Trazodone 100mg Capsules
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 get 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 Capsules are and what they are used for
2. Before you take Trazodone Capsules
3. How to take Trazodone Capsules
4. Possible side effects
5. How to store Trazodone Capsules
6. Further information
The name of your medicine is Trazodone 50mg or 100mg Capsules (called trazodone throughout this leaflet). Trazodone belongs to a group of medicines called antidepressants can be used to treat all types of depression including depression accompanied by anxiety.
Do not take this medicine and tell your doctor If you:
• Are allergic (hypersensitive) to trazodone hydrochloride or any of the other ingredients of the capsules (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
• Have recently had a heart attack
• Are a heavy drinker or if you are taking sleeping tablets
• Are under 18 years of age.
Do not take trazodone if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist prior to taking this medicine.
Take special care with 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. Trazodone should not be used by children or adolescents under 18 years of age.
Consult with your doctor or pharmacist before you take this medicine If any of the following apply to you:
• Epilepsy (fits or seizures)
• Severe liver, kidney or heart problems
• An overactive thyroid gland (hyperthyroidism)
• Problems passing water or needing to pass water (urine) more frequently
• Narrow angle glaucoma (an eye disease)
• Schizophrenia or other type of mental disorder
• Pregnant, trying to become pregnant or are breast-feeding
• Elderly, as you may be more prone to side effects.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking trazodone.
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. This is because 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 Parkinsoni’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 amitriptyline or fluoxetine
• Sedatives such as tranquilizers and sleeping pills
• Medicines used to treat epilepsy (e.g. carbamazepine or phenytoin)
• Medicines used to treat high blood pressure (e.g. clonidine) 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 used to treat infections)
• Levodopa (used for Parkinsoni’s disease)
• St. Johni’s Wort (a herbal medicine)
• Warfarin (a drug used to stop 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.
Taking trazodone 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
Do not take and tell your doctor before taking trazodone 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
• breast-feeding or planning to breast feed.
Driving and using machines
Trazodone 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 this medicine affects you.
Important information about some of the ingredients of trazodone
Trazodone capsules contain lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take trazodone 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. The capsules should always be taken with plenty of water. Taking trazodone with, or soon after, food will lower the risk of side effects. If you are to take your dose as a single dose it should be taken just 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 AND DEPRESSION ACCOMPANIED BY ANXIETY:
Adults:
The starting dose is 150mg each day in divided doses after food or as a single dose at bedtime. This may be increased up to 300mg each day in single or divided doses. The major portion of a divided dose is to be taken at bedtime. If you are in hospital the dose may be further increased to 600mg each day in divided doses.
Elderly:
Dosage in elderly or frail patients should be started at 100mg each day in divided doses or as a single dose at bedtime. This may be increased by your doctor depending on how you react to this medicine. Dosages above 300mg each day are unlikely to be required.
Children:
Trazodone is not recommended for use in children and adolescents under 18 years of age.
ANXIETY:
The starting dose is 75mg each day and this may be increased to 300mg each day as necessary.
If you take more trazodone than you should
It is important to stick to the dose on the label of the medicine. Do not adjust your dose without consulting with your doctor.
If you or someone else swallows several of these capsules all together, contact your doctor or nearest hospital emergency department immediately. Always take any capsules left over with you along with the box, as this will allow easier identification of the capsules.
The following effects may occur: nausea, sickness, drowsiness, dizziness, fainting, fits (seizures), confusion and problems with your heart or breathing.
If you forget to take trazodone
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
• 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 these capsules 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 and see a doctor or go to a hospital straight
away if you experience:
• A long lasting and painful erection, unrelated to sexual activity that will not go away (priapism)
• You get swelling of your face, lips, tongue, throat hands or ankles, swallowing or breathing difficulties or itching of the skin and nettle rash. This is an allergic reaction to trazodone
• Yellowing of the eyes or skin which could be a liver problem (such as jaundice) or other abnormalities of liver function
• You have severe abdominal pain and bloating, which may be accompanied by vomiting or constipation. These may be signs that your intestine is not working properly (paralytic ilius)
• Bruising more easily than usual. This could be because of a blood disorder (thrombocytopenia)
• Getting more infections than usual (sore throat, skin infections) which may indicate a blood disorder (agranulocytosis).
Talk to your doctor straight away if you notice the following
side-effects:
• Thoughts of harming or killing yourself
• Feeling tired, faint, dizzy, having pale skin. These could be signs of anaemia
• Convulsions, fits (seizures)
• 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
• Rapid, slow or irregular heartbeat.
Below is a list of other side effects that have been reported:
• 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)
• 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 any of the side effects get serious or last longer than a few days, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.
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 CAPSULES
• Keep out of the reach and sight of children
• Do not store above 25°C. Store in the original packaging
• Do not use trazodone after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month
• 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 Capsules contain
Each Trazodone 50mg Capsule contains 50mg of trazodone hydrochloride. Each Trazodone 100mg Capsule contains 100mg of trazodone hydrochloride. The other ingredients are lactose monohydrate, colloidal silica anhydrous, magnesium stearate, gelatin, titanium dioxide (E171), yellow iron oxide (E172), erythrosin (E127) and patent blue V (E131). In addition to these Trazodone 50mg Capsules also contain indigo carmine (E132).
What Trazodone Capsules look like and contents of the pack Trazodone 50mg Capsules are green-violet capsules.
Trazodone 100mg Capsules are yellow-violet capsules.
Trazodone 50mg Capsules are supplied in blister packs of 84 capsules and Trazodone 100mg Capsules are supplied in blister packs of 56 capsules. Marketing Authorisation Holder
The Marketing Authorisation Holder of these capsules is Focus Pharmaceuticals Limited, Capital House, 85 King William Street,
London EC4N 7BL UK
Manufacturer
Primegen Limited,
Unit 15 Moorcroft Harlington Road,
Uxbridge, UB8 3HD UK
This leaflet was last revised in December 2015.
103640-38/LF/332/02