PACKAGE LEAFLET: INFORMATION FOR THE USER

Carenoxa 10 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.

What is in this leaflet

1.    What Carenoxa is and what it is used for

2.    What you need to know before you take Carenoxa

3.    How to take Carenoxa

4.    Possible side effects

5.    How to store Carenoxa

6.    Contents of the pack and other information

1. What Carenoxa is and what it is used for

Carenoxa is a centrally acting, strong painkiller from the group of opioids.

Carenoxa 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 Carenoxa

Do not take Carenoxa

-    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),

-    if you have an acute abdomen or suffer from a delayed gastric emptying.

Warnings and precautions

Talk to your doctor or pharmacist before taking Carenoxa

-    if you are older or debilitated,

-    if you have a head injury,

-    if your lung, liver    or kidney function is severely impaired,

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

thyroid gland,

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

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

-    if you suffer from    alcoholism or are undergoing alcohol withdrawal

-    if you suffer from    known opioid-dependence,

-    if you suffer from    inflammatory bowel disorders

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

-    in conditions with increased brain pressure,

-    if you suffer from    disturbances of circulatory regulation,

-    if you suffer from    colic of the bile duct and ureter,

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

-    if you take or have taken MAO inhibitors (for the treatment of depression) within the last two

weeks

Talk to your doctor if any of these apply to you or if any of these conditions applied to you in the past. Dependence and tolerance

Carenoxa has a primary dependence potential. When used for a long time tolerance to the effects and progressively higher doses may be required to maintain pain control.

Chronic use of Carenoxa may lead to physical dependence and a withdrawal syndrome may occur upon abrupt cessation. When a patient no longer requires therapy with oxycodone hydrochloride, it may 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.

Carenoxa is for oral use only. In case of abusive injection (injection in a vein) the other tablet ingredients (especially talc) may lead to destruction (necrosis) of the local tissue, change of lung tissue (granulomas of the lung) or other serious, potentially lethal events.

Tablets should be avoided in patients with a history of or present alcohol and drug abuse.

Anti-doping warning

Athletes should be aware that this medicine may cause a positive reaction to “anti-doping tests”.

Use of Carenoxa as a doping agent may become a health hazard.

Children

Carenoxa has not been investigated in children under the age of 12 years. Safety and efficacy have not been established. Therefore use in children under 12 years of age is not recommended.

Other medicines and Carenoxa

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],

-    medicines used to treat allergies or vomiting [antihistamines, antiemetics])

-    other opiods or alcohol can enhance the side effects of oxycodone hydrochloride, in particular depressed breathing (respiratory depression).

-    Medicines with an anticholinergic effect e.g.

-    medicines that dampen psychoses [neuroleptics],

-    medicines used to treat allergies [antihistamines] or vomiting [antiemetics],

-    medicines used to treat Parkinson’s disease can enhance certain side effects of oxycodone hydrochloride (e.g. constipation, dry mouth or urinary disturbances).

-    Cimetidine and e.g. ketoconazole, voriconazole and erythromycin (inhibitors of cytochrome P450-3A) mayinhibit the metabolism of oxycodone. The influence of other medicines that can markedly affect the metabolism of oxycodone has not been investigated.

-    Monoamine oxidase inhibitors (MAOIs) can enhance the side effects of oxycodone hydrochloride (e.g. excitation decrease or increase in blood pressure)

-    In individual cases more or less blood clotting have been observed if medicinal products against blood clotting (anticoagulants of the coumarin type) are taken together with Carenoxa.

Carenoxa with alcohol

Drinking alcohol whilst taking Carenoxa 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 Carenoxa.

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

You should not take Carenoxa during pregnancy. There are limited data from the use of oxycodone in pregnant women.

Oxycodone crosses the placenta into the blood circulation of the baby.

Prolonged use of oxycodone during pregnancy can cause withdrawal symptoms in newborns. Use of oxycodone hydrochloride during delivery can cause depressed breathing (respiratory depression) in the newborn.

