Serzone
Nefazodone hydrochloride tablets
What is this leaflet for?
Read this leaflet carefully before taking Serzone. This leaflet answers some
common questions about Serzone. It does not contain all the available
information. Some of the information it contains may not apply to you. It does
not take the place of talking to your doctor or pharmacist. Do not throw this
leaflet away. You may need to refer to it again later.
Always follow the instructions that your doctor and pharmacist give you about
Serzone. If you have any concerns about taking Serzone, ask your doctor or
pharmacist.
What is Serzone?
Serzone is a trade name (manufacturer's name) for the medicine, nefazodone
hydrochloride. This medicine is present in the tablets your doctor has
prescribed for you.
What is Serzone used for?
Serzone is an antidepressant, a medicine used to treat depression.
What does Serzone do and how does it work?
Serzone tablets contain nefazodone hydrochloride. Nefazodone hydrochloride is
a medicine which can correct the imbalance of certain chemical substances that
can occur within the brains of depressed people. Restoration of the normal
balance of these brain chemicals returns brain function to normal and lifts
depression, usually within a few weeks of starting the medicine. Nefazodone
hydrochloride is a different type of antidepressant to any currently in use.
Your doctor will tell you why you need to take Serzone. Never let any one else
take your medicine.
What should my doctor know before I take Serzone?
Before taking Serzone for the first time, tell your doctor if you:
- are pregnant or may become pregnant
- are breastfeeding or intend to breastfeed
- are or have ever been suicidal or have ever tried to commit suicide
- are or have recently been taking any other medicines or drugs, but
particularly any other antidepressant medicines, or medicines known as
monoamine oxidase inhibitors (e.g. Eldepryl®, Aurorix®,
Nardil ®), Parnate®), or antihistamines for hay fever,
allergies, or symptoms of colds or flu (e.g.Hismanal®, Teldane®),
Seldane®, Alleract D®), or medicines taken to lower
blood pressure, or triazolam (Halcion®), or alprazolam (Xanax®,
Kalma®, Ralozan®), or cisapride (Prepulsid®),
or fluoxetine (Prozac®, Erocap®, Lovan®,
Zactin®), or some medicines that lower cholesterol - simvastatin
(Zocor®, Lipex®), atorvastatin (Lipitor®) or
lovastatin, or carbamazepine (Tegretol®, Teril®).
NOTE: the names of the medicines are included as examples and are not a
complete list.
You must tell your doctor if you are taking any other medicines. - have or have had heart problems (e.g. angina, heart attack) or strokes
- have ever been diagnosed as having mania or hypomania, or as being manic
or manic-depressive - have or have had any diseases of the kidneys or liver
- have pre-existing liver problems, or take other medicines or drugs which
may affect the liver, or drink alcohol - have had fits, convulsions or epilepsy
- have had an abnormal reaction or allergy to Serzone (or to any other
antidepressant) or to any ingredient listed at the end of this leaflet (signs
of an allergic reaction may include itchy skin rash, shortness of breath, or
swelling of your face or tongue). - have had an allergic reaction to any food, preservative or dye.
- have or have had breast cancer.
What should I know before taking Serzone?
Before taking Serzone, you should be aware that:
- you need to discuss with your doctor the potential risks and benefits of
taking Serzone if you are pregnant, may become pregnant, are breastfeeding, or
intend to breastfeed - Serzone should not be taken by patients under 18 years of age
- you should talk to your doctor before taking any other medicines for the
treatment of depression - you should not take Serzone if you are taking other medicines or
drugs which your doctor has not been told about - you must not take Serzone at the same time or within 2 weeks after
stopping a monoamine oxidase inhibitor (MAOI) medicine, as it can cause
serious and possibly life-threatening reactions. Examples of MAOIs
are phenelzine (Nardil®), tranylcypromine (Parnate®) and
selegiline (Eldepryl®). There may be others, so please check with
your doctor. - if your doctor wants you to take a MAOI you must stop taking Serzone
tablets at least one week before starting the MAOI - you must not take Serzone at the same time as some antihistamines
[e.g. astemizole (Hismanal®) or terfenadine(Teldane®,
Seldane®, Alleract D®)] used to treat hay fever,
allergies, or used in medicines to treat the symptoms of colds or flu because
taken together they can cause serious, possibly life-threatening problems. - you must not take Serzone at the same time as a medicine called cisapride
which is used to treat certain gastrointestinal disorders, as it can cause
serious and possibly life-threatening heart problems - you should discuss , with your doctor, the precautions you should take if
you are also taking medicines to lower blood pressure - Serzone can cause dizziness, lightheadedness or fainting, especially when
you get out of bed or up from a chair. This effect which may be worse if you
have heart problems, have had a stroke, are taking medicines to lower blood
pressure, or become dehydrated (i.e. low on body fluids, perhaps because you
have been sweating a lot and not replacing lost fluids). Tell your doctor if
you suffer from any of these problems - you should not drink alcohol while taking Serzone.
