Contiroxin 10 Mg Prolonged-Release Tablets
^ SANDOZ PACKAGE LEAFLET: INFORMATION FOR THE USER
Contiroxin™ 5 mg Prolonged-release Tablets Contiroxin™ 10 mg Prolonged-release Tablets
Oxycodone hydrochloride
SZ00000LT000
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Contiroxin tablets are and what they are used for
2. What you need to know before you take Contiroxin tablets
3. How to take Contiroxin tablets
4. Possible side effects
5. How to store Contiroxin tablets
6. Contents of the pack and other information
1. WHAT CONTIROXIN TABLETS ARE AND WHAT THEY ARE USED FOR
Contiroxin tablets are a centrally acting, strong painkiller from the group of medicines called opioids.
Contiroxin tablets are used 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)
• if you suffer from severely depressed breathing (respiratory depression) with too little oxygen in the blood (hypoxia) and/or too much carbon dioxide (hypercapnia) in the blood
• if you suffer from severe chronic obstructive lung disease, cor pulmonale (cardiac changes due to chronic overload of lung circulation) or acute, severe bronchial asthma
• if you suffer from intestinal paralysis (paralytic ileus)
• if you have an acute abdomen or suffer from delayed (stomach) emptying
• if you suffer from elevated carbon dioxide levels.
Warnings and precautions
Talk to your doctor before taking Contiroxin tablets
• if you are older or debilitated
• if your lung, liver or kidney function is severely impaired
• if you suffer from myxoedema (certain illnesses of the thyroid gland), impaired function of the thyroid gland
• if you suffer from Addison’s disease
• if you suffer from adrenocortical insufficiency
• if you suffer from enlargement of the prostate (prostatic hypertrophy)
• if you suffer from alcoholism or are undergoing alcohol withdrawal
• if you suffer from known opioid-dependence
• if you suffer from inflammation of the bowel or pancreas (pancreatitis)
• in conditions with increased brain pressure
• if you suffer from disturbances of circulatory regulation (e.g. low blood pressure, decreased blood volume in the circulation)
• if you suffer from colic of the bile duct and ureter
• if you suffer from epilepsy or have a seizure tendency
• if you take MAO inhibitors (for the treatment of depression)
• if you recently had abdominal surgery.
Contiroxin tablets have a primary dependence potential.
When used for a long time, patients can become tolerant to the effects 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. When a patient no longer requires therapy with oxycodone hydrochloride, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
An increased sensitivity for pain that will not respond to a further dose increase of Oxycodone Hydrochloride prolonged-release tablets may very rarely occur, particularly in high doses. An oxycodone dose reduction or change to an alternative opioid may be required.
When used as directed in patients suffering from chronic pain the risk of developing physical or psychological dependence is markedly reduced and needs to be weighed against the potential benefit. Please discuss this with your doctor.
Drinking alcohol whilst taking Contiroxin 5 mg/10 mg prolonged-release 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 5 mg/10 mg prolonged-release tablets.
Contiroxin 5 mg/10 mg prolonged-release tablets should be avoided in patients with a history of or present alcohol and drug abuse.
• Children under 12 years of age
Oxycodone Hydrochloride 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.
• Older people
In elderly patients the lowest dose should be administered with careful titration to pain control.
Athletes should be aware that this medicine, due to its active substance, may cause a positive reaction to “anti-doping tests”. Use of Contiroxin as a doping agent may become a health hazard.
Other medicines and Contiroxin tablets
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you take these tablets with some other medicines, the effect of these tablets or the other medicine may be changed.
• Medicines that dampen the activity of the central nervous system (e.g. sleeping pills or tranquillizers [sedatives, hypnotics], other medicines that act on the nervous system
[pheno-thiazines, neuroleptics], medicines used to treat allergies or vomiting [antihistamines, antiemetics]) as well as other opioids or alcohol can enhance the side effects of oxycodone, in particular depressed breathing (respiratory depression).
