PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OLDARAM 100 mg PROLONGED-RELEASE TABLETS OLDARAM 150 mg PROLONGED-RELEASE TABLETS OLDARAM 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, askyourdoctororyourpharmacist.

•    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 Oldaram is and what it is used for

2.    What you need to know before you take Oldaram

3.    HowtotakeOldaram

4.    Possible side effects

5.    Howto store Oldaram

6.    Contents of the pack and other information

1.    What Oldaram is and what it is used for

The lull name of your medicine is 'Oldaram 100mg, 150mg or 200mg Prolonged-release tablets'. It is referred to as 'Oldaram' in the rest of this leaflet. Tramadol - the active substance in Oldaram is a painkiller belonging to a class of opioids that acts on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal code and brain.

Oldaram is used forthe treatment of moderate to severe pain.

2.    What you need to know before you take Oldaram Do not take Oldaram

•    If you are allergic to tramadol or any of the other ingredients of this medicine (listed in see section 6).

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

•    if you are also taking MAO inhibitors (certain medicines used for the treatment of depression) or have taken them in the last 14 days before treatment with Oldaram (see “Other medicines and Oldaram”)

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

•    as asubstitute in drug wittidrawal Warnings and precautions

Talkto your doctor or pharmacist before taking Oldaram

•    if you thinkthat you are addicted to oth e r pain relievers (opioids)

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

•    if you are in a slate 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 orfits because the risk of a fit may increase

•    if you sufferf ram a liver or kidney disease

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 limit (400mg).

Please note that Oldaram may lead to physical and psychological addiction.

When Oldaram 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 Oldaram 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 Oldaram treatment or if they applied to you in the past.

Other medicines and Oldaram

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

Oldaram should not be taken together with MAO inhibitors (certain medicines forthe treatment of depression).

The pain relieving effect of Oldaram may be reduced and the length of time it acts may be shortened if you take medicines which contain:

•    carbamazepine (for epileptic fits)

•    ondansetron (prevents nausea)

Yourdoctorwilltellyou whetheryou shouldtake Oldaram, and which dose. The riskof side effects increases,

•    if you are taking tranquillizers, sleeping pills, other pain relievers such as morphine and codeine (such as cough medicine), and alcohol while you are taking Oldaram. You may feel drowsier or feel that you might faint. If this happens tell your doctor.

•    ifyouaretakingmedicineswhichmaycauseconvulsions (fits), such as certain antidepressants or antipsychotics. The risk of having a fit may increase if you take Oldaram at the same time. Your doctor will tell you whether Oldaram is suitable for you.

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

Oldaram with food and alcohol

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

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 this medicine.

There is very little information regarding the safety of tramadol in human pregnancy. Therefore you should not use Oldaram 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. After 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

Oldaram may cause drowsiness and blurred vision therefore may impair your reactions. If you feel that your reactions are affected, do not drive, 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 isan 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.

3. HowtotakeOldaram

Alwaystakethismedicineexactlyasyourdoctorhastoldyou. 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 400mg 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 aae of 12 years

One Oldaram 100mg prolonged-release tablet twice daily (equivalent to

200mg tramadol hydrochloride per day), preferably in the morning and

evening.

One Oldaram 150mg prolonged-release tablet twice daily (equivalent to 300mg tramadol hydrochloride per day), preferably in the morning and evening.

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

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

Use in children

Oldaram is not suitable for children belowthe age of 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 finsufficiencvVdialvsis patients Patients with severe liver and/or kidney insufficiency should not take Oldaram. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

How and when should vou take Oldaram?

Oldaram prolonged-release tablets are fororal use.

Always swallow Oldaram prolonged-release 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.

How Iona should vou take Oldaram?

You should not take Oldaram for longerthan 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 Oldaram and at what dose.

If you have the impression that the effect of Oldaram is too strong or too weak, talkto your doctor or pharmacist.

If you take more Oldaram 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 Oldaram 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, fall in blood pressure, fast heartbeat, collapse, unconsciousness, fits and breathing difficulties or shallow breathing.

If youforget to take Oldaram

If you forgetto 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 below.

If you stop taking Oldaram

If you interrupt or finish treatment with Oldaram 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 Oldaram is stopped.

However, on rare occasions, people who have been taking Oldaram for some time may feel unwell if they abruptly stop taking them. They may feel agitated, anxious, nervous or shaky. They may be hyperactive, have difficulty sleeping and have stomach or bowel disorders. Very few people may get panic attacks, hallucinations, 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 personaility (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 Oldaram, pleaseconsultyourdoctor.

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 have side effects, although not everybody gets them.

Serious side effects

You should see a doctor immediately if you experience symptoms of an allergic reaction such as swollen face, tongue and/or throat, and/or difficulty swallowing or hives together with difficulties in breathing.

Other side effects

Very common side effects: may affect more than 1 in 10 people

•    Dizziness

•    Feeling sick (nausea)

Common side effects: may affect up to1 inlOpeople

•    Headache

•    Drowsiness

•    Being sick (vomiting)

•    Constipation

•    Dry mouth

•    Sweating (hyperhidrosis)

Uncommon side effects: may affect up to 1 in 100 people

•    Effects on the heart and blood circulation (pounding of the heart, fast heartbeat, 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 pressure in the stomach, bloating), diarrhea

•    Skin reactions (e.g. Itching, rash)

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

•    Allergic reactions (e.g. difficulty in breathing, wheezing, swelling of skin) and shock (sudden circulation failure) have occurred in very rare cases

•    Slow heartbeat

•    Increase in blood pressure

•    Abnormal sensations (e.g. itching, tingling, numbness), trembling, epileptic fits, muscle twitches, uncoordinated movement, transient loss of consciousness (syncope), speech disorders

•    Epileptic fils have occurred mainly at high doses of tramadol or when tramadol was taken at the same time as other medicines which may inducefits

•    Change in appetite

•    Hallucination, confusional state, sleep disorders, delirium, anxiety and nightmares

•    Psychological complaints may appear after treatment with Oldaram. Their intensity and nature may vary (according to the patients personality and length of therapy). These may appear as a change in mood (mostly high spirits, occasionally irritated mood), changes in activity (usually suppression, occasionally increase) 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 slowdown.

•    Weakmuscles

•    Passing urine with difficulty or pain, passing less urine than normal (dysuria)

Very rare side effects: 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 Oldaram 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 may appear (see “If you stop taking Oldaram”).

Reporting of sideeffects

If you get any side effects, talkto your doctor or pharmacist. 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 safely of this medicine.

5.    Howto store Oldaram

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

Do not store above 25°C.

Do not use this medicine afterthe expiry date which is stated on the blister and carton after EXP 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 Oldaram contains

The active ingredient is tramadol hydrochloride.

Each Oldaram 100 mg prolonged-release tablet contains 100mg of tramadol hydrochloride

Each Oldaram 150 mg prolonged-release tablet contains 150mg of tramadol hydrochloride

Each Oldaram 200 mg prolonged-release tablet contains 200mg of tramadol hydrochloride

The otheringredierrts are:

Calcium hydrogen phosphate (E341), hydroxypropylcellulose (E463), colloidal silica (E551), and magnesium stearate (E470b).

What Oldaram looks like and contents of the pack

Oldaram 100 mg Prolonged-release tablets are round, biconvex, off white, prolonged-release tablets.

Oldaram 150 mg and 200 mg Prolonged-release tablets are capsuleshaped, off white, Prolonged-release tablets.

Oldaram prolonged-release tablets are available in pack of 60 tablets.

Not all packsizes maybe marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Ranbaxy (UK) Limited,

Building 4, Chiswick ParK 566 Chiswick High Road,

London, W45YE,

United Kingdom

Manufacturer

MEDOCHEMIELTD,

Factory AZ, Mich. Erakleous,

Ag. Athanasiod Industrial Area,

Limassol,

Cyprus

This leaflet was last revised in November 2015.