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LYNLOR 5MG CAPSULES HARD

Active substance(s): OXYCODONE HYDROCHLORIDE

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• accelerated heart rate, being aware of the heart
beat
• widening of the blood vessels (vasodilatation)
• difficulty in breathing, cough, sore throat, runny
nose, voice changes
• difficulty swallowing, mouth ulcers, inflammation
of the gums, inflamed mouth (stomatitis), wind,
belching, intestinal obstruction (ileus)
• increased liver enzymes
• dry skin
• difficulty in passing urine
• impotence
• pain (e.g. chest pain), chills, excessive fluid in
the tissues (oedema), feeling unwell, physical
dependence with withdrawal symptoms, drug
tolerance requiring increased dosage to maintain
effect, thirst
• injuries due to accidents

5 How to store Lynlor

Keep this medicine out of the sight and reach of
children.

Package leaflet: Information for the user

Do not use this medicine after the expiry date which
is stated on the label or carton after EXP. The expiry
date refers to the last day of that month.

Lynlor 5mg, 10mg and 20mg Capsules, hard
Oxycodone hydrochloride

Do not store above 30°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

Rare (may affect up to 1 in 1,000 people):
• herpes simplex (disorder of the skin and mucosa)
• lymph node disease (lymphadenopathy)
• increased appetite
• lowering of blood pressure, dizziness when
standing up from a sitting or lying position
• gum bleeding, tarry stools, tooth staining and
damage
• itchy skin rash (hives), increased sensitivity to light
(photosensitivity)
• muscle spasms
• blood in the urine (haematuria)
• changes in body weight (loss or rise), cellulitis
Very rare (may affect up to 1 in 10,000 people):
• scaly rash (exfoliative dermatitis)
Unknown frequency (cannot be estimated from the
availible data)
• severe hypersensitivity reactions (anaphylactic
reactions)
• aggression
• increased sensitivity to pain which cannot be
improved by increasing the dose
• tooth decay
• pain on the right side of the abdomen, itchiness
and jaundice caused by inflammation of the gall
bladder
• absence of menstrual periods (amenorrhoea)
Counteractive measures:
If you observe any of the above listed side effects
your doctor usually will take appropriate measures.
The side effect constipation may be prevented by
fibre enriched diet and increased intake of fluids.
If you are suffering from sickness or vomiting your
doctor will prescribe you an appropriate medicine.

What Lynlor contains

• The active substance is oxycodone hydrochloride.
• The other ingredients are: Capsule content:
microcrystalline cellulose, magnesium stearate.
Capsule shell: Gelatine, sodium laurilsulfate,
titanium dioxide (E71), iron oxide yellow (E172),
iron oxide red (E172), indigotine (E132). Printing
ink: shellac, iron oxide black (E172), potassium
hydroxide.

What Lynlor looks like and contents of the
pack
Lynlor 5mg: Hard capsules, 14.4 mm in length, with
a dark pink body marked with ‘5’ and a brown cap
marked with ‘OXY’.

Lynlor 10mg: Hard capsules, 14.4 mm in length,
with a white body marked with ‘10’ and a brown cap
marked with ‘OXY’.
Lynlor 20mg: Hard capsules, 14.4 mm in length, with
a light pink body marked with ‘20’ and a brown cap
marked with ‘OXY’.
Pack sizes: Non-child resistant blisters : 56 capsules
Marketing Authorisation Holder
Actavis Group PTC ehf
Reykjavíkurvegur 76‑78
220 Hafnarfjörður
Iceland
Manufacturer
Actavis
Barnstaple
EX32 8NS
UK

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 Lynlor is and what it is used for
2 What you need to know before you
take Lynlor
3 How to take Lynor
4 Possible side effects
5 How to store Lynlor
6 Contents of the pack and other
information

1 What Lynlor is and what it is used for

Lynlor is a centrally acting, strong painkiller from the
group of opioids.
Lynlor is used to treat severe pain, which can only be
adequately managed with opioid analgesics.

