Active ingredients: Oxycodone, Paracetamol
DEPALGOS 5 mg + 325 mg film-coated tablets
DEPALGOS 10 mg + 325 mg film-coated tablets
DEPALGOS 20 mg + 325 mg film-coated tablets
Why is Depalgos used? What is it for?
DEPALGOS 5 mg + 325 mg comes in the form of yellow film-coated tablets, in cartons of 14-28 or 56 tablets.
DEPALGOS 10 mg + 325 mg comes in the form of pink film-coated tablets in cartons of 14-28 or 56 tablets.
DEPALGOS 20 mg + 325 mg comes in the form of red film-coated tablets, in cartons of 14-28 or 56 tablets.
DEPALGOS is a "combination of pain relievers, one of which (oxycodone) belongs to the class of opioid analgesics.
DEPALGOS is indicated in the treatment of pain of moderate to severe degenerative origin in musculo-osteoarticular diseases not controlled by non-steroidal anti-inflammatory drugs (NSAIDs) or paracetamol used alone and in the treatment of pain of moderate to severe oncological origin.
Depalgos can only be taken by adults over 18 years old.
Contraindications When Depalgos should not be used
Do not take DEPALGOS:
- in case of hypersensitivity (allergy) to oxycodone, paracetamol or one of the ingredients of DEPALGOS
- if you are under 18
- if you are deficient in a particular enzyme (glucose-6-phosphate dehydrogenase)
- if you have severe haemolytic anemia
- if you suffer from porphyria
- if you suffer from severe liver failure
- if you have severe kidney failure
- if you suffer from respiratory failure
- if you suffer from acute or severe bronchial asthma
- if you suffer from hypercapnia (an increase in the frequency of breathing due to increased carbon dioxide in the blood)
- if you suffer from intestinal blockage (paralytic ileus)
- while breastfeeding
- if you are taking antidepressants or monoamine oxidase inhibitors (MAOIs) or if you have taken this type of medicine in the last two weeks.
Pay particular attention:
- if you have recently had a head injury or head injury
- if you suffer from increased intracranial pressure
- if you have mild to moderate liver or kidney failure (see "How to take Depalgos")
- if you suffer from hypothyroidism
- if you suffer from Addison's disease (a disease of the adrenal glands)
- if you suffer from prostatic hypertrophy or if you generally have difficulty urinating
- if you suffer from acute abdominal diseases
Precautions for use What you need to know before taking Depalgos
DEPALGOS should be used with caution in the elderly and debilitated people (see "How to take Depalgos"). If, after taking DEPALGOS, symptoms referable to an intestinal blockage arise, the treatment must be stopped immediately.
Interactions Which drugs or foods can modify the effect of Depalgos
Taking DEPALGOS with food and drink:
The simultaneous intake of alcohol or alcoholic beverages is to be avoided.
Tell your doctor or pharmacist if you are taking any other medicines, even those not prescribed, such as over-the-counter medicines (over-the-counter or OTC medicines).
Certain drugs can interact with DEPALGOS; in these cases it may be necessary to change the dosage or discontinue treatment.
It is especially important to tell your doctor if you have recently been given an anesthetic or if you are taking or have recently taken:
- sleep-promoting drugs (benzodiazepines, sedatives, and other tranquilizers)
- drugs against depression (antidepressants and monoamine oxidase inhibitors (MAOIs)); in particular, monoamine oxidase inhibitors interact with painkillers such as oxycodone and cause a sharp increase or decrease in blood pressure
- allergy medications (antihistamines)
- other pain relievers or cough medicines containing opioids
- antipsychotics (phenothiazines)
- muscle relaxants
- cyclosporine
Health education notes
It should be remembered that the achievement of adequate pain control can be favored, when possible, as well as by a correct lifestyle (weight reduction, moderate but regular physical exercise), by the association of non-pharmacological treatments such as the application of heat (using paraffin or mud), the use of ultrasound techniques and physiotherapy techniques.
Warnings It is important to know that:
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine. The use of DEPALGOS during pregnancy is not recommended
Feeding time
Ask your doctor or pharmacist for advice before taking any medicine. DEPALGOS should not be taken by women who are breastfeeding, as it can cause respiratory depression in the newborn.
Driving and using machines:
DEPALGOS can cause drowsiness and this can reduce alertness when driving or operating dangerous tools or machinery.
Important information about some of the ingredients of DEPALGOS:
For those who carry out sporting activities: the use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.
Dose, Method and Time of Administration How to use Depalgos: Posology
Always take DEPALGOS exactly as your doctor has told you. If you are not sure you should consult your doctor or pharmacist.
In the treatment of moderate to severe pain of degenerative origin in the course of musculo-osteoarticular diseases, the starting dose is one "5 mg + 325 mg" tablet administered 3-4 times a day (every 6-8 hours). The dose to be administered in the rest of the treatment depends on the intensity of the pain and is determined by your doctor. The therapy will in any case be continued until adequate pain control is achieved (this is generally achieved in about a month).
In the treatment of moderate to severe pain of cancer, the dose depends on the intensity of the pain and any previous treatment with other pain relievers and is determined by your doctor.
The total daily dose is divided into equal doses, to be taken every 6-8 hours.
Swallow the tablets with the help of a little water
In any case, you should never take more than:
- 12 tablets a day of DEPALGOS 5 mg + 325 mg,
- 8 tablets a day of DEPALGOS 10 mg + 325 mg
- 4 tablets a day of DEPALGOS 20 mg + 325 mg.
Important: If you have the impression that the effect of DEPALGOS is too strong or too weak, talk to your doctor or pharmacist.
If you have mild to moderate hepatic or renal insufficiency:
Tell your doctor, as the effects of DEPALGOS may be increased and / or prolonged. Depending on your clinical situation, your doctor may check your liver or kidney function regularly and possibly change or reduce the dosage of the medicine.
In elderly and / or debilitated subjects:
Your doctor may decide to start treatment with the lowest dosage. Furthermore, in consideration of the general condition of the patient, the interval between two administrations of DEPALGOS could be extended by the doctor.
Overdose What to do if you have taken too much Depalgos
If you take more DEPALGOS than you should:
If you have taken more DEPALGOS than you should, consult a doctor immediately.
Symptoms may be nausea, vomiting, profuse sweating, generally feeling unwell, difficulty in breathing, extreme sleepiness, muscle flabbiness, cold and sweaty skin, decreased heart rate, low blood pressure.
If you forget to take DEPALGOS
Do not take a double dose to make up for any forgotten doses.
Effects when treatment with DEPALGOS is stopped:
Do not stop treatment without first consulting your doctor.
In case of prolonged treatment, an abrupt interruption may lead to a withdrawal syndrome, characterized by the following symptoms: anxiety, irritability, chills, dilated pupils, hot flashes, sweating, tearing, runny nose, nausea, vomiting, abdominal pain, diarrhea , articolar pains.
Treatment of a withdrawal syndrome should be carried out under the direct supervision of the physician
Side Effects What are the side effects of Depalgos
Like all medicines, DEPALGOS can have side effects.
The most common side effects are constipation, confusion, sleepiness, nausea and vomiting.
During the treatment you may also have headaches, fatigue, dizziness, sedation, anxiety, strange dreams, nervousness, insomnia, strange thoughts, small muscle contractions, lowering of blood pressure when standing, difficulty in breathing, reduction of the stimulus of cough, dry mouth, anorexia (lack of appetite), digestive disorders, abdominal pain, diarrhea, redness of the skin, sweating, chills.
Certain side effects occur more rarely and among these are dehydration, swelling in various parts of the body, thirst, dizziness, hallucinations, disorientation, alterations and mood swings, restlessness, agitation, depression, tremor, withdrawal syndrome, decreased memory, decreased sensation, decreased muscle tone, feeling unwell, tingling, speech disturbances, seizures, visual disturbances, palpitations and increased heart rate, decreased blood pressure, fainting, slowed breathing, abdominal colic, stagnation of bile, increased laboratory values of liver enzymes, pain on swallowing, belching, flatulence, gastrointestinal disturbances, intestinal blockage, taste disturbance, gastritis, hiccups, dental disturbances, dry skin, urticaria, urinary retention, impotence, absence of menstruation, decreased libido, redness of the face, narrowing of the the pupils, muscle stiffness, allergies, anaphylactic and anaphylactoid reactions, fever.
