Leveraxo 80mg modified-release tablets

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:
Oxycodone hydrochloride
Available from:
Mylan
ATC code:
N02AA05
INN (International Name):
Oxycodone hydrochloride
Dosage:
80mg
Pharmaceutical form:
Modified-release tablet
Administration route:
Oral
Class:
Schedule 2 (CD)
Prescription type:
Caution - AMP level prescribing advised
Product summary:
BNF: 04070200; GTIN: 5016695007243
Authorization number:
PL 04569/1650; PL 04569/1651; PL 04569/1652; PL 04569/1653; PL 04569/1654; PL 04569/1655; PL 04569/1656

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Page 1

Package leaflet: Information for the user

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

What Leveraxo is and what it is used for

What you need to know before you take Leveraxo

How to take Leveraxo

Possible side effects

How to store Leveraxo

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 hydrochloride 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

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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 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).

Page 3

Inhibitors of CYP3A4, such as macrolide antibiotics, azole antifungals, protease inhibitors,

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 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. excitation,

decrease or increase in blood pressure).

In individuals a clinically relevant increase or decrease of blood clotting have been observed if

anticoagulants of the coumarin type (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 any 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. 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 medicinal product.

3.

How to take Leveraxo

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist

if you are not sure.

Page 4

For doses not realisable/practicable with this medicinal product other strengths and medicinal products

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:

Leveraxo must not be 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:

The prolonged-release tablet can be divided into equal doses.

The prolonged-release tablets must not be broken, 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 instruction for the blister

This medicinal product 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:

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Tear off a single dose along the perforation line of the blister.

Hereby an unsealed area is accessible which is located at the position, where the perforation lines

have crossed.

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.

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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 of 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. Apart from this oxycodone can cause constricted pupils,

bronchial spasms and spasms in smooth muscles and suppress the cough reflex.

agitation, emotional lability,

euphoric mood, hallucinations

anaphylactic responses.

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)

loss of appetite

anxiety, confusional state, depression

sleeplessness, nervousness, abnormal thinking

trembling (tremor)

depressed breathing (dyspnoea)

dry mouth

bellyache, diarrhoea, upset stomach (dyspepsia)

skin disorders such as rash

sweating including abnormally increased sweating

powerlessness.

Uncommon (may affect up to 1 in 100 people)

hypersensitivity

lack of water in the body (dehydration)

disturbances of sexual function (reduced sexual desire and erectile dysfunction)

drug dependence with withdrawal symptoms like palpitations

loss of memory (amnesia), convulsion

increased muscle tone, involuntary muscle contractions

reduced sense of touch (hypaesthesia)

speech disorders

fainting, paraesthesia, change in taste

visual impairment, constriction of the pupil

vertigo

widening of the blood vessels (vasodilatation)

respiratory depression

dysphagia, flatulence, burping, obstruction in the gut (ileus)

increased hepatic enzymes

dry skin

urinary disorders (urinary retention)

chills, general discomfort, thirst

Page 7

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)

hypotension, orthostatic hypotension

urticaria.

Frequency not known (cannot be estimated from the available data)

aggression

hyperalgesia

dental caries

cholestasis, biliary colic

absence of menstrual bleeding (amenorrhoea).

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.

Page 8

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.

Page 9

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.

The tablet can be divided into equal doses.

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.

The tablet can be divided into equal doses.

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.

The tablet can be divided into equal doses.

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.

The tablet can be divided into equal doses.

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.

The tablet can be divided into equal doses.

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.

The tablet can be divided into equal doses.

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 05/2016.

Read the complete document

Object 1

Leveraxo 5 mg prolonged-release tablets

Summary of Product Characteristics Updated 04-Jul-2017 | Generics UK T/A Mylan

1. Name of the medicinal product

Leveraxo 5 mg prolonged-release tablets

Leveraxo 10 mg prolonged-release tablets

Leveraxo 20 mg prolonged-release tablets

Leveraxo 30 mg prolonged-release tablets

Leveraxo 40 mg prolonged-release tablets

Leveraxo 60 mg prolonged-release tablets

Leveraxo 80 mg prolonged-release tablets

2. Qualitative and quantitative composition

Leveraxo 5 mg prolonged-release tablets

Each prolonged-release tablet contains 5 mg oxycodone hydrochloride equivalent to 4.5 mg oxycodone.

Leveraxo 10 mg prolonged-release tablets

Each prolonged-release tablet contains 10 mg oxycodone hydrochloride equivalent to 9 mg oxycodone.

Leveraxo 20 mg prolonged-release tablets

Each prolonged-release tablet contains 20 mg oxycodone hydrochloride equivalent to 17.9 mg

oxycodone.

Leveraxo 30 mg prolonged-release tablets

Each prolonged-release tablet contains 30 mg oxycodone hydrochloride equivalent to 26.9 mg

oxycodone.

Leveraxo 40 mg prolonged-release tablets

Each prolonged-release tablet contains 40 mg oxycodone hydrochloride equivalent to 36 mg oxycodone.

Leveraxo 60 mg prolonged-release tablets

Each prolonged-release tablet contains 60 mg oxycodone hydrochloride equivalent to 53.8 mg

oxycodone.

Leveraxo 80 mg prolonged-release tablets

Each prolonged-release tablet contains 80 mg oxycodone hydrochloride equivalent to 72 mg oxycodone.

Excipient with known effect:

Leveraxo 5 mg prolonged-release tablets

Each prolonged-release tablet contains a maximum of 15 mg sucrose.

Leveraxo 10 mg prolonged-release tablets

Each prolonged-release tablet contains a maximum of 30 mg sucrose.

Leveraxo 20 mg prolonged-release tablets

Each prolonged-release tablet contains a maximum of 12 mg sucrose.

Leveraxo 30 mg prolonged-release tablets

Each prolonged-release tablet contains a maximum of 18 mg sucrose.

Leveraxo 40 mg prolonged-release tablets

Each prolonged-release tablet contains a maximum of 24 mg sucrose.

Leveraxo 60 mg prolonged-release tablets

Each prolonged-release tablet contains a maximum of 36 mg sucrose.

Leveraxo 80 mg prolonged-release tablets

Each prolonged-release tablet contains a maximum of 48 mg sucrose.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Prolonged-release tablet.

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.

The tablet can be divided into equal doses.

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.

The tablet can be divided into equal doses.

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.

The tablet can be divided into equal doses.

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.

The tablet can be divided into equal doses.

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.

The tablet can be divided into equal doses.

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.

The tablet can be divided into equal doses.

4. Clinical particulars

4.1 Therapeutic indications

Severe pain, which can be adequately managed only with opioid analgesics.

Leveraxo is indicated in adults and adolescents aged 12 years and older.

4.2 Posology and method of administration

Posology

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)

Dose titration

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 to minimise the incidence of adverse

reactions.

Patients already receiving opioids may start treatment with higher doses taking into account their

experience with former opioid therapies.

For doses not realisable/practicable with this medicinal product, other strengths and medicinal products

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 Leveraxo prolonged-release tablets after conversion from other opioids,

with 50-75% of the calculated oxycodone dose.

Dose adjustment

Some patients who take Leveraxo following a fixed schedule need rapid release analgesics as rescue

medication in order to control breakthrough pain. Leveraxo prolonged-release tablets are 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 Leveraxo. Use of the rescue medication more than twice

daily indicates that the dose of Leveraxo 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.

Elderly patients

A dose adjustment is not usually necessary in elderly patients.

Duration of administration

Leveraxo should not be used for 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.

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.

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.

Paediatric population

Children under 12 years of age

Leveraxo should not be used in children under 12 years of age because of safety and efficacy concerns.

Method of administration

For oral use.

Leveraxo 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 (½ glass of water).

Leveraxo 5 mg prolonged-release tablets

Leveraxo must not be taken divided, broken, chewed or crushed.

Leveraxo 10 mg prolonged-release tablets

Leveraxo 20 mg prolonged-release tablets

Leveraxo 30 mg prolonged-release tablets

Leveraxo 40 mg prolonged-release tablets

Leveraxo 60 mg prolonged-release tablets

Leveraxo 80 mg prolonged-release tablets

Leveraxo must not be taken broken, chewed or crushed.

Leveraxo should not be used with alcoholic beverages.

