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OXYCODONE G. L. PHARMA 5 MG PROLONGED RELEASE TABLETS

Active substance(s): OXYCODONE HYDROCHLORIDE / OXYCODONE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Pharma
Pharma
Pharma
Pharma
Pharma

Oxycodone hydrochloride

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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 side effects not listed
in this leaflet.
What is in this leaflet:
1. What Oxycodone G.L. Pharma is and what it is
used for
2. What you need to know before you take
Oxycodone G.L. Pharma
3. How to take Oxycodone G.L. Pharma
4. Possible side effects
5. How to store Oxycodone G.L. Pharma
6. Contents of the pack and other information
1. WHAT OXYCODONE G.L. PHARMA IS
AND WHAT IT IS USED FOR
Oxycodone G.L. Pharma is a strong painkiller
(analgesic) from the group of opioids.
Oxycodone G.L. Pharma is used to treat severe
pain, which requires treatment with an opioid
analgesics because other painkillers have not
been effective.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE OXYCODONE G.L. PHARMA
Do not take Oxycodone G.L. Pharma
– if you are allergic to oxycodone hydrochloride,
soya, peanut, or any of the other ingredients of
this medicine (listed in section 6).
– if you have breathing problems, such as
breathing more slowly or more weakly than
expected (respiratory depression).
– if you have too much carbon dioxide in your
blood.
– if you suffer from a severe chronic lung disease
associated with narrowing of the airways (COPD
= chronic obstructive pulmonary disease).
– if you have a certain heart condition known as
cor pulmonale.
– if you have asthma.
– if you have a type of bowel obstruction called
paralytic ileus.
– if you have acute severe stomach pain or
suffer from a delayed stomach emptying.

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Warnings and precautions
Talk to your doctor or pharmacist before using
Oxycodone G.L. Pharma
– if you are elderly or debilitated (weak).
– if your lung, liver or kidney function is severely
impaired.
– if you have a certain disorder of the thyroid
gland (myxoedema) or if your thyroid
gland does not produce enough hormone
(underactive thyroid).
– if your adrenal glands are not producing
enough hormones (Addison’s disease or
adrenal insufficiency).
– if your prostate is abnormally enlarged.
– if you are addicted to alcohol or are undergoing
alcohol withdrawal treatment.
– if you are, or were previously, dependent on
strong pain killers (opioids).
– if you have an inflammation of the pancreas
(pancreatitis) or if you have problems with your
gall bladder.
– if you have difficulty or pain passing urine.
– if your brain pressure is increased.
– if you have low blood pressure or feel dizzy
standing up.
– if you suffer from epilepsy or are prone to fits.
– if you are also taking a type of medicine
known as MAO inhibitors (generally used for
the treatment of depression or Parkinson’s
disease).
Dependence and tolerance
When Oxycodone G.L. Pharma is used for longterm treatment, tolerance to the medicine may
occur. This means, that you may need a higher
dose to achieve the desired pain relief.
Oxycodone G.L. Pharma has a dependence
potential. If the treatment is stopped too suddenly,
withdrawal symptoms such as nausea, vomiting,
trembling, vertigo, diarrhoea, sweating or chills,
cramps, rapid pulse and high blood pressure
may occur. If you no longer need treatment, your
doctor will gradually reduce your daily dose.
If this medicine is used as intended in patients
suffering from chronic pain states, the risk for
physical and psychological dependence is low.
Your doctor will weigh the possible risks against
the expected benefit. Ask your doctor if you have
any questions about this.
Anti-Doping Warning
The use of Oxycodone G.L. Pharma may produce
positive results in doping controls.
Use of Oxycodone G.L. Pharma as a doping
agent may be a health hazard.
Other medicines and Oxycodone 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 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 may get worse.
Medicines that affect the way the brain works
include:
– other strong pain killers (opioids),
– sleeping pills and tranquillisers,
– antidepressants,
– medicines used to treat allergies, travel sickness
or nausea (antihistamines or antiemetics),
– other medicines which act on the nervous
system (phenothiazines, neuroleptics),

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05
10
20
40
80

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mg prolonged-release tablets
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mg prolonged-release tablets
mg prolonged-release tablets

– medicines used to treat Parkinson’s disease
(so-called MAO inhibitors, see also section
“Warnings and precautions”).
Further interactions may occur with
– cimetidine (used to manage excess of gastric
acid). It may prolong the duration of effects of
Oxycodone G.L. Pharma in your body.
– medicines against blood clotting (e.g. warfarin).
Oxycodone G.L. Pharma may influence their
effects.
– certain antibiotics, antifungal medicines and
medicines containing St. John’s Wort.
Oxycodone G.L. Pharma with food and drink
and alcohol
Drinking alcohol whilst taking Oxycodone
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’re
taking Oxycodone G.L. Pharma.
The tablets should be avoided in patients with
a history of or present alcohol and drug abuse.
Grapefruit juice may increase the levels of
Oxycodone G.L. Pharma in your blood. Check
with your doctor if you drink grapefruit juice
regularly.
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.

