Patient Leaflet Updated 20-May-2020 | Morningside Healthcare Ltd
Ixyldone 10 mg prolonged-release tablets
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
10mg Prolonged-Release Tablets
This medicine contains oxycodone hydrochloride 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 Ixyldone is and what it is used for
2. What you need to know before you take Ixyldone
3.How to take Ixyldone
4.Possible side effects
5.How to store Ixyldone
6.Content of the pack and other information
1. What Ixyldone is and what it is used for
This medicine has been prescribed for you for treating severe pain, which can be adequately managed only with opioid analgesics. It contains the oxycodone hydrochloride 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.
Ixyldone is indicated in adults and adolescents aged 12 years and older.
2. What you need to know before you take Ixyldone
Do not take Ixyldone
Warnings and precautions
Talk to your doctor or pharmacist before taking Ixyldone
Talk to your doctor if any of these apply to you or if any of these conditions applied to you in the past.
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.
Ixyldone are for oral use only. In case of abusive injection (injection in a vein) the tablet excipients (especially talc) may lead to destruction (necrosis) of the local tissue, change of lung tissue (granulomas of the lung) or other serious, potentially fatal events.
Athletes should be aware that this medicine may cause a positive reaction to “anti-doping tests”.
Use of Ixyldone as a doping agent may become a health hazard.
Children and adolescents
Oxycodone has not been investigated in children under 12 years. Safety and efficacy have not been established therefore use in children under 12 years of age is not recommended.
Other medicines and Ixyldone
Tell your doctor or pharmacist if you are taking, have recently taken any other medicines, including medicines obtained without a prescription. If you take these tablets with some other medicines, the effect of these tablets or the other medicine may be changed.
The tablets must not be used together with a monoamine oxidase inhibitor, or if you have taken this type of medicine in the last two weeks (see section 2 ‘Do not take...’).
Tell your doctor or pharmacist if you are taking:
Also, tell your doctor if you have recently been given an anaesthetic.
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 Ixyldone 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 Ixyldone 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.
Ixyldone with food, drink and alcohol
Drinking alcohol whilst taking Ixyldone 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 Ixyldone.
You should avoid drinking grapefruit juice during your treatment with Ixyldone.
Pregnancy and breast-feeding
Do not take Ixyldone 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 Ixyldone during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Do not take Ixyldone while you are breast-feeding as oxycodone hydrochloride passes into breast milk and will affect your baby.
Driving and using machines
These tablets may cause a number of side effects such as drowsiness which could affect your ability to drive or use machinery (see section 4 for a full list of side effects). These are usually most noticeable when you first start taking the tablets, or when changing to a higher dose. If you are affected you should not drive or use machinery.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Oxycodone hydrochloride impairs alertness and reactivity to such an extent that the ability to drive and operate machinery is affected or ceases altogether. To look at the possible side effects affecting the motor skills and concentration (see section 4).
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.
Ixyldone contains lactose
If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product.
3. How to take Ixyldone
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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.
The recommended dose is:
Adults and adolescents (12 years of age and older)
The usual initial dose is 10 mg oxycodone hydrochloride in 12 hourly intervals. However, your doctor will prescribe the dose required to treat pain.
Patients who have already taken opioids can start treatment with higher dosages taking into account their experience with opioid treatment.
For the treatment of non cancer pain a daily dose of 40 mg of oxycodone hydrochloride 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.
For doses not realizable/practicable with this strength other strengths of this medicinal product are available.
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.
Use in children and adolescents
Ixyldone is not recommended in children younger than 12 years of age.
Method of administration
Swallow the prolonged-release tablet 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 be swallowed whole, not chewed, divided or crushed as this leads to rapid oxycodone release due to the damage of the prolonged release properties. The administration of chewed, divided or crushed prolonged-release tablets leads to a rapid release and absorption of a potentially fatal dose of oxycodone (see section “If you take more Ixyldone than you should”).
The prolonged-release tablets may be taken with or independent of meals with a sufficient amount of liquid.
Ixyldone should not be taken with alcoholic beverages.
This medicinal product is in childproof packaging. The prolonged-release tablets cannot be pressed out of the blister. Please observe the following instructions when opening the blister.
1. Pull off a single dose by tearing along the perforated line on the blister.
2.An unsealed area is exposed/can be reached by this; this area is at the point where the perforated lines intersect with each other.
3.At the unsealed flap, peel away the cover foil from the bottom foil.
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.
Some patients who receive Ixyldone according to a fixed schedule need rapidly acting painkillers as rescue medication to control breakthrough pain. Ixyldone is not intended for the treatment of breakthrough pain.
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.
If you take more Ixyldone than you should
If you have taken more Ixyldone as prescribed you should inform your doctor or your local poison control center immediately. The following symptoms may occur: constricted pupils (miosis), depressed breathing (respiratory depression), drowsiness, skeletal muscle flaccidity and drop in blood pressure. In severe cases circulatory collapse, mental and motor inactivity (stupor), unconsciousness (coma) slowing of the heart rate and accumulation of water in the lungs (non-cardiogenic lung oedema) 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 Ixyldone
If you use a smaller dose of Ixyldone than directed or you miss the intake of a dose, pain relief will consequently be insufficient or cease altogether.
You can make up for a forgotten dose if the next regular intake is not due for at least another 8 hours. You can then continue to take this medicine as directed.
You should also take this medicine if the time to the regular next intake is shorter, but postpone the next intake by 8 hours. In principle, you should not take Ixyldone more than once every 8 hours.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Ixyldone
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.
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 Ixyldone 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):
Frequency not known (frequency cannot be estimated from the available data)
Long term use of Ixyldone 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.
When you stop taking Ixyldone, 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 Ixyldone, 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.
If you observe any of the above listed side effects your doctor usually will take appropriate measures.
The side effect constipation may be prevented by fiber enriched diet and increased drinking.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: 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 Ixyldone
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 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 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. Content of the pack and other information
What Ixyldone contains
The active substance is oxycodone hydrochloride.
Each prolonged-release tablet contains 10 mg oxycodone hydrochloride corresponding to 9 mg oxycodone
The other ingredients are:
Tablet core: Lactose monohydrate, ammonio methacrylate copolymer Type B dispersion 30%, povidone (K29/32), talc, triacetin, stearyl alcohol, magnesium stearate.
Tablet coating: Hypromellose, talc, macrogol 400, titanium dioxide (E171).
What Ixyldone looks like and contents of the pack
White, round, biconvex, prolonged-release tablets with a diameter of 6.9 - 7.3 mm and a height of 3.2 – 3.9 mm.
Ixyldone is available for 10, 14, 20, 25, 28, 30, 40, 50, 56, 60, 98 and 100 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
This leaflet was last revised in April 2020.
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