Author: Unknown

Patient Information Leaflet
DUTONIN^™
Nefazodone Hydrochloride

Your doctor has prescribed Dutonin for you.  Please read this leaflet before you take your medicine.  It gives a summary of information about your medicine.  If you want to know more, or are not sure about anything, ask your doctor or pharmacist.

REMEMBER:
This medicine is for YOU.  Only a doctor can prescribe it.  Never give it to any one else.  It may harm them even if they have the same symptoms as you.

WHAT IS IN DUTONIN TABLETS?
The active ingredient in Dutonin Tablets is nefazodone hydrochloride.  The tablets come in two different strengths.  Each tablet contains either 100mg or 200mg nefazodone hydrochloride.

The other ingredients are: colloidal silicon dioxide, iron oxides, magnesium stearate, microcrystalline cellulose, polyvidone, sodium starch glycolate.

Dutonin Tablets 100mg are supplied in a titration pack of 14 tablets or a calendar pack of 56 tablets.  Dutonin Tablets 200mg are supplied in a calendar pack of 56 tablets.

PRODUCT LICENCE HOLDER:
Bristol-Myers Squibb Pharmaceuticals Limited
141-149 Staines Road
Hounslow
Middlesex, England

PL Numbers:
100 mg	PL11184/28
200 mg	PL11184/29

PRODUCT AUTHORISATION HOLDER:
Bristol-Myers Squibb Pharmaceuticals Limited
Swords
Dublin, Ireland

PA Numbers:
100 mg	PA 2/60/2
200 mg	PA 2/60/3

Manufacturer:
Bristol-Myers Squibb SpA,
Contrada Fontana del Ceraso
03012 Anagni (Fr)., Italy

Q.	What is this medicine for?
A:	Dutonin is an antidepressant.  Depression is due to a chemical imbalance in your brain.  One of these naturally occurring chemicals is serotonin.  Dutonin helps to restore the serotonin balance

BEFORE TAKING YOUR MEDICINE:
Q.	Should I be taking Dutonin?
A.	DO NOT take these tablets if you have had an allergic reaction to similar tablets or any of the ingredients in Dutonin Tablets.

Q.	What if I am pregnant or breast-feeding?
A: 	If you are pregnant, or may become pregnant or are breast-feeding, you should speak to your doctor before taking Dutonin.

Q.	Are there any special directions for epileptic patients?
A.	If you are epileptic remind your doctor.

Q.	Can I take other medicines?
A.	Not unless they have been discussed with your doctor or pharmacist.

Q.	Who should I tell that I am taking Dutonin?

A.

Doctor
Dentist
Pharmacists

– before any surgery or emergency treatment, or if he/she prescribes any new treatment
– before having any dental surgery
– before buying any medicines

Q.	Is it all right to drink alcohol?
A.	Even small amounts of alcohol may make you feel drowsy.  You should check with your doctor whether drinking is advisable for you while taking Dutonin

Q:	Is it all right to drive?
A:	Dutonin may make you feel drowsy, dizzy, light-headed or have blurred vision, especially during the first two weeks of treatment.  Most people do not find their ability to carry out normal daily activities is affected.  However, you should be especially careful if you are driving, operating machinery or doing any other jobs that could be dangerous if these unwanted effects occur.

USING YOUR MEDICINE:
Q:	How should I take Dutonin Tablets?
A:	The label will tell you how many tablets and how often your doctor wants you to take the medicine.  Tablets should be swallowed with a glass of water.

Q:	How long will it take before I start to feel better?
A:	You may start to feel a little better within the first week of taking your tablets but you may not feel the full benefit until you have taken your tablets for a month .

Q:	Can I take the tablets before or after meals?
A:	It does not matter.

Q:	How long should I take them for?
A:	Continue with Dutonin tablets until your doctor tells you otherwise.  Keep your doctor’s appointments even if you feel well.  If you stop your medicine you may feel worse.

Q:	What it I miss or forget to take a dose?
A:	If you miss a dose do not worry.  Just carry on taking your normal dose when the next one is due.  DO NOT take a double dose to make up for the one you missed .

Q:	What it I take too many tablets or a child swallows some?
A:	Go to your nearest hospital Casualty Department or tell your doctor immediately.  Take the remaining tablets or the empty container with you.  You may feel sick or very drowsy so do not drive yourself

UNDESIRABLE EFFECTS:
Q:	Are there any unwanted effects of Dutonin?
A:	Any medicine may cause some unwanted or ‘side-effects’ in a few patients and you may notice side-effects al the beginning of treatment.  Check with your doctor if you notice dizziness, visual disturbances, tingling or numbness, chills and fever or confusion. Other side-effects not mentioned above may be noticed in a few patients.
	Check with your doctor if you notice any.

LOOKING AFTER YOUR MEDICINE:
You will see an ‘EXPIRY DATE’ on the outer packaging of Dutonin Tablets.
Do not use after this date.

Keep all your medicines where children cannot reach them.  Keep Dutonin Tablets at room temperature below 30ºC.  They should not get too hot or damp; so do not leave your tablets near a radiator, on a window sill or in the bathroom.

If your doctor decides to stop the medicine, ask your pharmacist to tell you what to do with any you have left.

DATE OF LAST REVISION: April 1993