5 mg, 10 mg, 15 mg prolonged-release tablet is
oxycodone hydrochloride
What Oxycodone Depot 1A Farma is and what it is used for
Oxycodone Depot 1A Farma contains the active substance oxycodone hydrochloride, which is a centrally acting, strong painkiller in the group of opioids.
Oxycodone Depot 1A Farma is used in adults and adolescents 12 years of age and older to treat severe pain that can only be alleviated with sufficient analgesic opioid drugs.
Oxycodone hydrochloride contained in Oxycodone Depot 1A Farma may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Oxycodone Depot 1A Farma
Do not take Oxycodone Depot 1A Farma if you
- is allergic to oxycodone hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- have breathing problems, such as severe respiratory distress ( respiratory depression )
- have the severe chronic obstructive pulmonary disease (COPD) or severe bronchial asthma. Symptoms may include shortness of breath, cough, or slower or weaker breathing than expected
- has elevated carbon dioxide content in the blood
- have heart problems caused by long-term lung disease (cor pulmonale)
- has intestinal obstruction (paralytic ileus ). Signs may be slower (delayed) emptying of the stomach or severe abdominal pain.
Warnings and cautions
Talk to your doctor or pharmacist before taking Oxycodone Depot 1A Farma if you
- is older or debilitated
- have severely impaired lung function
- have problems with the liver or kidneys
- has a thyroid disease with dry, cold, and swollen skin on the face, arms, and legs ( myxedema )
- has impaired thyroid function
- have adrenal insufficiency, which may cause symptoms such as weakness, weight loss, dizziness, nausea, or vomiting ( Addison’s disease )
- has an enlarged prostate, which causes urination difficulties (in men)
- suffers from alcoholism or undergoes alcohol withdrawal
- have previously experienced withdrawal symptoms such as agitation, anxiety, shaking, or sweating when you stop drinking alcohol or using drugs
- have or have had opioid dependence
- have a mental disorder due to poisoning e.g. with alcohol (toxic psychosis )
- has pancreatitis, which causes severe pain in the abdomen and back
- have problems with the gallbladder or bile ducts
- have an obstructive or inflammatory bowel disease
- have a head injury, severe headache, or nausea, as this may indicate increased pressure in the brain
- have low blood pressure
- have low blood volume ( hypovolemia ); this can happen with severe bleeding, severe burns, heavy sweating, severe diarrhea, or severe vomiting
- have epilepsy or a tendency to seizures/seizures
- take a type of medicine called monoamine oxidase inhibitor ( MAOI ) to treat depression or Parkinson’s disease or have taken such medicine within the last 2 weeks
- should undergo surgery or have undergone abdominal surgery very recently.
Tell your doctor if any of the above apply to you or if you have had any of them before
above.
Oxycodone Depot 1A Farma may induce addiction. When used for a long time, tolerance to the effects may arise and an increased dose may be required to maintain pain control.
Chronic use of Oxycodone Depot 1A Farma may lead to physical dependence and withdrawal symptoms may occur with abrupt discontinuation of treatment (see section “If you stop taking Oxycodone Depot 1A Farma”). Withdrawal symptoms may include yawning, enlarged pupils, abnormal or excessive tearing, runny nose, tremors or tremors, profuse sweating, anxiety, restlessness, cramps, difficulty sleeping, and muscle aches.
You may develop increased pain sensitivity (hyperalgesia) that does not respond to an increase in the oxycodone dose, especially if you take high doses. The dose of oxycodone may need to be reduced or you may need to switch to another opioid.
The risk of developing physical or psychological dependence is small when the drug is used as prescribed by patients suffering from chronic pain, and this risk
must be weighed against the potential benefit. Discuss this with your doctor.
The prolonged-release tablets should be used with special caution by patients with a history of alcohol or drug abuse.
In the case of drug injection ( injection into a vein), the ingredients of the tablet may lead to degradation ( necrosis ) of the nearby tissue, alteration of the lung tissue (lung granuloma), or other serious, potentially fatal events.
You can see remnants of the tablet in the stool. Do not worry, as the active substance oxycodone hydrochloride has been previously released while the tablet passed through the digestive system and has begun to act in the body.
Children
Oxycodone Depot 1A Farma prolonged-release tablets have not been studied in children under 12 years of age. Therefore, safety and efficacy have not been established, and use in children under 12 years of age is not recommended.
Other medicines and Oxycodone Depot 1A Farma
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking Oxycodone Depot 1A Farma at the same time as certain medicines that affect brain function (see below) may increase the risk of respiratory arrest, especially in case of overdose and in the elderly, and/or increase the sedative effect of Oxycodone Depot 1A Farma (you may feel very sleepy).
Concomitant use of Oxycodone Depot 1A Farma and drugs that affect brain function (eg sedatives such as benzodiazepines or similar drugs, see below) increase the risk of drowsiness, difficulty breathing ( respiratory depression ), coma, and may be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible.
If your doctor prescribes Oxycodone Depot 1A Farma at the same time as sedatives, dose one and
the treatment time is limited by the doctor. Tell your doctor if you are taking any sedatives and carefully follow your doctor’s dose recommendations. It may be helpful to inform friends or relatives about paying attention to the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.
Drugs that affect the brain include:
- other strong painkillers ( opioids )
- sleeping pills and sedatives (eg benzodiazepines )
- drugs for the treatment of depression, such as paroxetine
- medicines to treat allergies, motion sickness, and nausea ( antihistamines or antiemetics)
- drugs for the treatment of psychiatric or mental disorders (antipsychotics)
- drugs used to treat Parkinson’s disease.
The risk of side effects is increased if you take antidepressant drugs (for example, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline , venlafaxine ). These drugs can affect or be affected by oxycodone, and you may experience symptoms such as involuntary, rhythmic muscle contractions, including in the muscles that control eye movements, sudden movements, heavy sweating, tremors, excessive reflexive movements, increased muscle tension, body temperature above 38 ° C. Contact your doctor if you experience these symptoms.
Additional interaction may occur with
- certain medicines that prevent blood clots or dilute the blood (called coumarin anticoagulants, such as warfarin or phenprocoumon). Oxycodone Depot 1A Farma may affect their effects
- muscle relaxants
- certain antibiotics (eg clarithromycin, erythromycin, telithromycin, or rifampicin)
- certain medicines used to treat fungal infections (eg ketoconazole , voriconazole, itraconazole or posaconazole)
- certain medicines for HIV infection (eg boceprevir , ritonavir, indinavir, nelfinavir or saquvinavir)
- cimetidine, a medicine for heartburn
- carbamazepine (a medicine used to treat seizures or cramps and certain pain conditions)
- phenytoin , an anticonvulsant drug
- St. John’s wort, a medicine for depression
- quinidine (a drug for the treatment of rapid heartbeat )
- MAO inhibitors, or if you have taken this type of medicine within the last two weeks (see section 2 “Warnings and precautions”).
Oxycodone Depot 1A Farm with food, drink, and alcohol
If you drink alcohol while taking Oxycodone Depot 1A Farma, it may make you feel more sleepy or increase the risk of serious side effects such as shallow breathing with a risk of respiratory arrest and unconsciousness. Therefore, concomitant use of Oxycodone Depot 1A Farma is not recommended.
If you drink grapefruit juice while taking Oxycodone Depot 1A Farma, the risk of side effects may increase. Do not drink grapefruit juice while you are being treated with Oxycodone Depot 1A Farma.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, 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 Oxycodone Depot 1A Farma during pregnancy. Experience with oxycodone therapy during pregnancy is limited. Oxycodone passes through the placenta into the baby’s bloodstream.
Prolonged use of oxycodone during pregnancy may cause withdrawal symptoms in the newborn. The use of oxycodone during labor can cause shallow and slow breathing ( respiratory depression ) in the newborn.
Breast-feeding
You should not take Oxycodone Depot 1A Farma during the breastfeeding period as the active substance oxycodone may pass into breast milk and cause drowsiness or shallow and slow breathing ( respiratory depression ) in the breast-fed baby.
Driving and using machines
Oxycodone Depot 1A Farma may impair the ability to drive and use machines. General restrictions on driving may not apply during stable treatment; your doctor makes this decision based on your situation.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects
is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Oxycodone Depot 1A Farma contains lactose.
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 Oxycodone Depot 1A Farma
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
For dose adjustment, there may be other strengths of this medicine.
The recommended dose is
Oxycodone Depot 1A Farma 5 mg:
Adults and adolescents (12 years and older)
The usual starting dose is 2 prolonged-release tablets (10 mg oxycodone hydrochloride) every 12 hours. Your doctor will prescribe the dose you need for pain relief. Take the number of prolonged-release tablets prescribed by your doctor twice a day.
Oxycodone Depot 1A Farma 10 mg:
Adults and adolescents (12 years and older)
The usual starting dose is a prolonged-release tablet (10 mg oxycodone hydrochloride) every 12 hours. Your doctor will prescribe the dose you need for pain relief. Take the number of prolonged-release tablets prescribed by your doctor twice a day.
Oxycodone Depot 1A Farma 20 mg:
Adults and adolescents (12 years and older)
The usual starting dose is 10 mg oxycodone hydrochloride at 12-hour intervals. Your doctor will prescribe the dose you need for pain relief. Take that number
a prolonged-release tablet you as your doctor prescribed twice daily.
Further determination of the daily dose one, the division of the doses, and all dose adjustments during treatment are carried out by the treating physician and depend on the previous dose one.
Patients who have previously taken opioids can start treatment with higher doses, taking into account their previous experience with opioid treatment.
Some patients receiving Oxycodone Depot 1A Farma prolonged-release tablets according to an established schedule need fast-acting painkillers such as emergency medicine to control breakthrough pain. Oxycodone Depot 1A Farma prolonged-release tablets are not intended for the treatment of breakthrough pain.
In the treatment of non-cancer-related pain, a daily dose of 40 mg oxycodone hydrochloride is usually sufficient, but a higher dose may be needed. Patients with cancer pain usually need higher daily doses, from 80 mg to 120 mg oxycodone hydrochloride, which can be increased to 400 mg in individual cases.
The treatment needs to be checked regularly about pain relief and other effects to achieve the best possible pain treatment as well as the possibility of treating all side effects that occur in good time and deciding whether to continue the treatment.
Patients with renal and/or hepatic impairment
Your doctor may prescribe a lower starting dose.
Other at-risk patients
If you have low body weight or metabolize medicines more slowly, your doctor may prescribe a lower starting dose.
Taking the tablet
Intended for oral use only.
Swallow prolonged-release tablets with a sufficient amount of liquid (½ glass of water), with or without food, in the morning and evening according to a set schedule (eg at 8.00 and 20.00).
The prolonged-release tablet must not be split, broken, crushed, or chewed as this will lead to rapid release of oxycodone due to damage to the sustained release properties. If you swallow a prolonged-release tablet that has been broken, chewed, or crushed, this will lead to rapid release and absorption of a potentially lethal dose of the active substance oxycodone (see section “If you have taken too much
Oxycodone Depot 1A Farma ”).
Oxycodone Depot 1A Farma is for oral use only. In the case of drug injection ( injection into a vein), the ingredients of the tablet may lead to degradation ( necrosis ) of the nearby tissue, alteration of lung tissue (lung granuloma), or other serious, potentially fatal events.
If you take more Oxycodone Depot 1A Farma then you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Signs of overdose can be:
- decreased pupil er
- slower or weaker breathing ( respiratory depression )
- drowsiness that progresses even to unconsciousness
- reduced muscle tension
- slow pulse
- drop in blood pressure.
In severe cases, unconsciousness ( coma ), accumulation of water in the lungs, and circulatory collapse can occur, which can be fatal.
Never expose yourself to situations that require a high degree of concentration, such as driving.
If you forget to take Oxycodone Depot 1A Farma
If you take a smaller dose of Oxycodone Depot 1A Farma than you were prescribed or if you forget to take a tablet, the pain relief will be insufficient or stop completely.
If you forget to take a dose, follow the instructions below:
- If you are taking your next regular dose more than 8 hours later: Take the missed dose immediately and continue with your usual dosing schedule.
- If you are taking your next regular dose is less than 8 hours: Take the missed dose one and wait another 8 hours before taking the next dose. Try to return to your normal dosing schedule.
Do not take more than one dose within 8 hours.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Oxycodone Depot 1A Farma
Do not stop treatment without talking to your doctor.
If you no longer need treatment with Oxycodone Depot 1A Farma, it is advisable to reduce the dose gradually to prevent withdrawal symptoms.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The common side effects are nausea (especially at the beginning of treatment) and constipation. Side effect constipation can be prevented with measures such as intake of copious amounts of fluid and a high fiber diet. If you experience nausea or vomiting, your doctor may prescribe medication.
Important side effects or signs that you should be aware of and what to do if you get them:
Stop taking Oxycodone Depot 1A Farma and contact a doctor or see your nearest emergency department immediately if you experience any of the following symptoms.
- sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching, especially if it occurs on the whole body. This may be a sign of severe allergic reactions.
- slower or shallower breathing ( respiratory depression ). This is the most serious side effect of an overdose of straight painkillers such as oxycodone and it occurs mainly in the elderly and weak patients.
Other side effects are
Very common (may affect more than 1 user in 10):
- drowsiness, drowsiness, dizziness, headache
- constipation, nausea, vomiting
- skin itching.
Common (may affect up to 1 in 10 people):
- anxiety, depression, decreased activity, restlessness, increased activity, nervousness, difficulty sleeping, abnormal thoughts, confusion, tremors
- lack of energy, feeling weak, tired
- shortness of breath, wheezing
- dry mouth, hiccups, indigestion stomach pain, diarrhea, decreased appetite, and even loss of appetite
- skin rash, increased sweating
- painful urination, increased need for urination.
Uncommon (may affect up to 1 in 100 people):
- a condition in which you breathe slower and weaker than expected ( respiratory depression )
- allergic reactions
- dehydration _ _
- arousal, emotional instability, extreme happiness
- hallucinations changed perception of reality
- visual disturbances, pupil reduction
- hearing loss, dizziness
- taste changes
- increased muscle tension, involuntary muscle contractions, epileptic seizures, seizures
- tingling or numbness, decreased sensitivity to pain or touch
- problems with coordination or keeping balance
- memory loss, difficulty concentrating, speech disorders
- fainting
- rapid heartbeat, palpitations (associated with withdrawal syndrome)
- dilated blood vessels leading to low blood pressure
- cough, voice changes
- cold sores, tender gums
- weather tension, difficulty swallowing, belching
- armored
- decreased sex drive, impotence, low levels of sex hormones in the blood (called hypogonadism and seen in a blood test)
- injuries due to accidents
- general malaise, pain (eg chest pain)
- swelling of hands, ankles, or feet ( edema )
- migraine
- drug tolerance
- dry skin
- thirst
- problems urinating
- overindulge
- physically dependent with withdrawal symptoms (see section 3 “If you stop taking Oxycodone Depot 1A Farma”)
- elevated liver enzymes (seen in a blood test).
Rare (may affect up to 1 in 1,000 people):
- low blood pressure, dizziness, fainting caused by a sudden drop in blood pressure when standing up
- bleeding gums, increased appetite, dark-colored tar-like stools, dental problems
- blisters on the skin and mucous membranes (cold sores or herpes ), hives change in body weight (increased or decreased).
Has been reported (occurs in the unknown number of users):
- menstrual failure
- severe allergic reactions that cause difficulty breathing or dizziness
- aggression
- increased pain sensitivity (hyperalgesia)
- caries
- gallstone attacks (which cause abdominal pain), obstruction of the bile ducts
- withdrawal symptoms in newborns
- development of addiction to these tablets
- contraction of smooth muscle
- attenuation of the cough reflex.
How to store Oxycodone Depot 1A Farma
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 after EXP and on the jar and carton after EXP. or EXP.
The expiration date is the last day of the specified month.
Oxycodone Depot 1A Farma 5 mg prolonged-release tablets:
Blister packs: Do not store above 30 ° C.
Jars: No special storage instructions.
Oxycodone Depot 1A Farma 10 mg and 20 mg prolonged-release tablets:
No special storage instructions.
Jars: Shelf life after first opening: 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is oxycodone hydrochloride.
Oxycodone Depot 1A Farma 5 mg prolonged-release tablet is
One prolonged-release tablet contains 5 mg oxycodone hydrochloride equivalent to 4.5 mg oxycodone.
Oxycodone Depot 1A Farma 10 mg prolonged-release tablet is
One prolonged-release tablet contains 10 mg oxycodone hydrochloride equivalent to 9.0 mg oxycodone.
Oxycodone Depot 1A Farma 20 mg prolonged-release tablet is
One prolonged-release tablet contains 20 mg oxycodone hydrochloride equivalent to 17.9 mg oxycodone.
Other ingredients are:
Tablet core: Hydrogenated castor oil, copovidone, behenoyl polyoxyglycerides, lactose monohydrate, magnesium stearate, corn starch, colloidal anhydrous silica, triglycerides (medium chains)
Tablet coating: Microcrystalline cellulose, hypromellose, stearic acid, titanium dioxide (E171)
Oxycodone Depot 1A Farma 5 mg prolonged-release tablets only: Indigo carmine (E132) and hydrated alumina.
Oxycodone Depot 1A Pharma only 20 mg prolonged-release tablets: Red iron oxide (E172).
What the medicine looks like and the contents of the pack
Oxycodone Depot 1A Farma 5 mg is a blue, round, biconvex film-coated prolonged-release tablet with a diameter of 5.3 – 5.9 mm.
Oxycodone Depot 1A Farma 10 mg is a white, round, biconvex film-coated prolonged-release tablet with a diameter of 6.8 – 7.4 mm.
Oxycodone Depot 1A Farma 20 mg is a pink, round, biconvex film-coated prolonged-release tablet with a diameter of 6.8 – 7.4 mm.
The prolonged-release tablets are packaged in child-resistant blister packs or jars closed with a child-resistant screw cap with or without a desiccant capsule containing silica gel as a desiccant.
Pack sizes:
Blister packs: 7, 10, 14, 20, 28, 30, 50, 56, 60, 98, 100, 100 x 1 and 112 prolonged-release tablets
Jars: 100 and 250 prolonged-release tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
1A Farma A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturers _
Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia
or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany