OXYCODONE G.L. PHARMA 10 MG PROLONGED-RELEASE TABLETS - patient leaflet, side effects, dosage

Patient leaflet - OXYCODONE G.L. PHARMA 10 MG PROLONGED-RELEASE TABLETS

1. what oxycodone g.l. pharma is and what it is used for

This medicine has been prescribed for you for the treatment of severe pain , which requires treatment with an opioid analgesic because other painkillers have not been effective. It contains oxycodone which belongs to a class of medicines called opioids, which are ‘pain relievers’.

This medicine has been prescribed to you and should not be given to anyone else.

Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

2. what you need to know before you take oxycodone g.l. pharma

Do not take Oxycodone G.L. Pharma

– if you are allergic to oxycodone hydrochloride, soya, peanut, or any of the other ingredients of this medicine (listed in section 6).
– if you have breathing problems, such as breathing more slowly or more weakly 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 have a certain heart condition known as cor pulmonale.
– if you have asthma.
– if you have a type of bowel obstruction called paralytic ileus.
– if you have acute severe stomach pain or suffer from a delayed stomach emptying.

Warnings and precautions

Talk to your doctor or pharmacist before using Oxycodone G.L. Pharma

– if you are elderly or debilitated (weak).
– if your lung, liver or kidney function is severely impaired.
– if you have a certain disorder of the thyroid gland (myxoedema) or if your thyroid gland does not produce enough hormone (underactive thyroid).
– if you have poor adrenal gland function (your adrenal gland is not working properly) for example Addinson’s disease.
– if your prostate is abnormally enlarged.
– if you are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
– if you have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
– if you feel you need to take more of Oxycodone G.L. Pharma to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.
– if you have an inflammation of the pancreas (pancreatitis) or if you have problems with your gall bladder.
– if you have difficulty or pain passing urine.
– if your brain pressure is increased.
– if you have low blood pressure or feel dizzy standing up. – if you suffer from epilepsy or are prone to fits.
– if you are also taking a type of medicine known as MAO inhibitors (generally used for the treatment of depression or Parkinson’s disease ).

Dependence and tolerance

Taking this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment.

Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.

Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

Anti-Doping Warning

The use of Oxycodone G.L. Pharma may produce positive results in doping controls.

Use of Oxycodone G.L. Pharma as a doping agent may be a health hazard.

Other medicines and Oxycodone G.L. 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 G.L. Pharma at the same time as medicines which affect the way the brain works. For example, you may feel very sleepy, or breathing problems may get worse.

Medicines that affect the way the brain works include:

– other strong pain killers (opioids),
– sleeping pills and tranquillisers,
– antidepressants,
– medicines used to treat allergies, travel sickness or nausea (antihistamines or antiemetics),
– other medicines which act on the nervous system (phenothiazines, neuroleptics),
– medicines used to treat Parkinson’s disease (so-called MAO inhibitors, see also section “Warnings and precautions”).

Concomitant use of Oxycodone G.L. Pharma 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 G.L. 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.

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.

Further interactions may occur with

– cimetidine (used to manage excess of gastric acid).

It may prolong the duration of effects of Oxycodone G.L. Pharma in your body.

– medicines against blood clotting (e.g. warfarin). Oxycodone G.L. Pharma may influence their effects.
– certain antibiotics, antifungal medicines, medicines that inhibit the function of the protease enzyme (such as boceprevir, ritonavir, indinavir, nelfinavir, saquinavir) and medicines containing St. John’s Wort.

Oxycodone G.L. Pharma with food and drink and alcohol

Drinking alcohol whilst taking Oxycodone G.L. 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’re taking Oxycodone G.L. Pharma. The tablets should be avoided in patients with a history of or present alcohol and drug abuse.

Grapefruit juice may increase the levels of Oxycodone G.L. Pharma in your blood. Check with your doctor if you drink grapefruit juice regularly.

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

Do not take Oxycodone G.L. Pharma if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.

If you use Oxycodone G.L. Pharma during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Breast-feeding

Do not take Oxycodone G.L. Pharma while you are breastfeeding as oxycodone passes into breast milk and will affect your baby.

Driving and using 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:

– The medicine has been prescribed to treat a medical or dental problem and
– You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
– 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.

Oxycodone G.L. Pharma contains lecithin (soya)

If you are allergic to peanut or soya, do not use this medicinal product.

3. how to take oxycodone g.l. pharma

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

DOSAGE

For doses not realisable/practicable with this strength, other strengths of this medicinal product are available.

Your doctor will adjust your dosage according to pain intensity and to your individual susceptibility.

Please talk to your doctor, if you think that the effect of Oxycodone G.L. Pharma is too weak or too strong.

If not prescribed otherwise by your doctor, the recommended dose is

- for adults and adolescents (above 12 years):

The usual starting dose is 10 mg oxycodone hydrochloride every 12 hours.

- for children (below 12 years):

Use in children below 12 years is not recommended as the safety and efficacy of Oxycodone G.L. Pharma has 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 doses as given for adults above.

- for patients with kidney and/or liver disorders, or with low body weight:

Your doctor may prescribe a lower starting dose.

For patients who have been treated with other strong pain killers (opioids) before , the doctor may prescribe a higher starting dose.

Your doctor will decide how much you should take every day after that, 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 become necessary during treatment.

Your prescriber should have discussed with you, how long the course of tablets will last.

They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.

GI_GB, Oxycodone G.L. Pharma 5/10/20/40/80 mg Tab.

Patients with cancer pain usually require daily dosages between 80 and 120 mg of oxycodone hydrochloride daily. In individual cases, the doctor may increase the dose to up to 400 mg daily.

For the treatment of non-cancer pain a daily dose of 40 mg oxycodone hydrochloride is generally sufficient, but higher doses may be needed in some cases.

If you experience pain between doses of Oxycodone G.L. Pharma, you may need to take and additional fast-acting painkiller.

Oxycodone G.L. Pharma is not suitable for this. Please talk to your doctor if you have this problem.

Your doctor will check your treatment on a regular basis.

METHOD OF ADMINISTRATION

Take the prolonged-release tablets as a whole with a sufficient amount of liquid (e.g. 'A glass of water) in the morning and in the evening, every 12 hours (for instance, one tablet at 8 o’clock in the morning, and the next one at 8 o’clock in the evening). You can take the tablets with or without food.

Do not break, chew, or crush the tablets. Doing so may cause them to release all their contents into the body at once, which results in a risk of overdose and possibly even death (see also “If you take more Oxycodone G.L. Pharma than you should” below).

If you take more Oxycodone G.L. Pharma than you should Contact a doctor immediately if you have taken more tablets than you have been prescribed.

Symptoms of overdose are: a reduction in the size of the pupils, breathing problems, feeling weak in the muscles (low muscle tone, hypotonia), and a fall in blood pressure. In severe cases drowsiness or fainting due to a failure of the circulatory system (circulatory collapse), impairment of thinking and of movement, loss of consciousness (coma), reduced pulse rate and accumulation of fluid in the lungs (with symptoms such as difficulty breathing particularly when lying down and a cough productive of frothy sputum which may be pink or bloodstained, excessive sweating, anxiety and pale skin) may occur.

Use of large amounts of Oxycodone G.L. Pharma may result in death.

If you forget to take Oxycodone G.L. Pharma

If you take a smaller dose of Oxycodone G.L. Pharma than prescribed, or if you miss a dose, adequate pain relief will probably not be achieved.

If you forget to take one dose, you can take the forgotten dose as soon as you remember it.

Please note that you are supposed to take the tablets at 12 hourly (twice daily) intervals.

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

If you stop taking Oxycodone G.L. Pharma

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

– itchy rash, blisters on the skin and the mucous membranes (cold sores or herpes), increased sensitivity to light.
– blood in urine.
– changes in body weight (loss or rise), skin inflammation.

Very rare (may affect up to 1 in 10,000 people)

– speech disorders.
– scaly rash.
– soya lecithin may cause allergic reactions.

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

– severe allergic reactions.
– aggression.
– dependence and addiction (see section “How do I know if I am addicted?”).
– increased sensitivity to pain.
– cavities or tooth decay.
– absence of a menstrual period.
– Long term use of Oxycodone G.L. 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.

Drug Withdrawal

When you stop taking Oxycondone G.L. Pharma, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.

How do I know if I am addicted?

If you notice any of the following signs whilst taking Oxycodone G.L. Pharma, it could be a sign that you have become addicted.

– You need to take the medicine for longer than advised by your prescriber.
– You feel you need to use more than the recommended dose.
– You are using the medicine for reasons other than prescribed.
– When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again.

If you notice any of these signs, it is important you talk to your prescriber.

Reporting of side effects

If you get any of the side effects, talk to your doctor or pharmacist. This includes any possibble side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system:

Yellow Card Scheme

Website:

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE OXYCODONE G.L. PHARMA

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine 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 in connection with medicines such as Oxycodone G.L. Pharma (opioids), and may even be fatal after high doses of this medicine.
- Allergic reactions. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

OTHER SIDE EFFECTS

Very common (affects more than 1 user in 10)

– drowsiness, dizziness, headache.
– constipation, feeling or being sick, vomiting. Your doctor will prescribe an appropriate medicine to treat these symptoms.
– itching.

Common (affects 1 to 10 users in 100)

– decreased appetite.
– changes in mood (anxiety, confusion, depression, nervousness, sleep disorders, abnormal thoughts).
– uncontrolled trembling or shaking movements in one or more parts of your body, feeling weak.
– tingling or numbness (e.g. in the hands or feet), lowering of blood pressure, rarely accompanied by symptoms such as feeling your heartbeat or fainting.
– difficulty in breathing or wheezing.
– dry mouth, rarely accompanied by thirst and difficulty swallowing, general symptoms of indigestion such as stomach ache, diarrhoea, heartburn.
– rash, heavy sweating.
– sweating, weakness.

