Oxycodone and naloxone EG

Package leaflet: Information for the patient

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
Please read all of 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 give it to other people, even if they have the same symptoms as yours, because it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 taking 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 Ossicodone and Naloxone EG is and what it is used for

Ossicodone and Naloxone EG is a prolonged-release tablet, which means that the active substances it contains are released over an extended period of time. Their effect lasts for 12 hours.
These tablets are intended for use in adults only.

Pain relief
You have been prescribed Ossicodone and Naloxone EG for the treatment of severe pain that can be adequately managed only with opioid analgesics. Naloxone hydrochloride is added to counteract constipation.

How these tablets work to treat pain
These tablets contain oxycodone hydrochloride and naloxone hydrochloride as active substances. Oxycodone hydrochloride is responsible for the pain-relieving effect of Ossicodone and Naloxone EG and is a potent analgesic (painkiller) belonging to the opioid group.

The second active substance in Ossicodone and Naloxone EG, naloxone hydrochloride, acts against constipation.
Gastrointestinal dysfunction (e.g. constipation) is a typical adverse effect during treatment with opioid analgesics.

Restless legs syndrome
You have been prescribed Ossicodone and Naloxone EG for the second-line symptomatic treatment of moderate to very severe restless legs syndrome in patients who cannot be treated with dopaminergic medicinal products. People with restless legs syndrome experience unpleasant sensations in the limbs. These sensations typically begin as soon as sitting or lying down and are only relieved by an irresistible urge to move the legs, sometimes the arms and other parts of the body. This makes it very difficult to sit still and sleep. Naloxone hydrochloride is added to counteract constipation.

How these tablets work in restless legs syndrome
These tablets help relieve the unpleasant sensations and thereby reduce the need to move the limbs.

The second active substance in Ossicodone and Naloxone EG, naloxone hydrochloride, acts against constipation.
Gastrointestinal dysfunction (e.g. constipation) is a typical adverse effect during treatment with opioid analgesics.

2. What you should know before taking Oxycodone and Naloxone EG

Do not take Oxycodone 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 unable to supply enough oxygen to the blood and remove carbon dioxide produced in the body (respiratory depression);
• if you suffer from severe lung disease associated with narrowing of the airways (chronic obstructive pulmonary disease or COPD);
• if you have a condition known as cor pulmonale. In this condition, the right side of the heart enlarges due to increased pressure in the blood vessels of the lung, etc. (e.g. as a consequence of COPD – mentioned above);
• if you suffer from severe bronchial asthma;
• if you have paralytic ileus (a type of intestinal obstruction) not caused by opioids;
• if you have moderate to severe liver dysfunction.

Additionally, 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 Oxycodone and Naloxone EG

• in elderly or debilitated patients;
• if you suffer from opioid-induced paralytic ileus (a type of intestinal obstruction);
• if your kidney function is impaired;
• if you suffer from mild liver insufficiency;
• if you have severe pulmonary insufficiency (e.g. reduced respiratory capacity);
• if you suffer from a condition characterized by frequent interruptions in breathing during sleep that may cause excessive daytime sleepiness (sleep apnoea);
• if you have myxoedema (a thyroid disorder, with dry, cold and swollen skin (oedema) in facial and limb areas);
• 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 (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 sustained 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, isocarboxazid, moclobemide, linezolid;
• if drowsiness or episodes of sudden sleep occur.

If any of these warnings applied to you in the past, consult your doctor. Likewise, 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 may also cause reduced oxygen levels in the blood, potentially leading to fainting, etc.
Diarrhoea
If severe diarrhoea occurs at the beginning of treatment, this may be due to the effect of naloxone. It may be a sign that intestinal function is returning to normal. Diarrhoea may occur during the first 3–5 days of treatment. If diarrhoea persists beyond 3–5 days, or causes you concern, contact your doctor.
Switching to Oxycodone and Naloxone EG
When switching to treatment with Oxycodone and Naloxone EG, if you are currently using another opioid, withdrawal symptoms may initially occur, such as restlessness, sweating episodes, and muscle aches. 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 time. This means that a higher dose may be needed to achieve the desired effect. In addition, long-term use may lead to physical dependence. Withdrawal symptoms may occur if treatment is stopped too abruptly (agitation, sweating episodes, muscle aches). If you no longer require treatment, you should gradually reduce the daily dose under medical supervision.
Psychological dependence
The active substance oxycodone hydrochloride alone has a similar abuse profile to other strong opioids (strong analgesics). There is a possibility of developing psychological dependence. Medicines containing oxycodone hydrochloride should be avoided in patients with current or past alcohol, drug, or medicine abuse.
Cancer
Inform your doctor if you have cancer with peritoneal metastases or if there is onset of intestinal obstruction in advanced gastrointestinal or pelvic tumours.
If you are due to undergo surgery, inform your doctor that you are taking Oxycodone and Naloxone EG.
Hormonal effects
Like other opioids, oxycodone may affect the normal production of hormones in the body such as cortisol or sex hormones, particularly if high doses have been taken for prolonged periods. If you experience persistent symptoms such as malaise (including nausea), loss of appetite, fatigue, weakness, dizziness, changes in menstrual cycle, impotence, infertility, or decreased libido, consult your doctor, as you may require assessment of your hormone levels.
Incorrect use of Oxycodone and Naloxone EG
These tablets are not indicated for the treatment of withdrawal symptoms.
Oxycodone 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 Oxycodone and Naloxone EG than you should).
Oxycodone and Naloxone EG 10 mg/5 mg, 20 mg/10 mg, 30 mg/15 mg and 40 mg/20 mg
The tablet may 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 Oxycodone and Naloxone EG than you should).
Abuse
You must never abuse Oxycodone and Naloxone EG, especially if you suffer from substance dependence. If you are dependent on substances such as heroin, morphine, or methadone, severe withdrawal symptoms are likely to occur if you abuse these tablets, as they contain the component naloxone. Pre-existing withdrawal symptoms may worsen.
Improper use
You must never use these tablets improperly, such as dissolving and injecting them (e.g. into a blood vessel). In particular, they contain talc, which may cause local tissue destruction (necrosis) and changes in lung tissue (pulmonary granuloma). Such abuse may have other serious consequences and can be fatal.
Doping
The use of Oxycodone and Naloxone EG may produce positive results in anti-doping tests.
The use of Oxycodone and Naloxone EG as a doping agent may become hazardous to health.
Other medicines and Oxycodone and Naloxone EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
The risk of adverse effects increases when taking antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone and symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movements, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C may occur. Consult your doctor if you experience these symptoms.
Concomitant use of opioids, including oxycodone hydrochloride, and sedative medicines such as benzodiazepines or similar medicines, may increase the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For these reasons, concomitant use should only be considered if no alternative treatments are available.
However, if your doctor prescribes Oxycodone and Naloxone EG together with sedative medicines, the dose and duration of concomitant therapy should be limited.
Inform your doctor of all sedative medicines you are taking and follow their dosage recommendations carefully. It may be helpful to inform friends or relatives about the possibility of the above-mentioned signs and symptoms occurring. Consult your doctor if such symptoms occur.
Examples of these sedative or similar medicines include:

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

If you take these tablets together with other medicines, the effect of these tablets or the other medicine described below may be altered. Inform your doctor if you are taking:

• medicines that reduce blood clotting ability (coumarin derivatives), which may accelerate or slow down clotting time;
• macrolide antibiotics (such as clarithromycin, erythromycin, or telithromycin);
• azole antifungal medicines (such as ketoconazole, voriconazole, itraconazole, or posaconazole);
• a specific type of medicines known as protease inhibitors used to treat HIV (examples include ritonavir, indinavir, nelfinavir, or saquinavir);
• cimetidine (a medicine for treating stomach ulcers, indigestion, or heartburn);
• rifampicin (for treating tuberculosis);
• carbamazepine (for treating seizures, epileptic fits, or convulsions and certain types of pain);
• phenytoin (for treating epileptic seizures, fits, or convulsions);
• a herbal remedy called St John’s wort (also known as Hypericum perforatum);
• quinidine (a medicine for treating irregular heartbeat).

No interactions between Oxycodone and Naloxone EG and paracetamol, acetylsalicylic acid, or naltrexone are expected.
Oxycodone and Naloxone EG with food, drinks, and alcohol
Drinking alcohol while taking Oxycodone and Naloxone EG may cause drowsiness or increase the risk of serious adverse effects such as shortness of breath, with risk of respiratory arrest and loss of consciousness. It is recommended not to consume alcohol during treatment with Oxycodone and Naloxone EG.
Avoid drinking grapefruit juice during treatment with these tablets.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of these tablets should be avoided as much as possible during pregnancy. If used for prolonged periods during pregnancy, oxycodone hydrochloride may cause 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. Therefore, a risk to the breastfed infant cannot be excluded, particularly after multiple doses of Oxycodone and Naloxone EG.
Driving and using machines
Oxycodone and Naloxone EG may affect your ability to drive and use machines. This is particularly likely at the beginning of treatment with Oxycodone and Naloxone EG, after a dose increase, or after switching from another medicine. However, these adverse effects disappear once the dose of Oxycodone and Naloxone EG is stabilised.
Oxycodone and Naloxone EG has been associated with drowsiness and episodes of sudden sleep. If you experience this adverse effect, do not drive or operate machinery. Consult your doctor if you experience these adverse effects.
Ask your doctor whether you can drive or use machines.
Oxycodone and Naloxone EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to take Oxycodone and Naloxone EG

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Oxycodone and Naloxone EG is a prolonged-release tablet, meaning that its active substances
are released over an extended period. Its effect lasts for 12 hours.
Unless otherwise prescribed by your doctor, the usual dosage is as follows:
For the treatment of pain
Adults
The usual starting dose is 10 mg of oxycodone hydrochloride/5 mg of naloxone hydrochloride in the form of
prolonged-release tablets every 12 hours.
Your doctor will decide how much Oxycodone and Naloxone EG you should take each day and how to divide the
total daily dose between morning and evening. Your doctor will also determine any necessary dose adjustments during treatment. The dose will be adjusted according to the level of pain and individual sensitivity. You should be given the lowest dose necessary to relieve pain. If you have previously been treated with opioids, treatment with Oxycodone and Naloxone EG may be initiated at a higher dose.
The maximum daily dose is 160 mg of oxycodone hydrochloride and 80 mg of naloxone hydrochloride. If you
require a higher dose, your doctor may prescribe higher doses of oxycodone hydrochloride without
naloxone hydrochloride. The maximum daily dose of oxycodone hydrochloride must not exceed 400 mg. The benefit of
naloxone hydrochloride on intestinal function may decrease when higher doses of oxycodone hydrochloride
are administered without additional doses of naloxone hydrochloride.
If you switch from these tablets to another opioid medicine for pain treatment, your bowel function will likely worsen.
If you experience pain between doses of Oxycodone and Naloxone EG, a fast-acting painkiller may be needed. Oxycodone and Naloxone EG is not suitable for this purpose. In such cases, consult your doctor.
If you feel that the effect of these tablets is too strong or too weak, speak with your doctor or
pharmacist.
For the treatment of restless legs syndrome
Adults
The usual starting dose is 5 mg of oxycodone hydrochloride/2.5 mg of naloxone hydrochloride in the form of
prolonged-release tablets every 12 hours.
Your doctor will determine how much Oxycodone and Naloxone EG you should take each day and how to distribute the
total daily dose between morning and evening. Your doctor will also decide on any necessary dose adjustments during treatment. Your dose will be adjusted according to your individual sensitivity.
You should take the lowest dose necessary to relieve symptoms of restless legs syndrome.
If you feel that the effect of Oxycodone 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 the treatment of pain or restless legs syndrome
Elderly patients
In general, dose adjustment is not necessary in elderly patients with normal kidney and/or liver function.
Impaired liver or kidney function
If you have impaired kidney function or mild impairment of liver function, your doctor will prescribe these tablets with particular caution. If you have moderate or severe impairment of liver function, these tablets must not be used (see also "Do not take Oxycodone and Naloxone EG" and "Warnings and precautions").
Use in children and adolescents under 18 years of age
Oxycodone and Naloxone EG has not been studied in children and adolescents under 18 years of age. Its safety and efficacy have not been established in children and adolescents. For this reason, the use of Oxycodone and Naloxone EG in children and adolescents under 18 years of age is not recommended.
Method of administration
For oral use.
Take Oxycodone and Naloxone EG every 12 hours, according to a fixed time schedule (e.g., 8 a.m. and 8 p.m.).
Oxycodone and Naloxone EG 5 mg/2.5 mg
Take Oxycodone and Naloxone EG with an adequate amount of liquid (1/2 glass of water). The tablet
must be swallowed whole and must not be broken, chewed, or crushed. The tablet may be taken
with or without food.
Oxycodone and Naloxone EG 10 mg/5 mg, 20 mg/10 mg, 30 mg/15 mg and 40 mg/20 mg
Take Oxycodone and Naloxone EG with an adequate amount of liquid (1/2 glass of water). The tablet
may be divided into equal doses. The tablet must not be broken, chewed, or crushed. The tablet
may be taken with or without food.
Duration of treatment
In general, you should not take these tablets for longer than necessary. If you are on long-term treatment, your doctor should regularly check whether you still need these tablets.
If you take more Oxycodone and Naloxone EG than you should
If you have taken more than the prescribed dose of these tablets, you must inform your doctor immediately.
An overdose may cause:

• constricted pupils;
• slow and shallow breathing (respiratory depression);
• drowsiness, up to loss of consciousness;
• low muscle tone (hypotonia);
• reduced pulse rate; and
• drop in 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. Situations requiring a high level of alertness, such as driving, should be avoided.

If you forget to take Oxycodone and Naloxone EG
If you take a lower dose 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 due in 8 hours or more: take the missed tablet immediately, then continue with your regular dosing schedule.
• If your next usual dose is due in less than 8 hours: take the missed tablet. Then wait at least 8 hours before taking the next dose, trying to return to your original dosing schedule (e.g., 8 a.m. and 8 p.m.). Do not take more than one tablet within an 8-hour period.

Do not take a double dose to make up for a forgotten dose.
If you stop taking Oxycodone and Naloxone EG
Do not stop treatment without first consulting your doctor.
If you no longer require further treatment, you must gradually reduce the daily dose after speaking with your doctor. This will help you avoid withdrawal symptoms such as agitation, episodes of sweating, and muscle pain.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Important side effects to be aware of and what to do if they occur
If you experience any of the following serious side effects, contact your doctor immediately:
Slow and shallow breathing (respiratory depression) is the main danger of an opioid overdose. This occurs particularly in elderly and debilitated (weak) patients. Opioids may also cause a severe drop in blood pressure in predisposed patients.

Side effects are divided below into three sections: pain treatment, treatment with the active substance 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;
• diarrhoea;
• dry mouth;
• indigestion;
• vomiting (nausea);
• feeling unwell;
• flatulence (gas);
• decreased appetite up to complete loss of appetite;
• a feeling of dizziness or "spinning sensation";
• headache;
• hot flushes;
• a feeling of unusual weakness;
• fatigue or exhaustion;
• itching of the skin;
• skin reactions / rash;
• sweating;
• vertigo;
• difficulty sleeping;
• drowsiness.

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

• abdominal distension;
• abnormal thoughts;
• anxiety;
• confusion;
• depression;
• nervousness;
• feeling of chest tightness, especially if you already have coronary heart disease;
• reduction in blood pressure;
• withdrawal symptoms such as agitation;
• fainting;
• lack of energy;
• thirst;
• altered taste;
• palpitations;
• biliary colic;
• chest pain;
• feeling of general malaise;
• pain;
• swelling of hands, ankles or feet;
• difficulty concentrating;
• speech disorders;
• agitation;
• difficulty breathing;
• restlessness;
• chills;
• increase in liver enzymes;
• increase in blood pressure;
• reduced sexual desire;
• rhinorrhoea;
• cough;
• hypersensitivity / allergic reactions;
• weight loss;
• injuries from accidents;
• increased need to urinate;
• muscle cramps;
• muscle contractions;
• muscle pain;
• vision problems;
• seizures (especially in people with epilepsy or predisposition to seizures).

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

• increased heart rate;
• drug dependence;
• dental disorders;
• 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 of the skin (pins and needles);
• eructation.

The active substance oxycodone hydrochloride, when not combined with naloxone hydrochloride, is known to
cause the following different side effects:
Oxycodone can cause respiratory problems (respiratory depression), reduction in the size of the pupil of the eye, bronchial muscle spasms, and spasms of smooth muscle, and suppression of the cough reflex.

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

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

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

• reduced concentration;
• migraine;
• increased muscle tension;
• involuntary muscle contractions;
• a condition in which the intestine stops functioning properly (ileus);
• dry skin;
• drug tolerance;
• reduced sensitivity to pain or touch;
• abnormal coordination;
• voice changes (dysphonia);
• fluid retention;
• hearing difficulty;
• mouth ulcers;
• difficulty swallowing;
• inflamed gums;
• perceptual disturbances (e.g., hallucinations, derealization);
• skin redness;
• dehydration;
• agitation;
• a decrease in sex hormone levels which may alter sperm production in men or the menstrual cycle in women.

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

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

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

• acute generalized allergic reactions (anaphylactic reactions);
• increased sensitivity to pain;
• absence of menstruation;
• withdrawal symptoms in the newborn;
• problems with bile flow;
• dental caries.

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 complete loss of appetite;
• difficulty sleeping;
• depression;
• feeling of dizziness or "spinning sensation";
• difficulty concentrating;
• agitation;
• tingling in hands or feet;
• vision disturbances;
• vertigo;
• hot flushes;
• low blood pressure;
• high blood pressure;
• abdominal pain;
• dry mouth;
• vomiting (nausea);
• increased liver enzymes (increased alanine aminotransferase, increased gamma-glutamyltransferase);
• itching of the skin;
• skin reactions/rash;
• chest pain;
• chills;
• pain;
• thirst.

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

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

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

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

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 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 Oxycodone and Naloxone EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after the word EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ossicodone e Naloxone EG contains
The active substances 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 components 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, iron oxide red (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, iron oxide yellow (E172).
Ossicodone e Naloxone EG 40 mg/20 mg
Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172).

Appearance of Ossicodone e 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 lines 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 lines 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 lines 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 lines 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 e Naloxone EG is available in blisters of 28, 56, 60 and 98 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia 6, 20136 Milano
Manufacturer
Develco Pharma GmbH, Grienmatt 27 - 79650 Schopfheim (Germany)
STADA Arzneimittel AG, Stadastrasse 2 – 18, 61118 Bad Vilbel (Germany)

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