Patient leaflet - RELTEBON 5 MG PROLONGED-RELEASE TABLETS
0 How to store Reltebon
Keep this medicine out ofthe sight and reach of children. Accidental overdose bya child is dangerous and may be fatal.
Do not use this medicine after the expiry date which is stated on the blister, carton and containerafter"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. Askyour pharmacist how to throwaway medicines you no longer use. These measures will help protect the environment
Q Contents of the pack and other information
What Reltebon contains
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♦ The active substance is oxycodone hydrochloride. Each prolonged-release tablet contains either 5mg 10mg 15mg 20mg 30mg 40mg 60mg or 80mg of oxycodone hydrochloride.
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♦ The other ingredients are:
Tablet core: Lactose monohydrate, hypromellose, povidone, stearic acid, magnesium stearate, colloidal anhydrous silica.
Tablet coating:
5mg tablets: Polyvinyl alcohol, titanium dioxide (El 71), macrogol, talq blue Indigo Carmine Aluminium Lake (El 32), yellow iron oxide (E172). 10mg tablets:Titanium dioxide (E171), hypromellose, macrogol, polysorbate 80.
15mg tablets: Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), black iron oxide (E172).
20mg tablets: Polyvinyl alcohol, titanium dioxide (E171), macrogol, talq red iron oxide (E172).
30mg tablets: Polyvinyl alcohol, macrogol, talq red iron oxide (El 72), black iron oxide (El 72), blue Indigo Carmine Aluminium Lake (E132).
40mg tablets: Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172).
60mg tablets: Polyvinyl alcohol, macrogol, talq red iron oxide (El 72), carmine (El 20), black iron oxide (El 72).
80mg tablets: Polyvinyl alcohol, titanium dioxide (E171), macrogol, talq blue Indigo Carmine Aluminium Lake (E132), yellow iron oxide (E172).
What Reltebon looks like and contents ofthe pack
Reltebon 5mg prolonged-release tablets are blue, round, biconvex tablets 7 mm in diameter, with 'OX 5'debossed on one side.
Reltebon 10mg prolonged-release tablets are white, round, biconvex tablets 9 mm in diameter, with 'OX 10'debossed on one side.
Reltebon 15mg prolonged-release tablets are grey, round, biconvex tablets 9 mm in diameter, with 'OX 15'debossed on one side.
Reltebon 20mg prolonged-release tablets are pink round, biconvex tablets 7 mm in diameter, with 'OX 20'debossed on one side.
Reltebon 30mg prolonged-release tablets are brown, round, biconvex tablets 9 mm in diameter, with 'OX 30'debossed on one side.
Reltebon 40mg prolonged-release tablets are yellow, round, biconvex tablets 7 mm in diameter, with 'OX 40'debossed on one side.
Reltebon 60mg prolonged-release tablets are red, round, biconvex tablets 9 mm in diameter, with 'OX 60'debossed on one side.
Reltebon 80mg prolonged-release tablets are green, round, biconvex tablets 9 mm in diameter, with 'OX 80'debossed on one side.
Reltebon are available in blister packs (PVC/Aluminium) of 28s and 56s.
Marketing Authorisation Holder
Accord Healthcare Limited, Sage House, 319 Pinner Road
North Harrow, Middlesex, HA1 4HF, United Kingdom
If you notice any ofthese signs, it is important you talk to your doctor.
Reporting of side effects
If you get any side effects, talkto yourdoctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly via the YellowCard Scheme, Website: or search for MH RA Yellow Card in the Google Play or Apple App Store.
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51000051 BBBB1468
Manufacturer
Accord, Barnstaple, EX32 8NS, UK
This leaflet was last revised in June 2021
If you would like a leaflet with larger text, please contact01271 385257.
Package leaflet: Information for the patient
Reltebon 5mg, 10mg, 15mg, 20mg, 30mg, 40mg, 60mg and 80mg Prolonged -release Tablets
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
□ what reltebon is and what it is used for
H What you need to know before you take Reltebon
0 How to take Reltebon
Q Possible side effects
0 How to store Reltebon
0 Contents of the packand other information
Q What Reltebon is and what it is used for
This medicine has been prescri bed for you to relieve severe pain, which can only be controlled by opioid analgesics in adults and adolescents 12 years of age and older. Itcontains the active ingredient oxycodone hydrochloride which belongs to a class of medicines called opioids, which are'pain relieversf
This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms ifyou stoptaking it suddenly. Your doctor should have explained how long you will betaking itfor, when it is appropriate to stop and how to do this safely.
Q What you need to know before you take Reltebon
Do not take Reltebon ifyou:
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♦ are allergic to oxycodone hydrochloride or any of the other ingredients of this medicine (listed in section 6)
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♦ have breathing problems, such as severe chronic obstructive lung d isease, severe bronch ia I asthma or severe respi ratory depression. Yourdoctorwill have told you ifyou have any of these conditions Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected
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♦ have a condition where the small bowel does not work properly (paralytic ileus), your stomach empties more slowly than itshould (delayed gastric emptying) or you have severe pain in your abdomen
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♦ have a heart problem after long-term lung disease (cor pulmonale)
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♦ have increased carbon dioxide levels in the blood. Symptoms may include dizziness, drowsiness, fatigue, shortness of breath and headache
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♦ have moderate to severe liver problems. Ifyou have other long-term liver problems you should only take these tablets if recommended byyourdoctor
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♦ have ongoing problems with constipation.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine ifyou: ♦ are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs
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♦ have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating when you have stopped taking alcohol ordrugs
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♦ feel you need to take more Reltebon to get the same level of pain relief, as this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your doctor who will discuss yourtreatmentand may change your dose or switch you to an alternative pain reliever
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♦ are elderly or weakened
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♦ have an under-active thyroid gland (hypothyroidism), as you may need a lower dose
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♦ have myxoedema (a thyroid disorder with dryness, coldness and swelling (‚puffiness‘) of the skin affecting the face and limbs)
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♦ knowyou are suffering from a brain injury ortumour, or you havea head injury, severe headache orfeel sick as this may indicate that the pressu re in your skull is increased
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♦ have low blood pressure (hypotension)
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♦ have low blood volume (hypovolaemia), this can occur due to severe external or internal bleeding severe burns, excessive sweating severe diarrhoea or vomiting
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♦ feel very lightheaded orfaint
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♦ have a mental disorder fol low! ng use of certain medicines (toxic psychosis)
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♦ have inflammation of the pancreas (which causes severe pain in the abdomen and back)
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♦ have problems with your gall bladderor bile duct
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♦ have inflammatory bowel disease
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♦ have an enlarged prostate gland, which causes difficulty in passing urine (in men)
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♦ 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
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♦ have severely impaired lung function. Symptoms may include breathlessness and coughing
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♦ have long term pain unrelated to cancer
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♦ have a condition where yourbreathing stops forshort periods whilst you are asleep, known as sleep apnoea
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♦ have kidney or liver problems ♦ have recently had abdominal surgery.
Reltebon should be used with particular care in patients with a history of or present alcohol and drug abuse.
Taking this medicine regularly, particularly for a long time,can leadto addiction. Your doctor should have explained how long you will be taking itfor, when it is appropriate to stop and how to do this safely.
Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your doctor about your treatment
Addiction can cause withdrawal symptoms when you stop taking this medicine.Withdrawal symptoms can include restlessness, difficulty sleeping irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick diarrhoea, loss of appetite, shaking shivering or sweating. Yourdoctor will discuss with you how to gradually reduce yourdose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.
Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Ta king higher doses or more frequent doses of opioid may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.
Do not inject Reltebon. This can cause serious side effects including tissue death at the site of injection, infection, inflammation of the lungs and damage to the heart which may be fatal.
Ifyou are going to have an operation, or have just had an operation, please tell the doctoratthe hospital thatyou are taking these tablets. Yourdoctor may adjust your dose. Reltebon is not recommended for use before an operation or in the 12–24 hours afteran operation.
You may experience hormonal changes while taking these tablets. Yourdoctor may want to monitor these changes.
Children and adolescents
Oxycodone has not been investigated in children under 12 years. Safety and efficacy have not been established a nd therefore use in children under 12 years of age is not recommended.
Other medicines and Reltebon
Taking Reltebon at the same time as other medicines that slowdown the central nervous system can cause slow or difficulty breathing (respiratory depression), severe sleepiness, loss of consciousness and death.These medicines include:
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♦ other medicines used to treat pain known as opioids (such as codeine or morphine)
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♦ other medicines used to treat epilepsy (gabapentinoids) such as pregabalin
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♦ medicines used to treat anxiety
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♦ medicines used to make you feel sleepy (such as benzodiazepines)
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♦ medicines used to treat psychiatric or mental disorders (such as phenothiazines)
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♦ anaesthetics
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♦ muscle relaxants
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♦ medicines used to treat high blood pressure
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♦ a type of medicine used to treat depression known as monoamine oxidase inhibitors (MAOIs), such as tranylcypromine, phenelzine and isocarboxazid. You should not take Reltebon ifyou are currently taking this type of medicine, or have taken this medicine in the last two weeks.
Because of this, yourdoctor will only prescribe Reltebon where there are no other treatment options, and only in small doses for short periods of time. Ifyou oryourfriends,family orcaregivers notice that you are having difficulty breathing or thatyou have become very sleepy or lost consciousness you (or they) should info rm your doctor immediately.
Concomitant use of Reltebon 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 you r doctor does prescribe Reltebon together with sedative medicines the dose and duration of concomitant treatment should be limited by yourdoctor.