Can I drive or operate machinery while using Serzone?
In some people, dizziness, lightheadedness, drowsiness, or confusion have
occurred, particularly when nefazodone was first started. Make sure you are not
affected by Serzone before you drive a vehicle or operate machinery or are
responsible for the care of others, especially during initial dosing.
How should I take Serzone?
Serzone should be used only as directed by your doctor.
It is very important that you always follow your doctor's instructions
about how much Serzone you take, how often you should take it and for how long.
Do not stop taking Serzone without first checking with your doctor.
If your doctor has given you a Serzone Starter Pack you should follow the
dosage instruction sheet that the doctor has completed and which will be
supplied with the pack. If the instruction sheet has not been completed by your
doctor, contact your doctor again and get written instructions before you start
taking the tablets.
Serzone tablets are taken by mouth. Serzone is usually started at a dose of
100mg twice daily, then increased by 100 or 200mg per day on a weekly basis
depending on how you respond to the drug. Your doctor will decide which changes,
if any, should be made to your dosage. Most patients' depression can be treated
effectively with doses of 300 to 600mg per day. As with all antidepressants,
Serzone may need to be taken for several weeks to obtain the full benefit of the
drug.
If you are over 65 years of age, Serzone will be started at half the usual
starting dose (50mg twice daily). Lower starting doses of Serzone may also be
prescribed for other patients.
There should be a gap of at least 14 days between stopping a monoamine
oxidase inhibitor medicine (see above) and starting Serzone. In addition, there
should be a gap of at least seven days between stopping Serzone and starting a
monoamine oxidase inhibitor medicine.
If you think that the packaging for Serzone is faulty or has been tampered
with or if the tablets do not look right, do not take Serzone. Show the pack and
the tablets to your pharmacist.
What should I do if I forget a dose of Serzone?
If you forget to take one or more doses of Serzone, take your next dose at
the normal time and in the normal amount. Do not take any more than your doctor
prescribed. If you take too much Serzone, see your doctor or go to hospital
immediately.
Should I take Serzone with other medicines?
Some medicines can affect the way Serzone works. You should always tell your
doctor about any other medicines that you take, even if you have bought the
medicines without a doctor's prescription. It is especially important that you
tell your doctor if you are currently taking, have been taking, or intend to
take, any of the following:
- any antidepressant medicine
- monoamine oxidase inhibitor medicines (eg. Eldepryl®, Aurorix®,
Nardil®, Parnate®) - antihistamines for hay fever, allergies, or to relieve the symptoms of
colds or flu [e.g.astemizole (Hismanal®), terfenadine (Teldane®,
Seldane®, Alleract D®)] - medicines which lower blood pressure
- calcium channel blockers eg, amlodipine (Norvasc®); nifedipine
(Adalat®) - medicines which cause sleepiness, ie. sleeping pills, sedatives, hypnotics
[eg. triazolam (Halcion®), alprazolam (Xanax®, Kalma®,
Ralozan®), midazolam (Hypnovel®]. - fluoxetine (Prozac®, Erocap®, Lovan®,
Zactin®), or buspirone (Buspar®), or cyclosporin, or
clarithromycin (Klacid®), or erythromycin, or ketoconazole (Nizoral®),or
vinblastine, or digoxin, or propanolol. - a medicine called cisapride (Prepulsid®)
- a medicine called carbamazepine (Tegretol®, Teril®)
- some medicines that lower cholesterol e.g. simvastatin (Zocor®,
Lipex®), atorvastatin (Lipitor®) or lovastatin.
What side effects might Serzone cause?
All medicines, including Serzone, can sometimes cause unwanted effects.
