5 mg and 10 mg film-coated tablets
oxycodone hydrochloride
What Oxycodone GL is and what it is used for
Oxycodone GL is a strong painkiller that belongs to the group of opioids.
Oxycodone GL is used to treat severe pain that requires treatment with opioid analgesics as other painkillers have not been effective.
Oxycodone hydrochloride contained in Oxycodone GL may also be authorized for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Oxycodone GL
Do not take Oxycodone GL
– if you are allergic to oxycodone hydrochloride, peanuts or soy, or any of the other ingredients of this medicine (listed in section 6).
– if you have breathing problems, such as slower or weaker breathing than expected ( respiratory depression)
– if you have too much carbon dioxide in your blood
– if you suffer from a severe chronic lung disease associated with narrowing of the airways (COPD = chronic obstructive pulmonary disease )
– if you suffer from a specific heart disease called cor pulmonale.
– if you have asthma
– if you have a type of bowel obstruction called paralytic ileus
– if you have acute severe abdominal pain or suffer from delayed gastric emptying.
Warnings and cautions
Talk to your doctor or pharmacist before using Oxycodone GL.
– if you are elderly or debilitated (impaired general condition)
– if you have severe lung, liver, or kidney function
– if you have a certain disease in the thyroid gland ( myxedema ) or case of insufficient production of thyroid hormone (underactive thyroid gland )
– if you have a poor adrenal function (ie the adrenal glands do not work properly), for example, Addison’s disease
– if you have an enlarged prostate
– if you suffer from alcoholism or are undergoing treatment for alcohol dependence
– if you are or have previously been addicted to strong painkillers ( opioids )
– if you have pancreatitis ( pancreatitis ) or if you have problems with the gallbladder
– if you have difficulty urinating or experience pain when urinating
– in case of elevated pressure in the brain
– if you have low blood pressure or become dizzy when you get up
– if you have epilepsy or are prone to seizures
– if you are also taking MAOIs (usually used to treat depression or Parkinson’s disease ) or if you have been taking them for the last 2 weeks.
Dependence and tolerance
When Oxycodone GL is used for long-term treatment, tolerance to the medicine may develop. This means that you may need a higher dose to achieve the desired pain relief.
Oxycodone GL is potentially addictive. If treatment is stopped abruptly, withdrawal symptoms may occur. If you no longer need treatment, your doctor will gradually reduce your daily dose.
If this medicine is used as intended, the risk of physical and mental dependence is low. Your doctor will weigh any risks against the expected benefits. Talk to your doctor if you have any questions about this.
Other medicines and Oxycodone GL
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
The risk of side effects increases if you take Oxycodone GL at the same time as medicines that affect the way your brain works. For example, you may feel very sleepy or any breathing problems may worsen.
Drugs that affect how the brain works are:
– other strong painkillers ( opioids )
sleeping pills and sedatives
– antidepressants
– medicines used for allergies, motion sickness, or nausea ( antihistamines or antiemetics)
– other drugs that act on the nervous system (phenothiazines, neuroleptics )
– medicines for the treatment of Parkinson’s disease (so-called MAO inhibitors, see also section “Warnings and precautions”).
The risk of side effects is increased if you take antidepressant drugs (for example, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline , venlafaxine ). These drugs can affect or be affected by oxycodone, and you may experience symptoms such as involuntary, rhythmic muscle contractions, including in the muscles that control eye movements, sudden movements, heavy sweating, tremors, excessive reflexive movements, increased muscle tension, body temperature above 38 ° C. Contact your doctor if you experience these symptoms.
Concomitant use of Oxycodone GL and sedatives or medicines for sleep disorders such as benzodiazepines or similar medicines increases the risk of drowsiness, difficulty breathing ( respiratory depression ), coma and may be life-threatening. Due to this, concomitant use should only be considered when second treatment options are not possible.
If your doctor prescribes Oxycodone GL at the same time as sedatives, the dose and treatment time should be limited by your doctor.
Tell your doctor if you are taking any sedatives and carefully follow your doctor’s dose recommendations. It may be helpful to inform friends or relatives about paying attention to the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.
Additional interaction may occur with you
– cimetidine (used to regulate excess stomach acid). It can prolong the effects of Oxycodone GL in your body
medicines for blood clots (eg warfarin ). Oxycodone GL may affect its effects.
certain antibiotics, antifungals, and medicines containing St. John’s wort.
Oxycodone GL with food, drink, and alcohol
These tablets should not be taken with alcohol. Alcohol use can aggravate serious side effects of oxycodone, such as drowsiness and drowsiness and slow and shallow breathing.
The tablets should be avoided in patients with previous or ongoing alcohol and drug abuse.
Grapefruit juice may increase the levels of Oxycodone GL in the blood. Ask your doctor if you drink grapefruit juice regularly.
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
The use of Oxycodone GL should be avoided as far as possible during pregnancy.
