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OXYCODONE HYDROCHLORIDE/NALOXONE HYDROCHLORIDE G.L. PHARMA 5 MG/2.5 MG PROLONGED-RELEASE TABLETS

Active substance(s): NALOXONE HYDROCHLORIDE DIHYDRATE / OXYCODONE HYDROCHLORIDE

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Package leaflet: Information for the patient

Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma 5 mg/2.5 mg
prolonged-release tablets

oxycodone hydrochloride/naloxone 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 Oxycodone hydrochloride/Naloxone hydrochloride
G.L. Pharma is and what it is used for
2. What you need to know before you take Oxycodone
hydrochloride/Naloxone hydrochloride G.L. Pharma
3. How to take Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma
4. Possible side effects
5. How to store Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma
6. Contents of the pack and other information
1. What Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma is and what it is used for
Pain relief
You have been prescribed Oxycodone hydrochloride/
Naloxone hydrochloride G.L. Pharma for the treatment of
severe pain, which can be adequately managed only with
opioid analgesics.
How Oxycodone hydrochloride/Naloxone hydrochloride
G.L. Pharma works in pain relief
Oxycodone hydrochloride/Naloxone hydrochloride
G.L. Pharma contains oxycodone hydrochloride and
naloxone hydrochloride as active substances. Oxycodone
is responsible for the painkilling effect of Oxycodone
hydrochloride/Naloxone hydrochloride G.L. Pharma. It is
a strong analgesic (“painkiller”) that belongs to a group of
medicines called opioids.
Restless legs syndrome
You have been prescribed Oxycodone hydrochloride/
Naloxone hydrochloride G.L. Pharma for the second line
symptomatic treatment of severe to very severe restless legs
syndrome. The use of Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma is indicated for people who can’t
be treated with dopamine medicines. People with restless
legs syndrome have unpleasant sensations in their limbs. This
can start as soon as they sit or lie down and is only relieved
by an irresistible urge to move the legs, sometimes the arms
and other parts of the body. It makes sitting still and sleeping
very difficult.
How Oxycodone hydrochloride/Naloxone hydrochloride
G.L. Pharma work in restless legs syndrome
Oxycodone hydrochloride/Naloxone hydrochloride
G.L. Pharma helps to relieve the unpleasant sensations and
so reduces the urge to move the limbs.
Naloxone is intended to bring relief from constipation.
Constipation is a typical side effect of treatment with strong
painkillers (opioidpainkillers).
2. What you need to know before you take Oxycodone
hydrochloride/Naloxone hydrochloride G.L. Pharma
Do not take Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma
– if you are allergic to oxycodone, naloxone or any of the
other ingredients of this medicine (listed in section 6).
– if you have breathing problems, such as breathing more
slowly or weakly than expected (respiratory depression).
– if you suffer from a severe lung disease associated with
narrowing of the airways (chronic obstructive pulmonary
disease or COPD).
– if you suffer from a condition known as cor pulmonale.
In this condition, the right side of the heart becomes
enlarged, due to increased pressure inside blood vessels
in the lung etc. (e.g. as a result of COPD – see above).
– if you suffer from severe bronchial asthma.
– if you have a type of bowel obstruction (paralytic ileus) not
caused by opioids.
– if you have moderate to severe liver dysfunction.
Additionally for restless legs syndrome:
– if you have a history of opioid abuse.
Warnings and precautions
Talk to your doctor or pharmacist before taking Oxycodone
hydrochloride/Naloxone hydrochloride G.L. Pharma
– in the case of elderly or debilitated (weak) patients,
– if you have a type of bowel obstruction (paralytic ileus)
caused by opioids,
– if you have kidney problems,
– if you have mild liver problems,
