Daloxy 40 Mg Prolonged-Release Capsules Hard
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Daloxy 10 mg prolonged-release capsules, hard Daloxy 20 mg prolonged-release capsules, hard Daloxy 40 mg prolonged-release capsules, hard Daloxy 80 mg prolonged-release capsules, hard
Oxycodone hydrochloride
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 Daloxy is and what it is used for
2. What you need to know before you take Daloxy
3. How to take Daloxy
4. Possible side effects
5. How to store Daloxy
6. Contents of the pack and other information
1. What Daloxy is and what it is used for
Daloxy is a strong analgesic or “painkiller” and belongs to the group of opioids.
It is used to treat severe pain, which requires treatment with an opioid analgesics because other painkillers have not been effective.
2. What you need to know before you take Daloxy Do not take Daloxy:
• if you are allergic to oxycodone or any of the other ingredients of this medicine (listed in section 6),
• if you suffer from severe breathing problems, such as severe respiratory depression,
• if you suffer from elevated carbon dioxide levels in the blood (hypercapnia),
• if you suffer from severe chronic obstructive airways disease,
• if you have a heart problem after long-term lung disease (cor pulmonale),
• if you suffer from severe bronchial asthma,
• if you have a condition where the small bowel does not work properly (paralytic ileus),
• if you are pregnant or breast-feeding,
• If you have acute severe stomach pain or suffer from a delayed stomach emptying.
Warnings and precautions
Talk to your doctor or pharmacist before taking Daloxy
• if you are elderly or weak,
• if you have severe lung-, liver- or kidney problems,
• if you have myxoedema (a disease of the thyroid gland), underactive thyroid gland (hypothyroidism),
• if you have adrenal insufficiency (Addison’s disease),
• if you have an enlarged prostate gland (prostate hypertrophy),
• if you have toxic psychosis (a mental disorder as a result of an intoxication induced by, for example, alcohol),
• if you suffer from alcoholism, delirium tremens (a state of violent mental agitation caused by alcohol poisoning),
• if you have known opioid dependence (any substance that behaves in the body like an opium-derived substance),
• if you have a history of drug or alcohol abuse,
• if you have inflammation of the pancreas (pancreatitis),
• if you have gallstones (biliary calculi),
• if you have obstructive and inflammatory intestinal diseases; with the occurrence or suspicion of paralytic ileus, Daloxy should be immediately discontinued,
• if you have conditions involving increased cerebral pressure,
• if you have circulatory system dysfunction,
• if you have epilepsy or a predisposition to convulsions,
• if you use MAO inhibitors,
• if you are going to have an operation,
Please talk to your doctor if this information applies, or has applied to you.
The main risk of an opioid overdose is respiratory depression. It occurs most often in elderly or weakened patients. Opioids may cause a severe drop in blood pressure in vulnerable individuals.
Daloxy 80 mg
If you have not taken opioids before, you should not take Daloxy 80 mg as such a high quantity may lead to a life-threatening respiratory depression (breathing difficulties).
Tolerance
You may develop a tolerance with long-term use of oxycodone. Therefore you may require higher doses of oxycodone to achieve the desired pain control.
Dependence
Long-term use of oxycodone in chronic pain patients may lead to physical and mental dependence. You can reduce the risk of dependence if you use Daloxy as instructed.
Withdrawal symptoms
If you stop the treatment suddenly, you may suffer from withdrawal symptoms that include yawning, mydriasis, lacrimation, rhinorrhoea, tremor, hyperhidrosis, anxiety, agitation, palpitations, convulsions and insomnia. When therapy with oxycodone is no longer necessary, you should reduce the daily dose gradually in order to prevent withdrawal symptoms.
If you are concerned about tolerance, dependence or withdrawal symptoms, discuss this with your doctor. Children
Daloxy is not recommended in children under 12 years of age because safety and efficacy are not established.
Other medicines and Daloxy
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You may increase the side effects of Daloxy (particularly respiratory depression) by taking:
• medicines acting on the central nervous system, such as sleeping and calming medications (sedatives, hypnotics),
• other medications which affect the nervous system (phenothiazines, neuroleptics), antidepressants,
• medications for allergies or vomiting (antihistamines, anti-emetics),
• other opioids and alcohol.
