptopurine

Statut de autorisation:

Authorised

Date de l'autorisation:

2017-03-01

Notice patient

LIVER FUNCTION
* Puri-Nethol is toxic to your liver. Therefore, your doctor will
carry out weekly
liver function tests when you are taking Puri-Nethol. If you already
have liver
disease, or if you are taking other medications which may affect your
liver,
your doctor will carry out more frequent tests. If you notice the
whites of
your eyes or your skin turn yellow (jaundice) tell your doctor
immediately as
you may need to stop your treatment immediately.
INFECTIONS
* When you are treated with Puri-Nethol the risk of viral, fungal and
bacterial
infections is increased and the infections may be more serious. See
also
section 4.
* Tell your doctor before starting treatment whether or not you have
had
chickenpox, shingles or hepatitis B (a liver disease caused by a
virus).
If you think you have an infection, talk to your doctor immediately.
SUN AND UV LIGHT
* While you are taking Puri-Nethol, you are more sensitive to the sun
and UV
light. You must make sure you limit your exposure to sunlight and UV
light,
wear protective clothing and use a sun cream with a high sun
protection
factor (SPF).
NUDT15-GENE MUTATION
If you have an inherited mutation in the NUDT15-gene (a gene which is
involved in the break-down of Puri-Nethol in the body), you have a
higher risk
of infections and hair loss and your doctor may in this case give you
a lower
dose.
CHILDREN AND ADOLESCENTS
Low blood sugar levels (sweating more than usual, nausea, dizziness,
confusion, etc.) have been reported in some children receiving
Puri-Nethol;
however, most of the children were under the age of six years old and
had a
low body weight. If you are not sure if any of the above applies to
you, talk to
your doctor or pharmacist before taking Puri-Nethol.
OTHER MEDICINES AND PURI-NETHOL
Tell your doctor or pharmacist if you are taking, have recently taken
or might
take any other medicines, including medicines obtained without a
prescription. This includes herbal medicines.
In particular, tell your doctor or pharmacist if you are taking any of
the
following:
*

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Puri-Nethol 50mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of the active substance 6-mercaptopurine.
EXCIPIENTS WITH KNOWN EFFECT:
Each tablet contains lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from Italy_
Pale yellow, round tablets, biconvex, scored on one side, engraved GX
and EX2 on either side of the scoreline and
plain on the other side.
The scoreline is only to facilitate breaking of the tablets for ease
of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
As per PA1691/009/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1691/009/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose
Corn Starch
Corn Starch Hydrolysate
Stearic Acid
Magnesium Stearate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the bottle and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
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Store in the original container in order to protect from light.
Keep the container tightly closed in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Amber glass bottle con