Patient leaflet - MAROL 100 MG PROLONGED-RELEASE TABLETS
Marol 100 mg, 150 mg and 200 mg Prolonged Release Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
This medicine contains tramadol hydrochloride which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet :
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1. What Marol Tablets are and what they are used for.
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2. What you need to know before you take Marol Tablets.
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3. How to take Marol Tablets.
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4. Possible side effects.
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5. How to store Marol Tablets.
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6. Contents of the pack and other information.
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^1 ^ What Marol Tablets are and what they are used for
The name of your medicine is Marol 100 mg, 150 mg or 200 mg Prolonged-release Tablets.
This medicine has been prescribed for you for the treatment of moderate to severe 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.
Marol Prolonged-release tablets are referred to as Marol tablets below
2 what you need to know before you take marol tablets
Do not take Marol Tablets:
- If you are allergic to tramadol hydrochloride 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) or have taken them in the last 14 days before treatment with Marol Tablets (see “Other medicines and Marol Tablets”).
- If you are 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 Marol Tablets if:
- You are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs;
- You have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs;
- You feel you need to take more Marol Tablets 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;
- You suffer from depression and you are taking antidepressants as some of them may interact with tramadol (see ‘Other medicines and Marol Tablets’).
- You suffer from consciousness disorders (if you feel that you are going to faint);
- You are in a state of shock (cold sweat may be a sign of this);
- You suffer from increased pressure in the brain (possibly after a head injury or brain disease);
- You suffer from a liver or kidney disease;
- You have difficulty in breathing;
- You have a tendency towards epilepsy or fits because the risk of a fit may increase.
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’).
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 Marol Tablets may lead to physical and psychological addiction.
Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Marol Tablets:
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
Marol Tablets 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.
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.
Please also inform your doctor if one of these problems occurs during treatment with Marol Tablets or if they applied in the past.
Other medicines and Marol Tablets:
Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. Marol Tablets should not be taken together with MAO inhibitors (certain medicines for the treatment of depression).
Concomitant use of tramadol and sedative medicines such as benzodiazepines or related drugs 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 does prescribe Marol Tablets 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.
The pain relieving effect of Marol Tablets may be reduced and the length of time it acts may be shortened, if you also take medicines containing:
- Carbamazepine (for epileptic fits)
- Buprenorphine, nalbuphine, or pentazocine (pain killers)
- Ondansetron (prevents nausea)
Your doctor will tell you whether you should take Marol Tablets 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 Marol Tablets. You may feel drowsier or feel that you might faint. If this happens tell your doctor.
- Concomitant use of Marol Tablets and tranquillizers or sleeping pills (e.g. benzodiazepines), 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 Marol Tablets 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.
- 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 Marol Tablets at the same time. Your doctor will tell you whether Marol Tablets are suitable for you.
- if you take coumarin anticoagulants (medicines for blood thinning), such as warfarin, together with Marol Tablets. The effect of these medicines on blood clotting may be affected and bleeding may occur.
- if you take tranquillizers, sleeping pills, other pain relievers such as morphine and codeine (also as cough medicine), and alcohol while you are taking Marol Tablets. You may feel drowsier or feel that you might faint. If this happens tell your doctor.
- if you are taking certain antidepressants, Marol Tablets may interact with these medicines and you may experience serotonin syndrome (see section 4 ‘Possible side effects’).
Taking Marol Tablets with food and alcohol:
Do not drink alcohol during treatment with Marol Tablets as its effect may be intensified. Food does not influence the effect of Marol Tablets.
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, breast-feeding and fertility:
Do not take Marol Tablets 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 Marol Tablets during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Do not take Marol Tablets while you are breastfeeding as tramadol passes into breast milk and will affect your baby.
Driving and using machines:
Marol Tablets can 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.
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:
o The medicine has been prescribed to treat a medical or dental problem and
o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
o 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.
How to take Marol Tablets
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. 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.
Your prescriber should have discussed with you, how long the course of Marol 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.
Unless otherwise prescribed by your doctor, the recommended dose is:
Adults and adolescents from the age of 12 years:
One Marol 100mg Tablet twice daily (equivalent to 200 mg tramadol hydrochloride per day), preferably in the morning and evening.
One Marol 150mg Tablet twice daily (equivalent to 300 mg tramadol hydrochloride per day), preferably in the morning and evening.
One Marol 200mg 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 Marol Tablets if necessary.
Do not take more than 400 mg tramadol hydrochloride daily, except if your doctor has instructed you to do so.
Use in children
Marol Tablets 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 Marol Tablets. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.
