Patient Leaflet Updated 20-Jun-2022 | G.L Pharma UK Limited
Oxyact 5mg, 10mg, 20mg Film-coated Tablets
Oxyact 5 mg film-coated tablets
Oxyact 10 mg film-coated tablets
Oxyact 20 mg film-coated tablets
oxycodone hydrochloride
1. What Oxyact is and what it is used for
2. What you need to know before you take Oxyact
3. How to take Oxyact
4. Possible side effects
5. How to store Oxyact
6. Contents of the pack and other information
Oxyact is a strong painkiller from the group of opioids.
Oxyact is used to treat severe pain, which requires treatment with an opioid analgesics because other painkillers have not been effective.
Talk to your doctor or pharmacist before using Oxyact
Dependence and tolerance
When Oxyact is used for long-time treatment, tolerance to the medicine may occur. This means, that you may need a higher dose to achieve the desired pain relief.
Repeated use of Oxyact may lead to dependence and abuse which may result in life-threatening overdose. If you have concern that you may become dependent on Oxyact, it is important that you consult your doctor.
Oxyact has a dependence potential. If the treatment is stopped too suddenly, withdrawal symptoms may occur. If you no longer need treatment, your doctor will gradually reduce your daily dose.
Your doctor will weigh the possible risks against the expected and needs to be evaluated in relation to the benefit. Ask your doctor if you have any questions about this.
Oxyact can cause sleep-related breathing disorders such as sleep apnea (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.
The safety and efficacy of Oxyact in children under 12 years of age has not been established. Therefore use of Oxyact is not recommended in this age group.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The risk of side effects is increased if you take Oxyact at the same time as medicines which affect the way the brain works. For example, you may feel very sleepy, or breathing problems may get worse.
Medicines that affect the way the brain works include:
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.
Concomitant use of Oxyact 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 Oxyact 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.
Further interactions may occur with
Oxyact should not be taken with alcohol. Alcohol use could increase serious side-effects of oxycodone, such as sleepiness and drowsiness and slow and shallow breathing.
Oxyact should be avoided in patients with a history of or present alcohol and drug abuse.
Grapefruit juice may increase the levels of oxycodone in your blood. Check with your doctor if you drink grapefruit juice regularly.
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
The use of Oxyact should be avoided to the extent possible during pregnancy.
Prolonged use of oxycodone during pregnancy can cause withdrawal symptoms in newborns.
If oxycodone is given during childbirth, the baby may have breathing problems.
Breast-feeding
Breast-feeding should be discontinued during treatment with Oxyact Oxycodone hydrochloride passes into breast milk. Therefore, a risk for the suckling infant cannot be excluded in particular following intake of multiple doses of Oxyact
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Oxyact contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Oxyact contains soya. If you are allergic to peanut or soya, do not use this medicinal product.
Oxyact 5 mg film-coated tablets contain the colouring agent Ponceau 4R (E 124) which may cause allergic reactions.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
For doses not realisable/practicable with this strength, other strengths of this medicinal product are available.
Your doctor will adjust your dose according to pain intensity and to your individual susceptibility. Please talk to your doctor, if you think that the effect of Oxyact is too weak or too strong.
The usual starting dose is 5 mg oxycodone hydrochloride every 6 hours. If needed, the dosing interval may be shortened to 4 hours by your doctor. However, Oxyact should not be taken more often than 6 times a day.
Elderly patients with normal liver and/or kidney function may take the same doses as given for adults above.
Your doctor may prescribe a lower starting dose.
For patients who have been treated with other strong pain killers (opioids) before, the doctor may prescribe a higher starting dose.
Your doctor will decide how much you should take every day after that, and how to divide your total daily dose into morning and evening doses. Your doctor will also advise you on any dose adjustments that may become necessary during treatment.
If you experience pain between doses of Oxyact, you may require higher doses of Oxyact Please talk to your doctor if you have this problem.
If you require long-term treatment of severe pain, you will be switched to oxycodone hydrochloride prolonged tablets.
Oral use.
Take this medicine with a sufficient amount of liquid (e.g. ½ glass of water) every 4 to 6 hours as scheduled by your doctor. You can take this medicine with or without food.
Opening instructions for the blister:
This medicine is in child-resistant packaging. The film-coated tablets have to be pressed out firmly of the blister.
Contact a doctor immediately if you have taken more tablets than you have been prescribed.
Symptoms of overdose are: a reduction in the size of the pupils, breathing problems, feeling weak in the muscles (low muscle tone, hypotonia), and a fall in blood pressure. In severe cases drowsiness or fainting due to a failure of the circulatory system (circulatory collapse), impairment of thinking and of movement, loss of consciousness (coma), reduced pulse rate and accumulation of fluid in the lungs may occur.
Use of large amounts of Oxyact may result in death.
If you take a smaller dose of Oxyact than prescribed, or if you miss a dose, adequate pain relief will probably not be achieved.
If you forget to take one dose, you can take the forgotten dose as soon as you remember it. Please note that you are supposed to take this medicine at intervals of 4 to 6 hours.
Do not take a double dose to make up for a forgotten dose.
Do not stop treatment without first speaking with your doctor as withdrawal symptoms may occur.
If you do not require treatment with Oxyact anymore, your doctor will advise you on how to reduce the dose gradually to prevent the occurrence of withdrawal symptoms.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Not known: frequency cannot be estimated from the available data
If you get any of the 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the safety of this medicine.
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.
This medicinal product does not require any special storage conditions.
Do not throw away 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.
The active substance is oxycodone hydrochloride.
Oxyact 5 mg film-coated tablets
Each film-coated tablet contains 5 mg oxycodone hydrochloride equivalent to 4.48 mg oxycodone.
Oxyact 10 mg film-coated tablets
Each film-coated tablet contains 10 mg oxycodone hydrochloride equivalent to 8,97 mg oxycodone.
Oxyact 20 mg film-coated tablets
Each film-coated tablet contains 20 mg oxycodone hydrochloride equivalent to 17,93 mg oxycodone.
The other ingredients are
Tablet core: sodium starch glycolate type A, lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.
Film coating: polyvinyl alcohol, talc, titanium dioxide (E 171), macrogol 3350 (E 1521), lecithin soya (E 322), indigo carmine, aluminium lake (E 132), Ponceau 4R, aluminium lake (E 124) (5 mg film- coated tablets only),iron oxide yellow (E 172) (20 mg film-coated tablets only).
Oxyact 5 mg film-coated tablets
Oxyact 5 mg film-coated tablets are dark blue, round, vaulted and biconvex film-coated tablets.
Oxyact 10 mg film-coated tablets
Oxyact 10 mg film-coated tablets are middle blue, vaulted, oblong film-coated tablets with break score on both sides. The tablet can be divided into equal halves.
Oxyact 20 mg film-coated tablets
Oxyact 20 mg film-coated tablets are light blue, vaulted, oblong film-coated tablets with break score on both sides. Length: 12.1 mm, thickness: 3.5 mm, width: 5.2 mm.
The tablet can be divided into equal halves.
Oxyact 5/10/20 mg are available in PVC/PVdC/Aluminium Blisters containing 10, 20, 30, 56 or 60 film-coated tablets
Not all pack sizes may be marketed.
This leaflet was last revised in 03/2022.
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