Active ingredient
- oxycodone hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL 01883/0318, PL 01883/0319, PL 01883/0320, PL 01883/0321, PL 01883/0322, PL 01883/0323, PL 01883/0324, PL 01883/0325.
Abtard Prolonged Release Tablets
INFORMATION FOR THE PATIENT
Abtard 5 mg prolonged-release tablets
Abtard 10 mg prolonged-release tablets
Abtard 15 mg prolonged-release tablets
Abtard 20 mg prolonged-release tablets
Abtard 30 mg prolonged-release tablets
Abtard 40 mg prolonged-release tablets
Abtard 60 mg prolonged-release tablets
Abtard 80 mg prolonged-release tablets
Oxycodone hydrochloride
This medicine contains oxycodone which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Abtard is and what it is used for
2. What you need to know before you take Abtard
3. How to take Abtard
4. Possible side effects
5. How to store Abtard
6. Contents of the pack and other information
1. What Abtard is and what it is used for
This medicine has been prescribed for you to relieve severe pain, which can only be controlled by opioid analgesics in adults and adolescents 12 years of age and older. The Tablets are effective for 12 hours.
It contains the 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 Abtard
Your doctor may have prescribed another use or dose than that given in this leaflet. You should always follow your doctor’s instructions and the information on the dosage label.
Do not take Abtard
Warnings and precautions
Talk to your prescriber before taking this medicine if you:
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.
Abtard is not recommended for use before an operation or in the 24 hours after an operation.
If you have blood or urine tests, notify the clinic that you are taking Abtard as this may affect the test results.
Children and adolescents
Oxycodone has not been investigated in children under 12 years. Safety and efficacy have not been established and therefore use in children under 12 years of age is not recommended.
Elderly patients
If kidney or liver function is not impaired, a dose adjustment is usually not necessary for elderly patients.
Other medicines and Abtard
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription, medicines bought in another country, natural remedies and strong doses of vitamins and minerals.
The following medicines may influence the effect or side effects of Abtard
If you take Abtard with other medicines to prevent coronary thrombosis (coumarin anticoagulant, e.g. Warfarin), your blood’s capacity to coagulate (thicken) may be increased or reduced. It may be necessary to adjust the dose of Abtard.
The following medicines may possibly increase the blood levels of oxycodone and your doctor may need to reconsider the dose of Abtard;
Some medicines can limit the effect of Abtard, and make it necessary to increase the dose:
Please note that the above may also apply to medicine you took a few days ago or medicine that you must take within the next couple of days.
Concomitant use of Abtard and sedative medicines such as benzodiazepines 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 Abtard 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 sign 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.
Grapefruit juice may also increase the blood levels of oxycodone.
Abtard with food, drink and alcohol
You should not drink alcohol while you are taking Abtard. Drinking alcohol whilst taking Abtard 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.
You can take Abtard with or without food. Grapefruit juice can inhibit the metabolism of oxycodone which will increase its effect. Therefore you should avoid drinking grapefruit juice while taking Abtard.
Pregnancy
Do not take Abtard 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 Abtard 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 Abtard while you are breastfeeding as oxycodone passes into breast milk and will affect your baby.
Driving and using machines
Oxycodone may affect your ability to drive and use machines. With stable therapy, a general ban on driving a vehicle may be not necessary. The treating physician must assess the individual situation. Please discuss with your doctor whether or under what conditions you can drive a vehicle.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Abtard contains lactose
This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Abtard
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.
Adults and adolescents (12 years of age and older)
The recommended initial dose is 5 or 10 mg oxycodone hydrochloride, in 12 hourly intervals. However, your doctor will prescribe the dose required to treat pain.
Further determination of the daily dose, the division into the single doses and any dose adjustments during the further course of therapy are performed by the treating physician and depend on the previous dosage.
Patients who have already taken opioids can start treatment with higher dosages taking into account their experience with opioid treatment.
Some patients who receive Abtard according to a fixed schedule need rapidly acting painkillers as rescue medication to control breakthrough pain. Abtard is not intended for the treatment of breakthrough pain.
For the treatment of non cancer pain a daily dose of 40 mg of oxycodone hydrochloride (20 mg given twice a day) is generally sufficient, but higher dosages may be necessary. Patients with cancer pain usually require dosages from 80 to 120 mg of oxycodone hydrochloride which may be increased up to 400 mg in individual cases.
The treatment needs to be controlled regularly with regard to pain relief and other effects in order to achieve the best pain therapy possible as well as to be able to treat any occurring side effects in good time and to decide whether treatment should be continued.
Kidney/liver impairment or low body weight
If you have impaired kidney and/or liver function or if you have a low body weight your doctor may prescribe a lower starting dose.
Method and duration of administration
Swallow the prolonged-release tablets whole with a sufficient amount of liquid (½ glass of water) with or without food in the morning and in the evening following a fixed schedule (e.g. at 8 a.m. and 8 p.m.).
The tablets must not be broken, crushed or chewed as this leads to rapid oxycodone release due to the damage of the prolonged release properties.
The administration of broken, chewed or crushed Abtard leads to a rapid release and absorption of a potentially fatal dose of oxycodone (see section “If you take more Abtard than you should”). Abtard are for oral use only. In case of abusive injection (injection in a vein) the tablet excipients may lead to destruction (necrosis) of the local tissue, change of lung tissue (granulomas of the lung) or other serious, potentially fatal events.
