TRAZODONE 50MG AND 100MG CAPSULES
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
- Your doctor may have given you this medicine before, made by another company. It may have looked slightly different, but either brand will have the same effect.
In this leaflet:
- 1. What trazodone is and what it is used for
- 2. Before you take trazodone
- 3. How to take trazodone
- 4. Possible side effects
- 5. How to store trazodone
- 6. Further information
What Trazodone Is And What It Is Used For
The name of this medicine is Trazodone Hydrochloride 50mg or 100mg Capsules (called trazodone throughout this leaflet). This belongs to a group of medicines called anti-depressants.
Trazodone is used to treat anxiety and depression.
Before You Take Trazodone
Do not take trazodone and tell your doctor if
- You are allergic (hypersensitive) to trazodone, or any of the other ingredients in these capsules (see Section 6: Further Information).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
Do not take trazodone if the above applies to you. If you are not sure, talk to your doctor or pharmacist.
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.
Check with your doctor or pharmacist before taking this medicine if:
- You have ever had fits or seizures (epilepsy)
- You have severe liver, kidney or heart problems
Please talk to your doctor or pharmacist before taking trazodone if any of the above applies to you. Do this even if they applied only in the past.
Taking trazodone with other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because trazodone can affect the way some other medicines work. Also, some other medicines can affect the way trazodone works.
In particular tell your doctor or pharmacist if you are taking any of the following medicines:
- MAOI (monoamine oxidase inhibitor) medicines such as tranylcypromine, phenelzine and isocarboxazid (for depression) or selegiline (for Parkinson’s disease). Tell your doctor or pharmacist if you are taking them now or have taken them in the last 2 weeks.
- Other medicines for depression
- Medicines for epilepsy such as carbamazepine and phenytoin
- Medicines for high blood pressure such as clonidine
- Medicines for fungal infections such as ketoconazole and itraconazole
- Some medicines for HIV such as ritonavir and indinavir
- Digoxin - for heart problems
- Erythromycin – an antibiotic for infections
- Sedatives such as tranquillisers or sleeping pills
If you are not sure, talk to your doctor or pharmacist before taking trazodone.
Anaesthetics
If you are going to have an anaesthetic, tell your doctor or dentist, you are taking trazodone.
Taking trazodone with alcohol
- You should not drink alcohol while taking trazodone. This is because trazodone can change the way alcohol affects you.
Pregnancy and Breast-feeding
Talk to your doctor before taking trazodone if:
- You are pregnant, plan to get pregnant, or think you may be pregnant.
- You are breast-feeding, or planning to breast-feed.
Driving and using machines
You may feel sleepy or dizzy while taking trazodone. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of trazodone
Trazodone capsules contain lactose. If you have been told that you cannot digest or tolerate some sugars, talk to your doctor before taking trazodone.
How To Take Trazodone
Always take trazodone exactly as your doctor has told you. The dose of trazodone will depend on your needs and the illness being treated. Check with your doctor or pharmacist if you are not sure.
Taking trazodone capsules
- If trazodone is taken only once each day, you should take it before going to bed.
- Your doctor may decide you should take trazodone more than once a day.
- Take trazodone with or after food. This can help lower the chances of side effects.
Depression
Adults
- The usual dose of trazodone is 150mg each day. However, your doctor may decide to start you on a lower dose.
- This may be increased to as much as 300mg each day, depending on your illness.
- For adults in hospital the dose may be increased to 600mg each day.
Older people
- Older people or those who are frail will usually be given a starting dose of 100mg each day.
Anxiety
Adults and older people
- The usual starting dose of trazodone is 75mg each day.
- This may be increased to as much as 300mg each day.
Children
Do not give trazodone to children.
If you take more trazodone than you should
Talk to your doctor or go to the nearest hospital casualty department straight away. Remember to take with you any capsules that are left and the pack. This is so the doctor knows what you have taken.