If you notice any side effects, even if not mentioned in this leaflet, please tell your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date printed on the package
The expiry date refers to the product in intact packaging, correctly stored. Warning: do not use the medicine after the expiry date shown on the package
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Keep this medicine out of the reach and sight of children.
COMPOSITION:
DEPALGOS 5 mg + 325 mg film-coated tablets
One tablet contains:
Active principles:
Oxycodone hydrochloride 5 mg
Paracetamol 325 mg
Excipients: Microcrystalline cellulose, colloidal silica, povidone, crospovidone, pregelatinised starch, maize starch, stearic acid, magnesium stearate. Coating: hypromellose, titanium dioxide (E171), talc, macrogol 6000, yellow iron oxide (E172).
DEPALGOS 10 mg + 325 mg film-coated tablets
One tablet contains:
Active principles:
Oxycodone hydrochloride 10 mg
Paracetamol 325 mg
Excipients: Microcrystalline cellulose, colloidal silica, povidone, crospovidone, pregelatinised starch, maize starch, stearic acid, magnesium stearate. Coating: hypromellose, titanium dioxide (E171), talc, macrogol 6000, yellow iron oxide (E172), red iron oxide (E172).
DEPALGOS 20 mg + 325 mg film-coated tablets
One tablet contains:
Active principles:
Oxycodone hydrochloride 20 mg
Paracetamol 325 mg
Excipients: Microcrystalline cellulose, colloidal silica, povidone, crospovidone, pregelatinised starch, maize starch, stearic acid, magnesium stearate. Coating: hypromellose, titanium dioxide (E171), talc, macrogol 6000, red iron oxide (E172).
PHARMACEUTICAL FORM AND CONTENT:
DEPALGOS 5 mg + 325 mg film-coated tablets
Packs of 14-28-56 tablets.
DEPALGOS 10 mg + 325 mg film-coated tablets
Packs of 14-28-56 tablets.
DEPALGOS 20 mg + 325 mg film-coated tablets
Packs of 14-28-56 tablets.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
DEPALGOS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
DEPALGOS 5 mg + 325 mg film-coated tablets
One tablet contains:
Active principles:
Oxycodone hydrochloride 5 mg
Paracetamol 325 mg
For the full list of excipients, see section 6.1.
DEPALGOS 10 mg + 325 mg film-coated tablets
One tablet contains:
Active principles:
Oxycodone hydrochloride 10 mg
Paracetamol 325 mg
For the full list of excipients, see section 6.1.
DEPALGOS 20 mg + 325 mg film-coated tablets
One tablet contains:
Active principles:
Oxycodone hydrochloride 20 mg
Paracetamol 325 mg
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Film-coated tablets.
Round tablets, different in color for each strength:
"5 mg + 325 mg": yellow;
"10 mg + 325 mg": pink;
"20 mg + 325 mg": red
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
- Treatment of pain of moderate to severe degenerative origin in the course of osteoarticular muscle diseases not controlled by (NSAID) / paracetamol used alone.
- Treatment of moderate to severe cancer pain.
04.2 Posology and method of administration
DEPALGOS is only indicated in patients over 18 years of age.
The dosage depends on the intensity of the pain and on any previous analgesic treatments.
In any case, 4000 mg of acetaminophen per day or 80 mg of oxycodone per day should never be exceeded..
TREATMENT OF PAIN OF DEGENERATIVE ORIGIN FROM MODERATE TO SEVERE DURING MUSCULO-OSTEOARTICULAR DISEASES NOT CONTROLLED BY NSAIDs / PARACETAMOL USED ALONE
Treatment should be started with one "5 mg + 325 mg" tablet every 6-8 hours.
Continue therapy until pain is adequately controlled.
If necessary, the dose can be increased according to the patient's response using the dosages of DEPALGOS available, in 3-4 daily administrations. Generally, the period of about one month is sufficient to achieve adequate pain control.
