Candox 5 mg Prolonged-release Tablets

oxycodone hydrochloride

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 Candox is and what it is used for

2. What you need to know before you take Candox

3. How to take Candox

4. Possible side effects

5. How to store Candox

6. Contents of the pack and other information

What Candox is and what it is used for

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

Candox is used to treat severe pain, which can be adequately managed only with opioid analgesics.

What you need to know before you take Candox

Do not take Candox

•    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 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 Candox if you are older or debilitated if your lung, liver or kidney function is severely impaired (see also section 3 “Risk patients") 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 and problems occur (e.g. delirium tremens)

if you suffer from intoxication psychosis (e.g. alcohol) if you suffer from known opioid-dependence if you suffer from inflammation of the pancreas (pancreatitis)

in conditions with increased brain pressure such as head injury

if you suffer from disturbances of circulatory regulation

if you suffer from diseases of the biliary tract, colic of the bile duct and ureter

if you suffer from low blood pressure or reduced blood volume

if you suffer from epilepsy or have a seizure tendency if you take MAO inhibitors (for the treatment of depression)

if you have recently undergone bowel-surgery or abdominal surgery

if you suffer from an inflammatory bowel disorder.

Please 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

Candox 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 Candox 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 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.

Increased sensitivity to pain that does not respond to dose increases can rarely develop. If this happens, your doctor will reduce your dose or switch you to an alternative opioid painkiller.

Candox is not recommended for use before an operation or in the 12-24 hours after an operation.

Candox should be used with particular care in patients with a history of or present alcohol and drug abuse.

Please refer to section 4 “Possible side effects" for information on counteractive measures which may be used to ease certain side effects.

Children

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

Elderly patients

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

Anti-doping warning

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

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

Other medicines and Candox

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)

•    drugs used during surgeries (anaesthetics)

•    medicines used to treat depression

•    muscle relaxants

•    medicines used to treat allergies or vomiting (antihistamines, antiemetics)

•    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).

•    Cimetidine (a medicine used to treat heartburn) and quinidine (a medicine used to treat heart disease) can inhibit the metabolism of oxycodone.

•    Macrolide antibiotic, some antifungal and antiviral medicines can increase the effect of oxycodone and so the dose may need to be adjusted if you are taking these medicines.

•    Some antiepileptic medicines and also the herbal remedy 'St John Wort' can decrease the effect 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 (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 taken together with Candox.

Candox with food, drink and alcohol

Drinking alcohol whilst taking Candox 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're taking oxycodone.

Grapefruit juice can inhibit the metabolism of oxycodone which will increase its effect. Therefore you should avoid drinking grapefruit juice while taking Candox.

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 Candox 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. Infants born to mothers who have received opioids during the last 3 to 4 weeks before giving birth should be monitored for respiratory depression.

Breast-feeding

You should not use Candox when you are breast-feeding as oxycodone passes into breast milk and may cause respiratory depression in the newborn.

Driving and using machines

Oxycodone may impair the ability to drive and use machines.

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

To look at the possible side effects affecting the motor skills and concentration see section 4. “Possible side effects"

Candox 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 you take this medicinal product.

How to take Candox

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 (over 12 years of age)

The usual initial dose is 10 mg of oxycodone hydrochloride in 12 hourly intervals.

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

Method and duration of administration (oral use)

It is not recommended to take Candox with alcoholic beverages.

Swallow the prolonged-release tablets whole with a sufficient amount of liquid (/ 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 prolonged-release tablets must not be crushed, divided or chewed as this leads to rapid oxycodone

release due to the damage of the prolonged-release properties. The administration of chewed or crushed Candox leads to a rapid release and absorption of a potentially fatal dose of oxycodone (see section “If you take more Candox than you should").

Candox are for oral use only. In case of abusive injection (injection in a vein) the tablet excipients may lead to destruction (necrosis) of the local tissue, change of lung tissue (granulomas of the lung) or other serious, potentially fatal events.

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 Candox than you should

If you have taken more Candox than 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 should you expose yourself to situations requiring elevated concentration e.g. driving a car.

If you forget to take Candox

If you use a smaller dose of Candox than directed or you miss the intake of the tablets, 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 the tablets as directed.

You should also take the prolonged-release tablets if the time to the regular next intake is shorter, but postpone the next intake by 8 hours. In principle, you should not take Candox more than once every 8 hours.

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

If you stop taking Candox

Do not stop treatment without informing your doctor. When a patient no longer requires therapy with Candox, 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.

^ Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience the following, stop taking Candox and tell your doctor immediately or go to the casualty department of your nearest hospital:

•    A severe allergic reaction (anaphylactic reaction), signs and symptoms may include rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing.

This is a serious but rare side effect, which affects less than 1 user in 10,000 patients. You may need urgent medical attention or hospitalisation.

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 Candox 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, difficulty in breathing or wheezing 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

•    vomiting

•    itching

Common (may affect up to 1 in 10 people)

•    feeling weak (asthenia)

•    several psychological side effects such as

•    changes in mood (e.g. anxiety, depression)

•    changes in activity (mostly sedation, sometimes accompanied by lethargy, occasionally increase with nervousness and sleep disorders)

•    changes in performance (thought process disorder, confusion)

•    breathing difficult (dyspnoea)

•    bronchospasm (difficulty in breathing or wheezing)

•    dry mouth

•    gastrointestinal disorders such as bellyache, diarrhoea, upset stomach (dyspepsia), loss of appetite up to complete absence of appetite

•    skin disorders such as rash, rarely increased sensitivity to light (photosensitivity), in isolated cases scaly rash (exfoliative dermatitis)

•    frequent urination

•    increased sweating

•    trembling (tremor)

Uncommon (may affect up to 1 in 100 people)

•    abnormal production of antidiuretic hormone

•    lack of water in the body (dehydration)

•    change in perception such as depersonalisation, hallucinations

•    restlessness

•    extreme emotional behavior

•    a feeling of extreme happiness

•    disturbances of sexual function (reduced sexual desire)

•    impotence

•    drug dependence

•    change in taste

•    visual disturbances

•    changes in tear secretion

•    constriction of the pupil

•    abnormally acute sense of hearing (hyperacousis)

•    feeling of dizziness or spinning (vertigo)

•    both increased and decreased muscle tone

•    involuntary muscle contractions

•    seizures, (in particular in patients suffering from epilepsy or with a tendency to seizures)

•    reduced sense of touch (hypoaesthesia)

•    coordination disturbances

•    migraine

•    feeling unwell

•    speech disorder

•    loss of memory

•    syncope