Patient leaflet - Tramadol 50 mg capsules
1. What Tramadol 50 mg Capsules are and what they are used for
Tramadol 50 mg Capsules are 'analgesics' which act on the central nervous system (the brain and the spinal cord). Analgesics are often called 'pain killers' or 'pain relievers'. This medicine has been prescribed for you for relieving pain and can also be taken to prevent 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.
Pain is a symptom not an illness. There are many types of pain with many different causes, for example backache, toothache, pain after an operation or pain from broken bones.
Tramadol 50 mg Capsules help your body's system for relieving pain. It does this in two ways:
Acts directly on parts of your brain and spinal cord
to reduce the amount of pain you feel
Reduces the size of the pain message passed from
one nerve to another.
Tramadol 50 mg Capsules should only be taken by adults or children over 12 years.
2. What you need to know before you take Tramadol 50 mg Capsules
Do not take Tramadol 50 mg Capsules
If you are allergic to tramadol or any of the other
ingredients of this medicine (listed in section 6)
- If you are pregnant or if you are breast-feeding
If you are taking a monoamine oxidase inhibitor
(MAOI) or have taken one in the past two weeks. You should know if you are taking MAOI because your doctor or pharmacist will have told you, and you may also have a treatment card
If you suffer from epilepsy not controlled by
treatment
If you have drunk enough alcohol to make you feel
whoozy or drunk
If you feel 'high' or excited because you have taken
medicines that slow the nervous system. These medicines include tranquillisers, sleeping pills,
psycho-tropic medicines (medicines that affect your mood or emotions) or other pain relievers such as morphine and codeine
- as a substitute in drug withdrawal.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Tramadol 50 mg Capsules if you:
suffer from consciousness disorders (if you feel that
you are going to faint)
- are in a state of shock (cold sweat may be a sign of this)
have had a head injury or have brain disease. If you
have a very bad headache or vomit without feeling sick first, this could be a sign of this.
suffer from epilepsy, convulsions or seizures (fits) or
have had them in the past
- feel light-headed, faint, cold or clammy, or look pale
suffer from asthma, or other lung disease or have
difficulty in breathing
- suffer from kidney or liver disease
suffer from depression and you are taking
antidepressants as some of them may interact with tramadol (see ‘Other medicines and Tramadol 50 mg Capsules’).
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 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:
You or anyone in your family have ever abused or
been dependent on alcohol, prescription medicines or illegal drugs (“addiction”).
- You are a smoker.
You have ever had problems with your mood
(depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.
You have made repeated, unsuccessful attempts to
quit or control the use of the medicine.
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 50 mg Capsules).
Sleep-related breathing disorders
Tramadol 50 mg Capsules contain an active substance that belongs to the group of opioids. Opioids can cause sleep-related breathing disorders, such as sleep apnea (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. 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.
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 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.
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.
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.
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 is not recommended in children with breathing problems, since the symptoms of tramadol toxicity may be worse in these children.
Other medicines and Tramadol 50 mg Capsules
Tramadol 50 mg Capsules should not be taken together with MAO inhibitors (certain medicines for the treatment of depression).
The pain-relieving effect of Tramadol 50 mg Capsules may be reduced and the length of time it acts may be shortened, if you take medicines which contain
- carbamazepine (for epileptic fits);
- ondansetron (prevents nausea).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are taking other pain relievers such as
morphine and codeine (also as cough medicine), and alcohol while you are taking Tramadol 50 mg Capsules. You may feel drowsier or feel that you might faint. If this happens tell your doctor.
If you are taking carbamazepine, a treatment for
epilepsy, this may reduce the pain relieving effect of Tramadol 50 mg Capsules. Your doctor will tell you whether Tramadol 50 mg Capsules are suitable for you.
If you are taking selective serotonin reuptake
inhibitors (often referred to as SSRI's) or triptans or MAOI's because it has been shown that Tramadol 50 mg Capsules may interfere with these medicines and you may experience symptoms such as confusion, restlessness, fever, sweating, uncoordinated movement of limbs or eyes, uncontrollable jerking of muscles, or diarrhoea.
