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LEVERAXO 5 MG PROLONGED-RELEASE TABLETS

Active substance(s): OXYCODONE HYDROCHLORIDE

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Package leaflet: Information for the patient

Leveraxo 5 mg, 10 mg, 20 mg,
30 mg, 40 mg, 60 mg, 80 mg
Prolonged-release Tablets
(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 Leveraxo is and what it is used for
2. What you need to know before you take Leveraxo
3. How to take Leveraxo
4. Possible side effects
5. How to store Leveraxo
6. Contents of the pack and other information

1. What Leveraxo is and what it is used for
Leveraxo is a centrally acting, strong painkiller from the
group of opioids.
Leveraxo is used to treat severe pain in adults and
adolescents aged 12 years and older, which can be
adequately managed only with opioid analgesics.

2. What you need to know before you
take Leveraxo
Do not take Leveraxo:
• if you are allergic to oxycodone or any of the other
ingredients of this medicine (listed in section 6)
• if you 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
• if you suffer from severe chronic obstructive lung disease,
cor pulmonale (cardiac changes due to chronic overload
of lung circulation) or acute, severe bronchial asthma
• if you suffer from intestinal paralysis (paralytic ileus).

Warnings and precautions

Talk to your doctor or pharmacist before taking
Leveraxo if you:
• are older or debilitated
• have severely impaired lung, liver or kidney function
(see also section 3 “Risk patients”)
• suffer from myxoedema (certain illnesses of the thyroid
gland), or an impaired function of the thyroid gland
• suffer from adrenal insufficiency (Addison’s disease)
• suffer from toxic psychosis (e.g. alcohol)
• suffer from enlargement of the prostate
(prostate hypertrophy)
• suffer from alcoholism or are undergoing alcohol
withdrawal with symptoms such as shaking, feeling
anxious or disoriented, seeing, hearing or feeling
things that are not real (hallucinations)
• suffer from known opioid-dependence
• suffer from inflammation of the pancreas (pancreatitis)
• suffer from diseases of the biliary tract
• suffer from inflammatory bowel disorders
• suffer from an obstruction of the intestine
• are recovering from abdominal surgery
• suffer from low blood pressure
• suffer from decreased blood volume (hypovolaemia)
• suffer from head injury
• suffer from epilepsy or have a seizure (fits) tendency
• take MAO inhibitors (for the treatment of depression).
Long term treatment and abuse
Leveraxo has 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 Leveraxo may lead to physical
dependence and a withdrawal syndrome may occur
upon abrupt cessation of therapy. 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.
Leveraxo is for oral use only. In case of abusive injection
(injection in a vein) the other tablet ingredients may
lead to destruction (necrosis) of the local tissue, change
of lung tissue (granulomas of the lung) or other serious,
potentially lethal events.
Anti-doping warning
Athletes should be aware that this medicine may cause a
positive reaction to “anti-doping tests”. Use of Leveraxo
as a doping agent may become a health hazard.
Children under 12 years of age
Leveraxo should not be used in children under 12 years
of age because of safety and efficacy concerns.
Elderly patients
In elderly patients without impairment of kidney and/or
liver function a dose adjustment is usually not necessary.
Other medicines and Leveraxo
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 tranquillisers (sedatives, hypnotics)
* other medicines that act on the nervous system
(phenothiazines, neuroleptics, anaesthetics,
antidepressants, muscle relaxants)
* 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).
• inhibitors of CYP3A4, such as macrolide antibiotics
(e.g. clarithromycin, erythromycin, telithromycin),
azole antifungals (e.g. ketoconazole, voriconazole,
itraconazole, posaconazole), protease inhibitors (e.g.
boceprevir, ritonavir, indinavir, nelfinavir, saquinavir),
cimetidine and grapefruit juice may cause a reduced
clearance of oxycodone that could cause an increase of
the plasma concentrations of oxycodone. The influence
of other medicines that can markedly affect the
metabolism of oxycodone has not been investigated
• strong inhibitors of CYP2D6 (such as paroxetine,
quinidine) may affect the elimination of oxycodone. The
influence of other isoenzyme inhibitors that can markedly
affect the metabolism of oxycodone is not known
• CYP3A4 inducers such as rifampicin, carbamazepine,
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
• monoamine oxidase inhibitors (MAOIs) can enhance
the side effects of oxycodone (e.g. agitation, confusion,
sleepiness, 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 (medicinal products against blood
clotting) are co-applied with Leveraxo.

