Oxycodone Accord

PACKAGE LEAFLET: INFORMATION FOR THE USER

Oxicodone Accord 5 mg prolonged-release tablets, 10 mg prolonged-release tablets, 20 mg prolonged-release tablets, 40 mg prolonged-release tablets, 80 mg prolonged-release tablets

Equivalent medicinal product
Please read 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Oxicodone Accord is and what it is used for
2. What you need to know before taking Oxicodone Accord
3. How to take Oxicodone Accord
4. Possible side effects
5. How to store Oxicodone Accord
6. Contents of the pack and other information

1. What Oxicodone Accord is and what it is used for

This medicinal product contains the active substance oxycodone, which belongs to a group of
medicines called strong analgesics or "painkillers".
Oxicodone Accord is used to treat severe pain which can only be adequately managed with opioid analgesics. Oxicodone Accord is indicated in adults and adolescents over 12 years of age.

2. What you need to know before taking Oxicodone Accord

Do not take Oxicodone Accord tablets if:

• you are allergic to oxycodone hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• you have breathing problems, such as chronic obstructive pulmonary disease, severe bronchial asthma, or severe respiratory depression. Your doctor will tell you if you have any of these conditions. Symptoms may include shortness of breath, cough, or slower and weaker breathing than normal;
• you have a condition in which the small intestine does not work properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying), or you have sudden severe abdominal pain;
• you have heart problems caused by long-term lung disease (pulmonary heart disease);
• you have moderate to severe liver problems. If you have other long-term liver problems, you should take these tablets only if recommended by your doctor;
• you have ongoing constipation problems;
• you are under 12 years of age.

Warnings and Precautions
Talk to your doctor, pharmacist, or nurse before taking Oxicodone Accord

• if you are elderly or debilitated;
• if you have reduced thyroid function (hypothyroidism), as you may need a lower dose;
• if you have liver or kidney problems;
• if you have myxoedema (a thyroid disorder characterized by dry, cold, and swollen skin affecting the face and legs);
• if you have reduced adrenal gland function (the adrenal gland does not work properly, which may cause symptoms such as weakness, weight loss, dizziness, and feeling unwell), for example, Addison’s disease;
• if you have low blood pressure (hypotension);
• if you have low blood volume (hypovolemia); this may occur with external or internal bleeding, severe burns, excessive sweating, severe diarrhoea, or vomiting;
• if you have a mental disorder due to infection (toxic psychosis);
• if you have gallbladder or bile duct problems;
• if you have inflammatory bowel disease;
• if you have an enlarged prostate causing difficulty passing urine (in men);
• if you have or have had alcohol or drug dependence, or known opioid dependence;
• if you have inflammation of the pancreas (causing severe abdominal and back pain);
• if you have a severe headache or feel nauseous, as this may indicate increased pressure in your skull;
• if you have breathing problems, such as severe lung disease. Your doctor will tell you if you have any of these conditions. Symptoms may include shortness of breath and cough;
• if you have previously experienced withdrawal symptoms such as restlessness, anxiety, tremors, or sweating after stopping alcohol or medication;
• if you have increased sensitivity to pain;
• if you need to take a higher dose of Oxicodone Accord to achieve the same level of pain relief (tolerance).

If you are due to have surgery, inform your hospital doctor that you are taking these tablets.
Administration of chewed or crushed tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone (see section 3).

Children and adolescents
Oxicodone Accord has not been studied in children under 12 years of age. Safety and efficacy have not been established, therefore use in children under 12 years of age is not recommended.

Patients over 65 years
Geriatric patients at risk who have never taken opioids before generally need to start with the lowest dose.

Anti-Doping Warning
Athletes should be aware that this medicine may cause a positive reaction in anti-doping tests.
The use of Oxicodone Accord as a doping substance may become a health risk.

Taking Oxicodone Accord with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. If you take these tablets with certain other medicines, the effect of these tablets or the other medicines may be altered.

Tell your doctor or pharmacist if you are taking:

• certain types of medicines called monoamine oxidase inhibitors (MAOIs), or if you have taken these medicines within the last two weeks;
• medicines for sleep or to calm you down (e.g. tranquillisers, hypnotics, or sedatives);
• medicines for depression (e.g. paroxetine);
• medicines for psychiatric or mental disorders (such as phenothiazines or neuroleptics);
• other strong painkillers (analgesics);
• muscle relaxants;
• medicines for high blood pressure;
• quinidine (a medicine used to treat fast heart rate);
• cimetidine (a medicine used for stomach ulcers, indigestion, or heartburn);
• antifungal medicines (such as ketoconazole, voriconazole, itraconazole, or posaconazole);
• antibiotics (such as clarithromycin, erythromycin, or telithromycin);
• medicines known as "protease inhibitors", used to treat HIV (such as boceprevir, ritonavir, indinavir, nelfinavir, or saquinavir);
• rifampicin (used to treat tuberculosis);
• carbamazepine (a medicine used to treat seizures, epilepsy, convulsions, and certain types of pain);
• phenytoin (a medicine used to treat seizures, epilepsy, convulsions);
• a herbal remedy called St John’s wort (also known as Hypericum perforatum);
• antihistamines;
• medicines used to treat Parkinson’s disease.

