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Document: leaflet MAH BRAND_PL 25258-0217 change

• leaflet MAH BRAND_PL 21806-0077
• leaflet MAH BRAND_PL 25258-0217

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10 mm

Package leaflet: Information for the patient

Renocontin 5 mg prolonged-release tablets

Oxycodone hydrochloride

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. See section 4.

What is in this leaflet:

1.    What Renocontin is and what it is used for

2.    What you need to know before you take Renocontin

3.    How to take Renocontin

4.    Possible side effects

5.    How to store Renocontin

6.    Content of the pack and other information

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

•    medicines to treat fungal infections (such as ketoconazole, voriconazole, itraconazole, or posaconazole)

•    medicines used to treat infections (such as clarithromycin, erythromycin or telithromycin)

•    a specific type of medicine known as a protease inhibitor to treat HIV (examples include 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).

Also, tell your doctor if you have recently been given an

anaesthetic.

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.

Other medicines and Renocontin

Tell your doctor or pharmacist if you are taking, 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.

The 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...’).

Tell your doctor or pharmacist if you are taking:

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

•    medicines to treat depression (for example 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 heartbeat)

Use in children and adolescents

Renocontin is not recommended in children younger than 12 years of age.

Method of administration

Swallow the prolonged-release tablet whole with a sufficient amount of liquid (^ 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

Stanzkontur_200 x 690 mm Laetus.indd 1

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. 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 If you have taken more of this medicine than prescribed by your doctor you should seek immediate medical advice. The following symptoms may occur: constricted pupils (miosis), breathing difficulties (respiratory depression), drowsiness, skeletal muscle flaccidity and drop in blood pressure. In severe cases you may experience problems with your heart and circulation, have severe difficulty with breathing and lose consciousness. Taking high doses of strong opioids like oxycodone can be fatal. You should not drive yourself to hospital if you have taken too many tablets.

If you forget to take Renocontin

If you miss a dose, your pain may not be controlled. If there are at least 8hrs until your next due dose, you can take the forgotten dose when you remember. You then continue with your medicine as scheduled.

If there is less than 8hrs until your next dose, you should take the missed dose but make sure that you leave at least 8hrs until the next dose. You must not take this medicine more than once every eight hours. Never take a double dose to make up for a missed dose.

If you stop taking Renocontin

You must not stop taking this medicine without asking

for your doctor’s advice. When you no longer need

these tablets, your doctor will gradually lower your

dose to prevent you experiencing unpleasant withdrawal

symptoms.

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.

If you experience any of the following side effects, stop taking Renocontin and contact your doctor immediately:

All medicines can cause allergic reactions, although serious allergic reactions are uncommon. 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.

Depressed in breathing is the most significant risk induced by opioids and is most likely to occur in elderly or debilitated patients. As a consequence, in predisposed patients opioids can cause severe drops in blood pressure. Apart from this oxycodone can cause constricted pupils, bronchial spasms and spasms in smooth muscles and suppress the cough reflex.

Other possible side effects

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

•    Sedation (tiredness to drowsiness); dizziness; headache; constipation; nausea; vomiting; itching.

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

•    Several psychological side effects such as changes in mood (e.g. anxiety, depression); changes in activity (mostly sedation, sometimes accompanied by lethargy, occasionally increase with nervousness and sleep disorders) and changes in performance (thought process disorder, confusion, isolated cases of speech disorders),

•    feeling weak (asthenia); trembling (tremor),

•    difficulty in breathing or wheezing (dyspnoea, bronchospasm),

•    dry mouth, rarely accompanied by thirst and difficulty swallowing; gastrointestinal disorders such as bellyache; diarrhoea; upset stomach (dyspepsia); loss of appetite,

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

•    urinary disorders (frequent urination), increased sweating (hyperhidrosis),

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

•    A condition which causes abnormal production of a hormone reducing urination (syndrome of inappropriate antidiuretic hormone secretion),

•    change in perception such as depersonalisation, hallucinations (perception of things that are not there), emotional instability, change in taste, visual disturbances, abnormally acute sense of hearing (hyperacousis); euphoria; restlessness,

•    increased and decreased muscle tone involuntary muscle contractions, disturbance of memory (amnesia); fits, speech disorder; reduced sense of touch (hypaesthesia); coordination disturbances; feeling unwell; fainting; pins and needles (paraesthesia); feeling of spinning (vertigo),

•    accelerated pulse; fast or irregular beating of the heart (supraventricular tachycardia, palpitations (in context of withdrawal syndrome), widening of the blood vessels (vasodilatation),

•    increased coughing; inflammation of the throat (pharyngitis); runny nose; voice changes,

•    oral ulcers; inflammation of the gums, inflamed mouth (stomatitis); difficult in swallowing(dysphagia), passing wind (flatulence),

•    belching; a condition where the bowel does not work properly (ileus), taste disturbance, a worsening of liver function tests (seen in a blood test),

•    dry skin,

•    urinary retention,

•    disturbances of sexual function (reduced sexual desire and impotence),

•    accidental injuries; pain (e.g. chest pain); buildup of fluid in the body causing the affected tissue to become swollen (oedema); migraine; physical dependence producing symptoms and signs of withdrawal when the product is stopped suddenly, ;

•    lack of water in the body (dehydration),

•    hypersensitivity which may include symptoms as wheezing, chest tightness, swelling of the lips, eyes or face or rash and itching (allergic reactions),

•    thirst, a problem with the flow of tears in the eyes (lacrimation disorder),

•    chills,

•    a ringing or buzzing sound in the ears (tinnitus),

•    drug tolerance (i.e. an increase in dose becomes necessary to achieve the desired effect).

Rare (may affect up to 1 in 1,000 people):

•    Swollen lymph nodes (lymphadenopathy),

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

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

•    gum bleeding; increased appetite; tarry stool; tooth staining and damage,

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

•    changes in body weight (loss or rise); cellulitis. Frequency not known (frequency cannot be estimated from the available data)

•    Serious allergic reaction which causes difficulty in breathing or dizziness (anaphylactic reaction),

•    aggression,

•    increased sensibility to pain (hyperalgesia), tooth decay,

•    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,

•    colicky abdominal pain or discomfort (biliary colic), absence of menstrual bleeding (amenorrhoea).

Opioid withdrawal syndrome

As oxycodone hydrochloride has the potential to cause a drug addiction, there is a possibility to develop an opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, watery eyes (lacrimation), nasal discharge (rhinorrhea), yawning, perspiration, chills, muscle pain, dilation of the pupil and irregular heartbeat (palpitations). Other symptoms also may develop including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate or heart rate.

Counteractive measures

If you observe any of the above listed side effects your doctor usually will take appropriate measures.

The side effect constipation may be prevented by fiber enriched diet and increased drinking.

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.

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.

Do not store above 25°C

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.

[5 mg]:

Each prolonged-release tablet contains 5 mg oxycodone hydrochloride corresponding to 4.5 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), brilliant blue FCF (E133).

What Renocontin looks like and contents of the pack

[Renocontin 5 mg prolonged-release tablets:]

Light blue, round, biconvex, prolonged-release tablets with a diameter of 6.9 - 7.3 mm and a height of 3.5 - 4.2 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:

PS Pharma Service GmbH Lise-Meitner-Strahe 10 40670 Meerbusch Germany

This leaflet was last revised in October 2016

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