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Package leaflet: information for the user MANEO 100 mg, 150 mg AND 200 mg PROLONGED-RELEASE TABLETS

(tramadol hydrochloride)

Maneo 100 mg, 150 mg and 200 mg Prolonged-release tablets are referred as Maneo Tablets throughout this leaflet.

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, pharmacist or nurse.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4.

What is in this leaflet:

1.    What Maneo Tablets are and what they are used for

2.    What you need to know before you take Maneo Tablets

3.    How to take Maneo Tablets

4.    Possible side effects

5.    How to store Maneo Tablets

6.    Content of the pack and other information

1.    WHAT MANEo TABLETs ARE AND WHAT They Are usED For

Tramadol hydrochloride is a painkiller belonging to the class of opioids that act on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal cord and brain.

Maneo Tablets are used for the treatment of moderate to severe pain in adults and children over 12 years of age.

2.    WHAT You Need To KNoW BEFoRE

you take maneo tablets

Do not take Maneo Tablets

•    if you are allergic (hypersensitive) to tramadol hydrochloride or any of the other ingredients of Maneo Tablets (listed in section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue

•    if you have drunk too much alcohol or taken too many sleeping tablets, pain killers, opiates or other psychotropic medicines (medicines that affect mood and emotions)

•    if you are also taking MAOIs (monoamine oxidase inhibitors; used to treat depression) or have taken them in the last 14 days before treatment with Maneo Tablets

•    if you are an epileptic and your fits are not adequately controlled by treatment

•    as a substitute in drug withdrawal treatment.

Warnings and precautions

Talk to your doctor or pharmacist before taking Maneo Tablets if you

•    think you are addicted to other pain killers (opioids)

•    suffer from an increased pressure in the brain, causing symptoms such as headache and vomiting (possibly after a head injury or brain disease)

•    suffer from consciousness disorders (e.g. if you feel that you are going to faint)

•    are in a state of shock (cold sweat may be a sign of this)

•    have difficulty in breathing

•    have a tendency towards epilepsy or fits, because the risk of a fit may increase

•    suffer from kidney or liver disease;

In such cases please consult your doctor before taking the medicine.

Epileptic fits have been reported in patients taking tramadol at the recommended dose level. The risk may be increased when doses of tramadol exceed the recommended upper daily dose limit (400mg).

Please note that Maneo Tablets may lead to physical and psychological addiction. When Maneo Tablets are taken for a long time, their effect may decrease so that higher doses have to be taken (tolerance development). In patients with a tendency to abuse medicines or who are dependent on medicines, treatment with this medicine should only be carried out for short periods and under strict medical supervision. Please also inform your doctor if any of these problems occur during Maneo Tablets treatment or if they applied to you in the past.

other medicines and Maneo Tablets

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal medicines or any of the following:

•    Do not take Maneo Tablets at the same time, or within 14 days of taking MAOIs (moclobemide or phenelzine for depression, selegiline for Parkinson's disease).

The pain relieving effect of Maneo Tablets may be weakened or shortened if you also take medicines containing:

•    carbamazepine (used to treat epilepsy)

•    buprenorphine, nabulphine or pentazocine (pain killers)

•    ondansetron (prevents nausea)

The risk of side effects increases if:

•    You take tranquillisers, sleeping pills, other pain relievers such as morphine and codeine (also as cough medicine),

and alcohol while you are taking this medicine. You may feel drowsier or feel that you may faint. If this happens tell your doctor.

•    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 this medicine at the same time. Your doctor will tell you whether Maneo Tablets are suitable for you.

•    You are taking certain antidepressants. Maneo Tablets 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.

•    You take coumarin anticoagulants (medicines for blood thinning), e.g. warfarin, together with this medicine. The effect of these medicines on blood clotting may be affected and bleeding may occur.

Maneo Tablets with food, drink and alcohol.

Do not drink alcohol during treatment with Maneo Tablets as their effect may be intensified. Food does not influence the effect of Maneo Tablets.

Pregnancy, breast-feeding and fertility

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 any medicine. There is very little information regarding the safety of tramadol in human pregnancy. Therefore you should not use Maneo Tablets if you are pregnant. Chronic use during pregnancy may lead to withdrawal symptoms in newborns.