2 What you need to know before you
take Lynlor

This leaflet was last revised in July 2014

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

Do not take Lynlor if you

• are allergic to oxycodone hydrochloride or any
of the other ingredients of this medicine (listed in
section 6).
• suffer from severely depressed breathing
(respiratory depression) with too little oxygen
in the blood (hypoxia) and/or too much carbon
dioxide (hypercapnia) in the blood.
• suffer from severe chronic obstructive lung
disease, cor pulmonale (cardiac changes due to
chronic overload of lung circulation) or acute,
severe bronchial asthma.
• suffer from intestinal paralysis (paralytic ileus).
• have an acute abdomen or suffer from delayed
gastric emptying.

Warnings and precautions

Talk to your doctor or pharmacist before taking
Lynlor
• if you are older or debilitated.
• if your lung, liver or kidney function is severely
impaired.
• if you suffer from myxoedema (certain illnesses
of the thyroid gland), impaired function of the
thyroid gland.
• if you suffer from adrenal insufficiency (Addison´s
disease).
• if you suffer from enlargement of the prostate
(prostatic hypertrophy).
• if you suffer from alcoholism or are undergoing
alcohol withdrawal.
• if you suffer from known opioid‑dependence.
• if you suffer from inflammation of the pancreas
(pancreatitis).
• in conditions with increased brain pressure such
as head injury.
• if you suffer from disturbances of circulatory
regulation.
• if you suffer from colic of the bile duct and ureter.
• if you suffer from low blood pressure or reduced
blood volume.
• if you suffer from epilepsy or have a seizure
tendency.
• if you take MAO inhibitors (for the treatment of
depression).
• if you have recently undergone bowel‑surgery or
abdominal surgery.
• if you suffer from an inflammatory bowel disorder.
Please talk to your doctor if any of these apply to
you or if any of these conditions applied to you in
the past.
Lynlor has a primary dependence potential. When
used for a long time, tolerance to the effects may
develop and progressively higher doses may be
required to maintain pain control.
Chronic use of Lynlor may lead to physical
dependence and a withdrawal syndrome may
occur upon abrupt cessation. When a patient
no longer requires therapy with oxycodone
hydrochloride, it may be advisable to taper the dose
gradually to prevent symptoms of withdrawal.
When used as directed in patients suffering from
chronic pain the risk of developing physical or
psychological dependence is markedly reduced and
needs to be weighed against the potential benefit.
Please discuss this with your doctor.
Increased sensitivity to pain that does not respond
to dose increases can rarely develop. If this happens,
your doctor will reduce your dose or switch you to an
alternative opiod painkiller.
Lynlor is not recommended for use before an
operation or in the 24 hours after an operation.

Continued top of next column

AAAH0278 50810829

page 4

Continued top of next column

Continued over page

page 1

Lynlor should be used with particular care in patients
with a history of or present alcohol and drug abuse.
Drinking alcohol whilst taking Lynlor 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 Lynlor.
Please refer to section 4 “Possible side effects” for
information on counteractive measures which may
be used to ease certain side effects.

Lynlor with food, drink and alcohol

Oxycodone may be taken with or without food with
a sufficient amount of liquid.
Alcohol enhances the impairment of alertness and
reactivity and may enhance potential side effects
such as drowsiness and depressed breathing.
Grapefruit juice can inhibit the metabolism of
oxycodone which will increase its effect. Therefore
you should avoid drinking grapefruit juice while
taking Lynlor.

Pregnancy and breast‑feeding

Children and adolescents

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.

Lynlor has not been investigated in children
under 12 years. Safety and efficacy have not been
established and therefore use in children under
12 years of age is not recommended.

Pregnancy

Elderly patients

In elderly patients without impairment of kidney
and/or liver function a dose adjustment is usually
not necessary.

