Patient leaflet - TARGINACT 10 MG / 5 MG PROLONGED-RELEASE TABLETS
What is in this leaflet
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1. What Targinact is and what it is used for
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2. What you need to know before you take Targinact
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3. How to take Targinact
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4. Possible side effects
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5. How to store Targinact
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6. Contents of the pack and other information
1. What
2. what you need to know before you take if you are allergic to oxycodone hydrochloride, naloxone hydrorochloride or any of the other ingredients of this medicine (listed in section 6),
Driving and using machines
Targinact may affect your ability to drive or operate machines. In particular, this is likely at the start of Targinact therapy, after a dose increase or after switching from a different medication. However, these side effects disappear once you are on a stable Targinact dose.
Targinact has been associated with sleepiness and episodes of suddenly falling asleep. If you experience these side effects, you must not drive or operate machinery.
You should tell your doctor if this occurs.
- 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. Ask your doctor whether you may drive or operate machines.
Targinact contains lactose
This medicine contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.
3. how to take
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Targinact is a prolonged-release tablet, which means that its active substances are released over an extended period. Their action lasts for 12 hours.
You must swallow the prolonged-release tablet whole, so as not to affect the slow release of oxycodone hydrochloride from the prolonged-release tablet. Do not break, chew or crush the tablets. Taking broken, chewed or crushed tablets may lead to the absorption of a potentially lethal dose of oxycodone hydrochloride (see section 3 “If you take more Targinact than you should”).
Unless otherwise prescribed by your doctor, the usual dose is: To treat pain
Adults
The usual starting dose is 10 mg oxycodone hydrochloride / 5 mg naloxone hydrochloride as prolonged release tablet(s) every 12 hours.
Your doctor will decide how much you should take every day and how to divide your total daily dosage into morning and evening doses. Your doctor will also decide on any necessary dose adjustments during treatment. Your dose will be adjusted according to 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, Targinact treatment can be started at a higher dose.
The maximum daily dose is 160 mg oxycodone hydrochloride and 80 mg naloxone hydrochloride. If you need a higher dose, your doctor may give you additional oxycodone hydrochloride without naloxone hydrochloride. However, the maximum daily dose of oxycodone hydrochloride should not exceed 400 mg. The beneficial effect of naloxone hydrochloride on bowel activity may be affected if additional oxycodone hydrochloride is given without additional naloxone hydrochloride.
If you are switched from these tablets to another another opioid pain medication your bowel function will probably worsen.
If you experience pain between two doses of Targinact , you may need a rapid-acting painkiller. Targinact is not suitable for this. In this case, please talk to your doctor.
If you have the impression that the effect of these tablets is too strong or too weak, please talk to your doctor or pharmacist.
To treat restless legs syndrome
Adults
The usual starting dose is 5 mg oxycodone hydrochloride/ 2.5 mg naloxone hydrochloride as prolonged-release tablet(s) every 12 hours.
Your doctor will decide how much Targinact you should take every day and how to divide your total daily dosage into morning and evening doses. He/she will also decide on any necessary dose adjustments during treatment. Your dose will be adjusted according to your individual sensitivity. You should be given the lowest dose needed to relieve your restless legs syndrome symptoms.
If you have the impression that the effect of Targinact is too strong or too weak, please talk to your doctor or pharmacist. The maximum daily dose is 60 mg oxycodone hydrochloride and 30 mg naloxone hydrochloride.
To treat pain or restless legs syndrome
Elderly patients
In general, no dose adjustment is necessary for elderly patients with normal kidney and/or liver function.
Liver or kidney impairment
If you have an impairment of your kidney function or a mild impairment of your liver function, your attending doctor will prescribe these tablets with special caution. If you have a moderate or severe impairment of liver function, these tablets should not be used (see also Section 2 “Do not take Targinact..” and “Warnings and precautions”).
Children and adolescents below 18 years of age
Targinact has not yet been studied in children and adolescents under 18 years of age. Its safety and effectiveness have not been proven in children and adolescents. For this reason, Targinact use in children and adolescents under 18 years of age is not recommended.
Method of administration
Oral use
Swallow these tablets whole (without chewing), with sufficient liquid (% glass of water). You can take the prolonged-release tablets with or without food. Take the tablets every 12 hours, according to a fixed time schedule (e.g. at 8 o’clock in the morning and 8 o’clock in the evening). Do not break, chew or crush the prolonged-release tablets (see section 2 “Warnings and precautions”).
