Text only version for the visually impaired. Below is a text only representation of the Patient Information leaflet. The original may contain images.
OxyContin tablets are designed to work properly over 12 hours when swallowed whole. If a tablet is broken, crushed, dissolved or chewed, the entire 12-hour dose may be absorbed rapidly into your body. This can be dangerous, causing serious problems such as an overdose, which may be fatal.
(May affect up to 1 in 10 people) Uncommon side effects.
4. Possible side effects.
In each box there are 28 or 56 tablets.
All medicines can cause allergic reactions, although serious allergic reactions are rare. l your doctor immediay 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.
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You may see the remains of the tablets in your faeces. This should not affect how the tablets work.
Like all medicines, these tablets can cause side effects, although not everybody gets them.
Children and adolescents under 18 years of age should not take the tablets.
The tablets are all film coated in the following colours: 5 mg - light blue, 10 mg - white, 15 mg – grey, 20 mg - pink, 30 mg – brown, 40 mg - yellow, 60 mg – red, 80 mg – green, 120 mg – purple.
If you forget to take your OxyContin tablets.
for the marketing authorisation holder.
5 mg - brilliant blue (E133).
Always take these tablets exactly as your doctor has told you. The label on your medicine will l you how many tablets to take and how often.
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If you stop taking OxyContin tablets.
80 mg - hydroxypropylcellulose, iron oxide (E172), and indigo carmine (E132).
If you remember within 4 hours of the time your tablet was due, take your tablet straight away. Take your next tablet at your normal time. If you are more than 4 hours late, please call your doctor or pharmacist for advice. Do not take a double dose to make up for a forgotten tablet.
OxyContin 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg and 120 mg prolonged release tablets Oxycodone hydrochloride.
5. How to store OxyContin tablets.
(May affect up to 1 in 100 people) Frequency unknown.
l your doctor or pharmacist if you are taking:
Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure.
Patients with kidney or liver problems.
20 mg, 30 mg, 40 mg, 60 mg and 120 mg - polysorbate 80 (E433), and iron oxide (E172).
Do not take these tablets if you are pregnant or breastfeeding.
These tablets have been prescribed for you by your doctor to relieve moderate to severe pain over a period of 12 hours. They contain the active ingredient oxycodone which belongs to a group of medicines called strong analgesics or ‘painkillers’
(Frequency cannot be estimated from the available data).
Call your doctor or hospital straight away. People who have taken an overdose may feel very sleepy, sick or dizzy, or have hallucinations. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. When seeking medical attention make sure that you take this leaflet and any remaining tablets with you to show to the doctor.
The other ingredients are:
By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the reach and sight of children. Accidental overdose by a child is dangerous and may be fatal.
Take special care with OxyContin tablets.
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.
The usual starting dose is one 10 mg tablet every 12 hours. However, your doctor will prescribe the dose required to treat your pain. If you find that you are still in pain whilst taking these tablets, discuss this with your doctor.
Do not store your tablets above 25°C.
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15 mg – iron oxide (E172).
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 tablets are marked OC on one side and the strength on the other (5, 10, etc). All strengths are round, bi-convex, film coated tablets.
Driving and using machines.
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.
Do not use any tablets after the expiry date which is stated on the blister and carton.
10 mg – hydroxypropylcellulose.
Do not take your tablets if they are broken or crushed as this can be dangerous and can cause serious problems such as overdose.
Drinking alcohol whilst taking OxyContin tablets 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 OxyContin tablets.
1. What OxyContin tablets are and what they are used for 2. Before you take OxyContin tablets 3. How to take OxyContin tablets 4. Possible side effects 5. How to store OxyContin tablets 6. Further information.
This leaflet was last revised in April 2015.
Taking OxyContin tablets with food, drink and alcohol.
Cambridge Science Park, Milton Road, Cambridge, Cambridgeshire, CB4 0GW.
You should not suddenly stop taking these tablets unless your doctor ls you to. If you want to stop taking your tablets, discuss this with your doctor first. They will l you how to do this, usually by reducing the dose gradually so you do not experience unpleasant effects. Withdrawal symptoms such as agitation, anxiety, palpitations, shaking or sweating may occur if you suddenly stop taking these tablets.
As with all strong painkillers, there is a risk that you may become addicted or reliant on these tablets.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
What OxyContin tablets contain.
You must only take the tablets by mouth. The tablets should never be crushed or injected as this may lead to serious side effects, which may be fatal. Children.
EXP 08 2020 means that you should not take the tablets after the last day of that month i.e. August 2020.
OxyContin 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg and 120 mg prolonged release tablets.
Read all of this leaflet carefully before you start taking this medicine. In this leaflet:
Please click on the link to the left to view the PIL in PDF format.
OxyContin tablets are protected by European Patent (UK) Nos. 0576643, 1325746, 1438959 and 1502592.
These tablets contain lactose which is a form of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.
Also l your doctor if you have recently been given an anaesthetic.
Marketing Authorisation Holder and Manufacturer.
Text only version for the visually impaired Below is a text only representation of the Patient Information leaflet. The original may contain images or tables and can be viewed in PDF format using the link to the left. This PIL may be available from the RNIB in large print, Braille or audio CD. For further information please call the RNIB Medicine Leaflet line on 0800 198 5000. The product code(s) for this leaflet is/are: PL 16950/0123, PL 16950/0098, PL 16950/0099, PL 16950/0100, PL 16950/0097, PL16950/0150, PL16950/0141, PL16950/0140, PL16950/0139.
Very common side effects.
3. How to take OxyContin tablets.
Please l your doctor if you suffer from kidney or liver problems as they may prescribe a lower dose depending on your condition.
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POM - Prescription Only Medicine.
In addition, the tablet coatings contain the following:
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Please l your doctor or pharmacist if you are taking or 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.
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. Further information.
OxyContin 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg and 120 mg prolonged release tablets (SPC).
Last Updated on eMC 18-Aug-2015 View changes| Napp Pharmaceuticals Limited Contact details.
These are as follows: Product name: OxyContin Reference number: 16950/0123.
This medicine can affect your ability to drive as it may make you sleepy or dizzy.
This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line (free of charge) on: 0800 198 5000.
The most serious side effect is a condition where you breathe more slowly or weakly than expected (respiratory depression). l your doctor immediay if this happens to you.
Reporting of side effects.
What OxyContin tablets look like and the contents of the pack.
1. What OxyContin tablets are and what they are used for.
These 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…”).
You should avoid drinking grapefruit juice during your treatment with this medicine. Pregnancy and breastfeeding.
The tablets are made by.
You should take your tablets every 12 hours. For instance, if you take a tablet at 8 o’clock in the morning, you should take your next tablet at 8 o’clock in the evening.
(May affect more than 1 in 10 people) Common side effects.
Adults (over 18 years of age).
Package leaflet: Information for the user.
If you take more OxyContin tablets than you should or if someone accidentally swallows your tablets.
You will need to give details of the product name and reference number.
Before treatment with these tablets l your doctor or pharmacist if you:
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
OxyContin, NAPP and the NAPP device (logo) are Registered Trade Marks. http://www.napp.co.uk.
Before you contact this company : often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why? oxycodone hydrochloride.
2. Before you take OxyContin tablets.
Ask your doctor or pharmacist for advice before taking any medicine.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
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Important information about some of the ingredients of OxyContin tablets.
Swallow your tablets whole with water. Do not crush, dissolve or chew them.
Do not take OxyContin tablets if you:
If you are going to have an operation, please l the doctor at the hospital that you are taking these tablets. Taking other medicines.