PACKAGE LEAFLET: INFORMATION FOR THE USER Piritramide [MAH] 7.5 mg/ml solution for injection Piritramide
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet: 1. What Piritramide [MAH] is and what it is used for 2. What you need to know before you are given Piritramide [MAH] 3. How to use Piritramide [MAH] 4. Possible side effects 5. How to store Piritramide [MAH] 6. Contents of the pack and other information
1. WHAT PIRITRAMIDE [MAH] IS AND WHAT IT IS USED FOR
Piritramide [MAH] contains the active substance piritramide. It belongs to a group of medicines called opioid analgesics (strong painkillers). Piritramide [MAH] is used to relieve severe to strongest pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PIRITRAMIDE [MAH]
Do not use Piritramide [MAH]: - If you are allergic to piritramide or any of the other ingredients of this medicine (listed in section 6). - If you suffer from severely impaired consciousness from which you cannot be roused even by external stimuli. - If you have problems with breathing (respiratory depression).
Warnings and precautions
Talk to your doctor or pharmacist before you are given Piritramide [MAH] - If you have suffer from seizures (such as epileptic fits) - If you suffer from alcoholism - If you have head injuries - If you have an increased brain pressure - If you have an enlarged prostate (prostatic hypertrophy) - If you are in shock - If you have a severely slowed heart beat (bradycardia) or irregular heart beat (bradyarrhythmia). - If you are taking medicines that act on the brain function [e.g. alcohol, sleeping tablets (barbiturates, hypnotics), tranquillisers (certain benzodiazepines)] - If you have an under active thyroid (hypothyreosis) - If you have a decreased function of the adrenal cortex (adrenal cortex insufficiency) - If you have an impaired breathing function - If you have impaired liver or kidney function - If you are severely underweight (cachectic) or weak or if you are elderly.
Special care should be taken when using Piritramide [MAH] – If you have a tumour of the adrenal gland (phaeochromocytoma) – If you have a partial or complete blockade of the bowel and/or inflammatory bowel disease – If you have an impaired function of the gall bladder (biliary impairment) – If you have an inflamed pancreas (pancreatitis) – In children aged under 1 year
Blood pressure may fall after administering Piritramide [MAH]. This may exceed the norm if you have insufficient fluid in your circulatory system or were simultaneously given medicines that have a depressant effect on the central nervous system.
Piritramide [MAH] can cause physical and psychological dependence. The risk of dependence usually increases with the length of use and with increasing doses. Over time, your body may develop a tolerance to the active substance so that a higher dose is required to achieve the same pain-relieving effect.
CNS depressant effects and / or respiratory depression including respiratory depression and respiratory failure may occur in patients receiving Piritramide [MAH].
Medicine that blocks the effect of Piritramide [MAH] (opioid antagonist) should be available for immediate use. Due to the long duration of action of piritramide repeated administration of the antagonist may be necessary. Qualified personnel and adequate facilities should be available for monitoring and ventilation of patients administered high doses of Piritramide [MAH].
Discontinuing the medicine, substituting a milder opioid or administering a medicine that counteracts the effect of Piritramide [MAH] may trigger withdrawal symptoms such as balance disorders, tremor, anxiety, vomiting, diarrhoea and/or high blood pressure.
Other medicines and Piritramide [MAH] Concomitant use of piritramide and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor does prescribe piritramide together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This is especially important with the following medicines: - central nervous system depressants (medicines used to treat anxiety, calm you down or put you to sleep such as barbiturates, phenothiazines, inhalational anaesthetics) - monoamine oxidase inhibitors – MAOIs (medicines prescribed to treat depression). Administration of MAOIs must be stopped at least 10 days prior to the treatment with piritramide. - pentazocine (painkiller) - medicines that inhibit the degradation of piritramide (so-called CYP3A4 inhibitor). It may be necessary to reduce the initial dose of Piritramide [MAH].
Piritramide [MAH] with food, drink and alcohol Please tell your doctor if you consumed alcohol before receiving this medicine.
Pregnancy and breast-feeding 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 this medicine is administered to you.
Pregnancy Piritramide [MAH] should not be administered during pregnancy or lactation, unless clearly necessary. Repeated administration of this medicine during pregnancy may cause dependence and withdrawal symptoms in a newborn baby.
Lactation It is recommended that you stop breast-feeding for 24 hours after Piritramide [MAH] has been given to you.
Driving and using machines This medicine can make dizzy and drowsy. Therefore, you must not drive or operate any tools or machines for at least 24 hours.
3. HOW TO USE PIRITRAMIDE [MAH]
Piritramide [MAH] is given to you by your doctor or healthcare professional.
Use in adults - A usual single dose is 15-30 mg if this medicine is given into a muscle or under the skin. - Single doses of 7.5-22.5 mg will be slowly given into a vein (10 mg per minute) (only when a particularly rapid effect is required).
Intramuscular, subcutaneous and intravenous single doses can be repeated usually after 6-8 hours if the analgesic effect is fading.
