You can inject Oxycodone Paracetamol 10 325 mg

Patient Info Service - information for patients

4. What side effects are possible?

Like all medicines, this medicine can have side effects, although not everybody gets them.

Significant side effects to look out for and what to do if they are affected

If you are affected by any of the significant side effects listed below, call the nearest available doctor for help immediately.

Slow and shallow breathing (respiratory depression) is the most significant risk of opioid overdose and is most likely to occur in elderly or debilitated patients. In susceptible patients, opioids can also cause severe drops in blood pressure as a result.

Side effects are shown below in two sections, separated into pain treatment and treatment with the active ingredient oxycodone hydrochloride alone.

The following side effects have been seen in patients being treated for pain

Common (may affect up to 1 in 10 people)

• Decrease in appetite up to loss of appetite

• Insomnia, tiredness, or exhaustion

• Dizziness, headache, drowsiness

• Vertigo

• hot flashes

• Abdominal pain, constipation, diarrhea, dry mouth, indigestion, vomiting, nausea, gas

• Itching, skin reactions / rash, sweating

• states of weakness

Uncommon (may affect up to 1 in 100 people)

• Hypersensitivity reactions / allergic reactions

• Restlessness, thought disorders, anxiety, confusion, depression, nervousness

• Decrease in sex drive

• Seizures (especially in people with epilepsy or a tendency to seizures), attention disorders, speech disorders, fainting (syncope), (muscle) tremors

• Taste disorders

• Feeling sleepy or tired and sluggish (lethargy)

• Visual disturbances

• Chest tightness, especially if you have heart disease, palpitations

• drop in blood pressure, rise in blood pressure

• Difficulty breathing, runny nose, cough

• Feeling of fullness

• Increase in liver values, biliary colic

• muscle cramps, muscle twitching, muscle pain

• Increased need to urinate

• Withdrawal symptoms such as B. Over-excitability, chest pain, chills, malaise, pain, swelling in the hands, ankles and legs

• Thirst

• Weight loss

• Injuries from accidents

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

• Pulse acceleration

• yawning

• Changes in teeth

• weight gain

• Drug addiction

Not known (frequency cannot be estimated from the available data)

• Euphoric mood, hallucinations, nightmares

• Tingling in the hands and feet, severe drowsiness

• Flattening and slowing of breathing

• Belching

• Inability to urinate

• Erectile dysfunction

For the active ingredient oxycodone hydrochloride alone (if it is not combined with naloxone hydrochloride), the following side effects are known in addition to the above

Oxycodone can cause breathing problems (respiratory depression), constriction of the pupils, spasms of the bronchial muscles and spasms of the smooth muscles, as well as dampening the cough reflex.

Common (may affect up to 1 in 10 people)

• Changes in mood and personality (e.g. depression, euphoric mood), decreased activity, overactivity

• Hiccups

• Impairment of urination

Uncommon (may affect up to 1 in 100 people)

• Loss of body water (dehydration)

• Over-excitability, impaired perception (e.g. hallucinations, feeling of unreality), drug dependence

• Difficulty concentrating, migraines, increased muscle tension, involuntary muscle twitching, numbness, incoordination

• hearing impairment

• vasodilatation

• Changes in the voice (dysphonia)

• Difficulty swallowing, intestinal obstruction, mouth ulcers, inflammation of the oral mucosa

• Dry skin

• Swelling due to water retention (edema), development of tolerance

• Decrease in sex hormone levels (this can affect sperm production in men or the menstrual cycle in women)

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

• Herpes disease (herpes simplex)

• Increase in appetite

• Black discoloration of the stool (tarry stool), bleeding gums

• Itchy rash (urticaria)

Not known (frequency cannot be estimated from the available data)

• Acute allergic general reactions (anaphylactic reactions)

• aggressive behavior

• increased sensitivity to pain

• Caries

• Disturbances in the flow of bile

• No menstrual period

• Long-term use of oxycodone during pregnancy can cause life-threatening withdrawal symptoms in the newborn. Symptoms to look out for in the baby include irritability, hyperactivity and abnormal sleep patterns, high-pitched screams, tremors, nausea, diarrhea, and lack of weight.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects you can help provide more information on the safety of this medicine.

5. How should Oxycodone HCl / Naloxone HCl Mylan be stored?

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 outer carton, bottle and blister after "EXP". The expiry date refers to the last day of the month indicated.

Blister pack:

Do not store above 25 ° C.

Bottles:

Do not store above 30 ° C.

Shelf life after opening: 3 months

Never throw away any medicines via wastewater (e.g. not using the toilet or sink). Ask your pharmacy how to throw away medicines you no longer use. You help to protect our environment. For more information, see www.bfarm.de/arzneimittelentsorgung.

6. Contents of the pack and other information

What Oxycodone HCl / Naloxone HCl Mylan contains

The active ingredients are oxycodone hydrochloride (Ph.Eur.) And naloxone hydrochloride.

Each prolonged-release tablet contains 40 mg oxycodone hydrochloride (Ph.Eur.) (Equivalent to 36 mg oxycodone) and 20 mg naloxone hydrochloride (as 21.8 mg naloxone hydrochloride dihydrate, equivalent to 18 mg naloxone).

The other ingredients are:

Tablet core: Povidone (K30), poly (vinyl acetate), sodium dodecyl sulfate, highly dispersed silicon dioxide, microcrystalline cellulose, magnesium stearate (Ph.Eur.) [Vegetable].

Film cover: Poly (vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, ferric oxide (E172).

What Oxycodone HCl / Naloxone HCl Mylan looks like and contents of the pack

Pink-colored, elongated, biconvex prolonged-release tablet with a score line on both sides, a length of 14.2 mm, a width of 6.7 mm and a height of 3.6-4.6 mm.

The tablet can be divided into equal doses.

Oxycodone HCl / Naloxone HCl Mylan is available in child-resistant blister packs of 10, 14, 20, 28, 30, 50, 56, 60, 90, 98 and 100 prolonged-release tablets or

Bottles with child-resistant screw caps containing 50, 100 or 250 prolonged-release tablets.

Not all pack sizes may be marketed.

Pharmaceutic entrepreneur

Mylan Germany GmbH

Lütticher Strasse 5

53842 Troisdorf, Germany

Co-distribution

Mylan Healthcare GmbH

Lütticher Strasse 5

53842 Troisdorf, Germany

Manufacturer

Develco Pharma GmbH

Grienmatt 27

79650 Schopfheim

This medicinal product is approved in the member states of the European Economic Area (EEA) under the following names:

Germany:

Oxycodone HCl / Naloxone HCl Mylan 40 mg / 20 mg prolonged-release tablets

Czech Republic:

Oxykodon / Naloxon Mylan 40 mg / 20 mg tablety s prodlouženým uvolňováním

Ireland:

Oxyargin 40 mg / 20 mg prolonged release tablets

Italy:

Elatrex

Slovakia:

Oxykodon / Naloxon Mylan 40 mg / 20 mg tablety s predĺženým uvoľňovaním

Spain:

Oxicodona / Naloxona Mylan 40 mg / 20 mg comprimidos de liberación prolongada EFG

United Kingdom:

Oxyargin 40 mg / 20 mg prolonged release tablets

This leaflet was last revised in November 2019.