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ORMETONE 5 MG/2.5MG PROLONGED-RELEASE TABLETS

Active substance(s): NALOXONE HYDROCHLORIDE DIHYDRATE / OXYCODONE HYDROCHLORIDE

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Package leaflet: Information for the user
Ormetone 5 mg/2.5 mg prolonged-release tablets
oxycodone hydrochloride / naloxone hydrochloride
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 Ormetone is and what it is used for
2.
What you need to know before you take Ormetone
3.
How to take Ormetone
4.
Possible side effects
5.
How to store Ormetone
6.
Contents of the pack and other information
1.

What Ormetone is and what it is used for

Ormetone is a prolonged-release tablet, which means that its active substances are
released over an extended period. Their action lasts for 12 hours.
Pain relief
You have been prescribed Ormetone for the treatment of severe pain, which can be
adequately managed only with opioid analgesics. Naloxone is added to counteract
constipation.
How Ormetone works in pain relief
Ormetone tablets contain oxycodone and naloxone as active substances. Oxycodone is
responsible for the pain relieving effect of Ormetone. It is a strong analgesic
(“painkiller”) that belongs to a group of medicines called opioids. Naloxone is intended
to counteract constipation. Constipation is a typical side effect of treatment with opioid
painkillers.
2.

What you need to know before you take Ormetone

Do NOT take Ormetone tablets
• if you are allergic to oxycodone or naloxone 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 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
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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 a type of bowel obstruction (paralytic ileus) not caused by opioids,
• if you have moderate to severe liver problems.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Ormetone:






















in the case of elderly or debilitated (weak) patients,
if you have a type of bowel obstruction (paralytic ileus) caused by opioids,
if you have kidney problems,
if you have mild liver problems,
if you have severe lung problems (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 (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 heart disease,
if you have a head injury (due to the risk of increased brain pressure),
if you suffer from epilepsy or are prone to fits,
if you are also taking a type of medicine known as a MAO inhibitor (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 Ormetone.
These tablets are not recommended for use in patients with advanced digestive or pelvic
cancers where bowel obstruction may be a problem.
Children and adolescents
This medicine must not be given to children or adolescents under 18 years of age as
the safety and benefits have not been shown yet.

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How to use Ormetone correctly
If you experience severe diarrhoea at the start of treatment (within the first 3-5 days)
this may be due to the effect of naloxone. It may be a sign that your bowel movements
are returning to normal. If diarrhoea persists after 3-5 days, or it gives you cause for
concern, please contact your doctor.
If you have been using high doses of another opioid, withdrawal symptoms (such as
restlessness, bouts of sweating or muscle pain) may occur when you initially switch to
taking these tablets. If you experience withdrawal symptoms, you may need to be
specially monitored by your doctor.
If you need to undergo surgery, please tell your doctor that you are taking this medicine.
If you have been taking this medicine for a long time, you may become tolerant. This
means you may need a higher dose to achieve the desired effect. Long-term use of these
tablets may also lead to physical dependence. Medicines containing oxycodone should be
avoided in patients with a present or past abuse of alcohol, drugs or medicines.
Withdrawal symptoms may occur if treatment is stopped too suddenly. 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.
You may notice remains of the tablet in your stools. Do not be alarmed, as the active
substances will have already been released in the stomach and gut, and absorbed into your
body.
Incorrect use of Ormetone
Ormetone is not suitable for withdrawal treatment.
This medicine should never be abused, particularly if you have a drug addiction. If you
are addicted to drugs such as heroin, morphine or methadone, severe withdrawal
symptoms are likely if you abuse this medicine because it contains the ingredient
naloxone. Pre-existing withdrawal symptoms may be made worse.
You should never misuse the tablets by dissolving and injecting them (e.g. into a blood
vessel). They contain talc, which can cause destruction of local tissue (necrosis) and
changes in lung tissue (lung granuloma). Misuse can also have other serious
consequences which may be fatal.
Other medicines and Ormetone
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
The risk of side effects is increased if you take these tablets at the same time as medicines
which affect the way the brain works. For example, you may feel very sleepy, or
breathing problems (slow and shallow breathing) may get worse.
Examples of medicines that affect the way the brain works include:

other strong painkillers (opioids),
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sleep medication and tranquilisers (sedatives, hypnotics),
antidepressants,
medicines used to treat allergies, travel sickness or nausea (antihistamines or
antiemetics),
other medicines which act on the nervous system (phenothiazines, neuroleptics).

Tell your doctor if you are taking:

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)

antifungal medicines of the –azole type (e.g. ketoconazole)

ritonavir or other protease inhibitors (used to treat HIV)

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).
Ormetone with food, drink and alcohol
Drinking alcohol whilst taking Ormetone 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
are taking Ormetone.
You should avoid drinking grapefruit juice while you are taking this medicine.
Pregnancy and breast-feeding
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 Ormetone during pregnancy should be avoided unless your doctor finds
treatment with this medicine is essential. If used over prolonged periods during
pregnancy, oxycodone may lead to withdrawal symptoms in the new born baby. If
oxycodone is given during childbirth, the baby may have breathing problems such as
slow and shallow breathing (respiratory depression).
Breast-feeding
Breast-feeding should be stopped during treatment with this medicine as oxycodone
(one of the active substances of this medicine) passes into breast milk and it is not
known whether naloxone also passes into breast milk. Therefore, a risk for the
breastfed infant cannot be excluded in particular following intake of multiple doses of
this medicine.
Driving and using machines
This medicine can affect your ability to drive or operate machines as it may make you
sleepy or dizzy. This is most likely at the start of your treatment, after a dose increase
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or after switching from a different medication. These side effects should disappear once
you are on a stable 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.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive
while taking this medicine.
Ormetone contains lactose
Ormetone 5 mg/2.5 mg contains lactose (milk sugar). If you have been told by your
doctor that you have an intolerance to some sugars, contact your doctor before taking
Ormetone 5 mg/2.5 mg.
3.

How to take Ormetone

Always take this medicine exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
You must swallow the prolonged-release tablet whole, so as not to affect the slow release
of oxycodone from the tablet. Do not break, chew or crush the prolonged-release tablets.
Taking broken, chewed or crushed tablets may result in your body absorbing a potentially
fatal dose of oxycodone (see under “If you take more Ormetone than you should”).
Unless otherwise prescribed by your doctor, the
usual dose is:
To treat pain
Adults
The usual starting dose is one Ormetone 10 mg/5 mg prolonged-release tablet every 12
hours.
Your doctor will decide how much you should to take every day and how to divide the
total daily dose into morning and evening doses. The doctor will also decide on any
necessary dose adjustment during treatment depending on 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, your treatment with this medicine may 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 without naloxone. However, the maximum daily dose of oxycodone should
not exceed 400 mg. The beneficial effect of naloxone on bowel movements may be
affected if additional oxycodone is given without additional naloxone.
If you experience pain between doses of Ormetone, you may need to take an additional
fast-acting painkiller. Ormetone is not suitable for this. Please talk to your doctor.

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If you feel that these tablets are too strong or too weak, please talk to your doctor or
pharmacist.
Elderly patients
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 will prescribe Ormetone with
special caution. You must not take these tablets if you have moderate or severe liver
problems (see also Section 2 “Do not take Ormetone tablets” and “Warnings and
Precautions”).
Children and adolescents below 18 years of age
No studies have been carried out to show that this medicine work properly in children
and adolescents, or are safe for them to take. It is therefore not recommended for use
in patients under 18 years of age.
Method of administration
Swallow your tablets whole with a glass of water. You can take these tablets with or
without food. Take them every 12 hours, according to a fixed time schedule. For instance,
if you take a tablet at 8 o’clock in the morning, you should take your next tablet at 8
o’clock in the evening. Do not break, chew or crush the tablets.
Opening instructions
This medicinal product is in child-resistant packaging. The tablets cannot be pressed out
of the blister. Please observe the following instructions when opening the blister.
1.

Separate a single dose by carefully tearing along the perforated lines.

2.

An unsealed corner is revealed at the intersection point of the perforated lines.

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3.

Slowly peel off the foil at the marked corner to unveil the pocket.

Duration of use
You should not take Ormetone for any longer than you need to. If you have been taking
the medicine for a long time your doctor should regularly check that you still need it.
If you take more Ormetone than you should
If you have taken more than the prescribed dose, you must inform your doctor
immediately.
An overdose may result in:
small (constricted) pupils,
breathing more slowly or weakly than expected (respiratory depression),
drowsiness or loss of consciousness,
low muscle tone (hypotonia),
reduced pulse rate and
a fall in blood pressure.








In severe cases, loss of consciousness (coma), fluid on the lungs and circulatory collapse
may occur, which may be fatal.
You should avoid situations which require you to be alert, e.g. driving.
If you forget to take Ormetone
If you forget to take Ormetone or if you take a lower dose than the one prescribed, you
may not feel any effect.
If you should forget to take your dose, please follow the instructions
below:

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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 in less than 8 hours: Take the forgotten dose, then,
wait another 8 hours before taking your next dose. Try to get back in your normal
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 Ormetone
Do not stop taking your treatment without first consulting your doctor.
If you do not require any further treatment, your doctor will advise you how to reduce
the daily dose gradually. 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 or signs to look out for, and what to do if you are affected:
Stop taking Ormetone and contact a doctor or go to your nearest emergency department
immediately if you experience any of the following symptoms:




