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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Your medicine is called Targinact 10 mg/5 mg or 20 mg/10 mg prolonged release tablets, but will be referred to as Targinact tablets. Targinact 5 mg/2.5 mg and 40 mg/20 mg tablets are also available.

In this leaflet:

1.    What Targinact tablets are and what they are used for

2.    What you need to know before you take Targinact tablets

3.    How to take Targinact tablets

4.    Possible side effects

5.    How to store Targinact tablets

6.    Contents of the pack and other information

1. What Targinact tablets are and what they are used for

You have been prescribed Targinact tablets for the treatment of severe pain, which can be adequately managed only with opioid analgesics. Naloxone is added to counteract constipation.

How Targinact tablets work These tablets contain two medicines; oxycodone hydrochloride and naloxone hydrochloride. Oxycodone is responsible for the painkilling effect of the tablets.

It is a strong analgesic ('painkiller’) that belongs to a group of medicines called opioids. Naloxone is intended to bring relief from constipation. Constipation is a typical side effect of treatment with strong painkillers.

These are prolonged-release tablets. This means that the active ingredients are slowly released from the tablets over a period of 12 hours.

Do not take Targinact tablets

•    if you are allergic (hypersensitive) to oxycodone or naloxone, or any of the other ingredients of the tablets (listed in section 6);

•    if you have breathing problems, such as breathing more slowly or weakly than expected (respiratory depression);

•    if you suffer from a severe lung disease associated with narrowing of the airways (chronic obstructive pulmonary disease or COPD);

•    if you suffer from a condition known as cor pulmonale. In this condition, the right side of the heart becomes enlarged, due to increased pressure inside blood vessels in the lung etc. (e.g. as a result of COPD - see above);

•    if you suffer from severe bronchial asthma;

•    if you have a type of bowel obstruction (paralytic ileus) not caused by opioids;

•    if you have moderate to severe liver problems.

Warnings and Precautions

Talk to your doctor or pharmacist

before taking these tablets:

•    in the case of elderly or debilitated (weak) patients;

•    if you have a type of bowel obstruction (paralytic ileus) caused by opioids;

•    if you have kidney problems;

•    if you have mild liver problems;

•    if you have severe lung problems (i.e. reduced breathing capacity);

•    if you have myxoedema (a thyroid disorder, with dryness, coldness and swelling [‘puffiness’] of the skin, affecting the face and limbs);

•    if your thyroid gland is not producing enough hormones (underactive thyroid or hypothyroidism);

•    if your adrenal glands are not producing enough hormones (adrenal insufficiency or Addison's disease);

•    if you have a mental disorder as a result of an intoxication (toxic psychosis);

•    if you suffer from gallstone problems;

•    if your prostate gland is abnormally enlarged (prostate hypertrophy);

•    if you are or ever have been addicted to alcohol or drugs, or have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating upon stopping alcohol or drugs;

•    if your pancreas is inflamed (pancreatitis);

•    if you have low blood pressure (hypotension);

•    if you have high blood pressure (hypertension);

•    if you have heart problems;

•    if you have a head injury (due to the risk of increased brain pressure);

•    if you suffer from epilepsy or are prone to fits;

•    if you are also taking a type of medicine known as a MAO inhibitor (used to treat depression or Parkinson's disease) e.g. medicines containing tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolid.

These tablets are not recommended for use in patients with advanced digestive or pelvic cancers where bowel obstruction may be a problem.

Children and adolescents

These tablets must not be given to children or adolescents under 18 years of age as the safety and benefits have not been shown yet.

How to use Targinact tablets correctly

If you experience severe diarrhoea at the start of treatment (within the first 3-5 days) this may be due to the effect of naloxone. It may be a sign that your bowel movements are returning to normal. If diarrhoea persists after 3-5 days, or it gives you cause for concern, please contact your doctor.

If you have been using high doses of another opioid, withdrawal symptoms (such as restlessness, bouts of sweating or muscle pain) may occur when you initially switch to taking these tablets. If you experience withdrawal symptoms, you may need to be specially monitored by your doctor.

If you need to undergo surgery, please tell your doctor that you are taking these tablets.

