TAIOMA 5 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Taioma 5 mg prolonged-release tablets EFG

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.

Contents of the pack and other information:

1. What is Taioma and what is it used for
2. What you need to know before you take Taioma
3. How to take Taioma
4. Possible side effects
5. Storing Taioma
6. Contents of the pack and other information

1. What is Taioma and what is it used for

This medicine is a strong painkiller belonging to the group of opioids.

Taioma is indicated in adults and adolescents (from 12 years of age) for the treatment of severe pain, which can only be adequately managed with opioid analgesics.

2. What you need to know before you take Taioma

Do not take Taioma

• if you are allergicto oxycodone hydrochloride, peanut, soy, or any of the other ingredients of this medicine (listed in section 6),
• if you have severe chronic lung diseaseassociated with narrowing of the airways (COPD = chronic obstructive pulmonary disease),
• if you have a certain heart diseasecalled cor pulmonale,
• if you have asthma,
• if you have respiratory problems, such as breathing more slowly or more weakly than expected (respiratory depression),
• if you have a type of bowel obstruction called paralytic ileus.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Taioma:

• if you are elderlyor debilitated,
• if your lung, liver, or kidneyfunction is severely impaired,
• if you have a thyroid disorder in which the skin of the face and extremities is swollen, puffy, cold, and dry,
• if you have a certain thyroid disorder(myxoedema) or if your thyroid gland does not produce enough hormones (hypothyroidism),
• if you have poor adrenal gland function (your adrenal gland does not work properly), for example Addison's disease,
• if you have enlarged prostate,
• if you have a mental illness caused by alcohol or intoxication with other substances,
• if you are in a phase of alcohol withdrawal,
• if you have pancreatitis(inflammation of the pancreas) or problems with your bile ducts,
• if you have pancreatitisthat can cause severe abdominal or back pain,
• if you have inflammatory bowel disease,
• if your doctor suspects that you have paralytic ileus (a disease in which the intestine has stopped working),
• if you have a head injury with severe headache or discomfort - signs that you have increasedintracranial pressure,
• if you have low blood pressureor feel dizzy when standing up,
• if you have epilepsyor are prone to seizures,
• if you are taking a type of medicine for depression known as MAOIs(such as tranilcipromine, phenelzine, isocarboxazide, moclobemide, or linezolid), or if you have taken this type of medicine in the last two weeks,
• if you suffer from constipation.

This medicine can cause breathing problems during sleep. These problems can include pauses in breathing during sleep, waking up due to lack of air, difficulty staying asleep, or excessive sleepiness during the day. If you or someone else notices these symptoms, contact your doctor. Your doctor may want to reduce your dose.

If this applies to you, please contact your doctor.

The most relevant risk of opioid overdose is the flattening and slowing of breathing (respiratory depression). This is more likely to occur in the elderly and debilitated patients and can also cause a decrease in blood oxygen levels. This could lead to, for example, fainting.

This medicine is specially formulated to release the active substance over a period of 12 hours. The prolonged-release tablets must not be broken, divided, chewed, or crushed. This could lead to the absorption of a potentially dangerous dose of the active substance oxycodone hydrochloride (see the section "If you take more Taioma than you should or if someone else has taken your Taioma by mistake").

Tolerance, dependence, and addiction

When Taioma is used for a long period, toleranceto the medicine may develop. This means that you may need a higher dose to maintain pain control. Do not change the dose without consulting your doctor.

This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid analgesics can make the medicine less effective (you get used to it, which is known as tolerance). Repeated use of Taioma can lead to dependence, abuse, and addiction, which can result in a potentially life-threatening overdose. The risk of these side effects may increase with a higher dose and longer duration of use.

Dependence or addiction can make you feel that you no longer have control over the amount of medicine you need to take or how often you need to take it. You may feel that you need to keep taking the medicine even when it no longer helps to relieve your pain.

The risk of becoming dependent or addicted varies from person to person. You may have a higher risk of becoming dependent or addicted to Taioma:

• If you or a family member have a history of abuse or dependence on alcohol, prescription drugs, or illegal substances ("addiction")

• If you smoke

• If you have ever had problems with your mood (depression, anxiety, or personality disorder) or have received treatment from a psychiatrist for other mental health problems.

If you notice any of the following signs while taking Taioma, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than recommended by your doctor.
• You need to take more doses than recommended.
• You are using the medicine for reasons other than those prescribed, for example, "to calm down" or "to help you sleep",
• You have made repeated unsuccessful attempts to stop or control the use of the medicine.
• You do not feel well when you stop taking the medicine and feel better once you take the medicine again ("withdrawal symptoms").

If you notice any of these signs, talk to your doctor to discuss the best treatment for you, including when it is appropriate to stop taking it and how to do so safely (see section 3, If you stop taking Taioma).

Opioids are not the first choice of treatment for non-cancer pain and are not recommended as the only treatment. In the treatment of chronic pain, other medicines should be used together with opioids. Your doctor should closely monitor you and make the necessary adjustments to your dose while you are taking Taioma to prevent addiction and abuse.

Taioma has a potential for dependence. After sudden interruption, withdrawal symptoms such as yawning, dilated pupils, tearing, runny nose, tremors, sweating, anxiety, restlessness, convulsions, insomnia, or muscle pain may occur. If you no longer need treatment, your doctor will gradually reduce your daily dose.

The active substance oxycodone hydrochloride, like other high-potency opioids (strong painkillers), has a potential for abuse. Psychological dependence can develop. Taioma should only be used with special caution if there is or has been a history of alcohol, drug, or medicine abuse.

Especially at high doses, an increase in sensitivity to pain (hyperalgesia) may occur, which does not respond to a new increase in the dose of Taioma. Your doctor will then decide whether to reduce the dose or switch to this strong painkiller (opioid).

Taioma is for oral use only (swallow as a whole prolonged-release tablet). The prolonged-release tablets must not be dissolved and injected, as this can have serious and potentially life-threatening consequences.

If you need to undergo surgery, inform your doctor that you are taking Taioma.

Contact your doctor if you have severe abdominal pain that may radiate to the back, nausea, vomiting, or fever, as these may be symptoms associated with pancreatitis and biliary tract disease.

Like other opioids, oxycodone can affect the body's normal production of hormones (such as cortisol and sex hormones). This occurs especially after receiving high doses over long periods.

Pediatric population

Taioma is not recommended in children under 12 years of age due to a lack of safety and efficacy data.

Doping warning

Athletes are informed that this medicine contains a component that can result in a positive doping test.

The use of Taioma as a doping agent poses a risk to health.

Sleep-related breathing disorders

Taioma may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to difficulty breathing, difficulty staying asleep, or excessive sleepiness during the day. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Other medicines and Taioma

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Concomitant use of Taioma and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be life-threatening. Due to this, concomitant use should only be considered when no other treatment is possible.

However, if your doctor prescribes Taioma together with sedative medicines, the dose and duration of concomitant treatment should be limited by your doctor.

Tell your doctor about all sedative medicines you are taking and follow your doctor's dose recommendation. It may be useful to inform friends or relatives to be aware of the signs and symptoms indicated above. Consult your doctor if you experience any symptoms.

The side effects of Taioma may be more frequent or more severe if used at the same time as medicines that can affect brain function or are used to treat allergies, dizziness, or nausea. Side effects may include, for example, slowing and shallow breathing (respiratory depression), constipation, dry mouth, or difficulty urinating.

The risk of side effects increases if antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine) are used.

These medicines may interact with oxycodone and may cause symptoms such as involuntary muscle contractions, including muscles that control eye movements, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Contact your doctor if you experience these symptoms.

Tell your doctor or pharmacist if you are taking:

• medicines that help you sleep or stay calm (such as hypnotics or sedatives, including benzodiazepines),
• medicines for depression (such as paroxetine or amitriptyline), including those belonging to the group of MAOIs (such as tranilcipromine, phenelzine, isocarboxazide, moclobemide, or linezolid),
• medicines for allergies, dizziness, or nausea (antihistamines, antiemetics),
• medicines for psychiatric or mental disorders (such as psychotropic drugs, phenothiazines, or neuroleptics),
• medicines for epilepsy, pain, and anxiety, such as gabapentin and pregabalin,
• muscle relaxants used to treat muscle spasms (such as tizanidine),
• medicines for Parkinson's disease,
• other strong painkillers (opioids),
• cimetidine (a medicine for stomach ulcers, indigestion, or heartburn),
• medicines for fungal infections (such as ketoconazole, voriconazole, itraconazole, or posaconazole),
• medicines used to treat bacterial infections (such as clarithromycin, erythromycin, or telithromycin),
• a specific type of medicine known as protease inhibitors for HIV treatment (such as boceprevir, ritonavir, indinavir, nelfinavir, or saquinavir),
• rifampicin for tuberculosis treatment,
• carbamazepine (a medicine for epilepsy or convulsions and certain pain conditions),
• phenytoin (a medicine for seizures or convulsions),
• a herbal medicine called "St. John's Wort" (also known as Hypericum perforatum),
• quinidine (a medicine for rapid heart rhythm),
• certain medicines to prevent blood clotting or to thin the blood (such as phenprocoumon).

Using Taioma with food, drinks, and alcohol

Drinking alcohol while taking Taioma can make you feel more drowsy or increase the risk of serious side effects such as shallow breathing with a risk of respiratory arrest and fainting. It is recommended not to drink alcohol while taking Taioma.

Consumption of the tablets should be avoided in patients with a history of or current abuse of alcohol and drugs.

Grapefruit juice may increase the concentration of Taioma in the blood. If you regularly drink grapefruit juice, inform your doctor.

Pregnancy and breastfeeding

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

Pregnancy

Do not takeTaioma during pregnancy. There are no sufficient data on the use of oxycodone in pregnant women.

Prolonged useof oxycodone during pregnancymay cause withdrawal symptoms in newborns. The use of oxycodone during delivery may cause breathing problems (respiratory depression) in the newborn.

Breastfeeding

Do not useTaioma while breastfeeding, as oxycodone passes into breast milk and can cause sedation and slow, shallow breathing (respiratory depression) in the breastfed child.

Driving and using machines

Taioma may affect your ability to drive and use machines.

This is especially true at the start of treatment with Taioma, after a dose increase, or after switching from another medicine, as well as when Taioma is used in combination with alcohol or medicines that can impair brain function.

In the case of stable therapy, a general ban on driving is not absolutely necessary. Your doctor should assess your individual situation. Please talk to your doctor about whether you can drive or operate machinery and under what conditions.

Taioma contains soya lecithin.

If you are allergic to peanuts or soy, do not use this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per prolonged-release tablet; this is essentially "sodium-free".

3. How to Take Taioma

Follow your doctor's or pharmacist's administration instructions for this medication exactly. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and periodically during treatment, your doctor will discuss with you what you can expect from using this medication, when and for how long you should take it, when to contact your doctor, and when to stop taking it (see also "If you stop taking Taioma").

Dosage

For doses that are not feasible/practical with this concentration, other concentrations of this medication are available.

Your doctor will adjust the doseaccording to the intensity of the pain and individual susceptibility.

Do not change the dose without consulting your doctor.

You should receive the lowest effective dose sufficient to relieve your pain.

If you have been previously treated with opioids, your doctor may start your therapy with a higher dose.

It may be necessary to gradually increase the dose if pain relief is insufficient or if the pain worsens.

Talk to your doctor if you experience intermittent pain despite pain therapy (breakthrough pain). Your doctor may prescribe an additional analgesic (prolonged-release analgesic) or adjust your dose of this medication to treat breakthrough pain. You should not take this medication for breakthrough pain.

If your doctor does not indicate otherwise, the recommended dose is

• for adults and adolescents (from 12 years old):

The usual initial dose is one 10 mg tablet every 12 hours. In some cases, your doctor may prescribe an initial dose of 5 mg to reduce side effects that you may experience.

Your doctor will prescribe the necessary dose to treat your pain. If you continue to feel pain while taking these tablets, discuss it with your doctor.

In the treatment of non-tumoral pain, 40 mg of oxycodone hydrochloride (4 prolonged-release Taioma 10 mg tablets or 2 prolonged-release Taioma 20 mg tablets divided into two single doses) is generally a sufficient daily dose; however, higher doses may also be necessary. Patients with tumoral pain usually require doses of 80 to 120 mg of oxycodone hydrochloride, which can be increased up to 400 mg in individual cases.

Some patients who take Taioma with a fixed schedule need a rapid-acting analgesic as a rescue medication to control breakthrough pain. Taioma prolonged-release tablets are not intended for the treatment of these intercurrent pains.

