Patient Leaflet Updated 12-Nov-2018 | ADVANZ Pharma
Tramadol 100 mg/ml oral drops, solution
Package leaflet: Information for the user
Tramadol 100mg/ml oral drops, solution
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
The name of your medicine is Tramadol 100mg/ml oral drops, solution. It will be referred to as “Tramadol oral drops” for ease of use hereafter.
What is in this leaflet
1. What Tramadol oral drops are and what they are used for
2. What you need to know before you take Tramadol oral drops
3. How to take Tramadol oral drops
4. Possible side effects
5. How to store Tramadol oral drops
6. Contents of the pack and other information
1. WHAT TRAMADOL ORAL DROPS ARE AND WHAT THEY ARE USED FOR
Tramadol (tramadol hydrochloride) – the active substance in Tramadol oral drops - 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.
Tramadol oral drops are used for the treatment of moderate to severe pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL ORAL DROPS
Do not take Tramadol oral drops:
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Tramadol oral drops:
In such cases please consult your doctor before taking the medicine.
Epileptic fits have been reported in patients taking tramadol at the recommended dose level. The risk may be higher when doses of tramadol exceed the recommended upper daily dose limit (400mg).
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.
Please note that Tramadol oral drops may lead to physical and psychological addiction. When Tramadol oral drops are taken for a long time, its effect may decrease, so that higher doses have to be taken (tolerance development).
In patients with a tendency to abuse medicines or who are dependent on medicines, treatment with Tramadol oral drops should only be carried out for short periods and under strict medical supervision.
Please also inform your doctor if one of these problems occurs during treatment with Tramadol oral drops or if they applied to you in the past.
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 oral drops
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Tramadol oral drops should not be taken together with MAO inhibitors (certain medicines for the treatment of depression).
Concomitant use of Tramadol oral drops 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 Tramadol oral drops 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.
The pain-relieving effect of Tramadol oral drops may be reduced and the length of time it acts may be shortened, if you take medicines which contain
Your doctor will tell you whether you should take Tramadol oral drops, and which dose. The risk of side effects increases
If this happens tell your doctor
Tramadol oral drops with food, drink and alcohol
Do not drink alcohol during treatment with Tramadol oral drops as its effect may be intensified. Food does not influence the effect of Tramadol oral drops.
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 taking this medicine.
There is very little information regarding the safety of tramadol in human pregnancy. Therefore, you should not use Tramadol oral drops if you are pregnant. Chronic use during pregnancy may lead to withdrawal symptoms in newborns.
Tramadol is excreted into breast milk. For this reason, you should not take tramadol more than once during breast-feeding, or alternatively, if you take Tramadol oral drops more than once, you should stop breast-feeding.
Driving and using machines
Tramadol oral drops may cause drowsiness, dizziness and blurred vision and therefore may impair your reactions. If you feel that your reactions are affected, do not drive a car or other vehicle, do not use electric tools or operate machinery.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Tramadol oral drops contain sodium and sucrose.
This medicine contains less than 1 mmol sodium(23 mg) per 100mg/ml, that is to say essentially ‘sodium-free’.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE TRAMADOL ORAL DROPS
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The dosage should be adjusted to the intensity of your pain and your individual pain sensitivity. In general the lowest pain-relieving dose should be taken.
Unless otherwise prescribed by your doctor, the recommended dose is:
Adults and adolescents from the age of 12 years
The recommended dose for adults and children aged 12 and over is 50 mg to 100 mg tramadol (20 to 40 drops), three to four times per day. The maximum allowed dose of Tramadol oral drops is generally 400 mg (160 drops) per day. For acute pain, a starting dose of 100 mg is generally required since the effect begins later than with other pain relievers. If Tramadol oral drops are taken for acute pain, the user must be aware that the effect begins somewhat later than with a number of other pain-relievers.
For chronic pain, a starting dose of 50 mg is recommended.
Use in Children
Tramadol oral drops are not suitable for children below the age of 12 years.
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
Patients with severe liver and/or kidney insufficiency should not take Tramadol oral drops. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.
How and when should you take Tramadol oral drops?
Tramadol oral drops are for oral use.
Mix the drops in one glass of water. Then drink the whole content of the glass.
The drops may be taken before, during or after meals.
How long should you take Tramadol oral drops?
You should not take Tramadol oral drops for longer than necessary. If you need to be treated for a longer period, your doctor will check at regular short intervals (if necessary with breaks in treatment) whether you should continue to take Tramadol oral drops and at what dose. If you have the impression that the effect of Tramadol oral drops is too strong or too weak, talk to your doctor or pharmacist.
If you take more Tramadol oral drops than you should
If you have taken an additional dose by mistake, this will generally have no negative effects. You should take your next dose as prescribed. After taking very high doses, pin-point pupils, vomiting, fall in blood pressure, fast heart beat, collapse, disturbed consciousness up to coma (deep unconsciousness), epileptic fits, and difficulty in breathing up to cessation of breathing may occur.
In such cases a doctor should be called immediately.
If you forget to take Tramadol oral drops
If you have forgotten to take a dose, pain is likely to return.
Do not take a double dose to make up for forgotten individual doses, simply continue taking drops as before.
If you stop taking Tramadol oral drops
You should not suddenly stop taking this medicine unless your doctor tells you to. If you want to stop taking your medicine, discuss this with your doctor first, particularly if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may be by lowering the dose gradually to reduce the chance of developing unnecessary side effects (withdrawal symptoms).
Generally, there will be no after-effects when treatment with Tramadol oral drops is stopped. However, on rare occasions, people who have been taking Tramadol oral drops for some time may feel unwell if they abruptly stop taking them. They may feel agitated, anxious, nervous or shaky. They may be hyperactive, have difficulty sleeping and have stomach or bowel disorders. Very few people may get panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and noise in the ears (tinnitus). Further unusual CNS symptoms, i.e. confusion, delusions, change of perception of the own personality (depersonalization), and change in perception of reality (derealization) and delusion of persecution (paranoia) have been seen very rarely. If you experience any of these complaints after stopping Tramadol oral drops, please consult your doctor.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine if you experience any of the following:
Other side effects include:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000people):
Very rare (may affect up to 1 in 10,000 people):
Not known (frequency cannot be estimated based on available data):
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE TRAMADOL ORAL DROPS
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 the label after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light.
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 oral drops contain
Each 1ml oral drops, solution contains 100mg/ml Tramadol (as the hydrochloride).
What Tramadol oral drops look like and contents of the pack
Tramadol oral drops are clear, colourless or faint yellowish solution. They are delivered in boxes containing one, three or five amber glass bottles of 10ml, with an inserted dropper applicator and sealed with a child safe screw cap. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
This leaflet was last revised in July 2018.
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+44 (0)208 588 9131
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