Please tell your doctor about all sedative medicines you are taking, and fol low 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 yourdoctor when experiencing such symptoms.
Taking Reltebon with medicines used to treat depression known as Selective Serotonin Re-uptake Inhibitors (SSRIs) or Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs) can cause a condition known as serotonin toxicity. The risk of side effects increases, ifyou use these antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine,fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone and you may experience symptoms such as i nvol u ntary, rhythm ic contractions of m uscles, 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 yourdoctor when experiencing such symptoms as they may reduce your dose of Reltebon.
Tell you r doctor or pharmacist if you a re taki ng, have recently taken or might take any other medicines including medicines obtained without a prescription.
Tell your doctor or pharmacist ifyou are taking anyof the following medicines, as they may need to adjust your dose:
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♦ a type of medicine used to treat depression known as tricyclic antidepressants, such as amitriptyline, clomipramine, imipramine, lofepramineor nortriptyline
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♦ medicines used to treat allergies such as cetirizine, fexofenadine or chlorphenamine
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♦ medicines used to treat Parkinson's disease
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♦ antibiotics such as clarithromycin, erythromycin ortelithromycin
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♦ antifungal medicines such as ketoconazole, voriconazole, itraconazole, and posaconazole
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♦ medicines used to treat HIV known as protease inhibitors, such as boceprevir, ritonavir, indinavir, nelfinavir and saquinavir
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♦ cimetidine, a medicine used to treat stomach ulcers
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♦ rifampicin, a medicine used to treat tuberculosis
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♦ medicines used to treat seizures, fits or convulsions such as carbamazepine and phenytoin
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♦ a herbal remedy used to treat depression known as St John's Wort (also known as Hypericum perforatum)
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♦ quinidine, a medicine used to treat an irregular heartbeat.
Reltebon with food, drink and alcohol
You should not drink alcohol while you are taki ng Reltebon. Drinking alcohol whilst taking Reltebon may make you feel sleepieror increase the risk of serious side effects such as shallow breathing with a risk of stopping breathing and loss of consciousness.
Grapefruit juice can inhibit the metabolism of oxycodone which will increase its effect Therefore you should avoid drinking grapefruitjuice while taking Reltebon.
Pregnancy and breast-feeding
Ifyou are pregnant or breast-feeding think you may be pregnant or are planning to have a baby, ask your doctor or pharmacistforadvice before taking this medicine.
Pregnancy
Do not take Reltebon ifyou are pregnant or thinkyou might be pregnant unless you have discussed this with yourdoctorand the benefits of treatment are considered to outweigh the potential harm to the baby. Ifyou use Reltebon during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Breast-feeding
Do nottake Reltebon while you are breastfeeding as oxycodone passes into breast milk and will affect your baby.
Driving and using machines
This medicine may cause a number of side effects such as drowsiness or dizziness which cou Id affect your ability to drive or use machinery (see section 4'Possible side effects'for afull list of side effects). These are usually most noticeable when you first start taking the tablets, or when changing to a higher dose. Ifyou are affected you should not drive or use machinery.
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♦ Do not drive while taking this medicine until you know how it affects you.
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♦ It is an offence to drive if this medicine affects you r ability to drive.
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♦ Howeveryou would not be committing an offence if:
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– The medicine has been prescribed to treat a medical or dental problem and;
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– You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and;
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– It was not affecting your ability to drive safely.
Talk to your doctor or pharmacist ifyou are not sure whether it is safe for you to drive while taking this medicine.
Reltebon contains lactose
Ifyou have been told byyour doctor thatyou have an intolerance to some sugars, contact yourdoctor before taking this medicinal product
0 How to take Reltebon
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are notsure.
Your doctor should have discussed with you how long the course of tabletswill last They will arrange a plan for stopping treatment This will outline how to gradually reduce the dose and stop taking the medicine.
Adults and adolescents over 12 years of age
The recommended initial dose is 5 or 10 mg oxycodone hydrochloride, in 12 hourly intervals. However, your doctor will prescribe the dose required to treat pain.
Further determination ofthe daily dose, the division into the single dosesand any dose adjustments during the further course of therapy are performed by the treating physician and depend on the previous dosage.
Patients who have already taken opioids can start treatment with higher dosages, taking into accounttheirexperience with opioid treatment
Some patients who receive Reltebon according to a fixed schedule need rapidly acting painkillers as rescue medication to control breakthrough pain. Reltebon is not intended for the treatment of breakthrough pain.
For the treatment of non cancer pain, a daily dose of 40 mg of oxycodone hydrochloride (20 mg given twice a day) 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.
The treatment needs to be controlled regularly with regard to pain relief and other effects in order to achieve the best pain therapy possible as well as to be able to treat any occurring side effects in good time and to decide whether treatment should be continued.
