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TEVA UK Ref: 231-30-83780-B LEA TRAZODONE CAP TUK <RIV	Version: 1	10 March 2014		TEVA UK Ref: 231-30-83780-B LEA TRAZODONE CAP TUK <RIV	Version: 1	10 March 2014

TRAZODONE HYDROCHLORIDE 50 mg AND 100 mg CAPSULES

PACKAGE LEAFLET: INFORMATION FOR USER

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 signs of illness 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 Trazodone is and what it is used for

2.    What you need to know before you take Trazodone

3.    How to take Trazodone

4.    Possible side effects

5.    How to store Trazodone

6.    Contents of the pack and other information

[1 What Trazodone is and what it is used for

Trazodone belongs to a group of drugs known as antidepressants. They help to make you feel less depressed and less anxious. Trazodone is used: to treat depression to treat anxiety

to treat depression with anxiety.

^2 What you need to know before you take Trazodone

Do not take Trazodone if you:

•    are allergic (hypersensitive) to Trazodone Hydrochloride or any of the other ingredients of this medicine

•    are a heavy drinker of alcohol and had hypnotics (sleeping tablets) poisoning

•    have heart failure, or have had heart failure in the past.

Warnings and precautions Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

•    if you have previously had thoughts about killing or harming yourself

•    if you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Talk to your doctor or Pharmacist before taking Trazodone if you

•    are pregnant or trying to become pregnant

•    are breast-feeding

•    have epilepsy

•    have liver problems

•    have kidney problems

•    have heart problems including an irregular heart beat (such as a slower heart beat)

•    have problems with urinating or with your prostate

•    have an overactive thyroid gland which can cause increased appetite, weight loss or sweating have yellowing of your skin and eyes (jaundice)

•    have or have ever had glaucoma (signs include painful eyes with blurred vision)

•    have suffered from a manic depressive phase (bipolar disorder) or schizophrenia. If you have a manic phase, contact your doctor immediately. are elderly as you may be more prone to side effects are taking any medicines that affect your heart beat.

Withdrawal reactions:

When stopping treatment with Trazodone it is recommended to reduce the dose gradually over a period to minimise symptoms such as nausea, headache and the general feeling of being unwell. Other medicines and Trazodone When Trazodone is taken with other medicines that act on the brain, the combination may make you more drowsy. These medicines include: medicines used in the treatment of mental conditions (antipsychotics, hypnotics, sedative/anxiolytics) and drugs used in the treatment of allergies (antihistaminics).

Tell your doctor if you are taking, have recently taken or might take any of the following:

•    muscle relaxants

•    other anti-depressants including MAOIs, or have taken them within the past two weeks

•    sedatives e.g. barbiturates

•    oral contraceptives

•    phenytoin and carbamazepine (for treatment of epilepsy)

•    cimetidine (used to treat stomach acid problems)

•    drugs to treat high blood pressure or heart disease e.g. clonidine, digoxin, as dose reduction might be required

•    erythromycin (for treatment of bacterial infection)

•    ketoconazole, itraconazole (for treatment of fungal infection)

•    ritonavir, indinavir (medicines to treat HIV infections)

•    nefazodone (medicine to treat depression)

•    tricyclic antidepressants (e.g. amitriptyline, imipramine, lofepramine)

•    phenothiazines (e.g. chlorpromazine, fluphenazine, levomepromazine, perphenazine)

•    warfarin (to prevent blood clotting)

•    levodopa (a medicine to treat parkinson's disease)

•    fluoxetine (anti-depressant)

•    anaesthetics

•    medicines to treat abnormal heart rhythm

•    drugs containing Hypericum perforatum.

Tell the hospital or dentist you are taking Trazodone if you need to have an operation requiring an anaesthetic.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Trazodone with food, drink and alcohol

•    Do not drink alcohol while taking Trazodone. This is because alcohol may increase the sedative effect of Trazodone.

Pregnancy, breast-feeding and fertility

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking this medicine. You must speak to your doctor about the possible effects this medicine might have on your baby before you take this medicine. Trazodone is not recommended if you are pregnant or breast-feeding. Driving and using machines Trazodone Capsules may make you feel drowsy, give you blurred vision or affect your concentration. You should not drive or use machines when you first start to take this medicine until you are certain that you are not getting these side effects. If in any doubt, speak to your doctor before you drive or use machines.

Trazodone contains lactose

•    Patients who are intolerant to lactose should note that Trazodone Capsules contain a small amount of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

a How to take Trazodone

Always take Trazodone exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The capsules should be swallowed preferably with a glass of water.

The usual dose is:

Depression and depression with anxiety

•    Adults:

The usual starting dose is 150 mg a day, taken as divided doses after food or as a single dose before you go to bed. If necessary your doctor may increase the _dose up to 300 mg a day.