Zytram Sr 75mg Prolonged Release Tablets

Document: leaflet MAH BRAND_PL 40431-0035 change

Package leaflet: Information for the user

Zytram® SR 75 mg, 100 mg, 150 mg and 200 mg prolonged-release tablets

Tramadol hydrochloride

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 Zytram SR tablets are and what they are used for

2. Before you take Zytram SR tablets

3. How to take Zytram SR tablets

4. Possible side effects

5. How to store Zytram SR tablets

6. Further information

1. What Zytram SR 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 12 hours. They contain the active ingredient tramadol which belongs to a group of medicines called strong analgesics or ‘painkillers’.

2. Before you take Zytram SR tablets

Do not take Zytram SR 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;

• to 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 Zytram SR 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;

• if you have severe kidney or liver 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 Zytram SR 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 Zytram SR tablets at the same time. Your doctor will tell you whether Zytram SR tablets are suitable for you.

• if you are taking certain antidepressants. Zytram SR 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^oC.

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) ;

• ondansetron to stop you feeling or being sick.

Taking Zytram SR 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:

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

o 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 Zytram SR 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 Zytram SR 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 75 mg tablet twice 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.

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 Zytram SR 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.

Zytram SR tablets are designed to work properly over 12 hours when swallowed whole. If a tablet is broken, crushed, dissolved or chewed, the entire 12-hour dose may be rapidly absorbed into your body. This can be dangerous, causing problems such as an overdose, which may be fatal.

You should take your tablets every 12 hours. For instance, if you take a tablet at 8 o’clock in the morning, you should take your next tablet at 8 o’clock in the evening.

If you take more Zytram SR 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 Zytram SR tablets

If you remember within 4 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 4 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 Zytram SR 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 antisickness 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)

• Dry mouth.

• Sweating.

• Vomiting (being sick).

Uncommon side effects (probably occurring in 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 between 1 and 10 in 10,000 people taking Zytram SR tablets)

• Tingling or numbness.

• Blurred vision.

• Hallucinations.

• Nightmares.

• Mood changes, unpleasant or uncomfortable moods or a feeling of extreme happiness.

• Changes in activity levels.

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

• Seizures, fits or convulsions.

• High blood pressure.

• Shortness of breath, difficulty in breathing or wheezing.

• Worsening of asthma.

• Loss of appetite.

• Diarrhoea.

• Pain or difficulty in passing urine.

• Muscle weakness.

• Flushing of the skin.

• Slow heart beat.

Very rare side effects (probably affecting fewer that 1 in 10,000 people taking these tablets)

• Shaking.

• Agitation, anxiety or nervousness.

• Difficulty in sleeping.

• Being unusually overactive.

Very 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 Zytram SR 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^oC.

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 Zytram SR tablets contain

The active ingredient is tramadol hydrochloride. Each tablet contains 75 mg, 100 mg, 150 mg or 200 mg of tramadol hydrochloride.

The other ingredients are:

• Hydrogenated vegetable oil

• Talc

• Magnesium stearate

• Lactose monohydrate

• Macrogol

• Hypromellose (E464)

• Titanium dioxide (E171)

In addition, the tablet coatings contain the following:

75 mg, 150 mg and 200 mg - iron oxide (E172)

75 mg - indigo carmine (E132)

What Zytram SR tablets look like and contents of the pack

The tablets are marked “TBD” followed by the strength (e.g. 75, 100, 150 or 200) and are coloured as follows: 75 mg - pale grey, 100 mg - white, 150 mg - beige and 200 mg - orange.

In each box there are 7, 14, 28, 30, 56 or 60* tablets.

(* The printed leaflet will refer to marketed pack sizes only.)

Marketing Authorisation Holder

Qdem Pharmaceuticals Limited at Cambridge Science Park, Milton Road, Cambridge CB4 0AB. Manufacturer

The tablets are made by Bard Pharmaceuticals Limited, at Cambridge Science Park, Milton Road Cambridge CB4 0GW.

This leaflet was last revised in September 2016.

Zytram SR tablets are protected by European Patent Nos. 0654263 and 0699436.

® Zytram and Qdem are Registered Trade Marks.