Mycobutin 150mg Hard Capsules

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Rifabutin

Verfügbar ab:

Pfizer Healthcare Ireland

ATC-Code:

J04AB; J04AB04

INN (Internationale Bezeichnung):

Rifabutin

Dosierung:

150 milligram(s)

Darreichungsform:

Capsule, hard

Verschreibungstyp:

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

Therapiebereich:

Antibiotics; rifabutin

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2001-01-12

Gebrauchsinformation

Page 1 of 5
2020-0059555
PACKAGE LEAFLET: INFORMATION FOR THE USER
MYCOBUTIN (R) 150 MG HARD CAPSULES
RIFABUTIN
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 symptoms 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 Mycobutin is and what it is used for
2. What you need to know before you take Mycobutin
3. How to take Mycobutin
4. Possible side effects
5. How to store Mycobutin
6. Contents of the pack and other information
1.
WHAT MYCOBUTIN IS AND WHAT IT IS USED FOR
Mycobutin is an antibiotic. It is used to treat infections caused by
germs (bacteria) called mycobacteria.
These are bacteria which cannot be destroyed with usual antibiotics.
One of the most common mycobacterial infections is Mycobacterium
tuberculosis. Mycobutin can be
used in combination with other antibiotics for the treatment of
tuberculosis of the lung.
You should consult your doctor if you are unsure why you have been
given Mycobutin.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYCOBUTIN
Your doctor will discuss your condition with you before you start
taking your capsules. Your treatment
with Mycobutin will be combined with other anti-mycobacterial drugs
treatments. Tell your doctor if you
are taking other rifamycins (drugs used to treat bacteria).
DO NOT TAKE MYCOBUTIN

if you are allergic (hypersensitive) to rifabutin, rifamycins, other
drugs to treat tuberculosis or any
of the other ingredients of Mycobutin listed in section 6

if you have porphyria, a rare blood disorder.
_ _
WARNINGS AND PRECAUTION

Fachinformation

Health Products Regulatory Authority
24 February 2021
CRN00C1YW
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mycobutin 150mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 150.0mg Rifabutin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule (Capsule).
Opaque, red-brown, hard gelatin capsules marked “MYCOBUTIN” on the
cap and “Pharmacia&Upjohn” on the body.
Size No. 0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mycobutin is indicated:
As a second line treatment of patients with sensitive mycobacterium
tuberculosis. Treatment should be supervised by a
specialist physician.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Mycobutin can be administered as a single, daily, oral dose at any
time independently of meals.
POSOLOGY
ADULTS
The normal dose recommended for pulmonary tuberculosis is 150-450 mg
(1-3 capsules) in combination regimens for at least
6 months
When Mycobutin is given in association with clarithromycin (or other
macrolides) or fluconazole (and related compounds) or
certain antivirals, dosage should be reduced to 300 mg/day after the
first month of treatment (see Section 4.4 Special warnings
and precautions for use, and Section 4.5, Interaction with other
medicinal products and other forms of interaction).
_Paediatric population _There are inadequate data to support the use
of Mycobutin in children at the present time.
ELDERLY
No specific recommendations for dosage alterations in the elderly are
suggested.
4.3 CONTRAINDICATIONS
Mycobutin is contraindicated in patients with a history of
hypersensitivity to rifabutin or other rifamycins (e.g. rifampicin) or
to
any of the excipients listed in section 6.1. Patients who suffer from
porphyria.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Mycobutin may impart a red-orange colour to the urine, saliva and to
other skin and body secretions. Contact lenses, especially
soft, may be permanently stained.
In accordance with the commonly accepted criteria