ZERIDAME SR 100MG PROLONGED RELEASE TABLETS

Active substance: TRAMADOL HYDROCHLORIDE

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Zeridame SR 100mg, 150mg, 200mg
Prolonged Release tablets
Tramadol hydrochloride

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
•  eep this leaflet. You may need to read it again.
K
• f you have any further questions, ask your doctor or
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pharmacist.
•  his medicine has been prescribed for you only. Do not pass it
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on to others. It may harm them, even if their signs of illness are
the same as yours.
• f you get any side effects, talk to your doctor or pharmacist.
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This includes any possible side effects not listed in this leaflet.

Please note that Zeridame SR may lead to physical and psychological
addiction. When Zeridame SR 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 Zeridame SR should only
be carried out for short periods and under strict medical supervision.

Other medicines and Zeridame SR

Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Do not take Zeridame SR at the same time, or within 14 days of taking
medicines called monoamine oxidase inhibitors (moclobemide or
phenelzine for depression, selegiline for Parkinson’s disease).

What is in this leaflet:
1 What Zeridame SR is and what it is used for.
2  hat you need to know before you take Zeridame
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SR.
3  ow to take Zeridame SR.
H
4  ossible side effects.
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5  ow to store Zeridame SR.
H
6  ontents of the pack and other information
C

The pain relieving effect of Zeridame SR may be weakened and / or
shortened if you also take medicines containing:
•  arbamazepine (used to treat epilepsy)
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•  uprenorphine, nalbuphine, or pentazocine (pain killers)
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•  ndansetron (used to stop you feeling sick)
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The risk of side effects increases:
• f you are taking medicines which may cause convulsions (fits), such
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as certain antidepressants or antipsychotics. The risk of having a fit
may increase if you take Zeridame SR at the same time. Your doctor
will tell you whether Zeridame SR is suitable for you.
• f you are taking certain antidepressants. Zeridame SR may interact
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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.
• f you take Zeridame SR at the same time as sedative medicines
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such as tranquillisers, sleeping pills, antidepressants and strong pain
relievers (morphine, codeine, pethidine). You may feel excessively
drowsy or feel that you might faint.
• f you take Zeridame SR at the same time as blood thinning
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medicines, such as warfarin. The dose of these medicines may need
reducing, otherwise there could be an increased risk of serious
bleeding.
•  nticonvulsant drugs taken with tramadol can lower the seizure
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threshold and the risk of convulsions may increase in these patients.

1 What Zeridame SR is and what is it used for

Zeridame SR is a pain killer. Zeridame SR eases the pain by inhibition of
certain chemicals of the central nervous system (in the brain and the
spinal cord).
Zeridame SR can be used in adults and adolescents over 12 years of
age. It is used for the treatment of moderate to severe pain.
Zeridame SR is not suitable for children under the age of 12 years.

2  hat you need to know before you take
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Zeridame SR
DO NOT take Zeridame SR:

• f you are allergic to tramadol hydrochloride or any of the other
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ingredients of this medicine (listed in section 6).
• f you have recently drunk too much alcohol or taken too many
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sleeping tablets, pain killers, opiates or any medicines that work
via the brain (psychotropic medicines).
•  hen using certain medicines against depression (so-called MAOW
inhibitors) or when these have been used the last 14 days.
• f you suffer from epilepsy that is not controlled by medication.
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•  or the treatment of withdrawal symptoms in drug addicts.
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Zeridame SR with alcohol:

Zeridame SR should not be used in combination with alcohol.

Pregnancy and breast-feeding:

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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Zeridame SR:
• f you have recently had any head injuries, or an increased pressure
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in the head (e.g. after an accident)
• f you suffer from disorders of the kidneys or liver (see section 3: how
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to take Zeridame SR)
• f you suffer from difficulty to breathe
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• f you have a tendency towards epilepsy or fits because the risk
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of a fit may increase. Seizures 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).
• f you suffer from addiction to opiates
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• f you suffer from shock (cold sweat may be a sign of this)
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• f you use other medicines or substances that work via the brain,
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including alcohol.
After long term treatment (> 3 months) headache may develop or
aggravate. When tramadol has been used to treat tension or cluster
headache or migraine (which is not a registered use for tramadol) cases
have been reported of medication overuse headache (MOH).