If you have been taking these tablets for a long time, you may become tolerant. This means you may need a higher dose to achieve the desired pain relief. Long-term use of these tablets may also lead to addiction. Withdrawal symptoms may occur if treatment is stopped too suddenly. If you no longer need treatment, you should reduce your daily dose gradually, in consultation with your doctor.

As with other strong opioid painkillers, there is a risk that you may develop a psychological dependence to oxycodone. You may notice remains of the tablet in your stools. Do not be alarmed, as the active ingredients will have already been released in the stomach and gut, and absorbed into your body.

Incorrect use of Targinact tablets You must swallow these tablets whole so as not to affect the slow release of oxycodone. Do not break, chew or crush these tablets. Taking broken, chewed or crushed tablets may result in your body absorbing a potentially fatal dose of oxycodone (see under ‘If you take more Targinact tablets than you should’).

These tablets are not suitable for withdrawal treatment.

These tablets should never be abused, particularly if you have a drug addiction. If you are addicted to drugs such as heroin, morphine or methadone, severe withdrawal symptoms are likely if you abuse these tablets because they contain the ingredient naloxone. Pre-existing withdrawal symptoms may be made worse.

You should never misuse the tablets by dissolving and injecting them (e.g. into a blood vessel). They contain talc, which can cause destruction of local tissue (necrosis) and changes in lung tissue (lung granuloma). Misuse can also have other serious consequences which may be fatal. The use of these tablets may produce positive results in drugs tests.

Other medicines and Targinact tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The risk of side effects is increased if you take these tablets at the same time as medicines which affect the way the brain works. For example, you may feel very sleepy, or breathing problems may get worse.

Examples of medicines that affect the way the brain works include:

•    other strong painkillers (opioids);

•    sleep medication and tranquillisers (sedatives, hypnotics);

•    antidepressants;

•    medicines used to treat allergies, travel sickness or nausea (antihistamines or antiemetics);

•    other medicines which act on the nervous system (phenothiazines, neuroleptics).

Tell your doctor if you are taking;

•    medicines that decrease the blood's clotting ability (coumarin derivatives), this clotting time may be speeded up or slowed down;

•    antibiotics of the macrolide type (such as clarithromycin);

•    antifungal medicines of the -azole type (e.g. ketoconazole);

•    ritonavir or other protease inhibitors (used to treat HIV);

•    rifampicin (used to treat tuberculosis);

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

•    phenytoin (used to treat seizures, fits or convulsions).

Targinact tablets with food, drink and alcohol

Drinking alcohol whilst taking Targinact tablets 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 Targinact.

You should avoid drinking grapefruit juice while you are taking these tablets. Pregnancy and breastfeeding

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

Pregnancy

Use of these tablets during pregnancy should be avoided unless your doctor thinks treatment with this medicine is essential. If used over prolonged periods during pregnancy, oxycodone may lead to withdrawal symptoms in the newborn baby. If oxycodone is given during childbirth, the baby may have breathing problems (respiratory depression). Breastfeeding

Breastfeeding should be stopped during treatment with these tablets as oxycodone (one of the active ingredients of your medicine) passes into breast milk. Driving and using machines This medicine can affect your ability to drive as it may make you sleepy or dizzy. This is most likely at the start of your treatment, after a dose increase or after switching from a different medication. These side effects should disappear once you are on a stable dose.

•    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 according 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.

Targinact tablets contain lactose

These tablets contain lactose (milk sugar). If you have been told that you have an intolerance to some sugars, contact your doctor before taking these tablets.

Always take these tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults

The usual starting dose is 10 mg oxycodone hydrochloride / 5 mg naloxone hydrochloride every 12 hours.

Your doctor will decide how much you should take every day and how to divide your total daily dose into morning and evening doses. They will also decide on any necessary dose adjustments during treatment depending on your level of pain and individual sensitivity. You should be given the lowest dose needed for pain relief. If you have already been treated with opioids, your treatment with these tablets may be started at a higher dose. The maximum daily dose is 80 mg oxycodone hydrochloride and 40 mg naloxone hydrochloride. If you need a higher dose, your doctor may give you additional oxycodone without naloxone. However, the maximum daily dose of oxycodone should not exceed 400 mg. The beneficial effect of naloxone on bowel movements may be affected if additional oxycodone is given without additional naloxone.

