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PATIENT INFORMATION LEAFLET

DOLOCODON PR 5MG, 10MG, 20MG AND 40MG PROLONGED-RELEASE TABLETS

(oxycodone 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 further questions, please 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Dolocodon is and what it is used for

2.    Before you take Dolocodon

3.    How to take Dolocodon

4.    Possible side effects

5.    How to store Dolocodon

6.    Further information

1. WHAT DOLOCODON IS AND WHAT IT IS USED FOR

The name of your medicine is Dolocodon PR 5mg, 10mg, 20mg or 40mg Prolonged-Release Tablets (called Dolocodon throughout this leaflet). Dolocodon contains a medicine called oxycodone hydrochloride.

It belongs to a group of medicines called strong opioid analgesics (painkillers).

It is used to treat severe pain which cannot be controlled with weaker painkillers.

2. BEFORE YOU TAKE DOLOCODON

Do not take Dolocodon and tell your doctor if:

•    You are allergic (hypersensitive) to oxycodone hydrochloride or any of the other ingredients in this medicine (listed in Section 6: Further information). Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of the legs, arms, face, throat or tongue

•    You have breathing problems such as chronic obstructive airways disease, severe bronchial asthma or severe lung disease, or a condition where you breathe more slowly or weakly than expected (respiratory depression)

•    You have a condition where your small bowel does not work properly (paralytic ileus) or where your stomach empties more slowly than it should (delayed gastric emptying) or you have had constipation over a long period

•    You have severe pain in your abdomen which may be associated with vomiting, dizziness or a fever

•    You have a heart problem due to long-term lung disease (cor pulmonale)

•    You are pregnant, think you may be pregnant or plan to get pregnant

•    You are breast-feeding or planning to breast-feed

•    You are taking medicines to treat depression called MAOIs (monoamine oxidase inhibitors) or have taken them in the last 2 weeks.

Do not take Dolocodon if any of the above applies

to you. If you are not sure, talk to your doctor or

pharmacist before taking Dolocodon.

Take special care and check with your doctor

before taking Dolocodon if:

•    You have an under-active thyroid gland (hypothyroidism), as you may need a lower dose of this medicine

•    You have a severe headache or feel sick (nausea) as this may be a sign that the pressure in your skull is higher than it should be

•    You have problems with your liver, kidneys or lungs

•    You have problems with your adrenal glands (Addison's disease)

•    You have prostate problems (enlargement of the prostate gland)

•    You have a mental health problem that results from the poisonous effects of some chemicals including alcohol or drugs

•    You are or ever have been addicted to alcohol or drugs

•    You have ever suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, after stopping taking alcohol or drugs

•    You suffer from an inflamed pancreas (pancreatitis) or have problems with your gallbladder

•    You suffer from convulsions or fits (epilepsy)

•    You suffer from low blood pressure

•    You suffer from kidney stones (renal colic)

•    You have a head injury that causes a severe headache or makes you feel sick, because the tablets may make these symptoms worse or cover up the extent of the injury

Operations

Tell the doctor that you are taking these tablets if

•    You are going to have an anaesthetic

•    You are going to have an operation (including dental surgery)

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

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Dolocodon can affect the way some other medicines work. Also, some other medicines can affect the way Dolocodon works.

Do not take Dolocodon and tell your doctor if you are taking

• Medicines to treat depression called MAOIs (monoamine oxidase inhibitors) or have taken them in the last 2 weeks.

Tell your doctor or pharmacist if you are taking any of the following medicines:

•    Medicines to help you sleep (hypnotics, sedatives) or make you less anxious (tranquillisers)

•    If you have recently been given a medicine for muscle relaxation or are due to have an anaesthetic (to put you to sleep for an operation)

•    Medicines used in severe mental health problems (including schizophrenia, mania or depression) called antipsychotics or antidepressants,

•    Medicines used to treat allergies (antihistamines)

•    Medicines used to stop you feeling or being sick (antiemetics)

•    Other painkillers from the group of opioid medicines. Taking these medicines with Dolocodon can make you more likely to get side effects such as severe breathing problems

•    Medicines used in Parkinson's disease. Taking these with Dolocodon can make you more likely to get side effects such as dry mouth, constipation or urinary problems

•    Cimetidine used for stomach problems. Taking this with Dolocodon can make Dolocodon work less well

•    Medicines for thinning the blood such as warfarin If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Dolocodon.

Taking Dolocodon with food and drink

You can take Dolocodon with or without food.

Drinking alcohol whilst taking Dolocodon may make you feel more sleepy or increase the risk of serious side effects such as shallow breathing with a risk of stopping breathing, and loss of consciousness. It is recommended not to drink alcohol while you're taking Dolocodon.

