5 mg, 10 mg, 20 mg hard capsules
oxycodone hydrochloride
What Oxycodone Teva is and what it is used for
Oxycodone Teva is a centrally acting, potent painkiller in the opioid group.
Oxycodone Teva is used to treat severe pain that can only be alleviated sufficiently with painkillers opioid drugs.
Oxycodone hydrochloride contained in Oxycodone Teva 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 using Oxycodone Teva
Do not use Oxycodone Teva if you:
- is allergic to oxycodone hydrochloride or any of the other ingredients of this medicine (listed in section 6).
- have severely reduced respiratory capacity ( respiratory depression ) with too low oxygen levels in the blood ( hypoxia ) and/or too high carbon dioxide concentrations ( hypercapnia ) in the blood.
- have a severe chronic obstructive pulmonary disease (COPD), cor pulmonale (changes in the heart due to chronic congestion of the pulmonary circulation), or acute , severe bronchial asthma.
- has intestinal obstruction (paralytic ileus ).
- have acute severe abdominal pain or delayed emptying of the stomach.
Warnings and cautions
Talk to your doctor or pharmacist before taking Oxycodone Teva:
- if you are elderly or debilitated.
- if your lung, liver, or kidney function is severely impaired.
- if you have myxedema (a certain disease of the thyroid gland), impaired thyroid function.
- if you have impaired adrenal function (adrenal glands do not work properly), such as Addison’s disease.
- if you have an enlarged prostate ( prostate hyperplasia ).
- if you are an alcoholic or undergoing treatment for alcoholism and problems occur (eg delirium tremens ).
- if you have a poisoning psychosis (eg alcohol).
- if you know you are addicted to opioids.
- if you have inflammation of the pancreas ( pancreatitis ).
- in conditions with increased pressure in the brain, e.g. in case of head injury.
- if you have circulatory disorders.
- if you have biliary tract disease, severe painful cramps in the bile ducts or the urethra.
- if you have low blood pressure or decreased blood flow to the circulatory system.
- if you have epilepsy or a tendency to seizures.
- if you are taking MAOIs (to treat depression).
- if you have recently had surgery on your abdomen or intestines.
- if you have an inflammatory bowel disease.
Tell your doctor if any of the above apply to you or if you have had any of the above before.
Oxycodone Teva should be used with special caution in patients who are or have previously been addicted to drugs or alcohol.
Like other opioids, Oxycodone Teva can affect the normal production of hormones in your body, such as cortisol or sex hormones. This is especially true if you are taking high doses for a long time.
See section 4 “Possible side effects” for information on preventive measures that can be used to alleviate certain side effects.
Physical dependence and withdrawal symptoms
Oxycodone Teva has a primary dependence potential.
When the medicine is used for a long time, tolerance to the effects can arise, and this means that an increased dose is required to maintain pain control.
Chronic use of Oxycodone Teva may lead to physical dependence and withdrawal symptoms may occur with abrupt discontinuation of treatment. When you no longer need treatment with Oxycodone Teva, it is advisable to reduce the dose gradually to prevent withdrawal symptoms.
The risk of developing physical or psychological dependence is small when the drug is used as prescribed by patients suffering from chronic pain. Discuss this with your doctor.
In rare cases, an increased sensitivity to pain, which does not respond to increased dosing , may develop.
If this happens, tell your doctor, who will reduce the dose one or switch to another type of opioid painkiller.
Surgery
Tell your doctor or hospital staff that you are using these capsules if you are having surgery.
Children and young people
Oxycodone Teva is NOT recommended for children under 12 years of age, as safety and efficacy have not been established.
Elderly patients
In elderly patients without renal and / or hepatic impairment, no dose adjustment is usually required.
Other medicines and Oxycodone Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you take these capsules together with other medicines, the effect of these capsules or the other medicine may increase or decrease. The risk of side effects may increase. Tell your doctor or pharmacist if you are taking:
- a type of medicine called monoamine oxidase inhibitor ( MAOI ), or if you have been taking this medicine for the last two weeks (see section “Warnings and precautions”),
- medicines that help you sleep or stay calm (eg hypnotics or sedatives , including benzodiazepines ),
- medicines used to treat depression (eg paroxetine or fluoxetine ),
- medicines used to treat psychiatric or mental illnesses (such as phenothiazines or neuroleptic medicines),
- other strong painkillers ( opioids ),
- muscle relaxants,
- quinidine (a drug used to treat rapid heartbeat),
- cimetidine (a medicine used to treat stomach ulcers , indigestion or heartburn),
- medicines used to treat fungal infections (such as ketoconazole , voriconazole, itraconazole or posaconazole),
- drugs used to treat bacterial infections (such as clarithromycin, erythromycin or telithromycin),
- a specific drug called protease inhibitor used to treat HIV (eg boceprevir, ritonavir, indinavir, nelfinavir, saquvinavir),
- rifampicin to treat tuberculosis ,
- carbamazepine (a medicine for seizures, seizures, tremors and certain pain conditions),
- phenytoin (a medicine for seizures, seizures and tremors),
- St. John’s wort , a traditional herbal medicine ( Hypericum Perforatum ),
- medicines used to treat allergies ( antihistamines ) or vomiting (antiemetics),
- medicines used to treat Parkinson’s disease ,
- coumarin-type anticoagulants (medicines that reduce the blood’s ability to clot).
You should also tell your doctor if you have recently been anesthetized.
Concomitant use of Oxycodone Teva with sedatives or sleeping pills such as benzodiazepines or similar medicines increases 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 Teva at the same time as sedatives, the dose and treatment time should be limited by your 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.
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.
Oxycodone Teva with food, drink and alcohol
Oxycodone Teva can be taken with or without food with a sufficient amount of fluid.
Grapefruit juice
Grapefruit juice can impair the breakdown of oxycodone, which increases its effect. Therefore, you should avoid drinking grapefruit juice when using Oxycodone Teva.
Alcohol
If you drink alcohol while using Oxycodone Teva, it may make you feel more sleepy or increase the risk of serious side effects such as shallow breathing with risk of respiratory arrest and unconsciousness . You should NOT drink alcohol while using Oxycodone Teva.
Pregnancy and breastfeeding
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.
The use of Oxycodone Teva should be avoided as much as possible during pregnancy and lactation.
Pregnancy
There are limited data from treatment of pregnant women with oxycodone. Use of oxycodone during pregnancy may cause withdrawal symptoms in the newborn. Newborns to mothers who have received oxycodone during the last 3-4 weeks before delivery may have severe breathing difficulties. Oxycodone Teva should only be used during pregnancy if the benefit outweighs the potential risks to the baby.
Breast-feeding
Oxycodone can pass into breast milk and may cause breathing difficulties in the newborn baby. Oxycodone Teva should therefore not be used during breast-feeding.
Driving and using machines
Oxycodone impairs the ability to concentrate and react to such an extent that the ability to drive and use machines is affected or ceases completely. See section 4 “Possible side effects” for possible side effects that may affect your ability to drive and concentrate. With stable dosing , it may not be necessary to ban driving. The attending physician must assess the situation individually. Discuss with your doctor if and under what circumstances you can drive.
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 Teva contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per capsule, ie essentially ‘sodium-free’. is next to “sodium free”.
How to use Oxycodone Teva
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Adults and adolescents (12 years and older)
The usual starting dose is one 5 mg capsule every six hours.
However, your doctor will prescribe the appropriate dose and frequency of administration to treat your pain.
If you still feel pain while taking these capsules, discuss it with your doctor.
Use
Oxycodone Teva capsules should be swallowed whole with a sufficient amount of liquid and can be taken with or without food.
Oxycodone Teva must NOT be taken with alcoholic beverages (see section 2 “Oxycodone Teva with food, drink, and alcohol”).
You may only take the capsules by mouth. The contents of the capsules should never be injected, as this can lead to serious and potentially fatal side effects.
Only for peelable blister packs:
Instructions for use of peelable blister packs:
Do not push the capsule directly out of the blister.
Separate a blister cell from the strip at the perforation (see Figure 1).
Carefully pull off the back to open the blister (see Figures 2 and 3).
Only for child-resistant HDPE cans:
Instructions for use of child-resistant plastic cans:
Press the lid down and turn it to open.
Adults with impaired renal or hepatic function
The usual starting dose is half the recommended dose for adults. Your doctor will prescribe the appropriate dose based on your clinical situation and use a more appropriate formulation if available.
Use for children
Oxycodone Teva is NOT recommended for children under 12 years of age.
If you use more Oxycodone Teva than 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.
The following symptoms may occur: constricted pupils, decreased breathing, muscle weakness, and drop in blood pressure. In severe cases, circulatory collapse, mental and motor inactivity, unconsciousness, slow heartbeat, and accumulation of water in the lungs may occur. Abuse of high doses of strong opioids such as oxycodone can be fatal. You should NOT expose yourself to situations that require a high ability to concentrate, such as driving.
If you forget to use Oxycodone Teva
If you forget to take a dose, take the next dose as soon as you remember and then continue as usual. Never take two doses within 4 hours. Do not take a double dose to make up for a forgotten dose.
If you stop using Oxycodone Teva
DO NOT stop treatment without talking to your doctor.
When you no longer need treatment with Oxycodone Teva, 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.
If you experience any of the following side effects, stop using Oxycodone Teva immediately and contact your doctor or go to the nearest emergency room:
- respiratory depression (shallow breathing) which is most likely to occur in elderly or debilitated patients. This can also lead to a sharp drop in blood pressure.
- severe allergic reactions (anaphylactic shock ) which may cause hives, swelling of the face, lips, mouth, tongue, or throat, or difficulty breathing.
- reduction in pupil size
- sudden contraction of the airways which makes it difficult to breathe ( bronchospasm )
- stomach cramps
- subdued cough reflex.
Oxycodone Teva may cause contraction of the pupils, bronchospasm, and spasm in the smooth muscles and may dampen the cough reflex.
Other possible side effects are
Very common (may affect more than 1 user in 10):
- decreased level of consciousness (fatigue to drowsiness)
- dizziness
- headache
- constipation
- nausea
- vomiting
- itching.
Common (may affect up to 1 in 10 people):
- reduced appetite
- various psychological side effects are such as:
- mood swings (such as anxiety, depression)
- altered activity level (usually decreased, sometimes accompanied by fatigue, but sometimes increased with nervousness and sleep disorders)
- changed behavior (thought process disorders, confusion)
- tremors _ _
- hissing breathing, shortness of breath, hiccups
- dry mouth, stomach pain, diarrhea, indigestion ( dyspepsia )
- rash, increased sweating
- increased need to urinate
- a feeling of weakness ( asthenia ).
Uncommon (may affect up to 1 in 100 people):
- allergic reactions
- abnormal secretion of antidiuretic hormone
- lack of water in the body (dehydration)
- perceptual disorders such as personality change and seeing, hearing, or feeling things that are not there (hallucinations), decreased sex drive, restlessness, sharp mood swings, elation, drug dependence (see section 2)
- increased or decreased muscle tone, coordination difficulties, involuntary muscle contractions, seizures (especially in patients with epilepsy or tendency to seizures), increased muscle stiffness and difficulty stretching muscles, difficulty speaking, fainting, tingling or an ant crawling ( paresthesia ), decreased sensitivity to touch ( hypesthesia ), migraine , the altered experience of taste, memory loss
- changes in tear flow, contraction of the pupils, visual disturbances
- unusually sharp hearing (hyperacusis), feeling of dizziness, or dizziness ( vertigo ).
- increased heart rate, awareness of the heartbeat.
- dilated blood vessels (vasodilation).
- difficulty breathing, cough, sore throat, runny nose, voice changes
- difficulty swallowing, cold sores, inflammation of the gums
- inflammation of the mouth ( stomatitis ), gas, belching, intestinal obstruction ( ileus )
- elevated levels of liver enzyme
- dry skin
- problems urinating
- impotence
- pain (eg chest pain), chills, too much fluid in the tissues ( edema ), malaise, drug dependence with withdrawal symptoms, drug tolerance which means that an increased dose is required to maintain the effect, thirst
- injuries as a result of accidents.
Rare (may affect up to 1 in 1,000 people):
- herpes simplex (a disease that affects the skin and mucous membranes)
- a disease of the lymph nodes ( lymphadenopathy ).
- increased appetite
- lowered blood pressure, dizziness when walking from a lying or sitting position to standing
- bleeding gums, dark stools, stains, and damage to the teeth
- itchy skin rash ( hives ), increased photosensitivity ( photosensitivity )
- muscle spasms
- blood in the urine ( hematuria )
- changes in body weight (increased or decreased), cellulite.
Very rare (may affect up to 1 in 10,000 people):
- scaly rash (exfoliative dermatitis ).
Has been reported (occurs in an unknown number of users):
- aggressiveness
- increased pain sensitivity that does not respond to dose increase
- caries in the teeth
- pain on the right side of the abdomen, biliary colic
- missed period ( amenorrhea )
- Long-term use of Oxycodone Teva during pregnancy may cause life-threatening withdrawal symptoms in newborns. Symptoms of being vigilant in the child are e.g. irritability, hyperactivity and abnormal sleep patterns, screams, tremors, vomiting, diarrhea, and lack of weight gain.
Prevention
If you experience any of the side effects mentioned above, your doctor will usually take the necessary measures. Side effects in the form of constipation can be prevented through a fiber-enriched diet and increased fluid intake. If you suffer from nausea or vomiting, your doctor will prescribe a suitable medicine for this.
How to store Oxycodone Teva
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/label or carton after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
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 Teva 5 mg capsules: Each capsule contains 5.0 mg oxycodone hydrochloride equivalent to 4.48 mg oxycodone.
- Oxycodone Teva 10 mg capsules: Each capsule contains 10.0 mg oxycodone hydrochloride equivalent to 8.96 mg oxycodone.
- Oxycodone Teva 20 mg capsules: Each capsule contains 20.0 mg of oxycodone hydrochloride equivalent to 17.93 mg of oxycodone.
- The other ingredients are Capsule content: microcrystalline cellulose, magnesium stearate. Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), indigo carmine (E132). Printing inks: shellac, propylene glycol, ammonium solution, black iron oxide (E172), potassium hydroxide
What the medicine looks like and the contents of the pack
Oxycodone Teva 5 mg:
Hard capsules, 14.4 mm long. A dark pink lower part is marked with “5” and a brown upper part marked with “OXY”.
Oxycodone Teva 10 mg:
Hard capsules, 14.4 mm long. The white lower part is marked with “10” and the brown upper part is marked with “OXY”.
Oxycodone Teva 20 mg:
Hard capsules, 14.4 mm long. A light pink lower part is marked with “20” and a brown upper part is marked with “OXY”.
Pullable blister cards (PVC / PVdC / Al / PET / paper).
Pack sizes:
5 mg
14, 20, 28, 30, 50, 56 and 100 capsules
10 mg
20, 28, 30, 50, 56 and 100 capsules
20 mg
20, 28, 30, 50, 56 and 100 capsules
Blister Map (PVC / PVdC / Al)
Pack sizes:
5 mg
14, 20, 28, 30, 50, 56 and 100 capsules
10 mg
20, 28, 30, 50, 56 and 100 capsules
20 mg
20, 28, 30, 50, 56 and 100 capsules
Child protective plastic jars.
Pack sizes: 98, 100, and 250 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer:
Balkanpharma-Dupnitsa AD, 3 Samokovsko Shosse Str., Dupnitza 2600, Bulgaria
Merckle GmbH, Ludwig-Merckle-Str. 3, 89143 Blaubeuren, Germany