Patient leaflet - Contiroxin 40 mg prolonged-release tablets
1. WHAT CONTIROXIN TABLETS ARE AND WHAT THEY ARE USED FOR
Contiroxin tablets contains the active substance oxycodone hydrochloride which is a centrally acting, strong painkiller from the group of medicines called opioids.
Contiroxin tablets is used in adults and adolescents aged 12 years and older to treat severe pain, which can be adequately managed only with opioid analgesics.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CONTIROXIN TABLETS
Do not take Contiroxin tablets if you
- are allergic to oxycodone hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- have breathing problems, such as severely depressed breathing (respiratory depression), severe chronic obstructive lung disease, or severe bronchial asthma. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected.
- have elevated carbon dioxide blood levels
- have a heart problem after long-term lung disease (cor pulmonale)
- suffer from intestinal paralysis (paralytic ileus). Signs may be that your stomach empties more slowly than it should (delayed gastric emptying) or you have severe pain in your abdomen.
Warnings and precautions
Talk to your doctor or pharmacist before taking Contiroxin tablets if you
- are elderly or weakened
- have severely impaired lung function
- have liver or kidney problems
- have a thyroid disorder with dryness, coldness and swelling of the skin affecting the face and limbs (myxoedema)
- have impaired function of the thyroid gland
- suffer from adrenal insufficiency which may cause symptoms including weakness, weight loss, dizziness, feeling or being sick (Addison’s disease)
- have an enlarged prostate gland which cause difficulty in passing urine (in men)
- have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating upon stopping taking alcohol or drugs
- or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”)
- are a smoker
- have ever had problems with your mood (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental illnesses
- have a mental disorder as a result of poisoning, e.g. with alcohol (toxic psychosis)
- have inflammation of the pancreas which causes severe pain in the abdomen and back
- have problems with your gall bladder or bile duct
- have an obstructive or inflammatory bowel disease
- have a head injury, severe headache or feel sick as this may indicate that the pressure in your brain is increased
- have low blood pressure
- have low blood volume (hypovolaemia); this can happen with severe bleeding, severe burns, excessive sweating, severe diarrhoea or vomiting
- have epilepsy or a tendency to fits/convulsions
- are taking a type of medicine known as monoamine oxidase (MAO) inhibitors, for the treatment of depression or Parkinson’s disease, or have taken them in the last 2 weeks
- are going to have an operation or had an abdominal surgery most recently
Please talk to your doctor if any of these apply to you or if any of these conditions applied to you in the past.
Contact your doctor if you experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system.
Do not take Contiroxin™ 80 mg prolonged-release tablets if you have not taken strong pain killers (opioids) before, as their potency may lead to a life-threatening respiratory depression.
Tolerance, dependence and addiction
This medicine contains oxycodone which is an opioid medicine. Repeated use of opioid painkillers can result in the drug being less effective (you become accustomed to it, known as tolerance).
Contiroxin tablets may cause dependency. When used for a long time, tolerance to the effects may occur and progressively higher doses may be required to maintain pain control.
Chronic use of Contiroxin tablets may lead to physical dependence and a withdrawal syndrome may occur upon abrupt cessation. (see section 3. “If you stop taking Contiroxin tablets ”. Withdrawal symptoms may include yawning, dilation of the pupil of the eye, abnormal or excessive secretion of tears, running nose, trembling or shaking, increased sweating, anxiety, agitation, fits, sleeplessness and muscle pain.
An increased sensitivity to pain (hyperalgesia) that will not respond to a further dose increase of oxycodone may occur, particularly in high doses. An oxycodone dose reduction or change to an alternative opioid may be required.
Repeated use of Contiroxin tablets may lead to dependence, abuse, and addiction which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use.
Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it. You might feel that you need to carry on taking your medicine, even when it doesn’t help to relieve your pain.
The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent or addicted on [Nationally completed name] if:
- You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”).
- You are a smoker.
- You have ever had problems with your mood (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.
If you notice any of the following signs whilst taking [Nationally completed name], it could be a sign that you have become dependent or addicted.
This medicine contains oxycodone, which is an opioid. It can cause dependence and/or addiction.
