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RENOCONICA 15 MG PROLONGED RELEASE TABLETS

Active substance(s): OXYCODONE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Renoconica 15 mg prolonged-release tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains to 15 mg oxycodone hydrochloride
corresponding to 13.5 mg oxycodone.
Excipients with known effect:
Each prolonged-release tablet contains 51 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Prolonged-release tablet
Grey, round, biconvex, prolonged-release tablets with a diameter of 6.9 – 7.3 mm and
a height of 3.5 – 4.2 mm.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Severe pain, which can be adequately managed only with opioid analgesics.
Renoconica is indicated in adults and adolescents aged 12 years and older.

4.2

Posology and method of administration
The dosage depends on the intensity of pain and the patient’s individual susceptibility
to the treatment. The following general dosage recommendations apply:
Adults and adolescents 12 years of age and older
Dose titration and adjustment
In general, the initial dose for opioid naïve patients is 10 mg oxycodone
hydrochloride given at intervals of 12 hours. Some patients may benefit from a
starting dose of 5 mg oxycodone hydrochloride to minimize the incidence of adverse
reactions.
Patients already receiving opioids may start treatment with higher dosages taking into
account their experience with former opioid therapies.
For doses not realisable/practicable with this strength other strengths of this medicinal
product are available.
According to well-controlled clinical studies 10-13 mg oxycodone ¬hydrochloride
correspond to approximately 20 mg morphine sulphate, both in the prolonged-release
formulation.
Because of individual differences in sensitivity for different opioids, it is
recommended that patients should start conservatively with Renoconica after
conversion from other opioids, with 50-75% of the calculated oxycodone dose.
Some patients who take Renoconica following a fixed schedule need rapid release
analgesics as rescue medication in order to control breakthrough pain. Renoconica is
not indicated for the treatment of acute pain and/or breakthrough pain. The single
dose of the rescue medication should amount to 1/6 of the equianalgesic daily dose of
Renoconica. Use of the rescue medication more than twice daily indicates that the
dose of Renoconica needs to be increased. The dose should not be adjusted more
often than once every 1-2 days until a stable twice daily administration has been
achieved.
Following a dose increase from 10 mg to 20 mg taken every 12 hours dose
adjustments should be made in steps of approximately one third of the daily dose. The
aim is a patient-specific dosage which, with twice daily administration, allows for
adequate analgesia with tolerable undesirable effects and as little rescue medication
as possible as long as pain therapy is needed.
Even distribution (the same dose mornings and evenings) following a fixed schedule
(every 12 hours) is appropriate for the majority of the patients. For some patients it
may be advantageous to distribute the doses unevenly. In general, the lowest effective
analgesic dose should be chosen. For the treatment of non-malignant pain a daily dose
of 40 mg is generally sufficient; but higher dosages may be necessary. Patients with

cancer-related pain may require dosages of 80 to 120 mg, which in individual cases
can be increased to up to 400 mg. If even higher doses are required, the dose should
be decided individually balancing efficacy with the tolerance and risk of undesirable
effects.

Duration of treatment
Renoconica should not be taken longer than necessary. If long-term treatment is
necessary due to the type and severity of the illness careful and regular monitoring is
required to determine whether and to what extent treatment should be continued. If
opioid therapy is no longer indicated it may be advisable to reduce the daily dose
gradually in order to prevent symptoms of a withdrawal syndrome.

Discontinuation of treatment
When a patient no longer requires therapy with oxycodone, it may be advisable to
taper the dose gradually to prevent symptoms of withdrawal.

Elderly patients
Elderly patients without clinical manifestation of impaired liver and/or kidney
function usually do not require dose adjustments.

Risk patients
Risk patients, for example patients with low body weight or slow metabolism of
medicinal products, should initially half the recommended adult dose if they are
opioid naïve.
Therefore the lowest recommended dosage, i.e. 10 mg, may not be suitable as a
starting dose.
Dose titration should be performed in accordance with the individual clinical
situation.