Breast-feeding

You should not take Carenoxa when you are breast-feeding as oxycodone passes into breast milk.

Driving and using machines

Oxycodone hydrochloride impairs alertness and reactivity to such an extent that the ability to drive and operate machinery is affected or ceases altogether. To look at the possible side effects affecting the motor skills and concentration see section 4 (Possible Side Effects).

With stable therapy, a general ban on driving a vehicle may be not necessary. The treating physician must assess the individual situation. Please discuss with your doctor whether or under what conditions you can drive a vehicle.

Carenoxa contains sucrose

This medicinal product 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 Carenoxa

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is:

Adults and adolescents (over 12 years of age)

The usual initial dose is 10 mg oxycodone hydrochloride in 12 hourly intervals. However, your doctor will prescribe the dose required to treat pain.

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 Carenoxa according to a fixed schedule need rapidly acting painkillers as rescue medication to control breakthrough pain. Carenoxa 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.

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

Elderly patients

In elderly patients without impairment of kidney and/or liver function a dose adjustment is usually not necessary.

Patients with liver or kidney problems

If you have impaired kidney and/or liver function or if you have a low body weight your doctor may prescribe a lower starting dose.

Use in children

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

Method and duration of administration

Swallow the prolonged-release tablets (either whole or divided) with a sufficient amount of liquid (V glass of water) with or without food in the morning and in the evening following a fixed schedule (e.g. at 8 a.m. and 8 p.m.).

The tablets must not be crushed or chewed as this leads to rapid oxycodone hydrochloride release due to the damage of the prolonged release properties. The administration of chewed or crushed Carenoxa leads to a rapid release and absorption of a potentially lethal dose of oxycodone (see section “If you take more Carenoxa than you should”). 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 Carenoxa than you should

If you have taken more Carenoxa as prescribed you should inform your doctor or your local poison control center 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 hydrochloride 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 Carenoxa

If you use a smaller dose of Carenoxa than directed or you miss the intake of Carenoxa, 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 Carenoxa if the time to the regular next intake is shorter, but postpone the next intake by 8 hours. In principle, you should not take Carenoxa more than once every 8 hours.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Carenoxa

Do not stop treatment without informing your doctor.

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

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 Carenoxa 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 hydrochloride 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; nausea; vomiting,

Itching.

Common    (may affect up to 1 in 10 people):

Several psychological side effects such as changes in mood (e.g. anxiety, depression, euphoria), changes in activity (mostly sedation, sometimes accompanied by lethargy, occasionally increase with restlessness, nervousness and sleep disorders) and changes in performance (thought process disorder, confusion, amnesia, isolated cases of speech disorders),

Feeling weak (asthenia); pins and needles (paraesthesia),

Lowering of blood pressure, rarely accompanied by symptoms such as pounding or racing heartbeat; fainting,

Depressed breathing, dyspnoea, bronchospasm (difficulty in breathing or wheezing), Dry mouth, rarely accompanied by thirst and difficulty swallowing; gastrointestinal disorders such as bellyache; diarrhoea; belching; upset stomach (dyspepsia); loss of appetite,

Skin disorders such as rash, rarely increased sensitivity to light (photosensitivity), in isolated cases itchy (urticaria) or scaly rash (exfoliative dermatitis),

Urinary disorders (urinary retention, but also frequent urination),

Sweating, chills.

