TRAMADOL HYDROCHLORIDE MORNINGSIDE 50 MG PROLONGED-RELEASE CAPSULES, MAROL 50 MG PROLONGED-RELEASE CAPSULES - patient leaflet, side effects, dosage

Tramadol Hydrochloride Morningside

50 mg, 100 mg, 150 mg and 200 mg Prolonged-Release Capsules

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

• 1. What Tramadol is and what it is used for

• 2. What you need to know before you take Tramadol

• 3. How to take Tramadol

• 4. Possible side effects

• 5. How to store Tramadol

• 6. Contents of the pack and other information

1. what tramadol is and what it is used for

This medicine has been prescribed 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 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 tramadol

Do not take Tramadol:

• 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) or have taken them in the last 14 days (see “Other medicines and Tramadol”)
• if you are an epileptic and your fits are not adequately controlled by treatment
• as a substitute in drug withdrawal.

Warning and precautions

Talk to your doctor before taking Tramadol if you:

• Suffer from depression and you are taking antidepressants as some of them may interact with tramadol (see ‘Other medicines and Tramadol’).

Talk to your doctor or pharmacist if you experience any of the following symptoms while taking this medicine:

• 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
• if you feel you need to take more of Tramadol 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)
• ifyouareinasta­teofshock(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.

Sleep-related breathing disorders Tramadol 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.

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

Epileptic fits have been reported in patients taking Tramadol at the recommended dose level. The risk may be higher when doses of Tramadol exceed the recommended upper daily dose limit (400mg).

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.

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.

Tramadol hydrochloride 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.

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’).

Other medicines and Tramadol

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

The pain-relieving effect of Tramadol may be reduced and the length of time it acts may be shortened, if you take medicines which contain carbamazepine (for epileptic fits) or ondansetron (prevents nausea).

• Your doctor will tell you whether you should take Tramadol, and what dose. The risk of side effects increases: if you take tranquillizers, sleeping pills, other pain relievers such as morphine and codeine (also as cough medicine), and alcohol while you are taking Tramadol. You may feel drowsier or feel that you might faint. If this happens tell your doctor
• concomitant use of Tramadol 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 Tramadol 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 (e.g. venlafaxine) or antipsychotics. The risk of having a fit may increase if you take Tramadol at the same time as those medicines. Your doctor will tell you whether Tramadol is suitable for you
• if you are taking certain antidepressants Tramadol may interact with these medicines and you may experience serotonin syndrome (see section 4 ‘Possible side effects’)
• if you take coumarin anticoagulants (medicines for blood thinning), e.g. warfarin, together with Tramadol. The effect of these medicines on blood clotting may be affected and bleeding may occur.

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.

Taking Tramadol with food, drink and alcohol

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

Pregnancy and breast-feeding and fertility

Do not take Tramadol 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 take Tramadol during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated. Do not take Tramadol while you are breast-feeding as tramadol hydrochloride passes into breast milk and will affect your baby.

Driving and using machines Tramadol 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.

• 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.

Tramadol contains sucrose

This medicine contains sucrose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to take tramadol

Always take 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 Tramadol will last.

They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.

Adults and adolescents from the age of 12 years:

The usual initial dose is 50 – 100 mg twice daily, morning and evening. Your doctor may increase this dose up to 150 – 200 mg twice daily according to your needs. You should normally take your Tramadol every 12 hours, at the same time each morning and evening.

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. The maximum dose is usually 400 mg daily.

Children under 12 years of age: Tramadol should not be taken by children under 12 years of age.

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

• Ask your doctor or pharmacist if: you are not sure how many capsules to take or when to take them.
• Tell your doctor or pharmacist if you think that the effect is too strong or too weak.

Swallow the capsules whole with water without chewing.

If you take more Tramadol than you should

If you accidentally take more capsules than your prescribed dose, tell your doctor or pharmacist immediately and if necessary contact your nearest hospital casualty department. Remember to take the pack and any remaining medicines with you.

If you forget to take Tramadol Do not take a double dose to make up for a forgotten dose.

If you stop taking Tramadol

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 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:

• Allergic reaction (difficulty in breathing, wheezing and swelling of the face or throat)
• 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
• Vomiting and nausea (being and feeling sick).

Common (may affect up to 1 in

10 people)

• Headache
• Drowsiness, sleepiness (fatigue)
• Constipation, dry mouth
• Sweating.

Uncommon (may affect up to 1 in

100 people)

• Rapid heartbeat, palpitation, sudden drops in blood pressure. These adverse effects may occur especially on intravenous administration and in patients who are physically stressed
• Itching, skin rash
• Retching, feeling bloated or full.

Rare (may affect up to 1 in

1,000 people)

• Appetite changes
• Psychic effects including: changes in mood, activity, behaviour and perception, hallucinations, confusion, restless ness, sleep disturbances and nightmares
• Convulsions (fits)
• Tingling sensation and trembling
• Slow heartbeat, increase in blood pressure
• Muscle weakness
• Difficulty or inability in passing urine
• Blurred vision.

Very rare (may affect up to 1 in

10,000 people)

• Flushing
• Vertigo (feeling of dizziness or “spinning”)
• Asthma and breathing difficulties
• Elevated liver enzymes.

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

• 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’).

Drug Withdrawal

When you stop taking Tramadol, 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, 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 take 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 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 tramadol

Keep this medicine out of the sight and reach of children.

Do not take this medicine after the expiry date which is stated on the carton. 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 the pack and other information

What Tramadol contains:

The active substance is tramadol hydrochloride.

Tramadol Hydrochloride Morningside 50 mg, 100 mg, 150 mg and 200 mg prolonged-release capsules contain 50mg, 100mg, 150mg and 200mg tramadol hydrochloride.

The other ingredients of the capsule contents are:

Sugar spheres, colloidal silicon dioxide, ethylcellulose (E462), shellac refined bleached (E904), talc (E553b), ethanol, methacrylic acid methyl methacrylate copolymer (1:2), ammonio methacrylate copolymer Type B and purified water.

The capsule shell contains:

Gelatin; titanium dioxide (E171); iron oxide yellow (E172) [in 50 mg, 150 mg and 200 mg]; brilliant blue FCF (E133) [in 50 mg]; iron oxide black (E172) and iron oxide red (E172) [in 150 mg].

What Tramadol looks like and the contents of the pack:

Tramadol Hydrochloride Morningside 50 mg Prolonged-Release Capsules: Hard gelatin size ‘4’ capsule having dark green opaque colored body and dark green opaque colored cap containing white to off-white colored pellets.

Tramadol Hydrochloride Morningside 100 mg Prolonged-Release Capsules: Hard gelatin size ‘3’ capsule having white opaque colored body and opaque white colored cap containing white to off-white colored pellets.

Tramadol Hydrochloride Morningside 150 mg Prolonged-Release Capsules: Hard gelatin size ‘2’ capsule having grey opaque colored body and red opaque colored cap containing white to off-white colored pellets.

Tramadol Hydrochloride Morningside 200 mg Prolonged-Release Capsules: Hard gelatin size ‘1’ capsule having yellow opaque colored body and yellow opaque colored cap containing white to off-white colored pellets.

This medicinal product is in the form of a prolonged-release hard capsule. The capsules release the active ingredient over a period of time.

All the capsules are packaged in PVC/ PVDC-aluminium blisters of 10 capsules. Eachpackcontains1, 2, 3, 5, 6or10 blisters, i.e. each pack contains 10, 20, 30, 50, 60 or 100 capsules per pack.

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