Also inform your doctor if you have recently taken an anaesthetic.
The concomitant use of Oxicodone Accord and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor prescribes Oxicodone Accord together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.
Inform your doctor about all sedative medicines you are taking and follow your doctor’s dose recommendations carefully. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above.
Contact your doctor if you experience such symptoms.
The risk of side effects increases when taking 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 and rhythmic muscle contractions, including muscles controlling eye movements, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Contact your doctor if you experience these symptoms.

Taking Oxicodone Accord with food, drinks, and alcohol
Drinking alcohol while taking Oxicodone Accord prolonged-release tablets may increase drowsiness or the risk of serious side effects, such as shallow breathing with risk of breathing stopping, and loss of consciousness.
It is recommended not to drink alcohol during treatment with Oxicodone Accord prolonged-release tablets. During treatment with this medicine, you should avoid drinking grapefruit juice.
You may take Oxicodone Accord with or without food.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
You must not take Oxicodone Accord during pregnancy. There is limited data on the use of Oxicodone Accord in pregnant women. Newborns born to mothers who took oxycodone during the last 3–4 weeks before delivery have experienced severe breathing difficulties. Withdrawal syndrome may occur in newborns of mothers treated with oxycodone.

Breastfeeding
Oxycodone may pass into breast milk and may cause breathing difficulties in newborns. Oxicodone Accord must not be taken during breastfeeding.

Driving and using machines
Oxycodone alters alertness and reaction ability to such an extent that your ability to drive and operate machinery may be impaired or completely lost. With stable therapy, it may not be necessary to prohibit driving entirely. Your treating doctor should assess your individual situation. Discuss with your doctor whether and under what conditions you may drive a vehicle.
For information on possible side effects affecting motor skills and concentration, see section 4, “Possible side effects”.

Oxicodone Accord contains sucrose.
This medicine contains sucrose. If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Oxicodone Accord

These tablets have been prescribed by your doctor to relieve moderate to severe pain for a period of 12 hours.
Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
For doses that cannot be achieved/practically administered with this medicine, alternative concentrations and other medicines are available.

The recommended dose is
Oxicodone Accord 5 mg/10 mg/20 mg/40 mg/80 mg prolonged-release tablets
Adults and adolescents (over 12 years of age)
The usual starting dose is 10 mg of oxycodone hydrochloride every 12 hours.
Further determination of the daily dose, its division into individual doses, and any dose adjustments during ongoing therapy are made by your treating doctor and depend on your previous dosing.
Patients who have previously taken opioids may start treatment at higher doses, taking into account their prior experience with opioid therapy.

In some patients taking Oxicodone Accord prolonged-release tablets on a fixed schedule, it may be necessary to administer fast-acting analgesics as rescue medication to manage acute episodes of breakthrough pain.
Oxicodone Accord prolonged-release tablets are not indicated for the treatment of acute episodes of breakthrough pain.

For the treatment of non-malignant pain, a daily dose of 40 mg of oxycodone hydrochloride is generally sufficient, although higher doses may be required. Patients with cancer-related pain typically require doses of 80 to 120 mg of oxycodone hydrochloride, which may be increased up to 400 mg in individual cases.

Treatment should be regularly reviewed with regard to pain relief and other effects, in order to achieve optimal pain therapy and to allow timely management of adverse effects and decisions on whether treatment should continue.

Patients over 65 years of age
In elderly at-risk patients who have not previously taken opioids, the usual starting dose is one 5 mg tablet every 12 hours. Your doctor will prescribe the dose appropriate for controlling your pain. However, inform your doctor if the prescribed dose does not adequately control your pain.

At-risk patients
If you have impaired renal and/or hepatic function or low body weight, your doctor may prescribe a lower starting dose.

Method and duration of administration
Oxicodone Accord 5 mg prolonged-release tablets
Swallow the prolonged-release tablets whole with sufficient liquid (half a glass of water), with or without food, in the morning and evening, following a fixed schedule (e.g., at 8 a.m. and 8 p.m.).

Oxicodone Accord 10 mg, 20 mg, 40 mg, 80 mg prolonged-release tablets
Swallow the prolonged-release tablets either whole or cut, with sufficient liquid (half a glass of water), with or without food, in the morning and evening, following a fixed schedule (e.g., at 8 a.m. and 8 p.m.).

Prolonged-release tablets must not be crushed or chewed, as this causes rapid release of oxycodone due to damage to the prolonged-release properties. Administration of chewed or crushed Oxicodone Accord tablets results in rapid release and absorption of a potentially fatal dose of oxycodone (see section “If you take more Oxicodone Accord than you should”).

Oxicodone Accord is for oral use only. If injected for abuse purposes (injected intravenously), excipients in the tablet may cause local tissue destruction (necrosis), lung tissue damage (pulmonary granulomas), or other serious, potentially fatal events.

Your doctor will adjust the dose according to the intensity of your pain and your response to treatment. Take the number of prolonged-release tablets prescribed by your doctor twice daily.

Instructions for opening the blister pack:
This medicine is packaged in a child-resistant blister. It is not possible to push the prolonged-release tablets out of the blister pack. Follow the instructions below to open the blister pack:

1. Tear off a single dose along the perforation line of the blister pack.
2. This exposes an unsealed area located at the point where the perforation lines intersect.
3. Pull the unsealed “tab” to remove the top seal.

If you take more Oxicodone Accord than you should
If you have taken more Oxicodone Accord than prescribed, you must inform your doctor or the local Poison Control Centre immediately. The following symptoms may occur: pinpoint pupils (miosis), depressed breathing (respiratory depression), flaccidity of skeletal muscles, and reduced blood pressure. In severe cases, circulatory collapse, mental and motor inactivity (stupor), loss of consciousness (coma), slowed heart rate, and accumulation of fluid in the lungs (non-cardiogenic pulmonary edema) may occur. Abuse of high doses of strong opioids such as oxycodone can be fatal. Under no circumstances should you engage in situations requiring high concentration, such as driving a vehicle.

If you forget to take Oxicodone Accord
If you take a smaller dose of Oxicodone Accord than prescribed or forget to take your tablets, pain relief will be correspondingly inadequate or may cease completely.

You may take the missed tablet if the next regular dose is not due within at least 8 hours. You may then continue taking the tablets as directed.

If the next regular dose is due in less than 8 hours, you may still take the missed tablet but delay the next dose by 8 hours. As a general rule, you must not take Oxicodone Accord more than once every 8 hours.

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

If you stop taking Oxicodone Accord
Do not stop treatment without informing your doctor.
When a patient no longer requires treatment with Oxicodone Accord, it may be advisable to gradually reduce the dose to prevent withdrawal symptoms.

If you have any doubts about using Oxicodone Accord, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Oxicodone Accord can cause side effects, although not everyone experiences them.
All medicines can cause allergic reactions, even though serious allergic reactions are reported only rarely. Contact your doctor immediately if you experience wheezing, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching, especially if it spreads over the whole body.
The most serious side effect occurs if you breathe more slowly or more weakly than normal (respiratory depression). Contact your doctor immediately if this happens.
As with other strong painkillers, there is a risk of developing physical or psychological dependence on these tablets.

Other possible side effects

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

• Itching
• Drowsiness (this is more likely when you first start taking the tablets or when your dose is increased, but should disappear after a few days)
• Dizziness
• Headache
• Feeling unwell (these symptoms usually improve within a few days; however, your doctor may prescribe a medicine for nausea if the problem persists)
• Constipation (your doctor may prescribe a laxative to help with this)

Common (may affect up to 1 in 10 people)

• Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhoea
• Confusion, depression, feeling unusually weak, tremors, lack of energy, tiredness, anxiety, nervousness, difficulty sleeping, abnormal dreams, unusual thoughts
• Wheezing or difficulty breathing, shortness of breath, reduced cough reflex
• Skin rash
• Sweating

Uncommon (may affect up to 1 in 100 people)

• Difficulty swallowing, belching, hiccups, flatulence, condition in which the bowel does not work properly (ileus), inflammation of the stomach, altered taste
• Feeling dizzy or vertigo, hallucinations, mood swings, unpleasant feeling of malaise, feeling of extreme happiness, restlessness, agitation, general feeling of malaise, memory loss, difficulty speaking, reduced sensitivity to pain or touch, tingling or numbness, epileptic fit, seizure or convulsions, blurred vision, fainting, unusual muscle stiffness or relaxation, involuntary muscle contractions
• Difficulty passing urine, impotence, decreased sexual activity, low levels of sex hormones in the blood (“hypogonadism”, detectable with blood tests)
• Fast or irregular heartbeat, skin flushing
• Dehydration, thirst, chills, swelling of the hands, ankles or feet
• Dry skin, severe skin lesions or cracking, urticaria (irritating skin rash)
• Flushing of the face, reduced pupil size in the eyes, muscle spasms, increased body temperature
• Desire to take increasingly higher doses to achieve the same pain-relieving effect (tolerance)
• Pain or discomfort from abdominal colic
• Worsening of liver function tests (detectable with blood tests)

