Package leaflet: Information for the user

Oxycodone Hydrochloride 5mg/5ml Oral Solution (referred to as Oxycodone 5mg/5ml Solution in this leaflet)

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, please 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. See section 4.

What is in this leaflet:

1.    What Oxycodone 5mg/5ml Solution is and what it is used for

2.    What you need to know before you take Oxycodone 5mg/5ml Solution

3.    How to take Oxycodone 5mg/5ml Solution

4.    Possible side effects

5.    How to store Oxycodone 5mg/5ml Solution

6.    Contents of the pack and other information

1. What Oxycodone 5mg/5ml Solution is and what it is used for

This medicine has been prescribed for you by your doctor to relieve moderate to severe pain. It contains the active ingredient oxycodone which belongs to a group of medicines called strong analgesics or ‘painkillers'.

2. What you need to know before you take Oxycodone 5mg/5ml Solution

Do not take Oxycodone 5mg/5ml Solution if you:

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

•    have breathing problems, such as severe chronic obstructive lung disease, severe bronchial asthma or severe respiratory depression. Your doctor will have told you if you have any of these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected;

•    have a condition where the small bowel does not work properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying) or you have severe pain in your abdomen;

•    have a heart problem after long-term lung disease (cor pulmonale);

•    have moderate to severe liver problems. If you have other long-term liver problems you should only take this medicine if recommended by your doctor;

•    have ongoing problems with constipation;

•    are under 18 years of age.

Warnings and precautions

Talk to your doctor before using Oxycodone 5mg/5ml Solution if you:

•    are elderly or weakened;

•    have an under-active thyroid gland (hypothyroidism), as you may need a lower dose;

•    have myxoedema (a thyroid disorder with dryness, coldness and swelling (‘puffiness') of the skin affecting the face and limbs;

•    have a head injury, severe headache or feel sick as this may indicate that the pressure in your skull is increased;

•    have low blood pressure (hypotension);

•    have low blood volume (hypovolaemia); this can happen with severe external or internal bleeding, severe burns, excessive sweating, severe diarrhoea or vomiting;

•    have a mental disorder as a result of an infection (toxic psychosis);

•    have inflammation of the pancreas (which causes severe pain in the abdomen and back);

•    have problems with your gall bladder or bile duct; have inflammatory bowel disease;

•    have an enlarged prostate gland, which causes difficulty in passing urine (in men);

•    have poor adrenal gland function (your adrenal gland is not working properly which may cause symptoms including weakness, weight loss, dizziness, feeling or being sick), e.g. Addison's disease;

•    have breathing problems such as severe pulmonary disease. Your doctor will have told you if you have this condition. Symptoms may include breathlessness and coughing;

•    have kidney or liver problems;

•    have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, upon stopping taking alcohol or drugs;

•    are or have ever been addicted to alcohol or drugs or have a known opioid dependence;

•    have an increased sensitivity to pain;

•    need to take increasingly higher doses of Oxycodone 5mg/5ml Solution to gain the same level of pain relief (tolerance).

If you are going to have an operation, please tell the doctor at the

hospital that you are taking this medicine.

Other medicines and Oxycodone 5mg/5ml Solution

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you take this medicine with some other medicines, the effect of this medicine or the other medicine may be changed.

Tell your doctor or pharmacist if you are taking:

•    a type of medicine known as a monoamine oxidase inhibitor or you have taken this type of medicine in the last two weeks;

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

•    medicines to treat depression (such as paroxetine);

•    medicines to treat psychiatric or mental disorders (such as phenothiazines or neuroleptic drugs);

•    other strong analgesics (‘painkillers');

•    muscle relaxants;

•    medicines to treat high blood pressure;

•    quinidine (a medicine to treat a fast heart beat);

•    cimetidine (a medicine for stomach ulcers, indigestion or heartburn);

•    antifungal medicines (such as ketoconazole, voriconazole, itraconazole and posaconazole);

•    antibiotics (such as clarithromycin, erythromycin or telithromycin);

•    medicines known as ‘protease inhibitors' to treat HIV (e.g. boceprevir, ritonavir, indinavir, nelfinavir or saquinavir);

•    rifampicin (to treat tuberculosis);

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

•    phenytoin (a medicine to treat seizures, fits or convulsions);

•    a herbal remedy called St. John's Wort (also known as Hypericum perforatum);

•    antihistamines;

•    medicines to treat Parkinson's disease.

Also tell your doctor if you have recently been given an anaesthetic.

Oxycodone 5mg/5ml Solution with food, drink and alcohol

Drinking alcohol during your treatment with this medicine may make you 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 Oxycodone 5mg/5ml Solution liquid.

You should avoid drinking grapefruit juice during your treatment with this medicine.

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant or breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines

This medicine may cause a number of side effects such as drowsiness which could affect your ability to drive or use machinery (see section 4 for a full list of side effects).

These are usually more noticeable when you first start taking this medicine, 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.

Do not drive whilst taking this medicine until you know how this medicine affects you.

It may be an offence to drive if your ability to drive safely is affected.

There is further information for patients who are intending to drive in Great Britain - go to http://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.

Oxycodone 5mg/5ml Solution contains sodium A total daily dose of 400mg of this medicine contain approximately 277mg sodium. To be taken into consideration in patients in patients with a control sodium diet.

3. How to take Oxycodone 5mg/5ml Solution

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

Adults (over 18 years of age)

The usual starting dose is 5mg every four to six hours. However, your doctor will prescribe the dose required to treat your pain. If you find that you are still in pain whilst taking this medicine discuss this with your doctor.

