Patient leaflet - TRAMADOL 50 MG / ML SOLUTION FOR INJECTION OR INFUSION
Patient Information Leaflet:
(referred to as Tramadol Injection throughout this leaflet)
This medicine contains tramadol hydrochloride which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.
Read all of this leaflet carefully before being given Tramadol Injection, because it contains important information for you.
- Keep this leaflet. You may need to refer to it again.
- If you have any further questions, ask your doctor or nurse.
- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
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1. What Tramadol Injection is and what it is used for
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2. What you need to know before you are given Tramadol Injection
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3. How Tramadol Injection should be given
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4. Possible side effects
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5. Storing Tramadol Injection
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6. Contents of the pack and other information
1.
This medicine has been prescribed for you for pain relief or pain prevention. It contains the active ingredient tramadol hydrochloride, which belongs to a class of medicines called opioids, which are ‘pain relievers’.
This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.
2.
You must NOT be given Tramadol Injection and you should talk to your doctor immediately:
- If you are allergic to tramadol hydrochloride or any of the other ingredients of the solution. Allergic reactions to tramadol could include skin rash, swelling of the face, wheezing or difficulty breathing
- If you are epileptic and your fits are not well controlled by treatment
- If the patient is a child under 12 years of age
- If you are pregnant or breast-feeding
- If you are taking any of the following medicines:
o sleeping tablets or tranquillizers such as nitrazepam
o other pain-killers such as codeine or morphine
o psychotropic medicines such as chlorpromazine
o a monoamine oxidase inhibitor used to treat depression, or if you have taken one in the past two weeks
- If you have recently been drinking alcohol.
It should not be used in narcotic drug withdrawal treatment.
Sleep-related breathing disorders
Tramadol can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.
Tell your doctor before you are given Tramadol Injection, if you:
- are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
- have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or
sweating, when you have stopped taking alcohol or drugs.
- feel you need to take more of Tramadol Injection to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.
- have liver or kidney disease. You may need a lower dose or a longer interval between doses
- have a head injury or brain disease
- have a problem that makes you faint or feel faint
- are in a state of shock. You may feel light headed, faint, cold or clammy or look pale
- suffer from epilepsy, convulsions or seizures (fits) or have had them in the past
- suffer from asthma, other lung diseases or have difficulty in breathing
- have extreme fatigue, lack of appetite, severe abdominal pain, nausea, vomiting or low blood pressure. This may indicate that you have adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormone supplement.
- suffer from depression and you are taking antidepressants as some of them may interact with tramadol (see ‘Other medicines and Tramadol’).
There is a small risk that you may experience a so-called serotonin syndrome that can occur after having taken tramadol in combination with certain antidepressants or tramadol alone. Seek medical advice immediately if you have any of the symptoms related to this serious syndrome (see section 4 ‘Possible side effects’).
Taking this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely. In patients with a tendency to drug abuse, Tramadol Injection should only be given for short periods under strict medical supervision.
Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment.
Addiction can cause withdrawal symptoms when you stop taking this medicine.
Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating.
Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.
Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.
Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme and this can affect people in different ways. In some people, they may not get enough pain relief but other people are more likely to get serious side effects. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow
breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.
Children and adolescents
Use in children with breathing problems
Tramadol is not recommended in children with breathing problems, since the symptoms of tramadol toxicity may be worse in these children.
Other medicines and Tramadol
Tell your doctor if you are taking, or have recently taken, any of the following medicines.
This is important because Tramadol Injection could alter how other medicines work.
- Serotonin- norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, antipsychotics and other seizure threshold-lowering medicinal products (such as bupropion, mirtazapine, tetrahydrocannabinol) to cause convulsions.
