10 mg / ml solution for injection / infusion
oxycodone hydr,ochloride
What Lindoxa is and what it is used for
Lindoxa contains the active substance oxycodone hydrochloride which belongs to a group of medicines called opioids and has a strong analgesic effect.
Lindoxa is used to treat severe pain in adults (18 years and older) who require treatment with painkillers opioids because other painkillers have not been effective.
Oxycodone hydrochloride contained in Lindoxa may also be approved for the treatment of other conditions not mentioned in this product information. Ask doctors, pharmacists, or healthcare professionals if you have any further questions and always follow their instructions
What you need to know before using Lindoxa
Do not use Lindoxa
- if you are allergic to oxycodone hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- if you have breathing problems, such as slower or weaker breathing than expected ( respiratory depression ), too little oxygen or too much carbon dioxide in your blood
- if you have a severe chronic lung disease associated with narrowing of the airways (COPD = chronic obstructive pulmonary disease )
- if you have a certain heart disease due to a long-term lung disease (cor pulmonale)
- if you have severe tracheal asthma
- if you have a certain type of intestinal obstruction (paralytic ileus ).
Warnings and cautions
Talk to your doctor or pharmacist before using Lindoxa:
- if you are elderly or debilitated
- if you have impaired lung, liver or kidney function
- if you have impaired thyroid function ( hypothyroidism or myxedema )
- if you have impaired adrenal function (your adrenal glands do not function normally), e.g. Addison’s disease
- if you have a mental illness as a result of poisoning caused by another substance or alcohol
- if you are or have been addicted to alcohol, strong painkillers ( opioids ) or drugs
- if you have delirium tremens ( abstinence ) after stopping drinking alcohol which causes severe confusion, hallucinations and tremors
- if you have prostate enlargement
- if you have inflammation of the pancreas ( pancreatitis )
- if you have problems with the gallbladder or urinary tract including difficulty urinating or pain when urinating
- if you have an inflammatory bowel disease
- if you have elevated cerebral pressure e.g. as a result of a head injury
- if you have low blood pressure or if you have decreased blood volume
- if you have epilepsy or a tendency to seizures
- if you are also taking a type of medicine called an MAOI (commonly used to treat depression or Parkinson’s disease ) or if you have been taking it for the last two weeks
Lindoxa can reduce the cough reflex.
If you are going to have any operation tell your doctor at the hospital that you are using this medicine.
Dependence and tolerance
When Lindoxa is used for long-term treatment, tolerance to the drug may develop. This means that you may need a higher dose to achieve the desired pain relief.
Lindoxa can cause addiction. If treatment is stopped too suddenly, withdrawal symptoms may occur. If you no longer need treatment, your doctor will gradually reduce your daily dose.
If this medicine is used according to the instructions, the risk of physical and mental dependence is small. Your doctor weighs the potential risks against the expected risks and your needs and to the benefits. If you have any further questions, ask 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 or switch to another type of opioid painkiller.
Children and young people
Lindoxa is not recommended for children and adolescents under 18 years of age.
Other medicines and Lindoxa
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The risk of side effects increases if you take Lindoxa at the same time as medicines that affect the way your brain works. For example, you may feel very sleepy or your breathing problems may worsen.
Drugs that affect how the brain works include:
- other severe painkillers ( opioids )
- hypnotics and sedatives
- muscle relaxants
- drugs for the treatment of depression
- medicines used to treat allergies , motion sickness or nausea ( antihistamines or antiemetics)
- other drugs for the treatment of psychiatric or mental illness (phenothiazines, neuroleptics )
- medicines used to treat depression and Parkinson’s disease (so-called MAO inhibitors, see also section ‘Warnings and precautions’).
Concomitant use of Lindoxa and sedatives such as benzodiazepines or similar drugs increase the risk of drowsiness, difficulty breathing ( respiratory depression ), coma, and can be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor prescribes Lindoxa together with sedatives, the dose and treatment time for concomitant treatment should be limited by your doctor.
Tell your doctor about any sedatives you are taking and carefully follow your doctor’s dose recommendation. It may be helpful to inform friends or relatives about being aware of the signs and symptoms listed above. Contact your doctor when you experience such symptoms.
Additional interaction may occur with you
- cimetidine (medicine for stomach upset)
- anticoagulants (called anticoagulants, coumarin)
- quinidine (drug for the treatment of rapid heartbeat)
- drugs called protease inhibitors and used to treat HIV
- rifampicin (used to treat tuberculosis )
- certain antibiotics (so-called macrolides ) and antifungal drugs
- drugs for the treatment of epilepsy (carbamazepine, phenytoin )
- St. John’s wort (herbal remedy for depression).
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.
Lindoxa with food, drink and alcohol
Lindoxa should not be taken with alcohol. Alcohol can aggravate certain serious side effects of oxycodone, such as drowsiness, drowsiness, and slow and shallow breathing.
Grapefruit juice can increase the levels of Lindoxa in the blood. Ask your doctor if you drink grapefruit juice regularly.
Pregnancy, breastfeeding and fertility
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
The use of Lindoxa should be avoided as much as possible during pregnancy.
The use of oxycodone during pregnancy may cause withdrawal symptoms in newborns. If oxycodone is used during the last 3-4 weeks before delivery, the newborn baby may have difficulty breathing.
Breast-feeding
Do not use this medicine if you are breastfeeding. Oxycodone passes into breast milk and may cause breathing difficulties in infants.
Driving and using machines
Lindoxa can impair your ability to concentrate and react to such an extent that you can no longer drive or use machines.
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
Lindoxa contains sodium chloride
This medicine contains less than 1 mmol (23 mg) sodium per ampoule, ie essentially ‘sodium-free’.
How to use Lindoxa
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Your doctor or nurse will usually prepare and give you this medicine as an injection
Adults (18 years and older)
The doctor adjusts the dose based on pain intensity and your individual needs.
For patients who have been treated with other strong painkillers ( opioids ) before, the doctor may adjust dose one based on the previous dose one.
If you experience pain between doses of Lindoxa, you may need higher doses of Lindoxa. Talk to your doctor if you have this problem.
You should not be treated with Lindoxa for longer than necessary.
How Lindoxa is given
The healthcare professional gives Lindoxa as an injection or slow infusion into a vein or under the skin. In special cases, Lindoxa can be given as patient-controlled pain relief. Then you will receive instructions from a doctor about how much and when to take Lindoxa.
If you use more Lindoxa than you should
Lindoxa will be given to you by a doctor or nurse and it is, therefore, unlikely that you will receive too much. If you still suspect that you have been given an overdose, tell the hospital staff immediately.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately if you experience the following symptoms:
- very slow or weak breathing ( respiratory depression ). This is the most serious risk with drugs such Lindoxa ( opioid s), and may even be life threatening after high dose s of this drug.
Other side effects that may occur
Very common: may affect more than 1 user in 10
- drowsiness and drowsiness, sedation , dizziness, headache
- constipation, nausea or vomiting. Your doctor will prescribe an appropriate medicine to treat these symptoms.
- itching .
Common: may affect up to 1 in 10 users
- altered mood (anxiety, elation, confusion, depression, nervousness, sleep disturbances, abnormal thoughts or dreams)
- shaking
- decreased blood pressure , in rare cases together with symptoms such as palpitations, fainting or difficulty breathing or wheezing, respiratory cramps
- respiratory distress
- reduced pupil size
- dilated blood vessels which causes low blood pressure , drop in blood pressure when getting up which causes dizziness, dizziness or fainting
- dry mouth, in rare cases accompanied by thirst and difficulty swallowing, general symptoms of indigestion, such as stomach pain, diarrhea, heartburn, decreased appetite
- rash
- sweating (sometimes heavy), fatigue, chills
- weakness, fatigue, drowsiness
- increased release of antidiuretic hormone ( ADH ) into the bloodstream.
Uncommon: may affect up to 1 in 100 people
- allergic reactions
- dehydration in the body (dehydration)
- restlessness, mood swings, hallucinations, depression, decreased sexual desire, drug addiction
- memory loss
- tingling and numbness (eg in hands and feet)
- cramps, increased or decreased muscle tension or uncontrolled movements
- decreased sensitivity to pain or touch
- taste changes
- speech difficulties
- visual impairment, visual disturbances
- fainting or feeling of dizziness or instability ( vertigo )
- unpleasant feeling of irregular and / or heavy heartbeat (when discontinued ), increased heart rate, low blood pressure
- airway constriction causing difficulty breathing, increased cough, sore throat, runny nose, voice changes
- difficulty swallowing, cold sores, inflammation of the gums or mouth that causes soreness in the gums / mouth, flatulence (gas formation in the stomach or intestines), belching, blockages in the intestines (intestinal upset)
- elevated liver enzyme levels in the blood (seen in blood tests), spasms in the bile ducts
- dry skin, itchy rash
- difficulty urinating, increased need to urinate and cramps
- sexual disorders, impotence , decreased hormone production in the testes / ovaries ( hypogonadism )
- malaise, injuries due to accidents due to impaired attention, pain (eg chest pain), fluid retention ( edema ), migraine , thirst, physical dependence with withdrawal symptoms, tolerance.
Rare: may affect up to 1 in 1,000 users
- lymph node disease
- seizures (epileptic seizures), especially in patients with epilepsy or a tendency to seizures
- bleeding gums
- increased appetite
- dark-colored stools
- blisters on skin and mucous membranes (cold sores or herpes ), increased photosensitivity
- blood in the urine
- change in body weight (decrease or increase)
- painful skin inflammation ( cellulite ).
Very rare: may affect up to 1 in 10,000 people
- scaly rash.
Has been reported: occurs in an unknown number of users
- severe allergic reactions (which may cause difficulty breathing, dizziness, rash, fever)
- aggression
- increased sensitivity to pain
- caries or cavities in the teeth
- painful conditions due to blockage in the bile flow from the liver to the duodenum (cholestasis) or stomach pain due to a gallstone that temporarily blocks the bile duct (bile colic)
- missed menstruation
- Prolonged use of Lindoxa during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Such symptoms in the child may be irritability, hyperactivity and abnormal sleep patterns, such as screaming, shaking, vomiting, diarrhea or no weight gain.
The Medical Products Agency
Box 26
751 03 Uppsala
www.lakemedelsverket.se
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects that are not mentioned in this information. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address
How to store Lindoxa
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 expiration date is the last day of the specified month.
Do not freeze.
After opening the ampoule, the solution for injection/infusion should be used immediately. Any unused solution must be discarded. Chemical and physical in-use stability has been demonstrated for 48 hours at room temperature.
This medicine is for single use only.
Only a clear solution without visible particles or discoloration should be used.
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. 1 ml contains 10 mg oxycodone hydrochloride.
- The other ingredients are sodium chloride, citric acid monohydrate, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.
What the medicine looks like and contents of the pack
Lindoxa is a clear, colorless to pale yellow solution.
Lindoxa is delivered in clear, colorless glass ampoules of 1 ml or 2 ml and with OPC (one point cut).
Lindoxa is packaged in cartons containing 1, 3, 5, or 10 ampoules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
2care4 Generics ApS
Stenhuggervej 12-14
DK-6710 Esbjerg V
Manufacturer
GL Pharma GmbH,
Schlossplatz 1, Lannach 8502
Austria