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Focus Pharmaceuticals Ltd

PACKAGE LEAFLET: INFORMATION FOR THE USER

Trazodone Hydrochloride 50mg/5ml Oral Solution

Trazodone Hydrochloride

Seven important things you need to know about Trazodone Oral Solution.

You should read all of this leaflet carefully before taking your medicine. It includes a lot of additional important information.

■    Trazodone Oral Solution treats depression and depression accompanied by anxiety. Like all medicines it can cause side effects. Before you start taking your medicine it is important that you and your doctor discuss the benefits of treatment against the possible side effects (see section 4, Possible side effects).

■    Trazodone Oral Solution should not be used by children and adolescents under 18 years old (see section 3, How to take Trazodone Oral Solution).

•    Some people who are depressed or anxious think of harming or killing themselves. If you start to feel worse, or think of harming or killing yourself, see your doctor or go to a hospital straight away (see section 4, Possible side effects).

■    Trazodone Oral Solution may not work straight away. Some people taking antidepressants feel worse before feeling better. Your doctor should ask to see you again in a couple of weeks after you first start treatment. Tell your doctor if you haven’t started feeling better (see section 3, How to take Trazodone Oral Solution).

■    Don't stop taking Trazodone Oral Solution without talking to your doctor

(see section 3, How to take Trazodone Oral Solution).

•    Taking some other medicines with Trazodone Oral Solution can cause problems. You may need to talk to your doctor (see section 2, Before you take Trazodone Oral Solution).

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Read all of this leaflet. It includes a lot of important information about this medicine.

This medicine has been prescribed for you. Do not pass it onto others. It may harm them, even if their symptoms are the same as yours.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

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.

In this leaflet:

1.    What Trazodone Oral Solution is and what it is used for

2.    Before you take Trazodone Oral Solution

3.    How to take Trazodone Oral Solution

4.    Possible side effects

5.    How to store Trazodone Oral Solution

6.    Further information

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1.    What Trazodone Oral Solution is and what it is used for

Your medicine is called Trazodone Hydrochloride 50mg/5ml Oral Solution (called Trazodone Oral Solution throughout the rest of this leaflet).

What this medicine does

Your doctor has prescribed Trazodone Oral Solution to treat depression, including depression accompanied by feelings of anxiety.

Trazodone hydrochloride belongs to a group of medicines called antidepressants. Everyone has natural substances called serotonin and noradrenaline in their brain which help to lighten your mood. People who are depressed or anxious have lower levels of serotonin and noradrenaline than others. Trazodone works by helping to prolong the mood lightening effect of serotonin and noradrenaline which has been released in the brain.

-(S)^-

2.    Before you take Trazodone Oral Solution

Do not take Trazodone Oral Solution:

•    if you are allergic (hypersensitive) to trazodone or any of the other ingredients of Trazodone Oral Solution (see section 6, Further information);

•    if you are a heavy drinker or are taking sleeping tablets;

•    if you have recently had a heart attack.

Symptoms of an allergic reaction may include a red and lumpy skin rash, difficulty breathing, swelling of eyelids, face, lips, mouth or tongue, unexplained high temperature (fever) and feeling faint. If the swelling affects your throat and makes breathing and swallowing difficult, go to hospital straight away.

Discuss with your doctor or pharmacist if any of the following apply to you:

•    if you have problems with your liver, kidneys or heart;

•    if you have epilepsy (fits). Your doctor will monitor your dosage carefully;

•    if you have an overactive thyroid gland (hyperthyroidism);

•    if you have difficulty passing water (urine), or need to pass water more frequently;

•    if you suffer from increased pressure or pain in the eye (narrow angle glaucoma);

•    if you suffer from schizophrenia or any other type of mental disorder. If you start to have a manic period whilst taking this medicine, tell your doctor immediately;

•    if you are an older person, as you may be more likely to suffer from side effects.

Take special care when using Trazodone Oral Solution

•    Trazodone should not be used in children and adolescents under 18 years old.

•    If you are having a surgical operation or dental procedure, where you will be put to sleep, tell your doctor you are taking Trazodone Oral Solution as it may affect drugs you are given during the procedure.

