OxyNorm ® 5 mg Capsules

OxyNorm ® Capsules are a strong analgesic or “painkiller” and belongs to the opioid group. OxyNorm ® Capsules are used for the relief of moderate to severe pain in patients with cancer and post-operative pain, after gastrointestinal function has returned. OxyNorm ® Capsules are used for the relief of severe pain requiring the use of a strong opioid analgesic.

Do not take OxyNorm ® Capsules:

• if you are allergic (hypersensitive) to the active ingredient oxycodone hydrochloride or any of the other ingredients (see WHAT OxyNorm ® Capsules CONTAIN);
• if you suffer from severe breathing problems with a lowered supply of oxygen to the blood (hypoxia) and/or increased carbon dioxide saturation of the blood (hypercapnia);
• if you suffer from a long-term (chronic) obstructive lung disease;
• if you have a heart problem after long-term lung disease (cor pulmonale);
• if you suffer from long-term (chronic) bronchial asthma;
• where the small bowel does not work properly (paralytic ileus);
• during pregnancy and breastfeeding;
• in the presence of moderate to severe lung-, liver- or kidney diseases;
• if you are taking a type of medicine known as a monoamine oxidase inhibitor or if you have taken this type of medicine in the last two weeks (examples include tranylcypromide, phenelzine, isocarboxazid, moclobemide and linezolid) (see “Taking other medicines with OxyNorm ® Capsules”);
• in any situation where opioids are contra-indicated;
• if you suffer from a head injury that causes a severe headache or makes you feel sick;
• if you suffer from severe pain in your abdomen;
• if your stomach empties more slowly than it should (delayed gastric emptying);
• if you suffer from ongoing constipation (hard, infrequent stools).

Take special care with OxyNorm ® Capsules:

• if you are elderly or debilitated (weak);
• if you have an under-active thyroid (hypothyroidism), as you may need a lower dose of OxyNorm ® Capsules;
• if you have poor adrenal gland function (Addison’s disease);
• if you have prostate problems;
• if you have a mental disorder as a result of an infection (toxic psychosis);
• if you are or ever have been addicted to alcohol or drugs;
• if you have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, upon stopping taking alcohol or drugs;
• if you have inflammation of the pancreas (pancreatitis) or problems with your gall bladder;
• if you have a severe headache, have a head injury or feel sick as this may indicate that the pressure in your skull is increased;
• if you have decreased kidney or liver function;
• if you have difficulty breathing;
• if you have had abdominal (stomach) surgery;
• if you have low blood pressure (hypotension) or low blood volume (hypovolemia);
• if you have inflammatory bowel disease;
• for 6 hours before an operation and within the first 12-24 hours post-operatively.

If this information applies to you or formerly applied to you, please speak to your doctor. Use OxyNorm ® Capsules with special caution in cases if you are or ever have been addicted to alcohol or drugs. Increased sensitivity to pain that does not respond to dose increases can rarely develop. If this happens, your doctor will reduce your dose or switch you to an alternative opioid painkiller.

Do not share medicines prescribed for you with any other person. Always take OxyNorm ® Capsules exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure. Your doctor will tell you how long your treatment with OxyNorm ® Capsules will last. Do not stop treatment early because it may lead to withdrawal symptoms. If you feel that the effect of OxyNorm ® Capsules is too weak or too strong, tell your doctor or pharmacist.

Unless otherwise prescribed by your doctor, the usual starting dose for adults older than 18 years, is one capsule of OxyNorm ® 5 mg Capsules (5 mg oxycodone hydrochloride) every 4 – 6 hours. However, your doctor will prescribe the dose required to treat your pain based on your situation. Swallow the capsules whole with water. Do not chew or crush them. You must only take OxyNorm ® 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 OxyNorm ® Capsules than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

People who have taken an overdose may feel very sleepy and sick. 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 OxyNorm ® 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 a forgotten dose.

Effects when treatment with OxyNorm ® Capsules is stopped: Do not stop taking OxyNorm ® Capsules without telling your doctor. If you want to stop taking your capsules, discuss this with your doctor first. Your doctor will tell you how to reduce the dose gradually, so you do not experience unpleasant effects. If you have any further questions on the use of this product, ask your doctor or pharmacist.

OxyNorm ® Capsules can have side effects. Not all side effects reported for OxyNorm ® Capsules are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice. As with all strong painkillers, there is a risk that you may become addicted or reliant on OxyNorm ® Capsules. If any of the following happens stop taking OxyNorm ® Capsules, tell your doctor immediately or go to the closest casualty department or nearest hospital. 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). Frequent side effects (Probably affecting more than 1 in 100 people taking OxyNorm ® Capsules). Most people will have constipation when they take OxyNorm ® Capsules. Your doctor can prescribe a laxative to overcome this problem. You may feel sick or vomit (be sick) when you take these capsules, this should normally wear off after a few days however your doctor can prescribe an anti-vomiting medicine if it continues to be a problem. You may find that you feel sleepier than normal when you start taking your capsules or when your dose is increased. This should wear off after a few days.

The following side effects have also been commonly reported in patients treated with OxyNorm ® Capsules:

• Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhoea, hiccups;
• Headache, confusion, a feeling of unusual weakness, dizziness, anxiety, nervousness, twitching, difficulty in sleeping, abnormal thoughts or dreams, depression, uncontrollable shaking (tremor), mood or personality changes, feeling less active, restlessness;
• Frequent or painful urination;
• Difficulty in breathing or wheezing, shortness of breath;
• Rash, itchy skin;
• Sweating.

Less frequent side effects (Probably affecting fewer than 1 in 100 people taking OxyNorm ® Capsules):

• Hypersensitivity reactions;
• Inflamed mouth, oral ulcers, gum bleeding;
• Belching, wind, changes in taste, intestinal obstruction, abnormal dark tarry faeces containing blood, dental problems;
• Increased liver enzymes, abdominal pain related to the gallbladder due to gallstones;
• Increased appetite;
• Decrease in concentration, migraine;
• A feeling of dizziness or ‘spinning’, a feeling of ‘faintness’ especially on standing up, hallucinations, feeling strange (derealisation), a feeling of extreme happiness, restlessness, agitation, generally feeling unwell and emotional, loss of memory, difficulties with speech, reduced sensitivity to pain or touch, tingling or numbness, seizures, fits or convulsions, medicine dependence, chills;
• Decreased muscle tone, involuntary muscle spasm, changes in coordination;
• Herpes simplex (disorder of the skin and mucosa);
• Difficulty in passing urine;
• Reduced levels of sex hormones, impotence, decreased sexual drive;
• Fast or irregular heart beat, low blood pressure, flushing of the skin;
• Increased coughing, voice changes;
• Injuries due to accidents;
• Pain (e.g. chest pain);
• Dehydration, thirst, swelling of the hands, ankles or feet;
• Changes in body weight (loss or rise);
• Dry skin, hives (red itchy skin);
• Vision impairment (having sight problems), reduction in size of the pupils in the eye;
• A need to take increasingly higher doses of OxyNorm ® Capsules to gain the same level of pain relief (tolerance);
• Withdrawal symptoms such as restlessness, teary eyes, running nose, yawning, chills, muscle pain, increase in the size of the eye pupils, agitation, anxiety, backache, joint pain, weakness, stomach cramps, sleeplessness, nausea, weight loss, vomiting, diarrhoea, increased blood pressure, increased respiratory (breathing) rate, increased heart rate, or sweating upon stopping taking OxyNorm ® Capsules.

Side effects of which the frequency is unknown:

• Tooth decay;
• Problems with bile flow;
• Increased sensitivity to pain which cannot be improved by increasing the dose;
• Aggression;
• Acute generalized allergic reactions (anaphylactic and anaphylactoid reactions);
• Absence of menstrual periods;
• Withdrawal symptoms in newborn infants.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach of children. Store at or below 30 °C. Store in original package in the outer carton in order to protect from light. Do not use OxyNorm ® Capsules after the expiry date which is stated on the blister and carton after “Expiry date”. The expiry date refers to the last day of that month. Return all unused medicine to your pharmacist. Do not dispose of unused medicines in drains or sewerage systems (i.e. toilets).