Oxycodone Depot Lannacher - Oxycodone hydrochloride uses, dose and side effects

Oxycodone Depot Lannacher contains the active substance oxycodone hydrochloride. Oxycodone hydrochloride is a powerful painkiller that belongs to the group of opioidsb.

Oxycodone Depot Lannacher is used to treat severe pain, which requires treatment with analgesic opioids.

Oxycodone hydrochloride contained in Oxycodone Depot Lannacher may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 Lannacher

Do not take Oxycodone Depot Lannacher

• if you are allergic to oxycodone, soy, peanuts, 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 ).

• if you have too much carbon dioxide in your blood.

• if you have a severe chronic lung disease with narrow airways (COPD = chronic obstructive pulmonary disease ).

• if you have a specific heart condition called cor pulmonale.

• if you have asthma.

• if you have a type of bowel obstruction called paralytic ileus.

• if you have acute severe abdominal pain or delayed emptying of the stomach.

Warnings and cautions

Talk to your doctor or pharmacist before using Oxycodone Depot Lannacher

• if you are elderly or debilitated.

• if your lung, liver, or kidney function is severely impaired.

• if you have a specific disease of the thyroid gland ( myxedema ) or if your thyroid gland does not produce enough hormone (underactive thyroid gland ).

• if you have a poor adrenal function (ie the adrenal glands do not work properly), for example, Addison’s disease.

• if your prostate is abnormally enlarged.

• if you are an alcoholic or undergoing alcoholism treatment.

• if you are, or have been, addicted to strong painkillers ( opioids ).

• if you have inflammation of the pancreas ( pancreatitis ) or if you have problems with the gallbladder.

• if you have difficulty urinating or it hurts to urinate.

• if you have high brain pressure.

• if you have low blood pressure or feel dizzy when you get up.

• 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 ).

Dependence and tolerance

When Oxycodone Depot Lannacher is used for long-term treatment, tolerance to the drug may develop. This means that you may need a higher dose to get the desired pain relief.

Oxycodone Depot Lannacher may cause addiction. If treatment is stopped too suddenly, withdrawal symptoms such as nausea, vomiting, tremors, dizziness, diarrhea, sweating or chills, convulsions, rapid heartbeat, and high blood pressure may occur. If you no longer need treatment, your doctor will gradually reduce your daily dose.

If this medicine is used as intended for patients with chronic pain, the risk of physical and mental dependence is small. Your doctor weighs the potential risks against the expected benefit. Ask your doctor if you have any questions about this.

Other medicines and Oxycodone Depot Lannacher

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

The risk of side effects is increased if you take Oxycodone Depot Lannacher at the same time as medicines that affect brain function. For example, you may feel very sleepy or your breathing problems may worsen.

Drugs that affect brain function include:

• other strong painkillers ( opioids )

• sleeping pills and sedatives

• antidepressants

• medicines used to treat allergies, motion sickness or nausea ( antihistamines or antiemetics)

• other drugs that affect the nervous system (phenothiazines, neuroleptics )

• medicines used to treat Parkinson’s disease (so-called MAO inhibitors, see also section “Warnings and precautions”).

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.

Concomitant use of Oxycodone Depot Lannacher and sedatives or medicines for insomnia 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 Depot Lannacher 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 follow your doctor’s close

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.

Additional interactions may occur with

• cimetidine (medicine for stomach acid). It can prolong the effects of Oxycodone Depot Lannacher in your body.

• anticoagulants (eg warfarin ). Oxycodone Depot Lannacher may affect their effects.

• certain antibiotics, antifungals, and medicines containing St. John’s wort.

Oxycodone Depot Lannacher with food, drink, and alcohol

Taking alcohol while taking Oxycodone Depot Lannacher may cause drowsiness or increase the risk of serious side effects such as shallow breathing with a risk of respiratory arrest and unconsciousness. Taking alcohol is not recommended while you are taking Oxycodone Depot Lannacher.

Oxycodone Depot Lannacher should not be used in patients who have abused or are abusing alcohol or drugs.

