OXYLAN 80MG PROLONGED-RELEASE TABLETS

Active substance: OXYCODONE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Oxylan 5
Oxylan 10
Oxylan 20
Oxylan 40
Oxylan 80

mg
mg
mg
mg
mg

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

Active substance: Oxycodone hydrochloride Medicines that affect the way the brain works

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 opioid analgesics because other
painkillers have not been effective.
2. BEFORE YOU TAKE OXYLAN
Do not take Oxylan
• you are allergic (hypersensitive) to
if
oxycodone hydrochloride, soya, peanut, or any
of the other ingredients of Oxylan.
• you have breathing problems, such as
if
breathing more slowly or more weakly than
expected (respiratory depression).
• if you suffer from a severe chronic lung disease
associated with narrowing of the airways
(COPD = chronic obstructive pulmonary
disease), 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.
• if you are pregnant or breast-feeding.

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Take special care with Oxylan
• in the case of elderly or debilitated (weak)
patients.
• 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).
• your adrenal glands are not producing
if
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.
• you are also taking a type of medicine
if
known as MAO inhibitors (generally used for
the treatment of depression or Parkinson’s
disease).
If any of these warnings apply to you, talk to your
doctor before taking Oxylan.
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.
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.
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.
Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained without
a prescription.
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.
02.2014/981/GB

GI56703GB_Oxylan_Tab_Bli.indd 1

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.
Taking Oxylan with food and drink
These tablets should not be taken with alcohol.
Alcohol use could increase serious side-effects of
oxycodone, such as sleepiness and drowsiness
and slow and shallow breathing.
The tablets should be avoided in patients with
a history of or present alcohol and drug abuse.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.
Pregnancy
There are no sufficient 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.
Use of oxycodone during childbirth can cause
breathing problems in the newborn.
Breast-feeding
You must not use Oxylan when you are breastfeeding as oxycodone passes into breast milk.

+++#+#++#

In this leaflet:
1. What Oxylan is and what it is used for
2. Before you take Oxylan
3. How to take Oxylan
4. Possible side effects
5. How to store Oxylan
6. Further information

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),
• medicines used to treat Parkinson’s disease.

Driving and using 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.
3. HOW TO TAKE OXYLAN
Always take Oxylan exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
DOSAGE
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
usual 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.
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
generally sufficient, but higher doses may be
needed in some cases.
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.

+++#+#++#

+++#+#++#

Read all of this leaflet carefully before you start
taking this medicine.
– 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. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
– If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

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 Oxylan than you should” below).
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,
GI56703GB, Oxylan 5/10/20/40/80 mg Tab.

07.01.14 10:09

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.
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.
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 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, Oxylan 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)
• Nervous system: drowsiness, dizziness,
headache.
• Gastrointestinal tract: constipation, feeling or
being sick, vomiting. Your doctor will prescribe
an appropriate medicine to treat these
symptoms.
• Skin: itching.
Common (affects 1 to 10 users in 100)
• Psychiatric disorders: changes in mood
(anxiety, depression, feeling elated); changes
in the level of activity or behaviour (such as
lethargy, restlessness, nervousness or sleep
disorders); abnormal thoughts, confusion, loss
of memory.
• Nervous system: feeling weak, tingling or
numbness (e.g. in the hands or feet).
• Heart: lowering of blood pressure, rarely
accompanied by symptoms such as feeling
your heartbeat or fainting.
• Airways: shortness of breath, difficulty in
breathing or wheezing.
• Gastrointestinal tract: dry mouth, rarely
accompanied by thirst and difficulty swallowing,
general symptoms of indigestion such as
stomach ache, diarrhoea, belching, loss of
appetite.
• Skin: rash.
• Kidneys and urinary tract: problems passing
urine, frequent urination.
• General disorders: sweating, chills.
Uncommon (affects 1 to 10 users in 1,000)
• Hormones: 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.
• Psychiatric disorders: perception disturbances
(e.g. feeling detached, hallucinations), taste
changes, vision disturbances, unusual
acuteness of hearing.
• Nervous system: increased or decreased
muscle tension, trembling, tics, reduced
sensitivity to pain or touch, problems with
coordination or with keeping one’s balance,
feeling unwell.
• Eyes: changes in tear secretion, reduction in
the size of the pupils.
• Heart: increased pulse rate.
• Blood vessels: widening of the blood vessels
causing low blood pressure.
• Airways: increased coughing, sore throat,
runny nose, voice changes.
• Gastrointestinal tract: biliary colic (which
causes stomach pain), mouth ulcers, sore
gums, flatulence (excessive gas in the stomach
or bowel).
• Reproductive system: decreased sexual
desire and impotence.
• General disorders: injuries due to accidents
resulting from decreased alertness, pain
(e.g. chest pain), fluid retention (oedema),
migraine, physical dependence with withdrawal
symptoms, allergic reactions.
Rare (affects 1 to 10 users in 10,000)
• Blood and lymphatic system: lymph node
disease.
• Metabolism: lack of water in the body
(dehydration).
• Nervous system: muscle spasms, epileptic
seizures (fits), in particular in patients suffering
from epilepsy or with a tendency to seizures.
• Gastrointestinal tract: bleeding gums,
increased appetite, dark-coloured stools,
tooth staining and other changes of the teeth,
obstruction of the bowel (ileus).

02.2014/981/GB

Very rare (affects less than 1 user in 10 000)
• Psychiatric disorders: speech disorders.
• Skin: itchy or scaly rash.
• General disorders: serious allergic reaction
which causes breathing difficulty or dizziness;
very rarely soya lecithin may cause allergic
reactions.
Frequency not known (frequency cannot be
estimated from the available data)
• General disorders: tolerance to the medicine
and dependence may develop.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5. HOW TO STORE OXYLAN
Keep out of the reach and sight of children.
Do not use Oxylan 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.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
6. FURTHER 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 August 2013.

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 .:

• Skin: dry skin, blisters on the skin and the
mucous membranes (cold sores or herpes),
increased sensitivity to light.
• Kidneys and urinary tract: blood in urine.
• Reproductive system: absence of menstrual
bleeding.
• General disorders: changes in body weight
(loss or rise), skin inflammation.

GI56703GB



Oxylan ♦

Darreichungsform:

02.2014/981/GB ♦
P r od u k t i o n : I n t e r n
♦ F o r m at : 148
C od e .:

GI56703GB_Oxylan_Tab_Bli.indd 2

x

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
G r oss b r i ta n n i e n / GB ♦ 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
480 m m ♦ D at u m /V e r s i o n : 7. 1. 2014 – 1 ♦ F a r b e :
Schwarz

Land:



07.01.14 10:09

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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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