Patient leaflet - OXYCODONE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE GL PHARMA 30 MG / 15 MG PROLONGED-RELEASE TABLETS
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor or pharmacist.
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– 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.
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– 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
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1. What Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma is and what it is used for
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2. What you need to know before you take Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma
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3. How to take Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma
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4. Possible side effects
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5. How to store Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma
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6. Contents of the pack and other information
1. what oxycodone hydrochloride and naloxone hydrochloride gl pharma is and what it is used for
Pain relief
How Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma work in restless legs syndrome
Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma helps 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 (opioidpainkillers).
2. what you need to know before you take oxycodone hydrochloride and naloxone hydrochloride gl pharma
Do not take Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma
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– if you are allergic to oxycodone, naloxone or any of the other ingredients of this medicine
(listed in section 6).
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– if you have breathing problems, such as breathing more slowly or weakly than expected
(respiratory depression).
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– if you suffer from a severe lung disease associated with narrowing of the airways (chronic
obstructive pulmonary disease or COPD).
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– 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).
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– if you suffer from severe bronchial asthma.
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– if you have a type of bowel obstruction (paralytic ileus) not caused by opioids.
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– if you have moderate to severe liver dysfunction.
Additionally for restless legs syndrome:
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– if you have a history of opioid abuse.
Warnings and precautions
Talk to your doctor or pharmacist before taking Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma
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– in the case of elderly or debilitated (weak) patients,
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– if you have a type of bowel obstruction (paralytic ileus) caused by opioids,
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– if you have kidney problems,
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– if you have mild liver problems,
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– if you have severe lung problems (i.e. reduced breathing capacity),
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– if you suffer from a condition characterised by frequent breathing stops during the night which
may make you feel very sleepy during the daytime (sleep apnoea),
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– if you have myxoedema (a thyroid disorder, with dryness, coldness and swelling [“puffiness”]
of the skin, affecting the face and limbs),
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– if your thyroid gland is not producing enough hormones (underactive thyroid or
hypothyroidism),
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– if you have poor adrenal gland function (your adrenal gland is not working properly) for
example Addinson’s disease,
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– 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),
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– if you suffer from gallstone problems,
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– if your prostate gland is abnormally enlarged (prostate hypertrophy),
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– if you are or ever have been addicted to alcohol or drug, or have previously suffered from
withdrawal symptoms such as agitation, anxiety, shaking or sweating upon stopping alcohol or drugs,
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– if your pancreas is inflamed (pancreatitis),
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– if you have low blood pressure (hypotension),
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– if you have high blood pressure (hypertension),
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– if you have heart problems,
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– if you have a head injury (due to the risk of increased brain pressure),
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– if you suffer from epilepsy or are prone to fits,
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– if you are also taking or have taken in the last two weeks a type of medicine known as 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.
This medicine can cause breathing problems while sleeping. These problems may include pauses in breathing during sleep, being awoken by shortness of breath, difficulty staying asleep or excessive daytime drowsiness. If you or someone else observes these symptoms contact your doctor. Your doctor may want to lower your dose.
Tell your doctor if any of the above has ever applied to you in the past. Also, please contact your doctor if you develop any of them while you are taking Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma.
Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma is not recommended for use in patients with advanced digestive or pelvic cancers where bowel obstruction may be a problem.
If you experience severe diarrhoea at the start of treatment (within the first 3 to 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 to 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 and muscle pain) may occur when you initially switch to Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma. 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 Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma.
If you have been taking Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 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 this medicine 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.
There is a risk that you may develop a psychological dependence to oxycodone.
You may notice remnants of the prolonged-release 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 Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma
Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma must 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 Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma because it contains the active substance naloxone. Pre-existing withdrawal symptoms may be made worse.
You must never misuse Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma prolonged-release tablets by dissolving and injecting or inhaling 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.
Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 5 mg/2.5 mg
You must swallow these prolonged-release tablets whole so as not to affect the slow release of oxycodone from the tablets. Do not divide, break, chew or crush them. Taking divided, broken, chewed or crushed tablets may result in your body absorbing a potentially fatal dose of oxycodone (see section 3 “If you take more Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma than you should”).
Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 10mg/5mg, 20 mg/10 mg, 30 mg/15 mg and 40 mg/20 mg
Do not break, chew or crush these prolonged-release tablets so as not to affect the slow release of oxycodone from the tablets.. Taking broken, chewed or crushed tablets may result in your body absorbing a potentially fatal dose of oxycodone (see section 3 “If you take more Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma than you should”).
<The use of Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma may produce positive results in doping controls. The use of Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma as a doping agent may become a health hazard.> Children and adolescents
This medicine should not be given to children or adolescents under 18 years of age as the safety and efficacy have not been shown.
Other medicines and Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma
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 Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 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:
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– other strong painkillers (opioids)
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– sleep medicines and tranquilisers (sedatives, hypnotics)
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– antidepressants (such as paroxetine or fluoxetine)
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– medicines used to treat allergies, travel sickness or nausea (antihistamines or antiemetics)
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– other medicines which act on the nervous system (phenothiazines, neuroleptics)
The risk of side effects increases, if you use 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, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.
Concomitant use of Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma and sedative medicines such as benzodiazepines or related medicines 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 and Naloxone Hydrochloride GL Pharma 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.
Tell your doctor if you are taking:
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– medicines that decrease the blood’s clotting ability (coumarin derivatives), this clotting time
may be speeded up or slowed down
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– antibiotics of the macrolide type (e.g. clarithromycin, erythromycin, telithromycin)
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– antifungal medicines of the azole type (e.g. ketoconazole, voriconazole, itraconazole,
posaconazole)
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– ritonavir or other protease inhibitors (used to treat HIV, such as indinavir, nelfinavir, saquinavir)
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– cimetidine (used to treat stomach ulcers, indigestion or heartburn)
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– rifampicin (used to treat tuberculosis)
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– carbamazepine (used to treat seizures, fits or convulsions and certain pain conditions)
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– phenytoin (used to treat seizures, fits or convulsions)
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– St. John’s Wort
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– quinidine (used to treat an irregular heartbeat)
Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma with food, drink and alcohol
Drinking alcohol whilst taking Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 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 Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma.
You should avoid drinking grapefruit juice while you are taking Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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 Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma should be avoided to the extent possible during pregnancy. If used over prolonged periods during pregnancy, oxycodone may lead to withdrawal symptoms in newborn infants. If oxycodone is given during childbirth, respiratory depression (slow and shallow breathing) may occur in the newborn infant.
Breast-feeding
Breast-feeding should be discontinued during treatment with Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma. Oxycodone passes into breast milk. It is not known whether naloxone 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 and Naloxone Hydrochloride GL Pharma.
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 or after switching from a different medicines. 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 machines. 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.
Sodium
This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release tablet, that is to say essentially ‘sodium-free’.
3. how to take oxycodone hydrochloride and naloxone hydrochloride gl pharma
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
For doses not realisable/practicable with this strength other strengths of this medicine are available.
Unless otherwise prescribed by your doctor, the recommended dose is:
To treat pain
Adults
The usual starting dose is 10 mg oxycodone hydrochloride/5 mg naloxone hydrochloride every 12 hours.
Your doctor will decide how much you should take every day and how to divide your total daily dose into morning and evening doses. Your doctor will also decide on any necessary dose adjustments 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 Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 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 hydrochloride 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, you may need to take an additional fast-acting painkiller. Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma is not suitable for this. Please talk to your doctor.
If you feel that Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 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 every 12 hours.
Your doctor will decide how much you should take every day and how to divide your total daily dose 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 individual sensitivity. You should be given the lowest dose needed to relieve your restless legs syndrome symptoms.
The maximum daily dose is 60 mg oxycodone hydrochloride and 30 mg naloxone hydrochloride.
If you feel that Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma is 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 impairment
If you have kidney or mild liver problems, your doctor will prescribe Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma with special caution. You must not take Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma if you have moderate or severe liver problems (see also section 2. “Do not take Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma” and “Warnings and precautions”).
Method of administration
use.
Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 5 mg/2.5 mg Swallow the tablets whole with a glass of water.
Do not divide, break, chew or crush the prolonged-release tablets.
Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 10mg/5mg, 20 mg/10 mg, 30 mg/15 mg and 40 mg/20 mg The tablets can be divided into equal doses. Swallow the tablets with a glass of water. Do not break, chew or crush the prolonged-release tablets.
You can take the 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.
Opening instructions for the blister:
This medicinal product is in child-resistant packaging. The prolonged-release tablets have to be pressed out firmly of the blister.
Duration of use
You should not take Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma for any longer than you need to. If you have been taking Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma for a long time your doctor should regularly check that you still need it.
If you take more Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma than you should
If you have taken more than the prescribed dose, you must inform your doctor immediately.
An overdose may result in:
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– a reduction in size of pupils in the eye,
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– breathing more slowly or weakly than expected (respiratory depression),
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– drowsiness or loss of unconsciousness,
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– low muscle tone (hypotonia), – reduced pulse rate, – 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 Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma
If you forget to take Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma or if you take a lower dose than the one prescribed, you may not feel any effect.
If you 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.
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– 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 Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma
Do not stop taking Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma without first speaking with 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 Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 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 Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 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).
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
- 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 hands, ankles or feet
- impaired speaking
- shaking
- difficulties breathing
- restlessness
- 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)
- reduced sex drive
- lack of energy
- altered taste
- thirst
Rare (may affect up to 1 in 1,000 people)
- increase in pulse rate
- dental changes
- weight gain
- yawning
Not known (frequency cannot be estimated from the available data)
- euphoric mood
- sedation
- erectile dysfunction
- nightmares
- hallucinations
- shallow breathing
- difficulties in passing urine
- tingling in hands or feet
- belching
- aggression
- problems with breathing during sleep (sleep apnoea syndrome) , for more information see section 2 Warnings and precautions.
The active substance oxycodone, if not combined with naloxone, 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 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
- migraine
- increased muscle tension, involuntary muscle contractions
- drug tolerance
- ileus
- dry skin, flushing of skin
- reduced sensitivity to pain or touch
- abnormal coordination
- vocal changes (dysphonia)
- water retention
- difficulties in hearing
- mouth ulcers, sore gums
- difficulties in swallowing
- perception disturbances (e.g. hallucination, derealisation)
- dehydration
- a decrease in sex hormone levels which may affect sperm production in men or the menstrual cycle in females
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 generalized allergic reactions (anaphylactic reactions)
- absence of menstrual periods
- problems with bile flow
- tooth decay
- an increase in sensitivity to pain
- Long term use of Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma during pregnancy may cause life-threatening withdrawal symptoms in the new-born. Symptoms to look for in the baby include irritability, hyperactivity and abnormal sleep pattern, high pitched cry, shaking, being sick, diarrhoea and not putting on weight.
<The following side effects have been seen in patients being treated for restless legs syndrome
Very common (may affect more than 1 in 10 people)
- headache
- drowsiness
- constipation
- feel sick
- sweating
- tiredness or exhaustion
Common (may affect up to 1 in 10 people)
- decreased appetite to loss of appetite
- difficulty in sleeping
- depression
- a feeling of dizziness or “spinning”, vertigo
- difficulty in concentrating
- shaking
- tingling in hands or feet
- vision impairment
- hot flushes
- drop in blood pressure, rise in blood pressure
- pain, abdominal pain, chest pain
- dry mouth, thirst
- vomit (be sick)
- hepatic enzymes increased (alanine aminotransferase increased, gamma-glutamyltransferase
increased)
- itchy skin, skin reactions/rash
- chills
Uncommon (may affect up to 1 in 100 people)
- reduced sexual drive
- episodes of suddenly falling asleep
- altered taste
- difficulties breathing
- wind
- withdrawal symptoms such as agitation
- swelling of hands, ankles or feet
- injuries from accidents
Not known (frequency cannot be estimated from available data)
- hypersensitivity/allergic reactions
- abnormal thoughts, hallucinations, nightmares
- anxiety, confusion, nervousness, euphoric mood
- restlessness
- epileptic seizures (especially in persons with epileptic disorder or predisposition to seizures)
- severe drowsiness, fainting
- impaired speaking
- chest tightness especially if you already have coronary heart disease
- palpitations, increase in pulse rate
- shallow breathing, yawning
- cough
- runny nose
- abdominal bloating, diarrhoea, indigestion, belching
- dental changes
- biliary colic
- muscle cramps, muscle twitches, muscle pain
- difficulties in passing urine, increased urge to urinate
- erectile dysfunction
- generally feeling unwell
- weight loss, weight increase
- drug dependence
- aggression
- a feeling of unusual weakness
- lack of energy
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme () or search for MHRA Yellow Card in the Google Play or Apple App Store.