Other medicines and Lynlor

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
• Medicines that dampen the activity of the central
nervous system, e.g.
- sleeping pills or tranquillizers (sedatives,
hypnotics)
- other medicines that act on the nervous system
(phenothiazines, neuroleptics)
- medicines used to treat depression
- muscle relaxants
- medicines used to treat allergies or vomiting
(antihistamines, antiemetics)
- other opioids or alcohol
can enhance the side effects of oxycodone,
in particular depressed breathing (respiratory
depression).
• Medicines with an anticholinergic effect, e.g.
- other medicines that act against
parasympathetic and cholinergic nerve fibres
on the central nervous system (psychotropic
medicines)
- medicines used to treat allergies (antihistamines)
or vomiting (antiemetics)
- medicines used to treat Parkinson´s disease
can enhance certain side effects of oxycodone (e.g.
constipation, dry mouth or urinary disturbances).
• Macrolide antibiotics, some antifungal and antiviral
medicines can increase the effect of oxycodone
and so the dose may need to be adjusted if you are
taking these medicines.
• Cimetidine (a medicine used to treat heartburn)
can inhibit the metabolism of oxycodone.
• Some antiepileptic medicines and also the herbal
remedy ‘St John Wort’ can increase the effect of
oxycodone.

You should avoid Lynlor during pregnancy if
possible. 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. Use of
oxycodone during childbirth can cause breathing
problems in the newborn.

Breast-feeding

You should not use Lynlor when you are
breast‑feeding as oxycodone passes into breast milk
and may cause breathing problems in the newborn.

Driving and using machines

Oxycodone impairs alertness and reactivity to
such an extent that the ability to drive and operate
machinery is affected or ceases altogether, see
section 4 “Possible side effects” for any affecting
motor skills and concentration. With stable therapy,
a general ban on driving a vehicle may not be
necessary, the doctor must assess the individual
situation.
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.

3 How to take Lynlor

4 Possible side effects

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

Adults and adolescents over 12 years

The usual starting dose is one 5mg capsule every
6 hours. However, your doctor will prescribe the
appropriate dose and frequency of administration
required to treat your pain.
If you find that you are still in pain whilst taking
these capsules discuss this with your doctor.

Method of use

Lynlor capsules should be swallowed whole with a
sufficient amount of liquid.
Lynlor should not be taken with alcoholic beverages.
You must only take the capsules by mouth. The
capsules contents should never be injected as this
may lead to serious side effects, which may be fatal.

Adults with renal or liver impairment

The usual starting dose is half the recommended
dose for adults. Your doctor will prescribe the
appropriate dose based on your clinical situation and
by using a more suitable formulation if available.

Use in children

Lynlor is not recommended for children under
12 years of age.

If you take more Lynlor than you should

If you have taken more Lynlor than prescribed you
should inform your doctor or your local poison
control center immediately. The following symptoms
may occur: constricted pupils, depressed breathing,
muscle weakness and drop in blood pressure. In
severe cases circulatory collapse, mental and motor
inactivity, unconsciousness, slowing of the heart
rate and accumulation of water in the lungs may
occur; abuse of high doses of strong opioids such
as oxycodone can be fatal. In no case should you
expose yourself to situations requiring elevated
concentration e.g. driving a car.

If you forget to take Lynlor

If you miss a dose you should take the next dose as
soon as you remember and then carry on as before.
Do not take two doses within 4 hours. Do not take a
double dose to make up for forgotten capsules.

