Renocontin 20 mg prolonged-release tablets – patient leaflet, side effects, dosage

1. What Renocontin is and what it is used for

Renocontin (oxycodone hydrochloride) is a centrally acting, strong painkiller from the group of opioids.

Renocontin is used to treat severe pain, which can be adequately managed only with opioid analgesics. Renocontin is indicated in adults and adolescents aged 12 years and older.

2. What you need to know before you take Renocontin

Do not take Renocontin

• if you are allergic to oxycodone hydrochloride or any of

  the other ingredients of this medicine (listed in section 6),

• if you 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,

• if you 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;

• if you have a heart problem after long-term lung disease

  (cor pulmonale);

• if you have a head injury that causes a severe headache

  or makes you feel sick. This is because the tablets may make these symptoms worse or hide the extent of the head injury,

• if you have severe kidney problems or moderate to severe

  liver problems. If you have other long-term kidney or liver problems you should only take these tablets if recommended by your doctor,

• if you have ongoing problems with constipation,

• if you are taking a type of medicine known as a

  monoamine oxidase inhibitor (examples include tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolid), or you have taken this type of medicine in the last two weeks.

Warnings and precautions

Talk to your doctor or pharmacist before taking Renocontin

• if you are elderly or weakened;
• if you have lung, liver or kidney problems;

• if you suffer from myxoedema (a thyroid disorder with

  dryness, coldness and swelling[‘puffiness’] of the skin affecting the face and limbs);

• if you have an under-active thyroid gland

  (hypothyroidism), as you may need a lower dose;

• if you have poor adrenal gland function (your adrenal

  gland is not working properly), e.g. Addison’s disease;

• if you have an enlarged prostate gland, which causes

  difficulty in passing urine (in men);

• if you 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;

• if you have kidney or liver problems;

• if you have previously suffered from withdrawal

  symptoms such as agitation, anxiety, shaking or sweating, upon stopping taking alcohol or drugs;

• if you have inflammatory bowel disease;

• if you have inflammation of the pancreas which causes

  severe pain in the abdomen and back (pancreatitis);

• if you have head injury, severe headache or feel sick as this

  may indicate that the pressure in your skull is increased;

• if you have problems with the gall bladder, bile duct or the

  ureter;

• if you have epilepsy or have tendency to suffer seizures, fits

  or convulsions;

• if you take MAO inhibitors (a medicine for the treatment

  of depression);

• if you have a severe headache or feel sick as this may

  indicate that the pressure in your skull is increased;

• if you have low blood pressure (hypotension);

• if you have low blood volume (hypovolaemia); this can

  happen with severe external or internal bleeding, severe burns, excessive sweating, severe diarrhoea or vomiting;

• if you have a mental disorder as a result of an infection

  (toxic psychosis);

• if you have an increased sensitivity to pain;

• if you need to take increasingly higher doses of oxycodone

  to gain the same level of pain relief (tolerance). Talk to your doctor if any of these apply to you or if any of these conditions applied to you in the past. If you are going to have an operation, please tell the doctor at the hospital that you are taking these tablets.

Tolerance, dependence and addiction

This medicine contains oxycodone which is an opioid medicine. Repeated use of opioid painkillers can result in the drug being less effective (you become accustomed to it, known as tolerance).

Repeated use of Renocontin may lead to dependence, abuse and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use. Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it. You might feel that you need to carry on taking your medicine, even when it doesn’t help to relieve your pain. The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent or addicted on Renocontin if:

• you or anyone in your family have ever abused or been

  dependent on alcohol, prescription medicines or illegal drugs (“addiction”);

• you are a smoker;

• you have ever had problems with your mood (depression,

  anxiety or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs whilst taking Renocontin, it could be a sign that you have become dependent or addicted.

• You need to take the medicine for longer than advised by

  your doctor

• You need to take more than the recommended dose

• You are using the medicine for reasons other than

  prescribed, for instance, ‘to stay calm’ or ‘help you sleep’

• You have made repeated, unsuccessful attempts to quit or

  control the use of the medicine

• When you stop taking the medicine you feel unwell,

  and you feel better once taking the medicine again (‘withdrawal effects’)

If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop taking Renocontin).

