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RENOCONTIN 5 MG PROLONGED-RELEASE TABLETS

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

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10 mm

Package leaflet: Information for the patient

Renocontin 5 mg prolonged-release tablets
Oxycodone hydrochloride

• 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 Renocontin is and what it is used for
2. What you need to know before you take Renocontin
3. How to take Renocontin
4. Possible side effects
5. How to store Renocontin
6. Content of the pack and other information
1. What Renocontin is and what it is used for
Renocontin (oxycodone hydrochloride) is a centrally
acting, strong painkiller from the group of opioids.
10 mm

Renocontin is used to treat severe pain, which can be
adequately managed only with opioid analgesics.

Renocontin is indicated in adults and adolescents aged 12
years and older.
Do not take Renocontin
- if you are allergic to oxycodone hydrochloride or any of
the other ingredients of this medicine (listed in section
6),
- have breathing problems, such as chronic obstructive
lung disease, severe bronchial asthma or respiratory
depression. Your doctor will have told you if you
have any of these conditions. Symptoms may include
breathlessness, coughing or breathing more slowly or
weakly than expected,
- have a condition where the small bowel does not work
properly (paralytic ileus),
- your stomach empties more slowly than it should
(delayed gastric emptying) or you have severe pain in
your abdomen,
- if you have a head injury that causes a severe headache
or makes you feel sick. This is because the tablets may
make these symptoms worse or hide the extent of the
head injury,
- if you have severe kidney problems or moderate to
severe liver problems. If you have other long-term
kidney or liver problems you should only take these
tablets if recommended by your doctor,
- if you have ongoing problems with constipation,
- if you are taking a type of medicine known as a
monoamine oxidase inhibitor (examples include
tranylcypromine, phenelzine, isocarboxazid,
moclobemide and linezolid), or you have taken this
type of medicine in the last two weeks.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Renocontin
- if you are elderly or weakened,
- if you have lung, liver or kidney problems,
- if you suffer from myxoedema (a thyroid disorder with
dryness, coldness and swelling[‘puffiness’] of the skin
affecting the face and limbs,)
- if you have impaired function of the thyroid gland
(hypothyroidism), as you may need a lower dose,
- if you have poor adrenal gland function (Addison’s
disease), which may cause symptoms including
weakness, weight loss, dizziness, feeling or being sick),
- if you have an enlarged prostate gland which causes
difficulty in passing urine (prostatic hypertrophy),
- have previously suffered from withdrawal symptoms
such as agitation, anxiety, shaking or sweating upon
stopping taking alcohol or drugs,
- are or have ever been addicted to alcohol or drugs or
have a known opioid dependence,
- if you have inflammatory bowel disease,
- if you have inflammation of the pancreas which causes
severe pain in the abdomen and back (pancreatitis),
- if you have head injury, severe headache or feel sick
as this may indicate that the pressure in your skull is
increased,
- if you have disturbances of your blood circulation such
as fluid retention (oedema), blood loss (haemorrhage),
blood clots, etc,
- if you have problems with the gall bladder, bile duct or
the ureter,
- if you have epilepsy or have tendency to suffer seizures,
fits or convulsions,
- if you take MAO inhibitors (a medicine for the
treatment of depression),
- if you have a severe headache or feel sick as this may
indicate that the pressure in your skull is increased,
- if you have low blood pressure (hypotension),
- if you have low blood volume (hypovolaemia); this can
happen with severe external or internal bleeding,
- if you severe burns, excessive sweating, severe
diarrhoea or vomiting,
- if you have a mental disorder as a result of an infection
(toxic psychosis),
- if you have an increased sensitivity to pain,
- if you need to take increasingly higher doses of
oxycodone to gain the same level of pain relief
(tolerance).
Talk to your doctor if any of these apply to you or if any
of these conditions applied to you in the past. If you are
going to have an operation, please tell the doctor at the
hospital that you are taking these tablets.
Dependence and tolerance
Renocontin has a primary dependence potential.
When used for a long time tolerance to the effects and
progressively higher doses may be required to maintain
pain control.

Chronic use of Renocontin may lead to physical
dependence and a withdrawal syndrome may occur if
you stop using the product suddenly. When a patient no
longer requires therapy with oxycodone hydrochloride, it
may advisable to decrease 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.

Renocontin are for oral use only. In case of abusive
injection (injection in a vein) the tablet excipients
(especially talc) may lead to destruction (necrosis) of the
local tissue, change of lung tissue (granulomas of the lung)
or other serious, potentially fatal events.
This medicine should be avoided in patients with a history
of or present alcohol and drug abuse.

Anti-doping warning
Athletes should be aware that this medicine may cause a
positive reaction to “anti-doping tests”. Use of Renocontin
as a doping agent may become a health hazard.

Other medicines and Renocontin
Tell your doctor or pharmacist if you are taking, have
recently taken any other medicines, including medicines
obtained without a prescription. If you take these tablets
with some other medicines, the effect of these tablets or
the other medicine may be changed.

The tablets must not be used together with a monoamine
oxidase inhibitor, or if you have taken this type of
medicine in the last two weeks (see section 2 ‘Do not
take...’).

Tell your doctor or pharmacist if you are taking:
• medicines to help you sleep or stay calm (for example
tranquillisers, hypnotics or sedatives)
• medicines to treat depression (for example paroxetine)
• medicines to treat psychiatric or mental disorders (such
as phenothiazines or neuroleptic drugs)
• other strong analgesics (‘painkillers’)
• muscle relaxants
• medicines to treat high blood pressure
• quinidine (a medicine to treat a fast heartbeat)
• cimetidine (a medicine for stomach ulcers, indigestion
or heartburn)
• medicines to treat fungal infections (such as
ketoconazole, voriconazole, itraconazole, or
posaconazole)
• medicines used to treat infections (such as
clarithromycin, erythromycin or telithromycin)
• a specific type of medicine known as a protease
inhibitor to treat HIV (examples include boceprevir,
ritonavir, indinavir, nelfinavir or saquinavir)
• rifampicin to treat tuberculosis
• carbamazepine (a medicine to treat seizures, fits or
convulsions and certain pain conditions)
• phenytoin (a medicine to treat seizures, fits or
convulsions)
• a herbal remedy called St John’s Wort (also known as
Hypericum perforatum).
Also, tell your doctor if you have recently been given an
anaesthetic.

10 mm

8,5 mm
+1,5 mm
bleed

Read Direction
(Code centered)

335 mm

335 mm

2. What you need to know before you take Renocontin

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

Renocontin with food, drink and alcohol
Drinking alcohol whilst taking Renocontin may make
you feel more sleepy or increase the risk of serious side
effects such as shallow breathing with a risk of stopping
breathing, and loss of consciousness. It is recommended
not to drink alcohol while you are taking Renocontin.
You should avoid drinking grapefruit juice during your
treatment with Renocontin

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.

113,5 mm

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.

Pregnancy
Renocontin should not be taken in pregnancy unless
clearly necessary. There are only limited 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 delivery can cause respiratory depression in the
newborn.
Breast-feeding
You should not take Renocontin when you are breastfeeding as oxycodone passes into breast milk.

Driving and using machines
Oxycodone hydrochloride may cause a number of side
effects such as drowsiness which could affect your ability
to drive or use machinery (see section 4 for a full list of
side effects) 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).

With stable therapy, a general ban on driving a vehicle
may be not 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.
• 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.

Renocontin contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars contact your doctor before
taking this medicinal product.
3. How to take Renocontin
Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
The recommended dose is:

Adults and adolescents (12 years of age and older)
The usual initial dose is 10 mg oxycodone hydrochloride
in 12 hourly intervals. However, your doctor will prescribe
the dose required to treat pain.
Patients who have already taken opioids can start
treatment with higher dosages taking into account their
experience with opioid treatment.

For the treatment of non cancer pain a daily dose of 40 mg
of oxycodone hydrochloride is generally sufficient, but
higher dosages may be necessary.
Patients with cancer pain usually require dosages from
80 to 120 mg of oxycodone hydrochloride which may be
increased up to 400 mg in individual cases.

For those doses where this particular strength is not
suitable for you, other strengths of this medicinal product
are available.

Risk patients
If you have impaired kidney and/or liver function or if you
have a low body weight your doctor may prescribe a lower
starting dose.
Use in children and adolescents
Renocontin is not recommended in children younger than
12 years of age.
10 mm

Stanzkontur_200 x 690 mm Laetus.indd 1

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Method of administration
Swallow the prolonged-release tablet whole with a
sufficient amount of liquid (½ glass of water) with or
without food in the morning and in the evening following
a fixed schedule (e.g. at 8 a.m. and 8 p.m.).

The tablets must be swallowed whole, not chewed, divided
or crushed as this leads to rapid oxycodone release due
to the damage of the prolonged release properties. The
administration of chewed, divided or crushed prolongedrelease tablets leads to a rapid release and absorption of
a potentially fatal dose of oxycodone (see section “If you
take more Renocontin than you should”).





