Trazodone Hydrochloride 100mg Capsules
|
TEVA UK Ref: 231-30-83780-B LEA TRAZODONE CAP TUK <RIV |
Version: 1 |
10 March 2014 |
TEVA UK Ref: 231-30-83780-B LEA TRAZODONE CAP TUK <RIV |
Version: 1 |
10 March 2014 | |
TRAZODONE HYDROCHLORIDE 50 mg AND 100 mg CAPSULES
PACKAGE LEAFLET: INFORMATION FOR USER
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 signs of illness 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. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Trazodone is and what it is used for
2. What you need to know before you take Trazodone
3. How to take Trazodone
4. Possible side effects
5. How to store Trazodone
6. Contents of the pack and other information
[1 What Trazodone is and what it is used for
Trazodone belongs to a group of drugs known as antidepressants. They help to make you feel less depressed and less anxious. Trazodone is used: to treat depression to treat anxiety
to treat depression with anxiety.
^2 What you need to know before you take Trazodone
Do not take Trazodone if you:
• are allergic (hypersensitive) to Trazodone Hydrochloride or any of the other ingredients of this medicine
• are a heavy drinker of alcohol and had hypnotics (sleeping tablets) poisoning
• have heart failure, or have had heart failure in the past.
Warnings and precautions 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.
Talk to your doctor or Pharmacist before taking Trazodone if you
• are pregnant or trying to become pregnant
• are breast-feeding
• have epilepsy
• have liver problems
• have kidney problems
• have heart problems including an irregular heart beat (such as a slower heart beat)
• have problems with urinating or with your prostate
• have an overactive thyroid gland which can cause increased appetite, weight loss or sweating have yellowing of your skin and eyes (jaundice)
• have or have ever had glaucoma (signs include painful eyes with blurred vision)
• have suffered from a manic depressive phase (bipolar disorder) or schizophrenia. If you have a manic phase, contact your doctor immediately. are elderly as you may be more prone to side effects are taking any medicines that affect your heart beat.
Withdrawal reactions:
When stopping treatment with Trazodone it is recommended to reduce the dose gradually over a period to minimise symptoms such as nausea, headache and the general feeling of being unwell. Other medicines and Trazodone When Trazodone is taken with other medicines that act on the brain, the combination may make you more drowsy. These medicines include: medicines used in the treatment of mental conditions (antipsychotics, hypnotics, sedative/anxiolytics) and drugs used in the treatment of allergies (antihistaminics).
Tell your doctor if you are taking, have recently taken or might take any of the following:
• muscle relaxants
• other anti-depressants including MAOIs, or have taken them within the past two weeks
• sedatives e.g. barbiturates
• oral contraceptives
• phenytoin and carbamazepine (for treatment of epilepsy)
• cimetidine (used to treat stomach acid problems)
• drugs to treat high blood pressure or heart disease e.g. clonidine, digoxin, as dose reduction might be required
• erythromycin (for treatment of bacterial infection)
• ketoconazole, itraconazole (for treatment of fungal infection)
• ritonavir, indinavir (medicines to treat HIV infections)
• nefazodone (medicine to treat depression)
• tricyclic antidepressants (e.g. amitriptyline, imipramine, lofepramine)
• phenothiazines (e.g. chlorpromazine, fluphenazine, levomepromazine, perphenazine)
• warfarin (to prevent blood clotting)
• levodopa (a medicine to treat parkinson's disease)
• fluoxetine (anti-depressant)
• anaesthetics
• medicines to treat abnormal heart rhythm
• drugs containing Hypericum perforatum.
Tell the hospital or dentist you are taking Trazodone if you need to have an operation requiring an anaesthetic.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Trazodone with food, drink and alcohol
• Do not drink alcohol while taking Trazodone. This is because alcohol may increase the sedative effect of Trazodone.
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking this medicine. You must speak to your doctor about the possible effects this medicine might have on your baby before you take this medicine. Trazodone is not recommended if you are pregnant or breast-feeding. Driving and using machines Trazodone Capsules may make you feel 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.
Trazodone contains lactose
• Patients who are intolerant to lactose should note that Trazodone Capsules contain a small amount of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
a How to take Trazodone
Always take Trazodone exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The capsules should be swallowed preferably with a glass of water.
The usual dose is:
Depression and depression with anxiety
• Adults:
The usual starting dose is 150 mg a day, taken as divided doses after food or as a single dose before you go to bed. If necessary your doctor may increase the _dose up to 300 mg a day.
Follow the instructions your doctor gives you about how to take the dose.