A more slow or shallow breathing (respiratory depression). This is the most
serious side effect with Ormetone and it mostly occurs in elderly and weak
patients.
Opioids can also cause a severe drop in blood pressure in susceptible patients.
Swelling of the face, tongue or throat; difficulty swallowing; hives; breathing
difficulties and drop in blood pressure (anaphylactic reaction)

Other side effects that may occur are:
The following side effects have been seen in patients being treated for pain
Common (may affect up to 1 in 10 people)










Abdominal pain, indigestion, constipation, diarrhoea, wind
Dry mouth
Vomit (be sick), feel sick
Decreased appetite up to loss of appetite
A feeling of dizziness or ‘spinning’, vertigo
Headache
Hot flushes, sweating
General weakness, tiredness or exhaustion
Itchy skin, skin reactions/rash
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• Difficulty in sleeping, drowsiness

Uncommon (may affect up to 1 in 100 people)




























Abdominal bloating
Abnormal thoughts
Anxiety, confusion, depression, nervousness, difficulties to concentrate
Chest tightness especially if you already have coronary heart disease, chest pain
Drop in blood pressure, rise in blood pressure
Withdrawal symptoms such as agitation
Fainting
Palpitations
Biliary colic
Generally feeling unwell
Pain
Swelling of the hands, ankles or feet
Impaired speaking
Shaking
Restlessness
Difficulties breathing
Chills
Hepatic enzymes increased
Runny nose
Cough
Hypersensitivity/allergic reactions
Weight loss
Injuries from accidents
Increased urge to urinate
Muscle cramps, muscle twitches, muscle pain
Vision impairment
Epileptic seizures (especially in persons with epileptic disorder or predisposition to
seizures)

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





Increase in pulse rate
Dental changes
Yawning
Weight gain

Not known (cannot be estimated from the available data)










Euphoric mood
Severe drowsiness
Erectile dysfunction
Nightmares
Hallucinations
Shallow breathing
Difficulties in passing urine
Tingling in hands or feet
Belching

The active substance oxycodone hydrochloride, if not combined with naloxone
hydrochloride, is known to have the following differing side-effects:
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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 personality changes (e.g. depression, feeling of extreme happiness)
Decreased activity, increased activity
Difficulties in passing urine
Hiccups

Uncommon (may affect up to 1 in 100 people)


















Impaired concentration, agitation
Migraines
Taste anomalies
Increased muscle tension, involuntary muscle contractions
Drug dependence, drug tolerance
Ileus
Dry skin, flushing of skin
Reduced sensitivity to pain or touch
Abnormal coordination
Perception disturbances (e.g. hallucination, derealisation)
Vocal changes (dysphonia)
Water retention
Difficulties in hearing
Difficulties in swallowing
Mouth ulcers, sore gums
Reduced sex drive
Dehydration, thirst

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






Itching rash (urticaria)
Herpes simplex
Increased appetite
Black (tarry) stools
Gingival bleeding

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




Acute generalised allergic (anaphylactic reactions)
Absence of menstrual periods
Problems with bile flow

Reporting of side effects
If you get any side effects talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly via Yellow Card Scheme, Website:
www.mhra.gov.uk/yellowcard.
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By reporting side effects, you can help provide more information on the safety of this
medicine.
5.

How to store Ormetone

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.
Do not store above 25 ˚C.
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 information

What Ormetone contains
The active substances are oxycodone hydrochloride and naloxone hydrochloride
5 mg/2.5 mg prolonged-release tablets
Each prolonged-release tablet contains 5 mg oxycodone hydrochloride, equivalent to 4.5
mg oxycodone and naloxone hydrochloride dihydrate, equivalent to 2.5 mg naloxone
hydrochloride or 2.25 mg naloxone.
The other ingredients are:
5 mg/2.5 mg prolonged-release tablets
Tablet core: Microcrystalline cellulose, lactose monohydrate, ammonio methacrylate
copolymer, povidone, talc, triacetin, stearyl alcohol, magnesium stearate, anhydrous
colloidal silica.
Tablet coat: Hypromellose, macrogol, talc, titanium dioxide (E171), Brilliant Blue FCF
(E133).
What Ormetone looks like and contents of the pack
5 mg/2.5 mg prolonged-release tablets
Light blue, round, convex, blue film-coated tablets with a diameter of 7.2 mm.
The prolonged-released tablets are available in child-resistant perforated unit dose peeloff PVC/PVDC/PVC-Alu blisters.
Pack sizes are 10 x 1, 20 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1, 98 x 1 and 100 x 1.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation
Holder:
Acino AG
Am Windfeld 35

Manufacturer:
Acino AG
Am Windfeld 35
83714 Miesbach
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83714 Miesbach
Germany

Germany

This leaflet was last revised in 17th February 2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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