PAIN OF ONCOLOGICAL ORIGIN FROM MODERATE TO SEVERE
Initial dosage
- Patients receiving opiates for the first time or with pain not controlled by other weak opioids:
The daily dose is one "5 mg + 325 mg" tablet every 6 hours.
- Patients previously treated with strong opiates:
The starting daily dose should be based on the previously taken daily opioid dose. For the calculation of the initial daily dose it should be considered that the equi-analgesia ratio between oral oxycodone and oral morphine is approximately 1 to 2 (i.e. 10 mg of oxycodone corresponds to 20 mg of morphine).
The total dose obtained is divided and administered every 6 hours, using the most appropriate tablets among the available dosages ("5 mg + 325 mg", "10 mg + 325 mg" and "20 mg + 325 mg").
Adjustment of the dosage
If the prescribed doses prove insufficient, the dosage can be progressively increased using the available strengths "5 mg + 325 mg", "10 mg + 325 mg" and "20 mg + 325 mg" until pain control is achieved and taking present the maximum daily dosages reported above.
If repeated or prolonged treatment is necessary, it is advisable that this is interspersed with therapeutic breaks, carrying out careful and regular monitoring of the patient.
In any case, an abrupt interruption of treatment should be avoided by making a progressive reduction of the dosage (see also Section 4.4)
Patients with mild to moderate hepatic or renal insufficiency
The plasma concentration of the drug may be increased in mild or moderate renal or hepatic insufficiency. Therefore, in these patient groups, treatment should always be started with the lowest dosage: "5 mg + 325 mg" every 8 hours and with the utmost caution, with regular monitoring of hepatic and / or renal function (see also Section 4.4). .
Elderly patients
In elderly patients (> 65 years of age), it is advisable to start treatment with the lowest dosage: "5 mg + 325 mg"; in addition, depending on the general state of the patient, the interval between two administrations, if deemed necessary, can be increased (from 6 hours to 8-12 hours).
04.3 Contraindications
- Hypersensitivity to the active substances or to any of the excipients.
- Patients under the age of 18.
- Porphyria.
- Insufficiency of glucose-6-phosphate dehydrogenase and severe haemolytic anemia.
- Severe hepatocellular insufficiency.
- Severe renal insufficiency.
- Respiratory failure.
- Acute or severe bronchial asthma.
- Hypercapnia.
- Paralytic ileus.
- Breastfeeding (see also Section 4.6).
The product is also contraindicated in patients being treated with monoamine oxidase inhibitors and tricyclic antidepressants or serotonin reuptake inhibitors. In these cases, analgesic therapy can be started two weeks after the previous treatment has been discontinued.
04.4 Special warnings and appropriate precautions for use
Maximum daily dose
Do not exceed daily doses of 4000 mg of paracetamol or 80 mg of oxycodone, respectively.
Drug addiction
Oxycodone can cause morphine drug dependence. Psychic dependence, physical dependence and tolerance can occur after repeated administration and therefore it must be prescribed and administered with the same caution as for morphine.
In the context of the treatment of pain, the request for an increase in doses is generally not included in the field of addiction; it more often testifies to a genuine need for analgesia, not to be confused with addictive behavior.
Outside of its use in the treatment of pain, oxycodone is a drug that can lead to abuse.
In case of prolonged treatment, an abrupt interruption can lead to a withdrawal syndrome, characterized by the following symptoms: anxiety, irritability, chills, mydriasis, hot flashes, sweating, tearing, runny nose, nausea, vomiting, abdominal cramps, diarrhea, arthralgia. The appearance of this withdrawal syndrome can be avoided by a progressive decrease in doses.
Head trauma and increased intracranial pressure
In the case of head trauma, other intracranial injuries or a pre-existing increase in intracranial pressure, the respiratory depressant action of oxycodone and its ability to increase cerebrospinal fluid pressure can be significantly increased. Like all opiates, oxycodone produces side effects that can mask the clinical course of patients with head injuries.
Acute abdomen
Administration of DEPALGOS may confuse the diagnosis or clinical course of patients with acute abdominal disease.
