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Package leaflet: Information for the user

Zydol® XL 150 mg, 200 mg, 300 mg and 400 mg prolonged-release tablets

Tramadol hydrochloride

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Read all of this leaflet carefully before you start taking this medicine.

•    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. Do 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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet:

1.    What Zydol XL tablets are and what they are used for    4. Possible side effects

2.    Before you take Zydol XL tablets    5. How to store Zydol XL tablets

3.    How to take Zydol XL tablets    6. Further information

1.    What Zydol XL tablets are and what they are used for

These tablets have been prescribed for you by your doctor to relieve moderate to severe pain over a period of 24 hours. They contain the active ingredient tramadol which belongs to a group of medicines called strong analgesics or ‘painkillers’.

2.    Before you take Zydol XL tablets Do not take Zydol XL tablets:

•    if you are allergic (hypersensitive) to tramadol or any of the other ingredients of the tablets (see section 6 ‘Further Information’);

•    if you have drunk too much alcohol, or taken more than the recommended dose of sleeping tablets, painkillers or psychotropic medicines (used to treat psychiatric or mental disorders);

•    if you are taking a type of medicine known as a monoamine oxidase inhibitor (examples include tranylcypromide, phenelzine, isocarboxazid, moclobemide and linezolid), or if you have taken this type of medicine in the last two weeks;

•    fo treat withdrawal symptoms that may occur when you stop taking another strong painkiller;

•    if you are under 12 years of age.

Take special care with Zydol XL tablets

Before treatment with these tablets tell your doctor or pharmacist

if you:

•    are or have ever been addicted to drugs;

•    suffer from, or have ever suffered from epilepsy, seizures, fits or convulsions;

•    have a severe headache or feel sick due to a head injury or increased pressure in your skull (for instance due to brain disease). This is because the tablets may make symptoms worse or hide the extent of a head injury;

•    have severe liver or kidney problems;

•    are suffering from shock (this may make you suddenly feel very light-headed, faint, cold or clammy and look pale);

•    have a condition where you breathe more slowly and weakly than expected (respiratory depression).

Taking Zydol XL tablets with other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you take these tablets with some other medicines, the effect of these tablets or the other medicine may be changed.

These tablets must not be used together with a monoamine oxidase inhibitor or if you have taken this type of medicine in the last two weeks (see section 2 “Do not take...”).

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 Zydol XL tablets at the same time. Your doctor will tell you whether Zydol XL tablets are suitable for you.

•    if you are taking certain antidepressants. Zydol XL tablets 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.

Tell your doctor or pharmacist if you are taking:

•    medicines to help you sleep (for example tranquillisers, hypnotics or sedatives);

•    carbamazepine to treat seizures, fits or convulsions and certain pain conditions;

•    medicines to treat depression;

•    medicines to treat psychiatric or mental disorders;

•    ritonavir to treat HIV;

•    digoxin to treat heart failure or an irregular heart beat;

•    other strong analgesics or ‘painkillers’ (such as buprenorphine, nalbuphine and pentazocine);

•    certain morphine-like medicines used for example, to prevent or treat coughing, or to treat the symptoms of withdrawal;

•    medicines known as barbiturates to either treat fits or to help you sleep;

•    medicines known as benzodiazepines to treat anxiety or to help you sleep;

•    certain medicines to prevent your blood clotting or to help thin your blood (known as coumarin anticoagulants, for example warfarin).

Taking Zydol XL tablets with alcohol

Please ask your doctor or pharmacist for advice if you intend to drink alcohol while you are being treated with these tablets. Pregnancy and breastfeeding

Do not take these tablets if you are pregnant or breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

These tablets may cause a number of side effects such as drowsiness, blurred vision and dizziness which could affect your ability to drive or use machinery (see section 4 for a full list of side effects). These are usually most noticeable when you first start taking the tablets, or when changing to a higher dose. If you are affected you should not drive or use machinery.

This 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 while you have this medicine in your body over a specified limit unless you have a defence (called the ‘statutory defence’).

•    This defence applies when:

° The medicine has been prescribed to treat a medical or dental problem; and

° You have taken it accordingly to the instructions given by the prescriber and in the information provided with the medicine.

•    Please note that it is still an offence to drive if you are unfit because of the medicine (i.e. your ability to drive is being affected).

Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law.

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 Zydol XL tablets

These tablets contain lactose which is a form of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.

3. How to take Zydol XL tablets

Always take these tablets exactly as your doctor has told you. The label on your medicine will tell you how many tablets to take and how often.

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.

Adults and children over 12 years of age

The usual starting dose is one 150 mg tablet once a day. However, your doctor will prescribe the dose required to treat your pain. If you find that you are still in pain whilst taking these tablets discuss this with your doctor. You should not normally take more than 400 mg a day.

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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 Zydol XL tablets. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

Children under 12 years of age

Children under 12 years of age should not take the tablets. Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure.