Using other medicines with Trazodone Oral Solution

Make sure that your doctor knows if you are taking another medicine

listed here:

•    Erythromycin (an antibiotic, used to treat infections); if taken with trazodone, you may have more serious side effects and your doctor may decide to change your dose of Trazodone Oral Solution.

•    Ketoconazole or Itraconazole (used to treat fungal infections); if taken with trazodone, you may have more serious side effects and your doctor may decide to change your dose of Trazodone Oral Solution.

•    Ritonavir or Indinavir (for HIV infections); if taken with trazodone, your doctor may need to change your dose of Trazodone Oral Solution and you may experience increased side effects.

•    Carbamazepine (used to control epilepsy and also to treat serious mood disorders e.g. manic depression); if taken with trazodone, your doctor will need to monitor you carefully and may need to change your dose of Trazodone Oral Solution.

•    Muscle relaxants such as diazepam (used to relieve muscle spasms); if taken with trazodone, your doctor may need to change your dose of muscle relaxant.

•    Inhaled anaesthetics (used to put you to sleep prior to an operation), or other muscle relaxants (used to relax the muscles prior to surgical procedures); if you are planning to have an operation, tell the anaesthetist, or dentist, that you are taking Trazodone Oral Solution.

•    Other sedative and antidepressant drugs e.g. diazepam (a sedative, used to help you relax) and citalopram, nefazodone or fluoxetine (used for treating depression); if taken with trazodone, you may have more serious side effects and your doctor may decide to change your dose of Trazodone Oral Solution.

•    Antidepressant medicines known as tricyclics e.g. amitriptyline; your doctor may decide not to give you trazodone at the same time due to the possibility of increased side effects.

•    Monoamine Oxidase Inhibitors (MAOIs) such as phenelzine, isocarboxazid, tranylcypromine and moclobemide, used to treat depression and selegiline, used to treat Parkinson's disease.

-    Wait 14 days after stopping an MAOI before you take Trazodone Oral Solution.

-    Wait 7 days after stopping Trazodone Oral Solution before starting an MAOI.

•    Clonidine (used to treat high blood pressure, migraine and menopausal flushing); if taken with trazodone, this medicine may not be as effective.

•    Other drugs used to treat high blood pressure e.g. captopril, valsartan; if taken with trazodone, these medicines may not be as effective.

•    Digoxin (used to treat heart failure and other heart problems); if taken with trazodone, your doctor will need to monitor you carefully.

•    Phenytoin (used to control epilepsy); if taken with trazodone, your doctor will need to monitor you carefully.

•    Oral contraceptives; if taken with trazodone, your doctor may need to change your dose of Trazodone Oral Solution.

•    Barbiturates (medicines to help you sleep); if taken with trazodone, your doctor may need to change your dose of Trazodone Oral Solution.

•    Cimetidine (for heartburn and stomach ulcers); if taken at the same time as trazodone, you may experience increased side effects.

•    Levodopa (used to treat Parkinson's disease); if taken with trazodone, this medicine may not be as effective.

•    Medicines for treating mental illnesses (phenothiazines) e.g. chlorpromazine, fluphenazine, levomepromazine or perphenazine; if taken with trazodone, you may experience increased side effects.

•    St. John's Wort (a herbal remedy for depression); if taken with trazodone, you may experience increased side effects.

•    Warfarin (used to thin the blood); if taken with trazodone, the time it takes your blood to clot could be affected.

Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines; including ones you have bought yourself.

Taking Trazodone Oral Solution with food and alcohol

•    Trazodone Oral Solution can be taken with, or without food (see section 3, How to take Trazodone Oral Solution). Taking Trazodone Oral Solution with food can help to lower the chances of side effects such as feeling or being sick.

•    You should avoid drinking alcohol whilst taking Trazodone Oral Solution. Pregnancy and breast-feeding

If you are pregnant, thinking of becoming pregnant, or breast-feeding, ask your doctor or pharmacist for advice before taking Trazodone Oral Solution.

