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).
  Signs of an allergic reaction can include: red and lumpy skin rash, swallowing or breathing problems, swelling of your eyelids, lips, face, throat or tongue, unexplained high temperature (fever) and feeling faint
• have recently had a heart attack
• are a heavy drinker or are taking sleeping tablets
• 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 before taking Trazodone Oral Solution.

Warnings and precautions

Take special care with Trazodone Oral Solution

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.
• 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 or pharmacist 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
• are taking buprenorphine (a strong pain killer). The use of buprenorphine together with Trazodone Oral Solution can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Trazadone Oral Solution”).

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 or pharmacist 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.

Tell your doctor if you are taking any of the following medicines:

• MAOI (Monoamine Oxidase Inhibitors) medicines such as tranylcypromine, phenelzine and isocarboxazid (for depression) or selegiline (for Parkinson’s disease), or have taken them in the last 2 weeks
• other antidepressants (such as amitriptyline or fluoxetine)
• buprenorphine/opioids. These medicines may interact with Trazodone Oral Solution and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms
• sedatives (such as tranquilizers or sleeping pills)
• medicines used to treat epilepsy such as carbamazepine and phenytoin
• medicines used to treat high blood pressure, for example, clonidine
• digoxin (used to treat heart problems)
• medicines used to treat fungal infections such as ketoconazole and itraconazole
• some medicines used to treat HIV such as ritonavir and indinavir
• erythromycin, an 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.

Pregnancy, breast-feeding and fertility

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 Oral Solution 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 may make you feel sleepy or dizzy. If this happens do not drive or use any tools or machines.

Important information about some of the ingredients of Trazadone Oral Solution

• Sorbitol 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 or receive this medicine. If you are given more than 25 ml of this medicine daily, the sorbitol in this medicine may cause gastrointestinal discomfort and have a mild laxative effect.
• Ethanol This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per 30 ml.
• This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, that is to say essentially ‘sodium-free’.