Patient leaflet - Tramadol Hydrochloride / Paracetamol Brown & Burk 37.5 mg / 325 mg film-coated tablets
1. What Tramadol hydrochloride / Paracetamol Brown & Burk 37.5 mg / 325 mg film-coated tablets is and what it is 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 also contains paracetamol, another type of pain reliever. 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 / Paracetamol Brown & Burk 37.5 mg / 325 mg film-coated tablets
Do not take Tramadol hydrochloride / Paracetamol Brown & Burk 37.5 mg / 325 mg film-coated tablets
! if you are allergic to tramadol hydrochloride, paracetamol or any of the other ingredients of this
medicine (listed in section 6)
! in cases of acute alcohol poisoning
! if you are taking sleeping pills, pain relievers or medicines that affect mood and emotions ! if you are also taking medicines called monoamine oxidase inhibitors (MAOIs) or have taken
MAOIs in the last 14 days before treatment with Tramadol hydrochloride + Paracetamol Brown & Burk 37.5 mg + 325 mg film coated tablet. MAOIs are used in the treatment of depression or Parkinson's disease.
! if you have a severe liver disorder
! if you have epilepsy that is not adequately controlled by your current medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tramadol hydrochloride / Paracetamol Brown & Burk 37.5 mg / 325 mg film-coated tablets
! if you take other medicines containing paracetamol or tramadol
! if you have liver problems or disease as your eyes and skin may turn yellow, which may suggest
jaundice
! if you have kidney problems
! if you have severe difficulties in breathing, for example asthma or severe lung problems ! if you have epilepsy or have already experienced fits or seizures
! if you have recently suffered from a head injury, shock or severe headaches associated with
vomiting (being sick)
! if you take other medicines to treat pain that contain buprenorphine, nalbuphine or pentazocine ! if you are going to have an anaesthetic (tell your doctor or dentist that you are taking Tramadol
hydrochloride / Paracetamol Brown & Burk 37.5 mg / 325 mg film-coated tablets) ! if you are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs ! if you 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 Tramadol hydrochloride/ Paracetamol 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 depression and you are taking antidepressants as some of them may interact
with tramadol (see 'Other medicines and Tramadol hydrochloride / Paracetamol Brown & Burk 37.5 mg / 325 mg film-coated tablets').
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.
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').
Sleep-related breathing disorders
Tramadol hydrochloride / Paracetamol Brown & Burk 37.5 mg / 325 mg film-coated tablets contains an active substance that belongs to the group of opioids. Tramadol hydrochloride / Paracetamol can cause sleep-related breathing disorders such as sleep apnoea ( breathing pauses during sleep) and sleep-related hypoxemia (low level of oxygen in the blood). The
Size: 240(L) x 420(W) mm
Front Side
Size: 240(L) x 420(W) mm
Back Side
Tramadol hydrochloride / Paracetamol Brown & Burk
37.5 mg / 325 mg film-coated tablets
(tramadol hydrochloride/paracetamol) Package Leaflet: Information for the user
240 mm
Folding here
240 mm
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.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
3. How to take Tramadol hydrochloride / Paracetamol Brown & Burk 37.5 mg / 325 mg film-coated tablets
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 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.
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.
Take Tramadol hydrochloride / Paracetamol Brown & Burk 37.5 mg / 325 mg film-coated tablets for as short a time as possible and no longer than your doctor has told you.
Adults and adolescents over 12 years:
The recommended starting dose unless otherwise prescribed by your doctor is 2 tablets for adults and adolescents over 12 years. If required, further doses may be taken, as instructed by your doctor.
The shortest time between doses must be at least 6 hours.
Do not take more than 8 tablets per day.
Children under 12 years of age:
! not recommended.
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 / Paracetamol Brown & Burk 37.5 mg / 325 mg film-coated tablets. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.
Method of administration:
The tablets are for oral use.
Swallow the tablets whole with sufficient liquid.
Do not break or chew the tablets.
If you think that the effect of Tramadol hydrochloride / Paracetamol Brown & Burk 37.5 mg / 325 mg film-coated tablets is too strong (you feel very drowsy or have difficulty breathing) or too weak (you do not have enough pain relief), contact your doctor.
If you take more Tramadol hydrochloride / Paracetamol Brown & Burk 37.5 mg / 325 mg film-coated tablets than you should
Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.
