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LARAPAM 100MG SR TABLETS

Active substance(s): TRAMADOL HYDROCHLORIDE / TRAMADOL HYDROCHLORIDE / TRAMADOL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SZ00000LT000

Larapam 100 mg, 150 mg, 200 mg SR 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 Larapam SR Tablets are and what they are
used for
2. What you need to know before you take Larapam SR
Tablets
3. How to take Larapam SR Tablets
4. Possible side effects
5. How to store Larapam SR Tablets
6. Contents of the pack and other information

1

What Larapam SR Tablets are and what
they are used for

Tramadol, the active substance in Larapam SR Tablets, is a
painkiller (analgesic) of the opioid group. Its pain alleviating
effect is due to its influence on specific nerve cells in the spinal
cord and in the brain.
Larapam SR Tablets are used in the treatment of moderate to
severe pain.

2

What you need to know before you take
Larapam SR Tablets

Do not take Larapam SR Tablets:
• if you are allergic to tramadol or any of the other ingredients
of this medicine (listed in section 6)
• in acute poisoning with alcohol, sleeping agents, centrally
acting painkillers, opioids or other psychotropic medicines
(medicines which influence mood, emotional status and
disposition).
• if you are also taking certain medicines called “monoamine
oxidase inhibitors” or MAOIs (used to treat depression
or Parkinson’s disease) or have taken them in the last
14 days before treatment with Larapam SR Tablets (see
“Other medicines and Larapam SR Tablets”)
• if you have epilepsy and your fits are not adequately
controlled by treatment
• as a drug substitute in drug withdrawal treatment
Warnings and precautions
Talk to your doctor before taking Larapam SR Tablets if you:
• think you may already be dependent on other opioid
painkillers
• react sensitively to opiates
• have a consciousness disturbance (if you feel that you
are going to faint)
• are in shock (cold sweat can be an indication of this)
• have difficulty in breathing
• suffer from increased pressure in the brain (possibly
after a head injury or brain disease)
• have a liver or kidney disorder
• suffer from epilepsy or seizures (fits) or have had them
in the past.
If any of the above applies to you, please talk to your doctor
before starting to take this medicine.
Epileptic fits have been reported in patients taking tramadol
at the recommended dose level. The risk may be increased if
the recommended upper daily dose limit of 400 mg tramadol
hydrochloride is exceeded or if you are taking medicines
concomitantly which lower the seizure threshold (see “Other
medicines and Larapam SR Tablets”).
Please note that psychological and physical dependence can
develop in patients on Larapam SR Tablets. During long-term
use, the effects of this medicine may weaken, with the result
that it becomes necessary to use a higher dose (development
of tolerance). For this reason, Larapam SR Tablets must
be used for short periods only and under strict medical
supervision in patients at risk of developing drug dependence.
Please also inform your doctor if any of these problems
develops while you are taking this medicine and if you have
experienced such problems in the past.
Children
Larapam SR Tablets are not suitable for use in children of less
than 12 years of age (see section 3 “How to take Larapam SR
Tablets”).
Elderly
Patients of more than 75 years of age should be monitored
carefully as the elimination of tramadol can be prolonged (see
section 3 “How to take Larapam SR Tablets”).
Other medicines and Larapam SR Tablets
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.

