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LARAPAM 150MG SR TABLETS

Active substance(s): TRAMADOL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Larapam 100 mg, 150 mg, 200 mg SR Tablets
Tramadol hydrochloride
Read all of this leaflet carefully before you start using 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)
• if you have acute intoxication with alcohol, sleeping
agents, painkillers, opioids or other psychotropic agents
(medicines which influence mood, emotional status and
disposition)
• if you are taking, or have taken in the last two weeks,
certain medicines called “monoamine oxidase

inhibitors” or MAOIs (used to treat depression). (see
“Taking other medicines”)
• if you have epilepsy that is not controlled with your
current medicine
• as a drug substitute for the treatment of drug addiction
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 or are in shock (cold
sweat can be an indication of this)
• have difficulty in breathing
• have a head injury or brain diseases that may cause
elevated pressure in the skull
• have a liver or kidney disorder
• suffer from epilepsy or seizures (fits) or have had them
in the past.
• have or ever had a blood level low in sodium
If any of the above applies to you, please talk to your
doctor before starting to take this medicine.
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.
Other medicines and Larapam SR Tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Do not take Larapam SR Tablets at the same time as
medicines called “monoamine oxidase inhibitors” (which
are used to treat depression), or if you have taken one
in the past 2 weeks. 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)
00000000

• ondansetron (used to reduce vomiting)
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

(morphine, codeine). 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 alcohol
Do not drink alcohol while taking Larapam SR Tablets; this
could enhance the effects of the medicine.
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 this
medicine should not be used in pregnant women.
Breast-feeding: Very small quantities of tramadol are
excreted into breast milk. As a rule, it is not necessary
to interrupt breast-feeding after taking a single dose of
tramadol. If repeated administration is necessary you
should suspend breast-feeding. If you have to take
tramadol for several days, i.e. for more than 2 to 3 days,
you must not breast-feed.
Driving and using machines
This medicine may cause side effects such as 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 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.
Adults and children aged 12 years and over:
• The recommended initial dose is 100 mg twice daily.
• Take one 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.

Continued on the next page >>

Use in children under 12 years:
This medicine is not recommended in children under 12
years.
Older people:
• 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 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 very long period, there have been after-effects such as
restlessness, anxiety, nervousness, insomnia, tremor or
gastrointestinal upset. If you experience any of these side
effects when you stop taking Larapam SR Tablets, please
consult your doctor.
















hallucinations, confusion
breathing difficulties, worsening of asthma
blurred vision
reduced muscle strength
difficulty in passing urine, producing less urine than
normal
drug dependence (addiction), withdrawal symptoms
may occur when treatment is stopped (see “If you stop
taking Larapam SR Tablets”).
involuntary muscle contractions
lack of coordination
loss of consciousness
anxiety
difficulty and pain when passing urine

Very rare (may affect up to 1 in 10,000 people):
• sudden onset of skin redness
• a feeling of dizziness or “spinning”
• blood tests which show changes in the way the liver is
working
Not known (frequency cannot be estimated from the
available data):
• blood level low in sodium
• 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 package after “ Do not use after:” or “EXP:”
The expiry date refers to the last day of that month.
Do not store Larapam SR Tablets above 25°C.

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

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.

4

6

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 in breathing or dizziness
• swelling of the face 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 or being sick (nausea)
• dizziness
Common (may affect up to 1 in 10 people):
• headache
• drowsiness, fatigue
• constipation, dry mouth
• sweating
• vomiting
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
• retching, a feeling of pressure in the stomach, stomach
bloating
• pruritus, rash, and raised, red, itchy skin rash (hives)
• diarrhoea
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
• epileptic-like seizures
• difficulty sleeping, nightmares
• mood changes
• changes in activity (usually reduced, sometimes
increased)
• changes in sensory perception and impairment of
the ability to recognise, which can lead to inappropriate
decisions

Contents of the pack and other information

What Larapam SR Tablets contains
The active substance is tramadol hydrochloride. Each
Larapam SR 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, prolonged-release tablet: the
tablets are off white and round.
Larapam SR Tablets 150, prolonged-release tablet: the
tablets are off white and capsule-shaped.
Larapam SR Tablets 200, prolonged-release tablet: the
tablets are off white and capsule-shaped.
The contents of the packages are 10, 20, 30, 50, 60, 100
and 100x1 (unit dose) tablets in PVC/Aluminium blisters.
Not all package sizes may be marketed.
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 07/2014.

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SZ00000LT000

Artwork Proof Box

Ref: V051: Update SPC & PIL for incl of ADR “hypoglycaemia”
Proof no.
009.1

Date prepared:
31/07/2014

Colours:
Black
Dimensions: 168 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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