Leveraxo with alcohol

Drinking alcohol whilst taking Leveraxo 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 Leveraxo.

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
Leveraxo should not be used in pregnancy unless clearly
necessary. There are limited data regarding 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 (see section 4,
‘Possible side effects’). Use of oxycodone during delivery
can cause breathing problems (respiratory depression)
in the newborn.
Breast-feeding
Breast-feeding should be discontinued during
treatment with Leveraxo. Oxycodone passes into
breast milk and may affect your suckling child,
especially following the intake of multiple doses.

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. In these circumstances
Leveraxo has moderate to major influence on the ability
to drive and use machines.
With stable therapy, a general ban on driving a vehicle
may be not necessary. In these circumstances Leveraxo
has minor influence on the ability to drive and use
machines. The treating physician must assess the
individual situation. Please discuss with your doctor
whether or under what conditions you can drive a vehicle.

Leveraxo contains sucrose

If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicine.

3. How to take Leveraxo
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
For doses not realisable/practicable with this medicine,
other strengths and medicines are available.
The recommended dose is
Adults and adolescents (aged 12 years and older)
The usual initial dose is 10 mg of oxycodone
hydrochloride in 12 hourly intervals. Some patients may
benefit from a starting dose of 5 mg to minimise the
incidence of adverse reactions.
Further determination of the daily dose, the division into
the single doses and any dose adjustments during the
further course of therapy are performed by the treating
physician and depend on the previous dosage. Patients
who have already taken opioids can start treatment with
higher dosages taking into account their experience
with opioid treatment.
Some patients who receive Leveraxo according to a
fixed schedule need rapidly acting painkillers as rescue
medication to control breakthrough pain. Leveraxo is
not intended for the treatment of breakthrough pain.
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.
The treatment needs to be controlled regularly with
regard to pain relief and other effects in order to
achieve the best pain therapy possible as well as to be
able to treat any occurring side effects in good time and
to decide whether treatment should be continued.
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.
Route and method of administration
Oral use. It is not recommended to take Leveraxo with
alcoholic beverages.
Swallow the prolonged-release tablets 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.).
Leveraxo 5 mg prolonged-release tablets must be
swallowed whole and not taken divided, broken,
chewed or crushed as this leads to rapid oxycodone
release due to the damage of the prolonged-release
properties. The administration of divided, broken,
chewed or crushed Leveraxo leads to a rapid release and
absorption of a potentially fatal dose of oxycodone (see
section “If you take more Leveraxo than you should”).
Leveraxo 10 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg
prolonged-release tablets can be divided into equal
doses, however they must not be broken any smaller,
chewed or crushed as this leads to rapid oxycodone
release due to the damage of the prolonged-release
properties. The administration of broken, chewed
or crushed Leveraxo leads to a rapid release and
absorption of a potentially fatal dose of oxycodone (see
section “If you take more Leveraxo than you should”).
Opening instructions for the blister
This medicine is packed in a child-resistant perforated unit
dose blister. You cannot press out the prolonged-release
tablets through the blister. Please observe the following
opening instruction for the blister:

1

2

3

1. Tear off a single dose along the perforation line of
the blister.
2. Hereby an unsealed area is accessible which is
located at the position, where the perforation lines
have crossed.
3. Pull at the unsealed “strap” to peel off the cover seal.
Your doctor will adjust the dosage depending on the
pain intensity and how you respond to the treatment.
Take the number of prolonged-release tablets
determined by your doctor twice daily.