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G.L.
G.L.
G.L.
G.L.
G.L.

Pregnancy
You should not take Oxycodone G.L. Pharma
during pregnancy. There are no adequate data
from the use of oxycodone in pregnant women.
Oxycodone crosses the placenta into the blood
circulation of the baby.
Prolonged use of oxycodone during pregnancy
can cause withdrawal symptoms in newborns.
Infants born to mothers who have received
oxycodone during the last 3–4 weeks before
labour may experience severe difficulty.
Oxycodone G.L. Pharma should only be used
during pregnancy if the benefit outweighs the
possible risks to the baby.
Breast-feeding
Oxycodone passes into breast milk and may cause
breathing difficulties in the infant. Oxycodone
G.L. Pharma should therefore not be used during
breast-feeding.

Driving and using machines
Oxycodone G.L. Pharma may impair the ability to
drive and 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 G.L. Pharma contains lecithin
(soya)
If you are allergic to peanut or soya, do not use
this medicinal product.
3. HOW TO TAKE
OXYCODONE G.L. PHARMA
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
DOSAGE
For doses not realisable/practicable with this
strength, other strengths of this medicinal product
are available.
Your doctor will adjust your dosage according to
pain intensity and to your individual susceptibility.
Please talk to your doctor, if you think that the
effect of Oxycodone G.L. Pharma is too weak or
too strong.
If not prescribed otherwise by your doctor, the
recommended dose is
– for adults and adolescents (above 12 years):
The usual starting dose is 10 mg oxycodone
hydrochloride every 12 hours.
– for children (below 12 years):
Use in children below 12 years is not
recommended as the safety and efficacy of
Oxycodone G.L. Pharma has not been studied in
this age group.

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Oxycodone
Oxycodone
Oxycodone
Oxycodone
Oxycodone

– for the elderly (65 years and older):
Elderly patients with normal liver and/or kidney
function may take the same doses as given for
adults above.
– for patients with kidney and/or liver disorders,
or with low body weight:
Your doctor may prescribe a lower starting dose.

For patients who have been treated with other
strong pain killers (opioids) before, the doctor
may prescribe a higher starting dose.
Your doctor will decide how much you should
take every day after that, and how to divide your
total daily dose into morning and evening doses.
Your doctor will also advise you on any dose
adjustments that may become necessary during
treatment.
Patients with cancer pain usually require daily
dosages between 80 and 120 mg of oxycodone
hydrochloride daily. In individual cases, the doctor
may increase the dose to up to 400 mg daily.
For the treatment of non-cancer pain a daily
dose of 40 mg oxycodone hydrochloride is
GI_GB, Oxycodone G.L. Pharma 5/10/20/40/80 mg Tab.

