Leaflet: information for the user

Taioma 10 mg prolonged-release tablets EFG

Oxycodone hydrochloride

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

1. What Taioma is and what it is used for

2. What you need to know before you start taking Taioma

3. How to take Taioma

4. Possible side effects

5. Storage of Taioma

6. Contents of the pack and additional information

This medication is a strong opioid analgesic.

Taioma is indicated in adults and adolescents (12 years and older) for the treatment of intense pain, which can only be adequately treated with opioid analgesics.

Do not take Taioma

• if you areallergicto hydrochloride of oxicodone, peanuts, soy, or any of the other components of this medication (listed in section 6),
• if you have asevere chronic lung diseaseassociated with narrowing of the airways (COPD = chronic obstructive pulmonary disease),
• if you have a certainheart diseasecalled cor pulmonale,
• if you haveasthma,
• if you haverespiratory problems, such as breathing more slowly or more weakly than expected (respiratory depression),
• if you have a type of intestinal obstruction called paralytic ileus.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Taioma:

• if you areelderlyor aredebilitated,
• if your lung, liver, or kidney function 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 gland disorder (myxoedema) or if your thyroid gland does not produce enough hormones (hypothyroidism),
• if you have a poor adrenal gland function (your adrenal gland does not function correctly) for example Addison's disease,
• if you have an enlargedprostate,
• if you have a mental disorder caused by alcohol or intoxication with other substances,
• if you are in analcohol withdrawal phase,
• if you have inflammation of thepancreas(pancreatitis) or have problems with thebile duct,
• if you have an inflammation of thepancreasthat can cause intense pain in the abdomen or back,
• if you have aninflammatory bowel disease,
• if your doctor suspects that you have paralytic ileus (a disease in which the intestine has stopped functioning),
• if you have a head injury with severe headache or discomfort - signs that you haveincreasedintracranial pressure,
• if you havelow blood pressureor feel dizzy when standing up,
• if you haveepilepsyor are prone to seizures,
• if you are taking a type of medication for depression known asMAOIs(such as tranilcipromina, fenelzina, isocarboxazida, moclobemida, or linezolid), or if you have taken this type of medication in the last two weeks,
• if you suffer from constipation.

This medication may cause respiratory problems during sleep. These problems may include pauses in breathing during sleep, waking up due to lack of air, difficulty staying asleep, or excessive daytime sleepiness. If you or someone else observes 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 respiratory depression. This is more likely to occur in the elderly and debilitated patients, and may also cause decreased oxygen levels in the blood. This could cause, for example, a fainting spell.

This medication is especially formulated to administer the active ingredient over a period of 12 hours. The prolonged-release tablets should not be broken, divided, chewed, or crushed. This would lead to the absorption of a potentially dangerous dose of the active ingredient hydrochloride of oxicodone (see the section "If you take more Taioma than you should or if someone else has accidentally ingested Taioma").

Tolerance, dependence, and addiction

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

This medication contains oxicodone, which is an opioid medication. Repeated use of opioid analgesics may make the medication less effective (you become accustomed to it, known as tolerance). Repeated use of Taioma may cause dependence, abuse, and addiction, which may lead to a potentially fatal overdose. The risk of these adverse effects may increase with a higher dose and longer duration of use.

Dependence or addiction may make you feel that you no longer have control over the amount of medication you need to take or how often you need to take it. You may feel that you need to continue taking the medication, even when it no longer helps to alleviate 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 has a history of alcohol, medication, or substance abuse ("addiction"),
• if you smoke,
• if you have ever had problems with your mood (depression, anxiety, or a personality disorder) or have received treatment from a psychiatrist for other mental health conditions.

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

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

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

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

Taioma has a potential fordependence. After a sudden interruption, withdrawal symptoms such as yawning, dilated pupils, lacrimation, nasal discharge, tremors, sweating, anxiety, restlessness, seizures, insomnia, or muscle pain may appear. If you no longer need treatment, your doctor will gradually reduce your daily dose.

The active ingredient hydrochloride of oxicodone, like other high-potency opioids (strong analgesics), has a potential for abuse. It is possible to develop a psychological addiction. Taioma should only be used with special caution if there is or has been a history of alcohol, drug, or medication abuse.

Especially at high doses, it may cause an increase in sensitivity to pain (hyperalgesia), 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 analgesic (opioid).

Taioma is only for oral use (swallowing as a whole prolonged-release tablet). The prolonged-release tablets should not be dissolved and injected, as this may have severe and potentially fatal consequences.

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

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

Like other opioids, oxicodone may affect the normal production of hormones in the body (such as cortisol and sex hormones). This occurs especially after receiving large doses for long periods of time.

Pediatric population

Taioma is not recommended for children under 12 years due to a lack of safety and efficacy information.

Anti-doping warning

Warning to athletes: This medication contains a component that may establish a positive analytical result for doping control.

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

Respiratory disorders related to sleep

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

Other medications and Taioma

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

The concomitant use of Taioma and sedatives such as benzodiazepines or related medications increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may put your life at risk. Therefore, concomitant use should only be considered when no other treatment is possible.

