2 mg / ml, 10 mg / ml, 20 mg / ml, 50 mg / ml solution for injection / infusion
hydromorphone hydrochloride
What Palladon is and what it is used for
Palladone contains the active substance hydromorphone hydrochloride, which is a potent painkiller belonging to the opioid group.
You have been prescribed Palladon for the treatment of severe pain.
Hydromorphone hydrochloride contained in Palladon may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before using Palladon
Do not use Palladon if:
- you are allergic to hydromorphone or any of the other ingredients of this medicine (listed in section 6)
- you have breathing problems ( respiratory depression )
- you have severe asthma
- you have severe lung disease linked to contraction of the airways ( chronic obstructive pulmonary disease or COPD)
- you have heart problems after long-term lung disease (cor pulmonale)
- you have severe abdominal pain
- you have a disease where the small intestine does not work properly (paralytic ileus)
- you are taking a type of medicine called an MAOI (eg tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid) or you have been taking this type of medicine for the last two weeks.
Palladon must not be used if the patient is in a coma.
Warnings and cautions
Tell your doctor before treatment with Palladon about:
- you have severe breathing difficulties (impaired breathing function)
- you have sleep problems ( sleep apnea with breathing problems during sleep)
- you are addicted to strong painkillers
- you suffer from a head injury (due to the risk of high brain pressure)
- you suffer from seizures or convulsions
- you are addicted to alcohol
- you have previously suffered from withdrawal symptoms such as restlessness, anxiety, anxiety, difficulty sleeping, overactivity, tremors, or gastrointestinal problems when you stop using alcohol or drugs
- you suffer from mental illness as a result of intoxication (toxic psychosis)
- you have low blood pressure due to low blood volume ( hypotension with hypovolemia)
- you feel dizzy or faint
- you have gallbladder problems
- you suffer from pancreatitis ( pancreatitis )
- you have intestinal problems (eg obstructive or inflammatory bowel disease)
- you have problems with the prostate (eg difficulty throwing water)
- you have impaired adrenal function (eg Addison’s disease)
- you have an underactive thyroid gland ( hypothyroidism )
- you have a chronic obstructive pulmonary disease (COPD) or impaired lung function
- you suffer from a general debilitating condition or are older
- you have constipation
- you suffer from severe kidney problems (including renal colic)
- you suffer from severe liver problems.
This medicine can cause breathing problems while you sleep. These problems may include paused breathing during sleep, nocturnal awakenings due to shortness of breath, difficulty maintaining sleep, or excessive drowsiness during the day. If you or anyone else observes these symptoms, consult a doctor. Your doctor may reduce your dose one.
Like other opioids, Palladon can affect the normal production of certain hormones in your body, such as cortisol or sex hormones, especially if you have been taking high doses for long periods.
Talk to your doctor if this information applies or has been relevant to you.
The most serious risk of opioid overdose is difficulty breathing ( respiratory depression ).
Patients may develop tolerance to long-term use of Palladon. This means that you may need a higher dose to achieve the desired pain control.
Chronic use of Palladon can lead to physical dependence. If treatment is stopped abruptly, withdrawal symptoms such as restlessness, anxiety, anxiety, difficulty sleeping, involuntary muscle contractions, tremors, or gastrointestinal problems may occur. If you no longer need hydromorphone treatment, your doctor will gradually reduce your daily dose to prevent these symptoms from occurring.
The active substance hydromorphone hydrochloride has a similar abuse profile
to other strong opioids. Physically dependent may develop. Therefore, Palladon should be used with special caution in patients with a history of alcohol or drug abuse.
Increased pain sensitivity (hyperalgesia) that does not respond to an increased dose of Palladon may occur at particularly high doses. Your doctor will decide if a dose reduction or opioid replacement is required in your situation.
Tell your doctor if you have intestinal problems (paralytic ileus ) during treatment with Palladon. He or she will take appropriate action.
If you are going to have surgery, tell the doctors at the hospital that you are using Palladon as they may need to adjust the amount of injection you are given.
The use of Palladon may give positive results in doping controls.
Children
Palladon is not recommended for children under 12 years of age.
Other medicines and Palladon
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
In combination with other medicines or alcohol, the side effects of Palladon (such as drowsiness, difficulty breathing, constipation, dry mouth, difficulty swallowing water) or the other medicines may change.
Tell your doctor about:
- you use medicines to treat anxiety (eg sedatives)
- you have been treated with anesthetics (eg barbiturates)
- you use medicines to help you sleep (sedatives or sedatives including benzodiazepines)
- you use medicines to treat mental illness (antipsychotic medicines such as phenothiazines)
- you use medicines to treat depression (antidepressants)
- you use medicines to prevent nausea or vomiting (antiemetics)
- you use medicines to prevent or alleviate allergy symptoms ( antihistamines )
- you are using medicines to treat Parkinson’s disease
- you are using other strong painkillers or have recently used other painkillers from the opioid group.
Do not use Palladon if you are taking a specific type of medicine called an MAOI or if you have used this type of medicine in the last two weeks.
Concomitant use of Palladon and sedatives such as benzodiazepines or related drugs increases the risk of drowsiness, difficulty breathing ( respiratory depression ), and coma and can be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible.
If your doctor prescribes Palladon together with sedatives, your 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 such symptoms.
Palladon with alcohol
Using alcohol during treatment with Palladon may make you drowsy. If you are affected by this, you should avoid the use of alcohol.
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 use Palladon during pregnancy or childbirth unless your doctor specifically tells you to. Using Palladon during childbirth may reduce the ability of the uterus to contract. In addition, slow and shallow breathing ( respiratory depression ) may occur in the newborn baby. Newborns may experience abstinence (eg, crying, shaking, convulsions, poor appetite, and diarrhea) if their mothers have been taking hydromorphone for a long time during pregnancy.
Breast-feeding
Palladon should not be used during breastfeeding as the active substance may pass into breast milk.
Driving and using machines
Palladon can make you sleepy and thus affect your ability to drive or use machines. This is especially true:
- at the beginning of treatment
- if your dose is increased
- if you have switched to Palladon from another opioid
- if you drink alcohol or use drugs that affect brain function.
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.
Palladon contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per ml, ie essentially ‘sodium-free’.
How to use Palladon
A doctor or nurse will normally prepare and administer the injection.
Your doctor will decide how much Palladon you need based on:
- the severity of pain,
- what dose of painkiller you have previously received,
- your age and weight.
Your doctor will increase the amount of Palladon until your pain is relieved. Discuss with your doctor if you are still experiencing pain while undergoing treatment with Palladon.
You should not use Palladon 10 mg, 20 mg, or 50 mg as the initial opioid treatment. These higher dosage forms may only be used as individual doses if you no longer respond adequately to lower doses of hydromorphone (Palladon 2 mg) or comparatively strong painkillers as part of long-term pain treatment.
The usual starting doses for Palladon are:
Adults and adolescents (over 12 years)
- As a single injection into a vein, the usual dose is 1 to 1.5 mg administered slowly over 2 to 3 minutes. This can be repeated at three to four-hour intervals.
- As a single injection through a thin needle into the tissue under the skin, the usual dose is 1 to 2 mg. This can be repeated at three to four-hour intervals.
- As an infusion into a vein or through a thin needle into the tissue under the skin, the usual starting dose is 0.15 to 0.45 mg/hour (or 0.004 mg/kg body weight/hour).
- Administered as the patient-controlled analgesia (PCA), the usual recommended bolus dose is 0.2 mg with a stop interval of 5 to 10 minutes.
Elderly patients (over 75 years)
Lower doses may be sufficient for satisfactory pain relief in elderly patients.
Patients with liver and kidney problems
If you suffer from liver or kidney problems, you may need less Palladon to relieve your pain.
Children (under 12 years)
Palladon is not recommended for children under 12 years of age.
Method of administration
A doctor or nurse will normally administer Palladon to you.
Palladon is intended for injection or infusion into a vein (intravenous = IV) or through a thin needle under the skin ( subcutaneous = SC).
Treatment time
Palladon should only be used for as long as necessary. Your doctor will decide when and how to stop treatment. If you are receiving long-term treatment, your doctor should regularly determine if you still need to use Palladon. Do not stop treatment without talking to your doctor first (see “If you stop using Palladon”).
If you use more Palladon 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.
In severe cases, an overdose can lead to unconsciousness or even death. The following symptoms may occur after an overdose:
- pupil reduction
- lowered heart rate
- breathing problems
- low blood pressure
- unconsciousness leading to coma.
- pneumonia is caused by inhalation of vomit or other foreign matter (symptoms may include shortness of breath, cough, and fever)
If you have used too much Palladon, do not under any circumstances put yourself in a situation that requires alertness, e.g. driving.
You may need emergency hospital treatment. If you are seeking medical attention, be sure to bring this leaflet and any remaining ampoules to see your doctor.
If you forget to use Palladon
Use Palladon as soon as you notice that you have forgotten to take your dose. Never use a double dose.
If you forget to use Palladon or use a lower dose than prescribed, you will get unsatisfactory and/or insufficient pain relief.
If you stop using Palladon
You should not suddenly stop using Palladon unless your doctor tells you to. If you want to stop using Palladon first, talk to your doctor. If use is stopped abruptly after long-term treatment, withdrawal symptoms such as restlessness, anxiety, anxiety, difficulty sleeping, involuntary muscle contractions, tremors, and gastrointestinal problems may occur. Your doctor will tell you how to stop the treatment, usually by gradually reducing the dose so that you avoid unpleasant effects.
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 drug may cause allergic reactions (hypersensitivity). The occurrence of severe allergic reactions (anaphylactic reactions) is not known. Tell your doctor immediately if you experience sudden wheezing, difficulty breathing, eyelid, face, lip, mouth, or throat swelling, rash, or itching, especially those that cover the whole body.
Breathing difficulties ( respiratory depression ) are the main danger of opioid overdose.
Most people get constipation when they use Palladon. You can reduce the problem by increasing the amount of fiber (fruits, vegetables, wholemeal bread, pasta, brown rice) and fluid in your diet. If necessary, your doctor may prescribe laxatives.
You may experience nausea or vomiting while using Palladon. This usually subsides after a few days, but if it continues to be a problem, your doctor may prescribe antiemetics.
Very common side effects ( may affect more than 1 user in 10)
- dizziness, more sleepy than usual
- constipation
- nausea
Common side effects ( may affect up to 1 in 10 people)
- confusion
- dry mouth, vomiting
- itchy skin, sweating
- urinary incontinence
- unusual feeling of weakness
- lost appetite
- anxiety, insomnia
- headache
- pain or discomfort in the abdomen
- skin reactions at the injection site
Uncommon side effects ( may affect up to 1 in 100 people)
- restlessness
- extreme feelings of joy, hallucinations
- tremors, muscle twitching, tickling of hands and feet
- blurred vision
- low blood pressure
- indigestion
- rash
- difficulty throwing water
- decreased sex drive, impotence
- withdrawal symptoms such as restlessness, anxiety, anxiety, difficulty sleeping, overactivity, tremors, and gastrointestinal problems
- depression, nightmares
- shortness of breath
- diarrhea, taste changes
- may affect the results of blood tests designed to test if the liver is functioning properly
- fatigue
- general malaise
- hand, foot, or ankle swelling
Rare side effects ( may affect up to 1 in 1,000 people)
- sedation
- low heart rate, irregular heartbeat, fast heart rate
- breathing problems or wheezing
- may affect the results of blood tests designed to test the proper functioning of the pancreas
- flushing
- lack of energy
Very rare side effects ( may affect up to 1 in 10,000 people)
- irritation and hardening of the skin at the injection site (especially after repeated subcutaneous administration ).
Has been reported (occurs in an unknown number of users)
- breathing problems during sleep ( sleep apnea )
- drug addiction
- unpleasant or uncomfortable mood
- seizures, convulsions
- uncontrolled muscle movements
- drug tolerance
- elevated pain sensitivity (hyperalgesia, see “Warnings and Precautions” in section 2)
- condition in which the small intestine (part of the gastrointestinal tract) does not function properly (paralytic ileus)
- pupil reduction
- itchy rash, reddening of the skin
- withdrawal symptoms in newborns of mothers who have used Palladon during pregnancy (see section 2 “Pregnancy and lactation”)
How to store Palladon
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 carton or ampoule label after EXP. The expiration date is the last day of the specified month.
Store the ampoules in the outer carton. Sensitive to light.
Instructions for stability after use or dilution
This medicinal product should be used immediately after opening the package.
Physical and chemical in-use stability has been demonstrated for 7 days at 4 ° C, 25 ° C and 37 ° C except for dilute solutions in polycarbonate syringes which should not be stored for more than 24 hours.
From a microbiological perspective, the prepared solution should be used immediately. If not used immediately, in-use storage times and conditions before use, which should not normally exceed 24 hours at 2-8 ºC, unless opened/diluted under controlled and confirmed aseptic conditions.
The medicinal product must be inspected visually before use and even after dilution. Only clear particle-free solutions should be used.
For single use only.
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
Palladone 2 mg / ml:
- The active substance is hydromorphone hydrochloride. Each ampoule contains 2 mg of hydromorphone hydrochloride (equivalent to 1.77 mg of hydromorphone) in 1 ml solution.
Palladone 10 mg / ml:
- The active substance is hydromorphone hydrochloride. Each ampoule contains 10 mg of hydromorphone hydrochloride (equivalent to 8.87 mg of hydromorphone) in 1 ml solution.
Palladone 20 mg / ml:
- The active substance is hydromorphone hydrochloride. Each ampoule contains 20 mg of hydromorphone hydrochloride (equivalent to 17.7 mg of hydromorphone) in 1 ml solution.
Palladone 50 mg / ml:
- The active substance is hydromorphone hydrochloride. Each ampoule contains 50 mg of hydromorphone hydrochloride (equivalent to 44.33 mg of hydromorphone) in 1 ml solution.
Other ingredients are:
- Anhydrous citric acid
- Sodium citrate
- Sodium chloride
- Sodium hydroxide solution (4%)
- Hydrochloric acid 3.6%
- Water for injections.
What the medicine looks like and the contents of the pack
Palladon is a clear, colorless to pale yellow solution with a pH of 4.0 for injection or infusion. The medicine is delivered in clear glass ampoules and is available in packs of 5 x 1 ml ampoules.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Mundipharma AB
Mölndalsvägen 30B
412 63 Gothenburg
Manufacturer
Mundipharma DC BV
Listening 16
3832 RC Leusden
Netherlands