Leveraxo 40 Mg Prolonged-Release Tablets

Document: leaflet MAH BRAND_PL 40800-0018 change

Package leaflet: Information for the user

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

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 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

- if your lung, liver or kidney function is severely impaired (see also section 3 “Riskpatients”)

- if you suffer from myxoedema (certain illnesses of the thyroid gland), or an impaired function of the thyroid gland

- if you suffer from adrenal insufficiency (Addison’s disease)

- if you suffer from toxic psychosis (e.g. alcohol),

- if you suffer from enlargement of the prostate (prostate hypertrophy)

- if you suffer from alcoholism or are undergoing alcohol withdrawal

- if you suffer from known opioid-dependence

- if you suffer from inflammation of the pancreas (pancreatitis)

- if you suffer from diseases of the biliary tract,

- if you suffer from inflammatory bowel disorders

- if you suffer from low blood pressure

- if you suffer from decreased blood volume (hypovolaemia)

- if you suffer from head injury

- if you suffer from epilepsy or have a seizure (fits) tendency

- if you take MAO inhibitors (for the treatment of depression).

Longterm 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 opiods 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, azolantifungals, 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, carbamazepin, phenytoin and St Johns 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.

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 (‘A 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 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 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:

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 Leveraxoif 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 of signs occur

If you experience any of the following side effects, stop taking Leveraxo and contact your doctor immediately.

Depressed breathing is the most significant risk induced by opioids and is most likely to occur in elderly or debilitated patients. As a consequence, in predisposed patients opioids can cause severe drops in blood pressure.

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

Other possible side effects

Very common (may affect more than 1 in 10 people)

- sedation (tiredness to drowsiness), dizziness, headache

- constipation, 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)

- agitation, emotional lability, euphoric mood, hallucinations

- 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

- 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)

- anaphylactic responses

- 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, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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.

- The other ingredients are:

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:

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.

- The other ingredients are:

Tablet coating: 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.

- The other ingredients are:

Tablet coating: 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.

- The other ingredients are:

Tablet coating: 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.

- The other ingredients are:

Tablet coating: 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.

- The other ingredients are:

Tablet coating: 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.

- The other ingredients are:

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.