- You need to take the medicine for longer than advised by your doctor
- You need to take more than the recommended dose
- You are using the medicine for reasons other than prescribed, for instance, ‘to stay calm’ or ‘help you sleep’
- You have made repeated, unsuccessful attempts to quit or control the use of the medicine
- When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again (‘withdrawal effects’)
If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop taking [Nationally completed name]).
The prolonged-release tablets should be used with particular care in patients with a history of or present alcohol and drug abuse.
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.
Sleep-related breathing disorders
Contiroxin tablets can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.
Children
Oxycodone prolonged release tablets have not been studied in children under 12 years of age. Therefore, safety and efficacy have not been demonstrated and use of Contiroxin tablets is not recommended in children under 12 years.
Other medicines and Contiroxin tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Taking Contiroxin tablets at the same time as certain medicines which affect the way the brain works (see below) can enhance the risk for stopping breathing, especially in the case of overdose and in the elderly, and/or enhance the sedative effect of Contiroxin tablets (you may feel very sleepy).
Concomitant use of Contiroxin tablets and medicines which affect the way the brain works (e.g. sedative medicines such as benzodiazepines or related medicines, see below) 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 Contiroxin tablets 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.
Medicines that affect the way the brain works include:
- other strong pain killers (opioids)
- sleeping pills and tranquillisers (sedative medicines such as benzodiazepines)
- medicines to treat depression, such as paroxetine
- medicines used to treat allergies, travel sickness or nausea (antihistamines or antiemetics)
- medicines to treat psychiatric or mental disorders (antipsychotics)
- medicines used to treat Parkinson’s disease
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.
Further interactions may occur with:
- certain medicines to prevent your blood clotting or to help thin your blood (known as coumarin anticoagulants, for example warfarin or phenprocoumon). Contiroxin tablets may influence their effects.
- muscle relaxants
- certain antibiotics (e.g. clarithromycin, erythromycin, telithromycin or rifampicin)
- certain medicines to treat fungal infections (e.g. ketoconazole, voriconazole, itraconazole or posaconazole)
- certain medicines to treat HIV infection (e.g. boceprevir, ritonavir, indinavir, nelfinavir or saquinavir)
- cimetidine, a medicine to treat heartburn
- carbamazepine (a medicine to treat seizures or convulsions/fits and certain pain conditions)
- phenytoin, a medicine to treat seizures
- St. John’s wort, a medicine to treat depression
- quinidine (a medicine to treat a fast heartbeat)
- monoamine oxidase inhibitors, or if you have taken this type of medicine in the last two weeks (see section 2 ‘Warnings and precautions’)
Taking Contiroxin tablets with food, drink and alcohol
Drinking alcohol whilst taking Contiroxin 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 Contiroxin tablets.
Drinking grapefruit juice whilst taking Contiroxin tablets might increase the risk for side effects. You should avoid drinking grapefruit juice during treatment with Contiroxin tablets.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You should not take Contiroxin tablets during pregnancy. There is limited data from the use of oxycodone in pregnant women. Oxycodone crosses the placenta into the blood circulation of the baby.
Prolonged use of oxycodone during pregnancy can cause withdrawal symptoms in newborns. Use of oxycodone during childbirth can cause breathing problems (respiratory depression) in the newborn.
Breast-feeding
You should not use Contiroxin tablets when you are breast-feeding as the active substance oxycodone may pass into breast milk and cause drowsiness (sedation) or breathing problems (respiratory depression) in the suckling child.
Driving and using machines
Contiroxin tablets may impair the ability to drive or operate machinery.
General driving restrictions may not apply during stable treatment; your doctor makes this decision based upon the individual situation. Please discuss with your doctor whether or not, or under which conditions you may drive.
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:
O The medicine has been prescribed to treat a medical or dental problem and
o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
o 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.
Contiroxin tablets contain sucrose
If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicine.
3. HOW TO TAKE CONTIROXIN TABLETS
Always take this medicine exactly as your doctor has told you.Check with your doctor or pharmacist if you are not sure.
Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using Contiroxin tablets, when and how long you need to take it, when to contact your doctor, and when you need to stop it (see also if you stop taking Contiroxin Tablets).
For dose adjustment other strengths of this medicine may be available.
