Olbetam

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Acipimox 250mg

Available from:

Pfizer New Zealand Limited

INN (International Name):

Acipimox 250 mg

Dosage:

250 mg

Pharmaceutical form:

Capsule

Composition:

Active: Acipimox 250mg Excipient: Colloidal hydrated silica Gelatin Iron oxide red Iron oxide yellow Magnesium stearate Sodium laurilsulfate Starch Titanium dioxide

Units in package:

Blister pack, 30s, 30 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Olon SpA

Therapeutic indications:

OLBETAM is indicated for the treatment of lipid disorders characterised by elevated plasma levels of triglycerides (Fredrickson Type IV hyperlipoproteinaemia), or both triglycerides and cholesterol (Type IIb hyperlipoproteinaemia). OLBETAM should be prescribed only for patients with lipid or lipoprotein abnormalities demonstrated by laboratory tests and where diet alone is insufficient to correct the condition.

Product summary:

Package - Contents - Shelf Life: Blister pack, - 30 capsules - 48 months from date of manufacture stored at or below 30°C - Blister pack, - 100 capsules - 48 months from date of manufacture stored at or below 30°C

Authorization date:

1986-06-19

Patient Information leaflet

OLBETAM
_ACIPIMOX _
250 mg capsule
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Olbetam.
This leaflet answers some common questions about Olbetam. It does not
contain all
the available information. It does not take the place of talking to
your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using
Olbetam against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT OLBETAM IS USED FOR
This medicine contains acipimox, which is used to treat lipid
disorders by reducing
high blood levels of certain types of fats called triglycerides.
Olbetam should only be
used in patients where diet alone or other non-drug measures (weight
loss or
exercise) failed to correct the levels of these fats.
Your doctor may have prescribed Olbetam for another reason.
Ask your doctor if you have any questions about why Olbetam has been
prescribed
for you.
This medicine is available only with a doctor's prescription.
BEFORE YOU USE OLBETAM
_ _
_WHEN YOU MUST NOT USE IT _
Do not use Olbetam if:
•
If you are allergic to acipimox or any of the other ingredients of
this medicine
•
If you have an ulcer affecting the stomach or gut
1
•
If you have a severe kidney problem. Your doctor will tell you if this
is the
case.
If you are not sure whether you should start using Olbetam, talk to
your doctor.
_BEFORE YOU START TO USE IT _
You should have made changes to your diet, alcohol intake and physical
exercise
before being given this medicine.
Tell your doctor if:
•
You are taking other medicines to reduce blood fat levels
•
You have unexplained muscle pain, muscle tenderness or muscle weakness
while you are taking this medicine.
If you have not told your doctor about any of the above, tell them
before you start
using Olbetam.
This medicine is not effective for all lipid disorders. This medicine
is not give

Summary of Product characteristics

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NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
OLBETAM 250 mg capsule
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains acipimox 250mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule
Gelatin capsule shell, self-locking, red cap, red brown body, opaque,
size No. 1.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
OLBETAM is indicated for the treatment of lipid disorders
characterised by elevated plasma
levels of triglycerides (Fredrickson Type IV hyperlipoproteinaemia),
or both triglycerides and
cholesterol (Type IIb hyperlipoproteinaemia).
OLBETAM should be prescribed only for patients with lipid or
lipoprotein abnormalities
demonstrated by laboratory tests and where diet alone is insufficient
to correct the condition.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
The recommended dosage is one 250mg capsule 2 or 3 times daily to be
taken with or after
meals. The lower dose is advised in Type IV and the higher in Type IIb
hyperlipoproteinaemia.
In patients with renal impairment it is advisable to reduce the dosage
on the basis of creatinine
clearance values:
Clearance between 80 and 40mL/min - 250mg once daily.
Clearance between 40 and 20mL/min - 250mg every other day.
It is not recommended that OLBETAM be administered to children.
4.3 CONTRAINDICATIONS
•
Confirmed individual hypersensitivity to OLBETAM
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•
Peptic ulcer
•
Severe Renal Impairment.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Before instituting OLBETAM therapy, attempts should be made to control
serum lipids with
appropriate diet, exercise and weight loss in case of obesity. Since
long-term administration
of OLBETAM is recommended, all baseline values, including lipid
profile, should be measured
before treatment and periodic determinations of serum lipids should be
obtained to confirm
that the desired therapeutic effect has been achieved.
Acipimox is structurally related to nicotin