Skip to content
This is a text only leaflet, designed for the visually impaired. Please visit our electronic Medicines Compendium (eMC) website to view the original document which may contain images or tables.

You may be able to get this leaflet in large print, Braille or as an audio CD, call the RNIB Medicine Leaflet line on 0800 198 5000 for more information.

 

Trazodone Hydrochloride 50mg and 100mg Capsules

Company Details

Zentiva


One Onslow StreetGuildfordSurreyGU1 4YS
Telephone:
Fax:
Medical Information Direct Line:
Medical Information e-mail:UK-medicalinformation@sanofi.com
[view all information leaflets from this company]

Patient Information Leaflet

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

Go to top of the page

1. 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.

Go to top of the page

2. 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.
  • You have recently had a heart attack
  • You are a heavy drinker or are taking sleeping tablets
  • You are under 18 years of age.

Do not take this medicine if any of 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.

Trazodone should not be used in children and adolescents under 18 years of age.

If you are elderly, you may be more prone to side effects, increased caution is necessary especially when taking other medicines at the same time as trazodone or if you have some other diseases.

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
  • Are pregnant, trying to become pregnant or are breast-feeding
  • You have an overactive thyroid gland (hyperthyroidism)
  • You have problems passing water or need to pass water (urine) frequently
  • You have narrow angle glaucoma (an eye disorder)
  • You have schizophrenia or other type of mental disorder
  • Are elderly, as you may be more prone to side effects

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 (such as amitriptyline or fluoxetine)
  • 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
  • Levodopa (used to treat Parkinson’s disease)
  • St. John’s Wort (a herbal remedy)
  • Warfarin (used to stop your blood from clotting)

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.

Taking trazodone in the late stages of pregnancy may lead to your baby experiencing withdrawal symptoms when they are born.

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.

Go to top of the page

3. 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 and adolescents under 18 years of age.

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.
Go to top of the page

4. 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).
  • You have severe abdominal pain and bloating, are being sick (vomiting) and have constipation. These may be signs that your intestine is not working properly (paralytic ilius)

Talk to your doctor straight away if you notice the following side-effects:

  • You have thoughts of harming or killing yourself
  • 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.
  • Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin (paraesthsia).
  • Rapid, slow or irregular heartbeat

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, tiredness
  • Feeling sick (nausea) or being sick (vomiting), indigestion
  • Constipation or diarrhoea
  • Dry mouth, altered taste, increased amounts of saliva, blocked nose
  • Sweating more than usual
  • Blurred vision
  • Loss of appetite and weight loss
  • Dizziness, headache, confusion, weakness or tremor (shaking)
  • Feeling dizzy or light-headed when standing or sitting up quickly (postural hypotension), fainting (syncope)
  • Feeling restless and having difficulty sleeping
  • Water retention which may cause swollen arms or legs
  • Skin rash, itching
  • Chest pain
  • Pain in limbs, back pain, pain in your muscles, pain in your joints
  • Jerking movements that you can not control, mainly in the arms and legs, uncontrolled muscle movements or twitches
  • Frequent infections with high temperature, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called leucopenia.
  • Feeling anxious or more nervous than usual, feeling agitated
  • Overactive behaviour or thoughts (mania), believing things that are not true (delusions), memory disturbance
  • Nightmares
  • Decreased sex drive
  • Feeling dizzy, possibly with a “spinning” feeling (vertigo)
  • High blood pressure
  • High temperature
  • Flu type symptoms
  • Difficulty with speaking
  • Higher than normal number of white blood cells (seen by a blood test)
  • High levels of liver enzymes in your blood (shown by a blood test)
  • Feeling tired, weak and confused, having muscle that ache, are stiff or do not work well. There may also be headache, loss of appetite, nausea or vomiting, convulsion. This may be due to low sodium levels in your blood.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

Go to top of the page

5. 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.
Go to top of the page

6. 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 and ink (black iron oxide E172, shellac, propylene glycol and ammonium hydroxide (pH adjustment) or black iron oxide E172, shellac, propylene glycol, strong ammonia solution (pH adjustment) and potassium hydroxide (pH adjustment)).

100mg capsules Lactose monohydrate, magnesium stearate, gelatin, titanium dioxide E171, erythrosine E127, indigo Carmine E132, red iron oxide E172, yellow iron oxide E172 and ink (black iron oxide E172, shellac, propylene glycol and ammonium hydroxide (pH adjustment) or black iron oxide E172, shellac, propylene glycol, strong ammonia solution (pH adjustment) and potassium hydroxide (pH adjustment)).

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:

Zentiva
One Onslow Street
Guildford
Surrey
GU1 4YS
UK

The Manufacturer is:

Fawdon Manufacturing Centre
Edgefield Avenue
Fawdon
Newcastle Upon Tyne
NE3 3TT
UK
Go to top of the page

This leaflet was last revised in July 2013.

32020104


Text size normal Text size at 110% Text size at 120%

CHANGE FORMAT

 

USEFUL INFO