Patient leaflet - TRAMADOL HYDROCHLORIDE NOUMED 100 MG PROLONGED-RELEASE CAPSULES
2. What you need to know before you take Tramadol Hydrochloride Prolonged Release Capsules
3. How to take Tramadol Hydrochloride Prolonged Release Capsules
4. Possible Side effects
5. How to store Tramadol Hydrochloride Prolonged Release Capsules
6. Contents of the pack and other information
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1. What Tramadol Hydrochloride Prolonged Release capsules are and what they are used for
This medicine has been prescribed for you for the treatment of moderate to severe pain It contains the 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. what you need to know before you take tramadol hydrochloride prolonged release capsules
Do not take Tramadol Hydrochloride Prolonged Release Capsules:
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– if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6);
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– in acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions);
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– if you are also taking MAO inhibitors (certain medicines used for treatment of depression) or have taken them in the last 14 days before treatment with Tramadol Hydrochloride Prolonged Release Capsules (see “Taking Other medicines”);
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– if you are an epileptic and your fits are not adequately controlled by treatment
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– as a substitute in drug withdrawal.
Warnings and precautions
Sleep-related breathing disorders
Tramadol Hydrochloride Prolonged Release Capsules 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 before taking Tramadol Hydrochloride Prolonged Release Capsules
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– if you think that you are addicted to other pain relievers (opioids);
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– if you suffer from consciousness disorders (if you feel that you are going to faint);
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– if you are in a state of shock (cold sweat may be a sign of this);
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– if you suffer from increased pressure in the brain (possibly after a head injury or brain disease);
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– if you have difficulty in breathing;
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– if you have a tendency towards epilepsy or fits because the risk of a fit may increase;
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– if you suffer from a liver or kidney disease;
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– if you are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
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– If you have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
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– If you feel you need to take more of Tramadol hydrochloride Prolonged Release capsules 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.
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– If you 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.
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– If you suffer from depression and you are taking antidepressants as some of them may interact with tramadol (see ‘Other medicines and Tramadol Hydrochloride Prolonged Release Capsules’)
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.
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’).
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.
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).
Please note that Tramadol Hydrochloride Prolonged Release Capsules may lead to physical and psychological addiction. When Tramadol Hydrochloride Prolonged Release Capsules 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 Hydrochloride Prolonged Release Capsules 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 Tramadol Hydrochloride Prolonged Release Capsules treatment or if they applied to you in the past.
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.
Other medicines and Tramadol Hydrochloride Prolonged Release Capsules
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Tramadol Hydrochloride Prolonged Release Capsules should not be taken together with MAO inhibitors (certain medicines for the treatment of depression).
The pain-relieving effect of Tramadol Hydrochloride Prolonged Release Capsules may be reduced and the length of time it acts may be shortened, if you take medicines which contain – carbamazepine (for epileptic fits);
- pentazocine, nalbuphine or buprenorphine (pain relievers);
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– ondansetron (prevents nausea).
Your doctor will tell you whether you should take Tramadol Hydrochloride Prolonged Release Capsules, and what dose.
The risk of side effects increases,
- if you are taking tranquillizers, sleeping pills, other pain relievers such as morphine and codeine (also as cough medicine), and alcohol while you are taking Tramadol Hydrochloride Prolonged Release Capsules. You may feel drowsier or feel that you might faint. If this happens tell your doctor.
- if you are taking medicines which may cause convulsions (fits), such as certain antidepressants. The risk having a fit may increase if you take Tramadol Hydrochloride Prolonged Release Capsules at the same time. Your doctor will tell you whether Tramadol Hydrochloride Prolonged Release Capsules are suitable for you.
- if you are taking certain antidepressants, Tramadol Hydrochloride Prolonged Release Capsules may interact with these medicines and you may experience serotonin syndrome (see section 4 ‘Possible side effects’).
- if you are taking coumarin anticoagulants (medicines for blood thinning), e.g. warfarin, together with Tramadol Hydrochloride Prolonged Release Capsules. The effect of these medicines on blood clotting may be affected and bleeding may occur.
Tramadol Hydrochloride Prolonged Release Capsules with food and alcohol
Do not drink alcohol during treatment with Tramadol Hydrochloride Prolonged Release Capsules as its effect may be intensified.
Food does not influence the effect of Tramadol Hydrochloride Prolonged Release Capsules.
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.
Pregnancy and breast-feeding
Do not take Tramadol hydrochloride prolonged release 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 hydrochloride prolonged release 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 hydrochloride prolonged release capsules while you are breastfeeding 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.
Driving and using machines
Tramadol Hydrochloride Prolonged Release 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 other vehicle, do not use electric tools or operate machinery, and do not work without a firm hold.
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:
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– The medicine has been prescribed to treat a medical or dental problem and
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– You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
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– 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 hydrochloride prolonged release capsules
Always take this Tramadol Hydrochloride Prolonged Release Capsules 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 Tramadol hydrochloride prolonged release 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. Do not take more than 400 mg Tramadol Hydrochloride Prolonged Release Capsules daily, except if your doctor has instructed you to do so.
Unless otherwise prescribed by your doctor, the usual dose is: Adults and adolescents from the age of 12 years
One Tramadol Hydrochloride 100 mg Prolonged Release Capsules twice daily (equivalent to 200 mg tramadol hydrochloride per day), preferably in the morning and evening.
One Tramadol Hydrochloride 150 mg Prolonged Release Capsules twice daily (equivalent to 300 mg tramadol hydrochloride per day), preferably in the morning and evening.
One Tramadol Hydrochloride 200 mg Prolonged Release Capsules twice daily (equivalent to 400 mg tramadol hydrochloride per day), preferably in the morning and evening.
Your doctor may prescribe a different, more appropriate dosage strength of Tramadol Hydrochloride Prolonged Release Capsules if necessary.
If necessary, the dose may be increased up to 150 mg or 200 mg twice daily (equivalent to 300 mg – 400 mg tramadol hydrochloride per day).
Children
Tramadol Hydrochloride Prolonged Release Capsules are not suitable for children below the age of 12 years.
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
Patients with severe liver and/or kidney insufficiency should not take Tramadol Hydrochloride Prolonged Release Capsules. 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 Hydrochloride Prolonged Release Capsules?
Tramadol Hydrochloride Prolonged Release Capsules are for oral use.
Always swallow Tramadol Hydrochloride Prolonged Release Capsules whole, not divided or chewed, with sufficient liquid, preferably in the morning and evening. You may take the capsule on an empty stomach or with meals.
How long should you take Tramadol Hydrochloride Prolonged Release Capsules?
You should not take Tramadol Hydrochloride Prolonged Release Capsules 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 Hydrochloride Prolonged Release Capsules and at what dose.
If you have the impression that the effect of Tramadol Hydrochloride Prolonged Release Capsules is too strong or too weak, talk to your doctor or pharmacist.
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If you take more Tramadol Hydrochloride Prolonged Release Capsules 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.
If you (or someone else) swallow a lot of Tramadol Hydrochloride Prolonged Release Capsules 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, fall in blood pressure, fast heartbeat, collapse, unconsciousness, fits and breathing difficulties or shallow breathing.
If you forget to take Tramadol Hydrochloride Prolonged Release Capsules
If you forget to take the capsule, pain is likely to return. Do not take a double dose to make up for forgotten individual doses, simply continue taking the capsule as before.
If you stop taking Tramadol Hydrochloride Prolonged Release Capsules
If you interrupt or finish treatment with Tramadol Hydrochloride Capsules too soon, pain is likely to return. If you wish to stop treatment on account of unpleasant effects, please tell your doctor.
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.
Generally there will be no after-effects when treatment with Tramadol Hydrochloride Prolonged Release Capsules. However, on rare occasions, people who have been taking Tramadol Hydrochloride Prolonged Release Capsules 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 “ringing” in the ears (tinnitus). Further unusual CNS symptoms, i.e. confusion, delusions, change of perception of the own personaility (depersonalisation), and change in perception of reality (derealisation) and delusion of persecution (paranoia) have been seen very rarely. If you experience any of these complaints after stopping Tramadol Hydrochloride Prolonged Release Capsules, please consult your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In case one of the following situations occur, see your doctor straight away:
- allergic reactions e.g. difficulty in breathing, wheezing, swelling of skin (occurs rarely),
- swollen face, tongue and/or throat and/or difficulty to swallow or hives together with difficulties in breathing (occurs rarely),
- shock/sudden circulation failure (occurs rarely)
Usually the frequency of side effects is classified as follows: – very common (more than 1 out of 10 persons), – common (more than 1 out of 100 persons), – uncommon (more than 1 out 1,000 persons), – rare (more than 1 out of 10,000 persons) – very rare (less than 1 out of 10,000 persons).
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– not known: frequency cannot be estimated from the available data
The most common side effects during treatment with Tramadol Hydrochloride Prolonged Release Capsules are nausea and dizziness, which occur in more than 1 out of 10 patients.
Heart and blood circulation disorders
Uncommon: effects on the heart and blood circulation (pounding of the heart, fast heart beat, feeling faint or collapse). These adverse effects may particularly occur in patients in an upright position or under physical strain.
Rare: slow heart beat, increase in blood pressure.
Nervous system disorders
Very common: dizziness.
Common: headaches, drowsiness.
Rare: changes in appetite, abnormal sensations (e.g. itching, tingling, numbness), trembling, slow breathing, epileptic fits, muscle twitches, uncoordinated movement, transient loss of consciousness (syncope).
If the recommended doses are exceeded, or if other medicines that depress brain function are taken at the same time, breathing may slow down.
Epileptics 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.
Not known: 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 Hydrochloride Prolonged Release Capsules’). Psychiatric disorders
Rare: hallucinations, confusion, sleep disorders, anxiety and nightmares.
Psychological complaints may appear after treatment with Tramadol Hydrochloride Prolonged Release Capsules. Thein 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 (slowing down but sometimes an increase in activity) and being less aware and less able to make decisions, which may lead to errors in judgement.
Dependence may occur.
Unknown frequency: dependence and addiction (see section “How do I know if I am addicted?”)
Drug Withdrawal
When you stop taking Tramadol Hydrochloride Prolonged Release 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 Hydrochloride Prolonged Release Capsules, it could be a sign that you have become addicted.
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– You need to take the medicine for longer than advised by your prescriber
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– You feel you need to use more than the recommended dose
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– 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
5. how to store tramadol hydrochloride prolonged release capsules
Keep 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 blister. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. contents of the pack and other information
What Tramadol Hydrochloride Prolonged Release Capsules contain
50 mg
Each prolonged release capsule contains Tramadol Hydrochloride 50 mg.
The other ingredients are: Hypromellose, Cellulose microcrystalline, Silica, colloidal anhydrous and Magnesium stearate.
Tramadol Hydrochloride Noumed 50mg capsule shell contains gelatin, titanium dioxide, iron oxide yellow and Patent Blue V. The printing ink is composed of: Shellac, Black Iron Oxide, Potassium Hydroxide.
100 mg
Each prolonged release capsule contains Tramadol Hydrochloride 100 mg.
The other ingredients are: Hypromellose, Cellulose microcrystalline, Silica, colloidal anhydrous and Magnesium stearate.
Tramadol Hydrochloride Noumed 100mg capsule shell contains titanium dioxide and gelatin.
The printing ink is composed of: Shellac, Black Iron Oxide, Potassium Hydroxide.
150 mg
Each prolonged release capsule contains Tramadol Hydrochloride 150 mg.
The other ingredients are: Hypromellose, Cellulose microcrystalline, Silica, colloidal anhydrous and Magnesium stearate.
Tramadol Hydrochloride Noumed 150mg capsule shell contains titanium dioxide, gelatin and indigotine.
The printing ink is composed of: Shellac, Black Iron Oxide, Potassium Hydroxide.
200 mg
Each prolonged release capsule contains Tramadol Hydrochloride 200 mg.
The other ingredients are: Hypromellose, Cellulose microcrystalline, Silica, colloidal anhydrous and Magnesium stearate.
Tramadol Hydrochloride Noumed 200mg capsule shell contains titanium dioxide, gelatin and iron oxide yellow.
The printing ink is composed of: Shellac, Black Iron Oxide, Potassium Hydroxide.
What Tramadol Hydrochloride Prolonged Release Capsules look like and contents of the pack
50 mg:
Hard gelatin capsule of size ‘1’ with yellow opaque cap marked ‘50SR’ with black color and yellowish green opaque body.
100 mg:
Hard gelatin capsule of size ‘1’ with white opaque cap marked ‘100SR’ with black color and white opaque body.
150 mg:
Hard gelatin capsule of size ‘1’ with dark green opaque cap marked ‘150SR’ with black color and dark green opaque body.
200 mg:
Hard gelatin capsule of size ‘1’ with yellow cap marked ‘200SR’ with black color and yellow body.
Tramadol Hydrochloride Noumed 50 mg Prolonged Release Capsules are available in Alu/PVC-PVDC blister pack of 30, 60 or 100 capsules and also available in HDPE bottle pack contains 500’s and 1000’s capsules.
Tramadol Hydrochloride Noumed 100 mg, 150 mg and 200 mg Prolonged Release Capsules are available in Alu/PVC-PVDC blister pack of 10, 30 or 60 capsules and also available in HDPE bottle pack contains 500’s and 1000’s capsules.
Not all pack sizes may be marketed. | pqm|
Marketing Authorisation Holder and Manufacturer
N Noumed Life Sciences Limited
Noumed House, Shoppenhangers Road M Maidenhead, Berkshire SL6 2RB, UK
This leaflet was last revised in July 2021
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Please be ready to give the following information: Product name: Tramadol Hydrochloride Noumed 50 mg Prolonged Release Capsules
Reference number: PL 44041/0190
Product name: Tramadol Hydrochloride Noumed 100 mg Prolonged Release Capsules
Reference number: PL 44041/0191
Product name: Tramadol Hydrochloride 150 mg Noumed Prolonged Release Capsules Reference number: PL 44041/0192
Product name: Tramadol Hydrochloride 200 mg Noumed Prolonged Release Capsules Reference number: PL 44041/0193
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