If you have been taking Trazodone Oral Solution during the late stages of pregnancy, your baby may experience withdrawal symptoms when they are born.

Driving and using machines

Trazodone Oral Solution may make you feel drowsy, therefore care should be taken when driving or operating machinery.

Do not drive or use machines if you feel dizzy, sleepy, or your coordination is affected.

Important information about some of the other ingredients in Trazodone Oral Solution

Your medicine contains:

•    Sodium saccharin and sodium citrate - this medicinal product contains 0.13mmol (or 3mg) sodium per 5ml spoonful. To be taken into consideration by patients on a controlled sodium diet.

•    Sorbitol (E420) - if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

-(2©- 3.    How to take Trazodone Oral Solution Always take Trazodone Oral Solution exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. •    Your doctor may tell you to take your medicine either in divided doses, after food, or as a single dose before you go to bed. •    This medicine must not be mixed with other medicines. Adults •    The usual starting dose is I5ml (150mg trazodone hydrochloride) daily; •    this may be increased to 30ml (300mg trazodone hydrochloride) daily; •    if you are in hospital you may be given a higher dose, of up to 60ml (600mg trazodone hydrochloride) daily. Children and adolescents under 18 years of age •    Trazodone Oral Solution should not be given to children and adolescents under 18 years of age. Frail or older people •    The usual starting dose is 10ml (lOOmg trazodone hydrochloride) daily; •    this may be increased gradually to a maximum of 30ml (300mg trazodone hydrochloride) daily. It may take 1 to 2 weeks of treatment before you begin to feel better. This is normal for this type of medicine. Your doctor should ask to see you 3 to 4 weeks after you start taking your medicine. If you do not feel any better, tell your doctor. You must continue to take your medicine for as long as the doctor tells you to even if you feel better; this may be for several months after you start to feel better. Do not stop taking Trazodone Oral Solution suddenly. Your doctor will tell you how to reduce your dose gradually to help lower the chance of you getting withdrawal symptoms. Stopping Trazodone Oral Solution suddenly can lead to withdrawal symptoms such as feeling sick, headaches and feeling generally unwell. If you take more Trazodone Oral Solution than you should •    If you take more Trazodone Oral Solution than your doctor has told you to, contact your nearest hospital or casualty department immediately and take your Trazodone Oral Solution with you. •    Symptoms of overdose may include feeling sick or being sick, drowsiness, dizziness or feeling faint, seizures (fits), confusion, breathing difficulties, fast, slow or uneven heartbeat, coma or hyponatraemia (abnormally low levels of sodium in your blood). If you forget to take Trazodone Oral Solution •    If you forget to take a dose, do not worry. Take the next dose when it is due. •    Do not take double the amount to make up for a forgotten dose. -—- 4.    Possible side effects Like all medicines. Trazodone Oral Solution can cause side effects, although not everybody gets them. If you have any of the following side effects while taking your medicine tell your doctor immediately or go to hospital straight away: •    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 in suicidal behaviour in young 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. •    Severe allergic reaction which may include a red and lumpy skin rash, difficulty breathing, swelling of eyelids, face, lips, mouth or tongue, unexplained high temperature (fever) and feeling faint. If the swelling affects your throat and makes breathing and swallowing difficult, go to hospital straight away. •    You have convulsions or fits. •    You feel agitated, confused, restless, sweating, shaking, shivering, hallucinating (experiencing strange visions or sounds), sudden jerks of the muscles, a fast heartbeat, high temperature (fever). You may have a condition called Serotonin Syndrome. •    You have a high temperature (fever), sweating, experience changes in your blood pressure, a feeling of being dazed or almost unconscious and muscle stiffness. You may have a rare condition called Neuroleptic Malignant Syndrome. •    You feel tired, weak, have muscle cramps, headache, nausea or vomiting, feel confused, have fits. You may have a condition called hyponatraemia (abnormally low levels of sodium in your blood). •    You get infections more easily than normal, you bruise more easily than normal, or you start to suffer from tiredness, weakness, or feel faint and dizzy. You may have certain blood disorders. •    You experience frequent infections with high temperature, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called