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OLDARAM 200 MG PROLONGED-RELEASE TABLETS

Active substance(s): TRAMADOL HYDROCHLORIDE

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RXY Oldaram PR PIL NP 5.qxp

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PATIENT INFORMATION LEAFLET FOR THE USER

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.


Keep this leaflet. You may need to read it again.



If you have further questions, please ask your doctor or your 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:

6. Further information

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 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.

1. What Oldaram is and what it is used for

Please tell your doctor if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.

1. What Oldaram is and what it is used for
2. Before you take Oldaram
3. How to take Oldaram
4. Possible side effects
5. How to store Oldaram

Your medicine belongs to a group of medicines called analgesics,
which are more commonly known as painkillers. Such medicines act
on the brain and spinal cord to reduce the amount of pain you
experience.
Oldaram is used for the treatment and prevention of moderate to
severe pain.

2. Before you take Oldaram
Oldaram is not suitable for everyone.
Do not take Oldaram if you:
are, or have ever been told you are, allergic to tramadol or to
any of the other ingredients in these tablets (see section 6 for
a list of ingredients).
have recently taken sleeping tablets, pain killers or any
medicines to treat mental illness.
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 Tramadol.
have epilepsy that is not adequately controlled on your current
medicine.
are undergoing treatment to withdraw from the use of narcotics.

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Take special care with Oldaram if you:
have recently had any head injuries, suffered from any severe
headaches or felt sleepy for no reason (especially after an accident).
are in shock following a severe injury or blood loss.
have recently had an accident where you may still be in shock.
find it difficult to breathe, or your breathing is a lot slower than
normal.
have, or have had, an addiction to opioid analgesics (such as
morphine, diamorphine or codeine).
have epilepsy.
are known to be sensitive to opioids.
have liver or kidney problems.
If any of the above apply to you, please talk to your doctor or
pharmacist for advice if you have not already done so.

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Taking Oldaram with food and drink:
Oldaram can be taken before, with or after food. You should NOT
drink alcohol whilst taking these tablets.
Pregnancy and breast – feeding:
Oldaram should not be taken during pregnancy as it may affect the
unborn child. If you become pregnant while taking Oldaram you
should talk to your doctor immediately.
It is also not advised to take the tablets whilst breast-feeding.
However, if your doctor feels it necessary, you do not have to stop
breast-feeding for a once only dose of Oldaram.
Driving or using machines:
Oldaram may make you feel drowsy and can affect your ability to
drive and operate machinery, particularly when combined with other
medicines that can cause drowsiness. Make sure you are not
affected before you drive or operate machinery.

3. How to take Oldaram
Always take Oldaram as your doctor has told you. You should
check with your doctor if you are not sure.
The tablets should be swallowed whole, without breaking or
chewing, with a glass of water.
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.
The usual doses for Oldaram are given below. Sometimes doctors
prescribe different doses to those mentioned below. Speak to your
doctor if you have any questions about the dose that has been
prescribed for you.
Always follow your doctor’s instructions about when to take your
medicine, how much to take and how to take it. These instructions
should be on the label. If they are unclear, or you are not certain,
ask your doctor or pharmacist.
Your doctor will also tell you how long your treatment should last.

Taking other medicines:
In particular, you should talk to your doctor before taking Oldaram if
you are taking any of the following:
you must not take Oldaram together with monoamine oxidase
inhibitors (“MAOIs”). See section “Do not take Oldaram”.
other opioid pain killers (analgesics) (such as buprenorphine,
nalbuphine or pentazocine).
carbemazepine (for epilepsy).
medicines to thin the blood (such as warfarin).
ketoconazole (a medicine used to treat fungal infections).
erythromycin (an antibiotic used to treat infections).

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Adults: The usual starting dose is one 100 mg tablet twice a day (in
the morning and evening). If this is not sufficient to kill the pain,
your doctor may give you either one 150 mg tablet or one 200 mg
tablet twice a day.
Your doctor will prescribe the lowest possible dose that provides
pain relief. This is usually no more than 400 mg (two 200 mg
tablets) a day except in special circumstances.

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Oldaram should not be used for any longer than is absolutely
necessary. If you need to take these tablets for a long period your
doctor will monitor you regularly.
Children (under 12 years old): Oldaram is not suitable for children
under 12 years old.
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
Oldaram. If in your case the insufficiency is mild or moderate, your
doctor may recommend prolonging the dosage interval.
If you take more Oldaram than you should:
If you have taken too much Oldaram, or if someone else has taken your
tablets, you / they should contact your doctor or your nearest hospital
casualty department immediately. Please take any remaining medicine
with you in the carton in which it came so that staff will know what has
been taken. Symptoms of overdose include constriction of the pupils of
the eyes, vomiting, heart problems, narrowing of consciousness leading
to coma, fits and breathing difficulties.
If you forget to take a tablet:
Take it 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. Do not take a double dose to make up for a missed dose.
You may suffer from the following withdrawal effects when you stop
taking these tablets:
agitation
anxiety
nervousness
problems sleeping
feeling overactive
shaking
feeling sick or bloated, stomach pain or discomfort, and
similar stomach problems

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Rare side effects (affecting less than 1 person in every 1000) include:
slower heartbeat than normal
an increase in your blood pressure
changes in appetite
tingling of the hands and feet
shaking (tremor)
breathing slower than normal
convulsions (fits)
seeing or hearing things that are not there (hallucinations)
confusion
sleep disturbances and nightmares
changes in your mood, such as feeling unusually cheerful,
or sometimes emotional and moody
changes in activity levels, this is usually feeling slower but
some people may feel more energetic
a change in how you see things (perception) or your ability to
make decisions
blurred vision
muscle weakness
difficulty in passing water

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There have been a few isolated reports of an increase in liver
enzymes. This would only usually be seen after you have had a
blood test. Your doctor may check you for this, if the doctor thinks
it is necessary.
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.

5. How to store Oldaram
Keep out of the reach and sight of children.
Do not use Oldaram after the expiry date which is stated on the
blister and outer carton after EXP.
The expiry date refers to the last day of that month.
Do not store above 25˚C.
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.

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

6. Further information

4. Possible side effects

What Oldaram contains

Like all medicines, Oldaram can have side effects, although not
everybody gets them.
Stop taking the tablets and tell your doctor immediately if you
experience any of the following rare effects:
A severe or itchy skin rash, especially if this shows blistering
and there is soreness of the eyes, mouth or genital organs.
Swelling of the hands, face, lips or tongue.
Difficulty breathing, wheezing, narrowing of airways or
worsening of existing asthma.
A sudden and severe drop in blood pressure and blood flow
through the body because the heart is not pumping normally
(breathlessness, slower heart beat, sweating, tiredness, loss of
consciousness).

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The active ingredient is
100mg of Tramadol Hydrochloride in Oldaram 100mg
Prolonged-release tablets
150mg of Tramadol Hydrochloride in Oldaram 150mg
Prolonged-release tablets
200mg of Tramadol Hyrdrochloride in Oldaram 200mg
Prolonged-release tablets
The other ingredients are:
Calcium hydrogen phosphate (E341), hydroxypropylcellulose (E463),
colloidal silica (E551), and magnesium stearate (E470b).

These are all possible signs of a severe allergic reaction.

What Oldaram look likes and contents of the pack
Oldaram 100 mg Prolonged-release tablets are round, biconvex,
off white, prolonged-release tablets.

Very common side effects (affecting more than 10 people in every 100)
are nausea and dizziness.

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

Common side effects (affecting 1 to 10 people in every 100) include:
headache
drowsiness
being sick (vomiting)
constipation
dry mouth
sweating
fatigue (tiredness)

Pack sizes: 60 tablets.

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Uncommon side effects (affecting less than 1 person in every 100) include:
being aware of your heartbeat (heart palpitations)
heart beating faster than normal
dizziness or fainting when standing from a sitting or lying
position (hypotension);
retching
a feeling of pressure or bloating in the stomach
skin reactions, such as itching or a rash, reddening of the skin

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ranbaxy (UK) Limited,
Building 4, Chiswick Park,
566 Chiswick High Road,
London, W4 5YE,
United Kingdom
Manufacturer
MEDOCHEMIE LTD, Factory AZ,
Mich. Erakleous,
Ag. Athanasios Industrial Area,
Limassol,
Cyprus
POM

This leaflet was last revised in September 2012.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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