If you take more Leveraxo than you should

If you have taken more Leveraxo as prescribed you
should inform your doctor or your local poison control
centre immediately. The following symptoms may
occur: constricted pupils (miosis), depressed breathing
(respiratory depression), skeletal muscle flaccidity and
drop in blood pressure. In severe cases circulatory
collapse, mental and motor inactivity (torpor),
unconsciousness (coma), slowing of the heart rate and
accumulation of water in the lungs (non-cardiogenic
lung oedema) may occur; abuse of high doses of strong
opioids such as oxycodone can be fatal. In no case you
should expose yourself to situations requiring elevated
concentration e.g. driving a car.

If you forget to take Leveraxo

If you use a smaller dose of Leveraxo than directed or you
miss the intake of Leveraxo, pain relief will consequently
be insufficient or cease altogether.
You can make up for a forgotten dose if the next regular
intake is not due for at least another 8 hours. You can then
continue to take your recommended dose as directed.
You should also take Leveraxo if the time to the regular
next intake is shorter, but postpone the next intake by
8 hours. In principle, you should not take Leveraxo more
than once every 8 hours.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Leveraxo

Do not stop treatment without informing your doctor.
When a patient no longer requires therapy with
Leveraxo, it may be advisable to taper the dose
gradually to prevent symptoms of withdrawal.
A withdrawal syndrome may occur upon abrupt
cessation of therapy. For symptoms of the withdrawal
syndrome see section 4.
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 Leveraxo and contact your doctor immediately:
• depressed breathing. This 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
• constricted pupils, bronchial spasms and spasms in
smooth muscles or suppression of the cough reflex
• signs of a serious allergic reaction such as rash, itching
or hives on the skin with swelling of the face, lips,
tongue or throat
• obstruction of the gut (ileus) with symptoms such
as persistent constipation, abdominal swelling
and vomiting
• blockage of the bile duct (cholestasis) with
symptoms such as abdominal pain, tenderness and
swelling, vomiting
• inability to pass urine or empty the bladder
(urinary retention)
Other possible side effects
Very common (may affect more than 1 in 10 people):
• sedation (tiredness to drowsiness), dizziness, headache
• constipation, feeling or being sick
• itching.
Common (may affect up to 1 in 10 people):
• reduced appetite or loss of appetite
• altered mood and personality changes (anxiety),
confusional state, depression
• sleeplessness, nervousness, abnormal thinking
• lack of energy or enthusiasm (lethargy)
• trembling (tremor)
• depressed breathing (dyspnoea)
• dry mouth
• restlessness
• hyperactivity
• bellyache, diarrhoea, hiccups, upset stomach (dyspepsia)
• skin disorders such as rash
• pain, burning or discomfort when urinating
• frequent or urgent urination
• sweating including abnormally increased sweating
• powerlessness.
Uncommon (may affect up to 1 in 100 people):
• hypersensitivity
• lack of water in the body (dehydration)
• agitation, emotional lability
• euphoric mood, seeing, hearing or feeling things that
are not real (hallucinations)
• disturbances of sexual function (reduced sexual desire
and erectile dysfunction)
• reduced levels of sex hormones (hypogonadism),
which may cause changes to sperm production in
males or the menstrual cycle in females
• drug dependence with withdrawal symptoms like
fast or irregular heart beat (palpitations)
• loss of memory (amnesia), convulsion
• impaired hearing
• increased heart rate
• increased muscle tone, involuntary muscle contractions,
reduced coordination
• reduced sense of touch (hypaesthesia)
• speech disorders, cough
• fainting, paraesthesia, change in taste, migraine
• impaired concentration
• visual impairment, constriction of the pupil
• vertigo
• injuries from accidents
• widening of the blood vessels (vasodilatation)
• difficulty swallowing (dysphagia), flatulence, burping
• ulcers or inflammation of the mouth, tongue or lips
• increased liver enzymes
• dry skin
• chills, general discomfort, thirst
• drug tolerance
• swelling of any organ or tissue due to accumulation of
excess fluid (oedema).
Rare (may affect up to 1 in 1,000 people):
• decreased blood pressure (hypotension),
which may cause dizziness when standing up
(orthostatic hypotension)
• urticaria
• blisters that develop on the lips or around the mouth
(herpes simplex)
• increased appetite
• black tarry stools
• tooth disorder
• bleeding gums
• increase or decrease in weight.
Frequency not known (cannot be estimated from the
available data):
• anaphylactic responses
• aggression
• increased sensitivity to pain (hyperalgesia)
• dental caries
• pain in the abdomen, possibly with nausea and vomiting,
caused by a blockage of the bile duct (biliary colic)
• absence of menstrual bleeding (amenorrhoea)
• signs of withdrawal symptoms in newborn babies.
Tolerance and dependence may develop with chronic
use and a withdrawal syndrome may occur upon
abrupt cessation of therapy. The withdrawal syndrome
is characterised by some or all of the following:
restlessness, increased production of tears, runny
nose, yawning, sweating, chills, muscle pain, abnormal
dilatation of the pupil and sensation of irregular and
forceful heartbeat. Other symptoms may also develop,
including: irritability, anxiety, backache, joint pain,
weakness, belly cramps, sleeplessness, feeling sick, lack
of appetite, vomiting, diarrhoea, or increased blood
pressure, breathing 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 fibre enriched
diet and increased drinking. If you are suffering from
sickness or vomiting your doctor will prescribe you an
appropriate medicine.