5. how to store oxycodone hydrochloride and naloxone hydrochloride gl pharma
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 Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma contains
The active substance(s) are oxycodone hydrochloride and naloxone hydrochloride.
Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 5 mg/2.5 mg
Each prolonged-release tablet contains 5 mg of oxycodone hydrochloride (equivalent to 4.5 mg oxycodone) and 2.5 mg of naloxone hydrochloride (as 2.73 mg naloxone hydrochloride dihydrate, equivalent to 2.25 mg naloxone).
Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 10 mg/5 mg
Each prolonged-release tablet contains 10 mg of oxycodone hydrochloride (equivalent to 9 mg oxycodone) and 5 mg of naloxone hydrochloride (as 5.45 mg naloxone hydrochloride dihydrate, equivalent to 4.5 mg naloxone).
Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 20 mg/10 mg
Each prolonged-release tablet contains 20 mg of oxycodone hydrochloride (equivalent to 18 mg oxycodone) and 10 mg of naloxone hydrochloride (as 10.9 mg naloxone hydrochloride dihydrate, equivalent to 9 mg naloxone).
Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 30 mg/15 mg
Each prolonged-release tablet contains 30 mg of oxycodone hydrochloride (equivalent to 27 mg oxycodone) and 15 mg of naloxone hydrochloride (as 16.35 mg naloxone hydrochloride dihydrate, equivalent to 13.5 mg naloxone).
Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 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 naloxone hydrochloride dihydrate, equivalent to 18 mg naloxone).
The other ingredients are:
Tablet core:
Polyvinyl acetate, Povidone K30, Sodium lauryl sulphate, Silica, colloidal anhydrous, Cellulose, microcrystalline, Magnesium stearate
Tablet coating:
Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 5 mg/2.5 mg
Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.
Oxycodone Hydrochloride
and Naloxone Hydrochloride
GL Pharma 10 mg/5 mg
Polyvinyl alcohol, titanium dioxide (E171), iron oxide red (E172), macrogol 3350, talc.
Oxycodone Hydrochloride and
Naloxone Hydrochloride GL
Pharma 20 mg/10 mg
Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.
Oxycodone Hydrochloride and
Naloxone Hydrochloride GL
Pharma 30 mg/15 mg
Polyvinyl alcohol, titanium dioxide (E171), iron oxide yellow (E172), macrogol 3350, talc.
Oxycodone Hydrochloride and
Naloxone Hydrochloride GL
Pharma 40 mg/20 mg
Polyvinyl alcohol, titanium dioxide (E171), iron oxide red (E172), macrogol 3350, talc.
What Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma looks like and contents of the pack
Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 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.
Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 10 mg/5 mg
Pink, oblong, biconvex prolonged-release tablet with break scores 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.
Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 20 mg/10 mg
White, oblong, biconvex prolonged-release tablet with break scores 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.
Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 30 mg/15 mg
Yellow, oblong, biconvex prolonged-release tablet with break scores 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.
Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 40 mg/20 mg
Pink, oblong, biconvex prolonged-release tablet with break scores 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.
Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 5 mg/2.5 mg
Child-resistant blisters of 28 prolonged-release tablets
Oxycodone Hydrochloride and Naloxone Hydrochloride GL Pharma 10 mg/5 mg, 20 mg/10 mg, 30 mg/15 mg40 mg/20 mg,
Child-resistant blisters of 28 and 56 prolonged-release tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
This leaflet was last revised in November 2021.
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