Do not take trazodone oral solution:

• If you are allergic to trazodone hydrochloride or any of the other ingredients of this medicine (listed in Section 6). The signs of an allergic reaction include a rash, swallowing or breathing problems, swelling of your lips, eyelids, face, throat or tongue, unexplained high temperature (fever) and feeling faint
• If you have recently had a heart attack
• If you are a heavy drinker or taking sleeping tablets
• If you are under 18 years of age.

Do not take trazodone oral solution if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking trazodone oral solution.

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.

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 oral solution or if you have some other diseases.

Talk to your doctor, pharmacist or nurse before taking trazodone oral solution if you:

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

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking trazodone oral solution.

Children and adolescents

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

Other medicines and Trazodone oral solution

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

This includes medicines you buy without prescription, including herbal medicines. This is because trazodone can affect the way some other medicines work. Also some medicines can affect the way Trazodone Oral Solution works.

Some medicines and trazodone may interfere with each other. Tell your doctor if you are taking any of the following medicines:

• MAOI (Mono Amine Oxidase Inhibitors) 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 antidepressants (such as amitriptyline or fluoxetine)
• Sedatives (Such as tranquilizers or sleeping pills)
• Medicines used to treat epilepsy (e.g. carbamazepine or phenytoin)
• Medicines used to treat high blood pressure (e.g. clonidine) or heart disease (e.g. digoxin)
• Medicines used to treat fungal infections such as ketoconazole and itraconazole
• Some medicines used to treat HIV such as ritonavir and indinavir
• Erythromycin (a type of antibiotic used to treat infections)
• Levodopa (used to treat Parkinson’s disease)
• St. John’s Wort (a herbal remedy)
• Warfarin (used to stop your blood from clotting).

Anaesthetics

If you are going to have an anaesthetic (for an operation), tell your doctor or dentist that you are taking trazodone oral solution.

Trazodone oral solution with food, drink and alcohol

You should avoid drinking alcohol while taking trazodone oral solution. This is because trazodone can change the way alcohol affects you.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Driving and using machines

Trazodone oral solution is a drug which acts on the central nervous system and may make you feel sleepy or dizzy. Do not drive, operate machinery or do anything that requires you to be alert until you know how your medicine affects you.

Trazodone oral solution contains sorbitol, propylene glycol, benzoic acid, glycerol and sodium.

Trazodone oral solution contains 2g of sorbitol in each 5ml. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you take this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

This medicine contains 15.5-16.75 mg propylene glycol in each 5ml and 5 mg benzoic acid in each 5ml.

This medicine contains glycerol which may cause headache, stomach upset and diarrhea.

This medicine contains less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially ‘sodium-free’.