Pregnancy and breast-feeding

•    Do not use this medicine if you are pregnant, think you may be pregnant or plan to get pregnant. This is because taking Dolocodon regularly during pregnancy may cause your baby to have some “withdrawal symptoms” (see Section 3 - If you stop taking Dolocodon) when it is first born. Also, taking Dolocodon during delivery can cause your baby to have breathing problems when it is born

•    Do not use this medicine if you are breast-feeding or planning to breast-feed as Dolocodon can pass into your breast milk.

Driving and using machines

You should discuss with your doctor before taking Dolocodon whether or not you should drive or use machines or tools. You may feel less alert and be much slower to react to situations than usual while taking Dolocodon.

If this happens, do not drive or use any tools or machines.

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.

Anti-doping tests

This medicine may cause a positive reaction to “anti-doping tests”, such as those given to athletes.

Important information about some of the ingredients of Dolocodon

Dolocodon contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before you take this medicine.

3. HOW TO TAKE DOLOCODON

Always take Dolocodon exactly as your doctor has told you. The dose of Dolocodon will depend on your needs, the illness you are being treated for and how you respond to treatment. The dose will be decided by your doctor. The usual doses are listed below. Check with your doctor or pharmacist if you have any questions about your medicine and how to take it.

Dolocodon 10, 20 and 40 tablets have break scores on both sides. The tablet can be divided into equal halves.

Taking this medicine

•    Swallow the tablets whole or halved with a drink of water

•    Do not crush or chew the tablets as this will affect the way the medicine is taken into your body and could cause you to have too much medicine in your body at once. (See “If you take more Dolocodon than you should”)

•    Try to take your medicine at the same times each day so that it becomes part of your daily routine

•    Leave 12 hours between doses

How much to take

Adults and children aged 12 years and over

•    Your doctor will tell you exactly how much Dolocodon to take. This will depend on your medical condition, whether or not you have taken opioid medicines before and how you respond to treatment.

•    The usual starting dose of Dolocodon is 10mg every 12 hours

•    For the treatment of non-cancer pain, a total daily dose of 40mg is usually enough to control the pain

•    Patients with cancer pain usually need a total daily dose of between 80mg and 120mg of this medicine. This may be increased, by a doctor, to as much as 400mg each day for some patients.

People with liver or kidney problems or people with a low body weight

•    Your doctor may lower your dose

Children (under the age of 12 years)

•    Dolocodon should not be given to children under 12 years of age.

If you take more Dolocodon than you should

Taking too much of this medicine may be dangerous. If you have taken too many tablets, or if someone accidentally swallows some, contact your doctor or go to the nearest hospital casualty department immediately. Signs that someone has taken too much Dolocodon include breathing problems which may lead to unconsciousness or even death.

Remember to take the pack and any remaining tablets with you so that the doctor knows what has been taken.

If you forget to take Dolocodon

If you forget to take a dose at the right time, you may not get enough pain relief. 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 or pharmacist for advice. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Dolocodon

Do not change the dose or suddenly stop treatment without discussing this with your doctor. This is because suddenly stopping treatment can cause side effects (withdrawal symptoms) in some people. These side effects can include: becoming agitated, anxious or nervous, very fast, uneven or forceful heartbeat (palpitations), shaking, or sweating.

4. POSSIBLE SIDE EFFECTS

As with all medicines, Dolocodon can cause side effects, although not everybody gets them.

Most people will have constipation when they take these tablets. Your doctor can prescribe a laxative to overcome this problem.

You may feel sick or vomit (be sick) when you take your tablets. Your doctor can prescribe an anti-vomiting medicine if it causes problems.

You may find that you cannot concentrate or that you feel more sleepy than normal when you start taking your tablets or when your dose is increased. This should wear off after a few days.

The following side effects may happen with this medicine:

Stop taking Dolocodon and see a doctor or go

to a hospital straight away if:

•    You get swelling of your hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria).

This may mean you are having an allergic reaction to Dolocodon

•    Your breathing becomes very slow and weak. You may also feel dizzy or faint.

— These could be signs of a very serious

problem called respiratory depression. This is more likely to happen if you are elderly or have other major health problems

•    You get a bloated feeling and cramping pain in your stomach (abdomen), are sick (vomit) and also have some of the following symptoms: indigestion,

heartburn, an upset stomach, constipation, loss of appetite, dry mouth. This could be caused by an obstruction or blockage of the bowel which needs urgent medical attention.

Tell your doctor as soon as possible if:

•    You have fits (convulsions). This is more likely to happen in patients who already have epilepsy or a tendency to have fits

Becoming dependent on Dolocodon

Taking Dolocodon tablets regularly for a long time can make you become dependent on them. This may mean that you feel as if you need to have Dolocodon more often or at a higher dose to get the same level of pain relief. Tell your doctor as soon as possible if you think this is happening to you. Do not change the amount of Dolocodon you take, or how often you take it, without talking to your doctor first.

If any of the following side effects gets serious or lasts longer than a few days, tell your doctor or pharmacist:

Very common (affects more than 1 in 10 people)

•    Feeling sleepy or drowsy

•    Feeling dizzy

•    Headaches

•    Constipation, feeling sick (nausea), being sick (vomiting)

•    Itchy skin.

