Tramadol Hydrochloride 50mg Capsules

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PATIENT INFORMATION LEAFLET

TRAMADOL HYDROCHLORIDE 50mg CAPSULES

Please read this leaflet carefully before you start taking your medicine.

• Keep this leaflet; you may need to read it again.

• If you have further questions, please ask your doctor or pharmacist.

• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.

IN THIS LEAFLET

1. What your medicine is and what it is used for

2. Before you take your medicine

3. How to take your medicine

4. Possible side effects

5. Storing your medicine

6. More information

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DOSAGE

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 usual doses are as follows:

Adults and children aged 12 years and over

Take one or two capsules. Do not take more often than every four hours.

Do not take more than eight capsules (400mg) per day.

Do not take more than the doctor has prescribed.

Elderly patients

In elderly patients (above 75 years) the excretion of tramadol hydrochloride may be delayed. If this applies to you, your doctor may recommend prolonging the dosage interval.

WHAT YOUR MEDICINE IS AND WHAT ■ IT IS USED FOR

Tramadol Hydrochloride 50mg Capsules belong to a group of drugs called opioid analgesics. They work by acting on sites in the central nervous system to block the transmission of pain signals. Tramadol hydrochloride is used for the treatment and prevention of moderate to severe pain.

. BEFORE YOU TAKE YOUR MEDICINE

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Do not take your medicine if you:

• have previously suffered an allergic reaction to a medicine containing tramadol hydrochloride or other opioids

• are allergic to any of the other ingredients in this medicine (see section 6, More information)

• are taking or have taken monoamine oxidase inhibitors (MAOIs, medicines used to treat depression) in the last 2 weeks

• are suffering from uncontrolled epilepsy

• drink large amounts of alcohol regularly or are dependent/addicted to other drugs

• are undergoing treatment for drug or alcohol withdrawal

• are pregnant, planning to become pregnant or are breast-feeding

If the answer is yes to any of the above, please tell your doctor.

Take special care with your medicine

Always tell your doctor before using this medicine if you:

• have been or are presently addicted to alcohol or any other drug

• have a head injury

• are in a state of shock

• experience dizziness while taking this medicine as it may increase the risk of falling

• have a history of epilepsy or are susceptible to seizures or convulsions

• have severe liver or kidney problems

• suffer from or have a history of suffering from peptic (stomach) ulcers - tramadol hydrochloride may mask the effects of perforated ulcers

• have any problem with your breathing

If the answer is yes to any of the above, you must tell your doctor, he may decide to alter your treatment.

Taking other medicines

You should consult your doctor BEFORE taking any other medicine particularly any of the following:

• Monoamine oxidase inhibitors (MAOIs, medicines used to treat depression) now or within the last two weeks, or any other medicines used for depression (e.g. amitriptyline, fluoxetine and lithium)

• Selective serotonin reuptake inhibitors (SSRIs) taken with tramadol hydrochloride may cause confusion, agitation, fever, sweating, unsteadiness, muscle rigidity or spasms and diarrhoea. These symptoms may be an indication of a serious disorder called serotonin syndrome. If you experience any of these symptoms contact your doctor immediately.

• Other medicines which act on the central nervous system including hypnotics (drugs used to aid sleeping), painkillers and anaesthetics

• Carbamazepine (used to treat epilepsy)

• Anticoagulants (drugs used to thin the blood) for example warfarin

• Ondansetron (prevents nausea)

The risk of side effects increases 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 Hydrochloride 50mg Capsules at the same time. Your doctor will tell you whether Tramadol Hydrochloride 50mg Capsules is suitable for you.

• certain antidepressants. Tramadol Hydrochloride 50mg Capsules 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.

If you are to undergo surgery you should inform the anaesthetist of your treatment with Tramadol Hydrochloride 50mg Capsules.

Taking this medicine with food and drink

Do not drink alcohol while taking Tramadol Hydrochloride 50mg Capsules without first asking your doctor.

Pregnancy and breast-feeding

Do not take this medicine without first consulting with your doctor if you are pregnant, planning to become pregnant or are breast-feeding.

Chronic use during pregnancy may lead to withdrawal symptoms in the newborn baby.

Driving and using machines

This medicine may make you sleepy, confused, forgetful, unsteady, or affect your concentration or co-ordination. This may affect your performance at skilled tasks, e.g. driving or operating machinery. DO NOT drive or operate machinery if you are affected.

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 some of the ingredients of your medicine

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

Children

This medicine is not recommended for children under 12 years.

Patients with kidney or liver complaints

Your doctor may advise you to take the medicine every 12 hours.

Severe liver or kidney disease (insufficiency)/ dialysis patients

Patients with severe liver and/or kidney insufficiency should not take Tramadol Hydrochloride 50mg Capsules. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

If you take more of your medicine than you should

If you or anyone else has swallowed a lot of the capsules all together contact your nearest hospital casualty department or doctor immediately. Signs of an overdose may include narrowed pupils, being sick, heart problems, sleepiness, coma, fits and breathing difficulties.

If you forget to take your medicine

If you forget to take a dose, take it as soon as you remember, then go on as before. Do not take two doses within approximately two hours of each other.

If you stop taking your medicine

Always ask your doctor first before you stop taking your medicine.

In very rare cases, withdrawal symptoms may be experienced when your treatment is stopped (see section 4, Possible Side Effects).

■ POSSIBLE SIDE EFFECTS

This medicine, like most other medicines, may cause side effects in some people.

STOP taking your medicine and contact your doctor immediately if you experience:

• allergic reactions - these may include breathing difficulties (or could make your asthma worse if you already have asthma), angioedema (swelling of the skin), itching or a skin rash. If you experience any of these allergic reactions, stop taking these capsules immediately and contact your doctor.

Tell your doctor if you notice any of the following side effects:

Very common (more than 1 in 10 people)

• dizziness, nausea

• change in mood, change in level of activity, less able to make decisions

• dependence - see withdrawal symptoms below

• blurred vision

• difficulty passing urine

Not known (cannot be estimated from available data)

• speech disorders

• shallow breathing - if recommended dose is exceeded

In very rare cases long-term treatment with tramadol hydrochloride may lead to dependence and abuse, with withdrawal symptoms occurring after stopping treatment. Your doctor will advise you on this.

Withdrawal symptoms may include:

• agitation, anxiety, panic attacks, nervousness, confusion, delusion

• sleeping difficulties, restlessness

• hallucinations, paranoia, personality change

• pins and needles, abnormal muscle movements, shaking

• ringing in the ears

• abdominal pain

• outer body experience

If you experience any of the above or are concerned about anything or you notice anything unusual contact your doctor.

. STORING YOUR MEDICINE

This medicine should not be used after the expiry date stated on the pack. The expiry date refers to the last day of that month.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Store below 25°C, in a dry place.

Medicines should not be disposed of via wastewater and household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

. MORE INFORMATION

What your medicine looks like

Tramadol Hydrochloride 50mg Capsules are green and yellow in colour and printed with “TRA 50”. Your medicine comes in pack sizes of 30, 50, 100, 250 and 500 capsules. Not all pack sizes may be marketed.

What your medicine contains

Each capsule contains 50mg of tramadol hydrochloride, the active ingredient.

The capsules also contain the inactive ingredients microcrystalline cellulose, povidone, lactose monohydrate, sodium starch glycolate and magnesium stearate. The capsule shell contains gelatin and the colours titanium dioxide (E171), indigotin (E132), yellow iron oxide (E172) and erythrosin (E127). The ink on the capsule shell contains shellac, propylene glycol and the colour black iron oxide (E172).

Marketing Authorisation Holder

Athlone Pharmaceuticals Limited, Ballymurray,

Co. Roscommon, Ireland.

Manufacturer responsible for batch release

Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K.

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.

. HOW TO TAKE YOUR MEDICINE

Common (more than 1 in 100 people)

• headache, drowsiness, tiredness

• vomiting, constipation, dry mouth

• sweating

Uncommon (more than 1 in 1,000 people)

• bloating, diarrhoea

• fast heart beat, feeling faint, low blood pressure on standing

Distributor

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.

PL 30464/0037

This leaflet was last revised May 2015.

You should take your medicine as directed by your doctor. The pharmacist's label should tell you how much to take and how often. If it does not or you are not sure ask your doctor or pharmacist. Your doctor will keep you under regular supervision while you are taking this medicine, and will advise you how long to keep taking it.

The capsules should be swallowed with a drink of water.

Rare (more than 1 in 10,000 people)

• change in appetite

• slow heart rate, high blood pressure

• tingling feeling on the skin

• muscle twitching, uncoordinated movement

• muscle weakness

• shortness of breath

• convulsions, fainting

to • hallucinations, confusion, nightmares

CRTDL.50C.QM.V1P1

CR.TDL.50C.OM.V1R1

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Designer: TC

Product: Tramadol Hydrochloride 50mg Capsules PIL Dimensions: 148mm x 350mm Item Code: CP.TDL.50C.OM.V1P1 Proof No and Date: 1 21/05/2015

Revision:

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