Renocontin has a primary dependence potential. When used for a long time tolerance to the effects and progressively higher doses may be required to maintain pain control. Chronic use of Renocontin may lead to physical dependence and a withdrawal syndrome may occur if you stop using the product suddenly. When a patient no longer requires therapy with oxycodone hydrochloride, it may advisable to decrease the dose gradually to prevent symptoms of withdrawal. Renocontin are for oral use only. In case of abusive injection (injection in a vein) the tablet excipients (especially talc) may lead to destruction (necrosis) of the local tissue, change of lung tissue (granulomas of the lung) or other serious, potentially fatal events.

This medicine should be avoided in patients with a history of or present alcohol and drug abuse.

Anti-doping warning

Athletes should be aware that this medicine may cause a positive reaction to “anti-doping tests”. Use of Renocontin as a doping agent may become a health hazard.

Children and adolescents

Oxycodone has not been investigated in children under 12 years. Safety and efficacy have not been established therefore use in children under 12 years of age is not recommended. Sleep-related breathing disorders

Renocontin can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

Other medicines and Renocontin

Concomitant use of Renocontin and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However if your doctor does prescribe Renocontin together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s

dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the

signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

The risk of side effects increases, if you use antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone 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. Contact your doctor when experiencing such symptoms.

Please follow your doctor’s dosage recommendation closely. It could be helpful to inform friends or relatives to be aware of sign and symptoms stated above. Contact your doctor when experiencing such symptoms.

Please tell your doctor or pharmacist if you are taking have recently taken or might take 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.

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 hypnotics or sedatives, including benzodiazepines);
• 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 sezures, 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.

Renocontin with food, drink and alcohol

Drinking alcohol whilst taking Renocontin 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 are taking Renocontin.

You should avoid drinking grapefruit juice during your treatment with Renocontin.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy

Renocontin should not be taken in pregnancy unless clearly necessary. There are only limited data from the use of oxycodone in pregnant women.

Oxycodone crosses the placenta into the blood circulation of the baby.

Prolonged use of oxycodone during pregnancy can cause withdrawal symptoms in newborns. Use of oxycodone during delivery can cause respiratory depression in the newborn. Breast-feeding

You should not take Renocontin when you are breast-feeding as oxycodone passes into breast milk.

Driving and using machines

Renocontin may impair your ability to drive or use machines. This is particularly likely at the start of treatment with Renocontin, after a dose increase or changes in your medicinal product therapy and if Renocontin is combined with medicines which may affect brain function. General driving restrictions may not apply during stable treatment. Your doctor makes this decision based upon your individual situation. Please discuss with your doctor whether or not, or under which conditions you may drive or use 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:

  • The medicine has been prescribed to treat a medical or dental problem and
  • You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
  • 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. Renocontin contains lactose

If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product.

3. How to take Renocontin

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using Renocontin, when and how long you need to take it, when to contact your doctor, and when you need to stop it (see also if you stop taking Renocontin).

Adults and adolescents (12 years of age and older)

The usual initial dose is 10 mg oxycodone hydrochloride every 12 hours. However, your doctor will prescribe the dose required to treat pain. If you find that you are still in pain whilst taking these tablets, discuss this with your doctor. Patients who have already taken opioids can start treatment with higher dosages taking into account their experience with opioid treatment.

Package leaflet: Information for the patient Renocontin 15 mg prolonged-release tablets Renocontin 20 mg prolonged-release tablets Renocontin 30 mg prolonged-release tablets Renocontin 40 mg prolonged-release tablets Renocontin 60 mg prolonged-release tablets Renocontin 80 mg prolonged-release tablets

Oxycodone hydrochloride

For the treatment of non cancer pain a daily dose of 40 mg of oxycodone hydrochloride is generally sufficient, but higher dosages may be necessary.