If you stop taking Lynlor

Do not stop treatment without informing your
doctor.
When a patient no longer requires therapy with
Lynlor, it may be advisable to taper the dose
gradually to prevent symptoms of withdrawal.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

• Monoamine oxidase inhibitors (a medicine used to
treat depression) can enhance the side effects of
oxycodone (e.g. excitation, decrease or increase in
blood pressure).
• In individuals, a clinically relevant increase or
decrease of blood clotting have been observed if
anticoagulants of the coumarin type (medicines
against blood clotting) are co‑applied with
oxycodone hydrochloride.
Continued top of next column

Continued top of next column

page 2

Significant side effects or signs to consider and
measures to be taken when these side effects or
signs occur:
If you experience any of the following side effects,
stop taking Lynlor and contact your doctor
immediately.
Depressed breathing is the most significant risk
induced by opioids and is most likely to occur in
elderly or debilitated patients. As a consequence, in
predisposed patients opioids can cause severe drops
in blood pressure.
Apart from this oxycodone can cause constricted
pupils, bronchial spasms and spasms in smooth
muscles and suppress the cough reflex.

Other possible side effects

Very common (may affect more than 1 in
10 people):
• sedation (tiredness to drowsiness)
• dizziness
• headache
• constipation
• feeling sick
• vomiting
• itching
Common (may affect up to 1 in 10 people):
• loss of appetite
• several psychological side effects such as
- changes in mood (e.g. generalised fear,
depression)
- changes in activity (mostly sedation, sometimes
accompanied by tiredness, occasionally increase
with nervousness and sleep disorders)
- changes in performance (thought process
disorder, confusion)
• trembling (tremor)
• wheezing, shortness of breath, hiccups
• dry mouth, stomach pain, diarrhoea, indigestion
(dyspepsia)
• rash, increased sweating
• increased urge to urinate
• feeling weak (asthenia)
Uncommon (may affect up to 1 in 100 people):
• allergic reactions
• abnormal production of antidiuretic hormone
• lack of water in the body (dehydration)
• change in perception such as depersonalisation
and seeing, hearing or feeling things that are not
there (hallucinations), decreased sexual drive,
restlessness, extreme emotional behaviour, a
feeling of extreme happiness, drug dependence
(see section 2)
• increased or decreased muscle tone, coordination
disturbances, involuntary muscle contractions,
fits; in particular in patients suffering from
epilepsy or with a tendency to fits, increased
tightness and difficulty in stretching muscles,
speech disorders, fainting, tingling or pins and
needles (paraesthesia), reduced sense of touch
(hypaesthesia), migraine, change in taste, loss of
memory
• changes in tear secretion, constriction of the pupil,
visual impairment
• abnormally acute sense of hearing (hyperacousis),
feeling of dizziness or spinning (vertigo)
Continued over page

page 3

Package leaflet: Information for the user
Lynlor 5mg, 10mg and 20mg Capsules, hard
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 any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Lynlor is and what it is used for
2.
What you need to know before you take Lynlor
3.
How to take Lynor
4.
Possible side effects
5.
How to store Lynlor
6.
Contents of the pack and other information
1.

What Lynlor is and what it is used for

Lynlor is a centrally acting, strong painkiller from the group of opioids.
Lynlor is used to treat severe pain, which can only be adequately managed with opioid analgesics.
2.

What you need to know before you take Lynlor

Do not take Lynlor if you
are allergic to oxycodone hydrochloride or any of the other ingredients of this medicine (listed
in section 6).
suffer from severely depressed breathing (respiratory depression) with too little oxygen in the
blood (hypoxia) and/or too much carbon dioxide (hypercapnia) in the blood.
suffer from severe chronic obstructive lung disease, cor pulmonale (cardiac changes due to
chronic overload of lung circulation) or acute, severe bronchial asthma.
suffer from intestinal paralysis (paralytic ileus).
have an acute abdomen or suffer from delayed gastric emptying.
Warnings and precautions
Talk to your doctor or pharmacist before taking Lynlor
if you are older or debilitated.
if your lung, liver or kidney function is severely impaired.
if you suffer from myxoedema (certain illnesses of the thyroid gland), impaired function of the
thyroid gland.
if you suffer from adrenal insufficiency (Addison´s disease).
if you suffer from enlargement of the prostate (prostatic hypertrophy).
if you suffer from alcoholism or are undergoing alcohol withdrawal.
if you suffer from known opioid-dependence.
if you suffer from inflammation of the pancreas (pancreatitis).
in conditions with increased brain pressure such as head injury.
if you suffer from disturbances of circulatory regulation.
if you suffer from colic of the bile duct and ureter.
1

-

if you suffer from low blood pressure or reduced blood volume,
if you suffer from epilepsy or have a seizure tendency.
if you take MAO inhibitors (for the treatment of depression).
if you have recently undergone bowel-surgery or abdominal surgery.
if you suffer from an inflammatory bowel disorder.

Please talk to your doctor if any of these apply to you or if any of these conditions applied to you in
the past.
Lynlor has a primary dependence potential. When used for a long time, tolerance to the effects may
develop and progressively higher doses may be required to maintain pain control.
Chronic use of Lynlor may lead to physical dependence and a withdrawal syndrome may occur
upon abrupt cessation. When a patient no longer requires therapy with oxycodone hydrochloride, it
may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
When used as directed in patients suffering from chronic pain the risk of developing physical or
psychological dependence is markedly reduced and needs to be weighed against the potential benefit.
Please discuss this with your doctor.
Increased sensitivity to pain that does not respond to dose increases can rarely develop. If this
happens, your doctor will reduce your dose or switch you to an alternative opiod painkiller.
Lynlor is not recommended for use before an operation or in the 24 hours after an operation.
Lynlor should be used with particular care in patients with a history of or present alcohol and drug
abuse.
Drinking alcohol whilst taking Lynlor 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 Lynlor.

Please refer to section 4 “Possible side effects” for information on counteractive measures which may
be used to ease certain side effects.
Children and adolescents
Lynlor has not been investigated in children under 12 years. Safety and efficacy have not been
established and therefore use in children under 12 years of age is not recommended.
Elderly patients
In elderly patients without impairment of kidney and/or liver function a dose adjustment is usually not
necessary.
Other medicines and Lynlor
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
-

Medicines that dampen the activity of the central nervous system, e.g.
sleeping pills or tranquillizers (sedatives, hypnotics)
other medicines that act on the nervous system (phenothiazines, neuroleptics)
medicinse used to treat depression
muscle relaxants
medicines used to treat allergies or vomiting (antihistamines, antiemetics)
other opioids or alcohol
can enhance the side effects of oxycodone, in particular depressed breathing (respiratory
depression).
2

-

Medicines with an anticholinergic effect, e.g.
other medicines that act against parasympathetic and cholinergic nerve fibres on the
central nervous system (psychotropic medicines)
medicines used to treat allergies (antihistamines) or vomiting (antiemetics)
medicines used to treat Parkinson´s disease
can enhance certain side effects of oxycodone (e.g. constipation, dry mouth or urinary
disturbances).

-

Macrolide antibiotics, some antifungal and antiviral medicines can increase the effect of
oxycodone and so the dose may need to be adjusted if you are taking these medicines.

-

Cimetidine (a medicine used to treat heartburn) can inhibit the metabolism of oxycodone.

-

Some antiepileptic medicines and also the herbal remedy ‘St John Wort’ can increase the effect
of oxycodone

-

Monoamine oxidase inhibitors (a medicine used to treat depression) can enhance the side
effects of oxycodone (e.g. excitation, decrease or increase in blood pressure).

-

In individuals, a clinically relevant increase or decrease of blood clotting have been observed if
anticoagulants of the coumarin type (medicines against blood clotting) are co-applied with
oxycodone hydrochloride.

