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 is: PL 40431/0012.
Shortec 5, 10, 20 mg capsules, hard
PACKAGE LEAFLET: INFORMATION FOR THE USER
Shortec® 5 mg, 10 mg and 20 mg capsules
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.
In this leaflet:
1. What Shortec capsules are and what they are used for
2. What you need to know before you take Shortec capsules
3. How to take Shortec capsules
4. Possible side effects
5. How to store Shortec capsules
6. Contents of the pack and other Information
1. What Shortec capsules are and what they are used for
This medicine has been prescribed for you for the relief of moderate to severe pain. It contains oxycodone which belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been prescribed for 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 Shortec capsules
Do not take Shortec capsules if you:
Warnings and precautions
Talk to your doctor or pharmacist before taking these capsules if you:
Taking this medicine regularly, particularly for a long time, can lead to addiction. Your doctor should have explained how long you will be using 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 doctor 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 doctor 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.
If you are going to have an operation, please tell the doctor at the hospital that you are taking these capsules.
You may experience hormonal changes while taking these capsules. Your doctor may want to monitor these changes.
Other medicines and Shortec capsules
Concomitant use of opioids and benzodiazepines 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 benzodiazepines or related drugs with opioids the dosage and duration of concomitant treatment should be limited by your doctor.
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.
Please follow your doctor’s dosage 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.
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
If you take these capsules with some other medicines, the effect of these capsules or the other medicine may be changed.
Tell your doctor or pharmacist if you are taking:
Also tell your doctor if you have recently been given an anaesthetic.
Taking Shortec capsules with food, drink and alcohol
Drinking alcohol during your treatment with these capsules may make you 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 Shortec capsules. You should avoid drinking grapefruit juice during your treatment with this medicine.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
Do not take Shortec capsules if you are pregnant or think you might be pregnant unless you have discussed this with your doctor and the benefits of treatment are considered to outweigh the potential harm to the baby. If you take Shortec capsules 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 Shortec capsules while you are breastfeeding as oxycodone passes into breast milk and will affect your baby.
Driving and using machines
These capsules may cause a number of side effects such as drowsiness which may 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 capsules, or when changing to a higher dose. If you are affected you should not drive or use machinery.
This 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.
Shortec 5 mg capsules contain sunset yellow (E110)
The 5 mg capsules contain sunset yellow (E110) which may cause allergic reactions.
3. How to take Shortec capsules
Always take these capsules exactly as your doctor has told you. The label on your medicine will tell you how many capsules to take and how often.
Your doctor should have discussed with you how long the course of Shortec capsules 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 (over 18 years of age)
The usual starting dose is one 5 mg capsule every 4 to 6 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 capsules, discuss this with your doctor.
Children
Children and adolescents under 18 years of age should not take the capsules.
Patients with kidney or liver problems
Please tell your doctor if you suffer from kidney or liver problems as they may prescribe a lower dose depending on your condition.
Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure.
Swallow your capsules whole with water. Do not chew or crush them. You must only take the capsules by mouth. The capsule contents should never be injected as this may lead to serious side effects, which may be fatal.
If you take more Shortec capsules than you should or if someone accidentally swallows your capsules
Call your doctor or hospital straight away. People who have taken an overdose may feel very sleepy, sick or dizzy. 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 capsules with you to show to the doctor.
If you forget to take Shortec capsules
If you miss a dose you should take the next dose as soon as you remember then carry on as before. Do not take two doses within 4 hours. Do not take a double dose to make up for forgotten capsules.
If you stop taking Shortec capsules
Do not suddenly stop taking this medicine. If you want to stop taking this medicine discuss this with your doctor 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, these capsules 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.
The most serious side effect is a condition where you breathe more slowly or weakly than expected (respiratory depression). Tell your doctor immediately if this happens to you.
Drug withdrawal
When you stop taking Shortec capsules 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 Shortec capsules it could be a sign that you have become addicted.
If you notice any of these signs it is important you talk to your doctor.
Very common side effects
(May affect more than 1 in 10 people)
Common side effects
(May affect up to 1 in 10 people)
Uncommon side effects
(May affect up to 1 in 100 people)
Rare side effects
(May affect up to 1 in 1,000 people)
Frequency not known
(Frequency cannot be estimated from the available data)
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 this 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 Shortec capsules
Keep this medicine out of the sight and reach of children. Accidental overdose by a child is dangerous and may be fatal.
Do not use any capsules after the expiry date which is stated on the blister and carton. EXP 08 2020 means that you should not take the capsules after the last day of that month i.e. August 2020.
Do not store your capsules above 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Shortec capsules contain
The active substance is oxycodone hydrochloride. Each capsules contains 5 mg, 10 mg or 20 mg of oxycodone hydrochloride.
The other ingredients are:
In addition the 5 mg capsules contain sunset yellow (E110).
What Shortec capsules look like and the contents of the pack
The capsules are marked ONR and the strength (5, 10 or 20). The capsule colours are: 5 mg - orange/beige, 10 mg – white/beige, 20 mg – pink/beige. In each box there are 56 capsules.
Marketing Authorisation Holder and Manufacturer
The capsules are made by
The marketing authorisation holder is
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
You will need to give details of the product name and reference number. These are as follows:
Product name: Shortec capsules
Reference number: PL 40431/0010
This leaflet was last revised in November 2020
® SHORTEC, QDEM and the ‘Qdem pharmaceuticals’ logo are registered trade marks.
© 2013-2020 Qdem Pharmaceuticals Limited.
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+44(0)1223 426 929