PACKAGE LEAFLET: INFORMATION FOR THE USER_

Brimisol PR® 100 mg and 200 mg Prolonged-release Tablets Tramadol 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 Brimisol PR® is and what it is used for

2.    What you need to know before you take Brimisol PR®

3.    How to take Brimisol PR®

4 . Possible side effects

5.    How to store Brimisol PR®

6.    Contents of the pack and other information

1. What Brimisol PR® is and what it is used for

The name of your medicine is Brimisol PR® 100 mg and 200 mg Prolonged-release Tablets. Hereafter referred to as Brimisol PR® in the entire leaflet.

Brimisol PR^® contains the active ingredient tramadol, which belongs to a class of medicine known as opioids that act on specific nerves in the brain and spinal cord to relieve pain. Brimisol PR^® is used for the treatment of moderate to severe pain.

2. What you need to know before you take Brimisol PR^®

Do not take Brimisol PR^®:

•    if you are allergic to Tramadol or any of the other ingredients of Brimisol PR® (listed in section 6).

•    in acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions);

•    if you are also taking MAO inhibitors (certain medicines used for treatment of depression, examples include tranylcypromide, phenelzine and moclobemide) or have taken them in the last 14 days before treatment with Brimisol PR^® (see “Other medicines and Brimisol PR®”);

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

•    as a substitute in drug withdrawal;

•    if you are taking linezolid (an antibiotic used to treat severe bacterial infections such as MRSA);

•    if you are breastfeeding, in the case of long-term treatment (more than 2 to 3 days).

Warnings and Precautions

Talk to your doctor before taking Brimisol PR^®

•    if you think that you are addicted to other pain relievers (opioids);

•    if you suffer from consciousness disorders (if you feel that you are going to faint);

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

• if you suffer from increased pressure in the brain (possibly after a head injury or brain disease);

•    if you have difficulty in breathing;

•    if you have a tendency towards epilepsy or fits because the risk of a fit may increase;

•    if you suffer from a liver or kidney disease;

•    if you are taking carbamazepine for epileptic fits (the combination of these two medicines is not recommended);

•    if you suffer from diabetes.

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 (400 mg).

Please note that Brimisol PR^® may lead to physical and psychological addiction. When Brimisol PR^® is taken for a long time, its 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 Brimisol PR^® should only be carried out for short periods and under strict medical supervision. Please also inform your doctor if one of these problems occurs during Brimisol PR^® treatment or if they applied to you in the past.

Other medicines and Brimisol PR^®

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Brimisol PR^® should not be taken together with MAO inhibitors (certain medicines for the treatment of depression) because Serotonin Syndrome (diarrhoea, fast heart beat, sweating, tremor, confusion and coma) may develop, buprenorphine, nalbuphine, pentazocine (other painkillers), naltrexone (used for alcohol or drug abuse), antihistamines (for allergies) that cause sleepiness,treatments for anxiety, neuroleptics (to treat mental illness), some treatments for high blood pressure, thalidomide (for certain cancers and skin conditions) and baclophene (a muscle relaxant).

The pain-relieving effect of Brimisol PR^® may be reduced and the length of time it acts may be shortened, if you take medicines which contain carbamazepine (for epileptic fits) or ondansetron (prevents nausea).

Your doctor will tell you whether you should take Brimisol PR^®, and what dose. The risk of side effects increases:

•    if you take tranquillizers, sleeping pills, other pain relievers such as morphine and codeine (also as cough medicine), and alcohol while you are taking Brimisol PR^®.

You may feel drowsier or feel that you might faint. If this happens tell your doctor:

•    if you are taking medicines which may cause convulsions (fits), such as certain antidepressants (e.g. venlafaxine) or antipsychotics. The risk of having a fit may increase if you take Brimisol PR^® at the same time as those medicines. Your doctor will tell you whether Brimisol PR^® is suitable for you;

•    if you are taking certain antidepressants (e.g. venlafaxine). Brimisol PR^® 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 take coumarin anticoagulants (medicines for blood thinning), e.g. warfarin, together with Brimisol PR^®. The effect of these medicines on blood clotting may be affected and bleeding may occur;

•    if you are taking Linezolid (an antibiotic used to treat severe bacterial infections such as MRSA). Brimisol PR^® may interact with these medicines and you may experience symptoms such as diarrhoea, fast heartbeat , sweating, tremor, confusion and coma.

