Moclobemide 150mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Moclobemide

Available from:

Teva UK Ltd

ATC code:

N06AG02

INN (International Name):

Moclobemide

Dosage:

150mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030200; GTIN: 5017007301752

Patient Information leaflet

DRIVING AND USING MACHINES
Do not drive or operate machinery if you feel less alert or drowsy.
These side effects are
more likely to occur at the start of treatment.
MOCLOBEMIDE FILM-COATED TABLETS CONTAINS LACTOSE
If you have been told by your doctor that you have an intolerance to
some sugars, contact
your doctor before taking this medicinal product.
3. HOW TO TAKE MOCLOBEMIDE FILM-COATED TABLETS
Always take this medicine exactly as your doctor has told you. Check
with your doctor or
pharmacist if you are not sure.
Adults including the elderly:
The usual starting dose is 300 mg of moclobemide per day. This is to
be taken throughout
the day. Your doctor may decide to prescribe a different dose for you.
Based on personal
circumstances, the daily dose can range from 150 mg to 600 mg of
moclobemide a day.
The tablets should be swallowed with some water and should always be
taken after meals.
If you have liver problems your doctor may decide on a lower dose.
IF YOU TAKE MORE MOCLOBEMIDE FILM-COATED TABLETS THAN YOU SHOULD
If you take more Moclobemide film-coated tablets than you should,
contact your doctor or
nearest hospital casualty department immediately as an overdose can be
life threatening.
IF YOU FORGET TO TAKE MOCLOBEMIDE FILM-COATED TABLETS
If you forget to take Moclobemide film-coated tablets, take it as soon
as you remember. Then
go on as before. Do not take two doses at the same time.
IF YOU STOP TAKING MOCLOBEMIDE FILM-COATED TABLETS
Remember that you may need to take these tablets for 2 or more weeks
before you begin to
feel better. Do not stop taking this medicine if you begin to feel
better. Treatment should
carry on for 4 to 6 months once symptoms have improved. This will help
stop the symptoms
coming back.
If you are worried or feel your depression is getting worse, please
see your doctor.
_If you have any further questions on the use of this medicine, ask
your doctor or pharmacist._
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Moclobemide 150mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150mg moclobemide.
Excipient with known effect: Each tablet contains 156.6 mg lactose
(anhydrous).
For the full list of excipients, see 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Moclobemide- ratiopharm 150mg :Yellow, coated, oval, biconvex shaped
tablets with a white core, scored on one side and imprinted ”P”
logo ”150” on
the other side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Moclobemide is indicated for the treatment of major depressive
episodes.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults_
Initial usual dose 300mg, administered in divided doses after meals.
The
tablets should be taken with fluid.
If necessary, the daily dose can be increased to 600mg per day.
However, the
dose should not be increased during the 1
st
week of treatment, because the
bioavailability increases during this time and a clinical effect may
not be seen
for 1-3 weeks. In individual cases, the therapeutic dose can be
gradually
reduced to 150mg, per day, depending on effect.
_Duration of treatment _
Treatment with moclobemide should be continued for at least 4-6 weeks
to be
able to judge the efficacy of moclobemide.
Treatment with moclobemide should preferably be continued for a
symptom
free period of 4-6 months. Then treatment can be gradually tapered
off.
Antidepressants, particularly MAOIs, should be withdrawn gradually to
reduce
the risk of withdrawal symptoms.
_Elderly_
No special dose adjustment is required.
_Paediatric population _
In view of the lack of clinical data available, moclobemide is not
recommended for use in children.
_Patients with renal or hepatic impairment _
Patients with reduced renal function do not require a special dose
adjustment.
In patients with impaired hepatic function, the daily dose of
moclobemide
should be reduced to a half or one third.
4.3
CONTRAINDICATIONS
−
Hypersensitivi