You may intensify specific side effects of Daloxy (such as constipation, dry mouth or urinary excretion dysfunction) by taking:
• medicines with anti-cholinergic effects, such as other medications which act upon the nervous system (medicines to treat psychiatric or mental disorders), medications for allergies or vomiting (antihistamines, antiemetics),
• medicines for Parkinson’s disease.
In individual cases where Daloxy and anti-coagulants of the coumarin type were used at the same time, a clinically relevant decrease or increase in blood coagulation (measured as INR) has been observed.
Antiobiotics (such as clarithromycin, erythromycin and telithromycin, antifungal medicines (such as ketoconazole, voriconazole, itraconazole and posaconazole), protease inhibitors (such as boceprevir, ritonavir, indinavir, nelfinavir and saquinavir), cimetidine (gastric acid inhibitor) and grapefruit juice as well as paroxetine and quinidine may inhibit the metabolism of oxycodone.
Some medicines, such as rifampicin, carbamazepin, phenytoin and St John’s Wort may induce the metabolism of oxycodone.
These capsules must not be used together with a monoamine oxidase inhibitor, or if you have taken this type of medicine in the last two weeks.
Daloxy with food, drink and alcohol
Drinking alcohol whilst taking Daloxy 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 Daloxy.
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.
Do not take Daloxy if you are pregnant
You must not take Daloxy during pregnancy. There are 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. Infants born to mothers who have received opioids during the last 3 to 4 weeks before giving birth should be monitored for respiratory depression.
Do not take Daloxy if you are breast-feeding. Oxycodone hydrochloride passes into breast milk.
Driving and using machines
Daloxy may impair your ability to drive or operate machinery. This is particularly likely:
• when you start the treatment with Daloxy,
• after a dose increase or product rotation (the use of alternative medicines, to reduce side effects)
• if Daloxy is combined with alcohol or with medicines, which acting on the central nervous system.
Please discuss with your doctor whether or not, or under which conditions you may drive.
Daloxy 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 Daloxy
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will adjust the dosage to the intensity of the pain and to your personal sensitivity. Take the prescribed number of capsules twice a day.
Adults and adolescents (more than 12 years of age)
• Initial dosage
Initial dosage is usually 1 capsule of Daloxy 10 mg prolonged-release (10 mg oxycodone hydrochloride) at 12 hour intervals.
In order to minimize the incidence of adverse reactions, you may benefit from a starting dose of 5 mg. In this case, your doctor will prescribe you another oxycodone product available with this specific 5 mg strength.
Further determination of the daily dosage and dosage adjustments which may be required in the course of treatment is to be made by the treating doctor depending upon the preceding dosage. If you are already receiving opioids, you may begin Daloxy treatment by taking higher doses, based upon your previous opioid experience.
Some patients receiving Daloxy on a fixed time schedule require immediate-release painkillers for fast relief from breakthrough pain. Daloxy prolonged-release capsules are not intended for the treatment of breakthrough pain.
• Recommended dosage
If you suffer from pain not related to a cancer, 40 mg per day of the active substance oxycodone hydrochloride is normally enough; however, higher doses may be necessary.
If you suffer from a cancer related pain, you normally require doses of 80 to 120 mg of the active substance oxycodone hydrochloride, which, in exceptional cases, may be increased up to 400 mg.
While taking Daloxy, you need a regular monitoring with respect to pain relief as well as other effects, in order to achieve the best possible pain relief treatment, rapid treatment of any occurring side effects, and to determine continuation of treatment.
Elderly patients
In elderly patients without kidney and/or liver problems, dosage adjustment is usually not necessary. High-risk patients
If you have not received opioids before and also suffer from kidney and/or liver problems, you should initially take half of the recommended adult dose. This also applies to patients with low body weight and patients who metabolise medications at slower rates. Therefore the lowest recommended dose, i.e. 10 mg, may not be suitable as a starting dose. In this case, your doctor will prescribe you another oxycodone product available with this specific 5 mg strength.
Please tell your doctor or pharmacist if you feel that the effect of Daloxy is too strong or too weak.
Method of administration and duration of use
Daloxy is for oral use only. The capsules should never be injected as this may lead to serious side effects, which may fatal.
Swallow the capsules whole in the morning and evening in accordance to a fixed time schedule (e.g. in the morning at 8 a.m., in the evening at 8 p.m.).
You can take Daloxy with or without food but not concomitantly with alcohol.
Swallow the capsules whole and do not break, crush or chew the capsules or their contents (granules).
Taking broken, chewed or crushed granules leads to faster release of the active substance and to the absorption of a potentially lethal dose of oxycodone hydrochloride (see under “If you take more Daloxy than you should”).
If you take more Daloxy than you should
If you have taken more capsules than prescribed, you should inform a doctor, hospital or Poison Centre immediately. Keep the packaging of the medicine at hand.
The following may occur:
• narrowed pupils,
• respiratory depression,
• somnolence progressing up to stupor or loss of consciousness (coma),
• decreased tension of skeletal muscles,
• slowed pulse rate and drop in blood pressure,
• loss of consciousness (coma), water retention in the lung and circulatory collapse may occur in more severe cases and may lead to death.
If you have taken more Daloxy than you should have, never engage in situations which need a high degree of concentration, such as driving.
If you forget to take Daloxy
If you take a smaller dose of Daloxy than prescribed, or if you have completely forgotten to take your dose, this will lead to unsatisfactory and/or insufficient pain relief.
Do not take a double dose to make up for a forgotten dose.
If you have forgotten to take your dose once, you may take it later only if the next regular dose was scheduled more than 8 hours later. You may then continue to follow your usual schedule.
If the interval to the next dose is shorter, take the prolonged-release capsules, but postpone the next dose by 8 hours.
As a matter of principle, you should never take Daloxy more frequently than at 8-hourly intervals.
If you stop taking Daloxy
Do not stop taking Daloxy without consulting your doctor.
If treatment with Daloxy is no longer necessary, you are advised to reduce the daily dosage gradually. If you stop the treatment abruptly, you may suffer withdrawal symptoms e.g. agitation, palpitations, shaking and sweating.
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.
Call a doctor immediately if you are affected by any of the following significant side effects.
Respiratory depression (difficulty breathing) is the main risk of an opioid overdose and occurs most commonly in elderly or vulnerable patients.
Opioids may cause a severe drop in blood pressure in vulnerable individuals.
Oxycodone may cause respiratory depression, narrowing of the pupils, cramping of the bronchial muscles and cramping of the smooth muscles, as well as a depression of the cough reflex.
The most common side effects are nausea (especially at the beginning of therapy) and constipation.
Other possible side effects
Very Common (may affect more than 1 in 10 people):
• Constipation, vomiting, nausea
• Fatigue and/or drowsiness (sedation), dizziness, headache
• Itching (pruritus)
Common (may affect up to 1 in 10 people):
• Abdominal pain, diarrhoea, dry mouth, hiccups, indigestion
• Lower appetite up to loss of appetite
• Altered mood and personality changes (e.g. anxiety, depression, euphoric mood), decreased activity, restlessness, increased activity, agitation, nervousness, insomnia, abnormal thinking, confusion
• Loss of consciousness (syncope), tingling or numbness in the hands or feet (paraesthesia), shaking (tremor)
• Drop in blood pressure
• Skin reactions/rash, sweating (hyperhidrosis)
• Urinary retention, difficulty or pain on passing urine (dysuria), increased urge to urinate
• Chills, general weakness
• Difficulty breathing (Dyspnoea)
Uncommon (may affect up to 1 in 100 people):
• Physical dependence including withdrawal symptoms, pain (e.g. chest pain), a general feeling of unease or lack of health (malaise), swelling from excessive accumulation of fluid (edema), peripheral edema, drug tolerance, thirst
• Accidents causing injuries
• Allergic reactions (hypersensitivity)
• Perception disturbances (e.g. hallucination, derealisation), affect lability, decreased libido, drug dependence
• Difficulty in concentrating, migraine, distorted sense of taste, increased muscle tension, involuntary muscle contractions, reduced sense of touch, poor movement coordination, epileptic seizures (especially in persons with epileptic disorder or predisposition to seizures), amnesia, speech disorder
• Respiratory depression (difficulty breathing)
• Visual impairment, miosis
• Hearing difficulty, vertigo
• Increase in pulse rate, palpitations (in the context of withdrawal syndrome)
• Vasodilatation
• Voice changes (dysphonia), cough
• Oral ulcers, inflammation in the mouth (stomatitis), flatulence, difficult swallowing (dysphagia), eructation, blockage of the intestine (Ileus)
• Erectile dysfunction
• Dehydration
• Increase of liver enzymes levels
• Dry skin
Rare (may affect up to 1 in 1,000 people):
• Melaena (abnormally dark tarry feces containing blood), dental changes, gum bleeding
• Herpes simplex
• Increased appetite
• Weight increase, weight decrease
• Orthostatic hypotension
• Itching rash (urticaria)
Not known (frequency cannot be estimated from the available data):
• Exaggerated allergic reaction (Anaphylactic reaction)
• Aggression
• Hyperalgesia
• Dental caries
• Biliary colic (gallstones), cholestasis
• Amenorrhoea (abnormal lack of menstruation)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
5. How to store Daloxy
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 and 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 to protect the environment.
6. Contents of the pack and other information
What Daloxy contains
The active substance is oxycodone hydrochloride.
Daloxy prolonged-release capsules come in four strength containing 10 mg, 20 mg, 40 mg or 80 mg of oxycodone hydrochloride, corresponding respectively to 8.97 mg, 17.93 mg, 35.86 mg and 71.72 mg of oxycodone.
The other ingredients are:
• Capsule content:
Sugar spheres (containing sucrose and maize starch), Hypromellose, Polyacrylate dispersion 30%, Talc
• Capsule shell:
Black Printing Ink: Shellac, Black iron oxide (E172)
Daloxy 10 (Yellow): Gelatin, Titanium dioxide (E 171), Yellow iron oxide (E 172)
Daloxy 20 mg (Green): Gelatin, Indigo carmine, Black iron oxide (E172), Titanium dioxide (E 171), Yellow iron oxide (E 172)
Daloxy 40 mg (White): Gelatin, Titanium dioxide (E 171)
Daloxy 80 mg (Pink): Gelatin, Titanium dioxide (E 171), Red iron oxide (E 172)
What Daloxy looks like and contents of the pack
• Daloxy 10 mg are opaque yellow capsules with a black inscription “OCR” on the body and “10” on the cap, containing white spherical microgranules.
• Daloxy 20 mg are opaque green capsules with a black inscription “OCR” on the body and “20” on the cap, containing white spherical microgranules.
• Daloxy 40 mg are opaque white capsules with a black inscription “OCR” on the body and “40” on the cap, containing white spherical microgranules.
• Daloxy 80 mg are opaque pink capsules with a black inscription “OCR” on the body and “80” on the cap, containing white spherical microgranules.
Daloxy 10 mg, 20 mg, 40 mg and 80 mg is available in package sizes of 20, 25, 28, 50, 56, 98 and 100 prolonged-release capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
ETHYPHARM
194 Bureaux de la Colline - Batiment D
92213 Saint Cloud cedex
France
Manufacturer
ETHYPHARM Chemin de la Poudriere 76120 Grand Quevilly France
This medicinal product is authorised in the Member States of the EEA under the following names:
Iceland: Oxydol 10 mg / 20 mg / 40 mg / 80 mg, fordahylki, hart
Denmark: Oxydol 10 mg / 20 mg / 40 mg / 80 mg, depotkapsel, hard
Italy: Daloxy 10 mg / 20 mg / 40 mg / 80 mg, capsula rigida a rilascio prolungato
Sweden: Oxylor 10 mg / 20 mg / 40 mg / 80 mg, depotkapsel, hard
United Kingdom: Daloxy 10 mg / 20 mg / 40 mg / 80 mg, prolonged-release capsules, hard
This leaflet was last revised in 04/2013
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