29.06.17 18:39

generally sufficient, but higher doses may be
needed in some cases.
If you experience pain between doses of
Oxycodone G.L. Pharma, you may need to take
and additional fast-acting painkiller.
Oxycodone G.L. Pharma is not suitable for
this. Please talk to your doctor if you have this
problem.
Your doctor will check your treatment on a regular
basis.
METHOD OF ADMINISTRATION
Take the prolonged-release tablets as a whole
with a sufficient amount of liquid (e.g. ½ glass
of water) in the morning and in the evening, every
12 hours (for instance, one tablet at 8 o’clock in
the morning, and the next one at 8 o’clock in the
evening). You can take the tablets with or without
food.
Do not break, chew, or crush the tablets. Doing
so may cause them to release all their contents
into the body at once, which results in a risk of
overdose and possibly even death (see also
“If you take more Oxycodone G.L. Pharma than
you should” below).
If you take more Oxycodone G.L. Pharma than
you should
Contact a doctor immediately if you have taken
more tablets than you have been prescribed.
Symptoms of overdose are: a reduction
in the size of the pupils, breathing problems,
feeling weak in the muscles (low muscle tone,
hypotonia), and a fall in blood pressure. In severe
cases drowsiness or fainting due to a failure
of the circulatory system (circulatory collapse),
impairment of thinking and of movement, loss of
consciousness (coma), reduced pulse rate and
accumulation of fluid in the lungs (with symptoms
such as difficulty breathing particularly when lying
down and a cough productive of frothy sputum
which may be pink or bloodstained, excessive
sweating, anxiety and pale skin) may occur.
Use of large amounts of Oxycodone G.L. Pharma
may result in death.
If you forget to take Oxycodone G.L. Pharma
If you take a smaller dose of Oxycodone
G.L. Pharma than prescribed, or if you miss
a dose, adequate pain relief will probably not
be achieved.
If you forget to take one dose, you can take the
forgotten dose as soon as you remember it.
Please note that you are supposed to take the
tablets at 12 hourly (twice daily) intervals.
Do not take a double dose to make up for
a forgotten tablet.
If you stop taking Oxycodone G.L. Pharma
Do not stop treatment without first speaking with
your doctor as withdrawal symptoms may occur.
If you do not require treatment with Oxycodone
G.L. Pharma anymore, your doctor will advise you
on how to reduce the dose gradually to prevent
the occurrence of withdrawal symptoms.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Contact a doctor immediately if any of the
following symptoms occur:
– Very slow or weak breathing (respiratory
depression). This is the most serious risk in
connection with medicines such as Oxycodone
G.L. Pharma (opioids), and may even be fatal
after high doses of this medicine.
OTHER SIDE EFFECTS
Very common (affects more than 1 user in 10)
– drowsiness, dizziness, headache.
– constipation, feeling or being sick, vomiting.
Your doctor will prescribe an appropriate
medicine to treat these symptoms.
– itching.
Common (affects 1 to 10 users in 100)
– changes in mood (anxiety, confusion,
depression, nervousness, sleep disorders,
abnormal thoughts.
– uncontrolled trembling or shaking movements
in one or more parts of your body, feeling weak.
– lowering of blood pressure, rarely accompanied
by symptoms such as feeling your heartbeat or
fainting.
– difficulty in breathing or wheezing.
– dry mouth, rarely accompanied by thirst and
difficulty swallowing, general symptoms of
indigestion such as stomach ache, diarrhoea,
heartburn.
– rash, heavy sweating.
– sweating, weakness.
Uncommon (affects 1 to 10 users in 1,000)
– allergic reactions.
– increase in the amount of a certain hormone
(ADH = antidiuretic hormone) in the blood
with symptoms such as headache, irritability,
lethargy, nausea, vomiting, confusion and
disturbance of consciousness.
– lack of water in the body (dehydration).
– restlessness, mood swings, hallucinations,
euphoric mood, decreased libido.
– amnesia, tingling or numbness (e.g. in the
hands or feet), convulsions, increased or
decreased muscle tension, tics, reduced
sensitivity to pain or touch, , taste changes.
– visual impairment, reduction in the size of the
pupils.
– unpleasant sensation irregular and/or forceful
beating of the heart, increased pulse rate.
– widening of the blood vessels causing low
blood pressure.
– shortness of breath, increased coughing, sore
throat, runny nose, voice changes.
– difficulty swallowing, mouth ulcers, sore gums,
flatulence (excessive gas in the stomach or
bowel), belching, obstruction of the bowel
(ileus).
– increased blood levels of certain hepatic
enzymes.
– dry skin.
– decreased sexual desire and inability to have or
mainitain an erection during sexual intercourse.
– chills, feeling sick, injuries due to accidents
resulting from decreased alertness, pain (e.g.
chest pain), fluid retention (oedema), migraine,
thirst, physical dependence with withdrawal
symptoms, tolerance.