- carbamazepine, a treatment for epilepsy, as this may reduce the effectiveness of the tramadol
- triptans, such as sumatriptan, used to treat migraines, as this may increase the effectiveness of the triptans
- coumarin anticoagulants, used to thin the blood, such as warfarin, as this may alter the effectiveness of the anticoagulant
- selective serotonin reuptake inhibitors (SSRI’s), used to treat depression, such as fluoxetine, as this may increase the effect of the SSRI’s
- lithium, used to treat psychotropic disorders, as this may alter the effect of lithium
- ondansetron, used to prevent nausea and vomiting
Other active substances known to inhibit CYP3A4, such as ketoconazole and erythromycin, might inhibit the metabolism of Tramadol
The concomitant use of opioids with sedating medicinal products such as benzodiazepines or related products increases the risk of respiratory depression, sedation, coma and death because of additive CNS depressant effect. The dose of Tramadol and the duration of the concomitant use should be limited
Tell your doctor if you are taking have recently taken, or might take any other medicines. The risk of side effects increases,
- if you are taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk of having a fit may increase if you are given Tramadol Injection at the same time. Your doctor will tell you whether Tramadol Injection is suitable for you.
if you are taking certain antidepressants. Tramadol Injection may interact with these medicines and
you may experience serotonin syndrome (see section 4 ‘Possible side effects’).
This medicinal product contains less than 1 mmol sodium (1.4mg) per 2ml dose i.e. essentially ‘sodium free’
Pregnancy and breastfeeding
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.
Do not take Tramadol Injection if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby. If you use Tramadol Injection during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Tramadol is excreted into breast milk. Do not take Tramadol Injection while you are breastfeeding as tramadol hydrochloride passes into breast milk and will affect your baby.
Driving and using machines
Tramadol Injection may cause drowsiness, dizziness or blurred vision, these effects may be increased by alcohol and other depressants. Do not drive or use machinery if you are affected.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
- 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:
o The medicine has been prescribed to treat a medical or dental problem and
o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
o 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.
Continued overleaf......
3.
Your prescriber should have discussed with you, how long the course of Tramadol Injection will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. Your doctor or nurse will usually give you Tramadol Injection.
The solution may be given by an injection into either a vein or muscle.
If you are in hospital you may receive tramadol through a drip (infusion) or from a small machine that allows you to have tramadol when you need it by pushing a button. The doctor or nurse will explain how to use the machine.
The usual dose is one injection of 50mg or 100mg every 4 to 6 hours. After an operation you may need injections more often.
Elderly patients: In elderly patients (above 75 years) the excretion of tramadol may be delayed. If this applies to you, your doctor may recommend prolonging the dosage interval.
Severe liver or kidney disease (insufficiency)/dialysis patients should not be given Tramadol Injection. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.
Tramadol Injection should not be given to children under 12 years of age.
The dosage should be adjusted to the intensity of your pain and your individual pain sensitivity. In general, the lowest dose to relieve pain should be given for the shortest possible time.
If you receive too much Tramadol Injection.
If you think you have been given or have given yourself too much Tramadol Injection, tell a doctor or nurse immediately. Symptoms of intoxication are similar to those of other centrally acting analgesics (opioids) are to be expected. These include in particular miosis, vomiting, cardiovascular collapse, consciousness disorders up to coma, convulsions and respiratory depression up to respiratory arrest.
If you stop receiving Tramadol Injection
Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.
Other symptoms include nervousness, insomnia, hyperkinesia, tremor and gastrointestinal symptoms. Additional symptoms that have very rarely been seen with tramadol discontinuation include panic attacks, severe anxiety, hallucinations, paraesthesias, tinnitus and unusual CNS symptoms (i.e. confusion, delusions, personalisation, derealisation, paranoia).
4.
Like all medicines, Tramadol Injection can cause side effects.
However, do not be alarmed, as most patients do not have problems with this medicine.
Tell your doctor or a nurse immediately if you experience any of the following:
- swelling around the throat, tightness in your chest or difficulty in breathing.
You may have had an allergic reaction, these are rare but, if severe, can be serious and you may need urgent medical attention.
Tell a doctor or nurse if you get any of the following other side effects:
Very common side effects (occurring in more than 1 in 10 patients):
- nausea, dizziness.
Common side effects (occurring in less than 1 in 10 patients):
- headache, drowsiness, fatigue
- vomiting, constipation, dry mouth, sweating.