Uncommon (affects 1 to 10 users in 1,000)

– allergic reactions.
– increase in the amount of a certain hormone (ADH = antidiuretic hormone) in the blood with symptoms such as headache, irritability, lethargy, nausea, vomiting, confusion and disturbance of consciousness.
– lack of water in the body (dehydration).
– restlessness, mood swings, hallucinations, euphoric mood, decreased libido.
– convulsions, increased or decreased muscle tension, tics, reduced sensitivity to pain or touch, taste changes.
– visual impairment, reduction in the size of the pupils.
– feeling of spinning or whirling (vertigo).
– unpleasant sensation irregular and/or forceful beating of the heart, increased pulse rate.
– widening of the blood vessels causing low blood pressure.
– shortness of breath, increased coughing, sore throat, runny nose, voice changes.
– difficulty swallowing, mouth ulcers, sore gums, flatulence (excessive gas in the stomach or bowel), belching, obstruction of the bowel (ileus).
– increased blood levels of certain hepatic enzymes.
– dry skin.
– problems passing urine, frequent urination.
– decreased sexual desire and inability to have or mainitain an erection during sexual intercourse.
– chills, feeling sick, injuries due to accidents resulting from decreased alertness, pain (e.g. chest pain), fluid retention (oedema), migraine, thirst, physical dependence with withdrawal symptoms, tolerance.

Rare (affects 1 to 10 users in 10,000)

– lymph node disease.
– muscle spasms, epileptic seizures (fits), in particular in patients suffering from epilepsy or with a tendency to seizures.
– low blood pressure.
– drop in blood pressure after getting up from a lying or sitting position.
– bleeding gums, increased appetite, dark-coloured stools.

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not throw away 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 G.L. Pharma contains

– The active substance is oxycodone hydrochloride.

Oxycodone G.L. Pharma 5 mg: 1 tablet contains 5 mg oxycodone hydrochloride corresponding to 4.48 mg oxycodone.

Oxycodone G.L. Pharma 10 mg: 1 tablet contains 10 mg oxycodone hydrochloride corresponding to 8.97 mg oxycodone.

Oxycodone G.L. Pharma 20 mg: 1 tablet contains 20 mg oxycodone hydrochloride corresponding to 17.93 mg oxycodone.

Oxycodone G.L. Pharma 40 mg: 1 tablet contains 40 mg oxycodone hydrochloride corresponding to 35.86 mg oxycodone.

Oxycodone G.L. Pharma 80 mg: 1 tablet contains 80 mg oxycodone hydrochloride corresponding to 71.72 mg oxycodone.

– The other ingredients are

Tablet core: Kollidon SR (consisting of poly(vinylacetate); povidone (K = 22.5–27.0); sodium lauryl sulphate; silica); cellulose, microcrystalline; colloidal anhydrous silica; magnesium stearate, vegetable.

Tablet coating:

Oxycodone G.L. Pharma 5 mg: polyvinyl alcohol; talc (E 553b); titanium dioxide (E 171); macrogol 3350; lecithin (soya) (E 322); iron oxide yellow (E 172); iron oxide black (E 172); indigo carmine; aluminium lake (E 132).

Oxycodone G.L. Pharma 10 mg: polyvinyl alcohol; talc (E 553b); titanium dioxide (E 171); macrogol 3350; lecithin (soya) (E 322).

Oxycodone G.L. Pharma 20 mg: polyvinyl alcohol;, talc (E 553b); titanium dioxide (E 171); macrogol 3350; lecithin (soya) (E 322); iron oxide yellow (E 172); iron oxide black (E 172); iron oxide red (E 172).

Oxycodone G.L. Pharma 40 mg: polyvinyl alcohol; talc (E 553b); titanium dioxide (E 171); macrogol 3350; lecithin (soya) (E 322); iron oxide yellow (E 172); iron oxide black (E 172); iron oxide red (E 172).

Oxycodone G.L. Pharma 80 mg: polyvinyl alcohol; talc (E 553b); titanium dioxide (E 171); macrogol 3350; lecithin (soya) (E 322); iron oxide yellow (E 172); iron oxide black (E 172); indigo carmine, aluminium lake (E 132).

What Oxycodone G.L. Pharma looks like and contents of the pack

Oxycodone G.L. Pharma 5 mg prolonged-release tablets are light grey, round and biconvex film-coated tablets.

Oxycodone G.L. Pharma 10 mg prolonged-release tablets are white, round and biconvex film-coated tablets.

Oxycodone G.L. Pharma 20 mg prolonged-release tablets are pale pink, round and biconvex film-coated tablets.

Oxycodone G.L. Pharma 40 mg prolonged-release tablets are beige, round and biconvex film-coated tablets.

Oxycodone G.L. Pharma 80 mg prolonged-release tablets are pale green, round and biconvex film-coated tablets.

Oxycodone G.L. Pharma prolonged-release tablets are available in blisters containing 7, 10, 14, 20, 28, 30, 50, 56, 60, 72, 98, and 100 prolonged-release tablets or in unitdose blisters of 30×1, 50×1, 56×1, 60×1, 72×1, 98×1, and 100×1 prolonged-release tablets.

Not all pack sizes will be marketed.

Marketing Authorisation Holder and Manufacturer

G.L. Pharma GmbH

Schlossplatz 1, 8502 Lannach, Austria

Leaflet last revised February 2020.

Praparatenamen/Starke: