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Candox 10mg Prolonged-Release Tablets

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CANDOX 10 mg

PROLONGED-RELEASE TABLETS Oxycodone hydrochloride


PACKAGE LEAFLET: INFORMATION FOR THE USER


Read all of this leaflet carefully before you

start taking this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


INTHIS LEAFLET:


1.    What Candox 10 mg prolonged-release tablets are and what they are used for

2.    Before you take Candox 10 mg prolonged-release tablets

3.    How to take Candox 10 mg prolonged-release tablets

4.    Possible side effects

5.    How to store Candox 10 mg prolonged-release tablets

6.    Further information

OWHAT CANDOX 10 mg

PROLONGED-RELEASE TABLETS ARE AND WHAT THEY ARE USED FOR

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

Candox 10 mg prolonged-release tablets are used to treat severe pain, which can be adequately managed only with opioid analgesics.

©BEFORE YOU TAKE CANDOX 10 mg PROLONGED-RELEASE TABLETS

Do not take Candox 10 mg prolonged-release tablets

• if you are allergic (hypersensitive) to oxycodone hydrochloride or any of the other ingredients of this medicinal product • 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.

Take special care with Candox 10 mg prolonged-release tablets

• if you are older or debilitated • if your lung, liver or kidney function is severely impaired

• if you suffer from myxoedema (certain illnesses of the thyroid gland) or impaired function of the thyroid gland • if you suffer from adrenal insufficiency (Addison's disease)

• if you suffer from intoxication psychosis (e.g. alcohol)

• if you suffer from alcoholism or are undergoing alcohol withdrawal • if you suffer from known opioid-dependence • if you suffer from enlargement of the prostate (prostatic hypertrophy)

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

• if you suffer from colic of the bile duct and ureter

• if you suffer from obstructive and inflammatory intestinal disease • in conditions with increased brain pressure • if you suffer from disturbances of circulatory regulation

• if you suffer from epilepsy or have a seizure tendency

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

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 10 mg prolonged-release tablets have 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 Candox 10 mg prolonged-release tablets 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.

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

• Children

Oxycodone Hydrochloride has not been investigated in children under 12 years.

Safety and efficacy have not been established. 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, due to its active substance, may cause a positive reaction to "anti-doping tests"

Use of Oxycodone Hydrochloride as a doping agent may become a health hazard.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription.

Medicines that dampen the activity of the central nervous system, e.g.

• sleeping pills or tranquillizers (sedatives, hypnotics)

• other medicines that act on the nervous system (phenothiazines, neuroleptics)

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

• as well as 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 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 can inhibit 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 (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 Oxycodone.

Taking Candox 10 mg prolonged-release tablets with food and drink

Drinking alcohol whilst taking oxycodone 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.

Pregnancy and breast-feeding Pregnancy

Candox 10 mg prolonged-release tablets should not be used in pregnancy unless clearly necessary. There is insufficient experience regarding the use of the active substance oxycodone hydrochloride in humans during pregnancy. Oxycodone crosses the placenta into the blood circulation of the baby.

Long-term use of oxycodone during pregnancy can cause withdrawal symptoms in newborns. Use of oxycodone during delivery can cause breathing at an abnormally slow rate (respiratory depression) in the newborn.

Breast-feeding

You should not use Candox when you are breast-feeding as oxycodone passes into breast milk.

Ask your doctor or pharmacist for advice before taking any medicine.

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. 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 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.

Important information about some of the ingredients of Candox 10 mg prolonged-release tablets

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.

HOW TO TAKE CANDOX 10 mg PROLONGED-RELEASE TABLETS

Always take Candox 10 mg prolonged-release tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual 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. Your doctor will adjust the dosage depending on the pain intensity and how you respond to the treatment.

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 10 mg prolonged-release tablets according to a fixed schedule need rapidly acting painkillers as rescue medication to control breakthrough pain. Candox 10 mg prolonged-release tablets 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 mg to 120 mg of oxycodone hydrochloride which may be increased up to 400 mg in individual cases.

For different purpose and dose treatments Candox prolonged-release tablets containing 5 mg, 10 mg, 20 mg, 40 mg or 80 mg Oxycodone Hydrochloride are available.

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.

Use in children

Oxycodone is not recommended for children under 12 years of age.

Elderly patients

Elderly patients without clinical manifestation of impaired liver and/or kidney function usually do not require dose adjustments.

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.

Candox 10 mg prolonged-release tablets should not be taken with alcoholic beverages.

