Patient leaflet - Trazodone Hydrochloride 100 mg hard capsules

1. What Trazodone hydrochloride is and what it is used for

The name of your medicine is Trazodone hydrochloride 50 mg or 100 mg Capsules. Trazodone hydrochloride Capsules contain a medicine called trazodone hydrochloride. This belongs to a group of medicines called antidepressants. Trazodone hydrochloride Capsules can be used to treat anxiety and depression.

2. What you need to know before you take Trazodone hydrochloride Capsules

Do not take Trazodone hydrochloride Capsules:

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.
You have recently had a heart attack.
You are a heavy drinker or are taking sleeping tablets.
You 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 hydrochloride Capsules.

Take special care with Trazodone hydrochloride 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.
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.

Trazodone hydrochloride 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 hydrochloride 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 can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and trazodone”).
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Trazodone hydrochloride Capsules.
Other medicines and Trazodone hydrochloride Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Trazodone hydrochloride Capsules can affect the way some other medicines work. Also some medicines can affect the way Trazodone hydrochloride 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 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 ketoconozole 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 hydrochloride Capsules.

Trazodone hydrochloride Capsules with food, drink and alcohol

You should avoid drinking alcohol while taking Trazodone hydrochloride Capsules

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. Trazodone should only be taken during pregnancy if your doctor tells you that treatment with trazodone is essential for you and tells you to take this medicine.

Taking Trazodone hydrochloride 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 breast-feed, talk to your doctor or pharmacist before taking any medicine.

Driving and using machines

Trazodone hydrochloride Capsules may make you feel sleepy or dizzy.

If this happens do not drive or use any tools or machines.

Trazodone hydrochloride capsules contain lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking medicinal product

3. How to take Trazodone hydrochloride

Always take this medicine exactly as your doctor or pharmacist has told you. 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 hydrochloride
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 150mg 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 75mg each day
Your doctor may increase the dose to 300 mg each day

Package leaflet: Information for the user

Trazodone hydrochloride

50 mg capsules Trazodone hydrochloride

100 mg capsules

trazodone hydrochloride

Version: 08

Date & Time: 02.09.2021 & 2.40 pm

Submission Code: N00710

Elderly

Older people or those who are frail will usually
be given a starting dose of 100mg each day

Children

Children and adolescents under 18 years should not take Trazodone hydrochloride Capsules.

If you take more Trazodone hydrochloride Capsules than you should

If you take more Trazodone hydrochloride 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 hydrochloride 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 hydrochloride Capsules

Keep taking Trazodone hydrochloride Capsules until your doctor tells you to stop. Do not stop taking Trazodone hydrochloride 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.

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 hydrochloride 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 hydrochloride 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 (parasthesia)
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 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 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 hydrochloride Capsules

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 carton after EXP. The expiry date refers to the last day of that month.

Store below 30°C

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 hydrochloride Capsules contains

The active substance is Trazodone hydrochloride.
Each capsule contains 50 mg of trazodone hydrochloride.
Each capsule contains 100 mg of trazodone hydrochloride.

The other ingredients are

Capsule content:

Lactose monohydrate and magnesium stearate Capsule Shell:

Capsule Cap: Brilliant blue (E133), Erythrosine (E127),

Titanium Dioxide(E171) and Gelatin. Capsule body: 50 mg: Brilliant blue (E133), Quinoline yellow (E104), Titanium dioxide (E171), Erythrosine (E127) and gelatin. 100 mg: Iron Oxide Yellow (E 172), Titanium dioxide (E171) and gelatin. Printing ink: Shellac, Black Iron Oxide (E172) and Potassium hydroxide (present in traces)

What Trazodone hydrochloride Capsules looks like and contents of the pack

Hard capsules (capsules)

Trazodone hydrochloride 50 mg Capsules

Violet Cap/Green body, size ‘3’ hard gelatin capsule shells, imprinted with ‘TZD’ on cap and ‘50’ on body with black ink, filled with white to off- white powder. Trazodone hydrochloride 100 mg Capsules

Violet Cap/Fawn body, size ‘2’ hard gelatin capsule shells imprinted with ‘TZD’ on cap and ‘100’ on body with black ink, filled with white to off -white powder.

Trazodone hydrochloride capsules are available in PVC/ PVdC – Al blister.

Packsizes:

50 mg: 84 capsules

100 mg :56 capsules

Marketing Authorisation Holder

Milpharm Limited

Ares Block, Odyssey Business Park

West End Road

South Ruislip HA4 6QD

United Kingdom

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta