Trazodone Hydrochloride 50mg/5ml Oral Solution
Package leaflet: Information for the patient
Trazodone Hydrochloride 50mg/5ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 symptoms 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.
What is in this leaflet:
1. What Trazodone Oral Solution is and what it is used for
2. What you need to know before you take Trazodone Oral Solution
3. How to take Trazodone Oral Solution
4. Possible side effects
5. How to store T razodone Oral Solution
6. Contents of the pack and other information
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
Trazodone hydrochloride belongs to a group of medicines called antidepressants. Your doctor has prescribed Trazodone Oral Solution to treat depression, including depression accompanied by feelings of anxiety.
2. What you need to know 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.
Take special care when using Trazodone Oral Solution
Trazodone should not be used in children and adolescents under 18 years old.
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.
Discuss with your doctor or pharmacist if any of the following apply to you:
• if you have epilepsy (fits). Your doctor will monitor your dosage carefully;
• if you have problems with your liver, kidneys or heart;
• 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 elderly, as you may be more likely to suffer from side effects.
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);
• Ketoconazole or itraconazole (used to treat fungal infections);
• Ritonavir or indinavir (for HIV infections);
• Carbamazepine or phenytoin (used to control epilepsy);
• Muscle relaxants such as diazepam (used to relieve muscle spasms);
• 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);
• Sedatives e.g. diazepam;
• Antidepressant medicines known as tricyclics e.g. amitriptyline and other antidepressant drugs e.g. nefazodone or fluoxetine;
• 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);
• Other drugs used to treat high blood pressure e.g. captopril, valsartan;
• Digoxin (used to treat heart failure and other heart problems);
• Oral contraceptives;
• Barbiturates (medicines to help you sleep);
• Cimetidine (for heartburn and stomach ulcers);
• Levodopa (used to treat Parkinson’s disease);
• Medicines for treating mental illness (antipsychotics) e.g. chlorpromazine, fluphenazine, levomepromazine and perphenazine;
• St. John’s Wort (a herbal remedy for depression);
• Warfarin (used to thin the blood).
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
• T razodone 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 or vision is affected.
Important information about some of the other ingredients in Trazodone Oral Solution
Your medicine contains:
• 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. If you are given more than 50ml of this medicine daily, the sorbitol in this medicine may have a laxative effect (calorific value 2.6kcal/g sorbitol).
• Glycerol (E422) - may cause a headache, an upset stomach and diarrhoea.
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.
A 20ml measuring cup is provided with your medicine.
• Using the measuring cup provided, pour out the required amount of the liquid.
• Wash the measuring cup after use and keep it safe for the next dose.
Adults
• the usual starting dose is 15ml (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.
Elderly or frail
• the usual starting dose is 10ml (100mg trazodone hydrochloride) daily;
• this may be increased to a maximum of 30ml (300mg 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.
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.
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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:
• 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 thoughts of harming or killing yourself.
• 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 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 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, or have fits. This may be due to abnormally low levels of sodium in your blood.
• You experience a headache, fatigue, more frequent infections and mouth ulcers. These could be signs of a problem with your blood.
• You have a fast, irregular heartbeat, 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.
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.
• 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.
• 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
• weight gain
• 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 or diarrhoea
• blurred vision
• feeling restless and having 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 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 upset stomach, pain in your stomach
• problems with your liver (shown by a blood test)
• sweating more than usual
• back pain, aching limbs, 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).
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 Oral Solution
Keep out of the sight and reach of children.
Do not use this medicine 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 this medicine if you notice any visible signs of damage to the bottle or deterioration in your medicine. Return it to your pharmacist.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines that have passed the expiry date or have been open for more than one month. These measures will help protect the environment.
6. Contents of the pack and other 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 (E210), sodium saccharin (E954), sorbitol (E420), glycerol (E422), orange flavour (containing ethanol, benzyl alcohol (E1519)and propylene glycol (E1520)), sodium hydroxide (for pH adjustment) and purified water.
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.
The pack also contains a 20ml plastic measuring cup.
Marketing Authorisation Holder
RMR Pharmaceuticals Ltd., Capital House, 1st Floor, 85 King William Street, London EC4N 7BL,UK.
Tel: 00 44 (0)1283 495280 Fax: 00 44 (0)1283 495290 Email: medinfo@focuspharma.co.uk
Manufacturer
Rafarm S.A., Thesi Pousi-Hatzi, Agiou Louka, Peania, Attiki 19002 PO Box 37, Greece
For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above.
This leaflet was last revised in 06/2015.
Other sources of information
For information in large print, audio CD or Braille please telephone 00 44 (0)1283 495280 or email medinfo@focuspharma.co.uk