Pregnancy
Tramadol passes the placenta. There are not enough details known
to judge the possible harm in human. Long term treatment during
pregnancy may lead to withdrawal symptoms in the newborn after
birth, as a consequence of addiction. Therefore tramadol should not be
taken during pregnancy. Your doctor will advise you.
Breast-feeding:
Generally, the use of Zeridame SR 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.
Please ask your doctor for advice.

Driving and using machines:

Zeridame SR can cause drowsiness and dizziness, and blurred vision.
Because of this Zeridame SR can affect your ability to drive and operate
machinery. This can be intensified by alcohol or by medicine that acts
or works via the brain.
Do not drive a car or do other activities that need you to be alert,
until you know how tramadol affects you. Please see 4. Possible Side
Effects for a full list of possible effects that may impair alertness and
coordination.

AAAE3626

Tramadol SR (Z eridame SR) 100mg, 150mg, 200mg 60 Tablets - UK
item no:
print proof no:
origination date:

AAAE3626
5
02.10.12

originated by:
approved for print/date

revision date:

min pt size:

revised by:
supplier:

DR
Medochemie

1. Black
2.
3.

pharmacode:

4.
7.5pt

5.
6.

DR
02.01.13

dimensions:

180x295

colours/plates:

Non Printing Colours

Technical Approval
date sent:

02.10.12

technically app. date:

11.10.12

1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated
Any technical chanages made by the supplier after approval are not the responsibility of the Artwork Studio

Rare (affects 1 to 10 users in 10,000): blurred vision, slower heartbeat
than normal, increase in blood pressure, changes in appetite, itch
or tingling without cause, shaking, breathing slower than normal,
convulsions, hallucinations, confusion, sleep disturbances and
nightmares, allergic reactions (e.g. shortness of breath), tightness of the
chest by cramp of the muscles of the airways (bronchospasm), gasping,
sudden fluid accumulation in the skin and mucosa (e.g. throat or
tongue), breathing problems (respiration difficulties) and / or itch and
hypersensitiveness. Also reported: mood changes, changes in activity,
changes in the observation or the ability to make decisions, muscle
weakness, difficulties passing water, involuntary muscle contractions,
abnormal coordination, and fainting (syncope).

3  ow to take Zeridame SR.
H

Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
Dose
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 dosage is:
Adults and adolescents over 12 years of age:
The starting dose is:
Zeridame SR 100mg: one tablet (100mg tramadol hydrochloride) twice
a day
If this is not sufficient to kill the pain the dose can be increased to:
Zeridame SR 150mg: one tablet (150mg tramadol hydrochloride) twice
a day or
Zeridame SR 200mg: one tablet (200mg tramadol hydrochloride) twice
a day.

Frequency not known (cannot be estimated from the available data):
Enlarged pupils.
Side effects that occur at withdrawal, identical to withdrawal symptoms
with opiates, can be: agitation, anxiety, fear, nervousness, sleeplessness,
difficulty keeping still (hyperkinesias), shaking (tremor) and stomach
discomfort (gastro-intestinal disorders).

If the dose you are prescribed cannot be achieved with this strength
tablet, other strengths of this medicinal product are available to
achieve the dose.

Allergic reaction (e.g difficulty in breathing, wheezing, swelling of skin),
shock (sudden circulation failure) and increase in liver enzyme values
have occurred in very rare cases (affects less than 1 user in 10,000).
You should see a doctor immediately if you experience symptoms
such as swollen face, tongue and / or throat and / or difficulty to
swallow or hives together with difficulties in breathing.

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.

If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet.

Severe liver or kidney disease (insufficiency) / dialysis patients
Patients with severe liver and / or kidney insufficiency should not take
Zeridame SR. If in your case the insufficiency is mild or moderate, your
doctor may recommend prolonging the dosage interval.

5  ow to store Zeridame SR
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•  eep this medicine out of the sight and reach of children.
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Method of administration:
Zeridame SR is a tablet with a special core to let out the active
ingredient slowly and long-lasting in the body. Because of this it can
take a bit longer before you notice the effect.
Swallow the tablet whole (without chewing or breaking), with a glass
of water.
Preferably administer in the morning and evening. The tablets may be
taken on an empty stomach or during the meal.

