ELATREX 5 mg /2.5 Mg Extended-Release Tablet

Зміст інструкції

1. 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
   1. What is Elatrex and what is it used for
2. Elatrex relieves unpleasant sensations and the urge to move the arms and legs.
3. Elatrex is an extended-release tablet, which means that the active ingredients in
   1. What you need to know before taking Elatrex
   2. How to take Elatrex
   3. Possible side effects
   4. How to store Elatrex
   5. Package Contents and Other Information

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

Read this leaflet carefully before you start takingthis 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 Elatrex is and what it is used for
• 2. What you need to know before you take 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 is Elatrex and what is it used for

You have been prescribed Elatrex for the symptomatic treatment of severe pain, which can
only be adequately treated with opioid analgesics.
How Elatrex relieves pain
Elatrex contains the active ingredients oxycodone hydrochloride and naloxone hydrochloride.
Oxycodone hydrochloride is responsible for the pain-relieving effect of Elatrex and is a
potent analgesic (pain reliever) belonging to the opioid group.
Restless Legs Syndrome
You have been prescribed Elatrex as a secondary treatment for restless legs syndrome
from severe to very severe, which cannot be adequately treated with dopaminergic
medicines. Patients with restless legs syndrome have unpleasant sensations in their legs,
and more rarely also in their arms.
These sensations begin as soon as the person rests, for example when sitting or
lying down, and can only be relieved 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 sleep.
How Elatrex works in case of restless legs syndrome

Elatrex relieves unpleasant sensations and the urge to move the arms and legs.

Naloxone hydrochloride, the second active ingredient of Elatrex, counteracts constipation. Intestinal dysfunction (constipation) is a typical undesirable effect of treatment with opioid analgesics.

Elatrex is an extended-release tablet, which means that the active ingredients in

it are released over a prolonged period of time. Their action 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 breathing problems, such as breathing more slowly or weakly than expected (respiratory depression);
• if you suffer from a severe chronic 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 lungs, etc. (for example 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 have moderate to severe liver dysfunction.

In addition, 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 breathing problem accompanied by recurrent breathing interruptions and a feeling of sleepiness during the day (sleep apnea syndrome),
• if you have myxedema (a thyroid disorder, with dry, cold and swollen skin [swelling] in the areas of the face and limbs),
• if your thyroid gland does not produce enough hormones (thyroid insufficiency or hypothyroidism),
• if you have poor functioning adrenal glands (your adrenal glands are not working 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 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, Parkinson's disease), for example medicines containing tranylcypromine, phenelzine, isocarboxazide, moclobemide and linezolid,
• if you feel sleepy or if you sometimes fall asleep. Tell your doctor if any of the above cases had occurred in the past. Also, tell your doctor if you experience any of the above disorders while taking Elatrex.

The most serious effect of an opioid overdose is respiratory depression
(slow and shallow breathing). This also causes a lowering of oxygen levels in the
blood, resulting in possible fainting, etc.
There is no clinical experience with Elatrex in patients with cancer associated with peritoneal metastases or with onset of intestinal obstruction in advanced stage of the digestive and
pelvic cancer. Therefore, the use of Elatrex is not recommended in these
patients.

Children and adolescents
The safety and efficacy of Elatrex in children or adolescents under 18 years of age
have not yet been demonstrated.

How to use Elatrex correctly
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 the
diarrhea persists after 3-5 days, or if it causes you 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 agitation,
sweating attacks and muscle pain. If these symptoms occur, careful monitoring by your doctor may be necessary. Elatrex is not suitable for
treating withdrawal symptoms.
Surgical interventions
Tell your doctor that you are taking Elatrex if you are to undergo a surgical
intervention.
Long-term treatment
You may become tolerant to the medicine Elatrex if you use it for a long
period of time. This means that a higher dose may be needed to obtain the
desired pain relief. In addition, long-term use of Elatrex 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 treatment, you should gradually reduce the daily dose,
under the control of your doctor.
Psychological dependence
The active ingredient oxycodone hydrochloride, alone, has an abuse profile similar to
other strong opioids (strong painkillers). There is a possibility of developing a psychological
dependence. Medicines containing oxycodone hydrochloride should be avoided
in patients with alcohol, drug or medicine abuse - present or past.

Misuse
You should not misuse the prolonged-release tablets of Elatrex,
by dissolving them and injecting them (e.g. into a blood vessel). In particular, they
contain talc, which can locally destroy tissue (necrosis) and
changes in lung tissue (pulmonary granuloma). Such abuse can also have
other serious consequences and can even be fatal.
Incorrect use of Elatrex

Elatrex 5 mg/2.5 mg
The tablet should be swallowed whole and should not be divided, broken,
chewed or crushed.

Elatrex 10 mg/5 mg,
You should be aware that, although the tablets can be divided, they should 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 should not be broken, chewed or
crushed.
Taking chewed or crushed tablets can 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 should never abuse Elatrex, especially if you are dependent on drugs. If you
are dependent on substances such as heroin, morphine or methadone, withdrawal symptoms
are similar if you abuse Elatrex as it contains naloxone. Pre-existing withdrawal symptoms
may worsen.
Doping
Athletes should be aware that this medicine can cause a
positive result in "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
may take any other medicines.
The risk of side effects is increased if you take Elatrex at the same time as
medicines that affect brain function. In this case, the side effects of
Elatrex may be potentiated and may be life-threatening. For example,
tiredness/sleepiness may occur, or respiratory depression (slow and
shallow breathing) may worsen or lead to coma. For this reason, concomitant use should be considered only when other
treatment options are not possible.
Examples of medicines that affect brain function include:

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

However, if your doctor prescribes Elatrex together with sedatives, the dose and duration
of concomitant treatment must be limited by your doctor.
The risk of side effects increases with the intake of antidepressants (such as
citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline,
venlafaxine). These medicines can interact with oxycodone and you may experience
symptoms such as involuntary and rhythmic muscle contractions, including the muscles
that control eye movements, agitation, excessive sweating, tremor, exaggerated reflexes,
increased muscle tension and body temperature above 38 °C. Contact your doctor if you experience these symptoms.
Tell your doctor if you are taking any of the following medicines:

• medicines that decrease the ability of blood to coagulate (coumarin derivatives), the coagulation time may be accelerated or slowed down,
• 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 seizures, attacks or convulsions and in some conditions of pain),
• phenytoin (used to treat seizures, attacks or convulsions),
• St. John's Wort (a herbal medicine also known as Hypericum perforatum),
• quinidine (used to treat irregular heartbeat).

No interactions between Elatrex and paracetamol, acetylsalicylic acid or
naltrexone are expected.

Elatrex with food, drinks and alcohol
Drinking alcohol while taking Elatrex may increase the feeling of
sleepiness or the risk of serious side effects such as shallow breathing with the risk of
interruption of breathing 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, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice 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
lead to withdrawal symptoms in the newborn. If oxycodone hydrochloride is
administered during childbirth, the newborn may have 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 infant cannot be excluded
particularly after taking multiple doses of Elatrex.

Driving and using machines
Elatrex can affect your ability to drive or use machines. This is more
likely to happen at the beginning of therapy with Elatrex, after a dose increase or
after switching from a different medicine. However, these side effects
should disappear once you have stabilized the dose of Elatrex.
Medicines containing oxycodone/naloxone such as Elatrex have been associated with
drowsiness and sudden-onset episodes of sleep. If you experience this effect
you should not drive or use machines. Tell your doctor if you
experience these side effects.
Ask your doctor if you can drive or use machines.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means that it can be considered practically “sodium-free”.

3. How to take Elatrex

Take this medicine following exactly the instructions of your doctor. If you
have any doubts, ask your doctor or pharmacist.

