Trazodone hydrochloride 50 mg/5ml oral solution

• 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.

1. What Trazodone hydrochloride oral solution is and what it is used for
2. What you need to know before you use Trazodone hydrochloride oral solution
3. How to use Trazodone hydrochloride oral solution
4. Possible side effects
5. How to store Trazodone hydrochloride oral solution
6. Contents of the pack and other information

• you are allergic to active substance 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
• 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 before taking trazodone.

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 trazodone 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 Trazodone hydrochloride”).

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

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.

Tell your doctor or pharmacist if you are taking or have recently taken 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 works.

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

• MAOI (Monoamine oxidase inhibitors) medicine 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)

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

You should avoid drinking alcohol while taking trazodone.

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant.

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

If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine.

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

• This medicine contains 1700 mg 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 or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
• This medicine contains 2.5 mg benzoic acid in each 5ml and max. 9.9 mg of propylene glycol in each 5ml.
• This medicine contains less than 1 mmol sodium (23 mg) per dose that is to say essentially ‘sodium-free’.
• This medicine contains glycerol which may cause headache, stomach upset and diarrhoea.

• Take this medicine by mouth.
• The measuring cup should be rinsed with water immediately after administration.
• Take with or after food. This can help lower the chances of side effects
• If you have been told to take trazodone only once each day then you should take it before going to bed
• If you feel the effect of your medicine is too weak or strong, do not change the dose yourself, but ask your doctor

Adults:

Depression

• Adults usually start by taking 150mg (15ml) each day
• Your doctor may increase the dose to 300mg (30ml) each day depending on your condition
• For adults in hospital the dose may be as high as 600mg (60ml) each day

Anxiety

• Adults usually start by taking 75mg (7.5ml) each day
• Your doctor may increase the dose to 300mg (30ml) each day

Elderly:

• Older people or those who are frail will usually be given a starting dose of 100mg (10ml) each day
• Doses of more than 300mg (30ml) will not normally be given

Take the required dose of Trazodone oral solution using the measuring cup graduated at 3.75 ml, 5.0 ml, 7.5 ml, 10 ml, 15 ml and 20 ml markings. Each 5 ml of oral solution corresponds to 50 mg of trazodone hydrochloride.

If you take more trazodone than you should, tell a doctor or go to a hospital casualty department straight away.

Always take any medicine left over with you along with the box, as this will allow easier identification of the medicine. The following effects may happen:

Feeling sick or being sick, feeling sleepy, dizzy or faint, fits (seizures).

Confusion, breathing or heart problems.

If you forget to take a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.

Do not take a double dose to make up for a forgotten dose.

Keep taking trazodone until your doctor tells you to stop. Do not stop taking trazodone just because you feel better.

When your doctor tells you to stop taking this medicine he/she will help you to stop taking it gradually.

• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty swallowing or breathing, itching of the skin and nettle rash. This may mean you are having an allergic reaction to trazodone.
• Painful erection of the penis, unrelated 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 disorder (agranulocytosis).
• Bruising more easily than usual. This could be because of a blood disorder (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).

• You have thoughts of harming or killing yourself
• Feeling tired, faint, dizzy, having pale skin. These could be signs of anaemia
• Convulsions/fits
• Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin (parasthesia)
• Feeling confused, restless, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heartbeat, you may have something called Serotonin syndrome.
• Feeling very unwell, possibly with shortness of breath (dyspnoea), difficulty in walking or walking with a shuffling gait, shaking, uncontrolled muscle twitching and a high temperature (above 38°C). This could be a rare condition known as Neuroleptic Malignant Syndrome.
• Rapid, slow or irregular heartbeat

• Feeling drowsy or sleepy, tiredness
• Feeling less alert than usual
• Feeling sick (nausea) or being sick (vomiting), indigestion
• Constipation, diarrhoea
• Dry mouth, altered taste, increased amounts of saliva, blocked nose
• Sweating more than usual
• Dizziness, headache, confusion, weakness, tremor (shaking)
• Blurred vision
• Loss of appetite and weight loss
• Feeling dizzy or light-headed on 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 cannot control, mainly in of 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)
• Severe liver disorders such as hepatitis.
• Liver failure with potential fatal outcome.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

• The active substance is trazodone hydrochloride. Each 5ml of Trazodone oral solution contains 50 mg of trazodone hydrochloride.
• The other ingredients are sorbitol, glycerol anhydrous (E422), sucralose, benzoic acid (E210), sodium hydroxide pellets (E524), purified water and orange flavour #782(containing propylene glycol).

Trazodone Oral solution is a colourless to light yellow solution with an orange flavour.

It is available in an amber coloured glass bottle with 28 mm child resistant tamper evident polypropylene closure containing 120ml of medicine. A 20 ml graduated translucent polypropylene measuring cup is available within each pack.