• for children (under 12 years old):

The safety and efficacy of this medication have not been sufficiently proven in children under 12 years old. Therefore, treatment in children under 12 years old is not recommended.

• for elderly patients (65 years and older):

Elderly patients with normal liver and/or lung function may take the same doses indicated above for adults.

• for patients with renal and/or hepatic disorders, or with low body weight:

If you have liver or kidney problems and have not received opioids before, you should start with half the recommended dose for adults.

• for other patients at risk:

If you are slim or if your body metabolizes medications more slowly, the initial dose should be half the recommended dose for adults.

Method of administration

Oral.

Prolonged-release tablets must be swallowed whole with a sufficient amount of liquid(e.g., half a glass of water), in the morning and in the evening, every 12 hours(e.g., one tablet at 8 am, and the next at 8 pm). You can take the tablets with or without food.

Swallow the prolonged-release tablets whole so that the specific release of the active ingredient is not affected over a longer period. Prolonged-release tablets must be swallowed whole and must not be broken, divided, chewed, or crushed.

Duration of application

Your doctor will indicate the duration of your treatment with this medication.

Do not stop your treatment without talking to your doctor (see "If you stop taking Taioma").

If you take this medication for a long time, you must monitor your treatment and discuss it with your doctor regularly. This is necessary to achieve the best pain therapy, i.e., to allow for the timely treatment of side effects that occur, as well as a decision on dose adjustment and continuation of treatment.

Consult your doctor or pharmacist if you feel that the effect of this medication is too strong or too weak.

If you take more Taioma than you should

Contact a doctor immediately if you have taken more tablets than prescribedor call the Toxicology Information Service: 91 562 04 20, indicating the medication and the amount ingested.

An overdose can cause:

• a decrease in the size of your pupils,
• slower and weaker breathing than normal (respiratory depression),
• drowsiness up to absence (narcosis state),
• a decrease in muscle tone (hypotonia),
• a decrease in pulse,
• a drop in blood pressure.
• A brain disorder (known as toxic leukoencephalopathy)

In the most severe cases, it can cause loss of consciousness (coma), water retention in the lungs, and circulatory failure, possibly with a fatal outcome.

Never put yourself in situations that require greater attention, such as driving a car.

If you forget to take Taioma

If you take a lower dose of Taioma than prescribed, or forget a dose, pain relief may not be achieved.

If you forget to take a dose, you can take it again if the next regular dose is scheduled in more than 8 hours. If the time until the next dose is less, take the forgotten dose and take the next dose 8 hours later.

Then, you can continue with your usual intake plan.

In general, you should not take this medication more than every 8 hours.

Consult your doctor or pharmacist if you are unsure.

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

If you stop taking Taioma

Do not stop treatment without consulting your doctor first.

If you stop taking the medication, you may experience withdrawal symptoms (e.g., yawning, dilated pupils, tearing, nasal discharge, tremors, sweating, anxiety, restlessness, convulsions, insomnia, or muscle pain). Therefore, it may be advisable for your doctor to gradually reduce the dose.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Contact a doctor immediately if you have any of the following symptoms:

Slowing or weakening ofbreathing(respiratory depression). This is the greatest danger related to medications like Taioma (opioids) and can be fatal after high doses of the medication.

Other side effects

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

• drowsiness, dizziness, headache.
• constipation, discomfort, nausea, vomiting. Your doctor will prescribe a suitable medication to treat these symptoms.
• itching.

Common(may affect up to 1 in 10 people)

• mood changes (anxiety, confusion, depression, nervousness), sleep disorders, abnormal thoughts.
• tremors or uncontrolled movements in some part of the body, feeling of weakness.
• decrease in blood pressure, occasionally accompanied by symptoms such as strong or accelerated heartbeat.
• shortness of breath, difficulty breathing or wheezing.
• dry mouth, occasionally accompanied by thirst and difficulty swallowing, general symptoms of indigestion such as stomach pain, diarrhea, heartburn.
• rash, excessive sweating.
• sweating, weakness.

