CANDOX 40 MG PROLONGED-RELEASE TABLETS - patient leaflet, side effects, dosage

PACKAGE LEAFLET: INFORMATION FOR THE USER Candox 20 mg, 40 mg and 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 Candox prolonged-release tablets are and what they are used for

• 2. What you need to know before you take Candox prolonged-release tablets

• 3. How to take Candox prolonged-release tablets

• 4. Possible side effects

• 5. How to store Candox prolonged-release tablets

• 6. Contents of the pack and otherinformation

1. What Candox Prolonged-release Tablets are and what they are used for

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

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

2. what you need to know before you take candox prolonged-release tablets- if you are allergic to oxycodone hydrochloride or any of the other ingredients 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 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 have poor adrenal gland function (your adrenal gland is not working properly) for example Addison’s disease,

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

• – if you suffer from alcoholism or are undergoing alcohol withdrawal and problems occur (e.g.

delirium tremens),

• – 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 diseases of the biliary tract, colic of the bile duct and ureter,

• – if you suffer from obstructive and inflammatory intestinal disease

• – in conditions with increased brain pressure, such as head injury,

• – 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),

• – if you have recently undergone bowel surgery or abdominal surgery,

• – if you suffer from low blood pressure or reduced blood volume.

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 prolonged-release tablets has a 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 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, 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 very rarely develop. If this happens, your doctor will reduce your dose or switch you to an alternative opioid painkiller.

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

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

Similar to other opioids, Candox may affect the normal production of hormones in the body such as cortisol or sex hormones, particularly if you have taken high doses for long periods of time.

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

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

- Children

Oxycodone 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.

Other medicines and Candox Prolonged-release Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Concomitant use of Oxycodone Hydrochloride and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor does prescribe Oxycodone Hydrochloride together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

The risk of side effects increases, if you use antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.

If you take these tablets with some other medicines, the effect of these tablets or the other medicine may be changed. Tell your doctor or pharmacist if you are taking:

• – a type of medicine known as a monoamine oxidase inhibitor or you have taken this type of medicine in the last two weeks (see ‘Warnings and precautions),

• – medicines to help you sleep or stay calm (for example hypnotics or sedatives, including benzodiazepines),

• – medicines to treat depression (for example paroxetine or fluoxetine),

• – medicines to treat psychiatric or mental disorders (such as phenothiazines or neuroleptic drugs),

• – other strong analgesics (‘painkillers’),

• – muscle relaxants,

• – quinidine (a medicine to treat a fast heartbeat),

• – cimetidine (a medicine for stomach ulcers, indigestion or heartburn),

• – medicines to treat fungal infections (such as ketoconazole, voriconazole, itraconazole, or posaconazole),

• – medicines used to treat bacterial infections (such as clarithromycin, erythromycin or telithromycin),

• – a specific type of medicine known as a protease inhibitor to treat HIV (examples include boceprevir, ritonavir, indinavir, nelfinavir or saquinavir),

• – rifampicin to treat tuberculosis,

• – carbamazepine (a medicine to treat seizures, fits or convulsions and certain pain conditions),

• – phenytoin (a medicine to treat seizures, fits or convulsions),

• – a herbal remedy called St John’s Wort (also known as Hypericum perforatum),

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

• – medicines to treat Parkinson’s di­sease,

• – anticoagulants of the coumarin type (medicines used to reduce blood clotting).

Also, tell your doctor if you have recently been given an anaesthetic.

Candox prolonged-release tablets with food, drink and alcohol

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

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 Oxycodone Hydrochloride 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. Long-term use of oxycodone during pregnancy may 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.

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

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.

Candox Prolonged-release Tablets 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 candox prolonged-release tablets

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. 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 prolonged-release tablets according to a fixed schedule need rapidly acting painkillers as rescue medication to control breakthrough pain. Candox prolonged-release tablets are 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.

For different purpose and dose treatments 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 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 (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.).

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 prolonged-release tablets leads to a rapid release and absorption of a potentially fatal dose of oxycodone (see section “If you take more Candox prolonged-release tablets than you should”).

Candox 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.

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

If you have taken more Candox prolonged-release tablets than 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 (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 prolonged-release tablets

If you use a smaller dose of Candox 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 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 prolonged-release tablets

Do not stop treatment without informing your doctor.

When a patient no longer requires therapy with Candox 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 medicine, ask your doctor or pharmacist.

4. 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.

