OXICODONE 5 мг Таблетки с пролонгированным высвобождением

Содержание инструкции

1. What is Oxicodone Accord and what is it used for
2. What you need to know before you take Oxicodone Accord
3. How to take Oxicodone Accord
4. Possible side effects
5. How to store Oxicodone Accord
6. Package Contents and Other Information

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

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Oxicodone Accord and what is it used for

This medicine contains the active ingredient oxicodone, which belongs to a group of
medicines called potent analgesics or “painkillers”.
Oxicodone Accord is used for the treatment of severe pain, which can only be
adequately managed with opioid analgesics. Oxicodone Accord is
indicated in adults and adolescents over the age of 12 years.

2. What you need to know before you take Oxicodone Accord

Do not take Oxicodone Accord tablets if:

• you are allergic to oxicodone 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 expected;
• you suffer from a condition in which the small intestine does not function properly (paralytic ileus), the stomach empties more slowly than it should (delayed gastric emptying), or you have severe sudden abdominal pain;
• you have a heart problem after long-term lung disease (cor pulmonale)
• you have moderate to severe liver problems. If you have other long-term liver problems, you should only take these tablets if recommended by your doctor;
• you have persistent constipation;
• you are under the age of 12 years.

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 suffer from myxedema (a thyroid disease, characterized by dryness, coldness and swelling of the skin, affecting the face and legs)
• if you have reduced adrenal gland function (the adrenal gland does not function properly, and may cause symptoms such as weakness, weight loss, dizziness, feeling unwell), for example, Addison's disease;
• if you have low blood pressure (hypotension);
• if you have low blood volume (hypovolemia); this can occur with external or internal bleeding, severe burns, excessive sweating, severe diarrhea or vomiting;
• if you have a mental disorder following an infection (toxic psychosis);
• if you have problems with the gallbladder or bile duct;
• if you have inflammatory bowel disease;
• if you have an enlarged prostate, causing difficulty passing urine (in men);
• if you have or have suffered from alcohol or drug addiction or have a known opioid dependence;
• if you suffer from inflammation of the pancreas (causing severe pain in the abdomen and back);
• if you have a severe headache or feel nauseous, as this may indicate that the pressure in your skull has increased;
• 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 suffered from withdrawal symptoms such as agitation, anxiety, tremors or sweating that have occurred after stopping alcohol or drug use;
• you have an increased sensitivity to pain;
• you need to take a higher dose of Oxicodone Accord to get the same level of pain relief (tolerance).

If you are going to have surgery, tell the 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 oxicodone (see section 3).
Children and adolescents
Oxicodone Accord has not been studied in children under the age of 12 years. Safety and
efficacy have not been established, so use in children under the age of
12 years 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 to ‘doping tests’.
The use of Oxicodone Accord as a doping substance may become a risk to
health.

Taking Oxicodone Accord with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including those available without 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 or if you have taken these medicines in the last two weeks;
• medicines for sleeping or to stay calm (for example, tranquilizers, hypnotics or sedatives);
• medicines for depression (for example, paroxetine);
• medicines for psychiatric or mental disorders (such as phenothiazines or neuroleptic drugs);
• other potent analgesics (painkillers);
• muscle relaxants;
• medicines for high blood pressure;
• quinidine (a medicine for treating a fast heartbeat);
• cimetidine (a medicine 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 (for the treatment of tuberculosis);
• carbamazepine (a medicine for the treatment of seizures and convulsions, and some types of pain);
• phenytoin (a medicine for the treatment of seizures and convulsions);
• an herbal remedy called “St John's Wort” (also known as Hypericum perforatum);
• antihistamines;
• medicines for the treatment of Parkinson's disease.

Also, tell your doctor if you have recently received an anesthetic.
The concurrent use of Oxicodone Accord and sedatives such as benzodiazepines or
related medicines increases the risk of drowsiness, breathing difficulties
(respiratory depression), coma and can be life-threatening. For this reason,
concurrent use should only be considered when other treatment options
are not possible.
However, if your doctor prescribes Oxicodone Accord together with sedatives, the dose
and duration of concomitant treatment must be limited by your doctor.
Tell your doctor about all the sedatives you are taking and carefully follow
your doctor's recommendations on dosage. It may be helpful
to inform friends or family to watch out for the signs and symptoms listed above.
Contact your doctor if you experience these symptoms.
The risk of side effects increases with the use of antidepressants (such as
citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline,
venlafaxine). These medicines can interact with oxicodone and you may
experience symptoms such as involuntary and rhythmic muscle contractions, including
muscles that control 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
stopping breathing 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 can take Oxicodone Accord with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are
breastfeeding, ask your doctor or pharmacist for advice before
taking this medicine.
Pregnancy
You should not take Oxicodone Accord during pregnancy. There are limited data
on the use of Oxicodone Accord in pregnant women. Severe breathing difficulties have occurred
in newborns born to mothers who have taken oxicodone during the last 3-4 weeks before
delivery. Withdrawal syndrome may be observed in
newborns of mothers treated with oxicodone.
Breastfeeding
Oxicodone can pass into breast milk and may cause breathing difficulties in
newborns. Oxicodone Accord should not be taken during breastfeeding.

