OXYCODONE HYDROCHLORIDE/NALOXONE HYDROCHLORIDE 40 MG / 20 MG PROLONGED-RELEASE TABLETS - patient leaflet, side effects, dosage

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 further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet:

• 1. What Oxycodone hydrochloride/Na­loxone hydrochloride is and what it is used for

• 2. What you need to know before you take Oxycodone hydrochloride/Na­loxone hydrochloride

• 3. How to take Oxycodone hydrochloride/Na­loxone hydrochloride

• 4. Possible side effects

• 5. How to store Oxycodone hydrochloride/Na­loxone hydrochloride

• 6. Contents of the pack and other information

1. what oxycodone hydrochloride/naloxone hydrochloride is and what it is used for

Oxycodone hydrochloride/Na­loxone hydrochloride is a prolonged-release tablet, which means that its active substances are released over an extended period. Their action lasts for 12 hours.

These tablets are only for use in adults.

Pain relief

You have been prescribed Oxycodone hydrochloride/Na­loxone hydrochloride for the treatment of severe pain, which can be adequately managed only with opioid analgesics. Naloxone hydrochloride is added to counteract constipation.

How these tablets work in pain relief

These tablets contain oxycodone hydrochloride and naloxone hydrochloride as active substances.

Oxycodone hydrochloride is responsible for the pain-killing effect of Oxycodone hydrochloride/Na­loxone hydrochloride, and is a potent analgesic (“painkiller”) of the opioid group. The second active substance of Oxycodone hydrochloride/Na­loxone hydrochloride, naloxone hydrochloride, is intended to counteract constipation. Bowel dysfunction (e.g. constipation) is a typical side effect of treatment with opioid painkillers.

Restless legs syndrome

You have been prescribed Oxycodone hydrochloride/Na­loxone hydrochloride for the second line symptomatic treatment of severe to very severe restless legs syndrome in people who can’t be treated with dopamine medicines. People with restless legs syndrome have unpleasant sensations in their limbs. This can start as soon as they sit or lie down and is only relieved by an irresistible urge to move the legs, sometimes the arms and other parts of the body. It makes sitting still and sleeping very difficult. Naloxone hydrochloride is added to counteract constipation.

How these tablets work in restless legs syndrome

These tablets help to relieve the unpleasant sensations and so reduces the urge to move the limbs. Naloxone is intended to bring relief from constipation. Constipation is a typical side effect of treatment with strong painkillers.

2. what you need to know before you take oxycodone hydrochloride/naloxone hydrochloride

Do not take Oxycodone hydrochloride/Naloxone hydrochloride:

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

Additionally for restless legs syndrome

• if you have a history of opioid abuse

Warnings and precautions

Talk to your doctor or pharmacist before taking Oxycodone hydrochloride/Na­loxone hydrochloride:

• in the case of elderly patients or debilitated (weak) patients,
• if you have paralytic ileus (a type of bowel obstruction) caused by opioids,
• if you have kidney impairment,
• if you have mild liver impairment,
• if you have severe lung impairment (i.e. reduced breathing capacity),
• if you suffer with a condition characterised by frequent breathing stops during the night which may make you feel very sleepy during the daytime (sleep apnoea);
• if you have myxoedema (a thyroid disorder, with dryness, coldness and swelling [‘puffiness’] of the skin, affecting the face and limbs),
• if your thyroid gland is not producing enough hormones (underactive thyroid, or hypothyroidism),
• if your adrenal glands are not producing enough hormones (adrenal insufficiency, or Addison’s disease),
• if you have a mental illness accompanied by a (partial) loss of reality (psychosis), due to alcohol or intoxication with other substances (substance-induced psychosis),
• if you suffer from gallstone problems,
• if your prostate gland is abnormally enlarged (prostate hypertrophy),
• if you are or ever have been addicted to alcohol or drugs, or have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating upon stopping alcohol or drugs;
• if your pancreas is inflamed (pancreatitis),
• if you have low blood pressure (hypotension),
• if you have high blood pressure (hypertension),
• if you have heart problems,
• if you have a head injury (due to the risk of increased brain 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 and linezolid.
• if sleepiness or episodes of suddenly falling asleep occur.

Tell your doctor if any of the above has ever applied to you in the past. Also, please tell your doctor if you develop any of the above disorders while you are taking these tablets. The most serious result of opioid overdose is respiratory depression (slow and shallow breathing). This may also cause blood oxygen levels to fall, resulting in possible fainting, etc.

You must swallow the prolonged-release tablet whole, so as not to affect the slow release of oxycodone hydrochloride from the prolonged-release tablet. Do not break, chew or crush the tablets. Taking broken, chewed or crushed tablets may lead to the absorption of a potentially lethal dose of oxycodone hydrochloride (see section 3 “If you take more Oxycodone hydrochloride/Na­loxone hydrochloride than you should”).

If you experience severe diarrhoea at the start of treatment, this may be due to the effect of naloxone.

It may be a sign that bowel function is returning to normal. Such diarrhoea can occur within the first 35 days of treatment. If diarrhoea should persist after 3–5 days, or give you cause for concern, please contact your doctor.

If you have been using another opioid, withdrawal symptoms may occur when you initially switch to Oxycodone hydrochloride/Na­loxone hydrochloride treatment, e.g. restlessness, bouts of sweating and muscle pain. If you experience such symptoms, you may need to be specially monitored by your doctor.

If taken over the long term, you may become tolerant to these tablets. This means you may need a higher dose to achieve the desired effect. Also, long-term use may lead to physical dependence. Withdrawal symptoms may occur if treatment is stopped too suddenly (restlessness, bouts of sweating, muscle pain). If you no longer need treatment, you should reduce your daily dose gradually, in consultation with your doctor.

As with other strong opioid painkillers, there is a risk that you may develop a psychological dependence to oxycodone

Tell your doctor if you have advanced digestive or pelvic cancers where bowel obstruction may be a problem.

If you need to undergo surgery, please tell your doctors that you are taking Oxycodone hydrochloride/Na­loxone hydrochloride.

Similar to other opioids, oxycodone may affect the normal production of hormones in the body such as cortisol or sex hormones, particularly if you have taken high doses for long periods of time. If you experience symptoms which persist, such as feeling or being sick (including vomiting), loss of appetite, tiredness, weakness, dizziness, changes in menstrual cycle, impotence, infertility or decreased sex drive, talk to your doctor as he/she may want to monitor your hormone levels.

You may notice remnants of the prolonged-release tablet in your stools. Do not be alarmed, as the active substances (oxycodone hydrochloride and naloxone hydrochloride) have already been released in the stomach and gut, and absorbed into your body.

Incorrect use of Oxycodone hydrochloride/Naloxone hydrochloride

These tablets are not suitable for withdrawal treatment.

Oxycodone hydrochloride/Na­loxone hydrochloride should never be abused, particularly if you have a drug addiction. If you are addicted to substances such as heroin, morphine or methadone, severe withdrawal symptoms are likely if you abuse these tablets because they contain the ingredient naloxone. Pre-existing withdrawal symptoms may be made worse.

You should never misuse these tablets by dissolving and injecting them (e.g. into a blood vessel). In particular, they contain talc, which can cause destruction of local tissue (necrosis) and changes in lung tissue (lung granuloma). Such abuse can also have other serious consequences and may even be fatal.

The use of Oxycodone hydrochloride/Na­loxone hydrochloride may produce positive results in doping controls.

The use of Oxycodone hydrochloride/Na­loxone hydrochloride as a doping agent may become a health hazard.

Other medicines and Oxycodone hydrochloride/Naloxone hydrochloride

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Concomitant use of opioids, including oxycodone hydrochloride and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However if your doctor does prescribe Oxycodone hydrochloride/Na­loxone hydrochloride together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms. Examples of these sedatives or related medicines include:

• other potent painkillers (opioids);
• sleep medication and tranquilisers (sedatives including benzodiazepines, hypnotics, anxiolytics);
• medicines to treat depression;me­dicines used to treat allergies, travel sickness or nausea (antihistamines or antiemetics);
• medicines to treat psychiatric or mental disorders (antipsychotics which include phenothiazines and neuroleptics);
• medicines that decrease the blood’s clotting ability (coumarin derivatives), this clotting time may be speeded up or slowed down;
• antibiotics of the macrolide type (such as clarithromycin, erythromycin or telithromycin);
• antifungal medicines of the -azole type (e.g. ketoconazole, voriconazole, itraconazole or posaconazole);
• a specific type of medicine known as a protease inhibitor used to treat HIV (examples include ritonavir indinavir, nelfinavir or saquinavir);
• cimetidine (a medicine for stomach ulcers, indigestion or heartburn);
• rifampicin (used to treat tuberculosis);
• carbamazepine (used to treat seizures, fits or convulsions and certain pain conditions);
• phenytoin (used to treat seizures, fits or convulsions);
• a herbal remedy called St John’s Wort (also known as Hypericum perforatum);
• quinidine (a medicine to treat an irregular heartbeat).

No interactions are expected between Oxycodone hydrochloride/Na­loxone hydrochloride and paracetamol, acetylsalicylic acid or naltrexone.

Oxycodone hydrochloride/Naloxone hydrochloride with food, drink and alcohol

Drinking alcohol whilst taking Oxycodone hydrochloride/Na­loxone hydrochloride may make you feel more sleepy or increase the risk of serious side effects such as shallow breathing with a risk of stopping breathing, and loss of consciousness. It is recommended not to drink alcohol while you’re taking Oxycodone hydrochloride/Na­loxone hydrochloride.

You should avoid drinking grapefruit juice while you are taking these tablets.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Use of these tablets should be avoided unless your doctor thinks treatment with this medicine is essential. If used over prolonged periods during pregnancy, oxycodone hydrochloride may lead to withdrawal symptoms in newborn baby. If oxycodone hydrochloride is given during childbirth, the baby may have breathing problems (respiratory depression).

Breastfeeding

Breastfeeding should 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 for the suckling infant cannot be excluded in particular following intake of multiple doses of Oxycodone hydrochloride/Na­loxone hydrochloride.

Driving and using machines

Oxycodone hydrochloride/Na­loxone hydrochloride may affect your ability to drive or operate machines. In particular, this is likely at the start of Oxycodone hydrochloride/Na­loxone hydrochloride, after a dose increase or after switching from a different medication. However, these side effects disappear once you are on a stable Oxycodone hydrochloride/Na­loxone hydrochloride dose.

This medicine has been associated with sleepiness and episodes of suddenly falling asleep. If you experience these side effects, you must not drive or operate machinery. You should tell your doctor if this occurs.

• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive while you have this medicine in your body over a specified limit unless you have a defence (called the ‘statutory defence’).
• This defence applies when:

o The medicine has been prescribed to treat a medical or dental problem; and

o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine.

• Please note that it is still an offence to drive if you are unfit because of the medicine (i.e. your ability to drive is being affected).

Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here:

Ask your doctor whether you may drive or operate machines.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:

o The medicine has been prescribed to treat a medical or dental problem and

o You have taken it according to the instructions given by the prescriber or in the

information provided with the medicine and

o It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

3. how to take oxycodone hydrochloride/naloxone hydrochloride

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Oxycodone hydrochloride/Na­loxone hydrochloride is a prolonged-release tablet, which means that its active substances are released over an extended period. Their action lasts for 12 hours.

You must swallow the prolonged-release tablet whole, so as not to affect the slow release of oxycodone hydrochloride from the prolonged-release tablet. Do not break, chew or crush the tablets. Taking broken, chewed or crushed tablets may lead to the absorption of a potentially lethal dose of oxycodone hydrochloride (see section 3 “If you take more Oxycodone hydrochloride/Na­loxone hydrochloride than you should”).

Unless otherwise prescribed by your doctor, the usual dose is:

To treat pain

Adults

The usual starting dose is 10 mg oxycodone hydrochloride / 5 mg naloxone hydrochloride as prolonged release tablet(s) every 12 hours.

Your doctor will decide how much you should take every day and how to divide your total daily dosage into morning and evening doses. Your doctor will also decide on any necessary dose adjustments during treatment. Your dose will be adjusted according to your level of pain and individual sensitivity. You should be given the lowest dose needed for pain relief. If you have already been treated with opioids, Oxycodone hydrochloride/Na­loxone hydrochloride treatment can be started at a higher dose.

The maximum daily dose is 160 mg oxycodone hydrochloride and 80 mg naloxone hydrochloride. If you need a higher dose, your doctor may give you additional 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 affected if additional oxycodone hydrochloride is given without additional naloxone hydrochloride.

If you are switched from these tablets to another opioid pain medication your bowel function will probably worsen.

If you experience pain between two doses of Oxycodone hydrochloride/Na­loxone hydrochloride, you may need a rapid-acting painkiller. Oxycodone hydrochloride/Na­loxone hydrochloride is not suitable for this. In this case, please talk to your doctor.

If you have the impression that the effect of these tablets is too strong or too weak, please talk to your doctor or pharmacist.

To treat restless legs syndrome

Adults

The usual starting dose is 5 mg oxycodone hydrochloride/ 2.5 mg naloxone hydrochloride as prolonged-release tablet(s) every 12 hours.

Your doctor will decide how much you should take every day and how to divide your total daily dosage into morning and evening doses. They will also decide on any necessary dose adjustments during treatment. Your dose will be adjusted according to you individual sensitivity. You should be given the lowest dose needed to relieve your restless legs syndrome symptoms.

If you feel that these tablets are too strong or too weak, please talk to your doctor or pharmacist. The maximum daily dose is 60 mg oxycodone hydrochloride and 30 mg naloxone hydrochloride.

To treat pain or restless legs syndrome

Elderly

In general, no dose adjustment is necessary for elderly patients with normal kidney and/or liver function.

Liver or kidney problems

If you have kidney or mild liver problems your doctor may prescribe a lower dose. You must not take these tablets if you have moderate or severe liver problems, (see also Section 2 ‘Do not take Oxycodone hydrochloride/Na­loxone hydrochloride’ and ‘Take special care with Oxycodone hydrochloride/Na­loxone hydrochloride’ and ‘Warnings and Precautions’).

Children and adolescents below 18 years of age

No studies have been carried out to show that these tablets work properly in children and adolescents, or are safe for them to take. They are therefore not recommended for use in patients under 18 years of age.

Method of administration

Oral use.

Swallow these tablets whole (without chewing), with sufficient liquid (^ glass of water). You can take the prolonged-release tablets with or without food. Take the tablets every 12 hours, according to a fixed time schedule (e.g. at 8 o’clock in the morning and 8 o’clock in the evening). Do not break, chew or crush the prolonged-release tablets (see section 2 “Warnings and precautions”).

Opening instructions:

This medicinal product is available in peelable, child resistant perforated unit dose blisters.

Pull off a single dose by tearing along the perforated line on the blister and peel back the foil on the blister to expose the tablet.

Duration of use

In general, you should not take these tablets for any longer than you need to. If you are on long-term treatment, your doctor should regularly check whether you still need these tablets.

If you take more Oxycodone hydrochloride/Naloxone hydrochloride than you should

If you have taken more than the prescribed dose of these tablets you must inform your doctor immediately.

An overdose may result in:

• narrowed pupils
• slow and shallow breathing (respiratory depression)
• drowsiness up to loss of consciousness)
• low muscle tone (hypotonia)
• reduced pulse rate, and
• a drop in blood pressure.

In severe cases, loss of consciousness (coma), fluid on the lungs and circulatory collapse may occur, which may be fatal in some cases.

You should avoid situations which require a high level of alertness, e.g. driving.

If you forget to take Oxycodone hydrochloride/Naloxone hydrochloride

Or if you take a dose lower than the one prescribed, you may not feel any effect.

If you should forget to take your dose, please follow the instructions below:

• If your next usual dose is due in 8 hours or more: Take the forgotten dose immediately and continue with your normal dosing schedule.
• If your next usual dose is due within less than 8 hours: Take the forgotten dose. Then, wait another 8 hours before taking your next dose. Try to get back on track with your original dosing schedule (e.g. 8 o’clock in the morning and 8 o’clock in the evening). Do not take more than one dose within any 8-hour period.

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

If you stop taking Oxycodone hydrochloride/Naloxone hydrochloride

Do not stop your treatment without consulting your doctor.

If you do not require any further treatment, you must reduce the daily dose gradually after talking to your doctor. In this way, you will avoid withdrawal symptoms, such as restlessness, bouts of sweating and muscle pain.

If you have any further questions on 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 everybody gets them.

Important side effects to look out for, and what to do if you are affected:

If you are affected by 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 mostly occurs in elderly and debilitated (weak) patients. Opioids can also cause a severe drop in blood pressure in susceptible patients.

The following side effects have been seen in patients being treated for pain

Common (may affect up to 1 in 10 people)

The active substance oxycodone hydrochloride, if not combined with naloxone hydrochloride, is known to have the following differing side-effects:

Breathing problems, such as breathing more slowly or weakly than expected (respiratory depression), reduction in size of the pupils in the eye, muscle cramps and decreased cough reflex.