Uncommon (may affect up to 1 in 100 people):

A condition which causes abnormal production of a hormone reducing urination (syndrome of inappropriate antidiuretic hormone secretion),

Change in perception such as depersonalisation, hallucinations, change in taste, visual disturbances, abnormally acute sense of hearing (hyperacousis),

Increased and decreased muscle tone; trembling (tremor), tics; reduced sense of touch (hypaesthesia); coordination disturbances; feeling unwell, feeling of spinning (vertigo),

Changes in tear secretion, constriction of the pupil,

Accelerated pulse; widening of the blood vessels (vasodilatation),

Increased coughing; pharyngitis; runny nose; voice changes,

Biliary colics; oral ulcers; inflammation of the gums, inflamed mouth (stomatitis); facial flushing; flatulence,

Disturbances of sexual function (reduced sexual desire and impotence),

Accidential injuries; pain (e.g. chest pain); excessive fluid in the tissues (oedema); migraine; physical dependence with withdrawal symptoms; allergic reactions.

Rare    (may affect up to 1 in 1,000 people):

Lymph node disease (lymphadenopathy),

Lack of water in the body (dehydration),

Seizures, in particular in patients suffering from epilepsy or with a tendency to seizures, muscle spasms (involuntary contraction of the muscle),

Gum bleeding; increased appetite; tarry stool; tooth staining and damage, obstruction in the gut (ileus),

Dry skin; herpes simplex (disorder of the skin and mucosa),

Blood in urine (haematuria),

Absence of menstrual bleeding (amenorrhoea),

Changes in body weight (loss or rise); cellulitis.

Very rare    (may affect up to 1 in 10,000 people):

Severe allergic reactions (anaphylactic reactions).

Tolerance and dependence may develop.

Opioid withdrawal syndrome

As oxycodone hydrochloride has the potential to cause a drug addiction, there is a possibility to develop an opioid abstinence or withdrawal syndrome is characterised by some or all of the following: restlessness, watery eyes (lacrimation), rhinorrhoea, yawning, perspiration, chills, muscle pain, dilation of the pupil and irregular heartbeat (palpitations). Other symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhoea, or increased blood pressure, respiratory rate or heart rate.

Counteractive measures

If you observe any of the above listed side effects your doctor usually will take appropriate measures.

The side effect constipation may be prevented by fiber enriched diet and increased drinking.

If you are suffering from sickness or vomiting your doctor will prescribe you an appropriate medicine.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Carenoxa

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 the bottle and the carton after “EXP”. The expiry date refers to the last day of that month.

Do not store above 30°C.

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 Carenoxa contains

-    The active substance is oxycodone hydrochloride. Each prolonged-release tablet contains 10 mg oxycodone hydrochloride equivalent to 9.0 mg oxycodone.

-    The other ingredients are:

Tablet core: Sugar spheres (sucrose, maize starch), hypromellose, macrogol 6000, talc, ethylcellulose, hydroxypropylcellulose, , propylene glycol, cellulose microcrystalline, cellulose, powdered, magnesium stearate, silica, colloidal anhydrous.

Tablet coating: Hypromellose, talc, macrogol 6000, titanium dioxide (E171), iron oxide brown (E 172), iron oxide red (E 172).

What Carenoxa looks like and contents of the pack

Carenoxa 10 mg prolonged-release tablets are brown-red, biconvex, oblong, prolonged-release tablets with dimensions of 9.6/4.4/3.1 mm (l/w/h) to10.6/4.8/3.7 mm (l/w/h) anda breakline on both sides.

The tablet can be divided into equal doses.

Carenoxa 10 mg prolonged-release tablets are available in blisters with child-resistant closure of 10,

14, 20, 25, 28, 30, 40, 50, 56, 60, 98 and 100 prolonged-release tablets as well as in HDPE bottles with PP child-resistant screw caps of 14, 20, 25, 28, 30, 50, 56, 98, 100 and 200 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

ACINO AG Am Windfeld 35 83714 Miesbach, Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Carenoxa 10 mg depottabletter Oksikodolor 10 mg depottabletit Carenoxa 10 mg Retardtabletten Paroxanal depot 10 mg depottabletter Carenoxa Depot 10 mg depottabletter Oxycodolor 10 mg, tabletten met verlengde afgifte Carenoxa 10 mg prolonged release tablets

This leaflet was last revised in 05/2014.

May 2014 10 mg Page 8