Patient leaflet - Trazodone Hydrochloride G.L. 50 mg/5 ml oral solution
1. What trazodone is and what it is used for
The name of your medicine is Trazodone hydrochloride G.L. Pharma 50 mg/5 mL oral solution (called trazodone throughout this leaflet).
Trazodone contains the active substance called trazodone hydrochloride which belongs to a group of medicines called antidepressants.
Trazodone can be used to treat depression and anxiety in adults.
2. What you need to know before you take trazodone
Do not take trazodone
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: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
- if you have recently had a heart attack
- if you are a heavy drinker or are taking sleeping tablets
- if you are under 18 years of age
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.
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 or if you have some other diseases.
Talk to your doctor or pharmacist before taking trazodone 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
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking trazodone.
Children and adolescents
Trazodone should not be used in children and adolescents under 18 years of age.
Other medicines and trazodone
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without prescription, including herbal medicines. This is because trazodone can affect the way some other medicines work. Also some medicines can affect the way trazodone works.
Some medicines and trazodone may interfere with each other. Tell your doctor if you are taking any of the following medicines:
- MAOI (monoamine oxidase inhibitors) medicines such as tranylcypromine, phenelzine and isocarboxazid (for depression) or selegiline (for Parkinson’s disease). Tell your doctor or pharmacist if you are taking them now or have taken them in the last 2 weeks.
- Other antidepressants (such as amitriptyline or fluoxetine)
- Sedatives (such as tranquillisers or sleeping pills)
- Medicines used to treat epilepsy (e.g. carbamazepine or phenytoin)
Medicines used to treat high blood pressure
(e.g. clonidine)
- Digoxin (used to treat heart problems)
- 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 to treat Parkinson’s disease)
- St. John’s Wort (a herbal remedy)
- Warfarin (used to stop your 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.
Trazodone with alcohol
You should avoid drinking alcohol while taking trazodone. This is because trazodone can change the way alcohol affects you.
Pregnancy and breast-feeding
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 in the late stages of pregnancy may lead to your baby experiencing withdrawal symptoms when it is born.
Driving and using machines
Trazodone is a drug which acts on the central nervous system and may make you feel sleepy or dizzy. Do not drive, operate machinery or do anything that requires you to be alert until you know how your medicine affects you.
Trazodone contains sorbitol, sodium benzoate, and traces of sodium.
This medicine contains 280 mg sorbitol (E 420) in each mL. Sorbitol may cause gastrointestinal discomfort and mild laxative effect. 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.
This medicine contains 1.18 mg sodium benzoate (E 210) in each ml. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
trazodone contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially ‘sodium-free’.
3. How to take trazodone
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The dose of trazodone will depend on your needs and the illness being treated.
- Take this medicine by mouth.
- Take it with or after food. This can help lower the chances of side effects.
- If you have been told to take trazodone 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 too strong, do not change the dose yourself, but ask your doctor.
Adults
Adults usually start by taking 150 mg (15 mL) each day. Your doctor may increase the dose to 300 mg (30 mL) each day depending on your condition.
In hospital the dose may be as high as 600 mg (60 mL) each day.
Package leaflet: Information for the patient
Trazodone hydrochloride G.L. Pharma 50 mg/5 mL oral solution
InfoProd-08906 2.0 Elderly
Older people or those who are frail will usually be given a starting dose of 100 mg (10 mL) each day. Your doctor may increase the dose to 300 mg (30 mL) each day depending on your condition.
Doses of more than 300 mg (30 mL) will not normally be given.
Use in children and adolescents
Trazodone should not be used in children and adolescents under 18 years of age.
If you take more trazodone than you should
It is important to stick to the dose of the medicine. If you take more trazodone than you should, contact your doctor or nearest hospital emergency department immediately. Always take any medicine left over with you along with the box, as this will allow easier identification of the medicine.
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
If you forget to take a dose, take it as soon as you remember. 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
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 this medicine
he/she will help you stop taking them gradually.
Stopping your medicine too quickly could cause
symptoms such as sleeping problems, feeling nauseous, or headache.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking trazodone and tell your doctor immediately if you experience:
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.
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 ileus).
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
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
The following side effects have also been reported (not known: frequency cannot be estimated from the available data):
- 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 the 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 potentially 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 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.
Do not use this medicine 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.
Do not refrigerate or freeze.
Keep the bottle in the outer carton in order to protect from light.
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 protect the environment.
6. Contents of the pack and other information
What trazodone contains
The active substance is trazodone hydrochloride.
Each 5 mL contains 50 mg trazodone hydrochloride.
The other ingredients are liquid sorbitol (E 420), glycerol
85% (E 422), citric acid monohydrate, sodium benzoate (E 211), sodium citrate, propyl gallate, disodium edetate, saccharin sodium, orange flavour, and purified water.
What trazodone looks like and contents of the pack
Trazodone is a clear, slightly viscous, colourless to pale yellow liquid, with orange odour.
The ph value is 4.25.
It is supplied in an amber glass bottle containing 120 mL of solution and with a 30 mL measuring cup having a 5 mL graduation.
Marketing Authorisation Holder and Manufacturer
G.L. Pharma GmbH
Schlossplatz 1, 8502 Lannach, Austria
This leaflet was last revised in November 2023.
GI71900GB 0525
Präparatenamen/Stärke:
Trazodone hydrochloride G.L. Pharma 50 mg/5 ml korrekte Angabe der Dosierstärke (relevant für das Dosierschema und Ablagesystem): 10 mg/ml
Darreichungsform:
Sirup
Abpackungsart:
Glasflasche
Art.-Nr.: GI71900GB
Weber-Code-Nr.: XXXX
Land: Großbritannien / uk
Format: 180 x 400 mm
Packmittelart: Gebrauchsinformation
Produktion: intern
Schrift: Helvetica 9,0 – 17,0 Punkt
Druckfarbe: ♦ Schwarz
Korr.-Version: 1
Datum: 12.05.2025
Uhrzeit: 11:42:17
InfoProd-08906 2.0