TRAZODONE 50MG CAPSULES

Active substance: TRAZODONE HYDROCHLORIDE

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Date
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Read all of this leaflet carefully before you start taking 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 become serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
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
1. WHAT TRAZODONE CAPSULES ARE AND WHAT THEY ARE USED FOR
Trazodone Capsules contains the active substance trazodone hydrochloride which is an antidepressant with the
ability to help reduce anxiety. In the first days of treatment Trazodone may have a sedative effect which may
cause drowsiness.
Trazodone Capsules are used to treat symptoms in all types of depression, including when anxiety is also present.
2. BEFORE YOU TAKE TRAZODONE CAPSULES
DO NOT take Trazodone Capsules if you:
• Know that you are allergic to trazodone hydrochloride or any of the other ingredients in these Capsules (see
“section 6” of this leaflet). 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 are taking sleeping tablets
• Are under 18 years of age.
Speak to your doctor if the above applies to you before you take your medicine.
Take special care with Trazodone Capsules if you:
• Suffer from severe liver, kidney or heart problems
• Suffer from epilepsy (fits, seizures)
• Are pregnant, trying to become pregnant or are breast feeding
• Suffer from major depression or other behavior disorder or you suffer from two or more disorder at the same time
• Suffer from disease of thyroid gland
• Suffer from eye disorder (glaucoma)
• Have schizophrenia or other type of mental disorder
• Suffer from conditions like abdominal pain, muscle weakness, mental confusion (porphyria)
• Have problems passing water or need to pass water (urine) frequently
• Your age is above 65 years, as you may be more prone to side effects.
If any of these conditions apply to you, speak to your doctor before you take these Capsules.
Your doctor will want to monitor your response to this medicine carefully, particularly if you are young or elderly.
If you have 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 thoughts may be increased on 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 behavior 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 having recently taken any other medicines or food
supplements, including medicines obtained without a prescription. The effects of any of these medicines may
change, particularly if you are taking:
• Medicines for treating depression, such as nefazodone or Monoamine Oxidase Inhibitors (MAOIs) such as
phenelzine and isocarboxazid, or citalopram, fluoxetine, amitriptyline, paroxetine, duloxetine. You should not
take Trazodone Capsules if you are taking these medicines, or if you have taken them within the last two weeks
• Medicines for allergic reaction (antihistamines)
• Medicines for treatment of high blood pressure
• Anaesthetic medicines used during surgery (tell your anaesthetist you are taking Trazodone Capsules)
• Muscle relaxants
• Medicines to treat epilepsy (fits), such as phenytoin, primidone, carbamazepine and sodium amytal
• Medicines to manage your state of mind, such as chlorpromazine, clozapine, haloperidol, sulpiride,
trifluoperazine, lithium, pimozide
• Clonidine, to treat high blood pressure or migraine
• Digoxin used to treat heart problems
• Levodopa (used to treat Parkinson’s disease)
• St. John's Wort (a herbal remedy)
• Warfarin (used to stop your blood from clotting)
• Oral contraceptives
• Cimetidine (antacid)
• Sedatives (such as tranquilizers or hypnotics e.g. phenobarbital)
• Medicines to treat fungal infections (ketoconazole, itraconazole), medicines to treat HIV/AIDS (ritonavir,
indinavir) and Antibiotics like erythromycin used to treat infections.
Taking with food and drink
You should not drink alcohol whilst you are taking this medicine as it may increase the effects of Trazodone
Capsules.
Pregnancy and breast-feeding:
Ask your doctor or pharmacist for advice before taking any medicines.
You should let your doctor know if you are pregnant, think you are pregnant or are planning to become
pregnant, or if you are breast feeding. You must speak to your doctor about the
possible effects this medicine might have on your baby before you take this medicine. Taking Trazodone
Capsules in the late stages of pregnancy may lead to your baby experiencing withdrawal symptoms when they
are born.
You should NOT take this medicine if you are in the first three months of pregnancy or breast-feeding.
Driving and using machines:
Trazodone Capsules may make you feel sleepy or dizziness, drowsy, give you blurred vision or affect your
concentration. You should not drive or use machines when you first start to take this medicine until you are
certain that you are not getting these side effects. If in any doubt, speak to your doctor before you drive or use
machines.
Important information about some of the ingredients of Trazodone Capsules
This medicine contains lactose which is a sugar. If you have been told by your doctor that you have an
intolerance to sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE TRAZODONE CAPSULES
It is important to take your medicine at the right time. You must take it as directed by your doctor. The label will
tell you how much to take and how often. If it doesn’t or you are not sure, ask your doctor or pharmacist.
Taking Trazodone Capsules
Do not chew but swallow the Capsules with a glass of water, with or after food to reduce the chances of
side-effects.
How much to take
Adults:
Depression
• Adults usually start by taking 150mg each day, either in divided doses throughout the day, or as a single dose
just before bedtime.
• Your doctor will advise you if this needs to be increased.
Anxiety
• Adults usually start by taking 75mg each day.
• Your doctor will advise you if this needs to be increased.