If you experience pain between doses, you may need to take an additional fast-acting painkiller. These tablets are not suitable for this. Please talk to your doctor.

If you feel that these tablets are too strong or too weak, please talk to your doctor or pharmacist.

Liver or kidney problems

If you have kidney or mild liver problems your doctor may prescribe a lower dose. You must not take these tablets if you have moderate or severe liver problems,

(see also Section 2 ‘Do not take Targinact tablets’ and Take special care with Targinact tablets’).

Children and adolescents below 18 years of age

No studies have been carried out to show that these tablets work properly in children and adolescents, or are safe for them to take. They are therefore not recommended for use in patients under 18 years of age. Elderly patients

In general, no dose adjustment is necessary for elderly patients with normal kidney and/or liver function.

Method of administration Swallow your tablets whole with a glass of water. You can take these tablets with or without food. Take them 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. Do not break, chew or crush the tablets. Duration of use

You should not take these tablets for any longer than you need to. If you have been taking them for a long time your doctor should regularly check that you still need them.

If you take more Targinact tablets than you should

If you have taken more than the prescribed dose, you must inform your doctor immediately.

An overdose may result in:

•    a reduction in size of pupils in the eye;

•    breathing more slowly or weakly than expected (respiratory depression);

•    drowsiness or loss of consciousness;

•    low muscle tone (hypotonia);

•    reduced pulse rate;

•    a fall in blood pressure.

In severe cases, loss of consciousness (coma), fluid on the lungs and circulatory collapse may occur, which may be fatal. You should avoid situations which require you to be alert, e.g. driving.

If you forget to take Targinact tablets,

or if you take a lower dose than the one prescribed, you may not feel any painkilling effect.

•    If you forget to take your tablets and your next usual dose is due in 8 hours time or more: Take the forgotten tablet immediately and continue with your normal dosing routine.

•    If your next usual dose is due in less than 8 hours time: Take the forgotten tablet, then, wait another 8 hours before taking your next tablet. Try to get back in your normal dosing routine (e.g. 8 o’clock in the morning and 8 o’clock in the evening).

Do not take more than one dose within any 8 hour period.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Targinact tablets

Do not stop taking these tablets without first speaking with your doctor. If you do not require any further treatment, your doctor will advise you how to reduce the daily dose gradually. In this way, you will avoid withdrawal symptoms, such as restlessness, bouts of sweating and muscle pain.

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

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

The following terms are used to explain how frequently patients experience side effects:

Very common: may affect more than 1 in 10 people taking these tablets

may affect up to 1 in 10 people taking these tablets

may affect up to 1 in 100 people taking these tablets

may affect up to 1 in

1.000    people taking these tablets

may affect up to 1 in

10.000    people taking these tablets frequency cannot be estimated from the available data

Important side effects or signs to look out for, and what to do if you are affected:

The most serious side effect is a condition where you breathe more slowly or weakly than expected (respiratory depression). It mostly occurs in elderly and weak patients. Opioids can also cause a severe drop in blood pressure in susceptible patients. If you are affected by these important side effects, consult a doctor immediately.

Other important side effects are: Common

•    abdominal pain

•    constipation

•    diarrhoea

•    sweating

•    hot flushes

•    dry mouth

•    indigestion

•    wind

•    feeling or being sick

•    difficulty in sleeping

•    loss of appetite

•    general weakness

•    headache

•    itchy skin

•    skin reactions/rash

•    a feeling of dizziness or ‘spinning’

•    drowsiness Uncommon

•    abdominal bloating

•    difficulty in concentrating

•    withdrawal symptoms such as agitation

•    difficulties with speech

•    fall in blood pressure

•    rise in blood pressure

•    chest pain

•    restlessness

•    generally feeling unwell

•    chills

•    swelling of the hands, ankles or feet

•    abnormal thoughts

•    anxiety

•    confusion

•    depression

•    nervousness

•    colicky abdominal pain or discomfort

•    pain

•    weight loss

•    shaking

•    shortness of breath

•    palpitations

•    vision impairment

•    hypersensitivity/allergic reactions

•    an increased risk of accidental injuries

•    chest tightness (especially if you already have heart problems)

