Patient leaflet - Trazodone Hydrochloride 100 mg hard capsules
1. What Trazodone Capsules are and what they are used for
The name of your medicine is Trazodone Hydrochloride 50 mg or 100 mg Capsules (called Trazodone Capsules in this leaflet). Trazodone Capsules contain a medicine called Trazodone Hydrochloride. This belongs to a group of medicines called antidepressants. Trazodone Capsules can be used to treat anxiety and depression.
2. What you need to know before you take Trazodone Capsules
Do not take this medicine and tell your doctor if you:
are allergic to trazodone hydrochloride or any of
the other ingredients of Trazodone Capsules (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.
- 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 Capsules.
Take special care with Trazodone Capsules 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.
Trazodone Capsules should not be used in children and adolescents under 18 years of age.
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 Capsules or if you have some other diseases.
Check with your doctor or pharmacist before taking this medicine if you:
- have or have ever had fits or seizures (epilepsy)
- 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 with Trazodone Capsules can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Trazodone Capsules”).
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Trazodone Capsules.
Other medicines and Trazodone Capsules
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 Trazodone Capsules can affect the way some other medicines work. Also some medicines can affect the way Trazodone Capsules work.
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), or have taken them in the last 2 weeks
Other antidepressants (such as amitriptyline or
fluoxetine)
Buprenorphine/opioids. These medicines may
interact with Trazodone Capsules and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.
- Sedatives (such as tranquilizers or sleeping pills)
Medicines used to treat epilepsy such as
carbamazepine and phenytoin
Medicines used to treat high blood pressure, for
example, 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, an 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 Capsules.
Taking Trazodone Capsules with food and drink
You should avoid drinking alcohol while taking Trazodone Capsules.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant.
Trazodone Capsules should only be taken during pregnancy if your doctor tells you that treatment with Trazodone Capsules is essential for you and tells you to take this medicine. Taking Trazodone Capsules in the late stages of pregnancy may lead to your baby experiencing withdrawal symptoms when they are born.
If you are breast-feeding or planning to breastfeed, talk to your doctor or pharmacist before taking any medicine.
Driving and using machines
Trazodone Capsules may make you feel sleepy or dizzy. If this happens do not drive or use any tools or machines.
Trazodone Capsules contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Trazodone Capsules
Always take Trazodone Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
- Take this medicine by mouth
- Swallow the capsules whole with a drink of water
Take with or after food. This can help lower the
chances of side effects
If you have been told to take Trazodone Capsules
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 each day
Your doctor may increase the dose to 300 mg
each day depending on your condition
For adults in hospital the dose may be as high
as 600 mg each day
Anxiety
- Adults usually start by taking 75 mg each day
Your doctor may increase the dose to 300 mg
each day
Elderly
Older people or those who are frail will usually
be given a starting dose of 100 mg each day
Children
Children and adolescents under 18 years should not take Trazodone Capsules.
If you take more Trazodone Capsules than you should
If you take more Trazodone Capsules 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 Capsules
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 Capsules
Keep taking Trazodone Capsules until your doctor tells you to stop. Do not stop taking Trazodone Capsules just because you feel better. When your doctor tells you to stop taking these capsules he/she will help you to stop taking them gradually.
4. Possible side effects
Like all medicines, Trazodone Capsules can 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 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 (paresthesia)
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 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 potentially fatal outcome
- 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.
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: Yellow Card Scheme 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 Capsules
Keep this medicine in a safe place where children cannot see or reach it. Do not use Trazodone Capsules after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month. Store below 25°C. 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 Capsules contains
- Each Trazodone 50 mg capsule contains 50 mg of the active substance, trazodone hydrochloride.
- Each Trazodone 100 mg capsule contains 100 mg of the active substance, trazodone hydrochloride.
- Capsule fill: lactose monohydrate, magnesium stearate.
- Capsule Shell composition: gelatin, titanium dioxide (E171), erythrosine (E127), brilliant blue (E133), iron oxide red (E172), yellow iron oxide (E172)
Printing ink: Black iron oxide (E172), shellac
(E904), propylene glycol (E1520), strong ammonia solution (E527) and potassium hydroxide (E525).
What Trazodone Capsules look like and contents of the pack
Trazodone Hydrochloride 50 mg capsules, Hard: Capsule with opaque green body, imprinted with ‘50’ in black and a violet cap, containing white to off white powder.
Trazodone Hydrochloride 100 mg capsules, Hard: Capsule with opaque light yellow body, imprinted with ‘100’ in black and a violet cap, containing white to off white powder.
Trazodone 50 mg Capsules are supplied in blister packs of 28, 56, 84 and 100 capsules.
Trazodone 100 mg Capsules are supplied in blister packs of 28, 56, 84 and 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer:
Relonchem Limited,
Cheshire House, Gorsey Lane,
Widnes, Cheshire, WA8 0RP, UK.
PL 20395/0417 & PL 20395/0418
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in December 2025.
For information in large print, Braille or on CD, please contact the licence holder at the above address.
Trazodone Hydrochloride 50 mg and 100 mg Capsules, Hard PACKAGE LEAFLET INFORMATION FOR THE USER
148 mm
148 mm
PRODUCT NAME
PRODUCT LICENCE NO.
STRENGTH
PACK SIZE
FONT & SIZE
REMARKS
REASON FOR CHANGE
COUNTRY
MANUFACTURER
SOFTWARE
ARTIST
Trazodone Hydrochloride 50 mg and 100 mg Capsules, Hard
20395-0417-0418
Pil
148 x 400 mm
50 mg & 100 mg
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Arial Narrow, (15 pt, 9pt)
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Comments amended as per email received from Shivaraj on 08.12.2025.
UK (English)
Gpax
Adobe illustrator CC
Gurukiran
NO. OF COLORS 01
██ Black
██ Dieline
0.6
VERSION DATE 08.12.2025