Brimisol PR® 100 mg and 200 mg – patient leaflet, side effects, dosage

1. What Brimisol PR is and what it is used for

The name of your medicine is Brimisol PR 100 mg and 200 mg Prolonged-release Tablets. Hereafter referred to as Brimisol PR in the entire leaflet. This medicine has been prescribed for the treatment of moderate to severe pain. It contains tramadol which belongs to a class of medicines called opioids, which are “pain relievers”. This medicine act on specific nerves in the brain and spinal cord to relieve 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.

2. What you need to know before you take Brimisol PR

Do not take Brimisol PR:

• if you are allergic to Tramadol or any of the other ingredients of this medicine (listed in section 6). • in acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions);

  • if you are also taking MAO inhibitors (certain medicines used for treatment of depression, examples include tranylcypromide, phenelzine and moclobemide) or have taken them in the last 14 days before treatment with Brimisol PR (see “Other medicines and Brimisol PR”);
  • if you are an epileptic and your fits are not adequately controlled by treatment;
  • as a substitute in drug withdrawal;

Warnings and Precautions

Talk to your doctor or pharmacist before taking Brimisol PR

• are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
• feel you need to take more of Brimisol PR 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.
• if you suffer from consciousness disorders (if you feel that you are going to faint);
• if you are in a state of shock (cold sweat may be a sign of this);
• if you suffer from increased pressure in the brain (possibly after a head injury or brain disease); • if you have difficulty in breathing;
• if you have a tendency towards epilepsy or fits because the risk of a fit may increase;
• if you suffer from a liver or kidney disease;
• if you suffer from depression and you are taking antidepressants as some of them may interact with tramadol (see ‘Other medicines and Brimisol PR’)
• you are going to have an operation, or have just had an operation, please tell your doctor that you are taking Brimisol PR. Brimisol PR should not be taken for short-term pain relief after surgery because it may increase the risk of dependence and breathing problems.

Sleep-related breathing disorders

This medicine can cause sleep-related breathing disorders , for e.g. central sleep apnea (shallow/pause of breathing 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.

The risk of experiencing central sleep apnoea is dependent on the dose of opioids. Your doctor may consider decreasing your total opioid dosage if you experience central sleep apnoea.

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.

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 Brimisol PR 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 Brimisol PR 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.

If you notice any of the following signs whilst taking Brimisol PR, it could be a sign that you have become dependent or addicted: - You need to take the medicine for longer than advised by your doctor

• You need to take more than the recommended dose
• You are using the medicine for reasons other than prescribed, for instance, ‘to stay calm’ or ‘help you sleep’ - You have made repeated, unsuccessful attempts to quit or control the use of the medicine
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again (‘withdrawal effects’)

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 Brimisol PR).

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

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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 or pharmacist or nurse if you experience any of the following symptoms while taking this medicine: 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.

Other medicines and Brimisol PR

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Brimisol PR should not be taken together with MAO inhibitors (certain medicines for the treatment of depression) because Serotonin Syndrome (diarrhoea, fast heart beat, sweating, tremor, confusion and coma) may develop.

The pain-relieving effect of Brimisol PR 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).

Your doctor will tell you whether you should take Brimisol PR, and what dose.

The risk of side effects increases, if you are taking:

• other pain relievers such as morphine and codeine (also as cough medicine), and alcohol while you are taking Brimisol PR. You may feel drowsier or feel that you might faint. If this happens tell your doctor.
• concomitant use of Brimisol PR and tranquillizers, sleeping pills ( e.g. benzodiazepines ), or other sedatives or medicines that impair breathing activity (e.g. opioids) or gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma or 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 Brimisol PR 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 which may cause convulsions (fits), such as certain antidepressants (e.g. venlafaxine) or antipsychotics. The risk of having a fit may increase if you take Brimisol PR at the same time as those medicines. Your doctor will tell you whether Brimisol PR is suitable for you;
• certain antidepressants, Brimisol PR may interact with these medicines and you may experience serotonin syndrome (see section 4 ‘Possible side effects’).
• coumarin anticoagulants (medicines for blood thinning), e.g. warfarin, together with Brimisol PR. The effect of these medicines on blood clotting may be affected and bleeding may occur;
• 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.

Do not use Brimisol PR for acute post operative pain because of the increased risk of dependency and developing serious breathing problems.

If you are going to have an operation, or have just had an operation, please tell the doctor at the hospital if are taking Brimisol PR. Your doctor may adjust your dose.

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.

Brimisol PR with food, drink and alcohol

Do not drink alcohol during treatment with Brimisol PR as its effect may be intensified. Food does not influence the effect of Brimisol PR.

Pregnancy, breast-feeding and fertility

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.

Pregnancy

Do not take Brimisol PR 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 Brimisol PR during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated. Breast-feeding

Do not take Brimisol PR while you are breast-feeding as tramadol passes into breast milk and will affect your baby. Fertility

Based on human experience tramadol is suggested not to influence female or male fertility.

Driving and using machines

Brimisol PR 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.

This 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.

Brimisol PR contains Lactose

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 Brimisol PR

Always take this medicine exactly as your doctor or pharmacist 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. Do not take more than 400mg of Brimisol PR daily, except if your doctor has instructed you to do so. Unless otherwise prescribed by your doctor, the usual dose is:

Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using Brimisol PR, 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).

Adults and adolescents from the age of 12 years

One Brimisol PR 100 mg prolonged-release tablet twice daily (equivalent to 200 mg tramadol hydrochloride per day), preferably in the morning and evening.

One Brimisol PR 200 mg prolonged-release tablet 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 prolonged release tramadol 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 under 12 years of age

Brimisol PR is not suitable for children below the age of 12 years of age.

Elderly

In elderly people (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 Brimisol PR.

If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

Route and method of administration

Brimisol PR are for oral use. Always swallow Brimisol PR tablets whole, not divided or chewed, with sufficient liquid, preferably in the morning and evening. You may take the tablets on an empty stomach or with meals.

Duration of treatment

You should not take Brimisol PR 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 Brimisol PR and at what dose. If you have the impression that the effect of Brimisol PR is too strong or too weak, talk to your doctor or pharmacist.

If you take more Brimisol PR 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 Brimisol PR tablets at the same time you should go to hospital or call a doctor straight away. Signs of an overdose include pinpoint pupils, vomiting, a fall in blood pressure, a fast heart beat, collapse, disturbed consciousness up to coma (deep unconsciousness), epileptic fits, and difficulty in breathing up to cessation of breathing and death may occur. In such cases a doctor should be called immediately.

If you forget to take Brimisol PR

If you forget to take the tablets, pain is likely to return. Do not take a double dose to make up for forgotten individual doses; simply continue taking the tablets as before.

If you stop taking Brimisol PR

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 Brimisol PR is stopped. However, on rare occasions, people who have been taking Brimisol PR for some time may feel unwell if they abruptly stop taking them. They may feel agitated, anxious, nervous or shaky. They may be confused, hyperactive, have difficulty sleeping and have stomach or bowel disorders. Very few people may get panic attacks, delusions, paranoia, hallucinations or feeling a loss of identity. They may experience unusual perceptions such as itching, tingling and numbness, an “ringing” in the ears (tinnitus). Further unusual CNS symptoms, i.e. confusion, delusions, change of perception of the own personality (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 Brimisol PR, 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.

STOP TAKING this medicine and tell your doctor immediately if you suffer from any of the following:

• anaphylactic reaction (an extreme allergic reaction resulting in difficulty breathing, changes in heart rate, faintness, collapse or unconsciousness due to a drop in blood pressure)

  • convulsions (fits). 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.

Very common (may affect more than 1 in 10 people)

• dizziness
• feeling sick (nausea)

Common (may affect up to 1 in 10 people)

• headache
• drowsiness, sleepiness (fatigue)
• constipation, dry mouth, being sick (vomiting)
• sweating (hyperhidrosis)

Uncommon (may affect up to 1 in 100 people)

• 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.
• skin reactions (e.g. itching, rash)
• urge to be sick (retching), stomach trouble (e.g. feeling of pressure in the stomach, bloating), diarrhoea

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 disorder.
• changes in appetite
• hallucination, confusion, sleep disorders, delirium, anxiety and nightmares
• psychological complaints may appear after treatment with Brimisol PR. 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

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  Not known (frequency cannot be estimated from the available data)

  • Hiccups
  • decrease in blood sugar level
  • dependence and addiction (see section “How do I know if I am addicted?”).
  • 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 Brismiol PR’).

Drug Withdrawal

When you stop taking this medicine, 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 Brimisol PR, 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 Website: 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 Brimisol PR

• 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 store above 25⁰C.
• Do not use this medicine after the expiry date (EXP) which is stated on the carton. 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.

6. Contents of the pack and other information

What Brimisol PR contain

Brimisol PR come in two strengths containing 100 mg or 200 mg of the active ingredient Tramadol Hydrochloride.

The other ingredients are:

Tablet Core: Lactose Monohydrate, Microcyrstalline Cellulose, Hypromellose, Colloidal Anhydrous Silica and Magnesium Stearate.

Film Coating: Hypromellose, Macrogol 6000, Purified Talc and Titanium dioxide (E171). Each 200 mg prolonged release tablet also contains Quinoline yellow lake (E104) and Ferric oxide red (E172).

What Brimisol PR looks like and contents of the pack

• Brimisol PR 100 mg tablets are white to off white, round, biconvex film coated tablets with ‘100’ debossed on one side and “BL” on other side.
• Brimisol PR 200 mg tablets are light orange to light pink, round, biconvex film coated tablets with ‘200’ debossed on one side and “BL” on other side.
• Brimisol PR is available in packs of 30 or 60 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Name and address: Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom

Telephone: 0044 (0)1442 200922

E-mail: info@bristol-labs.co.uk

Manufacturer:

Bristol Laboratories Ltd.

Unit 5, Traynor Way, Whitehouse Business Park,

Peterlee, SR8 2RU, United Kingdom

Brimisol PR 100 mg Tablets; PL 17907/0134

Brimisol PR 200 mg Tablets; PL 17907/0136

This leaflet was last revised in October 2025

To request a copy of this leaflet in braille, large print or audio format, please contact the licence holder at the address (telephone or email) above.

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