If you experience any of the following side effects, stop taking Candox prolonged-release tablets and contact your doctor immediately:

• - depressed (shallow) breathing which is the most significant risk induced by opioids and most likely to occur in elderly or debilitated patients. As a consequence, in predisposed patients opioids can cause severe drops in blood pressure.

• - severe hypersensitivity reactions (anaphylactic reactions) which may cause nettle rash, swelling of the face, lips, mouth, tongue or throat or difficulty in breathing

• - constricted pupil

• - sudden constriction of the airways causing difficulty in breathing (bronchospasm)

• - abdominal cramps

• - suppression of 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):

• - 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) and changes in performance (thought process disorder, confusion)

• - trembling (tremor)

• - shortness of breath (dyspnoea)

• - 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), increased sweating

• - frequent urination.

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, disturbances of sexual function (reduced sexual desire), restlessness, extreme emotional behaviour, a feeling of extreme happiness, drug dependence

• - 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 (hypaesthesia), speech disorder, fainting, pins and needles (paraesthesia), coordination disturbances, change in taste, loss of memory

• - abnormally acute sense of hearing (hyperacousis), feeling dizziness or spinning (vertigo)

• - accelerated pulse, sensation of irregular and forceful heartbeat (in the context of withdrawal syndrome)

• - widening of the blood vessels (vasodilatation)

• - increased coughing, pharyngitis, runny nose, voice changes

• - oral ulcers, inflammation of the gums, inflamed mouth (stomatitis), flatulence, belching, difficulty swallowing, intestinal obstruction (ileus)

• - increased liver enzymes

• - dry skin

• - urinary retention

• - impotence

• - injuries due to accidents

• - chills, pain (e.g. chest pain), excessive fluid in the tissues (oedema), migraine, drug withdrawal symptoms, drug tolerance, feeling unwell, thirst

• - changes in tear secretion, vision disorder.

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

• - herpes simplex (disorder of the skin and mucosa)

• - lymph node disease (lymphadenopathy)

• - increased appetite

• - lowering of blood pressure, dizziness when standing up from a sitting or lying position

• - muscle spasms

• - gum bleeding, tarry stool, tooth staining and damage

• - itchy skin rashes

• - blood in urine (haematuria)

• - changes in body weight (loss or rise), cellulitis.

Not known (frequency cannot be estimated from the available data):

• – aggression

• – increased sensitivity to pain which cannot be improved increasing the dose

• – tooth decay

• – pain on the right side of abdomen, biliary colic

• – absence of menstrual periods (amenorrhoea)

• – long term use of Candox during pregnancy may cause life-threatening withdrawal symptoms in the new-born. Symptoms to look for in the baby include irritability, hyperactivity and abnormal sleep pattern, high pitched cry, shaking, being sick, diarrhoea and not putting on weight.

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 the Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store candox prolonged-release tablets

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 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 Candox prolonged-release tablets contains The active substance is oxycodone hydrochloride.

Each prolonged-release tablet contains:

20 mg:

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

40 mg:

Each prolonged-release tablet contains 40 mg oxycodone hydrochloride corresponding to 35.9 mg oxycodone.

80 mg:

Each prolonged-release tablet contains 80 mg oxycodone hydrochloride corresponding to 71.7 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.

Tablet coating:

20 mg:

Hypromellose; talc; macrogol 6000, titanium dioxide (E171); iron oxide, red (E172).

40 mg:

Hypromellose; talc; macrogol 6000, titanium dioxide (E171); iron oxide, yellow (E172); iron oxide, red (E172).

80 mg:

Hypromellose; talc; macrogol 6000, titanium dioxide (E171); iron oxide, yellow (E172).

What Candox prolonged-release tablets looks like and contents of the pack

Candox 20 mg prolonged-release tablets are pink, biconvex, oblong, prolonged-release tablets with a break line on both sides.

Candox 40 mg prolonged-release tablets are orange, biconvex, oblong, prolonged-release tablets with a break line on both sides.

Candox 80 mg prolonged-release tablets are yellow, biconvex, oblong, prolonged-release tablets with a break line on both sides.

The tablets can be divided into equal halves.

Pack sizes:

14 {20 mg only} , 20, 28, 30, 50, 56, 60, 98, 100, 100 × 1 prolonged-release tablets in blisters with child-resistant closure.

50, 100 and 250 prolonged-release tablets in HDPE bottles with PP twist-off caps.

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 05/2019

PL 00289/1711, PL 00289/1712, PL 00289/1713