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90 mm

Uncommon (affects less than 1 in 100 people):

•    faster, strongeror irregular heartbeat

•    collapse or a fall in blood pressure on standing up, which causes dizziness, lightheadedness orfainting

•    retching, a feeling of pressure in the stomach, stomach bloating, diarrhoea

•    pruritus, rash, and raised, red, itchy skin rash (hives)

Rare (affects less than 1 in 1000 people):

•    slower heartbeat

•    rise in blood pressure

•    changes in appetite

•    tingling or numbness in the hands and feet

•    tremor

•    epileptic-like seizures

•    difficulty sleeping, nightmares

•    mood changes

•    changes in activity (usually reduced, sometimes increased)

•    shortness of breath

•    changes in sensory perception and impairment of the ability to recognise, which can lead to inappropriate decisions

•    hallucinations, anxiety, confusion

•    breathing difficulties, worsening of asthma

•    blurred vision

•    reduced muscle strength

•    difficulty in passing urine, producing less urine than normal

•    drug dependence (addiction), withdrawal symptoms may occur when treatment is stopped (see "If you stop taking ACEON PR").

Very rare (affects less than 1 in 10,000 people):

•    sudden onset of skin redness (flushing)

•    a feeling of dizziness or “spinning"

•    blood tests which show changes in the way the liver is working

Not known (frequency cannot be estimated from the available data):

•    Decrease in blood sugar level

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

Package leaflet:

Information for the user

Aceon 100mg Prolonged-release Tablets Aceon 150mg Prolonged-release-Tablets Aceon 200mg Prolonged-release-Tablets

tramadol hydrochloride

Read all of this leaflet carefully before you start

taking this medicine because it contains important

information foryou.

•    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.

What is in this leaflet:

1.    What Aceon is and what it is used for

2.    What you need to know before you take Aceon

3.    How to take Aceon

4.    Possible side effects

5.    How to store Aceon

6.    Contents of the pack and other information

1. What Aceon is and what it is used for

158 mm

Yellow Card Scheme.

Website: www.mhra.gov.uk/yellowcard.

5. How to store Aceon

Keep this medicine out of the sight and reach of children.

Tramadol, the active substance in Aceon prolonged-release tablets, is a painkiller (analgesic) of the opioid group. Its pain-relieving effect is due to its influence on specific nerve cells in the spinal cord and in the brain.

Do not use Aceon after the expiry date which is stated on the package after “EXP". The expiry date refers to the last day of that month.

Aceon is used in the treatment of moderate to severe pain.

Store in the original package in orderto protect from light.

2. What you need to know before you take Aceon

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

WhatAceon contains

•    The active substance is tramadol hydrochloride. Each Aceon tablet contains either 100,150 or 200 mg tramadol hydrochloride.

•    The other ingredients are: calcium hydrogen phosphate dihydrate (E341), colloidal anhydrous silica (E551), hydroxypropyl cellulose (E463), magnesium stearate (E470B).

WhatAceon looks like and contents of the pack

Aceon 100mg: the tablets are off white, round, biconvex and plain on both sides. Aceon 150mg: the tablets are off white, capsule-shaped, biconvex and plain on both sides.

Aceon 200mg: the tablets are off white, capsule-shaped, biconvex and plain on both sides.

Pack contents are 10,20, 30, 50,60,100 and 150 tablets in PVC/PVdC -Aluminium blisters and 100 tablets in a polypropylene tablet container.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Brown & Burk UK Ltd

5 Marryat Close

Hounslow West

Middlesex

TW4 5DQ

UK.

This medicinal product is authorised in the Member States of the EEA under the following names:

SE: Opidol 100mg/150mg/200mg prolonged-release tablets UK: Aceon 100mg/150mg/200mg Prolonged-release Tablets

This leaflet was last approved on March 2014

XXXXXXX    ITEMCODE

Do not take Aceon

•    if you are allergic (hypersensitive) to tramadol or any of the other ingredients of this medicine

•    if you are pregnant

•    if you have recently drunk too much alcohol ortaken too many sleeping tablets, other painkillers or any medicines which influence mood such as antidepressants

•    if you are taking, or have taken in the last two weeks, certain medicines called “monoamine oxidase inhibitors" or MAOIs which are used to treat depression eg phenelzine or moclobemide. (see “Taking other medicines")

•    if you have epilepsy that is not properly controlled with your current medicine

•    as a drug substitute for the treatment of drug addiction

Ask your doctor or pharmacist if you are not sure about

anything before you start to take these tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Aceon if

you:

•    think you may already be dependent on other opioid painkillers (eg morphine, diamorphine orcodeine)

•    react sensitively to opioid painkillers

•    have a consciousness disturbance or are in shock (cold sweat can be an indication of this)

•    have difficulty in breathing or breathing is slower than normal

•    have a head injury or brain diseases that may cause elevated pressure in the skull, suffered from any severe headaches or felt sleepy for no reason (particularly after an accident)

•    have a liver or kidney disorder

•    suffer from epilepsy or seizures (fits) or have had them in the past.

If any of the above applies to you, please talk to your

doctor before starting to take this medicine.

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130mm

Please note that psychological and physical addiction can develop in patients on Aceon. During long-term use, the effects of this medicine may weaken, so that it becomes necessary to use a higher dose (development of tolerance). For this reason, Aceon must be used for short periods only and under strict medical supervision in patients at risk of developing drug dependence. Please also inform your doctor if any of these problems develops while you are taking this medicine and if you have experienced such problems in the past.

Other medicines and Aceon

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription (including any herbal remedies).

Do not take Aceon at the same time as medicines called “monoamine oxidase inhibitors” (which are used to treat depression), or if you have taken one in the past 2 weeks. The combination could result in a serious, potentially life threatening interaction.

The pain-relieving effect of Aceon may be weakened and/orshortened if you also take medicines containing:

•    carbamazepine (used to treat epilepsy)

•    pentazocine, nalbuphine or buprenorphine (painkillers)

•    ondansetron (used to prevent nausea orvomiting)

The risk of side effects increases:

•    if you are taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk of having a fit may increase if you take Aceon at the same time. Your doctorwill tell you whetherAceon is suitable for you.

•    if you are taking certain antidepressants. Aceon may interact with these medicines and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38 °C.

•    if you are taking sedative medicines such as tranquillizers, sleeping pills, antidepressants and other pain relievers (morphine, codeine). You may feel excessively drowsy or feel that you mightfaint.

•    if you are taking medicines that inhibit blood clotting, such as warfarin. The dose of these medicines may need to be reduced, otherwise there could be an increased risk of potentially serious bleeding

•    if you are taking ketoconazole (an antifungal medicine), ritonavir (an anti-HIV drug) or erythromycin (an antibiotic)

•    if you are taking alcohol

Aceon with alcohol

Do not drink alcohol while taking Aceon; this could make side effects more likely to occur.

The usual doses are given below. Your doctor may gradually increase or decrease your dose depending on how you respond to the treatment.

It is important that you do not continue to take this medicine for longer than absolutely necessary.

Adults and adolescents aged 12 years and over:

•    The usual initial dose is 100 mg twice daily.

•    Take one tablet in the morning and one in the evening.

There must be a minimum interval of 8 hours between each dose.

If this dose is not sufficient to control your pain, your doctor may give you either one 150mg tablet or one 200mg tablet twice daily.

As a general rule, you should take no more than the minimum dose you require to control your pain. You should not take a dose of more than 400 mg of the active substance daily unless there are specific medical reasons for this.

Children under 12 years:

This medicine should not be used in children under 12 years.

Elderly patients:

In elderly patients (above 75 years) the excretion of tramadol may be delayed. If this applies to you, your doctor may recommend prolonging the dosage interval.

Severe liver or kidney disease (insufficiency)/dialysis patients:

Patients with severe liver and/or kidney insufficiency, should not take Aceon . If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

If you take more Aceon than you should

If you have taken an additional dose by mistake, this will generally have no negative effects. You should take your next dose as prescribed.

If you have taken excessive doses of the medicine the following signs can occur: pin-point pupils, vomiting (being sick), a fall in blood pressure, rapid heartbeat, collapse, disturbed consciousness including coma, epileptic fits and difficulties in breathing. If you observe any of these symptoms or if a child accidentally takes this medicine, immediately contact your doctor or your nearest hospital. Please take any remaining medicine with you in the carton in which it came so that staff will know what has been taken.

If you forget to take Aceon

You may experience recurrence of pain. Take the tablet as soon as you remember then continue as before. If it is nearly time for your next tablet, leave the missed dose and continue as before. Do not take any more tablets in one day than your doctor has prescribed.

Ifyou stop taking Aceon

If you interrupt or prematurely stop treatment with Aceon, your pain will return. Ifyou decide you wish to stop taking this preparation because of unpleasant side effects, please consult your doctor.

There will normally be no after-effects when you stop taking Aceon. However, in a few cases in which patients have been taking these tablets for a very long period, there have been reports of after-effects such as restlessness, anxiety, nervousness, difficulty sleeping, shaking or stomach upset. Panic attacks, hallucinations, sensation of numbness or tingling on the skin and ringing in the ears may very rarely occur.

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Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy: There is very little information regarding the safety of tramadol in human pregnancy, therefore this medicine should not be used in pregnant women.

If you experience any of these side effects when you stop taking Aceon, please consult your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Breast-feeding: This medicine should not be used during breast-feeding, since small quantities of tramadol are excreted into breast milk. However, it is normally not necessary to interrupt breast-feeding for a single dose of tramadol. Please consult your doctor.

Driving and using machines

This medicine may cause side effects such as drowsiness and blurred vision. If this happens, do not drive or use any tools or machines and do not perform any hazardous tasks.

3. How to take Aceon

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

Serious side effects

This medicine can occasionally cause allergic reactions although serious allergic reactions are rare (affects less than 1 in 1000 people). Stop taking this medicine and tell your doctor straight away if you experience any of the following symptoms of a serious allergic reaction:

•    sudden wheezing, difficulty in breathing or dizziness

•    swellingofthefaceorthroat

Other possible side effects

Tell yourdoctor if any of the following side effects bothers you: