Trazodone Hydrochloride 150mg Tablets

Document: leaflet MAH BRAND_PLPI 15184-1356 change

Trazodone Hydrochloride 150mg Tablets Ref: 1356/290716/2/F

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine

* 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

* If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

0 What trazodone is and what it is used for Before you take trazodone How to take trazodone Possible side effects How to store trazodone Further information

^ What trazodone is and what it is used for

The name of this medicine is Trazodone Hydrochloride 150mg Tablets (called trazodone throughout this leaflet). This belongs to a group of medicines called antidepressants.

Trazodone can be used to treat anxiety and depression.

Before you take trazodone

Do not take this medicine and tell your doctor if:

* You are allergic (hypersensitive) to trazodone hydrochloride or any of the other ingredients of trazodone tablets (listed in Section 6: Further Information). 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.

Take special care with trazodone 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 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 or 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

Taking trazodone and other medicines

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 can affect the way some other medicines work. Also some medicines can affect the way trazodone 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)

* 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.

Taking trazodone with food and drink

You should avoid drinking alcohol while taking trazodone

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.

Taking trazodone 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 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

Trazodone contain lactose. If you have been told that you cannot digest or tolerate some sugars, talk to your doctor before taking trazodone.

How to take trazodone

Always take trazodone 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 tablets 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 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 300mg each day depending on your condition

* For adults in hospital the dose may be as high as 600mg each 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 100mg each day

Children

Children and adolescents under 18 years should not take trazodone.

Patient Information Leaflet (continued)

If you take more trazodone than you should

If you take more trazodone 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

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

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 these tablets he/she will help you to stop taking them gradually.

* 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 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: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

POM

^ Possible side effects

Like all medicines, trazodone can cause side effects, although not everybody

gets them.

Stop taking trazodone 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

* 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 (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

ra How to store trazodone

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not store above 25°C. Store in a dry place.

Store in the original package in order to protect from light. Do not use trazodone after the expiry date shown on the carton or blister label.

The expiry date refers to the last day of that month. If your doctor tells you to stop using trazodone, take any remaining trazodone back to the pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.If your medicine becomes discoloured or shows any signs of deterioration, ask your pharmacist who will advise you what to do. 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.

Further information

What Trazodone contains:

Each film-coated tablet contains 150mg trazodone hydrochloride.

The other ingredients are: lactose monohydrate, calcium hydrogen phosphate, microcrystalline cellulose, maize starch, sodium starch glycollate, povidone, magnesium stearate, hypromellose, propylene glycol, titanium dioxide E171 and red iron oxide E172.

What Trazodone looks like and contents of the pack

Trazodone Hydrochloride 150mg Tablets are salmon-pink circular, biconvex, film-coated tablets with a large score on one side and embossed with "MOLIPAXIN" and "150" on the other.

They come in blister packs of 28.

Manufacturer and Licence Holder

This product is manufactured by Sanofi Synthelabo Ltd., T/A Fawdon Manufacturing Centre, Edgefield Avenue, Fawdon, Newcastle Upon Tyne, NE3 3TT, United Kingdom and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

PL 15184/1356 Trazodone Hydrochloride 150mg Tablets.

Revision date: 29/07/16

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