Lynlor with food, drink and alcohol
Oxycodone may be taken with or without food with a sufficient amount of liquid.
Alcohol enhances the impairment of alertness and reactivity and may enhance potential side effects
such as drowsiness and depressed breathing.
Grapefruit juice can inhibit the metabolism of oxycodone which will increase its effect. Therefore you
should avoid drinking grapefruit juice while taking Lynlor.
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
You should avoid Lynlor during pregnancy if possible. 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. Use of
oxycodone during childbirth can cause breathing problems in the newborn.
Breast-feeding
You should not use Lynlor when you are breast-feeding as oxycodone passes into breast milk and may
cause breathing problems in the newborn.
Driving and using machines
Oxycodone impairs alertness and reactivity to such an extent that the ability to drive and operate
machinery is affected or ceases altogether. To look at the possible side effects affecting the motor
skills and concentration see section 4 “Possible side effects”. With stable therapy, a general ban on
driving a vehicle may not be necessary. The treating physician must assess the individual situation.
Please discuss with your doctor whether or under what conditions you can drive a vehicle.
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.
3

· 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.
3.

How to take Lynlor

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Adults and adolescents over 12 years
The usual starting dose is one 5mg capsule every 6 hours. However, your doctor will prescribe the
appropriate dose and frequency of administration required to treat your pain.
If you find that you are still in pain whilst taking these capsules discuss this with your doctor.
Method of use
Lynlor capsules should be swallowed whole with a sufficient amount of liquid.
Lynlor should not be taken with alcoholic beverages.
You must only take the capsules by mouth. The capsules contents should never be injected as this may
lead to serious side effects, which may be fatal.
Instructions for use of child resistant blisters:
1. Do not push the capsule directly out of the pocket
2. Separate one blister cell from the strip at the perforations

3. Carefully peel off the backing to open the pocket

Adults with renal or liver impairment
The usual starting dose is half the recommended dose for adults. Your doctor will prescribe the
appropriate dose based on your clinical situation and by using a more suitable formulation if
available.
Use in children
Lynlor is not recommended for children under 12 years of age.

4

If you take more Lynlor than you should
If you have taken more Lynlor than prescribed you should inform your doctor or your local poison
control center immediately. The following symptoms may occur: constricted pupils, depressed
breathing, muscle weakness and drop in blood pressure. In severe cases circulatory collapse, mental
and motor inactivity, unconsciousness, slowing of the heart rate and accumulation of water in the
lungs may occur; abuse of high doses of strong opioids such as oxycodone can be fatal. In no case
should you expose yourself to situations requiring elevated concentration e.g. driving a car.
If you forget to take Lynlor
If you miss a dose you should take the next dose as soon as you remember and then carry on as before.
Do not take two doses within 4 hours. Do not take a double dose to make up for forgotten capsules.
If you stop taking Lynlor
Do not stop treatment without informing your doctor.
When a patient no longer requires therapy with Lynlor, it may be advisable to taper the dose gradually
to prevent symptoms of withdrawal.
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.
Significant side effects or signs to consider and measures to be taken when these side effects or
signs occur:
If you experience any of the following side effects, stop taking Lynlor and contact your doctor
immediately.
Depressed breathing is the most significant risk induced by opioids and is most likely to occur in
elderly or debilitated patients. As a consequence, in predisposed patients opioids can cause severe
drops in blood pressure.
Apart from this oxycodone can cause constricted pupils, bronchial spasms and spasms in smooth
muscles and suppress the cough reflex.
Other possible side effects
Very common (may affect more than 1 in 10 people):
sedation (tiredness to drowsiness)
dizziness
headache
constipation
feeling sick
vomiting
itching
Common (may affect up to 1 in 10 people):
loss of appetite
several psychological side effects such as
changes in mood (e.g. generalised fear, depression)
changes in activity (mostly sedation, sometimes accompanied by tiredness, occasionally
increase with nervousness and sleep disorders)
changes in performance (thought process disorder, confusion)
trembling (tremor)
wheezing, shortness of breath, hiccups
dry mouth, stomach pain, diarrhoea, indigestion (dyspepsia)
rash, increased sweating
increased urge to urinate
feeling weak (asthenia)
5

Uncommon (may affect up to 1 in 100 people):
allergic reactions
abnormal production of antidiuretic hormone
lack of water in the body (dehydration)
change in perception such as depersonalisation and seeing, hearing or feeling things that are not
there (hallucinations), decreased sexual drive, restlessness, extreme emotional behaviour, a
feeling of extreme happiness, drug dependence (see section 2)
increased or decreased muscle tone, coordination disturbances, involuntary muscle
contractions, fits; in particular in patients suffering from epilepsy or with a tendency to fits,
increased tightness and difficulty in stretching muscles, speech disorders, fainting, tingling or
pins and needles (paraesthesia), reduced sense of touch (hypaesthesia), migraine, change in
taste, loss of memory
changes in tear secretion , constriction of the pupil, visual impairment
abnormally acute sense of hearing (hyperacousis), feeling of dizziness or spinning (vertigo)
accelerated heart rate, being aware of the heart beat
widening of the blood vessels (vasodilatation)
difficulty in breathing, cough, sore throat, runny nose, voice changes
difficulty swallowing, mouth ulcers, inflammation of the gums, inflamed mouth (stomatitis),
wind, belching, intestinal obstruction (ileus)
increased liver enzymes
dry skin
difficulty in passing urine
impotence
pain (e.g. chest pain), chills, excessive fluid in the tissues (oedema), feeling unwell, physical
dependence with withdrawal symptoms, drug tolerance requiring increased dosage to maintain
effect, thirst
injuries due to accidents
Rare (may affect up to 1 in 1,000 people):
herpes simplex (disorder of the skin and mucosa)
lymph node disease (lymphadenopathy)
increased appetite
lowering of blood pressure, dizziness when standing up from a sitting or lying position
gum bleeding, tarry stools, tooth staining and damage
itchy skin rash (hives), increased sensitivity to light (photosensitivity)
muscle spasms
blood in the urine (haematuria)
changes in body weight (loss or rise), cellulitis
Very rare (may affect up to 1 in 10,000 people):
scaly rash (exfoliative dermatitis)
Unknown frequency (cannot be estimated from the availible data)
severe hypersensitivity reactions (anaphylactic reactions)
aggression
increased sensitivity to pain which cannot be improved by increasing the dose
tooth decay
pain on the right side of the abdomen, itchiness and jaundice caused by inflamation of the gall
bladder
absence of menstrual periods (amenorrhoea)
Counteractive measures:
If you observe any of the above listed side effects your doctor usually will take appropriate measures.
The side effect constipation may be prevented by fiber enriched diet and increased intake of fluids. If
you are suffering from sickness or vomiting your doctor will prescribe you an appropriate medicine.
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Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
at: 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 Lynlor

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 label or carton after EXP. The
expiry date refers to the last day of that month.
Do not store above 30°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 Lynlor contains
-

The active substance is oxycodone hydrochloride.
The other ingredients are: Capsule content: microcrystalline cellulose, magnesium stearate.
Capsule shell: Gelatine, sodium laurilsulfate, titanium dioxide (E71), iron oxide yellow (E172),
iron oxide red (E172), indigotine (E132). Printing ink: shellac, iron oxide black (E172),
potassium hydroxide.

What Lynlor looks like and contents of the pack
Lynlor 5mg: Hard capsules, 14.4 mm in length, with a dark pink body marked with ‘5’ and a brown
cap marked with ‘OXY’.
Lynlor 10mg: Hard capsules, 14.4 mm in length, with a white body marked with ‘10’ and a brown cap
marked with ‘OXY’.
Lynlor 20mg: Hard capsules, 14.4 mm in length, with a light pink body marked with ‘20’ and a brown
cap marked with ‘OXY’.
Pack sizes: Child resistant blisters : 56 capsules
Marketing Authorisation Holder
Actavis Group PTC ehf
Reykjavíkurvegur 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Actavis
Barnstaple
EX32 8NS
UK

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This leaflet was last revised in July 2014

If you would like a leaflet with larger text, please contact 01271
311257.

LogoActavis
Pil Spec no
Actavis, Barnstaple, EX32 8NS, UK

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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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