Date
15/01/2013
Client Creo Pharma
Country UK

Trazodone Hydrochloride

Trazodone Capsules
50 mg & 100 mg
145 x 420 mm

Trazodone 50mg and 100mg Capsules

Elderly:
• Older people may need a lower daily dose (100mg), taken either in divided doses throughout the day, or
as a single dose at night time. Under supervision and depending on tolerance of effect, this dose may be
increased, but it is unlikely that it will exceed 300mg each day.
Children:
• Children should not take Trazodone Capsules.
If you stop taking Trazodone Capsules
Your doctor will advise you on how long you should take the Capsules. Do not stop taking the Capsules early.
Trazodone Capsules may take time to work, usually about two weeks but sometimes longer. If you feel your
depression or anxiety is getting worse, contact your doctor.
If you feel the effect of your medicine is too strong or too weak, talk to your doctor or pharmacist.
If you have to go to another doctor or to hospital tell them you are taking Trazodone Capsules.
If you take more Trazodone Capsules than you should
If you take too many Trazodone Capsules, contact your nearest hospital casualty department or doctor
immediately.
Take any remaining Capsules and this leaflet with you so that the medical staff know exactly what you have taken.
The following effects may happen: feeling sick or being sick, feeling sleepy, dizzy or faint, fits (seizures),
confusion, breathing or heart problems.
Your medicine is very dangerous if taken by young children, and care should be taken to keep the medicine
safely out of the reach of children.
If you forget to take your Trazodone Capsules
Take your dose as soon as you remember, then go on as before.
If it is almost time for the next dose, then do not take the missed dose at all. Do not take a double dose if you
miss a dose.
If you have any further questions about these Capsules, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Trazodone Capsules can sometimes cause side-effects, although not everybody gets
them.
Stop taking Trazodone Capsules and see a doctor or go to a hospital straight away if:
• 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 Capsules.
• 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)
Talk to your doctor straight away if you notice the following side-effects:
• 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 (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 can not 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 behavior 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 in passing urine
• 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 these side effects get serious, or if you notice any other side effect not listed in this leaflet, please tell
your doctor or pharmacist.
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side
effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone
0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your
local pharmacy.
5. STORING YOUR MEDICINE
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original package to protect from light and moisture.
If you have any of your medicine left after finishing your treatment, return it to your pharmacist.
Do not use your medicine if the pack is damaged or after the Expiry Date printed on the blister strip and carton.
6. FURTHER INFORMATION
The active substance in Trazodone Capsules is trazodone hydrochloride. Trazodone Capsules are available in
two strengths, containing either 50 mg or 100 mg trazodone hydrochloride.
The other ingredients are lactose monohydrate, magnesium stearate, colloidal silica anhydrous. The capsule
shell coating is made from titanium dioxide (E171), yellow iron oxide (E172), erythrosine (E127), patent blue V
(E131) and gelatin.
50mg capsule also contains Indigo carmine (E132).
What Trazodone Capsules look like and contents of pack:
Each Trazodone 50mg Capsule is green-violet, marked FW301. Each Trazodone 100mg Capsule is yellow-violet,
marked FW311. Trazodone Capsules are supplied in blister packs available in pack sizes of 28, 56, 84 or 112
Capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Rivopharm UK Ltd, 6th floor, 28 Kingsway, London WC2B 6JR
United Kingdom
Manufacturer: Laboratoires BTT, ZI de Krafft, 67150 Erstein, France
Distributed by: Creo Pharma Ltd, Felsted Business Centre, Felsted, Essex, CM6 3LY
This leaflet was last revised in June 2013.

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PATIENT INFORMATION LEAFLET

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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