Method and duration of administration

Swallow the prolonged-release tablets (either whole or divided) 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 tablets may be divided into two halves but must not be crushed 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 10 mg prolonged-release tablets leads to a rapid release and absorption of a potentially fatal dose of oxycodone (see section "If you take more Candox 10 mg prolonged-release tablets than you should").

Candox 10 mg prolonged-release tablets are for oral use only. In case of abusive injection (injection in a vein) the tablet excipients (especially talc) may lead to destruction (necrosis) of the local tissue, change of lung tissue (granulomas of the lung) or other serious, potentially fatal events.



This medicinal product is packed child-resistant. You cannot press out the prolonged-release tablets from the blister. Please observe the opening instruction for the blister below.

If you take more Candox 10 mg prolonged-release tablets than you should

If you have taken more Candox 10 mg prolonged-release tablets 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 (stupor), unconsciousness (coma) slowing of the heart rate (bradycardia) 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 10 mg prolonged-release tablets

If you use a smaller dose of Candox 10 mg prolonged-release tablets 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 tablet 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 10 mg prolonged-release tablets more than once every 8 hours.

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

If you stop taking Candox 10 mg prolonged-release tablets

Do not stop treatment without informing your doctor.

When a patient no longer requires therapy with Candox 10 mg prolonged-release tablets, 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 product, ask your doctor or pharmacist.

4 POSSIBLE SIDE EFFECTS

Like all medicines, Candox 10 mg prolonged-release tablets 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.

Assessment of the side effects is based on the following frequencies:

Very common:

May affect more than 1 of 10 patients treated

Common:

May affect up to 1 in 10 patients treated

Uncommon:

May affect up to 1 in 100 patients treated

Rare:

May affect up to 1 in 1,000 patients treated

Very rare:

May affect up to 1 in 10,000 patients treated

Not known:

Frequency cannot be estimated from the available data

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 Candox 10 mg prolonged-release tablets 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

•    sedation (tiredness to drowsiness)

•    dizziness

•    headache

•    constipation

•    nausea

•    vomiting

•    itching.

Common

•    feeling weak (asthenia)

•    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)

•    changes in performance (thought process disorder, confusion, amnesia, isolated cases of speech disorders)

•    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, anorexia

•    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

•    change in perception such as depersonalisation, hallucinations

•    change in taste

•    visual disturbances

•    abnormally acute sense of hearing (hyperacousis)

•    both increased and decreased muscle tone

•    trembling (tremor)

•    tics

•    reduced sense of touch (hypaesthesia)

•    coordination disturbances

•    feeling unwell

•    vertigo

•    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)

•    flatulence

•    disturbances of sexual function

•    injuries due to accidents

•    pain (e.g. chest pain)

•    excessive fluid in the tissues (oedema)

•    migraine

•    physical dependence with withdrawal symptoms

•    allergic reactions

•    changes in tear secretion

•    constriction of the pupil.

Rare

•    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

•    involuntary contraction of the muscle (muscle spasms)

•    gum bleeding

•    increased appetite

•    tarry stool

•    tooth staining and damage

•    intestinal hypomotility (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.

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, being 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 will usually 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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

HOW TO STORE CANDOX 10 mg PROLONGED-RELEASE TABLETS

Keep out of the reach and sight of children.

Do not use Candox 10 mg prolonged-release tablets after the expiry date which is stated on the blister and the carton after "EXP"The expiry date refers to the last day of that month.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

g FURTHER INFORMATION

What Candox 10 mg prolonged-release tablets contains

The active substance is oxycodone hydrochloride. Each prolonged-release tablet contains 10 mg oxycodone hydrochloride corresponding to 8.96 mg oxycodone.

The other ingredients are:

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

Tablet coating: Hypromellose, talc, macrogol 6000, titanium dioxide (E171), Iron oxide brown (E172), Iron oxide red (E172).

What Candox 10 mg prolonged-release tablets look like and contents of the pack

Candox 10 mg prolonged-release tablets are brown-red, biconvex, oblong, prolonged-release tablets with a breakline on both sides.

The tablet can be divided into equal halves.

Candox 10 mg prolonged-release tablets are sealed in blisters with child resistant closure and available in packs of 14, 20, 25, 28, 30, 50, 56, 60, 98 and 100 prolonged-release tablets and in HDPE bottles with PP child resistant twist-off caps of 100 and 250 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

TEVA UK Limited, Eastbourne, BN22 9AG, UK.

Manufacturer

Merckle GmbH, Ludwig-Merckle-Str. 3,

89143 Blaubeuren, Germany.

This leaflet was last revised in 07/2012

PL 00289/1710

Opening instruction:

Dear patient,

this medicinal product is packed child-resistant. You cannot press out the prolonged-release tablets from 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.



80035-C

209079.01-GB