Renocontin should not be taken with alcoholic beverages.

Opening instructions:
This medicinal product is in child resistant packaging.
The prolonged-release tablets cannot be pressed out of the
blister. Please observe the following instructions when
opening the blister.
1. P
 ull off a single dose
by tearing along the
perforated line on the
blister.







2. A
 n unsealed area is
exposed/can be reached
by this; this area is at the
point where the perforated
lines intersect with each
other.

3. A
 t the unsealed flap,
peel away the cover
foil from the bottom
foil.
Your doctor will decide your daily dose and when this
should be taken, depending on the level of pain you are
being treated for. Your dose may be changed during
treatment if your doctor thinks it is necessary. You must
not change the dose yourself.

Some patients who take this medicine regularly each
day, sometimes need additional rapid acting pain relief to
control breakthrough pain. You should not use additional
doses of Renocontin to control breakthrough pain.

Your doctor will regularly monitor your treatment to make
sure that your pain is adequately controlled, to treat any
side effects that you may experience and to decide if your
treatment needs to be continued.

If you take more Renocontin than you should
If you have taken more of this medicine than prescribed
by your doctor you should seek immediate medical advice.
The following symptoms may occur: constricted pupils
(miosis), breathing difficulties (respiratory depression),
drowsiness, skeletal muscle flaccidity and drop in blood
pressure. In severe cases you may experience problems
with your heart and circulation, have severe difficulty with
breathing and lose consciousness. Taking high doses of
strong opioids like oxycodone can be fatal. You should
not drive yourself to hospital if you have taken too many
tablets.
If you forget to take Renocontin
If you miss a dose, your pain may not be controlled. If
there are at least 8hrs until your next due dose, you can
take the forgotten dose when you remember. You then
continue with your medicine as scheduled.

If there is less than 8hrs until your next dose, you should
take the missed dose but make sure that you leave at least
8hrs until the next dose. You must not take this medicine
more than once every eight hours. Never take a double
dose to make up for a missed dose.
If you stop taking Renocontin
You must not stop taking this medicine without asking
for your doctor’s advice. When you no longer need
these tablets, your doctor will gradually lower your
dose to prevent you experiencing unpleasant withdrawal
symptoms.
If you have any further questions on how to take 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.
If you experience any of the following side effects,
stop taking Renocontin and contact your doctor
immediately:













disturbances, abnormally acute sense of hearing
(hyperacousis); euphoria; restlessness; mood changes,
unpleasant or uncomfortable mood; a feeling of extreme
happiness; agitation;
increased and decreased muscle tone; involuntary
muscle contractions; muscle spasms; disturbance
of memory (amnesia); fits; speech disorder;
reduced sense of touch (hypaesthesia); coordination
disturbances; feeling unwell; fainting; pins and needles
(paraesthesia); feeling of spinning (vertigo); seizures,
fits or convulsions; fainting; flushing of the skin;
accelerated pulse; fast or irregular beating of the heart
(supraventricular tachycardia, palpitations - in context
of withdrawal syndrome), widening of the blood vessels
(vasodilatation); hypotension;
increased coughing; inflammation of the throat
(pharyngitis); runny nose; voice changes;
oral ulcers; inflammation of the gums; inflamed mouth
(stomatitis); difficult in swallowing (dysphagia);
passing wind (flatulence); hiccups; gastritis; dental
caries;
belching; a condition where the bowel does not work
properly (ileus); taste disturbance; a worsening of liver
function tests (seen in a blood test);
dry skin; inflammation of stomach; a blockage in the
flow of bile from the liver (cholestasis) - this can cause
itchy skin, yellow skin, very dark urine and very pale
stools;
urinary retention;
disturbances of sexual function (reduced sexual desire
and impotence); absence of menstrual periods;
accidental injuries; pain (e.g. chest pain); buildup of
fluid in the body causing the affected tissue to become
swollen (oedema); migraine; physical dependence
producing symptoms and signs of withdrawal when the
product is stopped suddenly;
lack of water in the body (dehydration);
hypersensitivity which may include symptoms as
wheezing, chest tightness, swelling of the lips, eyes or
face or rash and itching (allergic reactions);
thirst; a problem with the flow of tears in the eyes
(lacrimation disorder); redness of face, reduction in
size of the pupils in the eye; muscle spasm; high
temperature;
a ringing or buzzing sound in the ears (tinnitus);
drug tolerance (i.e. an increase in dose becomes
necessary to achieve the desired effect);
serious allergic reaction which causes difficulty in
breathing or dizziness (anaphylactic reaction).

