OXYCONTIN 10 mg Extended-Release Tablets

Зміст інструкції

1. OxyContin 5 mg, 10 mg, 20 mg, 40 mg, 80 mg, prolonged-release tablets
   1. What is OxyContin and what is it used for?
   2. What you need to know before you take OxyContin
   3. How to take OxyContin
   4. Possible side effects
   5. How to store OxyContin
   6. Package Contents and Other Information

OxyContin 5 mg, 10 mg, 20 mg, 40 mg, 80 mg, prolonged-release tablets

Oxycodone hydrochloride

Read this leaflet carefully before 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is OxyContin and what is it used for?

These tablets have been prescribed by your doctor to treat severe pain, their effect lasts 12 hours .The tablets contain the active ingredient oxycodone which is a
potent analgesic (pain reliever) belonging to a group of medicines called
opioids.

2. What you need to know before you take OxyContin

Do not takeOxyContinif you:

• are allergic (hypersensitive) to oxycodone or to any of the other ingredients of this medicine (listed in section 6) or if you have experienced an allergic reaction to another strong painkiller or analgesic (such as morphine or other opioids) in the past;
• have breathing problems, such as severe chronic obstruction of the lungs, severe bronchial asthma or severe respiratory depression. Symptoms may include shortness of breath, coughing or slower and weaker breathing than expected;
• have a head injury that causes severe headache or discomfort. This is because these tablets can worsen these symptoms or mask the severity of the head injury;
• suffer from a condition in which the intestine does not function properly (paralytic ileus), if your stomach empties more slowly than it should (delayed gastric emptying), or if you have severe abdominal pain suddenly (acute abdomen);
• have heart problems caused by long-term lung disease (cor pulmonale).

Warnings and precautions:
Tell your doctor or pharmacist before using these tablets if:

• you are elderly or debilitated;
• you have reduced thyroid function (hypothyroidism);
• you suffer from myxedema (a thyroid disorder, characterized by dryness, coldness and swelling of the skin, affecting the face and legs);
• you suffer from severe headache or discomfort, which may indicate increased intracranial pressure;
• you have low blood pressure (hypotension);
• you suffer from mental disorders resulting from intoxication (toxic psychosis);
• you suffer from inflammation of the pancreas (which can cause severe pain in the abdomen or back) or disorders of the gallbladder or bile duct;
• you suffer from intestinal blockage or inflammatory bowel disorders;
• you suffer from pain or colic-type abdominal disorders;
• you suffer from an enlarged prostate gland that can cause difficulty passing urine (in men);
• you have reduced adrenal gland function (your adrenal gland does not work as it should), such as in Addison's disease;
• you have breathing problems such as severe impairment of lung function, chronic obstructive airway disorders, severe lung problems or reduced breathing capacity. Symptoms may include shortness of breath and cough;
• you have kidney or liver problems;
• you suffer from withdrawal symptoms such as agitation, anxiety, palpitations, tremors or sweating that have occurred after stopping alcohol or drug use;
• you suffer from epileptic seizures, convulsions or fits;
• you suffer from confusion or fainting;
• you need to take a higher dose of OxyContin to achieve the same level of pain relief (tolerance);
• you have an increased sensitivity to pain;
• you are taking medicines known as monoamine oxidase inhibitors (such as tranylcypromine, phenelzine, isocarboxazide, moclobemide and linezolid) or have taken this type of medicine in the last two weeks;
• you suffer from constipation.

This medicine can cause breathing problems during sleep. These problems
can include pauses in breathing during sleep, waking up from shortness of
breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or
someone else observes these symptoms, contact your doctor. The doctor may
want to reduce the dose.
If you are going to have surgery, tell the hospital doctor that you
are taking these tablets.
You may experience hormonal changes while taking these tablets. Your doctor
may want to monitor these effects.
The tablets should never be crushed or injected, as this can lead to
serious side effects that can be life-threatening.
Opioids are not the first choice of treatment for non-cancer pain and are not recommended as a single treatment. Other medicines should
be used together with opioids in the treatment of chronic pain. The doctor should
monitor you carefully and make the necessary adjustments to the dose while you
are taking OxyContinto prevent dependence and abuse.

Other medicines andOxyContin
The concomitant use of opioids, including oxycodone 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, concomitant use should only be considered when
other treatment options are not possible.
However, if your doctor prescribes Oxycontin together with sedatives, the dose and
duration of concomitant treatment must be limited by the doctor.
Please tell your doctor all the sedatives you are taking and follow your doctor's recommendations regarding the dose carefully. It may be
helpful to inform friends or family members to be aware of the signs and symptoms above
indicated. Tell your doctor when these symptoms occur.
Tell your doctor or pharmacist if you are taking, have recently taken or
may take any other medicines. If you take these tablets
at the same time as other medicines, the effect of these tablets or other
medicines may be altered.
The risk of side effects increases if you use antidepressants (such as
citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline,
venlafaxine). These medicines can interact with oxycodone and symptoms such as involuntary and rhythmic muscle contractions, including
muscles that control eye movement, agitation, excessive sweating, tremor, increased muscle tension, body temperature
above 38° C. Tell your doctor when these symptoms occur.
Tell your doctor or pharmacist if you are taking:

• certain types of antidepressant medicines called monoamine oxidase inhibitors or if you have taken these medicines in the last two weeks (see section 2 “What you need to know before you take OxyContin”).
• sleeping pills or to stay calm (for example hypnotics or sedatives including benzodiazepines);
• medicines for depression (for example paroxetine);
• medicines for psychiatric or mental disorders (such as phenothiazines or neuroleptic drugs);
• medicines to treat epilepsy, pain and anxiety such as gabapentin and pregabalin;
• other potent painkillers (analgesics);
• muscle relaxants;
• medicines for high blood pressure;
• quinidine (an antiarrhythmic medicine);
• cimetidine (an anti-ulcer medicine, for indigestion or heartburn);
• medicines for the treatment of fungal infections (such as ketoconazole, voriconazole, itraconazole or posaconazole);
• medicines for the treatment of bacterial infections (such as clarithromycin, erythromycin or telithromycin);
• a specific type of medicine 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 had an anesthetic.

OxyContinwith food, drinks and alcohol
These tablets can be taken with or without food.
Drinking alcohol while taking OxyContinextended-release tablets can
cause drowsiness or increase the risk of serious side effects such as
shortness of breath with the risk of respiratory depression and loss of consciousness. It is
recommended not to drink alcohol while taking OxyContintablets.
During treatment with OxyContinyou should avoid drinking grapefruit juice.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you
are breastfeeding, ask your doctor or pharmacist for advice before
taking this medicine.

Pregnancy
You should not take these tablets during pregnancy and labor, unless
you have been expressly advised to do so by your doctor. Depending on the dose and
duration of therapy with oxycodone, newborns may experience slow and
shallow breathing (respiratory depression) or withdrawal syndrome.

Breastfeeding
These tablets should not be taken during breastfeeding because the
active ingredient can pass into breast milk.

Driving and operating machinery
These tablets can cause a number of side effects, such as
drowsiness, which can affect your ability to drive and use machinery
(see section 4 for the complete list of side effects). These are usually particularly relevant when you start treatment with the
tablets for the first time or when the dose is increased. If you feel drowsy, you should avoid
driving and using machinery.

Oxycontin contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him
before taking this medicine.

3. How to take OxyContin

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, ask your doctor or pharmacist.
for how long.
Do not exceed the dose recommended by your doctor.
Take the tablets whole with a glass of water.

The tablets must not be chewed, crushed, or dissolved.
You must take the tablets every 12 hours. For example, if you take a tablet at
8 am, you must take the next one at 8 pm.
It is recommended to take this medicine consistently in relation to meal times.
The tablets must not be crushed or injected as this can cause
serious side effects, potentially fatal.
You must take the tablets only by mouth.

OxyContintablets are effective for a period of 12 hours when taken
whole. If a tablet is broken, crushed, dissolved, or chewed, the entire
dose covering the 12 hours can be absorbed rapidly into your body. This
can be dangerous, leading to serious problems such as an overdose that can
be fatal.
Adults (20 years and over)
The usual starting dose is one 10 mg tablet every 12 hours. However, your
doctor will prescribe the dose needed to treat your pain. If you still experience pain despite treatment with these tablets, discuss it
with your doctor.