Rare (affects 1 to 10 users in 10,000)
– lymph node disease.
– muscle spasms, epileptic seizures (fits), in
particular in patients suffering from epilepsy or
with a tendency to seizures.
– low blood pressure.
– bleeding gums, increased appetite, darkcoloured stools.
– itchy rash, blisters on the skin and the mucous
membranes (cold sores or herpes), increased
sensitivity to light.
– blood in urine.
– changes in body weight (loss or rise), skin
inflammation.
Very rare (may affect up to 1 in 10,000 people)
– speech disorders.
– scaly rash.
– soya lecithin may cause allergic reactions.
Frequency unknown (frequency cannot be
estimated from the available data)
– severe allergic reactions.
– increased sensitivity to pain.
– cavities or tooth decay.
– obstructed bile secretion, biliary colic (which
causes stomach pain).
If you get any of the side effects, talk to your
doctor or pharmacist. This includes any possibble
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 G.L. PHARMA
Keep 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 above 25°C.
Do not throw away 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 G.L. Pharma contains
– The active substance is oxycodone
hydrochloride.
Oxycodone G.L. Pharma 5 mg: 1 tablet
contains 5 mg oxycodone hydrochloride
corresponding to 4.48 mg oxycodone.
Oxycodone G.L. Pharma 10 mg: 1 tablet
contains 10 mg oxycodone hydrochloride
corresponding to 8.97 mg oxycodone.
Oxycodone G.L. Pharma 20 mg: 1 tablet
contains 20 mg oxycodone hydrochloride
corresponding to 17.93 mg oxycodone.
Oxycodone G.L. Pharma 40 mg: 1 tablet
contains 40 mg oxycodone hydrochloride
corresponding to 35.86 mg oxycodone.
Oxycodone G.L. Pharma 80 mg: 1 tablet
contains 80 mg oxycodone hydrochloride
corresponding to 71.72 mg oxycodone.
– The other ingredients are
Tablet core: Kollidon SR (consisting of
poly(vinylacetate); povidone (K = 22.5 - 27.0);
sodium lauryl sulphate; silica); cellulose,
microcrystalline; colloidal anhydrous silica;
magnesium stearate, vegetable.
Tablet coating:
Oxycodone G.L. Pharma 5 mg: polyvinyl
alcohol; talc (E 553b); titanium dioxide (E 171);
macrogol 3350; lecithin (soya) (E 322); iron
oxide yellow (E 172); iron oxide black (E 172);
indigo carmine; aluminium lake (E 132).
Oxycodone G.L. Pharma 10 mg: polyvinyl
alcohol; talc (E 553b); titanium dioxide (E 171);
macrogol 3350; lecithin (soya) (E 322).
Oxycodone G.L. Pharma 20 mg: polyvinyl
alcohol;, talc (E 553b); titanium dioxide
(E 171); macrogol 3350; lecithin (soya)
(E 322); iron oxide yellow (E 172); iron oxide
black (E 172); iron oxide red (E 172).
Oxycodone G.L. Pharma 40 mg: polyvinyl
alcohol; talc (E 553b); titanium dioxide (E 171);
macrogol 3350; lecithin (soya) (E 322); iron
oxide yellow (E 172); iron oxide black (E 172);
iron oxide red (E 172).
Oxycodone G.L. Pharma 80 mg: polyvinyl
alcohol; talc (E 553b); titanium dioxide (E 171);
macrogol 3350; lecithin (soya) (E 322); iron
oxide yellow (E 172); iron oxide black (E 172);
indigo carmine, aluminium lake (E 132).
What Oxycodone G.L. Pharma looks like and
contents of the pack
Oxycodone G.L. Pharma 5 mg prolonged-release
tablets are light grey, round and biconvex filmcoated tablets.
Oxycodone G.L. Pharma 10 mg prolongedrelease tablets are white, round and biconvex
film-coated tablets.
Oxycodone G.L. Pharma 20 mg prolongedrelease tablets are pale pink, round and biconvex
film-coated tablets.
Oxycodone G.L. Pharma 40 mg prolongedrelease tablets are beige, round and biconvex
film-coated tablets.
Oxycodone G.L. Pharma 80 mg prolonged-release
tablets are pale green, round and biconvex filmcoated tablets.
Oxycodone G.L. Pharma prolonged-release
tablets are available in blisters containing
7, 10, 14, 20, 28, 30, 50, 56, 60, 72, 98, and
100 prolonged-release tablets or in unit-dose
blisters of 30x1, 50x1, 56x1, 60x1, 72x1, 98x1, and
100x1 prolonged-release tablets.
Not all pack sizes will be marketed.
Marketing Authorisation Holder and Manu­
facturer
G.L. Pharma GmbH
Schlossplatz 1, 8502 Lannach, Austria
Leaflet last revised December 2016.

04.2015/1306/GB

GI_GB, Oxycodone G.L. Pharma 5/10/20/40/80 mg Tab.

Präparatenamen/Stärke:

Oxycodone GL Pharma ♦

Darreichungsform:

Retardtabletten ♦
Schrift:

Art.-Nr.:

GI_GB

Abpackungsart:

Blister

Helvetica 8,0 / 8,7 Punkt

♦ Code.: 04.2015/1306/GB ♦ Land: Großbritannien / uk ♦ Packmittelart: Gebrauchsinformation
♦ Format: 148 x 480 mm ♦ Datum/Version: 29. 6. 2017 – 3 ♦ Farbe:
Produktion: Intern
Schwarz

GI_uk_Oxycodone_GL_Tab_Bli.indd 2



29.06.17 18:39

Expand Transcript

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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