• Medicines with an anticholinergic effect (e.g. medicines that dampen psychoses [neuroleptics], medicines used to treat allergies [antihistamines] or vomiting [antiemetics]), medicines used to treat Parkinson’s disease) can enhance certain side effects of oxycodone (e.g. constipation, dry mouth or urinary disturbances).
Tell your doctor or pharmacist if you are taking:
• Cimetidine (a medicine for ulcers, indigestion or heartburn)
• Antibiotics (e.g. clarithromycin, rifampicin, erythromycin and telithromycin)
• Antifungals (e.g. ketoconazole, voriconazole, itraconazole, and posaconazole).
• Anticonvulsants (e.g. carbamazepin, phenytoin)
• Antidepressants (e.g. paroxetine, St. John’s Wort)
• Medicines to treat HIV infections (e.g. boceprevir, ritonavir, indinavir, nelfinavir and saquinavir)
• Quinidine (a medicine to treat a fast heart beat)
• Monoamine oxidase inhibitors (MAOIs), a medicine to treat depression) can enhance the side effects of oxycodone. Oxycodone should be used with caution if you currently take MAO-inhibitors or have taken MAO-inhibitors during the last two weeks.
• In individual cases more or less blood clotting have been observed if medicinal products against blood clotting (anticoagulants of the coumarin type) are taken together with Contiroxin tablets.
Contiroxin tablets with food, drink and alcohol
Alcohol enhances the impairment of alertness and reactivity and may enhance potential side effects such as drowsiness and depressed breathing.
Drinking grapefruit juice whilst taking oxycodone might increase the risk for side effects.
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 delivery can cause respiratory depression in the newborn.
Breast-feeding
You should not use Contiroxin tablets when you are breast-feeding as oxycodone may pass into breast milk.
Driving and using machines
Oxycodone impairs alertness and reactivity to such an extent that the ability to drive and operate machinery is affected or ceases altogether. For further information on possible side effects affecting the motor skills and concentration see section 4 (Possible Side Effects). 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.
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:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
- 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.
Important information about some of the ingredients of Contiroxin tablets
This medicinal product contains sucrose. 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 CONTIROXIN TABLETS
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults and adolescents (over 12 years of age)
The usual initial dose is 10 mg oxycodone hydrochloride (2 prolonged-release tablets) in 12 hourly intervals. However, your doctor will prescribe the dose required to treat 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 dosage. Continued on ^ next page >>
Patients who have already taken opioids can start treatment with higher dosages 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 (twice daily 20 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 these dose treatments other strengths of this medicinal product are available.
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.
Contiroxin 5 mg and 10 mg Prolonged-release Tablets should not be taken with alcoholic beverages.
Method and duration of administration
Swallow the prolonged-release tablets (either whole or divided) with a sufficient amount of liquid (/ 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 not be crushed or chewed as this leads to rapid oxycodone release due to the damage of the prolonged release properties. The administration of chewed or crushed Contiroxin tablets lead to a rapid release and absorption of a potentially fatal dose of 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 (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.
Your doctor will adjust the dosage 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.
Discontinuation of treatment
When you no longer require therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
If you take more Contiroxin tablets than you should
If you have taken more Contiroxin tablets as prescribed you should inform your doctor or your local poison control centre immediately. The following symptoms may occur: constricted pupils (miosis), depressed breathing (respiratory depression), skeletal muscle flaccidity and drop in blood pressure. In severe cases circulatory collapse, mental and motor inactivity (torpor), 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 should you expose yourself to situations requiring high levels of concentration e.g. driving a car or using machines.
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.
You can make up for a forgotten tablet if the next regular intake is not due for at least another 8 hours. You can then continue to take the tablets as directed.
You should also take the prolonged-release tablets if the time to the regular next intake is shorter, but postpone the next intake by 8 hours. In principle, you should not take Contiroxin tablets more than once every 8 hours.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Contiroxin tablets
Do not stop treatment without informing your doctor.
When a patient no longer requires 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 product, 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 Contiroxin tablets 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 thanl in 10 people):
Sedation (tiredness to drowsiness); dizziness; headache, constipation;nausea; vomiting, itching.
Common (may affect up to 1 in 10 people):
Feeling weak (asthenic conditions); anxiety, confusional state, depression, nervousness, sleep disorders, thought process disorder; trembling (tremor), depressed breathing (dyspnoea), bronchospasm (difficulty in breathing or wheezing), dry mouth, bellyache; diarrhoea; upset stomach (dyspepsia); decreased appetite,skin disorders such as rash, rarely increased sensitivity to light (photosensitivity), in isolated cases scaly rash (exfoliative dermatitis), increased sweating, frequent urination,
Uncommon (may affect up to 1 in 100 people):
Agitation, emotional lability, euphoric mood, hallucinations, change in taste, visual disturbances, constriction of the pupil
of the eye, abnormally acute sense of hearing (hyperacousis); both increased and decreased muscle tone; tics; involuntary contraction of the muscle; reduced sense of touch (hypaesthesia); coordination disturbances; feeling unwell, vertigo, accelerated pulse; pounding heartbeat; widening of the blood vessels (vasodilatation); respiratory depression; increased coughing; pharyngitis; runny nose; voice changes; oral ulcers; inflammation of the gums, inflamed mouth (stomatitis); flatulence; decreased libido, erectile dysfunction; injuries due to accidents; pain (e.g. chest pain); excessive fluid in the tissues (oedema); migraine; allergic reactions; lack of water in the body (dehydration); drug dependence; drug tolerance; amnesia; speech disorders; seizures; fainting; pins and needles (paraesthesia); difficulty in swallowing; belching; ileus; increased liver enzymes; dry skin; herpes simplex (disorder of the skin and mucosa); urinary retention; chills, drug withdrawal syndrome; thirst
Rare (may affect up to 1 in 1,000 people):
Lymph node disease (lymphadenopathy), muscle spasms; low blood pressure, sudden fall in blood pressure when standing up; gum bleeding; increased appetite; tarry stool; tooth staining and damage, itchy rash; blood in urine (haematuria), changes in body weight (loss or rise); cellulitis.
Not known (frequency cannot be estimated from the available data):
Severe allergic reactions (anaphylactic reactions); aggression; increased sensitivity for pain (hyperalgesia); dental caries; interruption in the excretion of bile, biliary colics; absence of menstrual bleeding (amenorrhoea)
Counteractive measures
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.
If you are suffering from sickness or vomiting your doctor will prescribe you an appropriate medicine.
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.
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.
Do not use this medicine after the expiry date which is stated on the blister/bottles and the carton after “EXP”. The expiry date refers to the last day of that month.
Do not store above 30°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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Contiroxin tablets contain
• The active substance is oxycodone hydrochloride.
• Each 5 mg prolonged-release tablet contains 5 mg oxycodone hydrochloride corresponding to 4.48 mg oxycodone.
• Each 10 mg prolonged-release tablet contains 10 mg oxycodone hydrochloride corresponding to 8.96 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, cellulose (10 mg only), colloidal anhydrous silica.
5 mg tablet coating: Hypromellose, talc, macrogol 6000, titanium dioxide (E171).
10 mg tablet coating: Hypromellose, talc, macrogol 6000, titanium dioxide (E171), iron oxide, brown (E172), iron oxide, red (E172).
What Contiroxin tablets look like and contents of the pack
Contiroxin 5 mg tablets are white, round, biconvex, prolonged-release tablets.
Contiroxin 10 mg tablets are brown-red, biconvex, oblong, prolonged-release tablets with a breakline on both sides.
Contiroxin tablets are available in blister with child resistant closure of 10, 20, 28, 30, 40, 50, 56, 60, 98 and 100 tablets and HDPE bottles of 100 and 250 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR,
UK.
Manufacturer
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1,
39179 Barleben,
Germany.
This leaflet was last approved in 08/2014.
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