The recommended dose is:
Adults and adolescents (12 years of age and older)
The usual initial dose is 10 mg of oxycodone hydrochloride in 12 hourly intervals. Your doctor will prescribe the dose required to treat your 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 dose.
Patients who have already taken opioids can start treatment with higher doses taking into account their experience with opioid treatment.
Some patients who receive Contiroxin tablets according to a fixed schedule need rapidly acting painkillers as rescue medication to control breakthrough pain. Contiroxin tablets are not intended for the treatment of breakthrough pain.
For the treatment of non-cancer pain a daily dose of 40 mg oxycodone hydrochloride is generally sufficient, but higher doses may be necessary. Patients with cancer pain usually require daily doses 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.
Patients with impaired kidney and/or liver function
Your doctor may prescribe a lower starting dose.
Other risk patients
If you have a low body weight your doctor may prescribe a lower starting dose.
Method and duration of administration
For oral use only.
Swallow the prolonged-release tablets 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 prolonged-release tablets can be divided into equal halves. The tablets must not be further 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 Contiroxin tablets leads to a rapid release and absorption of a potentially fatal dose of the active substance oxycodone (see section “If you take more Contiroxin Tablets than you should”).
Contiroxin tablets are for oral use only. In case of abusive injection (injection into 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 dose 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 Contiroxin tablets than you should
If you have taken more Contiroxin tablets than prescribed you should inform your doctor or your local poison control center immediately.
Signs of an overdose may be:
- narrowed pupils
- breathing more slowly or weakly (respiratory depression)
- sleepiness progressing up to loss of consciousness
- decreased muscle tone
- slowed pulse rate
- drop in blood pressure
- a brain disorder (known as toxic leukoencephalopathy)
In severe cases, loss of consciousness (coma), water retention in the lung and circulatory collapse may occur, which may be fatal.
Never engage in situations which require a high degree of concentration, such as driving.
If you forget to take Contiroxin tablets
If you use a smaller dose of Contiroxin tablets than directed or you forget to take a dose, pain relief will consequently be insufficient or cease altogether.
If you have forgotten to take a dose, please follow the instructions below:
- If the next regular dose was scheduled more than 8 hours later: Take the forgotten dose immediately and continue with your usual dosing schedule.
- If your next usual dose is due in less than 8 hours: Take the forgotten dose and wait another 8 hours before taking your next dose. Try to get back in your normal dosing schedule.
Do not take more than one dose within any 8-hour period.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Contiroxin tablets
Do not stop treatment without informing your doctor.
If you no longer require therapy with Contiroxin tablets, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
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.
The most common side effects are nausea (especially at the beginning of therapy) and constipation. The side effect constipation may be countered by preventive measures (such as drinking plenty of fluids, nutrition rich in fibre). If you experience nausea or vomiting, your doctor may prescribe medication for you.
Important side effects or signs which you should look out for and what to do if you are affected:
Stop taking Contiroxin tablets and contact a doctor or go to your nearest emergency department immediately if you experience any of the following symptoms.
- sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body. These may be signs of serious allergic reactions.
- a more slow or shallow breathing (respiratory depression). This is the most serious side effect with an overdose of strong painkillers such as oxycodone and it mostly occurs in elderly and weak patients.
Possible side effects
Very common (may affect more than 1 in 10 people)
- drowsiness, sleepiness, dizziness, headache
- constipation, feeling sick (nausea), vomiting
- itchy skin
Common (may affect up to 1 in 10 people)
- anxiety, depression, decreased activity, restlessness, increased activity, nervousness, difficulty in sleeping, abnormal thinking, confusion, shaking (tremor)
- lack of energy, feeling weak, tiredness
- shortness of breath, wheezing
- dry mouth, hiccups, indigestion, stomach ache, diarrhoea
- decreased appetite up to loss of appetite
- skin rash, increased sweating
- painful urination, increased urge to urinate
Uncommon (may affects up to 1 in 100 people)
- a condition where you breathe more slowly and weakly than expected (respiratory depression)
- allergic reactions
- lack of water in the body (dehydration)
- agitation, emotional lability, a feeling of extreme happiness
- hallucinations, derealisation
- vision disturbances, reduction in size of the pupils in the eye
- hearing impaired, a feeling of dizziness or ‘spinning’(vertigo)
- change in taste
- increased muscle tension, involuntary muscle contractions, epileptic seizures, convulsions (fits)
- tingling or numbness, reduced sensitivity to pain or touch
- problems with coordination or with keeping one’s balance
- loss of memory, concentration impaired, speech disorders
- fainting
- faster heart beat, feeling your heartbeat (in the context of withdrawal syndrome)
- widening of the blood vessels causing low blood pressure
- coughing, voice changes
- mouth ulcers, sore gums
- wind, difficulty in swallowing, belching
- obstruction of the bowel (ileus)
- decreased sexual desire, impotence, low levels of sex hormones in the blood called hypogonadism (seen in a blood test)
- injuries from accidents
- generally feeling unwell, pain (e.g. chest pain)
- swelling of the hands, ankles or feet (oedema)
- migraine
- drug tolerance
- dry skin
- thirst
- problems passing urine
- chills
- physical dependence including withdrawal symptoms (see section 3 ‘If you stop taking Contiroxin tablets )
- increase in liver enzymes (seen in a blood test)
Rare (may affect up to 1 in 1,000 people)
- low blood pressure; dizziness, fainting caused by sudden drop in blood pressure when standing up
- bleeding gums, increased appetite, dark-coloured, tarry stools, tooth disorders
- blisters on the skin and the mucous membranes (cold sores or herpes), hives (urticaria)
- changes in body weight (loss or rise)
Frequency not known (frequency cannot be estimated from the available data)
- absence of menstrual bleeding
- serious allergic reaction which causes breathing difficulty or dizziness
- aggression
- increased sensitivity to pain (hyperalgesia)
- dental caries
- biliary colic (which causes stomach pain), biliary congestion
- withdrawal symptoms in newborns
- becoming addicted or reliant on these tablets
- cramping of the smooth muscles
- depression of the cough reflex
- sleep apnoea (breathing pauses during sleep)
- a problem affecting a valve in the intestines that may cause severe upper abdominal pain (sphincter of Oddi dysfunction)
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 (www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card in 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 CONTIROXIN TABLETS
Keep this medicine out of the sight and reach of children. Store this medicine in a locked safe and secure storage space, where other people cannot access it. It can cause serious harm and be fatal to people when it has not been prescribed for them.
Do not use this medicine after the expiry date which is stated on the blister/bottle and the carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of 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. CONTENTS OF THE PACK AND OTHER INFORMATION
- The active substance is oxycodone hydrochloride.
- Each 20 mg prolonged-release tablet contains 20 mg oxycodone hydrochloride corresponding to 17.9 mg oxycodone.
- Each 40 mg prolonged-release tablet contains 40 mg oxycodone hydrochloride corresponding to 35.9 mg oxycodone.
- Each 80 mg prolonged-release tablet contains 80 mg oxycodone hydrochloride corresponding to 71.7 mg oxycodone.
The other ingredients are:
Tablet core: Sugar spheres (sucrose, maize starch), hypromellose, macrogol 6000, talc, ethyl cellulose, hydroxypropylcellulose, propylene glycol, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica.
20 mg tablet coating: Hypromellose, talc, macrogol 6000, titanium dioxide (E171), iron oxide, red (E172).
40 mg tablet coating: Hypromellose, talc, macrogol 6000, titanium dioxide (E171), iron oxide, yellow (E172), iron oxide, red (E172).
80 mg tablets coating: Hypromellose, talc, macrogol 6000, titanium dioxide (E171), iron oxide, yellow (E 172).
What Contiroxin tablets look like and contents of the pack
Contiroxin 20 mg tablets are pink, biconvex, oblong, film-coated tablets with a breakline on both sides.
Contiroxin 40 mg tablets are orange, biconvex, oblong, film-coated tablets with a breakline on both sides.
Contiroxin 80 mg tablets are yellow, biconvex, oblong, film-coated tablets with a breakline on both sides.
Contiroxin tablets are available in blister packs of 10, 20, 28, 30, 40, 50, 56, 60, 100 and 112 tablets and HDPE bottles with PP twist-off caps with 50, 100 and 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Limited
Maxis 1 Western Road
Bracknell
United Kingdom
RG12 1RF
Manufacturer
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1,
39179 Barleben,
Germany.