Kidney/liver impairment or low body weight
Ifyou have impaired kidney and/or liverfunction, or ifyou have a low body weight, your doctor may prescribe a lower starting dose.
Swallowyour tablets whole with water. Do not crush, dissolve or chew them.
Reltebon tablets are designed to work properly over 12 hours when swallowed whole. If a tablet is broken, crushed, dissolved or chewed, the entire 12-hour dose may be absorbed rapidly into your body.This can be dangerous, causing serious problems such as an overdose, which may be fatal.
You should take your tablets every 12 hours Forinstance, ifyou takea tablet at 8 o'clock in the morning you should take your next tablet at 8 o'clock in the evening.
You must only take the tablets by mouth. The tablets should never be crushed or injected as this may lead to serious side effects, which may be fatal (see section 2 Warnings and precautions').
Your doctor will adjust the dosage depending on the pain intensity and howyou respond to the treatment Take the numberofprolonged-release tablets determined by your doctor twice daily.
If you take more Reltebon than you should
Ifyou have taken more Reltebon than prescribed, you should inform yourdoctororyour local poison control centre immediately. The following symptoms may occur: constricted pupils, depressed breathing, skeletal muscle flaccidity, drowsiness and drop in blood pressure. I n severe cases circulatory collapse, mental and motor inactivity, unconsciousness, slowing ofthe heart rate, accumulation ofwaterinthe lungs, low blood pressureand death may occur; abuse of high doses of strong opioids such as oxycodone can be fatal. In no case should you expose yourself to situations requiring elevated concentration e.g. driving a car.
Ifyou forget to take Reltebon
Ifyou use a smaller dose of Reltebon than directed or you miss the intake ofthe tablets, pain relief will consequently be insufficient or cease altogether.
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You can make up for a forgotten tablet if the next regular intake is not due for at least another 8 hou rs. You can then continue to take the tablets as directed.
You should also take the prolonged-release tablets if the time to the regular next intake is shorter, but postpone the next intake by 8 hours. In principle, you should not take Reltebon more than once every 8 hours
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Reltebon
Do not suddenlystop taking this medicine. Ifyou want to stop taking this medicine, discuss this with your doctor first They will tell you howto do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking shivering or sweating may occur if you suddenly stop taking this medicine.
Ifyou have any further questions on the use of this medicine, ask your doctor or pharmacist
□ possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Ifyou experience any ofthe following sideeffects* stop taking Reltebon and contact your doctor immediately.
All medicines can cause allergic reactions, although serious allergic reactions are rare. Tell your doctor immediately ifyou get any sudden wheeziness, difficulties in breathing swelling ofthe eyelids,face or lips, rash or itching especially those covering your whole body. These may be signs of a serious allergic reaction.
The most serious side effect is a condition where you breathe more slowly or weakly than usual (respiratory depression) and can lead to severe sleepi ness and loss of consciousness. This side effect may affect upto 1 in 100 people and is more likely to occur when taking certain other medicines (see section 2 ‚Other medicines and Reltebon‘).Tell your doctor immediately if this happens to you. You may wish to ask yourfriend^ family or caregivers to monitoryou for these signs and symptoms.
Other possible side effects
Very common (may affect more than 1 in 10 people):
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♦ drowsiness (this is most likely when you start taking you rtablets or whenyourdose is increased, butitshould wearoffafterafewdays)
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♦ dizziness
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♦ headache
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♦ constipation (your doctor can prescribe a laxative to overcome this problem)
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♦ feeling or being sick (this should normally wear off after a few days, however yourdoctor can prescribe an anti-sickness medicine if it continues to be a problem)
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♦ itchy skin.
Common (may affect up to 1 in 10 people):
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♦ confusion, depression, feeling of unusual weakness shaking lack of energy, tiredness anxiety, nervousness difficulty in sleeping abnormal thoughts or dreams
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♦ difficulty in breathing or wheezing shortness of breath, decreased cough reflex
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♦ dry mouth, abdominal pain or discomfort, diarrhoea, indigestion, loss of appetite
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♦ skin disorders such as rash, increased sensitivity to light (photosensitivity), in isolated cases itchy or scaly rash, excessive sweating
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♦ urinary disorders (frequent urination).
Uncommon (may affect up to 1 in 100 people):
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♦ withdrawal symptoms (see'Drug withdrawal')
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♦ difficulty in swallowing belching wind, hiccups, a condition where the bowel does network properly (ileus), inflammation ofthe stomach, changes in taste or unpleasant taste
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♦ dehydration, thirst, chills, swelling ofthe hands, ankles orfeet
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♦ depersonalisation, a feeling of extreme happiness, hallucinations, abnormally acute sense of hearing a feeling of dizziness orspinning (vertigo), decreased sex drive, disorientation, mood changes,