Brimisol PR^® with food, drink and alcohol

Do not drink alcohol during treatment with Brimisol PR® as its effect may be intensified. Food does not influence the effect of Brimisol PR®.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planing to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There is very little information regarding the safety of tramadol in human pregnancy. Therefore you should not use Brimisol PR^® if you are pregnant. Chronic use during pregnancy may lead to withdrawal symptoms in newborns.

Generally the use of tramadol is not recommended during breast-feeding. Small amounts of tramadol are excreted into breast-milk. On a single dose it is usually not necessary to interrupt breast-feeding. Based on human experience tramadol is suggested not to influence female or male fertility.

Driving and using machines

Brimisol PR^® may cause drowsiness, dizziness and blurred vision and therefore may impair your reactions. If you feel that your reactions are affected, do not use electric tools or operate machinery, and do not work without a firm hold.

This 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.

Brimisol PR^® contains 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 Brimisol PR®    |

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

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

Adults and adolescents from the age of 12 years

One Brimisol PR® 100 mg prolonged-release tablet twice daily (equivalent to 200 mg tramadol hydrochloride per day), preferably in the morning and evening.

One Brimisol PR^® 200 mg prolonged-release tablet twice daily (equivalent to 400 mg tramadol hydrochloride per day), preferably in the morning and evening.

Your doctor may prescribe a different, more appropriate dosage strength of prolonged release tramadol if necessary.

If necessary, the dose may be increased up to 150 mg or 200 mg twice daily (equivalent to 300 mg - 400 mg tramadol hydrochloride per day).

Children under 12 years of age

Brimisol PR^® is not suitable for children below the age of 12 years of age.

Elderly

In elderly people (above 75 years) the excretion of tramadol may be delayed. If this

Brimisol PR Insert

SAME SIZE ARTWORK 450 x 140 mm Front

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 Brimisol PR®. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

Route and method of administration

Brimisol PR^® are for oral use. Always swallow Brimisol PR^® tablets whole, not divided or chewed, with sufficient liquid, preferably in the morning and evening. You may take the tablets on an empty stomach or with meals.

Duration of treatment

You should not take Brimisol PR^® for longer than necessary. If you need to be treated for a longer period, your doctor will check at regular short intervals (if necessary with breaks in treatment) whether you should continue to take Brimisol PR^® and at what dose. If you have the impression that the effect of Brimisol PR^® is too strong or too weak, talk to your doctor or pharmacist.

If you take more Brimisol PR^® 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 (or someone else) swallow a lot of Brimisol PR^® tablets at the same time you should go to hospital or call a doctor straight away. Signs of an overdose include very small pupils, being sick, a fall in blood pressure, a fast heart beat, collapse, unconsciousness, fits and breathing difficulty or shallow breathing. Serotonin syndrome may also occur, which include symptoms like 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 forget to take Brimisol PR^®

If you forget to take the tablets, pain is likely to return. Do not take a double dose to make up for forgotten individual doses; simply continue taking the tablets as before.

