OSSICODONE 5 mg /2.5 Mg Таблетки С Пролонгированным Высвобождением

Содержание инструкции

1. Oxycodone and Naloxone EG 5 mg/2.5 mg prolonged-release tablets, 10 mg/5 mg prolonged-release tablets, 20 mg/10 mg prolonged-release tablets, 30 mg/15 mg prolonged-release tablets, 40 mg/20 mg prolonged-release tablets
   1. What is Ossicodone e Naloxone EG and what it is used for
   2. What you need to know before taking Ossicodone and Naloxone EG
   3. How to take Ossicodone and Naloxone EG
   4. Possible side effects
   5. How to store Ossicodone e Naloxone EG
   6. Contents of the pack and other information

Oxycodone and Naloxone EG 5 mg/2.5 mg prolonged-release tablets, 10 mg/5 mg prolonged-release tablets, 20 mg/10 mg prolonged-release tablets, 30 mg/15 mg prolonged-release tablets, 40 mg/20 mg prolonged-release tablets

Generic medicine

Read this leaflet carefully before taking this medicine, as 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, as 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 Oxycodone and Naloxone EG is and what it is used for
• 2. What you need to know before you take Oxycodone and Naloxone EG
• 3. How to take Oxycodone and Naloxone EG
• 4. Possible side effects
• 5. How to store Oxycodone and Naloxone EG
• 6. Contents of the pack and other information

1. What is Ossicodone e Naloxone EG and what it is used for

Ossicodone e Naloxone EG is an extended-release tablet, which means that the active ingredients contained within it
are released over a long period of time. Their action lasts for 12 hours.
These tablets are only for use in adults.
Pain relief
You have been prescribed Ossicodone e Naloxone EG for the treatment of severe pain, which can only be adequately treated
with opioid analgesics. Naloxone hydrochloride is added to counteract
constipation.
How do these tablets work for pain treatment
These tablets contain oxycodone hydrochloride and naloxone hydrochloride as active ingredients. Oxycodone
hydrochloride is responsible for the pain-suppressing effect of Ossicodone e Naloxone EG and is a
powerful analgesic (pain reliever) belonging to the opioid group.
The second active ingredient of Ossicodone e Naloxone EG, naloxone hydrochloride, acts against constipation.
Intestinal dysfunction (e.g. constipation) is a typical undesirable effect in treatment with
opioid analgesics.
Restless Legs Syndrome
You have been prescribed Ossicodone e Naloxone EG for the symptomatic treatment of second-line severe to very severe
restless legs syndrome in people who cannot be treated with
dopaminergic medications. People with restless legs syndrome have unpleasant sensations
in the limbs. This can begin as soon as you sit or lie down and is only relieved by an irresistible urge
to move the legs, sometimes the arms and other parts of the body. It makes it very difficult to sit and
sleep. Naloxone hydrochloride is added to counteract constipation.
How do these tablets work in restless legs syndrome
These tablets help to relieve the unpleasant sensations and therefore reduce the need to move the
limbs.
The second active ingredient of Ossicodone e Naloxone EG, naloxone hydrochloride, acts against constipation.
Intestinal dysfunction (e.g. constipation) is a typical undesirable effect in treatment with
opioid analgesics.

2. What you need to know before taking Ossicodone and Naloxone EG

Do not take Ossicodone and Naloxone EG

• if you are allergic to oxycodone hydrochloride, naloxone hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if your breathing is not able to provide enough oxygen to the blood, and to eliminate the carbon dioxide produced in the body (respiratory depression);
• if you suffer from a severe lung disease associated with narrowing of the airways (chronic obstructive pulmonary disease or COPD);
• if you suffer from a condition known as cor pulmonale. In this condition, the right side of the heart becomes enlarged as a result of increased pressure within the blood vessels in the lung etc. (e.g. as a consequence of COPD - see above);
• if you suffer from severe bronchial asthma;
• if you suffer from paralytic ileus (a type of intestinal obstruction) not caused by opioids;
• if you suffer from moderate to severe hepatic dysfunction.

In addition, in the case of restless legs syndrome:

• if you have a history of opioid abuse.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ossicodone and Naloxone EG

• in case of elderly or debilitated patients (weak);
• if you suffer from paralytic ileus (a type of intestinal obstruction) caused by opioids;
• if your kidney function is impaired;
• if you suffer from mild hepatic insufficiency;
• if you have severe pulmonary insufficiency (e.g. reduced respiratory capacity);
• if you suffer from a condition characterized by frequent interruptions of breathing during the night that can cause you to be very sleepy during the day (sleep apnea);
• if you have myxedema (a thyroid disorder, with dry, cold and swollen skin (edema) in the areas of the face and limbs);
• if your thyroid gland does not produce enough hormones (thyroid insufficiency or hypothyroidism);
• if your adrenal glands do not produce enough hormones (adrenal insufficiency, or Addison's disease);
• if you have mental disorders accompanied by a (partial) loss of sense of reality (psychosis) due to alcohol or intoxication with other substances (substance-induced psychosis);
• if you suffer from gallstones;
• if your prostate gland is abnormally enlarged (prostatic hypertrophy);
• if you suffer from alcoholism or delirium tremens;
• if your pancreas is inflamed (pancreatitis);
• if you have low blood pressure (hypotension);
• if you have high blood pressure (hypertension);
• if you have pre-existing cardiovascular diseases;
• if you have had a head injury (due to the risk of increased intracranial pressure);
• if you suffer from epilepsy or are prone to seizures;
• if you are also taking MAO inhibitors (used to treat depression or Parkinson's disease), e.g. medicines containing tranylcypromine, phenelzine, isocarboxazide, moclobemide, linezolid;
• if you experience drowsiness or sudden episodes of falling asleep.

If any of these warnings have concerned you in the past, consult your doctor. Similarly, inform your doctor if any of the above conditions occur during treatment with these tablets.
The most serious effect of an opioid overdose is respiratory depression(slow and shallow breathing). This can also cause a lowering of oxygen levels in the blood, with possible fainting, etc.
Diarrhea
If you experience severe diarrhea at the beginning of treatment, this may be due to the effect of naloxone. It may be a sign that bowel function is returning to normal. Diarrhea may occur in the first 3-5 days of treatment. If diarrhea persists after 3-5 days, or if it causes you concern, contact your doctor.
Switching to Ossicodone and Naloxone EG
When switching to treatment with Ossicodone and Naloxone EG, if you are using another opioid, withdrawal symptoms may initially occur, such as restlessness, sweating attacks and muscle pain. If such symptoms occur, close monitoring by your doctor may be necessary.
Long-term treatment
You may become tolerant to these tablets if you take them for a long period. This means that a higher dose may be needed to achieve the desired effect. In addition, long-term use can lead to physical dependence. Withdrawal symptoms may occur if treatment is stopped too abruptly (agitation, sweating attacks, muscle pain). If you no longer need care, you should gradually reduce the daily dose, under the control of your doctor.
Psychological dependence
The active ingredient oxycodone hydrochloride, on its own, has an abuse profile similar to other strong opioids (strong painkillers). There is a possibility of developing psychological dependence. Medicines containing oxycodone hydrochloride should be avoided in patients with alcohol, drug or medicine abuse - present or past.
Cancer
Tell your doctor if you have cancer associated with peritoneal metastases or with the onset of intestinal obstruction in advanced tumors of the digestive and pelvic organs.
If you are going to have surgery, tell your doctor that you are taking Ossicodone and Naloxone EG.
Hormonal effects
Like other opioids, oxycodone can affect the normal production of hormones in the body such as cortisol or sex hormones, especially if you have taken high doses for a long time. If you experience persistent symptoms such as feeling unwell (including vomiting), loss of appetite, fatigue, weakness, dizziness, changes in your menstrual cycle, impotence, infertility or decreased sexual desire, consult your doctor as your hormone levels may need to be checked.
Incorrect use of Ossicodone and Naloxone EG
These tablets are not indicated for the treatment of withdrawal symptoms.

Ossicodone and Naloxone EG 5 mg/2.5 mg
The tablet must be swallowed whole and must not be divided, broken, chewed or crushed.
Swallowing divided, broken, chewed or crushed tablets may result in the absorption of a potentially lethal dose of oxycodone hydrochloride (see section 3: If you take more Ossicodone and Naloxone EG than you should).