Patients with renal or hepatic impairment
The dose initiation should follow a conservative approach in these patients. The
recommended adult starting dose should be reduced by 50% (for example a total daily
dose of 10 mg orally in opioid naïve patients), and each patient should be titrated to
adequate pain control according to their clinical situation.

Children under 12 years of age
Oxycodone has not been studied in children younger than 12 years of age. The safety
and efficacy of Renoconica have not been demonstrated and the use in children
younger than 12 years of age is therefore not recommended.

Method of administration
For oral use.

Renoconica should be taken twice daily based on a fixed schedule at the dosage
determined.
The prolonged-release tablets may be taken with or independent of meals with a
sufficient amount of liquid. Renoconica must be swallowed whole, not chewed,
divided or crushed. Taking chewed, divided or crushed Renoconica tablets may lead
to a rapid release and absorption of a potentially fatal dose of oxycodone.
Renoconica should not be taken with alcoholic beverages.

4.3

4.4

Contraindications


Hypersensitivity to the active substance or to any of the excipients listed in
section 6.1.



Severe respiratory depression with hypoxia and/or elevated carbon dioxide levels
in the blood (hypercapnia).



Severe chronic obstructive pulmonary disease.



Cor pulmonale.



Severe bronchial asthma.



Paralytic ileus.



acute abdomen, delayed gastric emptying

Special warnings and precautions for use
Respiratory and cardiac depression
Respiratory depression is the most significant risk induced by opioids and is most
likely to occur in elderly or debilitated patients. The respiratory depressant effect of
oxycodone can lead to increased carbon dioxide concentrations in blood and hence in
cerebrospinal fluid. In predisposed patients opioids can cause severe decrease in
blood pressure.
Tolerance and dependence
Long-term use of Renoconica can cause the development of tolerance which leads to
the use of higher doses in order to achieve the desired analgesic effect. There is a
cross-tolerance to other opioids. Chronic use of Renoconica can cause physical
dependence. Withdrawal symptoms may occur following abrupt discontinuation of
therapy.
If therapy with oxycodone is no longer required it may be advisable to reduce the
daily dose gradually in order to avoid the occurrence of a withdrawal syndrome.
Withdrawal symptoms may include yawning, mydriasis, lacrimation, rhinorrhoea,
tremor, hyperhidrosis, anxiety, agitation, convulsions and insomnia.

Hyperalgesia that will not respond to a further dose increase of oxycodone may very
rarely occur, particularly in high doses. An oxycodone dose reduction or change to an
alternative opioid may be required.
Renoconica has a primary dependence potential. However, when used as directed in
patients with chronic pain the risk of developing physical or psychological
dependence is markedly reduced or needs to be assessed in a differentiated manner.
There are no data available on the actual incidence of psychological dependence in
chronic pain patients. In patients with a history of alcohol and drug abuse the
medicinal product must be prescribed with special care.

Abuse
In case of abusive parenteral venous injection the tablet excipients (especially talc)
may lead to necrosis of the local tissue, granulomas of the lung or other serious,
potentially fatal events.
To avoid damage to the controlled release properties of the tablets the prolonged
release tablets must be swallowed whole, not chewed, divided or crushed. The
administration of chewed, divided or crushed prolonged-release tablets leads to rapid
release and absorption of a potentially fatal dose of oxycodone (see section 4.9).

Alcohol
Concomitant use of alcohol and Renoconica may increase the undesirable effects of
Renoconica; concomitant use should be avoided.
Special patient groups
Caution is required in elderly or debilitated patients, in patients with severe
impairment of lung, hepatic or renal function, myxoedema, hypothyroidism,
Addison’s disease (adrenal insufficiency), intoxication psychosis (e.g. alcohol),
prostatic hypertrophy, adrenocortical insufficiency, alcoholism, known opioid
dependence, delirium tremens, pancreatitis, disease of the biliary tract, biliary or
ureteric colic, inflammatory bowel disorders, conditions with increased brain
pressure, disturbances of circulatory regulation, epilepsy or seizure tendency and in
patients taking MAO inhibitors within the last two weeks. Patients with severe
hepatic impairment should be closely monitored.