Common (affects less than 1 in 10 people)

•    Skin disorders such as rash, rarely increased sensitivity to light (photosensitivity), in isolated cases itchy (urticaria) or scaly rash (exfoliative dermatitis)

•    Loss of appetite (anorexia), gastrointestinal disorders such as bellyache, diarrhoea, belching, upset stomach (dyspepsia)

•    Feeling weak (asthenia)

•    Several psychological side effects such as changes in mood (e.g. anxiety, depression, euphoria), changes in energy levels (mostly sedation, sometimes accompanied by lethargy, occasionally feeling more alert with restlessness, nervousness and sleep disorders) and changes in performance (thought process disorder, confusion, rarely amnesia, isolated cases of speech disorders), Pins and needles (paraesthesia)

•    Lowering of blood pressure, rarely accompanied by symptoms such as pounding or racing heartbeat, fainting,

•    Difficulties in breathing, wheezing or shortness of breath

•    Dry mouth, rarely accompanied by thirst and difficulty swallowing

•    Sweating and even chills.

Uncommon (affects less than 1 in 100 people)

•    Change in perception such as feeling detached from yourself (depersonalization), feeling depressed or on the contrary extremely happy, seeing or hearing things which are not there hallucinations), change in taste, visual disturbances, abnormally acute sense of hearing (hyperacousis)

•    Both increased and decreased muscle tone, trembling (tremor), tics, reduced sense of touch (hypaesthesia), coordination disturbances

•    Feeling unwell, accelerated pulse, widening of the blood vessels (vasodilatation)

•    Increased coughing, pharyngitis, runny nose, voice changes

•    Biliary colics, oral ulcers, inflammation of the gums, inflamed mouth (stomatitis), flatulence

•    Disturbances of sexual function, injuries due to accidents, pain (e.g. chest pain)

•    Excessive fluid in the tissues (oedema)

•    Migraine

•    Physical dependence with withdrawal symptoms

•    Allergic reactions, changes in tear secretion

•    The pupil in the centre of the eye gets smaller.

Rare (affects less than 1 in 1000 people)

•    Lymph node disease (lymphadenopathy)

•    Lack of water in the body (dehydration)

•    Seizures, in particular in patients suffering from epilepsy or with a tendency to seizures, muscle spasms (involuntary contraction of the muscle)

•    Gum bleeding, increased appetite, tarry stool, tooth staining and damage,

•    Dry skin, herpes simplex (disorder of the skin and mucosa)

•    Blood in urine (haematuria), absence of menstrual bleeding (amenorrhoea), changes in body weight (loss or rise), cellulitis.

Very rare (affects less than 1 in 10000 people):

• Severe hypersensitivity reactions (anaphylactic reactions).

If any of the side effects gets serious, lasts longer than a few days or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE DOLOCODON

6. FURTHER INFORMATION

What Dolocodon tablets contain:

The active substance is oxycodone hydrochloride.

Each:

•    5mg prolonged-release tablet contains 5mg oxycodone hydrochloride equivalent to 4.5mg oxycodone.

•    10mg prolonged-release tablet contains 10mg oxycodone hydrochloride equivalent to 9mg oxycodone.

•    20mg prolonged-release tablet contains 20mg oxycodone hydrochloride equivalent to 17.9mg oxycodone.

•    40mg prolonged-release tablet contains 40mg oxycodone hydrochloride equivalent to 36mg oxycodone.

The other ingredients are:

Active pellets: Sugar spheres (sucrose, maize starch), hypromellose, talc.

Pellet coating: Ethylcellulose, hydroxypropylcellulose, propylene glycol.

Final blending: Carmellose sodium, microcrystalline cellulose, magnesium stearate [plant-based], colloidal anhydrous silica.

Tablet coating: Titanium dioxide (E 171), hypromellose, macrogol 6000, talc.

•    Dolocodon 10 mg: iron (III) oxide red (E 172)

•    Dolocodon 40 mg: iron (III) oxide red(E 172)

What Dolocodon tablets look like and contents of the pack

•    Dolocodon 5 mg: white to off white, round, biconvex film coated tablets.

•    Dolocodon 10 mg: pink, oblong, biconvex film coated tablets with break scores on both sides.

•    Dolocodon 20 mg: white to off white, oblong, biconvex film coated tablets with break scores on both sides.

•    Dolocodon 40 mg: pink, oblong, biconvex film coated tablets with break scores on both sides.

Pack sizes:

10, 20, 28, 30, 56, 60, 90, 98, 112, 120 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Zentiva

One Onslow Street, Guildford, Surrey,

GU1 4YS, UK

Manufacturer

ZENTIVA k.s., U kabelovny 130, 102 37 Prague 10, Czech Republic

Or

Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

This leaflet was last updated in March 2014

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