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

• Low blood pressure
• Feeling faint, especially when standing
• Urticaria (irritating skin rash)

Frequency not known (frequency cannot be estimated from the available data)

• Increased sensitivity to pain
• Aggression
• Absence of menstrual periods
• Blockage of bile flow from the liver (cholestasis). This can cause itching, yellowing of the skin, very dark urine and very pale stools. Long-term use of Oxicodone Accord during pregnancy may cause potentially life-threatening neonatal withdrawal syndrome. Symptoms in the newborn include irritability, hyperactivity and disturbed sleep patterns, high-pitched crying, tremors, malaise, diarrhoea and failure to gain weight. You may see remnants of the tablets in your stools. This should not affect the effectiveness of the tablet.

Countermeasures
If you experience any of the side effects listed above, your doctor will usually take appropriate measures. The side effect of constipation can be prevented by eating a high-fibre diet and increasing fluid intake. If you have nausea and vomiting, your doctor will prescribe an appropriate medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Oxicodone Accord

Keep Oxicodone Accord out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister/ bottle and
carton after "Exp.". The expiry date refers to the last day of that month.
Do not use this medicine if you notice any deterioration of the tablets (cracked or
crushed).
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Package contents and other information

What Oxicodone Accord contains
The active substance is oxycodone hydrochloride.
Each prolonged-release tablet contains 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of oxycodone hydrochloride, equivalent to 4.5 mg, 9.0 mg, 17.9 mg, 36 mg or 72 mg of oxycodone.
The other components are:
Tablet core: Sugar spheres (containing sucrose, maize starch, starch hydrolysates and colouring additives), hypromellose, talc, ethylcellulose, hydroxypropylcellulose, propylene glycol, sodium carmellose, microcrystalline cellulose, magnesium stearate [plant-based], colloidal anhydrous silica.
Tablet coating: Titanium dioxide (E 171), macrogol 3350, talc (5 mg and 20 mg). Titanium dioxide (E 171), macrogol 3350, talc, red iron oxide (E172) (10 mg and 40 mg). Macrogol 3350, talc, red iron oxide (E172) (80 mg).

Description of the appearance of Oxicodone Accord and contents of the pack
Oxicodone Accord 5 mg are prolonged-release tablets, biconvex, round, white to off-white in colour.
Oxicodone Accord 10 mg are prolonged-release tablets, biconvex, oblong, pink in colour, with break lines on both sides. The tablet can be divided into two equal halves.
Oxicodone Accord 20 mg are prolonged-release tablets, biconvex, oblong, white to off-white in colour, with break lines on both sides. The tablet can be divided into two equal halves.
Oxicodone Accord 40 mg are prolonged-release tablets, biconvex, oblong, pale pink in colour, with break lines on both sides. The tablet can be divided into two equal halves.
Oxicodone Accord 80 mg are prolonged-release tablets, biconvex, oblong, red in colour, with break lines on both sides. The tablet can be divided into two equal halves.

Pack sizes:
10, 14, 20, 28, 30, 50, 56, 60, 98, 100, 120 prolonged-release tablets in PVC/PE/PVDC-aluminium blisters.
10, 20, 30, 50, 100 prolonged-release tablets in high-density polyethylene (HDPE) bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta
08039-Barcelona,
Spain

Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF
United Kingdom
Develco Pharma GmbH
Grienmatt 27,
79650 Schopfheim,
Germany
Accord Healthcare Polska Sp. z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland

This medicinal product is authorised in the European Economic Area Member States under the following names:

| Member State | Name of the medicinal product | |--------------|-------------------------------| | Ireland | Zomestine 5 mg 10 mg 20 mg 40 mg 80 mg prolonged-release tablets | | Italy | Oxicodone Accord | | Netherlands | Oxycodon-HCl Accord 5 mg 10 mg 20 mg 40 mg 80 mg tabletten met verlengde afgifte | | United Kingdom | Zomestine 5 mg 10 mg 20 mg 40 mg 80 mg prolonged-release tablets | | Poland | Accordeon 5 mg 10 mg 20 mg 40 mg 80 mg tabletki o przedłużonym uwalnianiu | | Finland | Oxycodon-HCl Accord 5 mg 10 mg 20 mg 40 mg 80 mg depottabletit |