Skip to Content

ZERIDAME SR 100MG PROLONGED RELEASE TABLETS

Active substance: TRAMADOL HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
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 pharmacist.
I
•  his medicine has been prescribed for you only. Do not pass it on
T
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. This
I
includes any possible side effects not listed in this leaflet. See
section 4.

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 SR.
W
3  ow to take Zeridame SR.
H
4  ossible side effects.
P
5  ow to store Zeridame SR.
H
6  ontents of the pack and other information
C

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
W
Zeridame SR
DO NOT take Zeridame SR:

• f you are allergic to tramadol hydrochloride or any of the other
I
ingredients of this medicine (listed in section 6).
• f you have recently drunk too much alcohol or taken too many
I
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.
I
•  or the treatment of withdrawal symptoms in drug addicts.
F

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 in
I
the head (e.g. after an accident)
• f you suffer from disorders of the kidneys or liver (see section 3: how to
I
take Zeridame SR)
• f you suffer from difficulty to breathe
I
• f you have a tendency towards epilepsy or fits because the risk of a fit
I
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
I
• f you suffer from shock (cold sweat may be a sign of this)
I
• f you use other medicines or substances that work via the brain,
I
including alcohol.

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).
The pain relieving effect of Zeridame SR may be weakened and / or
shortened if you also take medicines containing:
•  arbamazepine (used to treat epilepsy)
C
•  uprenorphine, nalbuphine, or pentazocine (pain killers)
B
•  ndansetron (used to stop you feeling sick)
O
The risk of side effects increases:
• f you are taking medicines which may cause convulsions (fits), such as
i
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
i
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 such as
i
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 medicines,
i
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
a
threshold and the risk of convulsions may increase in these patients.

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.
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.

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).

AAAG5858

Zeridame SR (Tramadol) 100mg, 150mg & 200mg PIL - UK
item no: AAAG5858

dimensions: 180 x 295

print proof no: 3

pharmacode:

origination date: 25.02.14

min pt size:

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 27.03.14

Technical Approval

revised by: S.Anson

date sent: 25.02.14

supplier: Medochemie

technically app. date: 04.03.14

Non Printing Colours
1.
2.
3.

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.
The medicine can affect your ability to drive as it may make you sleepy or
dizzy.
•  o not drive while taking this medicine until you know how it affects you.
D
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
-  he medicine has been prescribed to treat a medical or dental problem
T
and
-  ou have taken it according to the instructions given by the prescriber or
Y
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  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.
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.
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
Zeridame SR. If in your case the insufficiency is mild or moderate, your
doctor may recommend prolonging the dosage interval.
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.
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.
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.

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.

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.
AAAG5858

4  ossible side effects.
P

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.
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).
Frequency not known (cannot be estimated from the available data):
Enlarged pupils. Decrease in blood sugar level.
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).
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.

Reporting of side effects

If you get any side effects, talk to your doctor, or 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  ow to store Zeridame SR
H

•  eep this medicine out of the sight and reach of children.
K
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.
S
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  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 hydrochloride.
1
•  tablet of Zeridame SR 150mg, contains 150mg tramadol hydrochloride.
1
•  tablet of Zeridame SR 200mg, contains 200mg tramadol hydrochloride.
1
The other ingredients are: calcium hydrogen phosphate (E341),
hydroxypropyl cellulose (E463), colloidal anhydrous silica (E551), and
magnesium stearate (E470b).

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.
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.
Revision date of leaflet: February 2014

Actavis, Barnstaple, EX32 8NS, UK

Zeridame SR (Tramadol) 100mg, 150mg & 200mg PIL - UK
item no: AAAG5858

dimensions: 180 x 295

print proof no: 3

pharmacode:

origination date: 25.02.14

min pt size:

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 27.03.14

Technical Approval

revised by: S.Anson

date sent: 25.02.14

supplier: Medochemie

technically app. date: 04.03.14

Non Printing Colours
1.
2.
3.

Expand view ⇕

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.

Hide
(web3)