Do not use this medicine after the expiry date which is stated on the
blister and / or bottle and the carton after “exp”. The expiry date refers
to the last day of that month.
•  tore in the original package in order to protect from moisture.
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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.

Duration of the treatment with Zeridame SR
Your doctor will tell you how long you should use Zeridame SR. This
depends on the cause of the pain. Do not use Zeridame SR any longer
than necessary.

6  ontents of the pack and other information
C
What Zeridame SR contains:

The active substance is: tramadol hydrochloride
•  tablet of Zeridame SR 100mg, contains 100mg tramadol
1
hydrochloride.
•  tablet of Zeridame SR 150mg, contains 150mg tramadol
1
hydrochloride.
•  tablet of Zeridame SR 200mg, contains 200mg tramadol
1
hydrochloride.

If you notice that Zeridame SR is too strong or is not strong enough,
talk to your doctor or pharmacist.

If you take more Zeridame SR than you should:

If you have taken too many Zeridame SR you should immediately
contact your doctor, nearest hospital or clinic. The possible symptoms
that may occur are: pin-point pupils, vomiting, a fall in blood pressure, a
fast heartbeat, collapse, disturbed consciousness including coma (deep
unconsciousness), epileptic fits and difficulties in breathing.

The other ingredients are: calcium hydrogen phosphate (E341),
hydroxypropyl cellulose (E463), colloidal anhydrous silica (E551), and
magnesium stearate (E470b).

If you forget to take Zeridame SR:

If you forgot 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 tablets as before.

What Zeridame SR looks like and contents of the pack:

Zeridame SR 100mg Prolonged Release Tablets are off white, round
biconvex tablets.
Zeridame SR 150mg Prolonged Release Tablets are off white, capsule
shaped tablets.
Zeridame SR 200mg Prolonged Release Tablets are off white, capsule
shaped tablets.

If you stop taking Zeridame SR:

If you interrupt or finish treatment with Zeridame SR 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 Zeridame
SR is stopped. However, on rare occasions, people who have been
taking Zeridame SR tablets 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 noise in the ears (tinnitus). If you experience any of
these complaints after stopping Zeridame SR, please consult your
doctor.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

Zeridame SR 100mg; 150mg; 200mg: packs of -10, 20, 30, 50, 60,
90, 100, 120, 180 or 500 white tablets in blisters or in plastic tablet
containers. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Actavis Group hf
Reykjavíkurvegur 76-78, 220 Hafnarfjordur, Iceland
Manufacturer:
Medochemie Ltd
Facility A – Z, Mich. Erakleous, Ayios Athanassios Industrial Area,
Limassol, Cyprus.

4  ossible side effects.
P

Revision date of leaflet: November 2012

Like all medicines, Zeridame SR tablets can cause side effects, although
not everybody gets them.
The following side effects can occur:
Very common (affects 1 user in 10): nausea and dizziness.
Common (affects 1 to 10 users in 100): headache; confusion, vomiting,
constipation, dry mouth, sweating, drowsiness, fatigue.
Uncommon (affects 1 to 10 users in 1000): heart palpitations, irregular
heart beat, low blood pressure - especially when standing up, heart
failure (cardiovascular collapse), uneasiness (qualm), pressure on the
stomach, feeling of fullness, itch, rash and rash with severe itch and
forming of lumps (hives or urticaria), diarrhoea.

AAAE3626

Actavis, Barnstaple, EX32 8NS, UK

Tramadol SR (Z eridame SR) 100mg, 150mg, 200mg 60 Tablets - UK
item no:
print proof no:
origination date:

AAAE3626
5
02.10.12

originated by:
approved for print/date

revision date:

min pt size:

revised by:
supplier:

DR
Medochemie

1. Black
2.
3.

pharmacode:

4.
7.5pt

5.
6.

DR
02.01.13

dimensions:

180x295

colours/plates:

Non Printing Colours

Technical Approval
date sent:

02.10.12

technically app. date:

11.10.12

1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated
Any technical chanages made by the supplier after approval are not the responsibility of the Artwork Studio

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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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