If you forget to take trazodone
If you miss a dose do not worry. Take your normal dose when it is next due. Do not take a double dose to make up for a forgotten capsule.
Stopping treatment
- Keep taking the medicine until your doctor tells you to stop. Do not stop taking trazodone just because you feel better.
- When your doctor says that you can stop taking trazodone, you need to do this gradually. Your doctor will help you to do this.
Possible Side Effects
Like all medicines, trazodone can cause side effects, although not everybody gets them.
Stop taking trazodone and see a doctor or go to a hospital straight away if:
- You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). This may mean you are having an allergic reaction to trazodone.
- Painful erection of the penis (not related to sexual activity) that will not go away (priapism)
- Yellowing of the eyes or skin. This could be a liver problem (such as jaundice)
- Getting infections more easily than usual. This could be because of a blood problem (agranulocytosis).
- Bruising more easily than usual. This could be because of a blood problem (thrombocytopenia).
Talk to your doctor straight away if you notice the following side-effects:
- Fits or convulsions.
- Feeling confused, restless, sweating, shaking or shivering. Also strange visions or sounds (hallucinations), sudden jerks of the muscles or a fast heartbeat. This may mean you have something called “Serotonin syndrome”.
- Feeling very unwell possibly with shortness of breath, difficulty in walking or walking with a shuffling movement. Also shaking, uncontrolled muscle twitching and a high temperature. This could be a rare illness called “Neuroleptic Malignant Syndrome”.
- Feeling tired, faint, dizzy, having pale skin. These could be signs of anaemia.
If you do have any of the side-effects listed above, talk to your doctor straightaway. Your doctor may ask you to stop taking trazodone.
Other side effects include:
- Feeling drowsy or sleepy or less alert than usual
- Feeling sick (nausea) or being sick (vomiting)
- Constipation or diarrhoea
- Dry mouth or blurred vision
- Weight loss
- Dizziness, headache, confusion, weakness or tremor (shaking)
- Fast or slow heartbeat
- Feeling dizzy or light-headed when standing or sitting up quickly (postural hypotension)
- Feeling restless and having difficulty sleeping
- Water retention which may cause swollen arms or legs
- Skin rash
- Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin (paraesthsia)
If any of the side effects get serious or lasts longer than a few days, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.
How To Store Trazodone
- Keep your medicine in a safe place out of the reach and sight of children.
- Do not store above 30°C. Store in the original package in a dry place.
- Do not use this medicine after the expiry date shown on the pack.
- Ask your pharmacist how to dispose of medicines no longer required. Do not dispose of medicines by flushing down a toilet or sink or by throwing out with your normal household rubbish. This will help to protect the environment.
Further Information
What Trazodone contains
Each capsule contains 50mg or 100mg of trazodone hydrochloride as the active substance.
Other ingredients are:
50mg capsules
Lactose monohydrate,
magnesium stearate, gelatin,
titanium dioxide E171,
erythrosine E127, indigo Carmine
E132, yellow iron oxide E172
Ink (1028 (S-1-27794) or
1014 (SW-9008) Black)
100mg capsules
Lactose monohydrate,
magnesium stearate, gelatin,
titanium dioxide E171,
erythrosine E127, indigo Carmine
E132, red iron oxide E172, yellow
iron oxide E172
Ink (1028 (S-1-27794) or
1014 (SW-9008) Black)
What Trazodone looks like and contents of the pack
Trazodone 50mg Capsules are violet and green, printed with the Roussel logo on one half and R365B on the other.
Trazodone 100mg Capsules are violet and fawn, printed with the Roussel logo on one half and R365C on the other.
Trazodone Hydrochloride 50mg Capsules are supplied in blister packs of 84 capsules.
Trazodone Hydrochloride 100mg Capsules are supplied in blister packs of 56 capsules.
The Marketing Authorisation Holder is:
The Manufacturer is:
This leaflet was last revised in July 2008.
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