Patients with cancer pain usually require dosages from 80 to 120 mg of oxycodone hydrochloride which may be increased up to 400 mg in individual cases.

For those doses where this particular strength is not suitable for you, other strengths of this medicinal product are available.

Special populations

If you have impaired kidney and/or liver function or if you have a low body weight your doctor may prescribe a lower starting dose.

Method of administration

Swallow the prolonged-release tablet whole with a sufficient amount of liquid (½ glass of water) with or without food in the morning and in the evening following a fixed schedule (e.g. at 8 a.m. and 8 p.m.).

The tablets must be swallowed whole, not chewed, divided or crushed as this leads to rapid oxycodone release due to the damage of the prolonged release properties. The administration of chewed, divided or crushed prolonged-release tablets leads to a rapid release and absorption of a potentially fatal dose of oxycodone (see section “If you take more Renocontin than you should”).

Renocontin should not be taken with alcoholic beverages. Opening instructions:

This medicinal product is in child resistant packaging. The prolonged-release tablets cannot be pressed out of the blister. Please observe the following instructions when opening the blister.

1. 1.

   Pull off a single

   dose by tearing

   along the perforated

   line on the blister.

2. 2.

   An unsealed area

   is exposed/can be

   reached by this; this

   area is at the point

   where the perforated

   lines intersect with each

   other.

3. 3.

   At the unsealed flap,

   peel away the cover

   foil from the bottom

   foil.

Your doctor will decide

your daily dose and when this should be taken, depending on the level of pain you are being treated for. Your dose may be changed during treatment if your doctor thinks it is necessary. You must not change the dose yourself. Some patients who take this medicine regularly each day, sometimes need additional rapid acting pain relief to control breakthrough pain. You should not use additional doses of Renocontin to control breakthrough pain.

Your doctor will regularly monitor your treatment to make sure that your pain is adequately controlled, to treat any side effects that you may experience and to decide if your treatment needs to be continued.

If you take more Renocontin than you should

Call your doctor or hospital straight away. People who have taken an overdose may feel very sleepy, sick or dizzy, or have hallucinations. They may also have a brain disorder (known as toxic leukoencephalopathy), 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 to show to the doctor. You should not drive yourself to hospital if you have taken too many tablets.

If you forget to take Renocontin

If you use a smaller dose of Renocontin than directed or you miss a dose, pain relief will consequently be insufficient or cease altogether.

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

If you stop taking Renocontin

You should not suddenly stop taking these 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, palpitations, shaking or sweating may occur if you suddenly stop taking these tablets. If you have any further questions on how to take 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. As with other strong analgesics or painkillers, there is a risk that you may become reliant (physically dependent) or addicted on these tablets. Significant side effects or signs which you should be aware of and the measures to take if you are affected: If you are affected by any of the following significant side effects, call the next available doctor immediately

• Sudden difficulties in breathing, swelling of the eyelids,

  face or lips, rash or itching especially those covering your whole body – these are signs of severe allergic reactions

• Shallow and slowed down breathing – this occurs most

  commonly if you are elderly and debilitated, or if you have taken too much medicine

• A severe in blood pressure – you may feel dizzy and faint

  if this happens

• Reduction in the size of the pupils in the eye, cramping

  of the bronchial muscles (causing shortness of breath), reduced ability to cough when you need to

Other possible side effects

Very common (may affect more than 1 in 10 people):

• Constipation - this may be countered by preventative

  measures such as drinking plenty of fluids, eating foods rich in fibre

• Vomiting, nausea – especially at the beginning of therapy,

  if you experience nausea or vomiting, your doctor may prescribe medicine to prevent this

• Feel more sleepy than normal (up to sedation), dizziness,

  headache

Common (may affect up to 1 in 10 people):

• Abdominal pain, diarrhoea, dry mouth, hiccups,

  indigestion

• Decreased appetite up to loss of appetite

• Anxiety, confusion, depression, decreased activity,

  restlessness, increased activity, nervousness, difficulty in sleeping, abnormal thinking