Driving and using machines
Oxicodone alters alertness and reaction ability to such an extent that the ability to
drive and operate machinery is impaired or completely absent. With stable therapy, it is
probably not necessary to prohibit driving altogether. The treating doctor must assess the
individual situation. Discuss with your doctor whether or under what conditions you can drive a
vehicle.
See section 4. “Possible side effects” for possible side effects that affect motor skills and
concentration.

Oxicodone Accord contains sucrose.
This medicine contains sucrose. If you have been told by your doctor that you
have an intolerance to some 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 following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
For doses that cannot be achieved/practiced with this medicine, other concentrations and other medicines are available.

The recommended dose is

Oxicodone Accord5 mg/10 mg/20 mg/40 mg/80 mg prolonged-release tablets
Adults and adolescents (over 12 years of age)
The usual initial dose is 10 mg of oxicodone hydrochloride at intervals of 12 hours.
Further determination of the daily dose, division into single doses and any dose adjustment during further therapy are made by the treating physician and depend on the previous dosage.
Patients who have already taken opioids may start treatment at higher doses, taking into account their experience with opioid treatment.
In some patients taking Oxicodone Accord prolonged-release tablets according to a fixed schedule, administration of fast-acting analgesics is necessary as a rescue medicine to control acute exacerbations of pain.
Oxicodone Accord prolonged-release tablets are not indicated for the treatment of acute pain exacerbations.
For the treatment of non-oncological pain, a daily dose of 40 mg of oxicodone hydrochloride is generally sufficient, but higher doses may be necessary. Patients with oncological pain generally require doses of 80 to 120 mg of oxicodone hydrochloride, which may be increased to 400 mg in individual cases.
Treatment should be monitored regularly in relation to pain relief and other effects, to achieve the best possible pain therapy and to be able to treat adverse effects in time and decide whether treatment should be continued.
Patients over 65 years of age
In geriatric patients at risk who have never taken opioids, the usual initial dose is one 5 mg tablet at intervals of 12 hours. Your doctor will prescribe the dosage suitable for treating your pain. However, inform your doctor if the dosage you are taking does not control your pain.
Patients at risk
If you have impaired renal and/or hepatic function or if you have a low body weight, your doctor may prescribe a lower initial dose.
Method and duration of administration

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

Oxicodone Accord 10 mg, 20 mg, 40 mg, 80 mg prolonged-release tablets
Swallow the prolonged-release tablets whole or cut with a sufficient amount of liquid (half a glass of water) with or without food in the morning and evening, following a fixed schedule (e.g. at 8 am and 8 pm).
The prolonged-release tablets must not be crushed or chewed, as this causes rapid release of oxicodone due to damage to the prolonged-release properties. Administration of chewed or crushed Oxicodone Accord tablets causes rapid release and absorption of a potentially fatal dose of oxicodone (see section “If you take more Oxicodone Accord than you should”).
Oxicodone Accord is for oral use only. In case of injection for abuse (injection into a vein), the excipients of the tablet can cause destruction (necrosis) of local tissue, alteration of lung tissue (lung granulomas) or other serious, potentially fatal events.
The doctor will adjust the dosage according to the intensity of the pain and your response to treatment. Take the number of prolonged-release tablets prescribed by your doctor, twice a day.

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

• 1. Detach 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 cover seal.

If you take more Oxicodone Accordthan you should
If you have taken more Oxicodone Accord than prescribed, you must immediately inform your doctor or the local Poison Control Center. The following symptoms may occur: pinpoint pupils (miosis), depressed breathing (respiratory depression), flaccidity of skeletal muscles and decreased blood pressure. In severe cases, circulatory collapse, mental and motor inactivity (stupor), loss of consciousness (coma), slowing of heart rate and fluid accumulation in the lungs (non-cardiogenic pulmonary edema) may occur; abuse of high doses of strong opioids such as oxicodone can be fatal. In no case should you expose yourself to situations that require high concentration, e.g. driving a car.

If you forget to take Oxicodone Accord
If you use a smaller dose of Oxicodone Accord than indicated or if you forget to take the tablets, the pain relief will consequently be insufficient or will cease altogether.
You can compensate for forgetting the tablet if the subsequent regular administration is not scheduled for at least another 8 hours. You can then continue to take the tablets according to the instructions.
You should take the prolonged-release tablets even if the subsequent regular administration is shorter, but postpone the next administration by 8 hours. As a rule, you should not take Oxicodone Accord more than once every 8 hours.
Do not take a double dose to compensate for forgetting the tablet.

