Trazodone Hydrochloride 50mg/5ml Oral Solution
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE.
• 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. 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 if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
THE LEAFLET CONTAINS INFORMATION ON:
1. What trazodone hydrochloride oral solution is and what it is used for.
2. Before you take trazodone hydrochloride oral solution
3. How to take trazodone hydrochloride oral solution
4. Possible side effects
5. How to store trazodone hydrochloride oral solution
6. Further Information
1. WHAT TRAZODONE HYDROCHLORIDE ORAL SOLUTION IS
AND WHAT IT IS USED FOR?_
The name of your medicine is Trazodone hydrochloride 50mg/5ml Oral solution (called trazodone oral solution throughout this leaflet). Trazodone oral solution contains a medicine called trazodone hydrochloride which belongs to a group of medicines called antidepressants. Trazodone oral solution can be used to treat all types of depression including depression accompanied by anxiety.
2. BEFORE YOU TAKE TRAZODONE HYDROCHLORIDE ORAL
SOLUTION_
Do not take trazodone oral solution and tell your doctor if you are:
• allergic (hypersensitive) to trazodone hydrochloride or any of the other ingredients of the oral solution (listed in Section 6 Further information). The signs of an allergic reaction include a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
Do not take trazodone oral solution if the above applies to you. If you are not sure, talk to your doctor or pharmacist.
Take special care and consult with your doctor or pharmacist before you take 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
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking 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.
• 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines.
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
• Muscle relaxants and inhaled anaesthetics
• Other antidepressants such as nefazodone and sedatives
• Medicines used to treat epilepsy (e.g. carbamazepine or phenytoin)
• Medicines used to treat high blood pressure 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)
Anaesthetics
If you are going to have an anaesthetic (for an operation), tell your doctor or dentist that you are taking trazodone.
Taking trazodone oral solution with food and drink
You should avoid drinking 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 this medicine if you are:
• pregnant, might become pregnant, or think you may be pregnant.
• breast-feeding
Driving and using machines
Trazodone oral solution is a drug which acts on the central nervous system and may make you feel sleepy or less alert. Do not drive, operate machinery or do anything that requires you to be alert until you know how your medicine affects you.
Important information about some of the ingredients of trazodone oral solution
Trazodone oral solution contains sorbitol. If you have been told that you cannot digest or tolerate some sugars, talk to your doctor before taking trazodone.
Trazodone oral Solution also contains glycerol which may cause headache, stomach upset and diarrhoea
3. HOW TO TAKE TRAZODONE HYDROCHLORIDE ORAL SOLUTION_
Always take trazodone oral solution 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 this medicine
• Take this medicine by mouth
• Take with or after food. This can help lower the chances of side effects
• If you have been told to take trazodone oral solution 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 too strong, do not change the dose yourself, but ask your doctor
DEPRESSION:
Adults:
• 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
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
Children:
Trazodone oral solution is not recommended for use in children. ANXIETY:
• Adults usually start by taking 75mg (7.5ml) each day
• Your doctor may increase the dose to 300mg (30ml) each day
If you take more trazodone oral solution than you should
It is important to stick to the dose on the label of the medicine. If you or someone else takes more trazodone oral solution than you should, contact your doctor or nearest hospital emergency department immediately. Always take any medicine left over with you along with the box, as this will allow easier identification of the medicine.
If you forget to take trazodone oral solution
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose do not take a double dose to make up for a forgotten dose, just carry on as before.
If you stop taking trazodone oral solution
• Keep taking trazodone oral solution until your doctor tells you to stop. Do not stop taking trazodone oral solution just because you feel better.
• When your doctor tells you to stop taking this medicine he/she will help you stop taking them gradually.
• Stopping your medicine too quickly could cause sleep problems, leave you feeling more irritable than usual and cause you to sweat more than usual.
4. POSSIBLE SIDE EFFECTS_
Like all medicines, trazodone can cause side effects, although not everybody gets them.
Stop taking trazodone oral solution and tell your doctor immediately if you experience:
• 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 oral solution
• A long lasting and painful erection with trazodone.
• Yellowing of the eyes or skin which could be a liver problem (such as jaundice) or other abnormalities of liver function.
• 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).
Talk to your doctor straight away if you notice the following side-effects:
• 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 (paraesthesia)
• 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
The following side effects have also been reported:
• Drowsiness - this should wear off as you continue to take trazodone
• Headache, dizziness, confusion, feeling less alert, irritability,
• Sweating, unexplained fever or shivering
• Nausea and vomiting
• Constipation or diarrhoea
• Dizziness while standing up from sitting or lying
• Dry mouth and blurred vision
• Weakness
• Weight loss
• Slow or racing pulse
• Unexpected swelling (fluid retention)
• Restlessness or difficulty sleeping
• Difficulty in urination
• Skin rashes
• Any uncontrolled body movements, including tremor, twitching, spasms, muscle rigidity and an inability to sit still
Reporting of side effects
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.
5. HOW TO STORE TRAZODONE HYDROCHLORIDE ORAL
SOLUTION_
• Keep out of the sight and reach of children.
• Do not use trazodone oral solution after the expiry date, which is stated on the label and carton. The expiry date refers to the last day of the month.
• Store in the original package (bottle) in order to protect from light. This medicinal product does not require any special temperature storage conditions.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION_
What trazodone oral solution contains?
The name of this medicine is Trazodone hydrochloride 50mg/5ml oral solution.
The active substance in your medicine is trazodone hydrochloride. Each 5ml Spoonful contains 50mg of the active ingredient trazodone hydrochloride. Other ingredients include benzoic acid, glycerol, sorbitol liquid, orange favour (containing propylene glycol), sodium saccharin, sodium hydroxide and purified water.
What trazodone oral solution looks like and contents of the pack
Trazodone hydrochloride 50mg/5ml oral solution is a clear, colourless to pale yellow coloured solution, with orange colour, free from foreign particles. Each Bottle contains 120ml of solution.
Marketing Authorisation Holder & Manufacturer
The Marketing Authorisation holder of this oral solution is PRIMEGEN Limited Unit 15 Moorcroft, Harlington Road, Uxbridge, UB8 3HD United Kingdom.
This leaflet was prepared in 04/2015