Your doctor will adjust the dosage depending on the pain intensity and how you respond to the treatment. Take the number of prolonged-release tablets determined by your doctor twice daily.
If you take more Abtard than you should
If you have taken more Abtard as prescribed you should inform your doctor or your local poison control centre immediately. The following symptoms may occur: feeling very sleepy, constricted pupils, depressed breathing, skeletal muscle flaccidity and drop in blood pressure. In severe cases circulatory collapse, mental and motor inactivity, unconsciousness, slowing of the heart rate, accumulation of water in the lungs, low blood pressure and death may occur; abuse of high doses of strong opioids such as oxycodone can be fatal. In no case you should expose yourself to situations requiring elevated concentration e.g. driving a car.
If you forget to take Abtard
If you use a smaller dose of Abtard than directed or you miss the intake of the tablets, pain relief will consequently be insufficient or cease altogether. You can make up for a forgotten tablet if the next regular intake is not due for at least another 8 hours. You can then continue to take the tablets as directed.
You should also take the prolonged-release tablets if the time to the regular next intake is shorter, but postpone the next intake by 8 hours. In principle, you should not take Abtard more than once every 8 hours.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Abtard
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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although serious allergic reactions are rare. Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body.
Significant side effects or signs to consider and measures to be taken when these side effects or signs occur: If you experience any of the following side effects, stop taking Abtard and contact your doctor immediately.
Depressed breathing is the most significant risk induced by opioids and is most likely to occur in elderly or debilitated patients. As a consequence, in predisposed patients opioids can cause severe drops in blood pressure.
Apart from this oxycodone can cause constricted pupils, bronchial spasms and spasms in smooth muscles and suppress the cough reflex.
Other possible side effects
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Not known (frequency cannot be estimated from the available data):
Counteractive measures
If you observe any of the above listed side effects your doctor will usually take appropriate measures. The side effect constipation may be prevented by fibre enriched diet and increased intake of fluids. If you are suffering from sickness or vomiting your doctor may prescribe you an appropriate medicine.
Drug Withdrawal
When you stop taking Abtard, 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 Abtard, it could be a sign that you have become addicted.
If you notice any of these signs, it is important you talk to your prescriber.
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 the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Abtard
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 blister, carton and container after “EXP”.
The expiry date refers to the last day of that month.
Blister packs: Do not store above 25°C.
HDPE container:
5 mg, 10 mg, 15 mg: Do not store above 30°C. 20 mg, 30 mg, 40 mg, 60 mg, 80 mg: This medicinal product does not require any special storage conditions.Once opened use within 6 months.
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 Abtard contains
What Abtard looks like and contents of the pack
Abtard 5 mg prolonged-release tablets are blue, round, biconvex tablets, 7 mm in diameter, with ‘OX 5’ debossed on one side.
Abtard 10 mg prolonged-release tablets are white, round, biconvex tablets, 9 mm in diameter, with ‘OX 10’ debossed on one side.
Abtard 15 mg prolonged-release tablets are grey, round, biconvex tablets, 9 mm in diameter, with ‘OX 15’ debossed on one side.
Abtard 20 mg prolonged-release tablets are pink, round, biconvex tablets, 7 mm in diameter, with ‘OX 20’ debossed on one side.
Abtard 30 mg prolonged-release tablets are brown, round, biconvex tablets, 9 mm in diameter, with ‘OX 30’ debossed on one side.
Abtard 40 mg prolonged-release tablets are yellow, round, biconvex tablets, 7 mm in diameter, with ‘OX 40’ debossed on one side.
Abtard 60 mg prolonged-release tablets are red, round, biconvex tablets, 9 mm in diameter, with ‘OX 60’ debossed on one side.
Abtard 80 mg prolonged-release tablets are green, round, biconvex tablets, 9 mm in diameter, with ‘OX 80’ debossed on one side.
Abtard are available in blister packs (PVC/Aluminium) of:
5 mg: 1, 20, 28, 30, 50, 56, 60 and 100 prolonged-release tablets
10 mg, 20 mg, 40 mg, 80 mg: 1, 20, 28, 30, 50, 56, 60, 98 and 100 prolonged-release tablets
15 mg: 1, 20, 30, 56, 98 and 100 prolonged-release tablets 30 mg, 60 mg: 1, 20, 30, 50, 56, 98 and 100 prolonged-release tablets
Abtard are available in child resistant blister packs (PVC/PVdC/Al/PET/paper) of:
5 mg: 1, 20, 28, 30, 50, 56, 60 and 100 prolonged-release tablets
10 mg, 20 mg, 40 mg, 80 mg: 1, 20, 28, 30, 50, 56, 60, 98 and 100 prolonged-release tablets
15 mg: 1, 20, 30, 56, 98 and 100 prolonged-release tablets
30 mg, 60 mg: 1, 20, 30, 50, 56, 98 and 100 prolonged-release tablets
Abtard are also available in white, round, child-resistant, HDPE tablet containers with PP caps containing 98 or 100 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in April 2020.
D50194
Building A2, Glory Park Avenue, Wooburn Green, High Wycombe, Buckinghamshire, HP10 0DF, UK
+44 (0) 1277 266 600