If you stop taking Oxicodone Accord
Do not stop treatment without informing your doctor.
When a patient no longer requires therapy with Oxicodone Accord, it may be advisable to reduce the dose gradually to prevent withdrawal symptoms.
If you have any doubts about the use of Oxicodone Accord, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, Oxicodone Accord can cause side effects, although not everyone gets them.
All medicines can cause allergic reactions, although serious allergic reactions are rare. Tell your doctor immediatelyif you experience
difficulty breathing, shortness of breath, swelling of the eyelids, face or lips,
skin rash or itching, especially if widespread over the body.
The most serious side effect occurs if you breathe more slowly or
shallowly than usual (respiratory depression). Tell your doctor immediately
if this happens.
As with other potent 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 start taking the tablets or when you increase the dose, but should subside after a few days).
• Dizziness
• Headache
• Feeling unwell (these usually tend to subside within a few days, however your doctor may prescribe you a medicine for feeling unwell if the problem persists).
• Constipation (your doctor may prescribe a laxative to overcome this problem).

Common(may affect up to 1 in 10 people)

• Dry mouth, loss of appetite, indigestion, pain or discomfort at the level of the abdomen, diarrhea.
• Confusion, depression, feeling of unusual weakness, tremors, lack of energy, fatigue, anxiety, nervousness, difficulty sleeping, abnormal dreams, abnormal thoughts.
• Wheezing or difficulty breathing, shortness of breath, decreased cough reflex.
• Skin rash.
• Sweating

Uncommon(may affect up to 1 in 100 people)

• Difficulty swallowing, belching, hiccups, flatulence, a condition in which the intestine does not function as it should (ileus), inflammation of the stomach, changes in taste.
• Feeling of dizziness or spinning, hallucinations, mood swings, unpleasant and unwell feeling, feeling of extreme happiness, restlessness, agitation, general feeling of being unwell, memory loss, difficulty speaking, reduced sensitivity to pain or touch, tingling or numbness, epileptic seizure, 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, flushing of the skin.
• Dehydration, thirst, chills, swelling of the hands, ankles or feet.
• Dry skin, severe skin lesions or cracks, hives (itchy skin rash).
• Facial flushing, reduction in the size of the pupils in the eyes, muscle spasms, increased temperature.
• A desire to take increasingly higher doses to obtain 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.
• A feeling of fainting, especially when standing up.
• Hives (itchy skin rash).

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

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

Countermeasures
If you experience any of the effects listed above, your doctor will generally take the
appropriate measures. The side effect of constipation can be prevented with
a fiber-rich diet and increased fluid intake. If you experience nausea
and vomiting, your doctor will prescribe you an appropriate medicine.

Reporting of side effects
If you get any side effects, even those not listed in this
leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the blister/bottle and
on the carton after “Exp.”. The expiry date refers to the last day of that month.
Do not use this medicine if you notice deterioration of the tablets (broken or
crumbled).
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in the wastewater or household waste. Ask your
pharmacist how to eliminate medicines that you no longer use. This will help to protect
the environment.

6. Package Contents and Other Information

What Oxicodone Accord contains
The active ingredient is oxicodone hydrochloride.
Each prolonged-release tablet contains 5 mg, 10 mg, 20 mg, 40 mg or 80
mg of oxicodone hydrochloride equivalent to 4.5 mg, 9.0 mg, 17.9 mg, 36 mg or 72 mg of
oxicodone.
The other ingredients are:

Tablet core:Sugar spheres (contains sucrose, corn starch, hydrolysed
starch and colouring additives), hypromellose, talc, ethylcellulose, hydroxypropylcellulose,
propylene glycol, sodium carboxymethylcellulose, microcrystalline cellulose, magnesium stearate [based
on the plant], 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 package contents
Oxicodone Accord 5 mg are prolonged-release tablets, biconvex, round, of
colour from white to off-white.
Oxicodone Accord 10 mg are prolonged-release tablets, biconvex, oblong,
pink in colour, with fracture lines on both sides. The tablet can be divided into
equal halves.
Oxicodone Accord 20 mg are prolonged-release tablets, biconvex, oblong,
from white to off-white in colour with fracture lines on both sides. The tablet
can be divided into equal halves.
Oxicodone Accord 40 mg are prolonged-release tablets, biconvex, oblong,
pale pink in colour, with fracture lines on both sides. The tablet can be
divided into equal halves.
Oxicodone Accord 80 mg are prolonged-release tablets, biconvex, oblong,
red in colour with fracture lines on both sides. The tablet can be divided into
equal halves.
Package sizes:
10, 14, 20, 28, 30, 50, 56, 60, 98, 100, 120 prolonged-release tablets in blisters of
PVC/PE/PVDC-aluminium.
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 Member States of the European Economic Area
with 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 20mg 40 mg 80 mg tabletki o
przedłużonym uwalnianiu
Finland Oxycodon-HCl Accord 5 mg 10 mg 20 mg 40 mg 80 mg
depottabletit