Surgical procedures
Special care should be taken when oxycodone is applied to patients undergoing
bowel-surgery. Opioids should only be administered post-operatively when the bowel
function has been restored.
The safety of Renoconica used pre-operatively has not been established.
Renoconica is not recommended for pre-operative use or within the first 12 – 24
hours post operatively.

Paediatric population
The safety and efficacy of Renoconica in children younger than 12 years of age have
not been established. Renoconica should not be used in children younger than 12
years of age because of safety and efficacy concerns.

Anti-doping warning
Athletes must be aware that this medicine may cause a positive reaction to ‘antidoping’ tests.
Use of Renoconica as a doping agent may become a health hazard.
Excipient
This medicinal product contains lactose. Patients with rare hereditary problems of
galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
should not take this medicine.

4.5

Interaction with other medicinal products and other forms of interaction
Central nervous system depressants (e.g. sedatives, hypnotics, phenothiazines,
neuroleptics, anaesthetics, antidepressants, muscle relaxants) and other opioids or
alcohol can enhance the adverse reactions of oxycodone, in particular respiratory
depression.
MAO inhibitors are known to interact with narcotic analgesics, producing CNS
excitation or depression with hyper- or hypotensive crisis (see section 4.4).
Renoconica should be used with caution in patients administrered MAO-inhibitors or
who have received MAO-inhibitors during the last two weeks (see section 4.4).
Oxycodone is metabolised mainly by cytochrome P450 3A4, with a contribution from
CYP2D6. The activities of these metabolic pathways may be inhibited or induced by
various co-administered drugs or dietary elements. Drugs that inhibit CYP2D6
activity, such as paroxetine and quinidine, may cause decreased clearance of
oxycodone which could lead to an increase in oxycodone plasma concentrations.
CYP3A4 inhibitors, such as macrolide antibiotics (e.g. clarithromycin, erythromycin
and telithromycin), azolantifungals (e.g. ketoconazole, voriconazole, itraconazole,
and posaconazole), protease inhibitors (e.g. boceprevir, ritonavir, indinavir, nelfinavir
and saquinavir), cimetidine and grapefruit juice may cause a reduced clearance of
oxycodone that could cause an increase of the plasma concentrations of oxycodone.
Therefore the oxycodone dose may need to be adjusted accordingly. Some specific
examples are provided below:

Itraconazole, a potent CYP3A4 inhibitor, administered 200 mg orally for five
days, increased the AUC of oral oxycodone. On average, the AUC was
approximately 2.4 times higher (range 1.5 - 3.4).

Voriconazole, a CYP3A4 inhibitor, administered 200 mg twice-daily for four
days (400 mg given as first two doses), increased the AUC of oral oxycodone. On
average, the AUC was approximately 3.6 times higher (range 2.7 - 5.6).

Telithromycin, a CYP3A4 inhibitor, administered 800 mg orally for four
days, increased the AUC of oral oxycodone. On average, the AUC was
approximately 1.8 times higher (range 1.3 - 2.3).


Grapefruit Juice, a CYP3A4 inhibitor, administered as 200 ml three times a
day for five days, increased the AUC of oral oxycodone. On average, the AUC was
approximately 1.7 times higher (range 1.1 - 2.1).
CYP3A4 inducers, such as rifampicin, carbamazepin, phenytoin and St John´s Wort
may induce the metabolism of oxycodone and cause an increased clearance of
oxycodone that could cause a reduction of the plasma concentrations of oxycodone.
The oxycodone dose may need to be adjusted accordingly. Some specific examples
are provided below:

St Johns Wort, a CYP3A4 inducer, administered as 300 mg three times a day
for fifteen days, reduced the AUC of oral oxycodone. On average, the AUC was
approximately 50% lower (range 37-57%).

Rifampicin, a CYP3A4 inducer, administered as 600 mg once-daily for seven
days, reduced the AUC of oral oxycodone. On average, the AUC was approximately
86% lower
The effect of other relevant isoenzyme inhibitors on the metabolism of oxycodone is
not known. Potential interactions should be taken into account.
Clinically relevant changes in International Normalised Ratio (INR) in both directions
have been observed in individuals if coumarin anticoagulants are co-applied with
oxycodone.
There are no studies investigating the effect of oxycodone on CYP catalysed
metabolism of other drugs.
Alcohol may enhance the pharmacodynamic effects of Renoconica; concomitant use
should be avoided.

4.6

Fertility, pregnancy and lactation

Use of this medicinal product should be avoided to the extent possible in patients who
are pregnant or lactating.

Pregnancy
There are limited data from the use of oxycodone in pregnant women. Infants born to
mothers who have received opioids during the last 3 to 4 weeks before giving birth
should be monitored for respiratory depression. Withdrawal symptoms may be
observed in the newborn of mothers undergoing treatment with oxycodone.

Breast-feeding

Oxycodone may be secreted in breast milk and may cause respiratory depression in
the newborn. Oxycodone should, therefore, not be used in breastfeeding mothers.

4.7

Effects on ability to drive and use machines
At the beginning of therapy and after dose adjustment, oxycodone hydrochloride can
have major influence on the ability to drive and use machines. Alertness and
reactivity can be impaired to such an extent that the ability to drive and operate
machinery is affected or ceases altogether.
With stable therapy, a general ban on driving a vehicle is not necessary. In these
circumstances oxycodone hydrochloride has minor influence on the ability to drive
and use machines.
The treating physician must assess the individual situation.

4.8

Undesirable effects
Summary of the safety profile
Oxycodone can cause respiratory depression, miosis, bronchial spasms and spasms of
the smooth muscles and can suppress the cough reflex.
The adverse reactions considered at least possibly related to treatment are listed
below by system organ class and absolute frequency. Frequencies are defined as:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000),
not known (cannot be estimated from the available data)
Very common
(≥1/10)

Immune
system
disorders:
Blood and
lymphatic
system
disorders:
Endocrine

Common
(≥1/100 to
<1/10)

Uncommon
(≥1/1,000 to
<1/100)

Rare
(≥1/10,000 to
<1/1,000)

Hypersensitivity.
Lymphadenopathy.

Syndrome of

Very rare
(< 1/10,000)

Not known
(cannot be
estimated
from available
data)
Anaphylactic
reactions.

disorders:

Metabolism
and nutrition
disorders:
Psychiatric
disorders:

Nervous
system
disorders:

Eye disorders:

Ear and
labyrinth
disorders:
Cardiac
disorders:

Somnolence;
dizziness;
headache.

Anorexia;
decreased
appetite.
Various
psychological
adverse
reactions
including
changes in
mood (e.g.
anxiety,
depression);
changes in
activity
(mostly
suppression
sometimes
associated
with lethargy,
occasionally
increase with
nervousness
and insomnia)
and changes
in cognitive
performance
(abnormal
thinking,
confusion,
isolated cases
of speech
disorders).
Asthenia;
tremor.

inappropriate
antidiuretic
hormone
secretion.
Dehydration.

Change in
perception
such as
depersonalisation;
hallucinations;
affected
lability;
hyperacousis;
euphoric
mood;
agitation;
decreased
libido; drug
dependence
(see section
4.4).

Both
increased and
decreased
muscle tone;
amnesia;
convulsion;
hypertonia;
involuntary
muscle
contractions;
hypoaesthesia;
speech
disorder;
syncope;
paraesthesia;
dysgeusia;
coordination
disturbances.
Lacrimation
disorder;
visual
impairment;
miosis
Vertigo,
tinnitus
Supraventricular
tachycardia,
palpitations
(in context of

Aggression.

Seizures, in
particular in
epileptic
patients or
patients with
tendency to
convulsions;
muscle spasm.

Hyperalgesia.

withdrawal
syndrome).
Vasodilatation

Vascular
disorders:
Respiratory,
thoracic and
mediastinal
disorders:

Gastrointestin
al disorders:

Dyspnoea,
bronchospasm

Constipation;
nausea;
vomiting.