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 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 Leveraxo
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 or label, 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. Contents of the pack and other information
What Leveraxo contains
The active substance is oxycodone hydrochloride.
• Leveraxo 5 mg prolonged-release tablets: Each
prolonged-release tablet contains 5 mg oxycodone
hydrochloride as active substance, equivalent to
4.5 mg oxycodone.
Other ingredients are the tablet core consisting of
sugar spheres (sucrose, maize starch), hypromellose,
talc, ethyl cellulose, hydroxypropylcellulose, propylene
glycol, carmellose sodium, cellulose microcrystalline,
magnesium stearate (Ph. Eur.), silica colloidal anhydrous
and the tablet coating consisting of polyvinyl alcohol,
titanium dioxide (E171), macrogol 3350, talc.
• Leveraxo 10 mg prolonged-release tablets: Each
prolonged-release tablet contains 10 mg oxycodone
hydrochloride as active substance, equivalent to
9 mg oxycodone.
Other ingredients are the tablet core consisting of
sugar spheres (sucrose, maize starch), hypromellose,
talc, ethyl cellulose, hydroxypropylcellulose, propylene
glycol, carmellose sodium, cellulose microcrystalline,
magnesium stearate (Ph. Eur.), silica colloidal anhydrous
and the tablet coating consisting of polyvinyl alcohol,
titanium dioxide (E171), macrogol 3350, iron oxide red
(E172), talc.
• Leveraxo 20 mg prolonged-release tablets: Each
prolonged-release tablet contains 20 mg oxycodone
hydrochloride as active substance, equivalent to
17.9 mg oxycodone.
Other ingredients are the tablet core consisting of
sugar spheres (sucrose, maize starch), hypromellose,
talc, ethyl cellulose, hydroxypropylcellulose,
propylene glycol, carmellose sodium, cellulose
microcrystalline, magnesium stearate (Ph. Eur.), silica
colloidal anhydrous and the tablet coating consisting
of polyvinyl alcohol, titanium dioxide (E171),
macrogol 3350, talc.
• Leveraxo 30 mg prolonged-release tablets: Each
prolonged-release tablet contains 30 mg oxycodone
hydrochloride as active substance, equivalent to
26.9 mg oxycodone.
Other ingredients are the tablet core consisting of
sugar spheres (sucrose, maize starch), hypromellose,
talc, ethyl cellulose, hydroxypropylcellulose,
propylene glycol, carmellose sodium, cellulose
microcrystalline, magnesium stearate (Ph. Eur.), silica
colloidal anhydrous and the tablet coating consisting
of polyvinyl alcohol, titanium dioxide (E171), iron
oxide yellow (E172), macrogol 3350, talc.
• Leveraxo 40 mg prolonged-release tablets: Each
prolonged-release tablet contains 40 mg oxycodone
hydrochloride as active substance, equivalent to
36 mg oxycodone.
Other ingredients are the tablet core consisting of
sugar spheres (sucrose, maize starch), hypromellose,
talc, ethyl cellulose, hydroxypropylcellulose, propylene
glycol, carmellose sodium, cellulose microcrystalline,
magnesium stearate (Ph. Eur.), silica colloidal anhydrous
and the tablet coating consisting of polyvinyl alcohol,
titanium dioxide (E171), iron oxide red (E172), macrogol
3350, talc.
• Leveraxo 60 mg prolonged-release tablets: Each
prolonged-release tablet contains 60 mg oxycodone
hydrochloride as active substance, equivalent to
53.8 mg oxycodone.
Other ingredients are the tablet core consisting of
sugar spheres (sucrose, maize starch), hypromellose,
talc, ethyl cellulose, hydroxypropylcellulose, propylene
glycol, carmellose sodium, cellulose microcrystalline,
magnesium stearate (Ph. Eur.), silica colloidal anhydrous
and the tablet coating consisting of polyvinyl alcohol,
macrogol 3350, iron oxide yellow (E172), talc.
• Leveraxo 80 mg prolonged-release tablets: Each
prolonged-release tablet contains 80 mg oxycodone
hydrochloride as active substance, equivalent to
72 mg oxycodone.
Other ingredients are the tablet core consisting of
sugar spheres (sucrose, maize starch), hypromellose,
talc, ethyl cellulose, hydroxypropylcellulose, propylene
glycol, carmellose sodium, cellulose microcrystalline,
magnesium stearate (Ph. Eur.), silica colloidal anhydrous
and the tablet coating consisting of polyvinyl alcohol,
iron oxide red (E172), macrogol 3350, talc.

What Leveraxo looks like and contents of the pack

Leveraxo 5 mg prolonged-release tablets
White to off-white, round, biconvex, film-coated tablets.
The height of the tablet is between 3.3 and 4.3 mm, the
diameter is 5.2 mm.
Leveraxo 10 mg prolonged-release tablets
Pink, oblong, biconvex, film-coated tablets with break
scores on both sides. The height of the tablet is between
4 and 5 mm, the width is 4.8 mm and the length is 10.3 mm.
Leveraxo 20 mg prolonged-release tablets
White to off-white, oblong, biconvex, film-coated tablets
with break scores on both sides. The height of the tablet
is between 3.3 and 4.3 mm, the width is 4.8 mm and the
length is 10.3 mm.
Leveraxo 30 mg prolonged-release tablets
Yellow, oblong, biconvex, film-coated tablets with
break scores on both sides. The height of the tablet is
between 3.8 and 4.8 mm, the width is 5.3 mm and the
length is 11.3 mm.
Leveraxo 40 mg prolonged-release tablets
Pink, oblong, biconvex, film-coated tablets with
break scores on both sides. The height of the tablet is
between 4.8 and 5.8 mm, the width is 5.8 mm and the
length is 12.4 mm.
Leveraxo 60 mg prolonged-release tablets
Dark yellow, oblong, biconvex, film-coated tablets with
break scores on both sides. The height of the tablet
is between 5 and 6 mm, the width is 6.8 mm and the
length is 14.5 mm.
Leveraxo 80 mg prolonged-release tablets
Red, oblong, biconvex, film-coated tablets with
break scores on both sides. The height of the tablet is
between 5.8 and 6.8 mm, the width is 7.4 mm and the
length is 15.5 mm.
Pack sizes:
10x1, 14x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 98x1,
100x1 prolonged-release tablets in child resistant, white
opaque perforated unit dose blister.
10, 20, 30, 50, 100 prolonged-release tablets in bottles
with child-resistant closure.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom

Manufacturer

Develco Pharma GmbH, Grienmatt 27,
79650 Schopfheim, Germany
This leaflet was last revised in 10/2017.
1112522

+ 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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