– if you have severe lung problems (i.e. reduced breathing
capacity),
– if you suffer from a condition characterised by frequent
breathing stops during the night which may make you feel
very sleepy during the daytime (sleep apnoea),
– if you have myxoedema (a thyroid disorder, with dryness,
coldness and swelling [“puffiness”] of the skin, affecting
the face and limbs),
– if your thyroid gland is not producing enough hormones
(underactive thyroid or hypothyroidism),
– if your adrenal glands are not producing enough
hormones (adrenal insufficiency or Addison’s disease),
– if you have a mental illness accompanied by a (partial) loss
of reality (psychosis), due to alcohol or intoxication with
other substances (substance-induced psychosis),
– if you suffer from gallstone problems,
– if your prostate gland is abnormally enlarged (prostate
hypertrophy),
– if you are or ever have been addicted to alcohol or drug, or
have previously suffered from withdrawal symptoms such
as agitation, anxiety, shaking or sweating upon stopping
alcohol or drugs,
– if your pancreas is inflamed (pancreatitis),
– if you have low blood pressure (hypotension),
– if you have high blood pressure (hypertension),
– if you have heart problems,
– if you have a head injury (due to the risk of increased brain
pressure),
– if you suffer from epilepsy or are prone to fits,
– if you are also taking a type of medicine known as MAO
inhibitor (used to treat depression or Parkinson’s disease),
e.g. medicines containing tranylcypromine, phenelzine,
isocarboxazid, and moclobemide,
– if sleepiness or episodes of suddenly falling asleep occur.
Tell your doctor if any of the above has ever applied to you
in the past. Also, please contact your doctor if you develop
any of them while you are taking Oxycodone hydrochloride/
Naloxone hydrochloride G.L. Pharma.
Oxycodone hydrochloride/Naloxone hydrochloride
G.L. Pharma is not recommended for use in patients
with advanced digestive or pelvic cancers where bowel
obstruction may be a problem.
If you experience severe diarrhoea at the start of treatment
(within the first 3 to 5 days) this may be due to the effect of
naloxone. It may be a sign that your bowel movements are
returning to normal. If diarrhoea persists after 3 to 5 days, or it
gives you cause for concern, please contact your doctor.
If you have been using high doses of another opioid,
withdrawal symptoms (such as restlessness, bouts of
sweating and muscle pain) may occur when you initially switch
to Oxycodone hydrochloride/Naloxone hydrochloride
G.L. Pharma. If you experience withdrawal symptoms, you
may need to be specially monitored by your doctor.
If you need to undergo surgery, please tell your doctor
that you are taking Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma.
If you have been taking Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma for a long time, you may become
tolerant. This means you may need a higher dose to achieve
the desired effect. Long-term use of this medicine may
also lead to physical dependence. Medicines containing
oxycodone should be avoided in patients with a present
or past abuse of alcohol, drugs or medicines. Withdrawal
symptoms may occur if treatment is stopped too suddenly. If
you no longer need treatment, you should reduce your daily
dose gradually, in consultation with your doctor.
There is a risk that you may develop a psychological
dependence to oxycodone.
You may notice remnants of the prolonged-release tablet in
your stools. Do not be alarmed, as the active substances
will have already been released in the stomach and gut, and
absorbed into your body.
Incorrect use of Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma
Oxycodone hydrochloride/Naloxone hydrochloride
G.L. Pharma must never be abused, particularly if you have
a drug addiction. If you are addicted to drugs such as heroin,
morphine or methadone, severe withdrawal symptoms
are likely if you abuse Oxycodone hydrochloride/Naloxone
45.2015/991/BAL

hydrochloride G.L. Pharma because it contains the active
substance naloxone. Pre-existing withdrawal symptoms may
be made worse.
You must never misuse Oxycodone hydrochloride/
Naloxone hydrochloride G.L. Pharma prolonged-release
tablets by dissolving and injecting or inhaling them (e.g.
into a blood vessel). They contain talc, which can cause
destruction of local tissue (necrosis) and changes in lung
tissue (lung granuloma). Misuse can also have other serious
consequences which may be fatal.
You must swallow these prolonged-release tablets whole
so as not to affect the slow release of oxycodone from the
tablets. Do not divide, break, chew or crush them. Taking
divided, broken, chewed or crushed tablets may result in
your body absorbing a potentially fatal dose of oxycodone
(see section 3 “If you take more Oxycodone hydrochloride/
Naloxone hydrochloride G.L. Pharma than you should”).
The use of Oxycodone hydrochloride/Naloxone hydrochloride
G.L. Pharma may produce positive results in doping controls.
The use of Oxycodone hydrochloride/Naloxone hydrochloride
G.L. Pharma as a doping agent may become a health hazard.
Children and adolescents
This medicine should not be given to children or adolescents
under 18 years of age as the safety and efficacy have not
been shown yet.
Other medicines and Oxycodone hydrochloride/
Naloxone hydrochloride G.L. Pharma
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
The risk of side effects is increased if you take Oxycodone
hydrochloride/Naloxone hydrochloride G.L. Pharma at the
same time as medicines which affect the way the brain works.
For example, you may feel very sleepy, or breathing problems
(slow and shallow breathing) may get worse.
Examples of medicines that affect the way the brain works
include:
– other strong painkillers (opioids)
– sleep medicines and tranquilisers (sedatives, hypnotics)
– antidepressants
– medicines used to treat allergies, travel sickness or
nausea (antihistamines or antiemetics)
– other medicines which act on the nervous system
(phenothiazines, neuroleptics)
Tell your doctor if you are taking:
– medicines that decrease the blood’s clotting ability
(coumarin derivatives), this clotting time may be speeded
up or slowed down
– antibiotics of the macrolide type (e.g. clarithromycin,
erythromycin, telithromycin)
– antifungal medicines of the azole type (e.g. ketoconazole,
voriconazole, itraconazole, posaconazole)
– ritonavir or other protease inhibitors (used to treat HIV,
such as indinavir, nelfinavir, saquinavir)
– rifampicin (used to treat tuberculosis)
– carbamazepine (used to treat seizures, fits or convulsions
and certain pain conditions)
– phenytoin (used to treat seizures, fits or convulsions)
– St. John’s Wort
Oxycodone hydrochloride/Naloxone hydrochloride
G.L. Pharma with drink and alcohol
Drinking alcohol whilst taking Oxycodone hydrochloride/
Naloxone hydrochloride G.L. Pharma may make you feel more
sleepy or increase the risk of serious side effects such as
shallow breathing with a risk of stopping breathing, and loss
of consciousness. It is recommended not to drink alcohol
while you are taking Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma.
You should avoid drinking grapefruit juice while you are taking
Oxycodone hydrochloride/Naloxone hydrochloride
G.L. Pharma.
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
Use of Oxycodone hydrochloride/Naloxone hydrochloride
G.L. Pharma should be avoided to the extent possible during
pregnancy. If used over prolonged periods during pregnancy,
oxycodone may lead to withdrawal symptoms in newborn
infants. If oxycodone is given during childbirth, respiratory