Dose escalation of Piritramide [MAH] should be handled carefully to avoid an accumulation of piritramide that may increase the risk of respiratory depression. It may take up to 24 hours until a patient benefits from full analgesic effect of a piritramide dose.
Use in children - A usual single dose is 0.05-0.2 mg per kg body weight if this medicine is given into a muscle or under the skin. - A usual single dose should be 0.05-0.1 mg per kg body weight if Piritramide [MAH] is given into a vein (only when a particularly rapid effect is required).
Use in special patient groups In severely underweight (cachectic), weak or elderly patients, patients with impaired liver or kidney function the initial dose should be reduced.
Method of administration This medicine can be given as an injection into a muscle (intramuscular use), under the skin (subcutaneous use) or into a vein (intravenous use).
If you are given more Piritramide [MAH] than you should Since Piritramide [MAH] will usually be given to you under carefully controlled conditions, it is unlikely that you will be given too much or that you will miss a dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Piritramide [MAH] can cause side effects, although not everybody gets them.
The following side effects have been reported and are listed in order of decreasing frequency:
Very common: may affect more than 1 in 10 people - rapid heartbeat - low blood pressure in tests
Common: may affect up to 1 in 10 people - dizziness (vertigo) - severe light-headedness (stupor) - drowsiness - nausea - vomiting - retching - pallor
Uncommon: may affect up to 1 in 100 people - dependency on the medicine - headache - fall in blood pressure - increased sweating - low respiration rate
Not known: frequency cannot be estimated from the available data – severe allergic reactions (anaphylaxis, anaphylactic shock) – withdrawal symptoms after discontinuing the medicine (such as rapid heart rate, vomiting, muscle pain and sweating) – unconsciousness – constriction of the pupils – slow heart beat (bradycardia) – blue discolouration of the skin due to oxygen deficiency (cyanosis) – breathing problems (breathlessness, shallow breathing, respiratory arrest) – allergic skin inflammation – itching – reactions at the injection site – severe asthma attacks (status asthmaticus) – spasms of the bronchial muscles
Patients who are on Piritramide [MAH] may experience an absence of bowel movements which can lead to constipation.
With other opioids there have also been reports of dry mouth, increased muscle tone in urinary bladder, gall bladder and pancreas and, in rare cases, difficulties in passing water.
Reporting of side effects If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE PIRITRAMIDE [MAH]
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 and label after “EXP:”. The expiry date refers to the last day of that month.
Do not store above 25°C. Do not freeze. Keep the ampoules in the outer carton in order to protect from light.
For information about shelf life after first opening please see section "Preparation guide" for health care professionals.
Immediately prior to administration of Piritramide [MAH] the prepared syringe or the diluted solution (e.g. infusion solution) should be inspected visually for visible particles; if particles are present the solution should be discarded.
Do not throw away any medicines via wastewater
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Piritramide [MAH] contains
The active substance is piritramide. 1 ml solution for injection contains 7.5 mg piritramide.
1 ampoule of 1 ml solution for injection contains 7.5 mg piritramide. 1 ampoule of 2 ml solution for injection contains 15 mg piritramide. 1 ampoule of 6 ml solution for injection contains 45 mg piritramide.
The other ingredients are tartaric acid (Ph. Eur.) and water for injection.
What Piritramide [MAH] looks like and the contents of the pack
Piritramide [MAH] is a clear and colourless solution for injection.
Piritramide [MAH] is available in packs of: 5, 10 or 50 (10x5 or 5x10) ampoules, each filled with 1 ml, 2 ml or 6 ml solution for injection.
Not all pack sizes may be marketed.
Marketing authorisation holder [to be completed nationally]
Manufacturer [to be completed nationally]
This leaflet was last approved in {MM/YYYY}.
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The following information is intended for medical or healthcare professionals only:
PREPARATION GUIDE FOR:
Piritramide [MAH] 7.5 mg/ml solution for injection
Please refer to Summary of Product Characteristics for full prescribing and other information.
Dilution instructions
Piritramide [MAH] should only be diluted with sodium chloride 9 mg/ml (0.9%) solution and glucose 50 mg/ml (5%) solution.
Apart from the above two solutions, Piritramide [MAH] must not be mixed with any other medicinal product or infusion solution to prevent the possibility of precipitation. This can occur if the pH is above 4.8.
Shelf life after first opening / dilution
Piritramide [MAH] solution for injection is intended for single use only and should be used immediately after first opening. Any unused solution should be discarded.
The chemical and physical stability at room temperature (25°C) and under light influence of the dilution has been demonstrated for 24 hours with sodium chloride 9 mg/ml (0.9%) solution and for 72 hours with glucose 50 mg/ml (5%) solution.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions. The dilution with sodium chloride 9 mg/ml (0.9%) should not be applied for more than 24 hours.
Disposal
Any unused product or waste material should be disposed of in accordance with local requirements.