TRAZODONE HYDROCHLORIDE 100 MG HARD CAPSULES - patient leaflet, side effects, dosage

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Trazodone Hydrochloride 50 mg and 100 mg Hard Capsules

Trazodone hydrochloride

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 Capsules are and what they are used for

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

• 3. How to take Trazodone Capsules

• 4. Possible side effects

• 5. How to store Trazodone Capsules

• 6. Contents of the pack and other information

  297 mm

  
  

• 1. What Trazodone Capsules are and what they are used for

The name of this medicine is Trazodone hydrochloride 50 mg and 100 mg Hard Capsules, Hard (referred to as Trazodone Capsules throughout this leaflet). Trazodone Capsules contain a medicine called Trazodone hydrochloride. Trazodone belongs to a group of medicines called antidepressants.

Trazodone Capsules are used to treat anxiety and depression.

2. what you need to know before you take trazodone capsules

Do not take Trazodone Capsules if:

• You are allergic to active substance or any of the other ingredients of this medicine (listed in Section 6).

Signs of an allergic reaction can include: a rash, swelling of your lips, face, throat or tongue, swallowing or breathing problems,

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

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if any of the following points apply to 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

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking 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.
• 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 you have some other diseases.

Children and adolescents

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

Taking other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Particularly the following:

• MAOI (MonoAmine Oxidase Inhibitors) medicine such as tranylcypromine, phenelzine and isocarboxazid (for depression) or selegiline (for Parkinson's di­sease), or have taken them in the last 2 weeks
• Sedatives (such as tranquilizers or sleeping pills)
• Medicines used to treat epilepsy such as carbamazepine and phenytoin
• Other antidepressants (such as amitriptyline or fluoxetine)
• Medicines used to treat fungal infections such as ketoconazole and itraconazole

Medicines used to treat high blood pressure,

• for example, clonidine

Erythromycin, an antibiotic used to treat

• infections
• Medicines used to treat Parkinson's disease (such as Levodopa)
• St. John's Wort (a herbal remedy)
• Digoxin (used to treat heart problems)
• Warfarin (used to stop your blood from clotting)
• Some medicines used to treat HIV such as ritonavir and indinavir

Anaesthetics

If you are going to have an anaesthetic (for an operation), tell your doctor or dentist that you are taking Trazodone Capsules.

Trazodone Capsules with food and drink and alcohol

You should avoid drinking alcohol while taking Trazodone. This is because trazodone can change the way alcohol affects you.

Pregnancy and breast-feeding and fertility

Pregnancy

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant. Taking Trazodone Capsules in the late stages of pregnancy may lead to your baby experiencing withdrawal symptoms when they are born.

Breast-feeding

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.

Important information regarding the ingredients of this medicine 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 this medicine exactly as your doctor of pharmacist or pharmacist doctor 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 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 this to up to 300 mg per day depending on your condition
• For adults in hospital the dose may be as high as 600 mg per day.

Anxiety

• Adults usually start by taking 75mg each day
• Your doctor may increase the dose to 300mg each day

Elderly

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

Children

Trazodone Capsules is not recommended for children and adolescents under the age of 18.

If you take more Trazodone Capsulesthan 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 this medicine just because you feel better. When your doctor tells you to stop taking these capsules he/she will help you stop taking them gradually.

4. possible side effects

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

Stop taking this medicine and see a doctor or go to a hospital straight away if you experience any of the following side effects:

• 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 ilius)

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 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 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

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: 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 out of the sight and reach of children.
• Do not use this medicine 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 in the original package, in order to protect from moisture.
• 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 Capsules contain

• The active substance is Trazodone hydrochloride.
• Each hard capsule contains 50 mg or 100 mg of Trazodone hydrochloride.
• The other ingredients are lactose monohydrate, magnesium stearate. Capsule body and shell: brilliant blue (E133), erythrosine (E127), yellow iron oxide (E172), red iron oxide (E172), tit anium dioxide (E171), gelatin and edible ink (shellac, black iron oxide (E172) and propylene glycol).

What Trazodone Capsules look like and contents of the pack

• 50 mg: violet/opaque green body hard

gelatin capsule of size ‚3‘ and imprinted with ‚50‘ on body, containing white or almost white powder.

• 100 mg: violet/opaque light yellow hard

gelatin capsule of size ‚2‘ and imprinted with ‚100‘ on body, containing white or almost white powder.

• Trazodone capsules are available in blister packs of 28, 56, 84 and 100 capsules. Not all pack sizes may be marketed.