If you stop taking Brimisol PR^®

If you interrupt or finish treatment with Brimisol PR^® 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 Brimisol PR^® is stopped. However, on rare occasions, people who have been taking Brimisol PR^® 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 few people may get panic

attacks, delusions, paranoia, hallucinations or feeling a loss of identity. They may experience unusual perceptions such as itching, tingling and numbness, and “ringing” in the ears (tinnitus). Further unusual CNS symptoms, i.e. confusion, delusions, change of perception of the own personality (depersonalisation), and change in perception of reality (derealisation) and delusion of persecution (paranoia) have been seen very rarely. If you experience any of these complaints after stopping Brimisol PR^®, 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

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

STOP TAKING this medicine and tell your doctor immediately if you suffer from any of the following:

•    allergic reaction (difficulty in breathing, wheezing and swelling of the face or throat)

•    anaphylactic reaction (an extreme allergic reaction resulting in difficulty breathing, changes in heart rate, faintness, collapse or unconsciousness due to a drop in blood pressure)

•    convulsions (fits). Epileptic fits have occurred mainly at high doses of tramadol or when tramadol was taken at the same time as other medicines which may induce fits.

Very common (may affect more than 1 in 10 people)

•    dizziness

•    feeling sick (nausea)

Common (may affect up to 1 in 10 people)

•    headache

•    drowsiness, sleepiness (fatigue)

•    constipation, dry mouth, being sick (vomiting)

•    sweating (hyperhidrosis)

•    confusion

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.

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

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

Rare (may affect up to 1 in 1,000 people)

•    slow heartbeat

•    increase in blood pressure.

•    abnormal sensations (e.g. itching, tingling, numbness), trembling, muscle twitches, uncoordinated movement, transient loss of consciousness (syncope), speech disorder.

•    changes in appetite

•    hallucination, confusion, sleep disorders, delirium, anxiety and nightmares

•    psychological complaints may appear after treatment with Brimisol PR^®. 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 decreased cognitive and sensory perception (being less aware and less able to make decisions, which may lead to errors in judgement).

•    drug dependence may occur.

•    blurred vision, excessive dilation of the pupils (mydriasis), constriction of the pupil (miosis).

•    slow breathing, shortness of breath (dyspnoea).

•    worsening of asthma has been reported, however it has not been established whether it was caused by tramadol. If the recommended doses are exceeded, or if other medicines that depress brain function are taken at the same time, breathing may slow down.

•    weak muscles.

•    passing urine with difficulty or pain, passing less urine than normal (dysuria). Very rare (may affect up to 1 in 10,000 people)

•    hepatic enzyme increased

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

•    decrease in blood sugar level

If Brimisol PR^® is taken over a long period of time dependence may occur, although the risk is very low.

When treatment is stopped abruptly signs of withdrawal syndrome may appear (see “If you stop taking Brimisol PR®”).

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 Brimisol PR®

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

•    Do not store above 25⁰C.

•    Do not use this medicine after the expiry date (EXP) which is stated on the carton. The expiry date refers to the last day of that month.

•    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 Brimisol PR^® contain

Brimisol PR® come in two strengths containing 100 mg or 200 mg of the active ingredient Tramadol Hydrochloride.

The other ingredients are:

Tablet Core: Lactose Monohydrate, Microcyrstalline Cellulose, Hypromellose, Colloidal Anhydrous Silica and Magnesium Stearate.

Film Coating: Hypromellose, Macrogol 6000, Purified Talc and Titanium dioxide (E171). Each 200 mg prolonged release tablet also contains Quinoline yellow lake (E104) and Ferric oxide red (E172).

What Brimisol PR^® looks like and contents of the pack

•    Brimisol PR® 100 mg tablets are white to off white, round, biconvex, film-coated tablets with ‘100’ embossed on one side and ‘BL’ on other side.

•    Brimisol PR^® 200 mg tablets are light orange to light pink, round, biconvex, film-coated tablets with ‘200’ embossed on one side and ‘BL’ on other side.

•    Brimisol PR^® is available in packs of 30 or 60 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Name and address: Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road,

Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom Telephone:    0044 (0)1442 200922

Fax:    0044 (0)1442 873717

E-mail:    info@bristol-labs.co.uk

Brimisol PR® 100 mg Tablets; PL 17907/0134 Brimisol PR® 200 mg Tablets; PL 17907/0136 This leaflet was last revised in June 2016

To request a copy of this leaflet in braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

V15 03-06-16 D0

Brimisol PR Insert

SAME SIZE ARTWORK

450 x 140 mm

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