If you take coumarin anticoagulants (medicines for
blood thinning), e.g. warfarin, together with Tramadol 50 mg Capsules. The effect of these medicines on blood clotting may be affected and bleeding may occur.
If you are taking lithium, make sure your doctor or
dentist knows. Tramadol 50 mg Capsules could alter the effect of lithium.
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 fits may increase if you take Tramadol 50 mg Capsules at the same time. Your doctor will tell you whether Tramadol 50 mg Capsules are suitable for you.
If you are taking certain antidepressants. Tramadol
50 mg Capsules may interact with these medicines and you may experience serotonin syndrome (see section 4 ‘Possible side effects’).
Concomitant use of Tramadol 50 mg Capsules and
tranquillizers or sleeping pills (e.g. benzodiazepines), or other sedatives or medicines that impair breathing activity (e.g. opioids) or gabapentin or pregabalin to treat pilepsy or pain due to nerve problems neuropathic pain) 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 prescribes Tramadol 50 mg Capsules together with sedating medicines the dose and the duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedating 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.
medicines used to treat allergies, travel sickness or
nausea (antihistamines or antiemetics).
medicines to treat psychiatric disorders
(antipsychotics or neuroleptics).
- muscle relaxants.
- medicines to treat Parkinson’s disease.
Taking Tramadol 50 mg Capsules with food and drink
You should avoid alcohol during treatment with Tramadol 50 mg Capsules. If you use alcohol with Tramadol 50 mg Capsules you may feel drowsier than when you are taking alcohol alone.
Food does not influence the effect of Tramadol.
Pregnancy, breast-feeding and fertility
Do not take Tramadol 50 mg Capsules 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 50 mg Capsules during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Do not take Tramadol 50 mg Capsules while you are breast-feeding as tramadol hydrochloride passes into breast milk and will affect your baby.
Based on human experience Tramadol 50 mg Capsules is suggested not to influence female or male fertility.
Driving and using machines
Tramadol 50 mg Capsules 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 any 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.
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.
3. How to take Tramadol 50 mg Capsules
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your prescriber should have discussed with you, how long the course of capsules will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.
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.
You should usually swallow one or two capsules at a time. Do not take them more often than every four hours and do not take more than eight capsules in any 24 hours unless your doctor tells you to. Swallow the capsules whole, not divided or chewed, with sufficient liquid. Tramadol 50 mg Capsules do not need to be taken with food. If you are not sure, ask your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the usual dose is:
Adults and adolescents from the age of 12 years One or two Tramadol 50 mg Capsules (equivalent to 50 mg – 100 mg tramadol hydrochloride). Depending on the pain, the effect lasts for about 4-8 hours.
Your doctor may prescribe a different, more appropriate dosage of Tramadol 50 mg Capsules if necessary.
Children
Tramadol 50 mg Capsules are not suitable for children below the age of 12 years.
If you have chronic pain (pain that lasts for long periods of time) it is best to take Tramadol 50 mg Capsules over short periods and only when you need it.
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, see section 2 (Warnings and precautions) above.
If you take more Tramadol 50 mg Capsules than you should
If you take two single doses of Tramadol 50 mg Capsules at once by mistake, this will generally not be harmful.
If pain returns, continue taking Tramadol 50 mg Capsules as usual.
If high doses are taken accidentally (e.g. a dose of more than two Tramadol 50 mg Capsules at once), a number of symptoms may occur. These might include: pinpoint pupils, vomiting, a fall in blood pressure, a fast heartbeat, collapse, disturbed consciousness including coma (deep unconsciousness), epileptic fits and difficulties in breathing up to cessation of breathing and death may occur. If you suspect that you or someone else has taken an overdose of Tramadol 50 mg Capsules, contact your doctor or go to your local hospital immediately. Always take the carton and this leaflet with you if possible.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you forget to take Tramadol 50 mg Capsules
If you forget to take the capsules, pain is likely to return.
Do not take a double dose to make up for forgotten individual doses, simply continue taking the capsules as before.
If you stop taking Tramadol 50 mg Capsules
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.
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.
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 swelling of skin or hives together with difficulties in breathing, wheezing.
The most common side effects during treatment with Tramadol 50 mg Capsules are nausea and dizziness, which occur in more than 1 in 10 people.
Very common: may affect more than 1 in 10 people
- dizziness
- feeling sick (nausea).
Common: may affect up to 1 in 10 people
- headaches, drowsiness
- fatigue
constipation, dry mouth, being sick (vomiting),
excessive sweating (hyperhidrosis).
Uncommon: may affect up to 1 in 100 people
effects on the heart and blood circulation (pounding
of the heart, fast heartbeat, feeling faint or collapse). These adverse effects may particularly occur in patients in an upright position or under physical strain.
- urge to be sick (retching), stomach trouble (e.g. feeling of pressure in the stomach, bloating), diarrhoea
- skin reactions (e.g. itching, rash).
Rare: may affect up to 1 in 1,000 people
- allergic reactions (e.g. difficulty in breathing, wheezing, swelling of skin) and shock (sudden circulation failure) have occurred in very rare cases
- slow heartbeat
- increase in blood pressure
- abnormal sensations (e.g. itching, tingling, numbness), trembling, epileptic fits, muscle twitches, uncoordinated movement, transient loss of consciousness (syncope), speech disorders
- epileptic fits have occurred mainly at high doses of tramadol or when tramadol was taken at the same time as other medicines which may induce fits
- changes in appetite
- hallucination, confusional state, sleep disorders, delirium, anxiety and nightmares
- psychological complaints may appear after treatment with Tramadol 50 mg Capsules. Their intensity and nature may vary (according to the patient's personality and length of therapy). These may appear as a change in mood (mostly high spirits, occasionally irritated mood), changes in activity (usually suppression, occasionally increase) and decreased cognitive and sensory perception (being less aware and less able to make decisions, which may lead to errors in judgement).
blurred vision, excessive dilation of the pupils
(mydriasis), constriction of the pupil (miosis)
- slow breathing, shortness of breath (dyspnoea)
worsening of asthma has been reported, however it has not been established whether it was caused by tramadol.
If the recommended doses are exceeded, or if other medicines that depress brain function are taken at the same time, breathing may slow down.
- weak muscles
- passing urine with difficulty or pain, passing less urine than normal (dysuria).
Very rare: may affect up to 1 in 10,000 people
- hepatic enzyme increased.
Not known: frequency cannot be estimated from the available data
- decrease in blood sugar level
- dependence and addiction (see section ‘How do I know if I am addicted’)
- 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 Tramadol 50 mg Capsules’).
Drug Withdrawal
When you stop taking Tramadol 50 mg Capsules, 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 50 mg Capsules, 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, 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 50 mg Capsules
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. The expiry date refers to the last day of that month.
Do not store above 30ºC.
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 50 mg Capsules contain
The active substance is called tramadol hydrochloride. Each capsule contains 50 mg of tramadol hydrochloride. The other ingredients are calcium hydrogen phosphate (dihydrate), magnesium stearate and silica (colloidal anhydrous).
The capsule is made of gelatine and contains the colour titanium dioxide (E171).
The printing ink contains the ingredients shellac (E904), black iron oxide (E172), soya lecithin (E322) and antifoam (DC 1510).
What Tramadol 50 mg Capsules look like and the contents of the pack
Tramadol 50 mg capsules are all white and have 'TR50' printed on the outside. They are packed in blister strips and supplied in boxes of 30 or 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RP, UK.
Product Licence Number: PL 20395/0065.
This leaflet was last revised in September 2026.
170 mm
170 mm
PRODUCT NAME
PRODUCT LICENCE NO.
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PACK SIZE
FONT & SIZE
REMARKS
REASON FOR CHANGE
COUNTRY
MANUFACTURER
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ARTIST
Tramadol 50 mg Capsules
20395-0065
PIL
170 x 550 mm
50 mg
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Humanst521 BT (14pt & 9pt)
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Comments received from Ramakrishna on 03.09.2026.
UK (English)
Bafna
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VERSION XXXXXX DATE 03.09.2026