Patients in hospital may be given higher doses of up to 600 mg a day.
• Elderly or frail patients:
A lower dose will be needed. The usual starting dose is 100 mg a day, taken as divided doses after food or as a single dose before you go to bed. If necessary your doctor may increase the dose.
• Children:
Trazodone is not recommended for use in children and adolescents under 18.
Anxiety
Lower doses than those used to treat depression are usually needed.
• Adults:
The usual starting dose is 75 mg a day. If necessary your doctor may increase the dose up to 300 mg a day. Follow the instructions your doctor gives you carefully.
If you take more Trazodone than you should
If you (or someone else) take too many capsules all together, or if you think a child has swallowed any of the capsules, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause drowsiness, dizziness, feeling sick or being sick, unconsciousness, fits, confusion, breathing or heart problems.
Please take this leaflet, any remaining capsules and the container with you to the hospital or doctor so that they know which capsules were consumed.
If you forget to take Trazodone If you forget to take a dose at the right time, take it as soon as you remember. If it is almost time to take your next dose, wait until then and carry on as before. Do not take a double dose to make up for a forgotten dose.
If you stop taking Trazodone You should take Trazodone for as long as your doctor tells you to. Do not stop taking Trazodone without your doctor knowing, even if you feel better.Trazodone may need to be taken for a number of weeks or months. When your doctor tells you to stop taking Trazodone, it should be stopped gradually. Withdrawal symptoms such as nausea, headache and general feeling of being unwell may occur if you suddenly stop taking this medicine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
r4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the following happens, stop taking the capsules and tell your doctor immediately or go to the casualty department at your nearest hospital:
• an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives)
• 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).
These are very serious but rare side effects. You may need urgent medical attention or hospitalisation. Not known: frequency cannot be estimated from the available data
• blood disorders including agranulocytosis (a severe reduction in the number of white blood cells which makes infections more likely), thrombocytopenia (a reduction in blood platelets, which increases risk of bleeding or bruising) and anaemia (a reduction in red blood cells which can make the skin pale and cause weakness or breathlessness)
• feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable.This could be an illness called 'syndrome of inappropriate anti-diuretic hormone secretion' (SIADH).
• low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits or coma
• increase or decrease of appetite
• weight loss
• difficulty in sleeping, unusual behaviour (overexcited), nervousness, agitation, nightmares, reduced sexual desire
• feeling confused, restless, sweating, tremor (shaking), shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heart beat. You may have something called Serotonine syndrome.
• convulsion/fits
• 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 case of neuroleptic malignant syndrome.
• dizziness, headache, drowsiness (this should wear off as you continue to take Trazodone)
• eyesight problems, decreased alertness, memory disturbances
• swelling of the brain, loss of the ability to speak or write
• unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin (paraesthesia)
• abnormal muscle rigidity
• altered taste
• rapid or slow heart rate
• fall in blood pressure on standing up which causes dizziness, light-headedness or fainting, increase in blood pressure
• nausea, vomiting, dry mouth
• constipation, diarrhoea, indigestion, inflammation and pain of stomach, increased salivation, paralysis of intestine
• liver problems such as jaundice (yellowing of the skin and whites of the eyes caused by liver or blood problems) and liver damage
• skin rash, itching, increased perspiration
• joint pain, pain in the limbs, back pain, muscle pain
• urinary disorders
• long-lasting painful erections
• weakness, oedema, fatigue, chest pain, fever
• elevated liver enzymes
• heart problems.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.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
Keep this medicine out of the sight and reach of children.
Store your Trazodone in a dry place. Do not use Trazodone after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
©Contents of the pack and other information
What Trazodone Capsules contain:
• The active ingredient is Trazodone Hydrochloride, 50 mg or 100 mg.
• The other ingredients are lactose monohydrate, colloidal silica anhydrous, magnesium stearate, gelatin, titanium dioxide (E171), yellow iron oxide (E172), patent blue V (E131).The 50 mg capsules also contain indigo carmine (E132) and erythrosin (E127). The 100 mg capsules also contain erythrosin (E127).
What Trazodone Capsules look like and contents of the pack:
• Trazodone 50 mg Capsules are hard, gelatin, green/violet coloured capsules.
• Trazodone 100 mg Capsules are hard, gelatin, yellow/violet coloured capsules.
• All capsule strengths are available in pack sizes of 7, 14, 21, 28, 30, 42, 56, 63, 84 & 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: 01/2014
PL 00289/1630-1
ET7W71
_TEVA UK LIMITED
83780-B