Uncommon(may affect up to 1 in 100 people)

• allergic reactions.
• increase in the amount of a certain hormone (ADH = antidiuretic hormone) in the blood with symptoms such as headache, irritability, lethargy, nausea, vomiting, confusion, and altered consciousness.
• decrease in body water (dehydration).
• restlessness, mood changes, hallucinations, euphoria, decreased libido, drug dependence.
• amnesia, tingling or numbness (e.g., in hands or feet), convulsions, increased or decreased muscle tone, tics, fainting, decreased sense of pain or touch, taste disorders.
• visual disturbances, decreased pupil size.
• feeling of movement or that everything is spinning (vertigo).
• feeling of irregular or strong heartbeat, rapid pulse.
• vasodilation causing hypotension.
• shortness of breath, increased cough, sore throat, nasal congestion, voice changes.
• difficulty swallowing, oral ulcers, gum inflammation, flatulence (excessive gas in the stomach or intestine), belching, intestinal obstruction (ileus).
• increase in blood concentration of certain liver enzymes.
• dry skin.
• difficulty urinating, frequent urination.
• decreased sexual desire and inability to have or maintain an erection during sexual intercourse.
• chills, feeling of dizziness, injuries due to accidents due to decreased alertness, pain (e.g., chest pain), fluid retention (edema), migraine, thirst, physical dependence with withdrawal symptoms, tolerance.

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

• lymph node disease.
• muscle spasms, epileptic seizures (seizures), particularly in patients with epilepsy or a tendency to convulsions.
• low blood pressure.
• gum bleeding, decreased appetite, dark stools.
• pruritic rash, blisters on the skin and mucous membranes (oral ulcers or herpes), increased sensitivity to light.
• blood in the urine.
• changes in body weight (increase or decrease), skin inflammation.

Very rare(may affect up to 1 in 10,000 people)

• speech disorders.
• scaly skin rash.
• amenorrhea (absence of menstrual bleeding).

Frequency not known(cannot be estimated from available data):

• sleep apnea (pauses in breathing during sleep).
• severe allergic reactions.
• aggression.
• increased sensitivity to pain.
• dental caries.
• bile secretion obstruction, biliary colic (causing stomach pain).
• prolonged treatment with Taioma during pregnancy may cause withdrawal syndrome in newborns with a threat to their life. The symptoms seen in babies included irritability, hyperactivity, and abnormal sleep pattern, crying with high-pitched screams, tremors, sickly appearance, diarrhea, and no weight gain.
• a problem affecting a valve in the intestine, which can cause severe abdominal pain (Oddi's sphincter dysfunction).

If treatment is stopped abruptly, prolonged use of Taioma can lead to dependence and may cause withdrawal syndrome. If you no longer need treatment with Taioma, your doctor will gradually reduce the dose to prevent withdrawal symptoms (see also "Special precautions with Taioma").

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Taioma

Keep this medication out of sight and reach of children. Store this medication in a safe and closed place, where others cannot access it. It can cause serious harm and be fatal to people when not prescribed to them.

Do not use this medication after the expiration date shown on the blister pack and the packaging after EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Taioma composition

• The active ingredient isoxycodone hydrochloride. 1 tablet contains 5 mg of oxycodone hydrochloride equivalent to 4.48 mg of oxycodone.
• Other ingredients are

Tablet core: Kollidon SR (formed by polyvinylpyrrolidone (K = 27.0 - 32.4) (E 1201), lauryl sulfate, silica), microcrystalline cellulose (E-460), anhydrous colloidal silica, magnesium stearate (E470b).

Tablet coating: polyvinyl alcohol, talc (E-553b), titanium dioxide (E-171), macrogol 3350, soy lecithin (E-322), yellow iron oxide (E-172), black iron oxide (E-172), carmine, aluminum lake (E-132).

Appearance of Taioma and package contents

Taioma 5mg are prolonged-release tablets of light gray color, round, and biconvex.

They come in blister packs of 10, 28, 30, and 56 prolonged-release tablets.

Only some pack sizes may be marketed.

Marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26 28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer

G.L. Pharma GmbH,

Schlossplatz 1, 8502 Lannach,

Austria

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany: Oxycodonhydrochlorid G.L. 5 mg Retardtabletten

France: Oxycodone Viatris 5 mg prolonged-release tablet

Spain: Taioma 5 mg prolonged-release tablets EFG

Date of the last revision of this leaflet:April 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/