If not otherwise prescribed by your doctor, the recommended dose is:
For the treatment of pain
Adults
The recommended starting dose is 10 mg of oxycodone hydrochloride/5 mg of naloxone
hydrochloride as extended-release tablets every 12 hours.
The doctor will decide how much Elatrex you should take each day and how to divide the dose
total daily between morning and evening. The doctor will also decide on any adjustment
of the dose possibly necessary during treatment. The dose will be adjusted in
based on the level of pain and individual sensitivity. You should be given the
lowest dose necessary for pain relief. If you have already been treated with opioids,
treatment with Elatrex may be started at a higher dosage.
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 additional doses of
oxycodone hydrochloride without naloxone hydrochloride. However, the maximum
daily dose of oxycodone hydrochloride should not exceed 400 mg. The beneficial effect of
naloxone hydrochloride on bowel activity may be reduced if higher doses of oxycodone
hydrochloride are administered without further doses of naloxone hydrochloride.
If you switch from Elatrex to another strong opioid medicine for the treatment of
pain, bowel function will likely worsen.
If you feel pain between two doses of Elatrex, you may need a fast-acting pain reliever. Elatrex is not suitable for this. In this case, consult your doctor.
If you feel that the effect of Elatrex is too strong or too weak, talk to
your doctor or pharmacist.

For the treatment of restless legs syndrome
Adults
The recommended starting dose is 5 mg of oxycodone hydrochloride/2.5 mg of naloxone
hydrochloride as extended-release tablets every 12 hours
The doctor will decide how much Elatrex you should take each day and how to divide the dose
total daily between morning and evening. The doctor will also decide on any adjustment of the
dose possibly necessary during treatment. The dose will be adjusted based on the
individual sensitivity. You should be given the lowest dose necessary to relieve the
symptoms of restless legs syndrome.
If you feel that the effect of Elatrex is too strong or too weak, talk to
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/practicable with this dosage, other dosages are available
of this medicine.
Elderly
In general, no dose adjustment is necessary in elderly patients with
normal kidney and/or liver function.
Liver or kidney problems
If you have impaired kidney function or mild liver impairment, your doctor will prescribe Elatrex with particular caution. If you are affected
by moderate or severe liver impairment, Elatrex should not
be used (see also paragraph 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 demonstrated in children and
adolescents. For this reason, the use of Elatrex in children and adolescents under
18 years of age is not recommended.

Method of administration
Oral use.
Take Elatrex every 12 hours, according to a fixed schedule (e.g. at 8
in the morning and at 8 in the evening).

Elatrex 5 mg/2.5 mg
Take Elatrex with sufficient liquid (1/2 glass of water). The tablet must
be swallowed whole and must not be divided, broken, chewed or crushed. The
tablet can 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 liquid (1/2 glass of water). The tablet can
be divided into equal doses. The tablet must not be broken, chewed or
crushed.
The extended-release tablets can be taken with or without food.

Duration of use
In general, you should not take Elatrex for a period longer than necessary. If you
are being treated with Elatrex for a long time, your doctor should regularly check if
you still need treatment with Elatrex.

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 can cause:

• constricted pupils,
• slow and shallow breathing (respiratory depression),
• a state similar to narcosis (drowsiness, up to unconsciousness),
• low muscle tone (hypotonia),
• reduced pulse rate,
• decreased blood pressure. In severe cases, loss of consciousness (coma), fluid accumulation in the lungs and circulatory collapse may occur, which in some cases may be fatal.

You should avoid situations that require a high level of alertness, such as
driving.

If you forget to take Elatrex
If you forget to take Elatrex or if you take a dose lower than that
prescribed, you may not feel any pain relief.
If you forget to take the dose, follow these instructions:

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

Do not take a double dose to make up for the forgotten tablet.

If you stop taking Elatrex
Do not stop treatment with Elatrex without 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 the use of 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.

Important side effects to watch out for and what to do if they occur:
If you experience any of the following important side effects, consult your nearest 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.
The following side effects have been divided into three sections: treatment of pain, treatment with the active substance oxycodone hydrochloride alone, and treatment of restless legs syndrome.

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

• decreased appetite, up to loss of appetite
• difficulty sleeping, fatigue or weakness
• feeling of dizziness or “lightheadedness”, headache, drowsiness
• dizziness
• hot flashes
• abdominal pain, constipation, diarrhea, dry mouth, indigestion, feeling unwell, general discomfort, 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
• decreased sexual drive
• seizures (especially in people with epilepsy or a predisposition to convulsions), difficulty concentrating, speech disorders, fainting, tremors
• taste abnormalities
• feeling sleepy or fatigued and sluggishness (lethargy)
• vision impairment
• chest tightness, especially if you already have coronary heart disease, palpitations
• decreased blood pressure, increased blood pressure
• difficulty breathing, runny nose, cough
• abdominal bloating
• increased liver enzymes, biliary colic
• muscle cramps, muscle spasms, muscle pain
• increased urge to urinate
• withdrawal symptoms such as agitation, chest pain, tremors, feeling generally unwell, pain, swelling of the hands, ankles or feet
• thirst
• weight loss
• injuries from accidents.

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

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

Not known(frequency cannot be estimated based on available data)

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

It is known that the active substance oxycodone hydrochloride, when not in combination with naloxone hydrochloride, has the following side effects:
Oxycodone can cause respiratory problems (respiratory depression), reduced pupil size, bronchospasm and smooth muscle cramps, and depression 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 ability to concentrate, migraine, increased muscle tension, involuntary muscle contractions, reduced sensitivity to pain or touch, abnormal coordination
• hearing difficulties
• blood vessel dilation
• 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 that can affect sperm production in men or the menstrual cycle in women.

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

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

Not known(frequency cannot be estimated based on available data)

• acute generalized allergic reactions (anaphylactic reactions)
• aggressive behavior
• increased sensitivity to pain
• tooth decay
• problems with bile flow
• absence of menstruation
• long-term use of oxycodone during pregnancy can cause potentially fatal neonatal withdrawal syndrome. Symptoms in the newborn include irritability, hyperactivity and altered sleep patterns, acute crying, tremors, discomfort, diarrhea and failure to gain weight.

The following side effects have been observed in patients undergoing treatment 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
• insomnia, depression
• dizziness, attention deficit disorders, tremor (muscle), sensation of tingling
• visual disturbances
• feeling of dizziness or lightheadedness
• hot flashes, decreased blood pressure, increased 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 sleep attacks
• taste alterations
• difficulty breathing
• flatulence
• erectile dysfunction
• withdrawal symptoms such as agitation, swelling due to fluid retention (e.g., in the hands, ankles or feet)
• injuries from accidents.

Not known(frequency cannot be estimated based on 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 a predisposition to seizures), severe drowsiness, speech disorder, fainting (syncope)
• feeling of painful chest tightness (angina pectoris), especially if you already have

heart disease, palpitations, increased heart rate

• cough, runny nose, shallow and slowed breathing (respiratory depression), yawning
• stomach bloating, diarrhea, indigestion, burping, dental changes
• biliary colic
• muscle cramps, muscle contractions, muscle pain
• urge to urinate, difficulty urinating
• general feeling of discomfort
• feeling of sleepiness or fatigue and sluggishness (lethargy)
• lack of energy
• weight gain, weight loss.

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 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 at a temperature above 25°C.
Bottle:
Do not store at a temperature above 30°C.
Expiry date after first opening: 3 months.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. Package Contents and Other Information

What Elatrex contains
The active ingredients 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 ingredients 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 fracture line 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 fracture line 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 fracture line 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 fracture line 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 of 10, 14, 20, 28, 30, 50, 56, 60, 98 and 100 prolonged-release
tablets.
Bottle with child-resistant screw cap containing 50, 100 or 250 prolonged-release
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani, 20, 20124 Milan, Italy

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

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Czech Republic: Oxykodon/Naloxon Mylan 10 mg/5 mg, 20 mg/10 mg, 40 mg/20 mg
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
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
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
prolonged-release tablets