4.3 Contraindications

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

Oxycodone must not be used in any situation where opioids are contraindicated:

Severe chronic obstructive lung disease

Cor pulmonale

Severe bronchial asthma

Severe respiratory depression with hypoxia

Elevated carbon dioxide levels in the blood

Paralytic ileus

4.4 Special warnings and precautions for use

Caution must be exercised when administering oxycodone to the debilitated elderly, patients with

severely impaired pulmonary function, impaired hepatic or renal function, patients with myxoedema,

hypothyroidism, Addison's disease , toxic psychosis (e.g. alcohol), prostate hypertrophy, alcoholism,

known opioid dependence, delirium tremens, diseases of the biliary tract, pancreatitis, inflammatory

bowel disorders, hypotension, hypovolaemia, head injury (due to risk of increased intracranial pressure),

epilepsy or seizure tendency and in patients taking MAO inhibitors.

In suspicion or in case of paralytic ileus administration of Leveraxo has to be stopped immediately.

Surgical procedures

As with all opioid preparations, oxycodone products should be used with caution following abdominal

surgery as opioids are known to impair intestinal motility and should not be used until the physician is

assured of normal bowel function.

Leveraxo is not recommended for pre-operative use or within the first 12-24 hours postoperatively.

Respiratory- and cardiac depression

The major risk of opioid excess is respiratory depression. It 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

The patient may develop tolerance to the drug with chronic use and require progressively higher doses to

maintain pain control. There is a cross-tolerance to other opioids. Chronic use of oxycodone can cause

physical dependence and a withdrawal syndrome may occur upon abrupt cessation of therapy.

When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose

gradually to prevent symptoms of withdrawal. 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.

Abuse

Oxycodone has an abuse profile similar to other strong agonist opioids. Oxycodone may be sought and

abused by people with latent or manifest addiction disorders. There is potential for development of

psychological dependence (addiction) to opioid analgesics, including oxycodone. Leveraxo should be

used with particular care in patients with a history of alcohol and drug abuse.

Abuse of oral dosage forms by parenteral administration can be expected to result in serious adverse

events. The tablet excipients may lead to necrosis of the local tissue, granulomas of the lung or other

serious, potentially fatal events.

Leveraxo 5 mg prolonged-release tablets

To avoid damage to the controlled release properties of the prolonged release, tablets must be swallowed

whole, and not divided, broken, chewed or crushed. The administration of divided, broken, chewed or

crushed controlled release oxycodone tablets leads to a rapid release and absorption of a potentially fatal

dose of oxycodone (see section 4.9).

Leveraxo 10 mg prolonged-release tablets

Leveraxo 20 mg prolonged-release tablets

Leveraxo 30 mg prolonged-release tablets

Leveraxo 40 mg prolonged-release tablets

Leveraxo 60 mg prolonged-release tablets

Leveraxo 80 mg prolonged-release tablets

To avoid damage to the controlled release properties of the prolonged release, tablets must not be

swallowed broken, chewed or crushed. The administration of broken, chewed or crushed controlled

release oxycodone tablets leads to a rapid release and absorption of a potentially fatal dose of oxycodone

(see section 4.9).

Alcohol

Concomitant use of alcohol and Leveraxo may increase the undesirable effects of Leveraxo; concomitant

use should be avoided.

Special patient groups

Hepatic impairment

Patients with severe hepatic impairment should be closely monitored.

Paediatric population

The safety and efficacy of oxycodone in children under 12 years of age have not been established.

Leveraxo should not be used in children under 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 'anti-doping' tests. Use of

Leveraxo as a doping agent may become a health hazard.

Excipients

This medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance,

glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

- There can be an enhanced CNS depressant effect during concomitant therapy with medicinal products

which affect the CNS, such as sedatives, hypnotics, phenothiazines, neuroleptics, anaesthetics,

antidepressants, muscle relaxants) and other opioids or alcohol, in particular respiratory depression.

- Anticholinergics (e.g. neuroleptics, antihistamines, antiemetics, antiparkinson medicinal products) can

enhance the anticholinergic undesirable effects of oxycodone (such as constipation, dry mouth or

micturition disorders).

- Monoaminooxidase (MAO) inhibitors are known to interact with narcotic analgesics. MAO- inhibitors

causes CNS excitation or depression associated with hypertensive or hypotensive crisis (see section 4.4).