Grapefruit juice may increase the levels of Oxycodone Depot Lannacher in the blood. Ask your doctor if you drink grapefruit juice regularly.

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 Lannacher during pregnancy. There are insufficient data on the use of oxycodone in pregnant women.

Prolonged use of oxycodone during pregnancy may cause withdrawal symptoms in newborns. Infants born to mothers who have received oxycodone during the last 3-4 weeks before delivery may have severe breathing difficulties.

Oxycodone Depot Lannacher should only be used during pregnancy when the benefits outweigh the potential risks to the newborn.

Breast-feeding

Oxycodone can pass into breast milk and may cause breathing difficulties in the infant. Oxycodone Depot Lannacher should therefore not be used during breastfeeding.

Driving and using machines

Oxycodone Depot Lannacher may impair the ability to drive and use machines.

Oxycodone Depot Lannacher can impair your alertness and ability to react to such an extent that you can no longer drive or use tools or machines.

Ask your doctor if you can 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.

Oxycodone Depot Lannacher contains lecithin (soy)

Do not use this medicine if you are allergic to peanuts or soy.

How to take Oxycodone Depot Lannacher

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dosage

Your doctor will adjust your dose according to the intensity of the pain and your sensitivity.

For doses that are not achievable/practicable with this strength, other strengths of this medicine are available.

Unless your doctor prescribes otherwise, the recommended dose is:

• for adults and adolescents (over 12 years of age):

The usual starting dose is 10 mg oxycodone hydrochloride every 12 hours (morning and evening).

For patients who have been treated with other strong painkillers ( opioids ) before, your doctor may prescribe a higher starting dose.

Your doctor will then decide how much to take each day and how to divide your total daily dose into morning and evening doses. Your doctor will also inform you of any dose adjustments that may be necessary during treatment.

Patients with cancer pain usually need a daily dose of 80 to 120 mg oxycodone hydrochloride daily. In individual cases, the doctor may increase the dose by up to 400 mg daily.

For the treatment of non-cancer-related pain, 40 mg of oxycodone hydrochloride is usually sufficient, but a higher dose may be needed in some cases.

If you experience pain between doses of Oxycodone Depot Lannacher, you may need to take another fast-acting painkiller.

Oxycodone Depot Lannacher is not suitable for this. Talk to your doctor if you have this problem.

Your doctor will regularly check your treatment.

Special populations

• Elderly (65 years and older):

Elderly patients with normal liver and/or kidney function may take the same dose as is indicated for adults above.

• Patients with kidney and/or liver disease or with low body weight:

Your doctor may prescribe a lower starting dose.

Children (under 12 years of age):

The safety and efficacy of Oxycodone Depot Lannacher in children below 12 years of age have not been established. Oxycodone Depot Lannacher is not recommended for use in children below 12 years of age.

Method of administration

Oxycodone Depot Lannacher is for oral use.

Take the prolonged-release tablets whole with a sufficient amount of liquid (eg ½ glass of water). You can take the tablets with or without food.

Do not break, chew, divide or crush the tablets. This can cause them to release all their contents into the body at once, leading to the risk of overdose and possibly even death (see also “If you have taken too much Oxycodone Depot Lannacher” below).

If you take more Oxycodone Depot Lannacher then you should

Contact a doctor immediately if you have taken more tablets than prescribed.

Symptoms of overdose are: decreased pupil size, breathing problems, feeling of weakness in the muscles (low muscle tone, hypotension ), and drop in blood pressure. Drowsiness or fainting due to failing circulatory system (circulatory collapse), impaired thinking and movement, unconsciousness ( coma ), decreased heart rate and fluid retention in the lungs (with symptoms such as difficulty breathing, especially in a supine position, and coughing with the production of foamy mucus which may be pink or blood-stained, heavy sweating, anxiety, and pallor) may occur in severe cases.

Using large amounts of Oxycodone Depot Lannacher can lead to death.

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.

If you forget to take Oxycodone Depot Lannacher

If you take a smaller dose of Oxycodone Depot Lannacher than you should, or if you miss a dose, you will probably not get enough pain relief.

If you forget to take a dose, take the missed dose as soon as you remember.

Note that you should take the tablets at 12-hour intervals (twice daily).

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Oxycodone Depot Lannacher

Do not stop treatment without talking to your doctor first, as withdrawal symptoms may occur.

If you no longer need treatment with Oxycodone Depot Lannacher, your doctor will tell you how to gradually reduce dose one to prevent the onset of 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.

Contact a doctor immediately if any of the following symptoms occur:

• very slow or weak breathing ( respiratory depression ). This is the most serious risk with medicines such as Oxycodone Depot Lannacher (opioids ) and can even be life-threatening after high doses of this medicine.

OTHER SIDE EFFECTS AR

Very common (may affect more than 1 user in 10)

• drowsiness, dizziness, headache.

• constipation, nausea, vomiting. Your doctor will prescribe an appropriate medicine to treat these symptoms.

• itching.

Common (may affect up to 1 in 10 people)

• changed mood, anxiety, confusion, depression, nervousness, sleep disorders, abnormal thoughts.

• uncontrolled tremors or tremors in one or more parts of the body, feeling weak.

• decreased blood pressure, in rare cases with symptoms such as palpitations or fainting.

• difficulty breathing or wheezing.

Dry mouth, in rare cases together with thirst and difficulty swallowing, general symptoms of indigestion such as stomach pain, diarrhea, heartburn.

• decreased appetite.

• skin rash, heavy sweating.

• sweating, weakness.

Uncommon (may affect up to 1 in 100 people)

• allergic reactions

• increased amount of a certain hormone ( ADH = antidiuretic hormone ) in the blood with symptoms such as headache, irritability, lethargy, nausea, vomiting, confusion, and disturbances of consciousness.

• Dehydration in the body (dehydration).

• restlessness, mood swings, hallucinations, elation, decreased sexual desire.

• memory loss, tingling and numbness (eg in hands and feet), cramps, increased or decreased muscle tension, tics, speech disorders, decreased sensitivity to pain or touch, taste changes.

• visual impairment, reduced pupil size.

• dizziness.

• unpleasant feeling of irregular and/or heavy heartbeat, increased heart rate.

• dilated blood vessels, which results in low blood pressure.

• shortness of breath, increased cough, sore throat, runny nose, voice changes.

• difficulty swallowing, cold sores, sore gums, flatulence (gas in the stomach or intestines), belching, blockages in the intestines (intestinal upset).

• elevated liver enzyme levels in the blood.

• dry skin.

• decreased sexual drive and inability to get or keep an erection during intercourse.

• chills, malaise, injuries due to accidents due to decreased alertness, pain (eg chest pain), fluid retention ( edema ), migraine, thirst, physical dependence with withdrawal symptoms, tolerance.

Rare (may affect up to 1 in 1,000 people)

• lymph node disease.

• muscle cramps, epileptic seizures (seizures), especially in patients who have epilepsy or a tendency to seizures.

• low blood pressure.

• bleeding gums, increased appetite, dark stools.

Itchy rash, blisters on the skin and mucous membranes (cold sores or herpes ), increased photosensitivity.

• blood in the urine.

• changed body weight (decrease or increase), skin inflammation.

Very rare (may affect up to 1 in 10,000 people)

• speech disorders

• scaly rash.

Has been reported (occurs in an unknown number of users)

• severe allergic reactions.

• increased sensitivity to pain.

• caries or cavities in the teeth.

• blockage of bile flow, bile colic (which causes stomach pain).

Prolonged use of Oxycodone Depot Lannacher during pregnancy may cause life-threatening withdrawal symptoms in newborns. Symptoms to look for in the child are irritability, hyperactivity, and abnormal sleep patterns, including crying, shaking, nausea, diarrhea, and lack of weight gain.

How to store Oxycodone Depot Lannacher

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° 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.

6. Contents of the pack and other information

Content declaration

Oxycodone Depot Lannacher 5 mg prolonged-release tablet is

The active substance is oxycodone hydrochloride. One tablet contains 5 mg oxycodone hydrochloride equivalent to 4.48 mg oxycodone.