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RENOCONTIN 20 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 15 mg prolonged-release tablets
Renocontin 20 mg prolonged-release tablets
Renocontin 30 mg prolonged-release tablets
Renocontin 40 mg prolonged-release tablets
Renocontin 60 mg prolonged-release tablets
Renocontin 80 mg prolonged-release tablets
Oxycodone hydrochloride

335 mm

10 mm

1. What Renocontin is and what it is used for
Renocontin (oxycodone hydrochloride) is a centrally acting,
strong painkiller from the group of opioids.
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.
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.
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)

10 mm

8,5 mm
+1,5 mm
bleed

Read Direction
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335 mm

2. What you need to know before you take Renocontin

• 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.
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.
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 breast-feeding
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.

113,5 mm

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 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

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.
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.

10 mm

Stanzkontur_200 x 690 mm Laetus.indd 1

25.01.16 13:49

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:
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.
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.
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 (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 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

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 blister and the carton after “EXP”. The expiry date
refers to the last day of that month.
This medicinal product does not require any special storage
conditions
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. Content of the pack and other information
What Renocontin contains
- The active substance is oxycodone hydrochloride.
[15 mg]:
Each prolonged-release tablet contains 15 mg oxycodone
hydrochloride corresponding to 13.5 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),
Iron oxide black (E172)
[20 mg]:
Each prolonged-release tablet contains 20 mg oxycodone
hydrochloride corresponding to 17.9 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),
Iron oxide red (E172),
[30 mg]:
Each prolonged-release tablet contains 30 mg oxycodone
hydrochloride corresponding to 26.9 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),
Iron oxide brown (E172), Iron oxide black (E172)
[40 mg]:
Each prolonged-release tablet contains 40 mg oxycodone
hydrochloride corresponding to 35.9 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),
Iron oxide red (E172), Iron oxide yellow (E172)
[60 mg]:
Each prolonged-release tablet contains 60 mg oxycodone
hydrochloride corresponding to 53.8 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),
Iron oxide red (E172),
Erythrosine (E127)
[80 mg]:
Each prolonged-release tablet contains 80 mg oxycodone
hydrochloride corresponding to 71.7 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),
Indigo carmine (E132), Iron oxide yellow (E172)
What Renocontin looks like and contents of the pack
[Renocontin 15 mg prolonged-release tablets:]
Grey, round, biconvex, prolonged-release tablets with a
diameter of 6.9 – 7.3 mm and a height of 3.2 – 3.9 mm.
[Renocontin 20 mg prolonged-release tablets:]
Light pink, round, biconvex, prolonged-releasetablets with a
diameter of 6.9 – 7.3 mm and a height of 3.2 – 3.9 mm.
[Renocontin 30 mg prolonged-release tablets:]
Brown, round, biconvex, prolonged-release tablets with a
diameter of 6.9 – 7.3 mm and a height of 3.2 – 3.9 mm.
[Renocontin 40 mg prolonged-release tablets:]
Light orange to ochre, round, biconvex, prolonged-release
tablets with a diameter of 6.9 – 7.3 mm and a height of 3.2 –
3.9 mm.
[Renocontin 60 mg prolonged-release tablets:]
Pink-red, round, biconvex, prolonged-release tablets with a
diameter of 8.6 – 9.0 mm and a height of 4.6 – 5.3 mm.
[Renocontin 80 mg prolonged-release tablets:]
Green, round, biconvex, prolonged-release tablets with a
diameter of 8.6 – 9.0 mm and a height of 4.6 – 5.3 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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