Rare (may affect up to 1 in 1,000 people):
• Swollen lymph nodes (lymphadenopathy);
• seizures; in particular in patients suffering from
epilepsy or with a tendency to seizures;
• rarely accompanied by symptoms such as pounding or
racing heartbeat;
• gum bleeding; increased appetite; tarry stool; tooth
staining and damage;
• herpes simplex (disorder of the skin and mucosa);hives
(urticaria);
• changes in body weight (loss or rise); cellulitis.
Frequency not known (frequency cannot be estimated
from the available data)
• Aggression;
• increased sensibility to pain (hyperalgesia);
• biliary stasis, colicky abdominal pain or discomfort
(biliary colic).

Opioid withdrawal syndrome
As oxycodone hydrochloride has the potential to cause a
drug addiction, there is a possibility to develop an opioid
abstinence or withdrawal syndrome is characterized
by some or all of the following: restlessness, watery
eyes (lacrimation), rhinorrhoea, yawning, perspiration,
chills, muscle pain, dilation of the pupil and irregular
heartbeat (palpitations). Other symptoms also may
develop including: irritability, anxiety, backache, joint
pain, weakness, abdominal cramps, insomnia, nausea,
anorexia, vomiting, diarrhea, or increased blood pressure,
respiratory rate or heart rate.
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 drinking.

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the 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 Renocontin

All medicines can cause allergic reactions, although
serious allergic reactions are uncommon. Tell your
doctor immediately if you get any sudden wheeziness,
difficulties in breathing, swelling of the eyelids, face or
lips, rash or itching especially those covering your whole
body.

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

Apart from this oxycodone can cause constricted pupils,
bronchial spasms and spasms in smooth muscles and
suppress the cough reflex.

6. Content of the pack and other information

Depressed in 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.

Other possible side effects

Very common (may affect more than 1 in 10 people):
• Sedation (tiredness to drowsiness); dizziness; headache;
constipation (your doctor can prescribe a laxative to
overcome this problem); nausea and; vomiting (this
should normally wear off after few days, however your
doctor can prescribe an anti-sickness medicine if it
continues to be a problem); itching.

Common (may affect up to 1 in 10 people):
• Several psychological side effects such as changes in
mood (e.g. anxiety, depression); changes in activity
(mostly sedation, sometimes accompanied by lethargy,
occasionally increase with nervousness, shaking,
sleep disorders and abnormal thoughts or dreams) and
changes in performance (thought process disorder,
confusion, isolated cases of speech disorders);
• feeling weak (asthenia); trembling (tremor);
• difficulty in breathing or wheezing (dyspnoea,
bronchospasm);
• dry mouth, rarely accompanied by thirst and difficulty
swallowing; gastrointestinal disorders such as bellyache
diarrhoea, upset stomach (dyspepsia); loss of appetite;
indigestion;
• skin disorders such as rash; rarely increased sensitivity
to light (photosensitivity); in isolated cases itchy
(urticaria) or scaly rash (exfoliative dermatitis);
• urinary disorders (frequent urination); increased
sweating (hyperhidrosis);
• chills.
Uncommon (may affect up to 1 in 100 people):
• A condition which causes abnormal production of a
hormone reducing urination (syndrome of inappropriate
antidiuretic hormone secretion);
• change in perception such as depersonalisation,
hallucinations (perception of things that are not
there); emotional instability; change in taste; visual

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 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.
What Renocontin contains
- The active substance is oxycodone hydrochloride.
[5 mg]:
Each prolonged-release tablet contains 5 mg oxycodone
hydrochloride corresponding to 4.5 mg oxycodone.
The other ingredients are:
Tablet core: Lactose monohydrate, ammonio methacrylate
copolymer Type B dispersion 30%, povidone (K29/32),
talc, triacetin, stearyl alcohol, magnesium stearate.
Tablet coating: Hypromellose, talc, macrogol 400,
titanium dioxide (E171), brilliant blue FCF (E133).
What Renocontin looks like and contents of the pack
[Renocontin 5 mg prolonged-release tablets:]
Light blue, round, biconvex, prolonged-release tablets
with a diameter of 6.9 – 7.3 mm and a height of
3.2 – 3.9 mm.

Renocontin is available for 10, 14, 20, 25, 28, 30, 40, 50,
56, 60, 98 and 100 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B Draycott Avenue, Kenton, Middlesex
HA3 0BU
United Kingdom
Manufacturer:
PS Pharma Service GmbH
Lise-Meitner-Straße 10
40670 Meerbusch
Germany

This leaflet was last revised in November 2016

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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