Document: leaflet MAH GENERIC_PL 33414-0127 change

• leaflet MAH GENERIC_PL 16363-0335
• leaflet MAH GENERIC_PL 33414-0127

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

TRAMADOL 50 mg CAPSULES

TRAMADOL HYDROCHLORIDE

THIS LEAFLET CONTAINS

1.    What Tramadol is for

2.    Before you take Tramadol

3.    How to take Tramadol

4.    Possible side effects

5.    How to store Tramadol

6.    Further information

1. WHAT TRAMADOL IS FOR

Tramadol 50 mg Capsules contain the active substance tramadol hydrochloride, which belongs to a group of medicines called opioid analgesics. These act on specific nerve cells in the central nervous system to relieve pain.

Tramadol is used to relieve moderate to severe pain.

If you are not sure why you have been prescribed Tramadol, please ask your doctor.

2. BEFORE YOU TAKE TRAMADOL

Do not take Tramadol and tell your doctor if you:

•    are allergic to tramadol hydrochloride, or any of the other ingredients of these capsules (listed in section 6)

•    have recently taken alcohol, medicines to help you sleep, other pain killers or medicines that affect your mood and behaviour

•    have taken medicines known as monoamine oxidase inhibitors (MAOIs) to treat depression within the last 14 days (see "Other medicines and Tramadol”)

•    suffer from epilepsy and your fits are not well controlled by treatment

•    are undergoing treatment to withdraw from the use of narcotics

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor before taking Tramadol.

Warnings and precautions

Talk to your doctor before taking Tramadol if you:

•    are, or have ever been, addicted to alcohol or any drug

•    have recently suffered a head injury, or have increased pressure in the skull (which may cause severe throbbing headaches and changes in vision)

•    are in a state of shock, (you may experience disorientation, confusion, anxiety, palpitations or sweating), or suffer from reduced levels of consciousness

•    have breathing problems

•    are sensitive to opiates

•    have epilepsy, or have previously suffered a fit

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).

There is a risk that you may become addicted to or dependent on Tramadol. If you take it for a long time you can become used to the effects (tolerant) and so may need to take higher doses to control your pain. In patients with a tendency to abuse medicines or who are dependent on medicines, treatment with tramadol should only be carried out for short periods and under strict medical supervision.

Please also inform your doctor if one of these problems occurs during treatment with tramadol or if they applied to you in the past.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Tramadol.

Operations

If you are going to have an anaesthetic for a surgical procedure, tell your doctor, dentist or nurse that you are taking Tramadol.

Other medicines and Tramadol

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines bought without a prescription. This is because Tramadol can affect the way some medicines work, and some medicines can affect the way Tramadol works.

Tramadol should not be taken together with MAO inhibitors (certain medicines for the treatment of depression).

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 (used to treat epileptic fits)

•    Ondansetron (prevents nausea)

Your doctor will advise 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

•    are taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. On concurrent use of tramadol, the risk of having a fit may increase. Your doctor will tell you whether tramadol is suitable for you

•    are taking certain antidepressants tramadol may interact with these medicines and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C

•    are taking 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

Tramadol with food and alcohol

Alcohol may intensify the effects of Tramadol and make you feel very sleepy. Do not drink alcohol whilst taking Tramadol. Tramadol tablets can be taken with or without food.

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.

There is very little information regarding the safety of tramadol in human pregnancy. Therefore you should not use tramadol if you are pregnant.

Chronic use during pregnancy may lead to withdrawal symptoms in new borns. Generally, the use of tramadol is not recommended during breast-feeding. Small amounts of tramadol are excreted into breast milk. After a single dose it is usually not necessary to interrupt breast-feeding.

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

Driving and using machines

Tramadol can affect your ability to drive and use machines as it may make you sleepy, dizzy or cause blurred vision. Do not drive or use machines 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:

•    Tramadol 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.

3. HOW TO TAKE TRAMADOL

Always take Tramadol exactly as your doctor has told you. The dose will vary from person to person, and depends on the intensity of your pain and your individual pain sensitivity.

The lowest effective pain-relieving dose should be taken. Check with your doctor or pharmacist if you are not sure.

Tramadol Capsules should be swallowed whole with a drink of water, with or without food. Do not chew or crush the capsule.

Unless otherwise prescribed by your doctor, the recommended dose is:

Adults and children aged 12 years and over:

One or two Tramadol (equivalent to 50 mg- 100 mg Tramadol) depending on the pain the effect lasts for about 4-8 hours. Your doctor may prescribe a different, more appropriate dosage of Tramadol if necessary.

Do not take more than eight capsules (400 mg) in any 24 hour period, unless told to by your doctor in special situations.

You should not take Tramadol for longer than necessary. Your doctor will check at regular intervals whether you should continue to take Tramadol, (if necessary with breaks in treatment), and at what dose. If you feel that the effect of Tramadol is too strong or too weak, talk to your doctor or pharmacist.

Elderly patients (above 75 years):

In some elderly patients the excretion of tramadol may be delayed. If this applies to you, your doctor may recommend prolonging the dosage interval accordingly.

Patients with severe liver or kidney disease (including dialysis patients):

Patients with severe liver and/or kidney problems should not take Tramadol. If in your case the problem is only mild or moderate, your doctor may recommend prolonging the dosage interval accordingly.

Children below the age of 12 years:

Tramadol Capsules are not suitable for use in children under 12 years of age.

If you take more Tramadol 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 Tramadol at the same time you should go to hospital or call a doctor straight away.

The symptoms of an overdose include

•    a fall in blood pressure, a fast heartbeat

•    loss of consciousness, coma, fits

•    breathing difficulties

•    vomiting (being sick)

•    narrowed pupils

If you forget to take Tramadol

If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose and take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose, and remember to allow at least four hours between doses.

If you stop taking Tramadol

You should not stop taking Tramadol suddenly. If you want to stop taking Tramadol you should discuss this with your doctor and follow their advice. In very rare cases, withdrawal symptoms may be experienced when your treatment is stopped (see section 4).

Generally there will be no after-effects when treatment with Tramadol is stopped. However, on rare occasions, people who have been taking Tramadol for some time may feel unwell if they abruptly stop taking them. They may feel agitated, anxious, nervous or shaky. They may be hyperactive, have difficulty sleeping and have stomach or bowel disorders. Very few people may get panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and "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 Tramadol, 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, Tramadol can cause side effects, although not everybody gets them.

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 Tramadol are nausea and dizziness, which occur in more than 1 in 10 people.

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

•    being sick (vomiting), constipation, dry mouth

•    increased sweating (hyperhidrosis)

•    fatigue

Uncommon (may affect up to 1 in 100 people):

•    effects on the heart and blood circulation (pounding of the heart, fast heartbeat, feeling faint or collapse). These adverse effects may particularly occur in patients in an upright position or under physical strain

•    urge to sick (retching), stomach trouble (a feeling of pressure in the stomach, bloating), diarrhoea

•    skin reactions (e.g. itching, rash)

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

•    increased blood pressure, slow heart beat

•    abnormal sensations (e.g. itching, tingling, numbness), changes in appetite, epileptic fits, trembling, muscle twitches, uncoordinated movement, transient loss of consciousness (syncope), speech disorders.

•    epileptic fits, these may occur when high doses of Tramadol are being taken, or when Tramadol was taken at the same time as other medicines which may induce fits.

•    hallucinations, confusional state, sleep disorders, delirium, anxiety and nightmares.

•    Psychological complaints may appear after treatment with Tramadol. 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 pupils (mydriasis), constriction of pupils (miosis)

•    weak muscles

•    slow breathing, shortness of breath (dyspnoea)

•    worsening of asthma (breathing difficulties) 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.

•    passing urine with difficulty or pain, passing less urine than normal (dysuria).

•    drug dependence may occur. If Tramadol is taken over a long period of time dependence may occur, although the risk is very low. When treatment is stopped abruptly, signs of withdrawal may appear (see "If you stop taking Tramadol”).

Very Rare (may affect up to 1 in 10,000 people)

•    hepatic enzyme increased

Not known: frequency cannot be estimated from the available data

•    low blood sugar levels (hypoglycaemia)

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: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE TRAMADOL

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package. Keep the container tightly closed.

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. FURTHER INFORMATION

What Tramadol Capsules contain

The active substance, (the ingredient which makes the medicine work), is tramadol hydrochloride. Each capsule contains 50 mg of tramadol hydrochloride.

The other ingredients are:

•    capsule powder: colloidal anhydrous silica, magnesium stearate, microcrystalline cellulose (E460) and sodium starch glycolate (Type A)

•    capsule shell: gelatine, titanium dioxide (E171), yellow iron oxide (E172)

What Tramadol Capsules look like and contents of the pack

Tramadol Capsules are opaque, yellow and yellow hard gelatine capsules. The size of capsule is about 14.4 mm.

The capsules are available in blister packs and containers of 10, 20, 30, 50 and 100 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Chelonia Healthcare Limited 11 Boumpoulinas, 3rd Floor,

1060 Nicosia, Cyprus

Manufacturer

DDSA Pharmaceuticals Limited 310 Old Brompton Road,

London, SW5 9JQ, UK

For any further information about this medicine, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 12/2015

CL0127/O/PIL/CL1