Generally, the use of tramadol hydrochloride is not recommended during breast-feeding. Small amounts of tramadol hydrochloride are excreted into breast milk. With a single dose it is usually not necessary to interrupt breastfeeding. Please ask your doctor for advice.

Driving and using machines

Maneo Tablets may cause drowsiness, dizziness and blurred vision and therefore may impair your reactions. If you feel that your reactions are affected, do not drive a car or other vehicle, and do not use electric tools or operate machinery.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

•    Do not drive while taking this medicine until you know how it affects you.

•    It is an offence to drive if this medicine affects your ability to drive.

•    However, you would not be committing an offence if:

-    The medicine has been prescribed to treat a medical or dental problem and

-    You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

-    It was not affecting your ability to drive safely.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Maneo Tablets contains lactose

This medicine contains lactose, a type of sugar. 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 maneo tablets

Dosage

Always take Maneo Tablets exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The dosage should be adjusted to the intensity of your pain and your individual pain sensitivity. In general, the lowest pain relieving dose should be taken.

Maneo Tablets should normally be taken twice a day, preferably in the morning and evening. You must leave a minimum of 8 hours between each dose.

Do not take more than 2 doses in any 24 hour period.

Unless otherwise prescribed by your doctor, the recommended dose is:

Adults and children over 12 years of age:

Maneo 100 mg Tablets: one tablet (100 mg tramadol hydrochloride) twice a day, preferably in the morning and evening.

If this is not sufficient to kill the pain the dose can be increased to:

Maneo 150 mg Tablets: one tablet (150 mg tramadol hydrochloride) twice a day, preferably in the morning and evening. or:

Maneo 200 mg Tablets: one tablet (200 mg tramadol hydrochloride) twice a day, preferably in the morning and evening.

Your doctor may prescribe a different, more appropriate dosage strength of Maneo Tablets if necessary.

Do not take more than 400 mg of tramadol hydrochloride daily, except if your doctor has instructed you to do so.

use in children:

Do not give Maneo Tablets to children below the age of 12 years.

Elderly patients:

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

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

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

method of ADMiNisTRATioN

Always swallow the tablets whole with a glass of water, preferably in the morning and evening. Do not break, chew or crush

them. You can take the tablets on an empty stomach or with food.

Duration of treatment

Your doctor will tell you how long you should use Maneo Tablets. This depends on the cause of the pain. You should not take Maneo Tablets for longer than necessary. If you need to be treated for a longer period, your doctor will check at regular short intervals whether you should continue to take Maneo Tablets and at what dose.

If necessary you may have breaks in your treatment. If you have the impression that the effect of Maneo Tablets is too strong or too weak, talk to your doctor or pharmacist.

if you take more Maneo Tablets than you should

If you have taken one additional dose by mistake, you should contact your doctor or pharmacist for advice.

However, if you feel unwell at any time, or if you (or someone else) swallow several Maneo tablets at the same time, you

should contact your doctor or hospital emergency department immediately.

Symptoms of overdose may include very small pupils, vomiting, a fall in blood pressure, a fast heartbeat, collapse, loss of consciousness up to coma (deep unconsciousness), fits and breathing problems leading to cessation of breathing.

if you forget to take Maneo Tablets

If you forget to take your tablets, pain is likely to return. Take your dose as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

if you stop taking Maneo Tablets

If you interrupt or finish treatment with Maneo Tablets too soon, pain is likely to return. If you wish to stop treatment on account of unpleasant effects, please tell your doctor.

Generally there will be no after-effects when treatment with Maneo Tablets is stopped. However, on rare occasions, people who have been taking Maneo Tablets for some time may feel unwell if they abruptly stop taking them. They may feel agitated, anxious, nervous or shaky. They may be confused, hyperactive, have difficulty sleeping and have stomach or bowel disorders.

Very rarely, people may experience confusion, panic attacks, delusions persecution (paranoia), hallucinations, change in perception of reality (derealisation) or feeling a loss of identity (depersonalization). They may experience unusual perceptions such as itching, tingling and numbness, and 'ringing' in the ears (tinnitus).

If you experience any of these complaints after stopping Maneo Tablets, please consult your doctor.