leucopenia. •    Yellowing of the skin and whites of the eyes (jaundice). This could mean that your liver is not working properly. •    Some men have experienced long-lasting and painful erections with trazodone. If this happens to you it is important that you stop taking your medicine and tell your doctor immediately. •    You have a fast, irregular heart beat, fainting which could be symptoms of a life threatening condition known as Torsade de Pointes. •    You have stomach pain or bloating, are constipated or have diarrhoea and are vomiting. This could be a sign that your intestine is not working properly. •    You feel tired, faint or dizzy, as well as having pale skin. You may have a condition called anaemia. •    concentrated urine (dark in colour), feel or are sick, have muscle cramps, confusion and fits (which may be due to inappropriate anti-diuretic hormone secretion). If you have these symptoms contact your doctor as soon as possible.		Other possible side effects: •    you may feel sleepy when you first start taking Trazodone Oral Solution. This should wear off as you continue to take the oral solution. •    dizziness, possibly with a “spinning" sensation (vertigo) or disorientation •    headache •    feeling or being sick •    weakness •    feeling less alert •    altered taste, loss of appetite, weight loss •    increased appetite •    shaking (tremors) •    dry mouth or increased saliva •    a feeling of irregular and/or forceful beating of the heart (palpitations) •    slow or fast heart beat •    low blood pressure (leading to fainting or feeling dizzy) when you stand up if sitting or sit up after lying down, fainting spells •    high blood pressure •    swelling (fluid retention) •    constipation •    diarrhoea •    blurred vision •    feeling restless, difficulty in falling asleep •    becoming confused, difficulty concentrating •    memory loss •    strange dreams •    anxiety, agitation or nervousness •    becoming aggressive •    believing things that are not true •    strange visions or sounds (hallucinations) •    mania (great excitement, difficulty in concentrating or staying still) •    decreased sex drive •    skin rash, itching skin •    uncontrolled muscle contractions leading to abnormal movements and posture or twitching of the muscles •    difficulty speaking •    tingling, a feeling of pins and needles, and very sensitive skin •    blocked nose •    becoming short of breath •    indigestion or stomach upset, pain in your stomach •    sweating more than usual •    back pain, aching limbs, pain in muscles and joints •    difficulty passing urine or not being able to pass urine •    flu-like symptoms, tiredness, chest pain and fever •    higher levels of liver enzymes in your blood (shown by a blood test) •    higher than normal number of white blood cells (shown by a blood test) See section 2 of this leaflet for side effects that may be caused by some of the ingredients in your medicine (Important information about some of the other ingredients in Trazodone Oral Solution).		If you have any other symptoms that you do not understand, tell your doctor or pharmacist. Reorting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any 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. -(D- 5.    How to store Trazodone Oral Solution Keep out of the sight and reach of children. Do not use after the expiry date stated on the carton and bottle label. The expiry date refers to the last day of that month. Do not store above 25°C. Keep bottle in the outer carton in order to protect from light. Once opened, use within one month. Do not use if you notice any visible signs of damage to the bottle or deterioration in your medicine. Return it to your pharmacist. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that have passed the expiry date or have been open for more than one month. These measures will help to protect the environment. -—-©" 6.    Further information What Trazodone Oral Solution contains -    The active substance is trazodone hydrochloride. Each 5ml of Trazodone Oral Solution contains 50mg of trazodone hydrochloride. -    The other ingredients are benzoic acid, sodium saccharin, hypromellose, sorbitol (E420), glycerol, orange flavour, citric acid monohydrate, sodium citrate and purified water (see section 2, Before you take Trazodone Oral Solution). What Trazodone Oral Solution looks like and contents of the pack Trazodone Oral Solution is a colourless to yellowish clear solution with an orange odour. It is available in an amber glass bottle containing 120ml of medicine. Marketing Authorisation Holder Focus Pharmaceuticals Limited, Capital House, 1st Floor, 85 King William Street, London EC4N 7BL, UK. Manufacturer HELP S.A., Pedini loannina, 45500 loannina, Greece. For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above. This leaflet was last revised in 08/2015. 103491/LF/286/02