Prolonged use of oxycodone during pregnancy may cause withdrawal symptoms in newborns. If oxycodone is given during childbirth, the baby may have breathing problems.
Breast-feeding
Breast-feeding should be discontinued during treatment with Oxycodone GL. Oxycodone hydrochloride passes into breast milk. Therefore, a risk to the breast-fed infant can not be ruled out, especially after taking several doses of Oxycodone GL.
Driving and using machines
Oxycodone GL may impair alertness and responsiveness to such an extent that it is no longer possible to drive or use tools or machines.
Ask your doctor if you can drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Oxycodone GL contains lactose, soy lecithin, and nycockin (E 124)
This medicine 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 this medicine.
Do not use this medicine if you are allergic to peanuts or soy.
Oxycodone GL 5 mg film-coated tablets contain the dye nycockin (E 124) which may cause allergic reactions.
How to take Oxycodone GL
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
DOSAGE
For dosages that are not practically feasible with this strength, other strengths of this drug are available.
Your doctor will adjust the dose depending on your pain intensity and your sensitivity.
Talk to your doctor if you think the effect of Oxycodone GL is too weak or too strong.
Unless otherwise prescribed by your doctor, the recommended dose is one
– for adults and adolescents (12 years and older):
The usual starting dose is 5 mg oxycodone hydrochloride every 6 hours. If necessary, the dosing interval can be shortened to four hours by your doctor. However, Oxycodone GL should not be taken more often than 6 times a day.
– for children (under 12 years):
Use in children under 12 years of age is not recommended as the safety and efficacy of Oxycodone Hydrochloride GL have not been studied in this age group.
– for the elderly (65 years and older):
Elderly patients with normal liver and/or kidney function may take the same dose as is indicated for adults above.
– in patients with kidney and/or liver disease, or with low body weight:
Your doctor may prescribe a lower starting dose.
For patients who have been treated with other strong painkillers ( opioids ) before, the doctor may prescribe a higher starting dose.
Your doctor will decide how much to take each day thereafter, and how to divide your total daily dose into morning and evening doses. Your doctor will also advise you on any dose adjustments that may be necessary during treatment.
If you experience pain between doses of Oxycodone GL, you may need higher doses of Oxycodone GL. Talk to your doctor if you have this problem.
If you need long-term treatment of severe pain, you will need to switch to oxycodone hydrochloride tablets with a modified release.
METHOD OF ADMINISTRATION
The tablets should be swallowed. Take the film-coated tablets with a sufficient amount of liquid (eg ½ glass of water) every 4 to 6 hours as prescribed by your doctor. You can take the tablets with or without food.
If you take more Oxycodone GL then you should
Contact a doctor immediately if you have taken more tablets than you were prescribed.
Symptoms of overdose include decreased pupil size, difficulty breathing, muscle weakness (low muscle tension), and a drop in blood pressure. In severe cases, drowsiness or fainting may occur due to failing circulatory organs (circulatory collapse), impaired thinking and mobility, unconsciousness ( coma ), decreased heart rate, and fluid accumulation in the lungs.
Using large amounts of Oxycodone GL can be fatal.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to take Oxycodone GL
If you take a smaller dose of Oxycodone GL than you were prescribed or if you miss a dose, adequate pain relief is unlikely to be achieved.
If you forget to take a dose, you can take the missed dose as soon as you remember. Note that you should take the tablets at 4 to 6-hour intervals.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Oxycodone GL
Do not stop treatment without first talking to your doctor as withdrawal symptoms may occur.
If you no longer need Oxycodone GL treatment, your doctor will tell you how to reduce the dose gradually to prevent the onset of withdrawal symptoms.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Oxycodone GL can cause side effects, although not everybody gets them.
Contact a doctor immediately if any of the following symptoms occur :
• Very slow or weak breathing ( respiratory depression ). This is the most serious risk of taking medicines such as Oxycodone GL ( opioids ), and may even be fatal after high doses of this medicine.
OTHER SIDE EFFECTS AR
Very common (may affect more than 1 user in 10)
drowsiness to drowsiness, dizziness, headache.
– constipation, nausea, vomiting. Your doctor will prescribe an appropriate medication to treat these symptoms.
itching. _
Common (may affect up to 1 in 10 people)
– mood swings, anxiety, confusion, depression, nervousness, sleep disorders, abnormal thoughts.
– uncontrolled tremors and tremors in one or more parts of the body, feeling weak.
– drop in blood pressure in rare cases accompanied by symptoms such as e.g. feeling their heartbeat or fainting.
– difficulty breathing or wheezing.
dry mouth, in rare cases accompanied by thirst and difficulty swallowing, general symptoms of stomach upset such as stomach pain, diarrhea, heartburn.
– skin rash, heavy sweating.
– sweating, weakness.
Uncommon (may affect up to 1 in 100 people)
– allergic reactions.
– increased amount of a certain hormone ( ADH = antidiuretic hormone ) in the blood.
– dehydration in the body (dehydration)
restlessness, mood swings, hallucinations, elation, decreased sexual desire, drug addiction.
memory loss, tingling, and numbness (eg in hands and feet) increased or decreased muscle tension, tics, speech disorders, fainting, decreased sensitivity to pain or touch, taste changes.
– visual impairment, reduced pupil size.
– dizziness.
– the unpleasant feeling of irregular and/or heavy heartbeat, increased heart rate.
– dilation of blood vessels and low blood pressure.
shortness of breath, increased cough, sore throat, runny nose, voice changes.
– difficulty swallowing, cold sores, pain in the gums, flatulence in the stomach or intestines, belching, bowel obstruction.
elevated liver enzyme levels in the blood.
– dry skin.
– difficulty urinating, urinary incontinence.
decreased sexual desire and inability to get or keep an erection during intercourse.
chills, malaise, injuries due to accidents due to decreased alertness, pain (eg chest pain), fluid retention ( edema ), migraine, thirst, physical dependence with withdrawal symptoms, tolerance.
Rare (may affect up to 1 in 1,000 people)
a disease of lymph nodes.
muscle spasms, epileptic seizures (attacks), especially in patients with epilepsy or with a tendency to seizures.
– low blood pressure.
– bleeding gums, increased appetite, dark stools.
itchy rash, blisters on the skin and mucous membranes (cold sores or herpes ), increased sensitivity to light.
– blood in the urine.
changes in body weight (loss or increase), connective tissue inflammation.
Very rare (may affect up to 1 in 10,000 people)
– scaly rash.
– missed periods.
Has been reported (occurs in an unknown number of users)
severe allergic reactions.
– aggression.
– increased sensitivity to pain.
caries or cavities in the teeth.
stoppage of bile flow, bile colic (which causes stomach pain).
Prolonged use of Oxycodone GL during pregnancy may cause life-threatening withdrawal symptoms in newborns. Symptoms to look for in the child are irritability, hyperactivity, and abnormal sleep patterns, including crying, shaking, nausea, diarrhea, and lack of weight gain.
How to store Oxycodone GL
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister pack and carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
Content declaration
Oxycodone GL 5 mg film-coated tablets
– The active substance is oxycodone hydrochloride. 1 tablet contains 5 mg oxycodone hydrochloride, equivalent to 4.48 mg oxycodone.
Other ingredients are
Tablet core: sodium starch glycolate type A, lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.
Tablet coating: Polyvinyl alcohol, talc (E 553b), titanium dioxide (E 171), macrogol 3350, soy lecithin (E 322), Indigo carmine aluminum lacquer (E 132), neocon aluminum lacquer (E 124).
Oxycodone GL 10 mg film-coated tablets
– The active substance is oxycodone hydrochloride. 1 tablet contains 10 mg oxycodone hydrochloride, which is equivalent to 8.97 mg oxycodone.
Other ingredients are
Tablet core: sodium starch glycolate type A, lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.
Tablet coating: Polyvinyl alcohol, talc (E 553b), titanium dioxide (E 171), macrogol 3350, soy lecithin (E 322), Indigo carmine aluminum lacquer (E 132).
What the medicine looks like and the contents of the pack
Oxycodone GL 5 mg film-coated tablets
Oxycodone GL 5 mg film-coated tablets are dark blue, round, curved, and biconvex film-coated tablets.
Oxycodone GL 5 mg film-coated tablets are available in blisters containing 7, 10, 14, 20, 28, 30, 50, 56, 60, 72, 98 and 100 film-coated tablets or in single-dose blisters of 30×1, 50×1, 56×1, 60×1, 72×1, 98×1 and 100×1 film-coated tablets or in tablet cans containing 50, 100 and 250 tablets.
Oxycodone GL 10 mg film-coated tablets
Oxycodone GL 10 mg film-coated tablets are medium blue, curved, oblong film-coated tablets with a scoreline on both sides. The tablet can be divided into two equal parts.
Oxycodone GL 10 mg film-coated tablets are available in blisters containing 7, 10, 14, 20, 28, 30, 50, 56, 60, 72, 98 and 100 film-coated tablets or in single-dose blisters of 30×1, 50×1, 56×1, 60×1, 72×1, 98×1 and 100×1 film-coated tablets or in tablet cans containing 50, 100 and 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
GL Pharma GmbH
Schlossplatz 1
Launch 8502
Austria
Agent: GL Pharma Nordic Aktiebolag, 216 47 Limhamn
This medicinal product is authorized under the European Economic Area under the names:
Austria: Oxygerolan 5, 10 mg Film-Tablet
Denmark: Oxycodone hydrochloride GL 5, 10 mg film-coated tablets
Germany: Oxycodone Hydrochloride GL 5, 10 mg Film Tablet
Netherlands: Oxycodone HCl GL 5, 10 mg film-coated tablet
Sweden: Oxycodone GL 5, 10 mg film-coated tablet