Abtard Prolonged Release Tablets

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.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What 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

Do not take Abtard

• if you are allergic (hypersensitive) to oxycodone hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if you have severe problems breathing, low amounts of oxygen in your blood (hypoxia) or too much carbon dioxide in your blood.
• if you suffer from ‘smoker’s lungs’, also known as COPD (severe Chronic Obstructive Pulmonary Disease), cor pulmonale (cardiac changes due to chronic overload of lung circulation) or acute, severe bronchial asthma.
• if you suffer from intestinal paralysis.
• if you have a condition where the small bowel does not work properly (paralytic ileus).

Warnings and precautions

Talk to your prescriber before taking this medicine if you:

• are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
• feel you need to take more of Abtard 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.
• are older or debilitated,
• have lung, liver or kidney problems,
• suffer from certain illnesses of the thyroid gland, impaired function of the thyroid gland,
• suffer from adrenal insufficiency (Addison’s disease),
• suffer from enlargement of the prostate,
• suffer from inflammation of the pancreas,
• in conditions with increased brain pressure such as head injury,
• suffer from disturbances of circulatory regulation,
• suffer from colic of the bile duct and ureter,
• suffer from low blood pressure or reduced blood volume,
• suffer from epilepsy or have a seizure tendency,
• take MAO inhibitors (for the treatment of depression),
• suffer from an inflammatory bowel disorder,
• have recently had abdominal surgery,
• have a mental disorder as a result of an infection
• have pancreatitis (inflammation of the pancreas)
• take certain medicines to help you sleep or stay calm (benzodiazepines) or similar drugs that reduce brain activity, e.g. medicine to treat nausea, insomnia, psychiatric disorders, allergy, severe pain and anaesthetic)
• are more than 65 years old and debilitated.

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

• sleeping pills or tranquillizers (sedatives, hypnotics)
• anti-depressants
• anaesthetics
• muscle relaxants
• other opioids or alcohol can enhance the side effects of oxycodone, in particular depressed breathing (respiratory depression).
• other medicines that act against parasympathetic and cholinergic nerve fibres on the central nervous system
• medicines used to treat allergies (antihistamines)
• medicines used to treat vomiting (antiemetics)
• medicines to treat psychosis (phenothiazines, antipsychotics).
• medicines used to treat Parkinson’s disease can enhance certain side effects of oxycodone (e.g. constipation, dry mouth or urinary disturbances)
• anticoagulants of the coumarin type (medicines used to reduce blood clotting)
• monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, isoniazid, tranylcypromine or selegiline as these can enhance some side effects of oxycodone (e.g. excitation, decrease or increase in blood pressure).

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;

• Medicines used to treat infections (e.g. clarithromycin, erythromycin and telithromycin) or to treat fungal infections (e.g. ketoconazole, voriconazole, itraconazole, and posaconazole).
• Medicines such as rifampicin (used to treat tuberculosis).
• Medicines used to treat HIV (e.g. boceprevir, ritonavir, indinavir, nelfinavir and saquinavir).
• Cimetidine (to treat heart burn).
• Medicines such as paroxetine and fluoxetine (antidepressants) and St John’s Wort (herbal medicine).
• Quinidine (used in the treatment of heart diseases).
• Carbamazepine, phenytoin (used to treat epilepsy).
• Medicine used to treat stomach ulcers, indigestion or heartburn (cimetidine).

Some medicines can limit the effect of Abtard, and make it necessary to increase the dose:

• Medicine used to treat tuberculosis (rifampicin)
• Medicine used to treat convulsions and certain types of pain (carbamazepine)
• Medicine used to treat epileptic fits (phenytoin) the natural remedy called St John’s Wort (also known as Hypericum perforatum).

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.

• 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.

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.

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.

Other possible side effects

Very common (may affect more than 1 in 10 people):

• sedation (tiredness to drowsiness) - this is most likely when you start taking your tablets or when your dose is increased, but it should wear off after a few days.
• dizziness
• headache
• constipation
• feeling sick (nausea)
• being sick (vomiting)
• itching.

Common (may affect up to 1 in 10 people):

• feeling weak (asthenia)
• several psychological side effects such as
• changes in mood (e.g. anxiety, depression)
• changes in activity (nervousness and insomnia)
• changes in performance (abnormal thinking, confusion, amnesia, isolated cases of speech disorders)
• involuntary trembling or shaking
• depressed breathing
• difficulty in breathing or wheezing
• dry mouth, rarely accompanied by thirst; gastrointestinal disorders such as stomach pain; diarrhoea; upset stomach; loss of appetite
• skin disorders such as rash, rarely increased sensitivity to light (photosensitivity), in isolated cases itchy or scaly rash, excessive sweating
• urinary disorders (frequent urination).

Uncommon (may affect up to 1 in 100 people):

• dehydration
• agitation
• change in perception such as emotional instability, depersonalisation, a feeling of extreme happiness, hallucinations, change in taste, visual disturbances, abnormally acute sense of hearing, feeling of dizziness or spinning, decreased sex drive
• abnormal production of antidiuretic hormone
• loss of memory, fits, increased tightness and difficulty in stretching muscles, both increased and decreased muscle tone; tics; reduced sense of touch; coordination disturbances; speech disorders; fainting; tingling or pins and needles
• feeling unwell, accelerated pulse, being aware of the heart beat
• widening of the blood vessels
• increased coughing; pharyngitis; runny nose; voice changes; difficulty breathing
• oral ulcers; inflammation of the gums, inflamed mouth; difficulty swallowing, wind, flatulence, intestinal obstruction
• increased liver enzymes
• dry skin
• difficulty in passing urine
• disturbances of sexual function, impotence
• injuries due to accidents
• pain (e.g. chest pain); excessive fluid in the tissues (oedema); chills; thirst; migraine; drug withdrawal syndrome
• changes in tear secretion, constriction of the pupil, visual impairment.

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

• lymph node disease
• lowering of blood pressure, dizziness when standing up from a sitting or lying position
• muscle spasms (involuntary contraction of the muscle)
• gum bleeding; increased appetite; tarry stool; tooth staining
• herpes simplex (disorder of the skin and mucosa)
• itchy skin rash (hives)
• blood in urine
• changes in body weight (loss or rise); cellulitis.

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

• aggression
• increased sensitivity to pain which cannot be improved by increasing the dose
• tooth decay
• pain on the right side of the abdomen, itchiness and jaundice caused by inflammation of the gall bladder.
• absence of menstrual bleeding
• drug dependence and addiction (see “How do I know if I am addicted?”)

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.

• 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 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.

What Abtard contains

• The active substance is oxycodone hydrochloride. Each prolonged-release tablet contains 5, 10, 15, 20, 30, 40, 60 or 80 mg oxycodone hydrochloride.
• The other ingredients are:
  Tablet core: Lactose monohydrate, hypromellose, povidone, stearic acid, magnesium stearate, colloidal anhydrous silica.
  Tablet coating:
  5 mg tablets: Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, blue Indigo Carmine Aluminium Lake (E132), yellow iron oxide (E172).
  10 mg tablets: Titanium dioxide (E171), hypromellose, macrogol, polysorbate 80
  15 mg tablets: Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), black iron oxide (E172).
  20 mg tablets: Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172).
  30 mg tablets: Polyvinyl alcohol, macrogol, talc, red iron oxide (E172), black iron oxide (E172), blue Indigo Carmine Aluminium Lake (E132)
  40 mg tablets: Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172).
  60 mg tablets: Polyvinyl alcohol, macrogol, talc, red iron oxide (E172), carmine (E120), black iron oxide (E172).
  80 mg tablets: Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, blue Indigo Carmine Aluminium Lake (E132), yellow iron oxide (E172).

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.

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