Common (may affect up to 1 in 10 people)

• altered mood and decreased activity difficulties in passing urine
• personality changes (e.g. increased activity hiccups

depression, feeling of extreme happiness)

Uncommon (may affect up to 1 in 100 people)

the menstrual cycle in females

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

• itching rash (urticaria) increased appetite bleeding gums
• infections such as cold black (tarry) stools

sores or herpes (which may

cause blisters around the

mouth or genital area)

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

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

The following side effects have been seen in patients being treated for restless legs syndrome

Very common (may affect 1 in 10 people or more)

• constipation sweating
• feel sick tiredness or exhaustion

Common (may affect up to 1 in 10 people)

Uncommon (may affect up to 1 in 100 people)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

5. how to store oxycodone hydrochloride/naloxone hydrochloride

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 carton and blister after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other informationthe active substances are oxycodone hydrochloride and naloxone hydrochloride.

Oxycodone hydrochloride/Na­loxone hydrochloride 5 mg/2.5 mg

Each prolonged-release tablet contains 5 mg oxycodone hydrochloride, equivalent to 4.5 mg oxycodone, and 2.5 mg naloxone hydrochloride as 2.75 mg naloxone hydrochloride dihydrate, equivalent to 2.25 mg naloxone.

Oxycodone hydrochloride/Na­loxone hydrochloride 10 mg/5 mg

Each prolonged-release tablet contains 10 mg oxycodone hydrochloride, equivalent to 9 mg oxycodone, and 5 mg naloxone hydrochloride as 5.5 mg naloxone hydrochloride dihydrate, equivalent to 4.5 mg naloxone.

Oxycodone hydrochloride/Na­loxone hydrochloride 20 mg/10 mg

Each prolonged-release tablet contains 20 mg oxycodone hydrochloride, equivalent to 18 mg oxycodone, and 10 mg naloxone hydrochloride as 11.0 mg naloxone hydrochloride dihydrate, equivalent to 9.01 mg naloxone.

Oxycodone hydrochloride/Na­loxone hydrochloride 40 mg/20 mg

Each prolonged-release tablet contains 40 mg oxycodone hydrochloride, equivalent to 36 mg oxycodone, and 20 mg naloxone hydrochloride as 22 mg naloxone hydrochloride dihydrate, equivalent to 18.02 mg naloxone.

The other ingredients are:

Tablet core

hypromellose, polyvinyl acetate, povidone, sodium laurilsulfate, cellulose microcrystalline, silicon dioxide, colloidal anhydrous silica, magnesium stearate.

Oxycodone hydrochloride/Na­loxone hydrochloride 5 mg/2.5 mg

Tablet coat :

polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, brillant blue FCF aluminum lake (E133)

Oxycodone hydrochloride/Na­loxone hydrochloride 10 mg/5 mg

Tablet coat :

polyvinyl alcohol, titanium dioxide, macrogol 3350, talc

Oxycodone hydrochloride/Na­loxone hydrochloride 20 mg/10 mg

Tablet coat :

polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, red iron oxide (E172), yellow iron oxide (E172)

Oxycodone hydrochloride/Na­loxone hydrochloride 40 mg/20 mg

Tablet coat :

polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, red iron oxide (E172) , yellow iron oxide (E172), black iron oxide (E172)

What Oxycodone hydrochloride/Naloxone hydrochloride looks like and contents of the pack

Prolonged-release tablet.

Oxycodone hydrochloride/Na­loxone hydrochloride 5 mg/2.5 mg

Blue, 9.6×4.8mm, elliptic, biconvex coated tablet, engraved with “5” on one side.

Oxycodone hydrochloride/Na­loxone hydrochloride 10 mg/5 mg

White to off-white, 9.6×4.8mm, elliptic, biconvex coated tablet, engraved with “10” on one side.

Oxycodone hydrochloride/Na­loxone hydrochloride 20 mg/10 mg

Pink, 9.6×4.8mm, elliptic, biconvex coated tablet, engraved with “20” on one side.

Oxycodone hydrochloride/Na­loxone hydrochloride 40 mg/20 mg

Yellow, 11×5.5mm, elliptic, biconvex coated tablet, engraved with “40” on one side.

Oxycodone hydrochloride/Na­loxone hydrochloride prolonged release tablets are available in peelable, child resistant perforated unit dose blisters of: 10×1, 14×1, 20×1, 28×1, 30×1, 50×1, 56×1, 60×1, 98×1, 100×1, 100×1 (Hospital pack) tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ethypharm

194 Bureaux de la Colline, Batiment D

92213 Saint Cloud cedex

France

Manufacturer

Ethypharm

Chemin de la Poudriere

76120 Le Grand Quevilly

France

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last revised in {05/2019}.

Edition 05/2019

13/13