How and when you should take Marol Tablets:
Marol Tablets are for oral use.
Always swallow Marol 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.
How long should you take Marol Tablets:
You should not take Marol Tablets 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 Marol Tablets and at what dose. If you have the impression that the effect of Marol Tablets is too strong or too weak, talk to your doctor or pharmacist.
If you take more Marol Tablets 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.
After taking very high doses, pin-point pupils, vomiting, fall in blood pressure, fast heart beat, collapse, disturbed consciousness up to coma (deep unconsciousness), epileptic fits, and difficulty in breathing up to cessation of breathing may occur. In such cases a doctor should be called immediately!
If you forget to take Marol Tablets
If you forgot 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 tablets as before.
If you stop taking Marol 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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Usually the frequency of side effects is classified as follows:
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– very common (may affect more than 1 in 10 people),
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– common (may affect up to 1 in 10 people),
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– uncommon (may affect up to 1 in 100 people),
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– rare (may affect up to 1 in 1,000 people)
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– very rare (may affect up to 1 user in 10,000)
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– not known (frequency cannot be estimated from the available data).
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 hives together with difficulties in breathing.
The most common side effects during treatment with Marol Tablets are nausea and dizziness, which occur in more than in 1 in 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.
Metabolism and nutrition disorders
Rare: changes in appetite
Not known: decrease in blood sugar level
Nervous system disorders
Very common: dizziness.
Common: headaches, drowsiness.
Rare : speech disorders, abnormal sensations (e.g. itching, tingling, numbness), trembling, epileptic fits, muscle twitches, uncoordinated movement, transient loss of consciousness (syncope).
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 Marol Tablets’).
If the recommended doses are exceeded, or if other medicines that depress brain function are taken at the same time, breathing may slow down.
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.
Psychiatric disorders
Rare: hallucinations, confusion, sleep disorders, delirium, anxiety and nightmares.
Psychological complaints may appear after treatment with Marol Tablets. 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 (slowing down but sometimes an increase in activity) and being less aware and less able to make decisions, which may lead to errors in judgment.
Not known: dependence and addiction (see section “How do I know if I am addicted?”).
Eye disorders
Rare: blurred vision, constriction of the pupils (miosis), extreme pupil dilation (mydriasis).
Respiratory disorders
Rare: slow breathing, shortness of breath (dyspnoea).
Worsening of asthma has been reported, however it has not been established whether it was caused by tramadol.
Not known: hiccups
Stomach and bowel disorders
Very common: feeling sick.
Common: being sick, constipation, dry mouth.
Uncommon: urge to vomit (retching), stomach trouble (e.g. feeling of pressure in the stomach, bloating), diarrhoea.
Skin disorders
Common: sweating.
Uncommon: skin reactions (e.g. itching, rash).
Muscle disorders
Rare: weak muscles.
Liver and biliary disorders
Very rare: increase in liver enzyme values.
Urinary disorders
Rare: passing urine with difficulty or pain, passing less urine than normal
General disorders
Common: fatigue.
Immune system disorders
Rare: allergic reactions (e.g. difficulty breathing, wheezing, swelling of the skin) and shock (sudden circulatory failure) come in very rare cases.
When treatment is stopped abruptly signs of withdrawal may appear;
Drug Withdrawal
When you stop taking Marol 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 Marol Tablets, 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
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– 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 of the 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: 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 Marol 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 blister and / or bottle and the carton 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 to protect the environment.
Contents of the pack and other information
What Marol Tablets contain:
The active substance is: tramadol hydrochloride
- 1 Marol 100 mg tablet contains 100 mg tramadol hydrochloride
- 1 Marol 150 mg tablet contains 150 mg tramadol hydrochloride
- 1 Marol 200 mg tablet contains 200 mg tramadol hydrochloride
What Marol Tablets look like and contents of the pack
Marol 100mg Tablets are off white, round biconvex tablets
Marol 150mg Tablets are off white, capsule shaped tablets
Marol 200mg Tablets are off white, capsule shaped tablets
All the strengths are available in either clear or opaque coloured blister packs and pots of 10, 20, 30, 50, 60, 90, 100, 120, and 180 tablets but not all pack sizes may be marketed.
Marketing Authorisation Holder:
Morningside Healthcare Ltd.
Unit C, Harcourt Way
Leicester, LE19 1WP, UK
Manufacturers:
Morningside Pharmaceuticals Ltd
5 Pavilion Way Loughborough LE11 5GW, UK
This leaflet was last revised in July 2021.
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