Uncommon side effects (occurring in less than 1 in 100 patients):
- changes in heart beat or rhythm which may make you feeling faint or dizzy especially if you stand up quickly
- retching, stomach irritation or feeling bloated
- diarrhoea
- dermal reactions- rash, itching, hives
Rare side effects (occurring in less than 1 in 1000 patients):
- changes in appetite, abnormal touch sensations, trembling, difficulty breathing, fits, fainting, speech disorders
- slowing of the heart rate, increased blood pressure
- nightmares, disturbed sleep patterns, hallucinations (seeing things), feeling confused, changes in mood, activity or awareness, anxiety, delirium
- blurred vision, excessive dilation or constriction of the pupils
- muscle weakness or twitching, abnormal coordination
- increase in liver enzymes
- difficulty or pain passing water (urine)
- worsening of asthma, shortness of breath
- Rarely when some people stop taking tramadol they get withdrawal symptoms. These symptoms include agitation, nervousness, shaking, hyperactivity and difficulty in sleeping.
Very rarely panic attacks, severe anxiety, hallucinations, tinnitus or abnormal skin sensations, as well as confusion, delusions, personalisation, derealisation and paranoia, have occurred.
Unknown frequency:
- dependence and addiction (see section “How do I know if I am addicted?”).
- low blood sugar levels
- hypoglycaemia
- hiccups
- Serotonin syndrome, that can manifest as mental status changes (e.g. agitation, hallucinations, coma), and other effects, such as fever, increase in heart rate, unstable blood pressure, involuntary twitching, muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 ‘What you need to know before you take <product name>’).
Drug Withdrawal
When you stop taking Tramadol Injection, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat
(palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.
How do I know if I am addicted?
If you notice any of the following signs whilst taking Tramadol 50mg/ml Solution for Injection or Infusion,
it could be a sign that you have become addicted.
- You need to take the medicine for longer than advised by your prescriber
- You feel you need to use more than the recommended dose
- You are using the medicine for reasons other than prescribed
- When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again.
If you notice any of these signs, it is important you talk to your prescriber.
Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. 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/yellowcardr search MHRA Yellow Card on the Google Play or Apple App store.
By reporting side effects, you can help provide more information on the safety of this medicine.
5.
The hospital will store the medicines. Keep this medicine out of sight and reach of children. This medicinal product does not require any special storage conditions. Keep ampoule in the outer carton.
Do not use this product if there are signs of damage to the ampoule or if the solution is cloudy or contains particles.
Tramadol Injection should not be used after the ‘use by’ date on the carton.
6.
What Tramadol Injection contains:
Each 2 ml ampoule contains 100mg of tramadol hydrochloride.
The ampoules also contain sodium acetate trihydrate and water for injections.
What Tramadol Injection looks like and contents of the pack:
Tramadol Injection is a clear colourless solution. Each pack contains 5 glass ampoules
Marketing authorisation holder:
Beacon Pharmaceuticals Limited, DCC Vital, Westminster
Industrial Estate, Repton Road, Measham, DE12 7DT,
England.
Manufacturer:
Biologici Italia Laboratories S.r.l., Via F.
Serpero, 2 – 20060 Masate (MI), Italy
This leaflet does not include all the information about this medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
Date of revision: 10/2021
Information for the Healthcare Professional
Tramadol 50mg/ml Solution for Injection or
Tramadol Injection is presented as a clear colourless solution in a neutral glass ampoule.
Each ampoule contains 2ml of tramadol hydrochloride 50mg/ml.
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
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
Sodium acetate trihydrate and Water for Injections.
Incompatibilities
Precipitation will occur if Tramadol 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
2ml neutral glass type I glass ampoules for injections. Box of 5 ampoules.
Instructions for Use and Handling.
The prepared infusion solution should be made up immediately before use.
Tramadol Injection is physically and chemically compatible for up to 24 hours with 4.2% sodium bicarbonate and Ringer's solution; and for up to 5 days with the following infusion solutions:
- 0.9% sodium chloride
- 0.18% sodium chloride and 4% glucose
- sodium lactate compound
- 5% glucose