Dry mouth,
rarely
accompanied
by thirst and
difficulty
swallowing;
gastrointestinal disorders
such as
abdominal
pain;
diarrhoea;
dyspepsia.

Hepatobiliary
disorders:
Skin and
subcutaneous
tissue
disorders:

Renal and
urinary
disorders:

Reproductive
system and
breast
disorders:
General
disorders and
administration
site
conditions:

Pruritus

Skin eruptions
including
rash;
hyperhidrosis;
in rare cases
increased
photosensitivety; in
isolated cases
urticaria or
exfoliative
dermatitis.
Micturition
disturbances
(increased
urge to
urinate).

Respiratory
depression;
increased
coughing;
pharyngitis;
rhinitis; voice
changes.
Oral ulcers;
gingivitis;
stomatitis;
flatulence;
eructation;
dysphagia;
ileus.

Increased
hepatic
enzymes.
Dry skin.

Hypotension;
orthostatic
hypotension.

Gum
bleeding;
increased
appetite; tarry
stool; tooth
staining and
damage.

Cholestasis;
biliary colic.
Herpes
simplex,
urticaria.

Urinary
retention.

Erectil
dysfunction,
impotence.
Asthenic
conditions.

Dental caries.

Accidental
injuries; pain
(e.g. chest
pain);
malaise;
oedema;
peripheral
oedema;
migraine;
physical
dependence
with
withdrawal
symptoms;
drug
tolerance;
allergic

Amenorrhoea.

Weight
changes
(increase or
decrease);
cellulitis.

reactions;
chills; thirst.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard.

4.9

Overdose
Symptoms and intoxication:
Miosis, respiratory depression, somnolence, reduced skeletal muscle tone and drop in
blood pressure. In severe cases circulatory collapse, stupor, coma, bradycardia and
non-cardiogenic lung oedema may occur; abuse of high doses of strong opioids such
as oxycodone can be fatal.

Therapy of intoxications:
Primary attention should be given to the establishment of a patent airway and
institution of assisted or controlled ventilation.
In the event of overdosing intravenous administration of an opiate antagonist (e.g.
0.4-2 mg intravenous naloxone) may be indicated. Administration of single doses
must be repeated depending on the clinical situation at intervals of 2 to 3 minutes.
Intravenous infusion of 2 mg of naloxone in 500 ml isotonic saline or 5% dextrose
solution (corresponding to 0.004 mg naloxone/ml) is possible. The rate of infusion
should be adjusted to the previous bolus injections and the response of the patient.
Naloxone should not be administered in the absence of clinically significant
respiratory or circulatory depression secondary to oxycodone overdose. Naloxone
should be administered cautiously to patients who are known, or suspected, to be
physically dependent on oxycodone. In such cases, an abrupt or complete reversal of
opioid effects may precipitate pain and an acute withdrawal syndrome.
Gastric lavage can be taken into consideration. Consider activated charcoal (50 g for
adults, 10 - 15 g for children), if a substantial amount has been ingested within 1
hour, provided the airway can be protected. It may be reasonable to assume that late
administration of activated charcoal may be beneficial for prolonged release
preparations; however there is no evidence to support this.
For speeding up the passage a suitable laxative (e.g. a PEG based solution) may be
useful.
Supportive measures (artificial respiration, oxygen supply, administration of
vasopressors and infusion therapy) should, if necessary, be applied in the treatment of

accompanying circulatory shock. Upon cardiac arrest or cardiac arrhythmias cardiac
massage or defibrillation may be indicated. If necessary, assisted ventilation as well
as maintenance of water and electrolyte balance.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Analgesics; Opioids; Natural opium alkaloids
ATC-Code: N02A A05
Oxycodone shows an affinity to kappa, mu and delta opioid receptors in the brain and
spinal cord. It acts at these receptors as an opioid agonist without an antagonistic
effect. The therapeutic effect is mainly analgesic and sedative. Compared to rapidrelease oxycodone, given alone or in combination with other substances, the
prolonged-release tablets provide pain relief for a markedly longer period without
increased occurrence of undesirable effects.
Other pharmacological effects
In vitro and animal studies indicate various effects of natural opioids, such as
morphine, on components of the immune system; the clinical significance of these
findings is unknown.
Whether oxycodone, a semi-synthetic opioid, has immunological effects similar to
morphinie is unkown.

