Tramadol Hydrochloride 50 Mg/Ml Solution For Injection Or Infusion
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Package leaflet: Information for the user
Tramadol hydrochloride 50 mg/ml solution for injection or infusion
tramadol hydrochloride Important information about your medicine
► Your doctor or nurse will give you the injection or infusion.
► If this injection or infusion causes you any problems talk to your doctor, nurse or pharmacist.
► Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to any of the ingredients of this medicine.
► Please tell your doctor or pharmacist, if you are taking any other medicines.
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 pharamacist.
- 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 Tramadol hydrochloride solution for injection or infusion is and what it is used for
2. What you need to know before you use Tramadol hydrochloride solution for injection or infusion
3. How to use Tramadol hydrochloride solution for injection or infusion
4. Possible side effects
5. How to store Tramadol hydrochloride solution for injection or infusion
6. Contents of the pack and other information
1. What Tramadol hydrochloride solution for injection or infusion is and what it is used for
Tramadol - the active substance in this medicne - is a painkiller belonging to the class of opioids that acts on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal cord and brain.
This medicine is used for the treatment of moderate to severe pain.
2. What you need to know before you use Tramadol hydrochloride solution for injection or infusion
Do not use this medicine:
• if you are allergic to tramadol hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• if you are also taking MAO inhibitors (certain medicines used for treatment of depression) or have taken them in the last 14 days before treatment with this medicine (see “Other medicines and Tramadol hydrochloride solution for injection or infusion”)
• if you are an epileptic and your fits are not adequately controlled by treatment
• if you have drunk enough alcohol to make you feel woozy or drunk
• if you have taken more than the prescribed dose of your sleeping tablets or other pain killers, which can slow down your breathing and reactions. (See section “Other medicines and Tramadol hydrochloride solution for injection or infusion” for details)
You should not take this product for the treatment of withdrawal
symptoms caused by opiates (morphine- like medicines).
Warnings and precautions
Talk to your doctor or nurse before using this medicine:
• if you have a head injury, breathing difficulties or severe liver or kidney problems
• if you think that you are addicted to other pain relievers (opioids)
• if you feel that you are going to faint
• if you are in a state of shock (cold sweat may be a sign of this)
• if you have a tendency towards epilepsy or fits because the risk of a fit may increase
Children
This medicinal product is not suitable for children below the age of 12 years.
Other medicines and Tramadol hydrochloride solution for injection or infusion:
Tell your doctor or nurse if you are using, have recently used or might use any other medicines including medicines obtained without a prescription. This is especially important with the following medicines as they may interact with this medicine:
• Anticoagulants to thin your blood such as warfarin
• Medicines used to treat epilepsy such as carbamazepine.
• Ondansetron (prevents nausea)
• Monoamine oxidase inhibitors (moclobemide or phenezeline for depression, selegiline for Parkinson's disease).
• Medicines that act on the nervous system such as hypnotics, tranquillisers, sleeping pills and pain killers may make you feel drowsier or faint
• selective serotonin re- uptake inhibitors (SSRI's) to treat depression such as fluoxetine. You may experience symptoms such as confusion, restlessness, fever, sweating, uncoordinated movement of limbs or eyes, uncontrollable jerking of muscles, or diarrhoea
• medicines which may cause convulsions (fits), such as certain antidepressants
Pregnancy and breast feeding:
This medicine should not be given during pregnancy or while 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 taking this medicine.
Driving and using machines:
This medicine may cause drowsiness, dizziness and blurred vision and therefore may impair your reactions and your ability to drive.
• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
• The medicine has been prescribed to treat a medical or dental problem and
• You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
• It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
If you feel that your reactions are affected, do not use electric tools or operate machinery, and do not work without a firm hold!
Tramadol hydrochloride solution for injection or infusion with food, drink and alcohol:
Do not drink alcohol during treatment with this medicine as its effects may be intensified.
This medicine contains sodium. This medicinal product contains less than 1 mmol sodium (1.4mg) per 2ml dose i.e. essentially 'sodium - free'.
Information for the Healthcare Professional
Tramadol hydrochloride 50 mg/ml solution for injection or infusion
Please read this information carefully before using Tramadol hydrochloride 50 mg/ml solution for injection or infusion (referred to as Tramadol Injection). Further information is contained in the Summary of Product Characteristics.
Presentation
Tramadol Injection is presented as a clear colourless solution in a Type-I clear glass ampoule. Each 1 ml ampoule contains 50 mg of tramadol hydrochloride.
Dosage and Method of Administration
Whenever solution and container permit, parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration. Only a clear solution should be used.
Tramadol Injection is for parenteral injection either intramuscularly, by slow intravenous injection or diluted in solution for administration by infusion or patient controlled analgesia.
The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. The total daily dose of 400mg tramadol hydrochloride should not be exceeded, except in special clinical circumstances.
Tramadol Injection should not be given for longer than absolutely necessary. If long term pain treatment is necessary then careful regular monitoring should be carried out, with breaks in treatment if necessary.
Adults and Children over 12 years
The usual dose is 50 or 100mg 4 to 6 hourly by either intramuscular or intravenous routes. Intravenous injections must be given slowly over 2-3 minutes. The dose should be adjusted according to the severity of the pain and the response.
For post-operative pain, an initial bolus of 100mg is administered. During the 60 minutes following the initial bolus, further doses of 50mg may be given every 10-20 minutes, up to a total dose of 250mg including the initial bolus. Subsequent doses should be 50mg or 100mg 4-6 hourly up to a total daily dose of 400mg.
Elderly
A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency. In elderly patients over 75 years elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to the patient's requirements.
Renal insufficiency/dialysis and hepatic impairment
In patients with renal and/or hepatic insufficiency the elimination of tramadol is delayed. In these patients prolongation of the dosage intervals should be carefully considered according to the patient's requirements.
3. How to use Tramadol hydrochloride solution for injection or infusion
Your nurse or doctor will give you the injection or infusion.
Your doctor will decide the correct dosage for you and how and when the injection or infusion will be given.
Since the injection or infusion will be given to you by a doctor or nurse, it is unlikely that you will be given too much. If you think you have been given too much, you must tell the person giving you the injection or infusion.
If treatment with this medicine is interrupted or finished too soon, pain is likely to return. If you wish to stop treatment on account of unpleasant effects, please tell your nurse or doctor.
If you stop using Tramadol hydrochloride solution for injection or infusion
Generally there will be no after-effects when treatment with tramadol is stopped. However, on rare occasions, people who have been treated with tramadol for some time may feel unwell if the treatment is abruptly stopped. They may feel agitated, anxious, nervous or shaky. They may be confused, hyperactive, have difficulty sleeping and have stomach or bowel disorders. Very few people may get panic attacks, delusions, paranoia, hallucinations or feeling a loss of identity. They may experience unusual perceptions such as itching, tingling and numbness, and “ringing” in the ears (tinnitus). If you experience any of these complaints after stopping treatment tell your nurse or doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
• Allergic reactions to Tramadol hydrochloride have been reported. If you have any difficulty breathing, a rash or itchy skin, a swollen face or tongue or difficulty in swallowing, stop taking this medicine immediately and tell your doctor straight away.
• You may suffer from convulsions (fits), headache, blurred vision or dilated or constricted pupils
• You may notice that you are sweating more or are flushed, develop a rash or become itchy or numb
• You may feel drowsy, sleepy, weary, low in energy or dizzy or may have difficulty in speaking
• You may develop muscle twitches, uncoordinated movement, transient loss of consciousness (syncope), a tingling sensation and trembling or muscle weakness^
• Elevated liver enzymes may occur.
• You may experience changes in your heart beat (faster or slower) or high or low blood pressure.
• You may experience constipation, a dry mouth, appetite changes or diarrhoea
• You may experience psychic effects including: changes in mood, activity, behaviour or perception, hallucinations, confusion, restlessness, sleep disturbances, delirium, anxiety and nightmares
• You may experience nausea or vomiting, retching, feeling bloated or full
• Dependency on Tramadol may develop. Tell your doctor if you notice this
• Shortness of breath, slower breathing or worsening of asthma may occur
• You may find it difficult to pass urine
• You may experience a decrease in blood sugar levels, speech disorders or dilated or constricted pupils
Epileptic fits have been reported in patients taking tramadol at the recommended dose level. The risk may be increased when doses of tramadol exceed the recommended upper daily dose limit (400 mg). Tramadol may lead to physical and psychological addiction. When it is taken for a long time, its effect may decrease so that higher doses have to be taken (tolerance development).
If you think this injection or infusion is causing you side effects, or you are at all worried, talk to your doctor, nurse or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Tramadol hydrochloride solution for injection or infusion
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.
The nurse or doctor will check that the injection or infusion is not past its expiry date before giving you the injection or infusion.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Tramadol hydrochloride contains:
The active substance is tramadol hydrochloride.
Each 1ml ampoule contains 50 mg of tramadol hydrochloride.
Each 2 ml ampoule contains 100 mg of tramadol hydrochloride.
The other ingredients are sodium acetate trihydrate, water for injections.
What Tramadol hydrochloride solution for injection or infusion looks like and contents of the pack:
Solution for injection or infusion.
Clear and colourless solution.
Type-I clear glass ampoule containing either 1 ml or 2 ml of injection solution. Ampoules are placed in a preprinted carton. Cartons contain either 5, 50 and 100 ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom
Manufacturer
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom
This leaflet was last revised in 10/2016.
Children under 12 years Not recommended.
Contraindications
Tramadol Injection should not be given to patients who have previously demonstrated hypersensitivity towards tramadol or any of the other ingredients in this medicine. Tramadol Injection should not be given to patients suffering from acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs. In common with other opioid analgesics, tramadol should not be administered to patients who are receiving monoamine oxidase inhibitors or within two weeks of their withdrawal. Tramadol Injection is contraindicated in patients with epilepsy not adequately controlled by treatment. Tramadol must not be used in narcotic withdrawal treatment.
Pharmaceutical Information
Excipients: Sodium acetate trihydrate and Water for Injections. Incompatibilities
Precipitation will occur if Tramadol hydrochloride Injection is mixed in the same syringe with injections of diazepam, diclofenac sodium, indomethacin, midazolam and piroxicam.
Shelf-life: 3 years
Storage Precautions: Keep ampoule in the outer carton. This medicinal product does not require any special storage conditions. Nature of Container: Type-I clear glass ampoule containing either 1 ml or 2 ml of injection solution. Ampoules are placed in a pre-printed carton. Cartons contain either 5, 50 and 100 ampoules.
Instructions for Use and Handling.
The prepared infusion solution should be made up immediately before use.
Tramadol Hydrochloride solution for injection/infusion is physically compatible and chemically stable at controlled room temperature (i.e. 15-25°C) for up to 24 hours with 4.2% Sodium Bicarbonate Solution and Ringer's solution or up to 5 days when mixed with the following diluents for infusion over the concentration range of 0.5 mg/ml to 4.0 mg/ml.
• 0.9% Sodium Chloride Intravenous Infusion
• 5% Dextrose Intravenous Infusion
• 0.18% Sodium Chloride and 4% Dextrose Intravenous Infusion
• Ringer Lactate Solution
• Haemaccel
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 not normally be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.