Elatrex

Package leaflet: Information for the user

Elatrex 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

oxycodone hydrochloride and naloxone hydrochloride
Generic medicine
Please read all of 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

What this leaflet contains

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

1. What Elatrex is and what it is used for

You have been prescribed Elatrex for the symptomatic treatment of severe pain, which can
be adequately managed only with opioid analgesics.

How Elatrex relieves pain
Elatrex contains the active substances oxycodone hydrochloride and naloxone hydrochloride.
Oxycodone hydrochloride is responsible for the analgesic effect of Elatrex and is a
potent analgesic (painkiller) belonging to the opioid group.

Restless legs syndrome
You have been prescribed Elatrex as a second-line treatment for moderate to severe
restless legs syndrome that cannot be adequately managed with dopaminergic medicines.
Patients with restless legs syndrome experience unpleasant sensations in the legs, and less commonly also in the arms.
These sensations begin as soon as the person rests, for example when sitting or lying down, and can be relieved only by the irresistible urge to move the legs and sometimes also the arms and other parts of the body. These symptoms make it extremely difficult to stay still and to sleep.

How Elatrex works in restless legs syndrome
Elatrex reduces the unpleasant sensations and the urge to move the arms and legs.

Naloxone hydrochloride, the second active substance in Elatrex, counteracts constipation.
Gastrointestinal dysfunction (constipation) is a typical side effect of treatment with
opioid analgesics.

Elatrex is a prolonged-release tablet, meaning that the active substances it contains are released over an extended period of time. Their effect lasts for 12 hours.

2. What you need to know before taking Elatrex

Do not take Elatrex

• if you are allergic to oxycodone hydrochloride, naloxone hydrochloride, or any of the other ingredients of this medicine (listed in section 6);
• if you have respiratory problems, such as breathing more slowly or weakly than expected (respiratory depression);
• if you suffer from severe chronic lung disease associated with airway narrowing (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 within the blood vessels of the lungs, etc. (for example, as a consequence of COPD – see 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 case of restless legs syndrome:

• if you have a history of opioid abuse.

Warnings and precautions
Talk to your doctor or pharmacist before taking Elatrex:

• if you are elderly or debilitated (weak),
• if you suffer from paralytic ileus (a type of intestinal obstruction) caused by opioids,
• if you have kidney problems,
• if you have mild liver problems,
• if you have severe lung problems (for example, reduced breathing capacity),
• if you suffer from a respiratory disorder accompanied by recurrent breathing interruptions and daytime sleepiness (sleep apnoea syndrome),
• 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 you have poor adrenal gland function (your adrenal glands do not work properly), e.g. 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 suffered 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, Parkinson’s disease), for example medicines containing tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolid,
• if you feel drowsy or occasionally fall asleep. Inform your doctor if any of the above conditions have occurred in the past. Also, inform your doctor if you experience any of these disorders while taking Elatrex.

The most serious effect of an opioid overdose is respiratory depression (slow and shallow breathing). This also causes a drop in blood oxygen levels, potentially leading to fainting, etc.
There is no clinical experience with Elatrex in patients with cancer associated with peritoneal metastases or with the onset of intestinal obstruction in advanced gastrointestinal and pelvic tumours. Therefore, the use of Elatrex is not recommended in these patients.
Children and adolescents
The safety and benefits of Elatrex in children or adolescents under 18 years of age have not yet been established.
How to use Elatrex correctly
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 bowel 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 concern, contact your doctor.
Switching to Elatrex treatment
When switching to Elatrex treatment, if you are using high doses of another opioid, withdrawal symptoms may initially occur, such as restlessness, sweating episodes, and muscle aches. If such symptoms occur, careful monitoring by your doctor may be necessary. Elatrex is not suitable for the treatment of withdrawal symptoms.
Surgery
Inform your doctor that you are taking Elatrex if you are due to undergo surgery.
Long-term treatment
You may become tolerant to Elatrex if you use it for a long period of time. This means that a higher dose may be needed to achieve the desired pain relief. In addition, long-term use of Elatrex may lead to physical dependence. Withdrawal symptoms may occur if treatment is stopped too abruptly (restlessness, sweating episodes, muscle aches). If you no longer need treatment, you should gradually reduce the daily dose under medical supervision.
Psychological dependence
The active substance oxycodone hydrochloride alone has an abuse profile similar 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 abuse of alcohol, drugs or medicines.
Misuse
You must not misuse the prolonged-release tablets of Elatrex by 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 misuse may also have other serious consequences and may even be fatal.
Incorrect use of Elatrex
Elatrex 5 mg/2.5 mg
The tablet must be swallowed whole and must not be divided, broken, chewed or crushed.
Elatrex 10 mg/5 mg
You should be aware that, although the tablets may be divided, they must not be broken, chewed or crushed.
Elatrex 20 mg/10 mg, 30 mg/15 mg, 40 mg/20 mg
You should be aware that the tablets must not be broken, chewed or crushed.
Taking chewed or crushed tablets may result in the absorption of a potentially lethal dose of oxycodone hydrochloride (see section 3 “If you take more Elatrex than you should”).
Abuse
You must never abuse Elatrex, especially if you are drug-dependent. If you are dependent on substances such as heroin, morphine or methadone, severe withdrawal symptoms are similar when abusing Elatrex because it contains naloxone. Pre-existing withdrawal symptoms may worsen.
Doping
Athletes should be aware that this medicine may cause a positive result in anti-doping tests. The use of Elatrex as a doping agent may pose a health risk.
Other medicines and Elatrex
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The risk of adverse effects is increased if you take Elatrex together with medicines that act on brain function. In this case, the adverse effects of Elatrex may be enhanced and may be life-threatening. For example, fatigue/drowsiness may occur, or respiratory depression (slow and shallow breathing) may worsen or lead to coma. For this reason, concomitant use should only be considered when no other treatment options are available.
Examples of medicines that act on brain function include:

• other strong painkillers (opioids),
• medicines for sleep and tranquillisers (sedatives such as benzodiazepines, hypnotics, anxiolytics),
• antidepressants,
• medicines used to treat allergies, motion sickness or nausea (antihistamines or antiemetics),
• other medicines used to treat psychiatric or mental disorders (antipsychotics such as phenothiazines and neuroleptics).

However, if your doctor prescribes Elatrex together with sedative medicines, the dose and duration of concomitant treatment must be limited by the doctor.
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 you may experience symptoms such as involuntary and rhythmic muscle contractions, including those controlling eye movements, restlessness, excessive sweating, tremor, exaggerated reflexes, increased muscle tension and body temperature above 38°C. Talk to your doctor if you experience these symptoms.
Inform your doctor about all sedative medicines you are taking and follow the doctor’s dosage recommendations carefully. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above.
Contact your doctor if you experience such symptoms.
Inform your doctor if you are taking any of the following medicines:

• medicines that reduce blood clotting ability (coumarin derivatives), as clotting time may be accelerated or slowed,
• macrolide antibiotics (e.g. clarithromycin),
• azole antifungals (e.g. ketoconazole),
• ritonavir and other protease inhibitors (used to treat HIV),
• cimetidine (used to treat stomach ulcers, indigestion or heartburn),
• rifampicin (used to treat tuberculosis),
• carbamazepine (used to treat epileptic seizures, fits or convulsions and in some pain conditions),
• phenytoin (used to treat epileptic seizures, fits or convulsions),
• St John’s wort (a herbal medicine also known as Hypericum perforatum),
• quinidine (used to treat irregular heartbeat).

No interactions are expected between Elatrex and paracetamol, acetylsalicylic acid or naltrexone.
Elatrex with food, drinks and alcohol
Drinking alcohol while taking Elatrex may increase drowsiness or the risk of serious adverse effects such as shallow breathing, with risk of breathing stopping and loss of consciousness. It is recommended not to drink alcohol while taking Elatrex.
You should avoid drinking grapefruit juice when taking Elatrex.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of Elatrex should be avoided as much as possible during pregnancy. If used for prolonged periods during pregnancy, oxycodone hydrochloride may cause withdrawal symptoms in the newborn. If oxycodone hydrochloride is administered during childbirth, the newborn may experience breathing problems (respiratory depression).
Breastfeeding
Breastfeeding must be discontinued during treatment with Elatrex. 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 taking multiple doses of Elatrex.
Driving and using machines
Elatrex may affect your ability to drive or use machinery. This is more likely at the beginning of Elatrex therapy, after a dose increase, or after switching from another medicine. However, these adverse effects should disappear once your Elatrex dose has stabilised.
Medicines containing oxycodone/naloxone such as Elatrex have been associated with drowsiness and episodes of sudden sleep onset. If you experience this adverse effect, you must not drive or use machinery. Talk to your doctor if you experience these adverse effects.
Ask your doctor whether you can drive or use machinery.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning it is essentially "sodium-free".

3. How to take Elatrex

Take this medicine exactly as prescribed by your doctor. If
you have any doubts, consult your doctor or pharmacist.
If not otherwise prescribed by your doctor, the recommended dose is:
For the treatment of pain
Adults
The recommended initial dose is 10 mg of oxycodone hydrochloride / 5 mg of naloxone
hydrochloride as prolonged-release tablets every 12 hours.
Your doctor will decide how much Elatrex you should take each day and how to divide the
total daily dose between morning and evening. Your doctor will also determine any dose
adjustments that may be necessary 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 achieve pain relief. If you have previously been treated with opioids, treatment with
Elatrex may be initiated at a higher dosage.
The maximum daily dose is 160 mg of oxycodone hydrochloride and 80 mg of naloxone
hydrochloride. If a higher dose is required, your doctor may prescribe additional doses of
oxycodone hydrochloride without naloxone hydrochloride. However, the maximum daily
dose of oxycodone hydrochloride must not exceed 400 mg. The beneficial effect of
naloxone hydrochloride on intestinal activity may decrease if higher doses of oxycodone
hydrochloride are administered without additional doses of naloxone hydrochloride.
If you switch from Elatrex to another strong opioid medicine for pain treatment, intestinal
function will likely worsen.
If you experience pain between doses of Elatrex, you may need a fast-acting painkiller.
Elatrex is not suitable for this purpose. In such a case, consult your doctor.
If you feel that the effect of Elatrex is too strong or too weak, speak with your doctor or
pharmacist.
For the treatment of restless legs syndrome
Adults
The recommended initial dose is 5 mg of oxycodone hydrochloride / 2.5 mg of naloxone
hydrochloride as prolonged-release tablets every 12 hours.
Your doctor will decide how much Elatrex you should take each day and how to divide the
total daily dose between morning and evening. Your doctor will also determine any dose
adjustments that may be necessary during treatment. The dose will be adjusted according to
individual sensitivity. You should be given the lowest dose necessary to relieve symptoms of
restless legs syndrome.
If you feel that the effect of Elatrex is too strong or too weak, speak with 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
For doses not achievable/practical with this formulation, other strengths of this medicine
are available.
Elderly
In general, dose adjustment is not necessary in elderly patients with normal kidney and/or
liver function.
Liver or kidney problems
If you have impaired renal function or mild hepatic impairment, your doctor will prescribe
Elatrex with particular caution. If you have moderate or severe hepatic impairment, Elatrex
must not be used (see also section 2 “Do not take Elatrex” and “Warnings and precautions”).
Use in children and adolescents under 18 years of age
Elatrex has not yet been studied in children and adolescents under 18 years of age. Its
safety and efficacy have not been established in children and adolescents. Therefore, the
use of Elatrex in children and adolescents under 18 years of age is not recommended.
Method of administration
For oral use.
Take Elatrex every 12 hours according to a fixed schedule (e.g., 8 a.m. and 8 p.m.).
Elatrex 5 mg/2.5 mg
Take Elatrex with sufficient fluid (½ glass of water). The tablet must be swallowed whole
and must not be divided, broken, chewed, or crushed. The tablet may be taken with or
without food.
Elatrex 10 mg/5 mg, 20 mg/10 mg, 30 mg/15 mg, 40 mg/20 mg:
Take Elatrex with sufficient fluid (½ glass of water). The tablet may be divided into equal
doses. The tablet must not be broken, chewed, or crushed.
Prolonged-release tablets may be taken with or without food.
Duration of use
In general, you should not take Elatrex for longer than necessary. If you have been on
Elatrex treatment for a long time, your doctor should regularly assess whether you still
need Elatrex treatment.
If you take more Elatrex than you should
If you have taken more than the prescribed dose of Elatrex, inform your doctor immediately.
An overdose may cause:

• constricted pupils,
• slow and shallow breathing (respiratory depression),
• a narcotic-like state (drowsiness, up to unconsciousness),
• reduced muscle tone (hypotonia),
• reduced pulse rate,
• 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 requiring high alertness, such as
driving.
If you forget to take Elatrex
If you forget to take Elatrex or take a lower dose than prescribed, you may not experience
any analgesic effect.
If you miss a dose, follow these instructions:

• if your next scheduled dose is 8 hours or more away: take the missed tablet immediately, then continue with your regular dosing schedule.
• if your next scheduled dose is less than 8 hours away: take the missed tablet. Then wait at least 8 hours before taking the next tablet. Try to return to your original dosing schedule (e.g., 8 a.m. and 8 p.m.). Do not take more than one dose within an 8-hour period.

Do not take a double dose to make up for a missed tablet.
If you stop taking Elatrex
Do not stop Elatrex treatment without consulting your doctor.
If you no longer require treatment, you must gradually reduce the daily dose after speaking
with your doctor. This will help you avoid withdrawal symptoms such as restlessness,
sweating episodes, 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 experiences 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 nearest doctor immediately.

Slow and shallow breathing (respiratory depression) is the main danger of opioid overdose. This occurs especially in elderly and debilitated (weakened) patients. Opioids may also cause a severe drop in blood pressure in predisposed patients.

The following side effects have been divided into three sections: treatment for pain, treatment with the active substance oxycodone hydrochloride alone, and treatment for restless legs syndrome.

The following side effects have been observed in patients treated for pain:

Common (may affect up to 1 in 10 people)

• reduced appetite up to complete loss of appetite
• difficulty sleeping, fatigue or weakness
• dizziness or vertigo, headache, drowsiness
• dizziness
• hot flushes
• abdominal pain, constipation, diarrhoea, dry mouth, indigestion, feeling unwell, malaise, flatulence
• itching, skin reactions, sweating
• general weakness.

Uncommon (may affect up to 1 in 100 people)

• hypersensitivity/allergic reactions
• agitation, abnormal thoughts, anxiety, confusion, depression, nervousness
• reduced sexual drive
• seizures (especially in people with epilepsy or predisposition to seizures), difficulty concentrating, speech disorders, fainting, tremors
• taste disturbances
• feeling drowsy or fatigued and lethargic (lethargy)
• visual disturbances
• chest tightness, especially if you already have coronary heart disease, palpitations
• low blood pressure, high blood pressure
• breathing difficulties, runny nose, cough
• abdominal distension
• increased liver enzymes, biliary colic
• muscle cramps, muscle spasms, muscle pain
• increased urge to urinate
• withdrawal symptoms such as agitation, chest pain, tremors, general malaise, pain, swelling in hands, ankles or feet
• thirst
• weight loss
• injury-related lesions.

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

• increased heart rate
• yawning
• dental abnormalities
• weight gain
• drug dependence.

Not known (frequency cannot be estimated from available data)

• euphoria, hallucinations, nightmares
• tingling (pins and needles), excessive drowsiness
• shallow breathing
• belching
• difficulty urinating
• erectile dysfunction.

It is known that the active ingredient oxycodone hydrochloride, when not combined with naloxone hydrochloride, has the following side effects:
Oxycodone can cause breathing problems (respiratory depression), reduced pupil size (miosis), bronchial muscle spasms, 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
• hiccups
• difficulty urinating.

Uncommon (may affect up to 1 in 100 people)

• dehydration
• agitation, perceptual disturbances (e.g. hallucinations, derealization), drug dependence
• impaired concentration, migraine, increased muscle tension, involuntary muscle contractions, reduced sensitivity to pain or touch, abnormal coordination
• hearing difficulties
• dilation of blood vessels
• voice changes (dysphonia)
• difficulty swallowing, ileus, mouth ulcers, inflamed gums
• dry skin
• swelling due to fluid retention, tolerance to the medicine
• a decrease in sex hormone levels which may affect sperm production in men or menstrual cycle in women.

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

• herpes simplex
• increased appetite
• black, tarry stools, bleeding gums
• itchy rash (urticaria)

Not known (frequency cannot be estimated from available data)

• generalized acute allergic reactions (anaphylactic reactions)
• aggressive behaviour
• increased sensitivity to pain
• dental caries
• bile flow problems
• absence of menstruation
• long-term use of oxycodone during pregnancy may cause potentially life-threatening neonatal opioid withdrawal syndrome. Symptoms in the newborn include irritability, hyperactivity and disturbed sleep patterns, high-pitched crying, tremors, malaise, diarrhoea and failure to gain weight.

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)

• reduced appetite up to complete loss of appetite
• insomnia, depression
• dizziness, attention deficit disorders, tremor (muscular), tingling sensation
• visual disturbances
• feeling of dizziness or vertigo
• hot flushes, low blood pressure, high blood pressure
• abdominal pain, dry mouth, feeling unwell
• increased liver enzymes (alanine aminotransferase, gamma-glutamyltransferase)
• itching, skin reactions
• chest pain, chills, thirst, pain.

Uncommon (may affect up to 1 in 100 people)

• decreased sexual desire, sudden onset of sleep attacks
• taste disturbances
• breathing difficulties
• flatulence
• erectile dysfunction
• withdrawal symptoms such as agitation, swelling due to fluid retention (e.g. in hands, ankles or feet)
• injury-related lesions.

Not known (frequency cannot be estimated from available data)

• hypersensitivity/allergic reactions
• abnormal thoughts, anxiety, confusion, nervousness, restlessness, feeling of extreme happiness, hallucinations, nightmares, aggression
• drug dependence
• seizures (especially in people with epilepsy or predisposition to seizures), severe drowsiness, speech disorder, fainting (syncope)
• painful chest tightness (angina pectoris), especially if you already have coronary heart disease, palpitations, increased heart rate
• cough, runny nose, shallow and slow breathing (respiratory depression), yawning
• stomach swelling, diarrhoea, indigestion, belching, dental abnormalities
• biliary colic
• muscle cramps, muscle contractions, muscle pains
• need to urinate, difficulty urinating
• general feeling of malaise
• drowsiness or fatigue and lethargy (lethargy)
• lack of energy
• weight gain, weight loss.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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 Elatrex

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 label after
Exp. The expiry date refers to the last day of that month.
Blister:
Do not store above 25°C.
Bottle:
Do not store above 30°C.
Expiry after first opening: 3 months.
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 Elatrex contains
The active substances are oxycodone hydrochloride and naloxone hydrochloride.
Elatrex 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 (as 2.74
mg of naloxone hydrochloride dihydrate, equivalent to 2.25 mg of naloxone).
Elatrex 10 mg/5 mg:
Each prolonged-release tablet contains 10 mg of oxycodone hydrochloride (equal to 9
mg of oxycodone) and 5 mg of naloxone hydrochloride (as 5.45 mg of naloxone hydrochloride
dihydrate, equivalent to 4.5 mg of naloxone).
Elatrex 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 (as 10.9 mg of
naloxone hydrochloride dihydrate, equivalent to 9 mg of naloxone).
Elatrex 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 (as 16.35 mg of
naloxone hydrochloride dihydrate, equivalent to 13.5 mg of naloxone).
Elatrex 40 mg/20 mg:
Each prolonged-release tablet contains 40 mg of oxycodone hydrochloride (equivalent
to 36 mg oxycodone) and 20 mg of naloxone hydrochloride (as 21.8 mg of naloxone
hydrochloride dihydrate, equivalent to 18 mg of naloxone).

The other components are:
Tablet core:
Elatrex 5 mg/2.5 mg prolonged-release tablets
Elatrex 10 mg/5 mg prolonged-release tablets
Elatrex 20 mg/10 mg prolonged-release tablets
Elatrex 30 mg/15 mg prolonged-release tablets
Elatrex 40 mg/20 mg prolonged-release tablets
Polyvinyl acetate, povidone K30, sodium lauryl sulfate, anhydrous colloidal silica, microcrystalline cellulose, magnesium stearate.

Tablet coating:
Elatrex 5 mg/2.5 mg
Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.
Elatrex 10 mg/5 mg
Polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), macrogol 3350, talc.
Elatrex 20 mg/10 mg
Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.
Elatrex 30 mg/15 mg
Polyvinyl alcohol, titanium dioxide (E171), yellow iron oxide (E172), macrogol 3350, talc.
Elatrex 40 mg/20 mg:
Polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), macrogol 3350, talc.

What Elatrex looks like and contents of the pack
Elatrex 5 mg/2.5 mg
White, round, biconvex prolonged-release tablet with a diameter of 4.7 mm and a height of 2.9 - 3.9 mm.
Elatrex 10 mg/5 mg
Pink, oblong, biconvex prolonged-release tablet with a breakline on both sides, with a length of 10.2 mm, a width of 4.7 mm and a height of 3.0 - 4.0 mm. The tablet can be divided into equal doses.
Elatrex 20 mg/10 mg
White, oblong, biconvex prolonged-release tablet with a breakline on both sides, with a length of 11.2 mm, a width of 5.2 mm and a height of 3.3 - 4.3 mm. The tablet can be divided into equal doses.
Elatrex 30 mg/15 mg
Yellow, oblong, biconvex prolonged-release tablet with a breakline on both sides, with a length of 12.2 mm, a width of 5.7 mm and a height of 3.3 - 4.3 mm. The tablet can be divided into equal doses.
Elatrex 40 mg/20 mg
Pink, oblong, biconvex prolonged-release tablet with a breakline on both sides, with a length of 14.2 mm, a width of 6.7 mm and a height of 3.6 - 4.6 mm. The tablet can be divided into equal doses.

Elatrex is available in:
Child-resistant blisters containing 10, 14, 20, 28, 30, 50, 56, 60, 98 and 100 prolonged-release tablets.
Bottles with child-resistant screw caps containing 50, 100 or 250 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani, 20, 20124 Milano, Italy

Manufacturer
Develco Pharma GmbH, Grienmatt 27, Schopfheim, 79650, Germany

This medicinal product is authorized in the European Economic Area Member States under the following names:
Czech Republic: Oxykodon/Naloxon Mylan 10 mg/5 mg, 20 mg/10 mg, 40 mg/20 mg
tablety s prodlouženým uvolňováním
Germany: Oxycodon-HCl/Naloxon-HCl Mylan 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg, 30
mg/15 mg, 40 mg/20 mg Retardtabletten
Ireland: Oxyargin 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg, 30 mg/15 mg, 40 mg/20 mg
prolonged release tablets
Italy: Elatrex
Slovakia: Oxykodon/Naloxon Mylan 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg, 30 mg/15
mg, 40 mg/20 mg tablety s predĺženým uvoľňovaním
Spain: Oxicodona/Naloxona Mylan 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg, 40 mg/20 mg
comprimidos de liberación prolongada EFG
United Kingdom: Oxyargin 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg, 30 mg/15 mg, 40 mg/20
mg prolonged-release tablets