Swallow your tablets whole with water. Do not crush, dissolve or chew them.

Zydol XL tablets are designed to work properly over 24 hours when swallowed whole. If a tablet is broken, crushed, dissolved or chewed, the entire 24-hour dose may be absorbed rapidly into your body. This can be dangerous, causing serious problems such as an overdose, which may be fatal.

You should take your tablets at the same time every day. For instance, if you take a tablet at 8 o’clock in the morning, you should take your next tablet at 8 o’clock the next morning.

If you take more Zydol XL tablets than you should or if someone accidentally swallows your tablets Call your doctor or local hospital straight away. People who have taken an overdose may feel very sleepy, sick or dizzy. They may have seizures, fits or convulsions. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. When seeking medical attention make sure that you take this leaflet and any remaining tablets with you.

If you forget to take Zydol XL tablets

If you remember within 10 hours of the time your tablet was due, take your tablet straight away. Take your next tablet at your normal time. If you are more than 10 hours late, please call your doctor for advice. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Zydol XL tablets

You should not suddenly stop taking your tablets unless your doctor tells you to. If you want to stop taking your tablets, discuss this with your doctor first. They will tell you how to do this usually by reducing the dose gradually so you do not experience unpleasant effects. Withdrawal symptoms such as agitation, anxiety, nervousness, difficulty in sleeping, being unusually overactive, shaking or gastrointestinal disorders e.g. upset stomach, may occur if you suddenly stop taking these tablets.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, these tablets can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions are rare. Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body.

The most serious side effect is a condition where you breathe more slowly or weakly than expected (respiratory depression).

As with all strong painkillers, there is a risk that you may become addicted or reliant on these tablets.

Very common side effects (probably affecting more than 1 in 10 people taking these tablets)

•    Feeling sick (this should normally wear off after a few days, however your doctor can prescribe an anti-sickness medicine if it continues to be a problem.

•    Dizziness.

Common side effects (probably affecting between 1 and 10 out of every 100 people taking these tablets)

•    Drowsiness.

•    Dry mouth.

•    Sweating.

•    Vomiting (being sick).

Uncommon side effects (probably affecting between 1 and 10 out of every 1,000 people taking these tablets)

•    Headache.

•    Fast heart beat, palpitations or severe heart problems.

•    A feeling of ‘faintness’ especially on standing up.

•    Constipation.

•    Upset stomach.

•    Rash or itchy skin.

Rare side effects (probably affecting fewer than 1 in 1,000 people taking these tablets)

•    Tingling or numbness.

•    Blurred vision.

•    Hallucinations.

•    Nightmares.

•    Mood changes.

•    Changes in activity levels.

•    Problems with recognition, changes in thinking, memory and behaviour.

•    Seizures, fits or convulsions.

•    High blood pressure.

•    Shortness of breath.

•    Worsening of asthma.

•    Loss of appetite.

•    Diarrhoea.

•    Difficulty in passing urine.

•    Muscle weakness.

•    Flushing of the skin.

•    Slow heart beat.

Rarely, these tablets may affect the results of blood tests to check that your liver is working properly.

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

•    Decrease in the blood sugar level.

You may see the remains of the tablets in your faeces. This should not affect how the tablets work.

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

5.    How to store Zydol XL tablets

Keep out of the reach and sight of children.

Do not use the tablets after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.

Do not store your tablets above 30°C.

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

6.    Further information What Zydol XL tablets contain

The active ingredient is tramadol hydrochloride. Each tablet contains 150 mg, 200 mg, 300 mg or 400 mg of tramadol hydrochloride.

The other ingredients are:

•    Hydrogenated vegetable oil

•    Talc

•    Magnesium stearate

•    Lactose monohydrate

•    Macrogol

•    Hypromellose (E464)

•    Titanium dioxide (E171)

What Zydol XL tablets look like and the contents of the pack

They are white, film-coated tablets marked T followed by the strength (e.g. 150, 200, 300 or 400).

In each box there are 30 tablets.

Marketing Authorisation Holder and Manufacturer

The tablets are made by Grunenthal GmbH, Zieglerstr. 6, 52078 Aachen, Germany for the marketing authorisation holder Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UK.

Zydol XL 150 mg, 200 mg, 300 mg and 400 mg tablets are supplied by Grunenthal Ltd, Regus Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge, Middlesex, UB11 1BD, UK.

This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line (free of charge) on:

0800 198 5000

You will need to give details of the product name and reference number.

These are as follows:

Product name: Zydol XL prolonged release tablets Reference number: 16950/0089

This leaflet was last revised in June 2016.

Zydol® XL 150 mg, 200 mg, 300 mg, and 400 mg tablets are protected by European Patent (UK) No. 0699436 and 0654263.

® ZYDOL is a registered trademark of Grunenthal GmbH.

© 2009 - 2014 Napp Pharmaceuticals Limited

93022150    50/036/23

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