5.2

Pharmacokinetic properties
Absorption:
The relative bioavailability of Renoconica is comparable to that of rapid release
oxycodone with maximum plasma concentrations being achieved after approximately
3 hours after intake of the prolonged-release tablets compared to 1 to 1.5 hours. Peak
plasma concentrations and oscillations of the concentrations of oxycodone from the
prolonged-release and rapid-release formulations are comparable when given at the
same daily dose at intervals of 12 and 6 hours, respectively.
The tablets must not be crushed, devided, or chewed as this leads to rapid oxycodone
release and absorption of a potentially fatal dose of oxycodone due to the damage of
the prolonged release properties.
Distribution:

The absolute bioavailability of oxycodone is approximately two thirds relative to
parenteral administration. In steady state, the volume of distribution of oxycodone
amounts to 2.6 l/kg; plasma protein binding to 38-45%; the elimination half-life to 4
to 6 hours and plasma clearance to 0.8 l/min. The elimination half-life of oxycodone
from prolonged-release tablets is 4-5 hours with steady state values being achieved
after a mean of 1 day.

Metabolism:
Oxycodone is metabolized in the intestine and liver via the P450 cytochrome system
to noroxycodone and oxymorphone as well as to several glucuronide conjugates. In
vitro studies suggest that therapeutic doses of cimetidine probably have no relevant
effect on the formation of noroxycodone. In man, quinidine reduces the production of
oxymorphone while the pharmacodynamic properties of oxycodone remain largely
unaffected. The contribution of the metabolites to the overall pharmacodynamic
effect is irrelevant.

Elimination:
Oxycodone and its metabolites are excreted via urine and faeces. Oxycodone crosses
the placenta and is found in breast milk.

Linearity/non-linearity:
Across the 5-80 mg dose range of prolonged release oxycodone tablets linearity of
plasma concentrations was demonstrated in terms of rate and extent of absorption.

5.3

Preclinical safety data
Oxycodone had no effect on fertility and early embryonic development in male and
female rats in doses of up to 8 mg/kg body weight and induced no malformations in
rats in doses of up to 8 mg/kg and in rabbits in doses of 125 mg/kg bodyweight.
However, in rabbits, when individual foetuses were used in statistical evaluation, a
dose related increase in developmental variations was observed (increased incidences
of 27 presacral vertebrae, extra pairs of ribs). When these parameters were
statistically evaluated using litters, only the incidence of 27 presacral vertebrae was
increased and only in the 125 mg/kg group, a dose level that produced severe
pharmacotoxic effects in the pregnant animals. In a study on pre- and postnatal
development in rats F1 body weights were lower at 6 mg/kg/d when compared to
body weights of the control group at doses which reduced maternal weight and food
intake (NOAEL 2 mg/kg body weight). There were neither effects on physical,
reflexological, and sensory developmental parameters nor on behavioural and
reproductive indices.
Long-term carcinogenicity studies were not performed.
Oxycodone shows a clastogenic potential in in vitro assays. No similar effects were
observed, however, under in vivo conditions, even at toxic doses. The results indicate

that the mutagenic risk of oxycodone to humans at therapeutic concentrations may be
ruled out with adequate certainty.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
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)

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
3 years

6.4

Special precautions for storage

This medicinal product does not require any special storage conditions

6.5

Nature and contents of container
Child resistant PVC/PVdC-Aluminium blisters with 10, 14, 20, 25, 28, 30, 40, 50, 56,
60, 98 and 100 prolonged-release tablets.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
No special requirements.

7

MARKETING AUTHORISATION HOLDER
ACINO AG
Am Windfeld 35
83714 Miesbach
Germany

8

MARKETING AUTHORISATION NUMBER(S)
PL 21806/0055

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
06/11/2013

10

DATE OF REVISION OF THE TEXT
29/12/2015

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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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