Skip to Content

OXYLAN 80MG PROLONGED-RELEASE TABLETS

Active substance: OXYCODONE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Oxycodone 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 side effects not listed
in this leaflet.
What is in this leaflet:
1. What Oxylan is and what it is used for
2. What you need to know before you take Oxylan
3. How to take Oxylan
4. Possible side effects
5. How to store Oxylan
6. Contents of the pack and other information
1. WHAT OXYLAN IS AND WHAT IT IS USED
FOR
Oxylan is a strong painkiller (analgesic) from the
group of opioids.
Oxylan 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 OXYLAN
Do not take Oxylan
– if you are allergic to oxycodone hydrochloride,
soya, peanut, or any of the other ingredients of
this medicine (listed in section 6).
– you have breathing problems, such as
if
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.

+++#+#++#

Warnings and precautions
Talk to your doctor or pharmacist before using
Oxylan
– 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 Oxylan is used for long-term treatment,
tolerance to the medicine may occur. This means,
that you may need a higher dose to achieve the
desired pain relief.
Oxylan 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.

prolonged-release tablets
prolonged-release tablets
prolonged-release tablets
prolonged-release tablets
prolonged-release tablets
– other medicines which act on the nervous
system (phenothiazines, neuroleptics),
– 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
Oxylan in your body.
– medicines against blood clotting (e.g. warfarin).
Oxylan may influence their effects.
– certain antibiotics, antifungal medicines and
medicines containing St. John’s Wort.
Oxylan with food and drink and alcohol
Drinking alcohol whilst taking Oxylan 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 Oxylan.
The tablets should be avoided in patients with
a history of or present alcohol and drug abuse.
Grapefruit juice may increase the levels of Oxylan
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.

+++#+#++#

mg
mg
mg
mg
mg

Pregnancy
You should not take Oxylan 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.
Oxylan 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. Oxylan
should therefore not be used during breastfeeding.
Driving and using machines
Oxylan may impair the ability to drive and use
machines.
Oxylan may impair alertness and reactivity to
such an extent that you may no longer be able to
drive or operate tools and machines.
Ask your doctor whether you may drive or operate
machines.
Oxylan contains lecithin (soya)
If you are allergic to peanut or soya, do not use
this medicinal product.
3. HOW TO TAKE OXYLAN
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 Oxylan 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
Oxylan has not been studied in this age group.
– 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.

+++#+#++#

Oxylan 5
Oxylan 10
Oxylan 20
Oxylan 40
Oxylan 80

Anti-Doping Warning
The use of Oxylan may produce positive results in
doping controls.
Use of Oxylan as a doping agent may be
a health hazard.

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.

Other medicines and Oxylan
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.

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.

The risk of side effects is increased if you take
Oxylan 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.

For the treatment of non-cancer pain a daily
dose of 40 mg oxycodone hydrochloride is
generally sufficient, but higher doses may be
needed in some cases.

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),
02.2014/981/GB

GI56703GB_uk_Oxylan_Tab_Bli.indd 1

If you experience pain between doses of Oxylan,
you may need to take and additional fast-acting
painkiller.
Oxylan 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.
GI56703GB, Oxylan 5/10/20/40/80 mg Tab.

12.12.14 10:04

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.


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.

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 Oxylan than you should” below).

Very rare (may affect up to 1 in 10,000 people)
• speech disorders.
• scaly rash.
• soya lecithin may cause allergic reactions.

If you take more Oxylan 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 Oxylan may result in
death.

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.

If you forget to take Oxylan
If you take a smaller dose of Oxylan than
prescribed, or if you miss a dose, adequate pain
relief will probably not be achieved.

Keep out of the sight and reach of children.

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 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 take a double dose to make up for
a forgotten tablet.

Do not store above 25°C.

If you stop taking Oxylan
Do not stop treatment without first speaking with
your doctor as withdrawal symptoms may occur.
If you do not require treatment with Oxylan
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 Oxylan
(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.

02.2014/981/GB

GI56703GB

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 Oxylan contains
– The active substance is oxycodone
hydrochloride.
Oxylan 5 mg: 1 tablet contains 5 mg oxycodone
hydrochloride corresponding to 4.48 
mg
oxycodone.
Oxylan 10 mg: 1 tablet contains 10 
mg
oxycodone hydrochloride corresponding to
8.97 mg oxycodone.
Oxylan 20 mg: 1 tablet contains 20 
mg
oxycodone hydrochloride corresponding to
17.93 mg oxycodone.
Oxylan 40 mg: 1 tablet contains 40 
mg
oxycodone hydrochloride corresponding to
35.86 mg oxycodone.
Oxylan 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:
Oxylan 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).
Oxylan 10 mg: polyvinyl alcohol; talc (E 553b);
titanium dioxide (E 
171); macrogol 3350;
lecithin (soya) (E 322).
Oxylan 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).
Oxylan 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).
Oxylan 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 Oxylan looks like and contents of the
pack
Oxylan 5 mg prolonged-release tablets are light
grey, round and biconvex film-coated tablets.
Oxylan 10 mg prolonged-release tablets are
white, round and biconvex film-coated tablets.
Oxylan 20 mg prolonged-release tablets are pale
pink, round and biconvex film-coated tablets.
Oxylan 40 mg prolonged-release tablets are
beige, round and biconvex film-coated tablets.
Oxylan 80 mg prolonged-release tablets are pale
green, round and biconvex film-coated tablets.
Oxylan 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
Lannacher Heilmittel Ges.m.b.H.
Schlossplatz 1
8502 Lannach
Austria
Manufacturer
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
Leaflet last revised December 2014.

GI56703GB, Oxylan 5/10/20/40/80 mg Tab.

P r ä pa r at e n a m e n /S tä r k e :

A r t .-N r .:

5. HOW TO STORE OXYLAN



Oxylan ♦

P r od u k t i o n :

Darreichungsform:

R e ta r d ta b l e t t e n ♦

A b pa c k u n g s a r t :

Blister

S c h r i f t : H e lv e t i c a 8,0 / 9,0 P u n k t
02.2014/981/GB ♦ L a n d : G r oss b r i ta n n i e n / UK ♦ P a c k m i t t e l a r t : G e b r a u c h s i n f o r m at i o n
I n t e r n ♦ F o r m at : 148 x 480 m m ♦ D at u m /V e r s i o n : 12. 12. 2014 – 3 ♦ F a r b e :
Schwarz

C od e .:

GI56703GB_uk_Oxylan_Tab_Bli.indd 2



12.12.14 10:04

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.

(web4)