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Do not take Larapam SR Tablets at the same time as
medicines called “monoamine oxidase inhibitors” or MAOIs
(which are used to treat depression or Parkinson’s disease),
or if you have taken them in the last 14 days. The combination
could result in a serious, potentially life-threatening interaction.
The pain-relieving effect of Larapam SR Tablets may be
weakened and/or shortened if you also take medicines
containing:
• carbamazepine (used to treat epilepsy)
• pentazocine, nalbuphine or buprenorphine
(painkillers)
• ondansetron (used to treat nausea)
The risk of side effects is greater if you take Larapam SR
Tablets at the same time as:
• sedative medicines such as tranquillizers, sleeping
pills, antidepressants and other pain relievers such
as morphine and codeine (also as cough medicine),
and alcohol. You may feel excessively drowsy or feel
that you might faint.
• medicines which may cause convulsions (fits), such as
certain antidepressants or antipsychotics. The risk
having a fit may increase if you take Larapam SR
Tablets at the same time. Your doctor will tell you
whether Larapam SR Tablets is suitable for you.
• certain antidepressants. Larapam SR Tablets 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.
• medicines that inhibit blood clotting, such as warfarin.
The dose of these medicines may need to be reduced,
otherwise there could be an increased risk of potentially
serious bleeding.
Larapam SR Tablets with food and alcohol
Do not drink alcohol while taking Larapam SR Tablets; this
could enhance the effects of this medicine.
Food does not influence the effect of Larapam SR Tablets (see
section 3 “How to take Larapam SR Tablets”).
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.
Pregnancy
There is very little information regarding the safety of tramadol
in human pregnancy, therefore you should not take Larapam
SR Tablets if you are pregnant.
Chronic use of Larapam SR Tablets during pregnancy may
lead to withdrawal symptoms in newborns.
Breast-feeding
Small amounts of tramadol are excreted into breast milk. You
should not take Larapam SR Tablets if you are
breast-feeding. As a rule, it is not necessary to interrupt
breast-feeding after taking a single dose of tramadol.
Fertility
Based on human experience tramadol hydrochloride is
suggested not to influence female or male fertility.
Driving and using machines
This medicine may cause side effects such as dizziness,
drowsiness and blurred vision. If this happens, do not drive or
use any tools or machines and do not perform any hazardous
tasks.

3

How to take Larapam SR
Tablets

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.




Swallow the prolonged-release tablets whole with a glass
of water.
Do not break or chew the tablets.
The tablets can be taken with or without food.

The recommended doses are given below. Your doctor may
gradually increase or decrease your dose depending on how
you respond to the treatment.
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.
It is important that you do not continue to take this medicine
for longer than absolutely necessary.
Continued on the next page >>

Adults and children aged 12 years and over:
• The recommended initial dose is 100 mg twice daily.
• Take one prolonged-release tablet in the morning and one
in the evening.
There must be a minimum interval of 8 hours between each dose.
As a general rule, you should take no more than the minimum
dose you require to control your pain. You should not take a
dose of more than 400 mg of the active substance daily unless
there are specific medical reasons for this.
Use in children under 12 years:
This medicine is not recommended in children under 12 years.
Elderly:
• In elderly people (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 Larapam SR Tablets. If in your case
the insufficiency is mild or moderate, your doctor may
recommend prolonging the dosage interval.
If you take more Larapam SR Tablets than you should
If you take one prolonged release tablet more than prescribed
by mistake this will not normally have any negative
consequences for you. Continue to take Larapam SR Tablets
as your pain recurs as usual.
If you have taken an excessive dose of the medicine, the
following signs can occur: pin-point pupils, vomiting (being
sick), a fall in blood pressure, rapid heartbeat, collapse,
disturbed consciousness including coma, epileptic fits and
difficulties in breathing. If you observe any of these symptoms
or if a child accidentally takes this medicine, immediately
contact the nearest doctor or hospital for help!
If you forget to take Larapam SR Tablets
You may experience recurrence of pain. Do not take a double
dose to make up for a forgotten dose, but continue to take the
preparation as prescribed.
If you stop taking Larapam SR Tablets
If you interrupt or prematurely stop treatment with Larapam SR
Tablets, your pain will return. If you decide you wish to stop
taking this preparation because of unpleasant side effects,
please consult your doctor.
There will normally be no after-effects when you stop taking
Larapam SR Tablets. However, in a few cases in which
patients have been taking Larapam SR Tablets for a longer
period, they 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). Further
unusual CNS symptoms, i.e. confusion, delusions, change
of perception of the own personality (depersonalization), 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 you stop taking
Larapam SR Tablets, please consult your doctor.
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 cause side effects,
although not everybody gets them.
Serious side effects
This medicine can occasionally cause allergic reactions
although serious allergic reactions are rare (may affect up to
1 in 1,000 people). Stop taking this medicine and tell your
doctor straight away if you experience any of the following
symptoms of a serious allergic reaction:
• sudden wheezing, difficulty swallowing or hives
together with difficulty in breathing or dizziness
• swelling of the face, tongue and/or throat
Other possible side effects
Tell your doctor if any of the following side effects bothers you:
Very common: may affect more than 1 in 10 people
• feeling sick (nausea)
• dizziness