Ossicodone and Naloxone EG 10 mg/5 mg, 20 mg/10 mg, 30 mg/15 mg and 40 mg/20 mg
The tablet can be divided but must not be broken, chewed or crushed.
Swallowing broken, chewed or crushed tablets may result in the absorption of a potentially lethal dose of oxycodone hydrochloride (see section 3: If you take more Ossicodone and Naloxone EG than you should).
Abuse
You should never abuse Ossicodone and Naloxone EG, especially if you suffer from addiction. If you are addicted to substances such as heroin, morphine or methadone, severe withdrawal symptoms are likely to occur if you abuse these tablets, as they contain the naloxone component. Pre-existing withdrawal symptoms may worsen.
Improper use
You should never use these tablets improperly, dissolving them and injecting them (e.g. into a blood vessel). In particular, they contain talc, which can locally cause tissue destruction (necrosis) and changes in lung tissue (pulmonary granuloma). Such abuse can also have other serious consequences and can be fatal.
Doping
The use of Ossicodone and Naloxone EG may produce positive results in doping controls.
The use of Ossicodone and Naloxone EG as a doping agent can be dangerous to your health.

Other medicines and Ossicodone and Naloxone EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The risk of side effects increases with the intake of antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone and symptoms such as involuntary and rhythmic muscle contractions, including muscles, including the muscles that control eye movements, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tension and body temperature above 38°C may occur. Contact your doctor if you experience these symptoms.
The concomitant use of opioids, including oxycodone hydrochloride and sedatives such as benzodiazepines or similar medicines may increase the risk of drowsiness, difficulty breathing (respiratory depression), coma and may be life-threatening. For these reasons, concomitant use should only be considered if there are no alternative treatments.
However, if your doctor prescribes Ossicodone and Naloxone EG together with sedatives, the dose and duration of concomitant therapy must be limited.
Tell your doctor about all the sedatives you are taking and carefully follow their recommendations on dosage. It may be helpful to inform friends or relatives of the possibility of the above signs and symptoms occurring. Contact your doctor when these symptoms occur.
Examples of these sedatives or similar medicines include:

• other potent painkillers (opioids);
• medicines to treat epilepsy, pain and anxiety such as gabapentin and pregabalin;
• sleeping and tranquillizing medicines (sedatives including benzodiazepines, hypnotics, anxiolytics);
• medicines to treat depression;
• medicines used to treat allergies, motion sickness or nausea (antihistamines or antiemetics);
• medicines to treat psychiatric or mental disorders (antipsychotics including phenothiazines and neuroleptics).

If you take these tablets at the same time as other medicines, the effect of these tablets or the other medicine described below may be altered. Tell your doctor if you are taking:

• medicines that decrease the ability of blood to clot (coumarin derivatives), the coagulation time may be accelerated or slowed down;
• macrolide antibiotics (such as clarithromycin, erythromycin or telithromycin);
• azole antifungal drugs (such as ketoconazole, voriconazole, itraconazole or posaconazole);
• a specific type of medicine known as protease inhibitors used to treat HIV (examples include ritonavir, indinavir, nelfinavir or saquinavir);
• cimetidine (a medicine for the treatment of stomach ulcers, indigestion or heartburn);
• rifampicin (for the treatment of tuberculosis);
• carbamazepine (for the treatment of seizures, attacks or convulsions and some types of pain);
• phenytoin (for the treatment of seizures, attacks or convulsions);
• an herbal remedy called St. John's wort (also known as Hypericum perforatum);
• quinidine (a medicine for the treatment of irregular heartbeat).

No interactions are expected between Ossicodone and Naloxone EG and paracetamol, acetylsalicylic acid or naltrexone.

Ossicodone and Naloxone EG with food, drinks and alcohol
Drinking alcohol while taking Ossicodone and Naloxone EG may cause drowsiness or increase the risk of serious side effects such as shallow breathing with the risk of respiratory arrest and loss of consciousness. It is recommended not to consume alcohol during treatment with Ossicodone and Naloxone EG.
Avoid drinking grapefruit juice during treatment with these tablets.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The use of these tablets should be avoided as much as possible during pregnancy. If oxycodone hydrochloride is used for prolonged periods during pregnancy, it can lead to withdrawal symptoms in newborns. If oxycodone hydrochloride is administered during childbirth, respiratory depression (slow and shallow breathing) may occur in the newborn.
Breastfeeding
Breastfeeding must be discontinued during treatment with these tablets. Oxycodone hydrochloride passes into breast milk. It is not known whether naloxone hydrochloride also passes into breast milk. A risk to the infant cannot therefore be excluded, especially after taking multiple doses of Ossicodone and Naloxone EG.

Driving and operating machinery
Ossicodone and Naloxone EG can affect your ability to drive and use machines. In particular, this is more likely to happen at the beginning of therapy with Ossicodone and Naloxone EG, after a dose increase or after switching from a different medicine. However, these side effects disappear once the dose of Ossicodone and Naloxone EG is stabilized.
Ossicodone and Naloxone EG has been associated with the occurrence of drowsiness and sudden episodes of falling asleep. If you experience this side effect, do not drive vehicles and do not operate machinery. Consult your doctor if these effects occur.
Ask your doctor if you can drive or use machines.

Ossicodone and Naloxone EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially ‘sodium-free’.

3. How to take Ossicodone and Naloxone EG

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Ossicodone and Naloxone EG is an extended-release tablet, which means that its active ingredients
are released over a prolonged period. Their action lasts 12 hours.

Unless otherwise prescribed by your doctor, the usual dosage is as follows:
For pain relief
Adults
The usual starting dose is 10 mg of oxycodone hydrochloride/5 mg of naloxone hydrochloride in the form of
extended-release tablets every 12 hours.
The doctor will decide how much Ossicodone and Naloxone EG you should take each day and how to divide the total daily dose of medicine between morning and evening. The doctor will also decide on any dose adjustments
that may be necessary during treatment. The dose will be adjusted according to the level of pain and your
individual sensitivity. You should be given the lowest dose necessary for pain relief. If you have already
been treated with opioids, treatment with Ossicodone and Naloxone EG may be started at a higher dose.
The maximum daily dose is 160 mg of oxycodone hydrochloride and 80 mg of naloxone hydrochloride. If you
need a higher dose, your doctor may give you higher doses of oxycodone hydrochloride without naloxone
hydrochloride. The maximum daily dose of oxycodone hydrochloride should not exceed 400 mg. The benefit of
naloxone hydrochloride on bowel function may be reduced with higher doses of oxycodone hydrochloride
administered without further doses of naloxone hydrochloride.
If you switch from these tablets to another opioid medicine for pain relief, your bowel function will likely worsen.
If you feel pain between two doses of Ossicodone and Naloxone EG, you may need a pain reliever that
acts quickly. Ossicodone and Naloxone EG is not suitable for this. In this case, consult your doctor.
If you feel that the effect of these tablets is too strong or too weak, talk to your doctor or
pharmacist.

For treating restless legs syndrome
Adults
The usual starting dose is 5 mg of oxycodone hydrochloride/2.5 mg of naloxone hydrochloride in the form of
extended-release tablets every 12 hours.
The doctor will determine how much Ossicodone and Naloxone EG you should take each day and how to distribute the total daily dose of medicine between morning and evening. The doctor will also decide on any dose adjustments
needed during treatment. Your dose will be adjusted according to your individual sensitivity.
You should take the lowest dose necessary to relieve the symptoms of restless legs syndrome.
If you feel that the effect of Ossicodone and Naloxone EG is too strong or too weak, consult your
doctor or pharmacist.
The maximum daily dose is 60 mg of oxycodone hydrochloride and 30 mg of naloxone hydrochloride.

For treating pain or restless legs syndrome
Elderly patients
In general, no dose adjustment is necessary in elderly patients with normal kidney and/or liver function.
Impaired liver or kidney function
If you have impaired kidney function or mild impaired liver function, your doctor will prescribe these tablets with particular caution. If you have moderate or
severe impaired liver function, these tablets should not be used (see also "Do not take Ossicodone and Naloxone EG" and "Warnings and precautions").

Use in children and adolescents under 18 years of age
Ossicodone and Naloxone EG has not yet been studied in children and adolescents under 18 years
of age. Its safety and efficacy have not been demonstrated in children and adolescents. For this reason,
the use of Ossicodone and Naloxone EG in children and adolescents under 18 years of age is not
recommended.

Method of administration
Oral use.
Take Ossicodone and Naloxone EG every 12 hours, according to a fixed time schedule (for example, at 8 am
and 8 pm).