Special risk patients
DEPALGOS should be administered with caution to debilitated patients, particularly the elderly or with moderate hepatic or renal insufficiency (see also Section 4.2), hypothyroidism, Addison's disease, prostatic hypertrophy, urethral stricture.
If paralytic ileus is suspected or occurring during use, Depalgos should be discontinued immediately.
The simultaneous intake of alcohol or alcoholic beverages is to be avoided
Health Education Notes
The achievement of adequate pain control can be favored, when possible, as well as by a correct lifestyle (weight reduction, moderate but regular physical exercise), by the association of non-pharmacological treatments such as the application of heat (using paraffin or mud), the use of ultrasound techniques and physiotherapy techniques.
04.5 Interactions with other medicinal products and other forms of interaction
The depressant effects on the nervous system may be potentiated by concomitant therapy with other opioids, anesthetics, phenothiazines, tranquilizers, sedatives, or other CNS depressants, including alcohol. In this case, the dose of one or both drugs should be In case of concomitant administration of cyclosporine, it may be necessary to increase its dosage.
Monoamine oxidase inhibitor drugs or tricyclic antidepressants / serotonin reuptake inhibitors may potentiate the effects of the antidepressant or oxycodone and are therefore contraindicated.
Monoamine oxidase inhibitors are known to interact with narcotic analgesics giving rise to CNS excitation or depression with hypertensive or hypotensive crisis.
Concomitant therapy with anticholinergics can cause paralytic ileus.
Oxycodone is metabolised by the cytochrome P450 3A and 2D6 enzyme system. The metabolism of oxycodone may be impaired by drugs that act as inhibitors or inducers of cytochrome P450 3A and 2D6 such as ketonazole or erythromycin or rifampicin.
04.6 Pregnancy and lactation
Pregnancy
There are currently insufficient data to evaluate a possible malformative or teratogenic effect of DEPALGOS when administered during pregnancy.
The use of DEPALGOS during pregnancy is therefore not recommended.
Feeding time
Although oxycodone is excreted in breast milk in low concentrations, it can cause respiratory depression in the newborn. Therefore, DEPALGOS should not be used during breastfeeding.
04.7 Effects on ability to drive and use machines
Oxycodone can reduce alertness needed to perform potentially dangerous tasks such as driving vehicles or operating machinery. Patients should therefore be warned of this possibility.
04.8 Undesirable effects
The most frequent side effects are: constipation (which can be prevented by adequate treatment), confusion, drowsiness, nausea and vomiting (which appear to be more pronounced in ambulatory patients than in bedridden patients and can be relieved by laying the patient down).
The following side effects are described:
Metabolism and nutrition disorders
Uncommon:
dehydration, edema, peripheral edema, thirst.
Disorders of the nervous system
Common:
headache, confusion, asthenia, fatigue, dizziness, sedation, anxiety, abnormal dreams, nervousness, insomnia, disturbed thinking, somnolence, myoclonia
Uncommon:
dizziness, hallucinations, disorientation, mood changes, restlessness, agitation, depression, tremor, withdrawal syndrome, amnesia, decreased sensitivity, hypotonia, malaise, paraesthesia, speech disturbances, euphoria, dysphoria, seizures, disturbances of vision.
Heart ailments
Uncommon:
palpitations, supraventricular tachycardia.
Disorders of the vascular system
Common:
orthostatic hypotension
Uncommon:
hypotension, syncope, vasodilation.
Respiratory, chest and mediastinal disorders
Common:
bronchospasm, dyspnoea, decreased cough reflex
Uncommon:
respiratory depression.
Disorders of the gastrointestinal system .
Common:
constipation, nausea, vomiting, dry mouth, anorexia, dyspepsia, abdominal pain, diarrhea
Uncommon:
spasm of the biliary tract, dysphagia, belching, flatulence, gastrointestinal disturbances, intestinal obstruction, taste disturbance, gastritis, hiccups, dental disorders.
Disorders of skin and adnexa
Common:
erythema, itching
Uncommon:
dry skin, exfoliative dermatitis, urticaria.
Disorders of the urinary system
Uncommon:
urinary retention, ureter spasm.
Disorders of the reproductive system and breast
Uncommon:
impotence, amenorrhea, decreased libido.
General unrest
Common:
sweating, chills
Uncommon:
redness of the face, miosis, muscle stiffness, allergic reactions, fever.
Alterations of the immune system
Uncommon:
anaphylactic and anaphylactoid reactions.
Psychiatric disorders
Uncommon:
withdrawal syndrome.
Alterations of the hepatobiliary system
Uncommon:
cholestasis, increased liver enzymes.
04.9 Overdose
Paracetamol
Signs and symptoms : In case of overdose, paracetamol can cause hepatic cytolysis which can evolve towards massive and irreversible necrosis. Overdose can also manifest as renal tubular necrosis, hypoglycemic coma and thrombocytopenia.
In adults, liver toxicity occurred in acute poisoning with less than 10 grams, and mortality with less than 15 grams.
The early symptoms of a potential hepatotoxic overdose are: nausea, vomiting, diaphoresis and a feeling of general malaise. Clinical signs and laboratory values demonstrating liver toxicity do not appear before 48-72 hours after ingestion.
Treatment : In case of suspected acute paracetamol intoxication, the patient should be treated by gastric lavage or vomiting induced with syrup of ipecac. It is also advisable to request a dosage of paracetamol in the blood, but in any case not earlier than 4 hours after ingestion. Liver function should be evaluated initially and at 24 hour intervals.
The antidote, N-acetylcysteine, should be administered as soon as possible for best results, if possible within 16 hours of ingestion and in any case within 24 hours.
Oxycodone
Signs and symptoms : Symptoms are respiratory depression (decreased respiratory rate and / or tidal volume, Cheyne-Stokes breathing and cyanosis), extreme sleepiness which can progress to numbness or coma, musculoskeletal flaccidity, cold and sweaty skin, and sometimes bradycardia and hypotension. In the event of a severe overdose, apnea, cardiovascular collapse, cardiac arrest and death can occur.
Treatment : Particular attention must be paid to restoring adequate respiratory exchange by freeing the airways and instituting assisted or controlled ventilation.
An opioid antagonist, eg naloxone, specific antidote to respiratory depression induced by overdose or "unusual hypersensitivity to opioids, should also be administered, and breathing should be controlled with adequate supportive measures.
The starting dose for adults is 0.4-2 mg of naloxone administered intravenously; since oxycodone may have a longer duration of action than the antagonist, the patient should be kept under close surveillance and should receive repeated doses of naloxone in order to maintain adequate respiratory capacity.
The antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.
If necessary, oxygen, intravenous solutions, vasopressors and other supportive measures should be used.
Gastric lavage should be used to remove unabsorbed drug.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: natural alkaloids of opium: oxycodone, combinations, ATC code: N02AA55
DEPALGOS is the combination of 2 active ingredients, paracetamol and oxycodone.
Oxycodone is a complete opioid agonist with morphine-like action. It has affinity for the k, µ and δ receptors of the brain and spinal cord. The therapeutic effect is mainly due to its analgesic, anxiolytic and sedative properties.
Paracetamol has remarkable analgesic and antipyretic activity with a weak anti-inflammatory action. Paracetamol is a weak inhibitor of prostaglandin biosynthesis. It has only a slight effect on platelets and no effect on bleeding time or uric acid excretion.
05.2 Pharmacokinetic properties
Oxycodone has a high absolute bioavailability which can reach 87% after oral administration. The half-life of oxycodone after a single oral dose is approximately 3.5 hours. It is mainly metabolised to nor-oxycodone and oxymorphone. Oxymorphone has analgesic properties but, given the low blood concentrations found, it is not believed to contribute to the pharmacological effect of oxycodone.
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract (95-98%). Plasma levels peak between 60 and 90 minutes after oral administration. It is metabolised in the liver and excreted in the urine mainly in the form of glucuronide and sulfate conjugates; less than 5% is excreted unchanged. The half-life ranges from 1 to 4 hours. Paracetamol crosses the fetal-placental barrier and passes into breast milk.
05.3 Preclinical safety data
The safety data of the combination oxycodone-paracetamol are extrapolated from the preclinical safety studies available for the individual components.
At therapeutic doses, oxycodone does not show significant toxicity. The acute toxicity of oxycodone in cats (LD50 = 426 mg / kg) is many times higher than the therapeutic dose. In animal and human studies, high-dose oxycodone has a sedative effect and may induce marked respiratory depression.
After administration of therapeutic doses, paracetamol does not cause significant toxic effects in the animal due to the fast hepatic metabolization involving glutathione. At very high doses, paracetamol can cause hepatic necrosis in the animal; the mechanism of hepatic toxicity seems to be related to the oxidative metabolism of paracetamol into active metabolites and to a process of hepatic and extrahepatic alkylation. Furthermore, at very high doses, paracetamol can induce haemolysis in the animal.
There are no teratogenic, mutagenic or carcinogenic studies conducted with paracetamol in animals or humans.
In studies conducted in rabbits and goats, paracetamol was observed to be excreted in milk in significant quantities. There are no preclinical data on the excretion of oxycodone in milk.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
DEPALGOS 5 mg + 325 mg film-coated tablets
Excipients: microcrystalline cellulose, anhydrous colloidal silica, povidone, polysorbate 80, magnesium stearate.
Coating: hypromellose, titanium dioxide (E171), talc, macrogol 6000, yellow iron oxide (E172).
DEPALGOS 10 mg + 325 mg film-coated tablets
Excipients: microcrystalline cellulose, anhydrous colloidal silica, povidone, polysorbate 80, magnesium stearate.
Coating: hypromellose, titanium dioxide (E171), talc, macrogol 6000, yellow iron oxide (E172), red iron oxide (E172).
DEPALGOS 20 mg + 325 mg film-coated tablets
Excipients: microcrystalline cellulose, anhydrous colloidal silica, povidone, polysorbate 80, magnesium stearate.
Coating: hypromellose, titanium dioxide (E171), talc, macrogol 6000, red iron oxide (E172).
06.2 Incompatibility
Not relevant.
06.3 Period of validity
2 years.
06.4 Special precautions for storage
Store at a temperature below 25 ° C.
Store in the original package to protect from light and moisture.
06.5 Nature of the immediate packaging and contents of the package
DEPALGOS 5 mg + 325 mg film-coated tablets
Aluminum and PVC / PE / PVDC blister in cardboard box.
Packs of 14-28-56 tablets.
DEPALGOS 10 mg + 325 mg film-coated tablets
Aluminum and PVC / PE / PVDC blister in cardboard box.
Packs of 14-28-56 tablets.
DEPALGOS 20 mg + 325 mg film-coated tablets
Aluminum and PVC / PE / PVDC blister in cardboard box.
Packs of 14-28-56 tablets.
06.6 Instructions for use and handling
No special instructions
07.0 MARKETING AUTHORIZATION HOLDER
L. Molteni & C. dei F.lli Alitti Company of Exercise S.p.A., Strada Statale 67 Fraz. Granatieri, Scandicci (FI)
08.0 MARKETING AUTHORIZATION NUMBER
DEPALGOS 5 mg + 325 mg film-coated tablets:
14 tablets AIC N. 035313016
DEPALGOS 5 mg + 325 mg film-coated tablets:
28 tablets AIC N. 035313028
DEPALGOS 5 mg + 325 mg film-coated tablets:
56 tablets AIC N. 035313030
DEPALGOS 10 mg + 325 mg film-coated tablets:
14 tablets AIC N. 035313042
DEPALGOS 10 mg + 325 mg film-coated tablets:
28 tablets AIC N. 035313055
DEPALGOS 10 mg + 325 mg film-coated tablets:
56 tablets AIC N. 035313067
DEPALGOS 20 mg + 325 mg film-coated tablets:
14 tablets AIC N. 035313079
DEPALGOS 20 mg + 325 mg film-coated tablets:
28 tablets AIC N. 035313081
DEPALGOS 20 mg + 325 mg film-coated tablets:
56 tablets AIC N. 035313093
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
December 2004 / October 2010
10.0 DATE OF REVISION OF THE TEXT
AIFA determination of 29 October 2010