• epileptic fits: occurred mainly after the use of high
doses of tramadol or when tramadol was taken at the
same time as other medicines which may induce fits
• difficulty sleeping, nightmares
• hallucinations, confusion, delirium, anxiety
• Psychological complaints may appear after treatment
with Larapam SR Tablets. 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 (usually suppression, occasionally
increase) and decreased cognitive and sensory
perception (changes in senses and recognition, which
may lead to errors in judgment).
• slow breathing, shortness of breath (dyspnoea)
If the recommended doses are exceeded, or if other
medicines that depress brain function are taken at the
same time, breathing may slow.
• worsening of asthma has been reported, however it
has not been established whether it was caused by
tramadol.
• blurred vision
• constriction of the pupil (miosis)
• widening of the pupils (mydriasis)
• weak muscles
• dependence (addiction): Although the risk is slight,
dependence can develop when Larapam SR Tablets
are used for longer periods. Withdrawal symptoms may
occur when treatment is stopped (see section 3 “If you
stop taking Larapam SR Tablets”).
• involuntary muscle contractions
• lack of coordination
• transient loss of consciousness (syncope)
• speech disorders
• passing urine with difficulty or pain, excretion of less
urine than normal
Very rare: may affect up to 1 in 10,000 people
• blood tests which show changes in the way the liver is
working
Not known: frequency cannot be estimated from the available
data
• decrease in blood sugar level
Reporting of side effects
If you get any side effects, talk to 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 (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 Larapam SR Tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated
on the blister and the carton after “EXP”. The expiry date
refers to the last day of that month.
Do not store Larapam SR Tablets above 25°C.
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 Larapam SR Tablets contains
• The active substance is tramadol hydrochloride.
• Each prolonged-release tablet contains 100, 150 or
200 mg tramadol hydrochloride.
• The other ingredients are: calcium hydrogen phosphate
dihydrate (E341), colloidal anhydrous silica (E551),
hyprolose (E463), magnesium stearate (E470b).
What Larapam SR Tablets looks like and contents of the pack
Larapam SR Tablets 100 mg, prolonged-release tablets are off
white, round and biconvex tablets.
Larapam SR Tablets 150 mg, prolonged-release tablets are off
white and capsule-shaped tablets.

Common: may affect up to 1 in 10 people
• headache
• drowsiness, tiredness
• constipation, dry mouth, vomiting
• sweating

Larapam SR Tablets 200 mg, prolonged-release tablets are off
white and capsule-shaped tablets.

Uncommon: may affect up to 1 in 100 people
• faster, stronger or irregular heartbeat, collapse or a fall in
blood pressure on standing up, which causes dizziness,
light-headedness or fainting
• These side effects may particularly occur in patients in
an upright position or under physical strain.urge to vomit
(retching), a feeling of pressure in the stomach, stomach
bloating, diarrhoea
• itching, rash, and raised, red, itchy skin rash (hives)

Not all pack sizes may be marketed.

Rare: may affect up to 1 in 1,000 people
• slower heartbeat
• rise in blood pressure
• changes in appetite
• tingling or numbness in the hands and feet
• tremor

The contents of the packages are 10, 20, 30, 50, 60, 100 or
100x1 (unit dose) tablets in PVC/Aluminium blisters.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Limited
Frimley Business Park, Frimley
Camberley, Surrey, GU16 7SR
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
This leaflet was last revised in 04/2017.

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draft: 44033909, 44033910,
44033566
laetus code: supplier to add
mat.no.: supplier to add

Artwork Proof Box

Ref: V054: Update SPC, PIL and labelling in acc with the EU PSUR
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012.0

Date prepared:
05/04/2017

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Dimensions: 165 x 360 mm

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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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