• Shaking (tremors), feeling lethargic
• Skin reactions/rash, sweating
• Pain whilst urinating, increased urge to urinate
• A feeling of unusual weakness, fatigue

Uncommon (may affect up to 1 in 100 people):

• Withdrawal symptoms, a need to take increasing doses

  of Renocontin to achieve the same level of pain relief (tolerance)

• Injuries from accidents
• Allergic reactions
• Dehydration

• Agitation, mood swings, a feeling of extreme happiness,

  perception disturbances (e.g. hallucinations, derealisation)

• Decreased sexual drive

• Epileptic seizures (especially in persons with epileptic

  disorder or predisposition to seizures)

• Loss of memory, concentration impaired, migraine

• Unusual muscle stiffness, involuntary muscle contractions,

  reduced sensitivity to pain or touch, abnormal coordination

• Difficulty in speaking, tingling (pins and needles), changes

  in taste

• Impaired vision
• Hearing impaired, a feeling of dizziness or ‘spinning’
• A fast heart beat, palpitations
• Flushing of the skin
• Vocal changes (dysphonia), cough
• Mouth ulcers, sore mouth, difficulty in swallowing

• Flatulance (wind), belching , a condition where the bowel

  stops working properly (ileus)

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

  • Dry skin
  • Inability to fully empty the bladder
  • Impotence, reduced level of sex hormones
  • Chills
  • Pain (e.g. chest pain), generally feeling unwell
  • Swelling of the hands, ankles or feet, thirst Rare (may affect up to 1 in 1,000 people):
  • A feeling of faintness, especially on standing up
  • Dark coloured tarry stools, dental changes, bleeding gums
  • Infections such as cold sores or herpes (which may cause blisters around the mouth or genital area)
  • Increased appetite
  • Hives (urticaria)
  • Weight increase, weight decrease

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

• Aggression
• An increase in sensibility to pain
• Tooth decay
• Colicky abdominal pain, problems with bile flow
• Absence of menstrual periods
• Long term use of Renocontin during pregnancy may cause life threatening withdrawal symptoms in the new-born. Symptoms to look for in the baby include irritability, hyperactivity and abnormal sleep pattern, high pitched cry, shaking, being sick, diarrhea and not putting on weight
• Sleep apnoea (breathing pauses during sleep). Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website:

www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Renocontin

Keep this medicine out of the sight and reach of children. Store this medicine in a locked safe and secure storage space, where other people cannot access it. It can cause serious harm and be fatal to people when it has not been prescribed for them.

Do not use this medicine after the expiry date which is stated on the blister and the carton after “EXP”. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions

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. Content of the pack and other information

What Renocontin contains

• The active substance is oxycodone hydrochloride. [15 mg]:

Each prolonged-release tablet contains 15 mg oxycodone hydrochloride corresponding to 13.5 mg oxycodone. The other ingredients are:

Tablet core:

Lactose monohydrate, Ammonio Methacrylate Copolymer, Type B dispersion 30%, Povidone (K29/32), Talc, Triacetin, Stearyl alcohol, Magnesium stearate

Tablet coating:

Hypromellose, Talc, Macrogol 400, Titanium dioxide (E171), Iron oxide black (E172)

[20 mg]:

Each prolonged-release tablet contains 20 mg oxycodone hydrochloride corresponding to 17.9 mg oxycodone. The other ingredients are:

Tablet core:

Lactose monohydrate, Ammonio Methacrylate Copolymer, Type B dispersion 30%, Povidone (K29/32), Talc, Triacetin, Stearyl alcohol, Magnesium stearate,

Tablet coating:

Hypromellose, Talc, Macrogol 400, Titanium dioxide (E171), Iron oxide red (E172),

[30 mg]:

Each prolonged-release tablet contains 30 mg oxycodone hydrochloride corresponding to 26.9 mg oxycodone. The other ingredients are:

Tablet core:

