Patient leaflet - Trazodone Hydrochloride 50 mg / 5 ml oral solution

1. What Trazodone oral solution is and what it is used for

The name of your medicine is Trazodone Hydrochloride 50 mg/5 ml Oral Solution (called Trazodone Oral Solution throughout this leaflet). It contains a medicine called trazodone hydrochloride.

This belongs to a group of medicines called antidepressants. Trazodone Oral Solution can be used to treat anxiety and depression.

2. What you need to know before you take Trazodone oral solution

Do not take Trazodone Oral Solution if you:

are allergic to trazodone hydrochloride or any of the other ingredients of this medicine
(listed in section 6).

Signs of an allergic reaction can include: red and lumpy skin rash, swallowing or breathing problems, swelling of your eyelids, lips, face, throat or tongue, unexplained high temperature (fever) and feeling faint

have recently had a heart attack
are a heavy drinker or are taking sleeping tablets
are under 18 years of age.

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Trazodone Oral Solution.

Warnings and precautions

Take special care with 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.
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.

If you are elderly, you may be more prone to side effects, increased caution is necessary especially when taking other medicines at the same time as Trazodone Oral Solution or if you have some other diseases.

Talk to your doctor or pharmacist before taking 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
have an overactive thyroid gland (hyperthyroidism)
have problems passing water or need to pass water (urine) frequently
have narrow angle glaucoma (an eye disorder)
have schizophrenia or other type of mental disorder
are elderly, as you may be more prone to side effects
are taking buprenorphine (a strong pain killer). The use of buprenorphine together with
Trazodone Oral Solution can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Trazodone Oral Solution”).

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Trazodone Oral Solution.

Children and adolescents

Trazodone Oral Solution should not be used in children and adolescents under 18 years of age.

Trazodone Oral Solution with food, drink and alcohol

You should avoid drinking alcohol while taking Trazodone Oral Solution.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Taking Trazodone Oral Solution in the late stages of pregnancy may lead to your baby experiencing withdrawal symptoms when they are born.

Driving and using machines

Trazodone Oral Solution may make you feel sleepy or dizzy. If this happens do not drive or use any tools or machines.

Important information about some of the ingredients of Trazodone Oral Solution.

Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, that is to say essentially ‘sodium-free’.

3. How to take Trazodone oral solution

Always take this medicine exactly as your doctor has told you. 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 strong, do not change the dose yourself, but ask your doctor.

How much to take

Adults:

Depression

Adults usually start by taking 150 mg (15 ml) each day.
For adults in hospital the dose may be as high as 600 mg (60 ml) each day.

Anxiety

Adults usually start by taking 75 mg (7.5 ml) each day.

Your doctor may increase the dose to 300 mg (30 ml) each day depending on your condition.

Elderly:

Older people or those who are frail will usually be given a starting dose of 100 mg (10 ml) each day.

Doses of more than 300 mg (30 ml) will not normally be given.

If you take more Trazodone Oral Solution than you should

If you take more Trazodone Oral Solution than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows 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.

If you forget to take Trazodone Oral Solution

If you forget to take a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.

Do not take a double dose to make up for a forgotten dose.

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 to stop taking it gradually.

Package leaflet: Information for the user

Trazodone Hydrochloride 50 mg/5 ml Oral Solution

Trazodone Hydrochloride

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Trazodone Oral Solution 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 Oral Solution.
have a painful erection of the penis,unrelated to sexual activity, that will not go away
(priapism).
have yellowing of the eyes or skin. This could be a liver problem (such as jaundice).
are getting infections more easily than usual. This could be because of a blood disorder
(agranulocytosis).
are bruising more easily than usual. This could be because of a blood disorder
(thrombocytopenia).
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 ileus).

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 cannot control, mainly in 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)
severe liver disorders such as hepatitis
liver failure with potential fatal outcome
feeling tired, weak and confused, having muscles 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.

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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Trazodone oral solution

Keep this medicine 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 after EXP. The expiry date refers to the last day of that month.

Keep the bottle in the outer carton in order to protect from light.

After first opening use within 30 days.

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. Contents of the pack and other information

What Trazodone Oral Solution contains

Each 5 ml of Trazodone Oral Solution contains 50 mg of the active substance, trazodone hydrochloride.
Other ingredients include Benzoic acid (E210), Glycerol (85%) (E422), Sorbitol liquid
(Non-Crystallising) (E420), Saccharin sodium, Orange flavour (containing propylene glycol, E1520), Sodium hydroxide, Purified Water

What Trazodone Oral Solution looks like and contents of the pack

Trazodone Oral Solution is clear, colourless solution with an orange odour.

It is available in an amber glass bottle closed with child resistant closure in pack size of 120ml

The pack also contains a 30 ml plastic measuring cup with graduations ranging from 2.5ml

30ml.

Marketing Authorisation Holder

Milpharm Limited,

1 Roundwood Avenue,

Stockley Park,

Uxbridge,

UB11 1AF

United Kingdom

Manufacturer

APL Swift Services (Malta) Ltd

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000, Malta.