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.

if you get any of the following contact your doctor straight away or seek emergency help immediately:

•    allergic reactions e.g. difficulty breathing, wheezing or swelling of skin (rare, may affect up to 1 in 1,000 people)

•    swollen face, tongue and/or throat and/or difficulty to swallow or hives together with difficulties in breathing (rare, may affect up to 1 in 1,000 people),

•    shock/sudden circulation failure (rare, may affect up to 1 in 1,000 people).

Other side effects:

Very common: may affect more than 1 in 10 people

•    dizziness

•    feeling sick

Common: may affect up to 1 in 10 people

•    headache, drowsiness

•    being sick, constipation, dry mouth

•    tiredness

•    sweating

uncommon: may affect up to 1 in 100 people

•    effects on the heart and blood circulation (pounding of the heart, fast heart beat, feeling faint or collapse). These adverse effects may particularly occur in patients in an upright position or under physical strain

•    urge to be sick (retching), stomach trouble (e.g. feeling of pressure in the stomach, bloating), diarrhoea

•    skin reactions (e.g. itching, rash)

Rare: may affect up to 1 in 1,000 people

•    slow heart beat, increase in blood pressure

•    slow breathing and shortness of breath (dyspnoea)

•    changes in appetite, abnormal sensations (e.g. itching, tingling, numbness), trembling

•    muscle twitches, weak muscles, uncoordinated movement

•    fainting (syncope)

•    blurred vision

•    difficulty or pain when passing water, less urine than normal

•    hallucinations, confusion, sleep disorders, anxiety and nightmares

Psychological complaints may appear after treatment with Maneo tablets. Their intensity and nature may vary (according to the patient's personality and length of therapy). These may appear as a change in mood (mostly high spirits, occasionally irritated mood), changes in activity (slowing down but sometimes an increase in activity) and being less aware and less able to make decisions, which may lead to errors in judgement. Dependence may occur.

Very rare: may affect up to 1 in 10,000 people

•    increase in liver enzyme values

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

•    low sugar levels in the blood (hypoglycaemia)

•    dilated pupils

•    speech disorders, worsening of asthma, however it has not been established whether it was caused by tramadol hydrochloride.

If the recommended doses are exceeded, or if other medicines that depress brain function are taken at the same time, breathing may slow down.

If Maneo Tablets are taken over a long period of time dependence may occur, although the risk is very low. When treatment is stopped abruptly, signs of withdrawal may appear (see 'If you stop taking Maneo Tablets').

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.

5.    how to store maneo tablets

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

This medicinal product does not require any special storage conditions.

If the tablets become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.

Do not use this medicine after the expiry date stated on the carton or bottle after 'EXP'. The expiry date refers to the last day of that month.

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.    content of the pack and other iNFoRMATioN

What Maneo Tablets contain

•    The active substance is tramadol (as hydrochloride). Each prolonged- release tablet contains: 100 mg, 150 mg or 200 mg of the active substance.

•    The other ingredients are microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate

•    The tablet coating contains the following: hypromellose, lactose, talc, macrogol, propylene glycol, titanium dioxide, iron oxide red, iron oxide brown, lake quinoline yellow

What Maneo Tablets look like and contents of the pack

Maneo 100 mg Prolonged-release tablets are white to off white, round, film coated tablets debossed with 'M' on one side and 'TM1' on other side.

Maneo 150 mg Prolonged-release tablets are pale orange coloured, oval-shaped, film coated tablets, debossed with 'M' on one side and 'TM2' on other side.

Maneo 200 mg Prolonged-release tablets are brownish orange coloured, capsule shaped, film coated tablets debossed with 'M' on one side and 'TM3' on other side.

Maneo Tablets are packed in:

•    blisters and are supplied in cardboard cartons containing 10, 20, 28, 30, 50, 56, 60, 90 and 100 prolonged-release tablets.

•    HDPE Bottles with polypropylene child-resistant closures containing 100 prolonged-release tablets.

•    HDPE Bottles with polypropylene screw closures containing 500 and 1000 prolonged-release tablets (dispensing package).

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan

Potters Bar, Hertfordshire, EN6 1TL, UK

Manufacturer

Generics [UK] Ltd.

Potters Bar, Hertfordshire, EN6 1TL, UK

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Mylan Hungary Kft., H-2900 Komarom,

Mylan utca 1, Hungary

This leaflet was last revised in: August 2014

Code No.: MH/DRUGS/25/NKD/89    485974

Date: 27 AUG 2014