Use in children

Children and adolescents under 18 years of age should not take the medicine.

Patients with kidney and liver disease

Please tell your doctor if you suffer from kidney or liver problems as they may prescribe a lower dose depending on your condition.

Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure.

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You must only take this medicine by mouth. The medicine should never be injected as this may lead to serious side effects, which may be fatal.

If you take more Oxycodone 5mg/5ml Solution than you should or if someone accidentally swallows your medicine

Call your doctor or hospital immediately. People who have taken an overdose may feel very sleepy, sick or dizzy. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. Make sure you take this leaflet and any remaining medicine with you to show the doctor.

If you forget to take Oxycodone 5mg/5ml Solution If you miss a dose you should take the next dose as soon as you remember then carry on as before. Do not take two doses within four hours. Do not take two doses within four hours. Do not take a double dose to make up for a forgotten dose.

If you stop taking Oxycodone 5mg/5ml Solution You should not suddenly stop taking this medicine unless your doctor tells you to. If you want to stop taking this medicine, 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, palpitations, shaking or sweating may occur if you suddenly stop taking this medicine.

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

4. Possible side effects

Like all medicines, this medicine 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). Tell your doctor immediately if this happens to you.

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

Very common side effects

(May affect more than 1 in 10 people)

•    Constipation (your doctor can prescribe a laxative to overcome this problem).

•    Feeling or being 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).

•    Drowsiness (this is most likely when you start taking your medicine or when your dose is increased, but it should wear off after a few days).

•    Dizziness.

•    Headache.

•    Itchy skin.

Common side effects

(May affect more up to 1 in 10 people)

•    Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhoea.

•    Confusion, depression, a feeling of unusual weakness, shaking, lack of energy, tiredness, anxiety, nervousness, difficulty in sleeping, abnormal thoughts or dreams.

•    Difficulty in breathing or wheezing, shortness of breath, decreased cough reflex.

•    Rash.

•    Sweating.

Uncommon side effects

(May affect up to 1 in 100 people)

•    Difficulty in swallowing, belching, hiccups, wind, a condition where the bowel does not work properly (ileus), inflammation of the stomach, changes in taste.

•    A feeling of dizziness or ‘spinning', hallucinations, mood changes, unpleasant or uncomfortable mood, a feeling of extreme happiness, restlessness, agitation, generally feeling unwell, loss of memory, difficulty in speaking, reduced sensitivity to pain or touch, tingling or numbness, seizures, fits or convulsions, blurred vision, fainting, unusual muscle stiffness or slackness, involuntary muscle contractions.

•    Difficulty in passing urine, impotence, decreased sexual drive, low levels of sex hormones in the blood (‘hypogonadism', seen in a blood test).

•    Fast, irregular heart beat, flushing of the skin.

•    Dehydration, thirst, chills, swelling of the hands, ankles or feet.

•    Dry skin, severe flaking or peeling of the skin.

•    Redness of the face, reduction in size of the pupils in the eye, muscle spasm, high temperature.

•    A need to take increasingly higher doses of this medicine to obtain the same level of pain relief (tolerance).

•    Colicky abdominal pain or discomfort.

•    A worsening of liver function tests (seen in a blood test).

Rare side effects

(May affect up to 1 in 1,000 people)

•    Low blood pressure.

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

•    Hives (nettle rash).

Frequency not known

(Frequency cannot be estimated from the available data)

•    An increased sensitivity to pain.

•    Aggression.

•    Tooth decay.

•    Absence of menstrual periods.

•    A blockage in the flow of bile from the liver (cholestasis). This can cause itchy skin, yellow skin, very dark urine and very pale stools.

•    Long term use of Oxycodone 5mg/5ml Solution during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Symptoms to look for in the baby include irritability, hyperactivity and abnormal sleep pattern, high pitched cry, shaking, being sick, diarrhoea and not putting on weight.

Reporting of side effects

If you get any side effects, talk to your doctor, or pharmacist or nurse.

This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting systems listed below:

United Kingdom:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Malta:

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal

By reporting side effects you can help provide more information on the

safety of this medicine.

5. How to store Oxycodone 5mg/5ml Solution

Keep this medicine out of the sight and reach of children.

•    Do not store above 25°C

•    Store in the original package in order to protect from light.

•    Do not use after the expiry date (shown as Exp. On the packaging). The expiry date refers to the last day of the month, your doctor or nurse will check for this.

•    Once opened this medicine must be used within 1 month.

•    Consult a pharmacist if signs of deterioration of the product are observed.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Oxycodone 5mg/5ml Solution contains

The active ingredient is oxycodone hydrochloride. Each 5ml contains oxycodone hydrochloride 5mg (equivalent to 4.5mg oxycodone base). The other ingredients are: citric acid monohydrate, sodium citrate, sodium benzoate, sodium saccharin, hypromellose (methocel-E15 premium LV) and purified water).

What Oxycodone 5mg/5ml Solution looks like and the contents of the pack

This medicine is a clear colourless solution. Each bottle contains 250ml of solution.

Marketing Authorisation Holder:

Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK Manufacturer:

CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK This medicinal product is authorised in the Member States of the EEA under the following names:

UK: Oxycodone Hydrochloride 5mg/5ml Oral Solution Malta: Oxycodone Hydrochloride 5mg/5ml Oral Solution Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only). Please be ready to give the following information:

Product name	Reference number
Oxycodone Hydrochloride 5mg/5ml Oral Solution	PL 29831/0458

This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in 07/2016

WOCKHARDT