Serzone can cause lightheadedness and fainting on standing, a side effect which
can be worse in patients with heart problems, those who have had a stroke,
patients who are taking medicines to lower blood pressure, or those who become
dehydrated. If you take medicine to lower cholesterol you must tell your doctor
immediately if you have unexplained muscle pain, tenderness or weakness, or
severe pain anywhere else. Rarely, a very small number of patients on Serzone
have experienced a reduction in the speed at which the heart beats, or
convulsions, or prolonged or inappropriate erections. If you have any of these
serious side effects contact your doctor immediately.
In rare circumstances, Serzone has been associated with hepatitis or liver
damage. Symptoms of liver damage include yellowing of the skin or whites of the
eyes, vomiting, pale stools, stomach pain and swelling, dark urine, weight loss,
swelling of hands, ankles or feet, reduced urine output, impaired consciousness,
general feeling of unwellness/sickness or a high temperature.
Although these symptoms may not be due to any damage to your liver it is
important that you contact your doctor immediately if you notice any of them.
Your doctor can check to find out what is causing the symptoms and let you know
if you should stop Serzone. You need to make sure of what is causing your
symptoms. Although it is extremely rare, a very small number of patients who
were taking Serzone have suffered serious, potentially life threatening, liver
disease.
The most common side effects of Serzone are dry mouth, nausea, drowsiness,
dizziness/lightheadedness, constipation, lack of energy, headache and blurred
vision. These side effects may decrease gradually over the first six weeks of
therapy.
This is not a complete list of side effects. If you have a side effect or any
other problem which worries you while taking Serzone, tell your doctor as soon
as possible.
What should I do if someone takes an overdose of Serzone?
Immediately telephone your doctor or Poisons Information Centre (in Australia
telephone 131126), (in New Zealand telephone 0800 POISON or 0800 764 766); or go
to casualty at your nearest hospital, if you or anyone else may have taken too
much Serzone
Is there any other information that I should know about?
Serzone does not appear to be addictive or habit-forming. Serzone is
available only upon prescription from your doctor. Do not stop taking Serzone
unless your doctor tells you to.
How should I store Serzone?
The expiry date for Serzone is marked on its packaging. Do not take Serzone
after this date or if Serzone starts to change in appearance, colour or taste.
Keep all medicines out of reach of children. Store Serzone at room temperature,
below 30 degrees Celsius.
Product description
What it looks like
Serzone 50mg tablets - pink, hexagonal, flat -faced, bevelled -edged tablets
with 50 on one side. Packs of 14. AUST R 57705 (blister).
Serzone 100mg tablets - white, hexagonal, flat-faced, bevelled-edged tablets
with 100 on one side and bisect scores on both sides. Packs of 14 & 56 . AUST R
57706 (blister).[The 56 tablet pack is not available in New Zealand]
Serzone 200mg tablets - light-yellow, hexagonal, flat-faced, bevelled-edged
tablets with 200 on one side . Packs of 14 & 56. AUST R 57708 (blister)
Serzone 300mg tablets - peach, hexagonal, flat-faced, bevelled-edged tablets
with 300 on one side and bisect scores on both sides. Packs of 56 . AUST R 57710
(blister) [This strength is not available in New Zealand]
Starter pack containing, in sequence, one blister platform of 14 Serzone
Tablets 50mg, one blister platform of 14 Serzone Tablets 100mg and one blister
platform of 14 Serzone Tablets 200mg. AUST R 58862
Active ingredients
Serzone 50mg tablets - 50mg nefazodone hydrochloride per tablet.
Serzone 100mg tablets - 100mg nefazodone hydrochloride per tablet
Serzone 200mg tablets - 200mg nefazodone hydrochloride per tablet.
Serzone 300mg tablets - 300mg nefazodone hydrochloride per tablet.
Other ingredients
Serzone tablets contain microcrystalline cellulose, povidone, sodium starch
glycollate, colloidal silicon dioxide, magnesium stearate, and iron oxides (red
- 50mg, 300mg and/or yellow 200mg, 300mg) as colours.
How current is this information and where can I find out more?
This leaflet was produced based on information known by Bristol-Myers Squibb
Australia Pty Ltd in January 1999. You need to consult your doctor regularly as
your doctor has access to information on any changes which may affect you.