Oxycodone should be used with caution in patients administered MAO- inhibitors or who have received

MAO-inhibitors during the last two weeks (see section 4.4).

Oxycodone is metabolised mainly by CYP3A4, with a contribution from CYP2D6. The activities of these

metabolic pathways may be inhibited or induced by various co-administered medicinal products or

dietary elements.

- 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).

- Strong CYP2D6 inhibitors may have an effect on the elimination of oxycodone. The effect of

other relevant isoenzyme inhibitors on the metabolism of oxycodone is not known. Potential

interactions should be taken into account. Medicinal products 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.

- Clinically relevant changes in International Normalised Ratio (INR) in both directions have been

observed in individuals if coumarin anticoagulants are co-applied with oxycodone.

- Alcohol may enhance the pharmacodynamic effects of Leveraxo; concomitant use should be avoided.

- There are no studies investigating the effect of oxycodone on CYP catalysed metabolism of other active

substances.

- 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 John's 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.

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.

Breastfeeding

Oxycodone may be secreted in breast milk and may cause respiratory depression in the newborn.

Oxycodone should, therefore, not be used in breastfeeding mothers.

Fertility

Human data are not available. In animal studies, oxycodone had no adverse effects on fertility (see

section 5.3).

4.7 Effects on ability to drive and use machines

Oxycodone may impair the ability to drive and use machines. 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 is 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.

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. Tolerance and dependence may occur (see below).

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)

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Immune system disorders:

Uncommon:

hypersensitivity

Very rare:

anaphylactic responses.

Metabolism and nutrition disorders

Common:

decreased appetite

Uncommon:

dehydration

Psychiatric disorders

Common:

anxiety, confusional state, depression, insomnia, nervousness. abnormal

thinking

Uncommon:

agitation, affect lability, euphoric mood, hallucinations, decreased libido, drug

dependence (see section 4.4).

Frequency not known:

aggression.

Nervous system disorders

Very common:

somnolence, dizziness, headache

Common:

tremor

Uncommon:

amnesia, convulsion, hypertonia, hypoaesthesia, involuntary muscle

contractions, speech disorder, syncope, paraesthesia, dysgeusia

Frequency unknown:

hyperalgesia.

Eye disorders

Uncommon:

visual impairment, miosis

Ear and labyrinth disorders:

Uncommon:

vertigo

Cardiac disorders

Uncommon:

palpitations (in the context of withdrawal syndrome)

Vascular disorders

Uncommon:

vasodilatation

Rare:

hypotension, orthostatic hypotension.

Respiratory, thoracic and mediastinal disorders

Common:

dyspnea.

Uncommon:

respiratory depression

Gastrointestinal disorders

Very common:

constipation, nausea, vomiting

Common:

abdominal pain, diarrhoea, dry mouth, dyspepsia

Uncommon:

dysphagia, flatulence, eructation, ileus

Frequency not known:

dental caries

Hepatobiliary disorders:

Uncommon:

increased hepatic enzymes

Frequency unknown:

cholestasis, biliary colic

Skin and subcutaneous tissue disorders

Very common:

pruritus

Common:

rash, hyperhidrosis

Uncommon:

dry skin

Rare:

urticaria

Renal and urinary disorders

Uncommon:

urinary retention.

Reproductive system and breast disorders

Uncommon:

erectile dysfunction Frequency unknown: amenorrhoea

General disorders and administration site conditions

Common:

asthenic conditions

Uncommon:

chills, drug withdrawal syndrome, malaise, oedema, peripheral oedema, drug

tolerance, thirst

Description of selected adverse reactions

Tolerance and dependence may develop with chronic use and a withdrawal syndrome may occur upon

abrupt cessation of therapy. The opioid abstinence or withdrawal syndrome is characterised by some or

all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia,

mydriasis and palpitations. Other symptoms also may develop, including: irritability, anxiety, backache,

joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhoea, or increased

blood pressure, respiratory rate or heart rate.

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

Acute overdose with oxycodone can be manifested by respiratory depression, somnolence progressing to

stupor or coma, hypertonia, miosis, bradycardia, hypotension, and death. In severe cases circulatory

collapse and non-cardiogenic lung oedema may occur; abuse of high doses of strong opioids such as

oxycodone can be fatal.

Management

A patent airway must be maintained.

The pure opioid antagonists such as naloxone are specific antidotes against symptoms from opioid

overdose.

Other supportive measures should be employed as needed.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Analgesics; Opioids; Natural opium alkaloids

ATC-Code: N02AA05

Mechanism of action

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 rapid-release 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.

Endocrine system

Opioids may influence the hypothalamic-pituitary-adrenal or – gonadal axes. Some changes that can be

seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone. Clinical

symptoms may be manifest from these hormonal changes.

5.2 Pharmacokinetic properties

Absorption

The relative bioavailability of Leveraxo is comparable to that of rapid release oxycodone with maximum

plasma concentrations being achieved after approximately 3-5 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.

A fat-rich meal before the intake of the tablets does not affect the maximum concentration or the extent of

absorption of oxycodone.

The tablets must not be crushed or chewed as this leads to rapid oxycodone release 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.

Biotransformation

Oxycodone is metabolised 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

In rat studies, oxycodone had no effect on fertility and embryonic development. However, in rabbits, at

dose levels which produced maternal toxicity, a dose related increase in developmental variations was

observed (increased number of presacral vertebrae, extra pairs of ribs). In a rat study on pre- and post-

natal development, there were neither effects on physical, reflexological, and sensory developmental

parameters nor on behavioural and reproductive indices

Data from genotoxicity studies with oxycodone reveal no special hazard for humans. Long-term studies

on carcinogenicity have not been performed.

Oxycodone showed a clastogenic potential in some in vitro investigations. However, under in vivo

conditions such findings were not observed, 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:

Sugar spheres (sucrose, maize starch)

Hypromellose

Talc

Ethyl cellulose

Hydroxypropylcellulose

Propylene glycol

Carmellose sodium

Cellulose, microcrystalline

Magnesium stearate (Ph. Eur.)

Silica, colloidal anhydrous

Tablet coating:

Leveraxo 5 mg:

Polyvinyl alcohol

Titanium dioxide (E171)

Macrogol 3350

Talc

Leveraxo 10 mg:

Polyvinyl alcohol

Titanium dioxide (E171)

Macrogol 3350

Iron oxide red (E172)

Talc

Leveraxo 20 mg:

Polyvinyl alcohol

Titanium dioxide (E171)

Macrogol 3350

Talc

Leveraxo 30 mg:

Polyvinyl alcohol

Titanium dioxide (E171)

Iron oxide yellow (E172)

Macrogol 3350

Talc

Leveraxo 40 mg:

Polyvinyl alcohol

Macrogol 3350

Titanium dioxide (E171)

Iron oxide red (E172)

Talc

Leveraxo 60 mg:

Polyvinyl alcohol

Macrogol 3350

Iron oxide yellow (E172)

Talc

Leveraxo 80 mg:

Polyvinyl alcohol

Iron oxide red (E172)

Macrogol 3350

Talc

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 white opaque PVC/PE/PVDC-aluminium perforated unit dose blisters. HDPE bottles with

PP child-resistant closure.

Pack sizes:

10x1, 14x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 98x1, 100x1 prolonged-release tablets in blister.

10, 20, 30, 50, 100 prolonged-release tablets in HDPE bottles.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7. Marketing authorisation holder

Generics [UK] Ltd t/a Mylan

Station Close,

Potters Bar,

Hertfordshire,

EN6 1TL.

United Kingdom

8. Marketing authorisation number(s)

PL 04569/1650

PL 04569/1651

PL 04569/1652

PL 04569/1653

PL 04569/1654

PL 04569/1655

PL 04569/1656

9. Date of first authorisation/renewal of the authorisation

September 2015

10. Date of revision of the text

March 2016

Company Contact Details

Generics UK T/A Mylan

Address

Building 4, Trident Place, Mosquito Way, Hatfield, Hertfordshire, AL10 9UL

Telephone

+44 (0)1707 853 000

Medical Information Direct Line

+44 (0)1707 853 000

Customer Care direct line

+44 (0)1707 853 000 select option 2

Stock Availability

+44 (0)1707 853 000 select option 2

http://www.mylan.com

+44 (0)1707 261 803

Medical Information e-mail

[email

protected]

Medical Information Fax

+44 (0)1707 261 803

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