Children and adults under 20 years
Children and adults under 20 years must not take these tablets.

Patients with kidney or liver problems
Tell your doctor if you suffer from kidney or liver problems so that they can prescribe
another medicine or a lower dose depending on your condition.

If you take moreOxyContinthan you should or if someone accidentally ingests
the tabletscontact your doctor or hospital immediately.
An overdose can manifest with:

• a reduction in pupil size
• slower or weaker breathing than normal (respiratory depression)
• drowsiness or loss of consciousness
• loss of muscle tone (hypotonia)
• reduced heart rate
• reduced blood pressure
• difficulty breathing due to fluid in the lungs (pulmonary edema).

In severe cases, an overdose can lead to unconsciousness and even death. When you
stayed to show them to the doctor.
If you have taken too many tablets, do not put yourself in situations where attention is required, such as driving a car.

If you forget to takeOxyContin
If you remember within 4 hours of when you were supposed to take the tablet, take
it immediately. Then take the next tablet at the scheduled time. If, however,
more than 4 hours have passed since you were supposed to take the tablet, call
your doctor or pharmacist for advice. Do not take a double dose to
make up for the missed tablet.

If you stop takingOxyContin
You must not suddenly stop taking the tablets unless instructed by your doctor. If you want to stop treatment, discuss it first with your
doctor. The doctor will be able to tell you how to do it, generally by reducing the dose in
a gradual manner, in order to avoid unpleasant effects. Withdrawal symptoms such as
yawning, abnormal dilation of the pupils, tearing disorders, runny nose,
agitation, anxiety, convulsions, difficulty sleeping, palpitations, tremors or
sweating may occur if you suddenly stop taking
these tablets.
If you have any doubts about the use of this medicine ,ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, these tablets can cause side effects, although
not everyone will experience them.
This medicine can cause allergic reactions, although serious allergic reactions
are reported in rare cases. Immediately inform your doctor if you experience wheezing
sudden respiratory difficulties, swelling of the eyelids, face or
lips, skin rash or itching, especially if widespread over the body.
The most serious side effect occurs when breathing becomes slower or
shallower than expected (respiratory depression – a typical manifestation
of opioid overdose).
As with other potent painkillers or analgesics, there is a risk of developing
physical or psychological dependence on these tablets .
Very common side effects
(may affect more than 1 in 10 people treated)

• Constipation (your doctor may prescribe a laxative to counteract this problem).
• Feeling unwell or vomiting (these usually tend to subside within a few days, however your doctor may prescribe an antiemetic medicine if the problem persists).
• Drowsiness (more easily at the beginning of treatment or following increases in the dose, but should resolve spontaneously after a few days).
• Dizziness.
• Headache.
• Itching.

Common side effects
(may affect up to 1 in 10 people treated)

• Dry mouth, loss of appetite, indigestion, pain or discomfort at the abdominal level, diarrhea.
• Confusion, depression, feeling unusually weak, tremors, lack of energy, fatigue, anxiety, nervousness, difficulty sleeping, abnormal dreams, abnormal thoughts.
• Wheezing or difficulty breathing, shortness of breath.
• Difficulty urinating.
• Skin rash.
• Sweating, increased body temperature.

Uncommon side effects
(may affect up to 1 in 1,000 people treated)

• A condition in which you breathe more slowly or more shallowly than normal (respiratory depression).
• Difficulty swallowing, belching, hiccups, flatulence, a condition in which the intestine does not function as it should (ileus), inflammation of the stomach, gastrointestinal disorders (e.g. stomach upset), changes in taste, mouth ulcers, mouth pain.
• A condition that causes abnormal production of antidiuretic hormone (syndrome of inappropriate secretion of antidiuretic hormone).
• Feeling of dizziness or spinning (vertigo), hallucinations, mood swings, euphoria, agitation, general feeling of discomfort, memory loss, difficulty speaking, reduced sensitivity to pain or touch, tingling or numbness, epileptic seizure, convulsion or fits, abnormal gait, depersonalization, unusual hyperactivity, fainting, reduced state of consciousness, unusual muscle stiffness or relaxation, involuntary muscle contractions.
• Impotence, decreased libido, low levels of sex hormones in the blood (hypogonadism, detectable in blood tests).
• Hot flashes.
• Dehydration, changes in body weight, thirst, swelling of the hands, ankles or feet.
• Dry skin.
• Disturbances in tear production, blurred vision, reduced pupil size.
• A desire to take increasingly higher doses to achieve the same pain-relieving effect (tolerance).
• Auditory perception of ringing or sounds.
• Swelling and irritation inside the nose, nosebleeds, changes in voice.
• Chills.
• Chest pain.
• Inability to completely empty the bladder.
• Worsening of liver function tests (to be seen in blood tests).
• Withdrawal symptoms (see section 3 “If you stop taking OxyContin”).

Rare side effects
(may affect up to 1 in 10,000 people treated)

• A feeling of fainting, especially when standing up.
• Low blood pressure.
• Urticaria.

Frequency not known
(the frequency cannot be estimated on the basis of the available data)

• Sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching, especially when it appears all over the body.
• Deterioration of teeth.
• Colic-like abdominal pain or discomfort.
• Blockage of bile flow from the liver. This can cause itching, yellow skin, very dark urine and very pale stools.
• Absence of menstrual cycle.
• Increased sensitivity to pain.
• Aggression.
• Long-term use of OxyContinduring pregnancy can cause potentially fatal neonatal withdrawal syndrome. Symptoms in the newborn include irritability, hyperactivity and altered sleep patterns, acute crying, tremor, malaise, diarrhea and failure to gain weight.
• Problems breathing during sleep (sleep apnea syndrome)

You may see remnants of the tablets in your stools. This should not affect
the effectiveness of the tablet.

Reporting of side effects
If you experience any side effects, including those not listed in
this leaflet, tell your doctor or pharmacist. Side effects can also be reported
directly through the national reporting system
at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side
effects helps to provide more information
on the safety of this medicine.

5. How to store OxyContin

Keep this medicine out of sight and reach of children. Accidental overdose in a child is extremely dangerous and potentially
fatal.
Do not use this medicine after the expiry date stated on the blister and the packaging.
The expiry date refers to the last day of that month.
For example EXP 08 2020 means that the tablets must not be taken after the last day of August 2020.
Do not store at a temperature above 25°C.
Do not take broken or crushed tablets, as this may be dangerous and cause
serious problems such as an overdose.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. Package Contents and Other Information

What the medicine containsOxyContin
The active ingredient is oxycodone hydrochloride. Each tablet contains 5 mg, 10 mg, 20
mg, 40 mg or 80 mg of oxycodone hydrochloride.
The other ingredients are:

• Lactose monohydrate
• Povidone
• Ammoniomethacrylate copolymer dispersion
• Sorbic acid
• Triacetin
• Stearyl alcohol
• Talc
• Magnesium stearate
• Hypromellose (E464)
• Titanium dioxide (E171)
• Macrogol

In addition, the tablet coating contains:
5 mg – brilliant blue (E133)
10 mg – hydroxypropylcellulose
20 mg & 40 mg – polysorbate 80 (E433) and iron oxide (E172)
80 mg – hydroxypropylcellulose, iron oxide (E172) and indigo carmine (E132).

Description of the appearance ofOxyContinand package contents.
The tablets are stamped with OC on one side and the dosage on the other (5, 10, etc).
All tablets are round and biconvex. The 5, 10, 20 and 40 mg
tablets have a diameter of approximately 7 mm and the 80 mg tablets have a diameter of approximately
9 mm.
All tablets are coated in the following colours: 5 mg – sky blue, 10 mg – white,
20 mg – pink, 40 mg – yellow, 80 mg – green.
The tablets are packaged in blisters and then inserted into cartons. Each
package contains 28 tablets.

Marketing Authorisation Holder
Mundipharma Pharmaceuticals srl
Via F. Turati 40, 20121 Milan

Manufacturers responsible for batch release
Mundipharma DC B.V.
Leusderend 16
3832 RC Leusden
Netherlands

This medicinal product is authorised under the nameOxyContinin the member states of the
European Community:
Austria
Ireland
Spain
Italy

Date of last leaflet revision