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The product code(s) for this leaflet is: PL20117/0354.
Tramadol Hydrochloride 10mg/ml Oral Solution
Tramadol Hydrochloride
10 mg/ml Oral Solution
This medicine contains tramadol hydrochloride which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.
1. What Tramadol oral solution is and what it is used for
2. What you need to know before you take Tramadol oral solution
3. How to take Tramadol oral solution
4. Possible side effects
5. How to store Tramadol oral solution
6. Contents of the pack and other information
This medicine has been prescribed for you for the treatment of moderate to severe pain.
It contains 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.
Talk to your doctor before taking Tramadol oral solution if you:
Sleep-related breathing disorders
Tramadol oral solution 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.
Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Tramadol oral solution:
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.
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.
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.
Tolerance, dependence, and addiction
This medicine contains tramadol which is an opioid medicine. Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Tramadol oral solution can also lead to dependence, abuse and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use.
Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it.
The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to Tramadol oral solution if:
If you notice any of the following signs whilst taking Tramadol oral solution, it could be a sign that you have become dependent or addicted:
If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop taking Tramadol oral solution).
Epileptic fits have been reported in patients taking Tramadol oral solution at the recommended dose level. The risk may be higher when doses of Tramadol oral solution exceed the recommended upper daily dose limit 400 mg (40 ml).
Please also inform your doctor if one of these problems occurs during treatment with Tramadol oral solution or if they applied to you in the past.
Tramadol hydrochloride 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.
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’).
Children and adolescents
Use in children with breathing problems:
Tramadol oral solution is not recommended in children with breathing problems, since the symptoms of tramadol toxicity may be worse in these children.
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 solution should not be taken together with MAO inhibitors (certain medicines for the treatment of depression).
The pain-relieving effect of Tramadol oral solution 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 solution, and which dose.
The risk of side effects increases:
Do not drink alcohol during treatment with Tramadol oral solution as its effect may be intensified.
Food does not influence the effect of Tramadol oral solution.
Do not take Tramadol oral solution 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 oral solution during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Do not take Tramadol oral solution while you are breast-feeding as Tramadol hydrochloride passes into breast milk and will affect your baby.
Based on human experience tramadol is suggested not to influence female or male fertility.
Tramadol oral solution 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.
This medicine contains:
Propylene glycol: This medicine contains 101.96 mg propylene glycol in each ml which is equivalent to 509.8 mg per dose of 5 ml or 1019.6 mg per dose of 10ml.
Glycerol (E 422): This medicine contains 100mg in each ml, which is equivalent to 500 mg per dose of 5 ml or 1g per dose of 10ml.
Sodium: This medicine contains 1.70 mg in each ml, which is equivalent to 8.5 mg per dose of 5 ml and 17 mg per dose of 10ml.
Your prescriber should have discussed with you, how long the course of Tramadol oral solution will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using Tramadol oral solution, when and how long you need to take it, when to contact your doctor, and when you need to stop it (see also section 2).
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. Do not take more than 400 mg (40 ml) tramadol hydrochloride daily, except if your doctor has instructed you to do so.
Unless otherwise prescribed by your doctor, the usual dose is:
5 ml to 10 ml Tramadol oral solution (equivalent to 50 mg – 100 mg tramadol hydrochloride).
Depending on the pain the effect lasts for about 4 to 6 hours.
Your doctor may prescribe a different, more appropriate dosage of Tramadol oral solution if necessary.
Tramadol oral solution is not suitable for children below the age of 12 years.
In elderly patients (above 75 years) the excretion of tramadol hydrochloride may be delayed. If this applies to you, your doctor may recommend prolonging the dosage interval.
Patients with severe liver and/or kidney insufficiency should not take Tramadol oral solution. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.
If you have taken an additional dose by mistake, this will generally have no negative effects. You should take your next dose as prescribed.
If you (or someone else) take a lot of Tramadol oral solution at the same time you should go to hospital or call a doctor straight away. Signs of an overdose include very small pupils, being sick, a fall in blood pressure, a fast heart beat, collapse, unconsciousness, fits and breathing difficulties or shallow breathing.
If you forget 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 the medicine as before.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should see a doctor immediately if you experience symptoms of an allergic reaction such as swollen face, tongue and/or throat, and/ or difficulty swallowing or hives together with difficulties in breathing.
The most common side effects during treatment with Tramadol oral solution are nausea and dizziness, which occur in more than 1 in 10 people.
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 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
Drug Withdrawal
When you stop taking Tramadol oral solution, 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.
If you notice any of the following signs whilst taking Tramadol oral solution, it could be a sign that you have become addicted.
If you notice any of these signs, it is important you talk to your prescriber.
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 affects you can help provide more information on the safety of this medicine.
This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Store this medicine in a safe and secure storage space, where other people cannot access it. It can cause serious harm and be fatal to people when it has not been prescribed for them.
Do not take Tramadol oral solution after the expiry date which is stated on the blister or carton after EXP. The expiry date refers to the last day of that month.
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.
Tramadol Hydrochloride 10 mg/ml Oral Solution is a clear, brown solution with orange odour. It is packed in amber, type III 100ml or 150ml glass bottles sealed with a child-resistant tamper-evident screw cap and with a dosing cup of 15ml with 5ml and 10ml graduations.
This leaflet was last revised in April 2025.
MPL17468 - P1.2