Duration of use
In general, you should not take these tablets for any longer than you need to. If you are on long-term treatment, your doctor should regularly check whether you still need these tablets.
If you take more Targinact than you should
If you have taken more than the prescribed dose of these tablets you must inform your doctor immediately.
An overdose may result in:
- narrowed pupils
- slow and shallow breathing (respiratory depression)
- drowsiness up to loss of consciousness
- low muscle tone (hypotonia)
- reduced pulse rate, and
- a drop in blood pressure.
In severe cases, loss of consciousness (coma), fluid on the lungs and circulatory collapse may occur, which may be fatal in some cases.
You should avoid situations which require a high level of alertness, e.g. driving.
If you forget to take Targinact
Or if you take a dose lower than the one prescribed, you may not feel any effect.
If you forget to take your dose, please follow the instructions below:
- If your next usual dose is due in 8 hours or more: Take the forgotten dose immediately and continue with your normal dosing schedule.
- If your next usual dose is due within less than 8 hours: Take the forgotten dose. Then, wait another 8 hours before taking your next dose. Try to get back on track with your original dosing schedule (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 dose.
If you stop taking Targinact
Do not stop your treatment without consulting your doctor. If you do not require any further treatment, you must reduce the daily dose gradually after talking to your doctor. 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 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.
Important side effects to look out for, and what to do if you are affected:
If you are affected by any of the following important side effects, consult your nearest doctor immediately.
Slow and shallow breathing (respiratory depression) is the main danger of an opioid overdose. It mostly occurs in elderly and debilitated (weak) patients. Opioids can also cause a severe drop in blood pressure in susceptible patients.
The following side effects have been seen in patients being treated for pain
Common (may affect up to 1 in 10 people)
- abdominal pain
- constipation
- diarrhoea
- dry mouth
- indigestion
- vomit (be sick)
- feel sick
- flatulence (wind)
- decreased appetite up to loss of appetite
- a feeling of dizziness or ‘spinning’
- headache
- hot flushes
- a feeling of unusual weakness
- tiredness or exhaustion
- itchy skin
- skin reactions/rash
- sweating
- vertigo
- difficulty in sleeping
- drowsiness
Uncommon (may affect up to 1 in 100 people)
- abdominal bloating
- abnormal thoughts
- anxiety
- confusion
- depression
- nervousness
- chest tightness especially if you already have coronary heart disease
- drop in blood pressure
- withdrawal symptoms such as agitation
- fainting
- lack of energy
- thirst
- altered taste
- palpitations
- biliary colic
- chest pain
- generally feeling unwell
- pain
- swelling of hands, ankles or feet
- difficulties to concentrate
- impaired speaking
- shaking
- difficulties breathing
- restlessness
- chills
- hepatic enzymes increased
- rise in blood pressure
- reduced sexual drive
- runny nose
- cough
- hypersensitivity/allergic reactions
- weight loss
- injuries from accidents
- increased urge to urinate
- muscle cramps
- muscle twitches
- muscle pain
- vision impairment
- epileptic seizures (especially in persons with epileptic disorder or predisposition to seizures)
Rare (may affect up to 1 in 1,000 people)
- increase in pulse rate
- drug dependence
- dental changes
- weight gain
- yawning
Not known (frequency cannot be estimated from the available data)
- euphoric mood
- severe drowsiness
- erectile dysfunction
- nightmares
- hallucinations
- shallow breathing
- difficulties in passing urine
- aggression
- tingling skin (pins and needles)
- belching
- problems with breathing during sleep (sleep apnoea syndrome), for more information see section 2 Warnings and precautions.
The active substance oxycodone hydrochloride, if not combined with naloxone hydrochloride, is known to have the following differing side-effects:
Oxycodone can cause breathing problems (respiratory depression), reduction in size of the pupil in the eye, cramping of the bronchial muscles and cramping of the smooth muscles, as well as depression of the cough reflex.
Common (may affect up to 1 in 10 people)
- altered mood and personality changes (e.g. depression, feeling of extreme happiness)
- decreased activity
- increased activity
- difficulties in passing urine
- hiccups
Uncommon (may affect up to 1 in 100 people)
- impaired concentration
- migraines
- increased muscle tension
- involuntary muscle contractions
- a condition where the bowel stops working properly (ileus)
- dry skin
- drug tolerance
- reduced sensitivity to pain or touch
- abnormal coordination
- vocal changes (dysphonia)
- water retention
- difficulties in hearing
- mouth ulcers
- difficulties in swallowing
- sore gums
- perception disturbances (e.g. hallucination, derealisation)
- flushing of skin
- dehydration
- agitation
- a decrease in sex hormone levels which may affect sperm production in men or the menstrual cycle in females
Rare (may affect up to 1 in 1,000 people)
- itching rash (urticaria)
- infections such as cold sores or herpes (which may cause blisters around the mouth or genital area)
- increased appetite
- black (tarry) stools
- bleeding gums
Not known (frequency cannot be estimated from the available data)
- acute generalized allergic reactions (anaphylactic reactions)
- an increase in sensitivity to pain
- absence of menstrual periods
- withdrawal symptoms in the newborn
- problems with bile flow
- tooth decay
The following side effects have been seen in patients
being treated for restless legs syndrome
Very common (may affect 1 in 10 people or more)
- headache
- drowsiness
- constipation
- feel sick
- sweating
- tiredness or exhaustion
Common (may affect up to 1 in 10 people)
- decreased appetite up to loss of appetite
- difficulty in sleeping
- depression
- a feeling of dizziness or ‘spinning’
- difficulties to concentrate
- shaking
- tingling in hands or feet
- vision impairment
- vertigo
- hot flushes
- drop in blood pressure
- rise in blood pressure
- abdominal pain
- dry mouth
- vomit (be sick)
- hepatic enzymes increased (alanine aminotransferase increased, gamma-glutamyltransferase increased)
- itchy skin
- skin reactions/rash
- chest pain
- chills
- pain
- thirst
Uncommon (may affect up to 1 in 100 people)
- reduced sexual drive
- episodes of suddenly falling asleep
- altered taste
- difficulties breathing
- wind
- erectile dysfunction
- withdrawal symptoms such as agitation
- swelling of hands, ankles or feet
- injuries from accidents
Not known (frequency cannot be estimated from the available data)
- hypersensitivity/ allergic reactions
- abnormal thoughts
- anxiety
- confusion
- nervousness
- restlessness
- euphoric mood
- hallucinations
- nightmares
- epileptic seizures (especially in persons with epileptic disorder or predisposition to seizures)
- drug dependence
- severe drowsiness
- impaired speaking
- fainting
- chest tightness especially if you already have coronary heart disease
- palpitations
- increase in pulse rate
- shallow breathing
- cough
- runny nose
- yawning
- abdominal bloating
- diarrhoea
- aggression
- indigestion
- belching
- dental changes
- biliary colic
- muscle cramps
- muscle twitches
- muscle pain
- difficulties in passing urine
- increased urge to urinate
- generally feeling unwell
- weight loss
- weight increase
- a feeling of unusual weakness
- lack of energy
5. how to store
Keep out of the sight and reach of children.
Do not use any tablets after the expiry date which is stated on the carton and blister, after ‘EXP…’ The expiry date refers to the last day of the month.
Do not store above 25°C. Store in the original package in order to protect from light.
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 to protect the environment.
If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6. contents of the pack and other informationthe active ingredients are oxycodone hydrochloride and naloxone hydrochloride.
Each 10 mg/5 mg 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 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 (10 mg/5 mg, 20 mg/10 mg and 40 mg/20 mg strength tablets only), 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 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.
Targinact 10 mg/5 mg and 20mg/10mg tablets are available as blister packs of 28 & 56 tablets.
PL No: 41103/0030 Targinact 10mg/5mg Prolonged Release Tablets
PL No: 41103/0031 Targinact 20mg/10mg Prolonged Release Tablets
Manufactured by:
Mundipharma GmbH, Mundipharma str.2, 65549 Limburg, Germany and/or BARD Pharmaceuticals Ltd./191 Cambridge Science Park, Milton Road, Cambridge CB4 0GW, United Kingdom and procured from within the EU and repackaged by the Product Licence holder: Community Pharmacy Supplies Ltd., Unit 20/21, Easter Park, Ferry Lane South, Rainham, Essex, RM13 9BP
Leaflet revision date: 10.06.2021.
Targinact ®is a registered trademark of Mundipharma AG.
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RML86 V10