Patient leaflet - Tramadol Hydrochloride/paracetamol 37.5/325 mg film-coated tablets
1. What Tramadol/Paracetamol is and what it is used for
This medicine has been prescribed for you for moderate to severe pain when your doctor recommends that a combination of tramadol hydrochloride and paracetamol is needed. 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.
2. What you need to know before you take Tramadol/Paracetamol
Do not take Tramadol/Paracetamol
- 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/Paracetamol. 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 before taking Tramadol/Paracetamol if you;
- take other medicines containing paracetamol or tramadol hydrochloride;
- 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 Tramadol/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.
- have liver problems or disease as your eyes and skin may turn yellow, which may suggest jaundice;
- have kidney problems;
- have severe difficulties in breathing, for example asthma or severe lung problems
- have epilepsy or have already experienced fits or seizures;
- have recently suffered from a head injury, shock or severe headaches associated with vomiting (being sick);
- are dependent on any medicine (for example morphine);
- take other medicines to treat pain that contain buprenorphine, nalbuphine or pentazocine;
- are going to have an anaesthetic (tell your doctor or dentist that you are taking Tramadol/Paracetamol).
- suffer from depression and you are taking antidepressants as some of them may interact with tramadol (see ‘Other medicines and Tramadol/Paracetamol’).
- have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick (nausea) and being sick (vomiting).
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’).
Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Tramadol/Paracetamol:
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.
Sleep-related breathing disorders
Tramadol/Paracetamol 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.
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.
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/Paracetamol 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/Paracetamol 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 Tramadol/Paracetamol, 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 Tramadol/Paracetamol).
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.
If any of the above-mentioned points applied to you in the past or applies to you while you are taking Tramadol/Paracetamol, please make sure your doctor knows. He/she can then decide whether you should continue to use this medicine.
Children and adolescents
This medicine is not recommended for children under 12 years of age.
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/Paracetamol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
- flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (high anion gap metabolic acidosis) that must have urgent treatment (see section 2).Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).
Do not exceed the maximum daily doses of paracetamol or tramadol from this or other medicines.
Do not take Tramadol/Paracetamol with MAOIs (see section ‘Do not take Tramadol/Paracetamol’).
Tramadol/Paracetamol is not recommended to be taken with the following:
- carbamazepine (a medicine used to treat epilepsy or some types of pain);
- buprenorphine, nalbuphine or pentazocine (opioid-type pain relievers).
The risk of side effects increases:
- if you are taking triptans (used for migraine) or selective serotonin re-uptake inhibitors (SSRIs, used for depression). Check with your doctor if you experience confusion, restlessness, fever, sweating, uncoordinated movement of limbs or eyes, uncontrollable jerking of muscles or diarrhoea.
if you are taking tranquilizers, sleeping pills, other pain relievers such as morphine and codeine (also as cough medicine), baclofen (a muscle relaxant), medicines used to lower blood pressure or medicines to treat allergies. Check with your doctor if you feel drowsy or feel faint. Concomitant use of Tramadol/Paracetamol and sedative medicines such as benzodiazepines or
- hing (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 does prescribe Tramadol/Paracetamol together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative 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.
- if you are taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk of having a fit may increase if you take Tramadol/Paracetamol at the same time. Your doctor will tell you whether Tramadol/Paracetamol is suitable for you.
- if you are taking certain antidepressants. Tramadol/Paracetamol may interact with these medicines and you may experience serotonin syndrome (see section 4 ‘Possible side effects’);
- if you are taking warfarin or phenprocoumon (for blood thinning). The effectiveness of such medicines may be altered and bleeding may occur (see section 4).
The effectiveness of Tramadol/Paracetamol may be altered if you also take:
- metoclopramide, domperidone or ondansetron (medicines used to treat nausea and vomiting/being sick);
- cholestyramine (medicine used to reduce cholesterol in the blood).
Tramadol/Paracetamol with food and alcohol
Do not drink alcohol while you are taking Tramadol/Paracetamol, as you may feel drowsier.
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.
Do not take Tramadol/Paracetamol while you are pregnant or breast-feeding.
Check with your doctor if you become pregnant during treatment with Tramadol/Paracetamol and before taking any further tablets.
Breast-feeding
Tramadol is excreted into breast milk. For this reason, you should not take Tramadol/Paracetamol more than once during breast-feeding, or alternatively, if you take Tramadol/Paracetamol more than once, you should stop breast-feeding.
Based on human experience tramadol is suggested not to influence female or male fertility. No data on the influence of the combination of tramadol and paracetamol on fertility are available.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If you feel drowsy while taking Tramadol/Paracetamol, do not drive, use tools or use 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.
Important information about Tramadol/Paracetamol
This medicine contains less than 1 mmol sodium (23 mg) per tablet that is to say essentially ‘sodium-free’.
3. How to Take Tramadol/Paracetamol
Your prescriber should have discussed with you, how long the course of Tramadol/Paracetamol will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.
Always take this medicine exactly as you 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/Paracetamol, 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 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/Paracetamol for as short a time as possible as 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/Paracetamol. 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/Paracetamol 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/Paracetamol 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/Paracetamol
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/Paracetamol
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 experience any of these complaints after stopping this medicine, please contact your doctor. Other side effect information is listed in section 4.
4. Possible side effects
Like all medicines, this medicine can cause side effects, however 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/Paracetamol 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
- difficulty or pain on passing water
- 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
- increase in liver enzyme values
- difficulty swallowing, blood in the stools
- shivering, hot flushes, pain in the chest
- difficulty breathing.
Rare: may affect up to 1 in 1,000 people
- fits, uncoordinated movements, transient loss of consciousness (syncope)
- drug dependence
- delirium
- vision blurred, constriction of the pupil (miosis)
- speech disorders
- excessive dilation of the pupils (mydriasis)
Unknown: frequency unknown
- 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/Paracetamol’).
- A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2).
Drug Withdrawal
When you stop taking Tramadol/Paracetamol, 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/Paracetamol, 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 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/Paracetamol
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 use this medicine after the expiry date which is printed on the carton and blister. 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 medicine via waste water 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/Paracetamol Tablets contain
The active substances are tramadol hydrochloride and paracetamol.
Each tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol.
The other ingredients are:
- Tablet core: pregelatinised starch, sodium starch glycolate, microcrystalline cellulose and magnesium stearate.
- Tablet coating: hypromellose, titanium dioxide (E171), macrogol 400, iron oxide yellow (E172) and polysorbate 80.
What Tramadol/Paracetamol Tablets look like and contents of the pack
Tramadol/Paracetamol Tablets are yellow coloured, elongated, film-coated tablets with “325” debossed on one side and “37.5” debossed on other side.
Tramadol/Paracetamol Tablets are packed in white PVC/PVDC/aluminium blister packs of 10 tablets and are available in boxes of 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Morningside Healthcare Ltd.
Unit C, Harcourt Way, Leicester, LE19 1WP, UK
Manufacturer
Morningside Pharmaceuticals Ltd.
5 Pavilion Way, Loughborough, LE11 5GW, UK