•    runny nose

•    cough

•    a sudden urge to pass urine

•    muscle pain, cramps or twitches

•    changes in the results of blood tests that show how well your liver is working

•    fainting

•    epileptic fits (especially in people with epilepsy or a predisposition to fits)

Rare

•    increase in pulse rate

•    dental changes

•    yawning

•    weight gain Not known

•    a feeling of extreme happiness

•    severe drowsiness

•    impotence

•    nightmares

•    hallucinations

•    breathing more slowly or weakly than expected

•    difficulty in passing urine

•    tingling or numbness in the hands or feet

•    belching

The active ingredient oxycodone hydrochloride, if not combined with naloxone hydrochloride, is known to have the following differing side effects:

Breathing problems, such as breathing more slowly or weakly than expected (respiratory depression), reduction in size of the pupils in the eye, muscle cramps and decreased cough reflex.

Common

•    altered mood and personality changes (e.g. depression, a feeling of extreme happiness)

•    decreased or increased activity

•    difficulty in passing urine

•    hiccups

Uncommon

•    difficulty in concentrating

•    voice alteration

•    difficulty in hearing

•    mouth ulcers

•    sore gums

•    flushing of the skin

•    migraines

•    changes in taste

•    increased muscle tension

•    involuntary muscle contractions

•    reduced sensitivity to pain or touch

•    problems with coordination

•    water retention

•    perception disturbances (e.g. hallucinations, feeling detached)

•    decreased sexual drive

•    drug dependence

•    dry skin

•    a condition where the small bowel (part of your gut) does not work properly (ileus)

•    a need to take increasingly higher doses to gain the same level of pain relief (tolerance)

•    difficulty in swallowing

•    dehydration

•    agitation

•    thirst Rare

•    increased appetite

•    infections such as cold sores or herpes (which may cause blisters around the mouth or genitals)

•    dark coloured, tarry stools

•    bleeding gums

•    itchy rash (urticaria)

Not known

•    serious allergic reactions

•    absence of menstrual periods

•    problems with bile flow

If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

What Targinact tablets contain

The active ingredients are oxycodone hydrochloride and naloxone hydrochloride.

Each 10 mg/5 mg prolonged release tablet contains 10 mg of oxycodone hydrochloride (equivalent to 9 mg oxycodone), and 5.45 mg naloxone hydrochloride dihydrate (equivalent to 5 mg naloxone hydrochloride and 4.5 mg naloxone).

Each 20 mg/10 mg prolonged release tablet contains 20 mg of oxycodone hydrochloride (equivalent to 18 mg oxycodone) and 10.9 mg naloxone hydrochloride dihydrate (equivalent to 10 mg naloxone hydrochloride and 9 mg naloxone).

The other ingredients are:

Tablet core:

povidone K30, ethyl cellulose, stearyl alcohol, lactose monohydrate, talc, magnesium stearate.

Tablet coat:

polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc. The 20 mg/10 mg tablets also contain iron (III) oxide red (E172).

What Targinact tablets look like and the contents of the pack

Targinact 10 mg/5 mg tablets are white, oblong, film coated tablets, marked “OXN” on one side and “10” on the other.

Targinact 20 mg/10 mg tablets are pink, oblong, film coated tablets, marked “OXN” on one side and “20” on the other.

In each box there are 28 or 56 tablets.

Manufacturers:

Mundipharma GmbH

Mundipharma Str. 2, 65549 Limburg -

Germany

BARD Pharmaceuticals Ltd.,

191 Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UK. Procured from within the EU.

Product Licence Holder and repackaged by: S.C.A.C. Ltd., Unit2A, Bandeath Industrial Estate, Throsk, Stirling,

FK7 7NP, United Kingdom.

Targinact® 10 mg/5 mg PL30984/0106 Targinact® 20 mg/10 mg PL30984/0107

This leaflet was last revised in 14/01/2015

Targinact® is a registered trade mark of Mundipharma AG