Lactose monohydrate, Ammonio Methacrylate Copolymer, Type B dispersion 30%, Povidone (K29/32), Talc, Triacetin, Stearyl alcohol, Magnesium stearate

Tablet coating:

Hypromellose, Talc, Macrogol 400, Titanium dioxide (E171), Iron oxide brown (E172), Iron oxide black (E172) [40 mg]:

Each prolonged-release tablet contains 40 mg oxycodone hydrochloride corresponding to 35.9 mg oxycodone. The other ingredients are:

Tablet core:

Lactose monohydrate, Ammonio Methacrylate Copolymer, Type B dispersion 30%, Povidone (K29/32), Talc, Triacetin, Stearyl alcohol, Magnesium stearate

Tablet coating:

Hypromellose, Talc, Macrogol 400, Titanium dioxide (E171), Iron oxide red (E172), Iron oxide yellow (E172) [60 mg]:

Each prolonged-release tablet contains 60 mg oxycodone hydrochloride corresponding to 53.8 mg oxycodone. The other ingredients are:

Tablet core:

Lactose monohydrate, Ammonio Methacrylate Copolymer, Type B dispersion 30%, Povidone (K29/32), Talc, Triacetin, Stearyl alcohol, Magnesium stearate

Tablet coating:

Hypromellose, Talc, Macrogol 400, Titanium dioxide (E171), Iron oxide red (E172),

Erythrosine (E127)

[80 mg]:

Each prolonged-release tablet contains 80 mg oxycodone hydrochloride corresponding to 71.7 mg oxycodone. The other ingredients are:

Tablet core:

Lactose monohydrate, Ammonio Methacrylate Copolymer, Type B dispersion 30%, Povidone (K29/32), Talc, Triacetin, Stearyl alcohol, Magnesium stearate

Tablet coating:

Hypromellose, Macrogol 400, Titanium dioxide (E171), Indigo carmine aluminium lake (E132), Iron oxide yellow (E172)

What Renocontin looks like and contents of the pack

[Renocontin 15 mg prolonged-release tablets:] Grey, round, biconvex, prolonged-release tablets with a diameter of 6.9 – 7.3 mm and a height of 3.2 – 3.9 mm. [Renocontin 20 mg prolonged-release tablets:] Light pink, round, biconvex, prolonged-releasetablets with a diameter of 6.9 – 7.3 mm and a height of 3.2 – 3.9 mm. [Renocontin 30 mg prolonged-release tablets:] Brown, round, biconvex, prolonged-release tablets with a diameter of 6.9 – 7.3 mm and a height of 3.2 – 3.9 mm. [Renocontin 40 mg prolonged-release tablets:] Light orange to ochre, round, biconvex, prolonged-release tablets with a diameter of 6.9 – 7.3 mm and a height of 3.2 – 3.9 mm.

[Renocontin 60 mg prolonged-release tablets:] Pink-red, round, biconvex, prolonged-release tablets with a diameter of 8.6 – 9.0 mm and a height of 4.6 – 5.3 mm. [Renocontin 80 mg prolonged-release tablets:] Green, round, biconvex, prolonged-release tablets with a diameter of 8.6 – 9.0 mm and a height of 5.0 – 5.6 mm. Renocontin is available for 10, 14, 20, 25, 28, 30, 40, 50, 56, 60, 98 and 100 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Glenmark Pharmaceuticals Europe Limited

Laxmi House, 2B Draycott Avenue, Kenton, Middlesex HA3 0BU

United Kingdom

Manufacturer:

SK Pharma Logistics GmbH

Remusweg 8

33729 Bielefeld

Germany

This leaflet was last revised in February 2023.

PRODUCT: Amends: Approval:

Indesign CS 5

GM568

Renocontin 15/20/30/40/60/80 mg prolonged-release tablets

UK (Oxycodone hydrochloride)

17.5.16

200x690 mm

18

17.2.23

gc

Leaflet

Text free

Y

Times New Roman ALL10.5 pts body copy (min)

Internal proof approval

External proof approval Signed (digitally)

Signed (digitally)

off (digitally):