If you forget to take Tramadol hydrochloride / Paracetamol Brown & Burk 37.5 mg / 325 mg film-coated tablets
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 Tramadol hydrochloride / Paracetamol Brown & Burk 37.5 mg / 325 mg film-coated tablets
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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects could be serious. Contact your doctor immediately if any of the following occur:
! rarely cases of skin rash, indicating an allergic reaction, may develop with sudden swelling of
the face and neck, difficulties breathing or drop of blood pressure and fainting. If this happens to you, stop treatment. Do not take the medicine again.
! prolonged or unexpected bleeding, from the use of Tramadol hydrochloride / Paracetamol
Brown & Burk 37.5 mg / 325 mg film-coated tablets with medicines used to thin the blood (e.g. warfarin, phenprocoumon).
Additionally, if any of the following side effects get serious, contact your doctor or pharmacist:
Very common: may affect more than 1 in 10 people
! nausea
! dizziness, drowsiness.
Common: may affect up to 1 in 10 people
! vomiting (being sick), digestion problems (constipation, flatulence, diarrhoea), stomach pain,
dry mouth
! itching, sweating (hyperhidrosis)
! headache, shaking
! confusional state, sleep disorders, mood changes (anxiety, nervousness, feeling of high spirits).
Uncommon: may affect up to 1 in 100 people
! increase in pulse or blood pressure, heart rate or heart rhythm disorders
! skin reactions (for example rashes, hives)
! tingling, numbness or feeling of pins and needles in the limbs, ringing in the ears, involuntary
muscle twitching
! depression, nightmares, hallucinations (hearing, seeing or sensing things that are not really
there), memory lapses
! difficulty swallowing, blood in the stools
! shivering, hot flushes, pain in the chest
! difficulty breathing
! increase in liver enzyme values
! presence of albumin in urine, difficulties or pain on passing urine
Rare: may affect up to 1 in 1,000 people
! fits, uncoordinated movements, transient loss of consciousness (syncope) ! delirium
! vision blurred, constriction of the pupil (miosis)
! speech disorders
! excessive dilation of the pupils (mydriasis)
Unknown: frequency cannot be estimated from the available data
! decrease in blood sugar level (hypoglycaemia)
! 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 hydrochloride / Paracetamol Brown & Burk 37.5 mg / 325 mg film-coated tablets').
Drug Withdrawal
When you stop taking Tramadol hydrochloride / Paracetamol Brown & Burk 37.5 mg / 325 mg film-coated tablets, 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 / Paracetamol Brown & Burk 37.5 mg / 325 mg film-coated tablets, 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.
In addition, the following side effects have been reported by people using medicines that contain only tramadol or only paracetamol:
! feeling faint when getting up from a lying or sitting position, slow heart rate, fainting ! changes in appetite
! muscle weakness, slower or weaker breathing
! mood changes, changes in activity, changes in perception
! worsening of existing asthma
! nose bleeds or bleeding gums, which may result from a low blood platelet count. ! very rare cases of serious skin reactions have been reported with paracetamol. ! rare cases of respiratory depression have been reported with tramadol.
Reporting of side effects
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 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 Tramadol hydrochloride / Paracetamol Brown & Burk 37.5 mg / 325 mg film-coated tablets.
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 pack after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 pack and other information
What Tramadol hydrochloride / Paracetamol Brown & Burk 37.5 mg / 325 mg film-coated tablets contains
The active substances are tramadol hydrochloride and paracetamol.
One (1) tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol.
The other ingredients are:
! Tablet core: Maize starch, Powdered cellulose, Sodium starch Glycolate (Type A),
Starch, Pregelatinised, Magnesium Stearate.
! Film-coating: Opadry light yellow YS-1-6382G containing Hypromellose 6cP, Hypromellose
3cP, Titanium dioxide (E171), Macrogol 400, Iron oxide yellow (E172), Polysorbate 80.
What Tramadol hydrochloride / Paracetamol Brown & Burk 37.5 mg / 325 mg film-coated tablets looks like and contents of the pack
Light yellow, oblong shaped, biconvex, film coated tablets debossed with “I 03” on one side and plain on the other side.
Supplied in blister packs of 2, 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100 tablets Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Brown & Burk UK Ltd
5 Marryat Close
Hounslow West
Middlesex
TW4 5DQ
UK.