Targaxan 550mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Rifaximin

Available from:

Norgine Pharmaceuticals Ltd

ATC code:

A07AA11

INN (International Name):

Rifaximin

Dosage:

550mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010700; GTIN: 5012748008335

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TARGAXAN
® 550MG FILM-COATED TABLETS
(rifaximin)
Throughout this leaflet Targaxan 550mg film coated tablets will
be referred to as Targaxan.
_ _
_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 Targaxan is and what it is used for
2.
What you need to know before you take Targaxan
3.
How to take Targaxan
4.
Possible side effects
5.
How to store Targaxan
6.
Contents of the pack and other information
1.
WHAT TARGAXAN IS AND WHAT IT IS USED FOR
Targaxan contains the active substance rifaximin. Targaxan is an
antibiotic that destroys bacteria, which can cause a disease
called hepatic encephalopathy (symptoms include agitation,
confusion, muscle problems, difficulty in speaking and in some
cases coma). Targaxan is used in adults with liver disease to
reduce the recurrence of episodes of overt hepatic
encephalopathy. Targaxan can either be used alone or more
commonly together with medicines containing lactulose (a
laxative).
_ _
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TARGAXAN
_ _
_DO NOT TAKE TARGAXAN:_

if you are allergic to:

rifaximin

similar types of antibiotics (such as rifampicin or rifabutin)

any of the other ingredients of this medicine (listed in
section 6).

if you have a blockage in your intestine
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Targaxan.
While you are taking Targaxan your urine may turn a reddish
colour. This is quite normal. Treatment with any an

Summary of Product characteristics

OBJECT 1
TARGAXAN 550 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 21-Oct-2016 | Norgine
Limited
1. Name of the medicinal product
TARGAXAN 550 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 550 mg rifaximin.
Excipients:
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Pink, oval biconvex 10 mm x 19 mm film-coated tablets embossed with
“RX” on one side.
4. Clinical particulars
4.1 Therapeutic indications
TARGAXAN is indicated for the reduction in recurrence of episodes of
overt hepatic encephalopathy in
patients ≥ 18 years of age (see section 5.1).
In the pivotal study, 91% of the patients were using concomitant
lactulose.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 Posology and method of administration
Posology
Recommended dose: 550 mg twice a day. The clinical benefit was
established from a controlled study in
which subjects were treated for 6 months. Treatment beyond 6 months
should take into consideration the
individual balance between benefits and risks, including those
associated with the progression of hepatic
dysfunction (see sections 4.4, 5.1 and 5.2).
TARGAXAN can be administered with or without food.
_Paediatric population_
The safety and efficacy of TARGAXAN in paediatric patients (aged less
than 18 years) have not been
established.
_Elderly_
No dosage adjustment is necessary as the safety and efficacy data of
TARGAXAN showed no differences
between the elderly and the younger patients.
_Hepatic impairment_
No dosage adjustment is necessary for patients with hepatic
insufficiency (see section 4.4).
_Renal impairment_
Although dosing change is not anticipated, caution should be used in
patients with impaired renal
function (see section 5.2).
Method of administration
Orally with a glass of water.
4.3 Contraindications
• Hypersensitivity to rifaximin, rifamycin-derivatives or to any of
the excipients listed in section 6.1.
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