Ossicodone and Naloxone EG 5 mg/2.5 mg
Take Ossicodone and Naloxone EG with an adequate amount of liquid (1/2 glass of water). The tablet
should be swallowed whole and should not be broken, chewed, or crushed. The tablet can be taken
with or without food.

Ossicodone and Naloxone EG 10 mg/5 mg, 20 mg/10 mg, 30 mg/15 mg and 40 mg/20 mg
Take Ossicodone and Naloxone EG with an adequate amount of liquid (1/2 glass of water). The tablet
can be divided into equal doses. The tablet should not be broken, chewed, or crushed. The tablet
can be taken with or without food.

Duration of treatment
In general, you should not take these tablets for longer than necessary. If you have been treated
for a long time, your doctor should regularly check if you still need these tablets.

If you take more Ossicodone and Naloxone EG than you should
If you have taken more than the prescribed dose of these tablets, you should immediately inform your doctor.
An overdose can cause:

• constriction of the pupils;
• slow and shallow breathing (respiratory depression);
• drowsiness, up to loss of consciousness;
• low muscle tone (hypotonia);
• reduced pulse rate and
• low blood pressure. In severe cases, loss of consciousness (coma), fluid accumulation in the lungs and circulatory collapse may occur, which in some cases can be fatal. You should avoid situations that require a high level of alertness, such as driving.

If you forget to take Ossicodone and Naloxone EG
If you take a dose lower than prescribed, you may not feel any effect.
If you forget to take your dose, follow the instructions below:

• If your next usual dose is 8 hours or more away: take the forgotten tablet immediately, then continue with your normal prescription schedule.
• If your next usual dose is less than 8 hours away: take the forgotten tablet. Then wait at least 8 hours before taking the next dose, trying to return to the original prescription schedule (e.g. 8 am and 8 pm). Do not take more than one tablet within an 8-hour period.

Do not take a double dose to make up for a missed dose.

If you stop taking Ossicodone and Naloxone EG
Do not stop treatment without first consulting your doctor.
If you no longer need further treatment, you should gradually reduce the daily dosage after
talking to your doctor. This will avoid withdrawal symptoms such as agitation, sweating attacks and
muscle pain.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
manifest.

Important side effects to watch out for and what to do if they occur
If you experience any of the following serious side effects, consult your doctor immediately:
Slow and shallow breathing (respiratory depression) is the main danger of an opioid overdose.
It occurs especially in elderly and debilitated (weak) patients. Opioids can also
cause a severe drop in blood pressure in predisposed patients.
Side effects are subdivided below into three sections: pain treatment, treatment with the active
ingredient oxycodone hydrochloride alone and treatment of restless legs syndrome.

The following side effects have been observed in patients treated for pain
Common (may affect up to 1 in 10 people):

• abdominal pain;
• constipation;
• diarrhea;
• dry mouth;
• indigestion;
• vomiting (feeling sick);
• feeling unwell;
• flatulence (gas);
• decreased appetite up to loss of appetite;
• a feeling of dizziness or “lightheadedness”;
• headache;
• hot flushes;
• a feeling of unusual weakness;
• fatigue or exhaustion;
• itching skin;
• skin reactions / rash;
• sweating;
• dizziness;
• difficulty sleeping;
• drowsiness.

Uncommon (may affect up to 1 in 100 people):

• abdominal bloating;
• abnormal thoughts;
• anxiety;
• confusion;
• depression;
• nervousness;
• chest tightness especially if you already suffer from coronary heart disease;
• decreased blood pressure;
• withdrawal symptoms such as agitation;
• fainting;
• lack of energy;
• thirst;
• altered taste;
• palpitations;
• biliary colic;
• chest pain;
• general feeling of discomfort;
• pain;
• swelling of hands, ankles or feet;
• difficulty concentrating;
• speech disorders;
• agitation;
• difficulty breathing;
• restlessness;
• chills;
• increased liver enzymes;
• increased blood pressure;
• decreased sexual drive;
• runny nose;
• cough;
• hypersensitivity / allergic reactions;
• weight loss;
• injury due to accidents;
• increased need to urinate;
• muscle cramps;
• muscle contractions;
• muscle pain;
• vision problems;
• seizures (especially in people with an epileptic disorder or a predisposition to convulsions).

Rare (may affect up to 1 in 1000)

• increased heart rate;
• drug dependence;
• dental changes;
• weight gain;
• yawning;

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

• euphoric mood;
• severe drowsiness;
• erectile dysfunction;
• nightmares;
• hallucinations;
• shortness of breath;
• difficulty urinating;
• aggression;
• tingling skin (pins and needles);
• belching.

The active ingredient oxycodone hydrochloride, if not in combination with naloxone hydrochloride, is known to
have the following different side effects:
Oxycodone can cause breathing problems (respiratory depression), reduction in the diameter of the pupil
of the eye, spasms of the bronchial muscles and spasms of the smooth muscles, depression of the reflex of
coughing.
Common (may affect up to 1 in 10 people):

• altered mood and personality changes (e.g. depression, extreme happiness);
• decreased activity;
• increased activity;
• difficulty urinating;
• hiccups.

Uncommon (may affect up to 1 in 100 people):

• reduced concentration;
• migraines;
• increased muscle tension;
• involuntary muscle contractions;
• a condition in which the intestine stops functioning properly (ileus);
• dry skin;
• tolerance to drugs;
• reduced sensitivity to pain or touch;
• abnormal coordination;
• changes in voice (dysphonia);
• water retention;
• hearing difficulties;
• mouth ulcers;
• difficulty swallowing;
• inflamed gums;
• perception disorders (e.g. hallucinations, derealization);
• skin flushing;
• dehydration;
• agitation;
• a decrease in sex hormone levels that can alter sperm production in men or the menstrual cycle in women.

Rare (may affect up to 1 in 1000)

• itchy skin rash (urticaria);
• infections such as cold sores or herpes (which can cause blisters around the mouth or genitals);
• increased appetite;
• black stools (tarry stools);
• gum bleeding.

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

• acute generalized allergic reactions (anaphylactic reactions);
• an increase in sensitivity to pain;
• absence of menstruation;
• withdrawal symptoms in the newborn;
• problems in the flow of bile;
• tooth decay.

The following side effects have been observed in patients treated for restless legs
syndrome
Very common (may affect more than 1 in 10 people):

• headache;
• drowsiness;
• constipation;
• feeling unwell;
• sweating;
• fatigue or weakness.

Common (may affect up to 1 in 10 people):

• decreased appetite up to loss of appetite;
• difficulty sleeping;
• depression;
• feeling of dizziness or “lightheadedness”;
• difficulty concentrating;
• agitation;
• tingling in the hands or feet;
• visual disturbances;
• dizziness;
• hot flushes;
• decreased blood pressure;
• increased blood pressure;
• abdominal pain;
• dry mouth;
• vomiting (feeling sick);
• increased liver enzymes (increased alanine aminotransferase, increased gamma- glutamyltransferase);
• itching skin;
• skin reactions/rash;
• chest pain;
• chills;
• pain;
• thirst.

Uncommon (may affect up to 1 in 100 people):

• reduced sexual drive;
• sudden attacks of sleep;
• altered sense of taste;
• difficulty breathing;
• gas;
• erectile dysfunction;
• withdrawal symptoms such as agitation;
• swelling of hands, ankles or feet;
• injury due to accidents.

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

• hypersensitivity/allergic reactions;
• abnormal thoughts;
• anxiety;
• confusion;
• nervousness;
• restlessness;
• feeling of extreme happiness;
• hallucinations;
• nightmares;
• seizures (especially in people with epileptic disorders or a predisposition to convulsions);
• drug dependence;
• severe drowsiness;
• speech disorders;
• fainting (syncope);
• painful chest tightness (angina pectoris), especially if you already suffer from coronary heart disease;
• increased heart rate;
• cough;
• runny nose;
• slowed breathing;
• yawning;
• bloated stomach;
• diarrhea;
• aggression;
• indigestion;
• belching;
• dental changes;
• biliary colic;
• muscle cramps;
• muscle contractions;
• muscle pain;
• difficulty urinating;
• urgent need to urinate;
• general feeling of discomfort;
• weight loss;
• weight gain;
• a feeling of unusual weakness;
• lack of energy.

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 https://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 Ossicodone e Naloxone EG

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 packaging and on the blister after the
wording EXP. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ossicodone and Naloxone EG contains
The active ingredients are oxycodone hydrochloride and naloxone hydrochloride.

Ossicodone e Naloxone EG 5 mg/2,5 mg
Each prolonged-release tablet contains 5 mg of oxycodone hydrochloride (equivalent to 4.5 mg of
oxycodone) and 2.5 mg of naloxone hydrochloride (equivalent to 2.74 mg of naloxone hydrochloride dihydrate and 2.25 mg
of naloxone).

Ossicodone e Naloxone EG 10 mg/5 mg
Each prolonged-release tablet contains 10 mg of oxycodone hydrochloride (equivalent to 9 mg of
oxycodone) and 5 mg of naloxone hydrochloride (equivalent to 5.45 mg of naloxone hydrochloride dihydrate and 4.5 mg of
naloxone).

Ossicodone e Naloxone EG 20 mg/10 mg
Each prolonged-release tablet contains 20 mg of oxycodone hydrochloride (equivalent to 18 mg of
oxycodone) and 10 mg of naloxone hydrochloride (equivalent to 10.9 mg of naloxone hydrochloride dihydrate and 9 mg of
naloxone).

Ossicodone e Naloxone EG 30 mg/15 mg
Each prolonged-release tablet contains 30 mg of oxycodone hydrochloride (equivalent to 27 mg of
oxycodone) and 15 mg of naloxone hydrochloride (equivalent to 16.35 mg of naloxone hydrochloride dihydrate and 13.5
mg of naloxone).

Ossicodone e Naloxone EG 40 mg/20 mg
Each prolonged-release tablet contains 40 mg of oxycodone hydrochloride (equivalent to 36 mg of
oxycodone) and 20 mg of naloxone hydrochloride (equivalent to 21.8 mg of naloxone hydrochloride dihydrate and 18 mg of
naloxone).
The other ingredients are:
Tablet core
Polyvinyl acetate, povidone K30, sodium lauryl sulfate, anhydrous colloidal silica, microcrystalline cellulose,
magnesium stearate.
Tablet coating

Ossicodone e Naloxone EG 5 mg/2,5 mg
Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

Ossicodone e Naloxone EG 10 mg/5 mg
Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, red iron oxide (E172).

Ossicodone e Naloxone EG 20 mg/10 mg
Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

Ossicodone e Naloxone EG 30 mg/15 mg
Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

Ossicodone e Naloxone EG 40 mg/20 mg
Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, red iron oxide (E172).

Appearance of Ossicodone and Naloxone EG and contents of the pack

Ossicodone e Naloxone EG 5 mg/2,5 mg
Prolonged-release tablets, round, biconvex, white in colour, with a diameter of 4.7 mm and a
height of 2.9-3.9 mm.

Ossicodone e Naloxone EG 10 mg/5 mg
Prolonged-release tablets, oblong, biconvex, pink in colour, with break notches on both
sides, measuring 10.2 mm in length, 4.7 mm in width and 3.0-4.0 mm in height.
The tablet can be divided into equal doses.

Ossicodone e Naloxone EG 20 mg/10 mg
Prolonged-release tablets, oblong, biconvex, white in colour, with break notches on both
sides, measuring 11.2 mm in length, 5.2 mm in width and 3.3-4.3 mm in height.
The tablet can be divided into equal doses.

Ossicodone e Naloxone EG 30 mg/15 mg
Film-coated tablets, oblong, biconvex, yellow in colour, with break notches on both sides,
measuring 12.2 mm in length, 5.7 mm in width and 3.3-4.3 mm in height.
The tablet can be divided into equal doses.

Ossicodone e Naloxone EG 40 mg/20 mg
Prolonged-release tablets, oblong, biconvex, pink in colour, with break notches on both
sides, measuring 14.2 mm in length, 6.7 mm in width and 3.6-4.6 mm in height.
The tablet can be divided into equal doses.
Ossicodone and Naloxone EG is available in blisters of 28, 56, 60 and 98 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., Via Pavia 6, 20136 Milan

Manufacturer
Develco Pharma GmbH, Grienmatt 27 - 79650 Schopfheim (Germany)
STADA Arzneimittel AG, Stadastrasse 2 – 18, 61118 Bad Vilbel (Germany)

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations: