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The product code(s) for this leaflet is: PL 36722/0119.
Tramadol Hydrochloride 50mg Effervescent Tablets
Tramadol Hydrochloride 50mg Effervescent Tablets
1 What Tramadol Tablet is and what it is used for
2 What you need to know before you take Tramadol Tablets
3 How to take Tramadol Tablets
4 Possible side effects
5 How to store Tramadol Tablets
6 Contents of the pack and other information
Tramadol Hydrochloride is a pain reliever belonging to a group of medicines called opioids.
Opioids work by imitating the action of naturally occurring pain-reducing chemicals in the body called endorphins. They do this by combining with the opioid receptors in the brain and spinal cord. This blocks the transmission of pain signals sent by the nerves to the brain. Therefore, even though the cause of the pain may remain, less pain is actually felt.
Tramadol is used to treat moderate to severe pain. 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.
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 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 if:
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).
Talk to your doctor before taking Tramadol:
Tramadol contains an active substance that belongs to the group of opioids. Opioids can cause sleep-related breathing disorders, for example central sleep apnea (shallow/pause of breathing during sleep) and sleep-related hypoxemia (low level of oxygen in the blood).
The risk of experiencing central sleep apnea is dependent on the dose of opioids. Your doctor may consider decreasing your total opioid dosage if you experience central sleep apnea.
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”).
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).
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.
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.
Talk to your doctor if you experience any of the following symptoms while taking tramadol:
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.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.
Medicines which may interact with or be affected by Tramadol:
During treatment with Tramadol, it is recommended not to drink alcohol. Food does not influence the effect of Tramadol
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.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy:
Breast-feeding:
Tramadol may cause drowsiness, dizziness and blurred vision and therefore may impair your reactions. This is more likely to occur if you drink alcohol or are taking CNS depressants or psychotropic drugs (any drug capable of affecting the mind, emotions and behaviour) (see “Other medicines and Tramadol”). If any of these symptoms are experiences, it may be necessary to avoid driving or operating machinery or pursuing any activity in which full attention is required.
This 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.
Always take Tramadol exactly as your doctor 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, 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 dose of Tramadol should be adjusted according to the intensity of your pain and your individual pain sensitivity. The lowest possible dose should be taken.
In general the lowest pain-relieving dose should be taken. Do not take more than 400 mg tramadol hydrochloride daily, except if your doctor has instructed you to do so.
Short-term (acute) treatment of pain:
Treatment of pain for long-term (chronic) conditions:
A maximum daily dose of 400mg should not be exceeded unless under specialist medical supervision.
In older people (over 75 years of age) the rate at which Tramadol is excreted from the body may be delayed.
Therefore, if necessary, the time interval between doses may need to be extended according to your requirements.
Your prescriber should have discussed with you, how long the course of tablets will last. They will arrange a plan for stopping treatment.
This will outline how to gradually reduce the dose and stop taking the medicine.
If you accidently take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.
If you have taken an additional dose by mistake, this will generally have no negative effects. You should take your next dose as prescribed.
Constriction of the pupil of the eye (miosis), being sick (vomiting), a sudden and marked drop in blood pressure (cardiovascular collapse), sedation and consciousness disorders up to coma, fits (seizures) and respiratory depression (breathing becomes slower or weaker than usual) up to respiratory arrest (stop breathing).
If you forget to take the tablets, pain is likely to return. Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.
It is important that you keep taking Tramadol for as long as your doctor has told you to.
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).
If you interrupt or prematurely stop treatment with Tramadol, your pain will return. If you decide you wish to stop taking this medicine because of unpleasant side effects, please consult your doctor. One side effect of this medicine is drug dependence. Drug dependence occurs when a person’s body becomes used to a drug and begins to need it to continue functioning normally. Dependence withdrawal symptoms may occur when treatment is stopped.
Dependence, misuse and withdrawal effects are known with the use of Tramadol. Withdrawal effects include: agitation, anxiety, nervousness, difficulty in sleeping (insomnia), unusual uncontrolled muscle movement (hyperkinesia), shakiness (tremor) and stomach disorders.
Other possible symptoms associated with stopping the use of Tramadol include: panic attacks, severe anxiety, seeing or hearing things that are not real (hallucinations), tingling or numbness in the hands or feet (paraesthesia), ringing in the ears (tinnitus) and unusual Central Nervous System (CNS) symptoms such as confusion, mental health disorders (delusions), a feeling of loss of identity/feeling detached from yourself (depersonalisation), feeling dissociated from your environment (derealisation) and unfounded or excessive fears about others (paranoia).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, Tramadol may cause side effects, although not everybody gets them.
Very common side effects (may affect more than 1 in 10 people)
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1000 people)
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from available data
When you stop taking Tramadol, 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, 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 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 atwww.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.
Each effervescent tablet contains 50mg of Tramadol Hydrochloride.
The other ingredients are: citric acid, sodium hydrogen carbonate, lactose monohydrate, sodium sulfate, sodium carbonate, povidone, sodium cyclamate, aspartame, macrogol, orange flavouring, simethicone emulsion, water, isopropanol.
Tramadol Hydrochloride 50mg Effervescent Tablets are white or off-white, round, biplane, effervescent tablets, of approximate diameter of 17.8-18.3mm with bevel-edges on both sides, and have an orange flavour.
Tramadol effervescent tablets are available in a tablet tube with a stopper containing silica gel as desiccant in packs of 10, 20, 30 or 100 tablets per pack.
Not all pack sizes will be marketed.
Product Licence Number:
PL 36722/0119
The leaflet was last revised in
April 2025
Till-Ver.1.1s