depression (slow and shallow breathing) may occur in the
newborn infant.
Breast-feeding
Breast-feeding should be discontinued during treatment
with Oxycodone hydrochloride/Naloxone hydrochloride
G.L. Pharma. Oxycodone passes into breast milk. It is not
known whether naloxone also passes into breast milk.
Therefore, a risk for the suckling infant cannot be excluded,
in particular following intake of multiple doses of Oxycodone
hydrochloride/Naloxone hydrochloride G.L. Pharma.
Driving and using machines
The medicine can affect your ability to drive as it may make
you sleepy or dizzy.
– Do not drive while taking this medicine until you know how
it affects you.
– It is an offence to drive if this medicine affects your ability
to drive.
– However, you would not be committing an offence if:
– the medicine has been prescribed to treat a medical or
dental problem and
– you have taken it according to the instructions given by
the prescriber or 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.
Oxycodone hydrochloride/Naloxone hydrochloride
G.L. Pharma contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking
this medicine.
3. How to take Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Unless otherwise prescribed by your doctor, the
recommended dose is:
To treat pain
Adults
The usual starting dose is 10 mg oxycodone hydrochloride/
5 mg naloxone hydrochloride every 12 hours.
Your doctor will decide how much you should take every day
and how to divide your total daily dosage into morning and
evening doses. Your doctor will also decide on any necessary
dose adjustments during treatment depending on your level of
pain and individual sensitivity. You should be given the lowest
dose needed for pain relief. If you have already been treated
with opioids, your treatment with Oxycodone hydrochloride/
Naloxone hydrochloride G.L. Pharma may be started at
a higher dose.
The maximum daily dose is 160 mg oxycodone hydrochloride
and 80 mg naloxone hydrochloride. If you need a higher
dose, your doctor may give you additional oxycodone without
naloxone. However, the maximum daily dose of oxycodone
hydrochloride should not exceed 400 mg. The beneficial
effect of naloxone on bowel movements may be affected if
additional oxycodone is given without additional naloxone.
If you experience pain between doses, you may need to take
an additional fast-acting painkiller. Oxycodone hydrochloride/
Naloxone hydrochloride G.L. Pharma is not suitable for this.
Please talk to your doctor.
If you feel that Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma is too strong or too weak, please
talk to your doctor or pharmacist.
To treat restless legs syndrome
Adults
The usual starting dose is 5 mg oxycodone hydrochloride/
2.5 mg naloxone hydrochloride as prolonged-release tablet(s)
every 12 hours.
Your doctor will decide how much you should take every
day and how to divide your total daily dose into morning and
evening doses. Your doctor will also decide on any necessary
dose adjustments during treatment. Your dose will be
adjusted according to your individual sensitivity. You should
be given the lowest dose needed to relieve your restless legs
syndrome symptoms.
The maximum daily dose is 60 mg oxycodone hydrochloride
and 30 mg naloxone hydrochloride.
If you feel that Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma is too strong or too weak, please
talk to your doctor or pharmacist.
Elderly patients
In general, no dose adjustment is necessary for elderly
patients with normal kidney and/or liver function.
GI_uk,, Oxycodon Naloxon G.L. Pharma 5/2,5 mg Tab.

Liver or kidney impairment
If you have kidney or mild liver problems, your doctor will
prescribe Oxycodone hydrochloride/Naloxone hydrochloride
G.L. Pharma with special caution. You must not take
Oxycodone hydrochloride/Naloxone hydrochloride
G.L. Pharma if you have moderate or severe liver problems
(see also section 2 “Do not take Oxycodone hydrochloride/
Naloxone hydrochloride G.L. Pharma” and “Warnings and
precautions”).
Children and adolescents below 18 years of age
No studies have been carried out to show that Oxycodone
hydrochloride/Naloxone hydrochloride G.L. Pharma works
properly in children and adolescents or is safe for them to
take. It is therefore not recommended for use in patients
under 18 years of age.
Method of administration
Oral use.
Swallow the tablets whole with a glass of water. You can take
the tablets with or without food. Take them every 12 hours
according to a fixed time schedule. For instance, if you take
a tablet at 8 o’clock in the morning, you should take your next
tablet at 8 o’clock in the evening. Do not divide, break, chew
or crush the prolonged-release tablets.
Opening instructions for the blister:
This medicinal product is in childproof packaging. The
prolonged-release tablets have to be pressed out firmly of the
blister.
Duration of use
You should not take Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma for any longer than you need to.
If you have been taking Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma for a long time your doctor should
regularly check that you still need it.
If you take more Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma than you should
If you have taken more than the prescribed dose, you must
inform your doctor immediately.
An overdose may result in:
– a reduction in size of pupils in the eye,
– breathing more slowly or weakly than expected
(respiratory depression),
– drowsiness or loss of unconsciousness,
– low muscle tone (hypotonia),
– reduced pulse rate,
– a fall in blood pressure.
In severe cases, loss of consciousness (coma), fluid on the
lungs and circulatory collapse may occur, which may be fatal.
You should avoid situations which require you to be alert, e.g.
driving.
If you forget to take Oxycodone hydrochloride/
Naloxone hydrochloride G.L. Pharma
If you forget to take Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma or if you take a lower dose than
the one prescribed, you may not feel any effect.
If you forget to take your dose, please follow the instructions
below:
– If your next usual dose is due in 8 hours or more: Take the
forgotten dose immediately and continue with your normal
dosing schedule.
– If your next usual dose is due in less than 8 hours: Take
the forgotten dose, then wait another 8 hours before
taking your next dose. Try to get back in your normal
dosing schedule (e.g. 8 o’clock in the morning and
8 o’clock in the evening).
Do not take more than one dose within any 8 hour period.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma
Do not stop taking Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma without first speaking with your
doctor.
If you do not require any further treatment, your doctor will
advise you how to reduce the daily dose gradually. In this way,
you will avoid withdrawal symptoms, such as restlessness,
bouts of sweating and muscle pain.
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.
Important side effects or signs to look out for, and
what to do if you are affected:
Stop taking Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma and contact a doctor or go to your
nearest emergency department immediately if you experience
any of the following symptoms:
– A more slow or shallow breathing (respiratory depression).
This is the most serious side effect with Oxycodone
hydrochloride/Naloxone hydrochloride G.L. Pharma and it
mostly occurs in elderly and weak patients.
– Opioids can also cause a severe drop in blood pressure in
susceptible patients.
– Swelling of the face, tongue or throat; difficulty swallowing;
hives; breathing difficulties and drop in blood pressure
(anaphylactic reaction).
The following side effects have been seen in patients
being treated for pain
Common (may affect up to 1 in 10 people)
– abdominal pain, indigestion, constipation, diarrhoea, wind
– dry mouth
– vomit (be sick), feel sick
– decreased appetite up to loss of appetite
– a feeling of dizziness or “spinning”, vertigo
– headache
– hot flushes, sweating
– general weakness, tiredness or exhaustion
– itchy skin, skin reactions/rash
– difficulty in sleeping, drowsiness
Uncommon (may affect up to 1 in 100 people)
– abdominal bloating
– abnormal thoughts
– anxiety, confusion, depression, nervousness, difficulties to
concentrate
– chest tightness, especially if you already have coronary
heart disease, chest pain
– drop in blood pressure, rise in blood pressure
– withdrawal symptoms such as agitation
– fainting
– palpitations
– biliary colic
– generally feeling unwell
– pain
– swelling of hands, ankles or feet
– impaired speaking
– shaking
– difficulties breathing
– restlessness
– chills
– hepatic enzymes increased
– runny nose
– cough
– hypersensitivity/allergic reactions
– weight loss
– injuries from accidents
– increased urge to urinate
– muscle cramps, muscle twitches, muscle pain
– vision impairment
– epileptic seizures (especially in persons with epileptic
disorder or predisposition to seizures)
Rare (may affect up to 1 in 1,000 people)
– increase in pulse rate
– dental changes
– weight gain
– yawning
Not known (frequency cannot be estimated from the
available data)
– euphoric mood
– sedation
– erectile dysfunction
– nightmares
– hallucinations
– shallow breathing
– difficulties in passing urine
– tingling in hands or feet
– belching
The active substance oxycodone, if not combined with
naloxone, is known to have the following differing side
effects:
Breathing problems, such as breathing more slowly or weakly
than expected (respiratory depression), reduction in size of the
pupils in the eye, muscle cramps and decreased cough reflex.
Common (may affect up to 1 in 10 people)
– altered mood and personality changes (e.g. depression,
feeling of extreme happiness)
– decreased activity, increased activity
– difficulties in passing urine
– hiccups
Uncommon (may affect up to 1 in 100 people)
– impaired concentration, agitation
– migraine

















taste anomalies
increased muscle tension, involuntary muscle contractions
drug dependence, drug tolerance
ileus
dry skin, flushing of skin
reduced sensitivity to pain or touch
abnormal coordination
vocal changes (dysphonia)
water retention
difficulties in hearing
mouth ulcers, sore gums
difficulties in swallowing
perception disturbances (e.g. hallucination, derealisation)
reduced sexual drive
dehydration, thirst

Rare (may affect up to 1 in 1,000 people)
– itching rash (urticaria)
– herpes simplex
– increased appetite
– black (tarry) stools
– gingival bleeding
Not known (frequency cannot be estimated from the
available data)
– acute generalized allergic reactions (anaphylactic
reactions)
– absence of menstrual periods
– problems with bile flow
The following side effects have been seen in patients
being treated for restless legs syndrome
Very common (may affect more than 1 in 10 people)
– headache
– drowsiness
– constipation
– feel sick
– sweating
– tiredness or exhaustion
Common (may affect up to 1 in 10 people)
– decreased appetite to loss of appetite
– difficulty in sleeping
– depression
– a feeling of dizziness or “spinning”, vertigo
– difficulty in concentrating
– shaking
– tingling in hands or feet
– vision impairment
– hot flushes
– drop in blood pressure, rise in blood pressure
– pain, abdominal pain, chest pain
– dry mouth, thirst
– vomit (be sick)
– hepatic enzymes increased (alanine aminotransferase
increased, gamma-glutamyltransferase increased)
– itchy skin, skin reactions/rash
– chills
Uncommon (may affect up to 1 in 100 people)
– reduced sexual drive
– episodes of suddenly falling asleep
– altered taste
– difficulties breathing
– wind
– withdrawal symptoms such as agitation
– swelling of hands, ankles or feet
– injuries from accidents
Not known (frequency cannot be estimated from available
data)
– hypersensitivity/allergic reactions
– abnormal thoughts, hallucinations, nightmares
– anxiety, confusion, nervousness, euphoric mood
– restlessness
– epileptic seizures (especially in persons with epileptic
disorder or predisposition to seizures)
– severe drowsiness, fainting
– impaired speaking
– chest tightness especially if you already have coronary
heart disease
– palpitations, increase in pulse rate
– shallow breathing, yawning
– cough
– runny nose
– abdominal bloating, diarrhoea, indigestion, belching
– dental changes
– biliary colic
– muscle cramps, muscle twitches, muscle pain
– difficulties in passing urine, increased urge to urinate
– erectile dysfunction
– generally feeling unwell
– weight loss, weight increase
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 national
reporting system:
Yellow Card Scheme
Website: 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 Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma
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 carton. The expiry date refers to the last day
of that month.
Do not store 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 Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma contains
The active substances are oxycodone hydrochloride and
naloxone hydrochloride.
Each prolonged-release tablet contains 5 mg oxycodone
hydrochloride equivalent to 4.5 mg oxycodone and
2.5 mg naloxone hydrochloride as 2.75 mg of naloxone
hydrochloride, equivalent to 2.25 mg naloxone.
The other ingredients are:
Tablet core
Polyvinyl acetate
Povidone K 30
Sodium laurilsulfate
Silica
Microcrystalline cellulose
Lactose monohydrate
Colloidal anhydrous silica
Magnesium stearate
Film-coat
Polyvinyl alcohol, partially hydrolysed
Macrogol 3350
Titanium dioxide (E 171)
Talc
Brilliant blue FCF aluminium lake (E 133)
What Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma looks like and contents of
the pack
Oxycodone hydrochloride/Naloxone hydrochloride
G.L. Pharma is a prolonged-release tablet, which means that
its active substances are released over an extended period.
Their action lasts for 12 hours.
Oxycodone hydrochloride/Naloxone hydrochloride
G.L. Pharma 5 mg/2.5 mg prolonged-release tablets are light
blue, round and biconvex prolonged-release tablets with a film
coating, with “5” embossed on one side.
Blister packs with 7, 10, 14, 20, 28, 30, 50, 56, 60, 98 and
100 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria
This medicinal product is authorised in the Member
States of the EEA under the following names:
Germany:
Oxycodon/Naloxon G.L.
5/2.5 mg // 10 mg/5 mg //
20 mg/10 mg // 30 mg/15 mg //
40 mg/20 mg-Retardtabletten
Italy:
Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma
5/2.5 mg // 10 mg/5 mg // 20 mg/10 mg //
30 mg/15 mg // 40 mg/20 mg
Spain:
Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma Pharma
5/2.5 mg // 10 mg/5 mg // 20 mg/10 mg //
30 mg/15 mg // 40 mg/20 mg comprimidos
de liberación prolongada EFG
United Kingdom: Oxycodone hydrochloride/Naloxone
hydrochloride G.L. Pharma Pharma
5/2.5 mg // 10 mg/5 mg // 20 mg/10 mg //
30 mg/15 mg // 40 mg/20 mg prolongedrelease tablet
This leaflet was last revised in August 2017.

Präparatenamen/Stärke:

Oxycodon Naloxon
G.L. Pharma 5/2,5 mg
Darreichungsform: Tabletten
Abpackungsart: Blister
Art.-Nr.:

GI30875BG

Code-Nr.:
Land:

29.2017/209/BG

Großbritannien / uk
160 x 600 mm

Format:

Packmittelart:
Produktion:
Schrift:

♦ Schwarz
1
Datum: 23.08.2017
Uhrzeit: 10:35:21
Version:

GI_uk,, Oxycodon Naloxon G.L. Pharma 5/2,5 mg Tab.

intern

Helvetica 8,0 / 8,7 Punkt, narrow

Druckfarbe:

45.2015/991/BAL

Gebrauchsinformation

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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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