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

Inform your doctor about all sedatives you are taking, and follow your doctor's recommended dose. It may be helpful to inform friends or family members to be aware of the symptoms and signs mentioned above. Consult your doctor if you experience any symptoms.

The side effects of Taioma may be more frequent or severe if used at the same time as medications that can affect the brain or are used to treat allergies, dizziness, or vomiting. Side effects may include respiratory depression, constipation, dry mouth, or urinary problems.

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

These medications may interact with oxicodone and may cause symptoms such as involuntary muscle contractions, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and a body temperature above 38°C. Contact your doctor if you experience these symptoms.

Inform your doctor or pharmacist if you are taking:

• medications that help you sleep or stay calm (such as hypnotics or sedatives, including benzodiazepines),
• medications for depression (such as paroxetine or amitriptyline), including those belonging to the MAOI group (such as tranilcipromina, fenelzina, isocarboxazida, moclobemida, or linezolid),
• allergy, dizziness, or vomiting medications (antihistamines, antiemetics),
• medications for psychiatric or mental disorders (such as psychotropic drugs, phenothiazines, or neuroleptics),
• medications for epilepsy, pain, and anxiety, such as gabapentin and pregabalin,
• muscle relaxants used for muscle spasms (such as tizanidine),
• medications for Parkinson's disease,
• other strong analgesics (opioids),
• cimetidine (a medication for stomach ulcers, indigestion, or heartburn),
• medications used to treat fungal infections (such as ketoconazole, voriconazole, itraconazole, or posaconazole),
• medications used to treat bacterial infections (such as clarithromycin, erythromycin, or telithromycin),
• a specific type of medications known as protease inhibitors for HIV (such as boceprevir, ritonavir, indinavir, nelfinavir, or saquinavir),
• rifampicin for tuberculosis,
• carbamazepine (a medication for epilepsy or seizures and certain situations with pain),
• phenytoin (a medication for seizures or convulsions),
• a medicinal herb called "St. John's Wort" (also known asHypericum perforatum),
• quinidine (a medication for rapid heart rhythm),
• certain medications to prevent blood clotting or dilute it (such as phenprocoumon).

Use of Taioma with food, drinks, and alcohol

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

You should avoid consuming the tablets in patients with a history or current abuse of alcohol and drugs.

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

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not takeTaioma during pregnancy. There is not enough information about the use of oxicodone in pregnant women.

Thelong-term use of oxicodoneduring pregnancy may causewithdrawal symptoms in newborns. The use of oxicodone during delivery may cause respiratory problems (respiratory depression) in the newborn.

Lactation

Do not useTaioma when breastfeeding, as oxicodone passes into breast milk and causes sedation and shallow breathing and slow breathing (respiratory depression) in the breastfed infant.

Driving and operating machinery

Taioma may affect your ability to drive and operate machinery.

This is expected, especially at the beginning of treatment with Taioma, after increasing the dose, or after switching to a different preparation, as well as when Taioma interacts with alcohol or substances that can impair brain function.

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

Taioma contains lecithin (soy).

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

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Before starting treatment and periodically during treatment, your doctor will talk to you about what you can expect from the use of 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 interrupt treatment with Taioma").

Dosage

For doses not achievable/practicable 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 minimum 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.

You may need to gradually increase the dose if the pain relief is insufficient or if the pain worsens.

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

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

•for adults and adolescents (12 years and older):

The usual initial dose is a 10 mg tablet every 12 hours. In some cases, your doctor may prescribe an initial dose of 5 mg to reduce the side effects 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 clorhidrato de oxicodona (4 prolonged-release tablets of Taioma 10 mg or 2 prolonged-release tablets of Taioma 20 mg 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 clorhidrato de oxicodona, which can be increased to 400 mg in individual cases.

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

•for children (under 12 years):

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

•for elderly patients (65 years and older):

Elderly patients with normal liver and/or lung function may take the same doses as indicated 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 yet received opioids, you should start with half the recommended dose for adults.

•for other high-risk patients:

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

Administration form

Oral route.

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

Swallow the prolonged-release tablets whole to avoid affecting the specific release of the active ingredient for a longer period. The prolonged-release tablets must be swallowed whole and not broken, divided, chewed, or crushed.

Duration of application

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

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

If you take this medication for a long time, you should 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 any side effects that may occur, as well as a decision on adjusting the dose and continuing 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 Toxicological Information Service: 91 562 04 20, indicating the medication and the amount ingested.

A overdose may cause:

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

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

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

If you forgot to take Taioma

If you take a lower dose of Taioma than prescribed, or if you forget a dose,you will probably not achieve pain relief.

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

Then, you can continue with your regular intake plan.

Generally, do 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 compensate for missed doses.

If you interrupt Taioma treatment

Do not interrupt treatment without consulting your doctor.

If you stop taking the medication, withdrawal symptoms (e.g., yawning, dilated pupils, tearing, nasal secretion, tremors, sweating, anxiety, restlessness, convulsions, insomnia, or muscle pain) may occur. Therefore, your doctor may recommend gradually reducing the dose.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Immediately contact a doctor if you experience any of the following symptoms:

?Slowing or weakening ofbreathing (respiratory depression). This is the greatest risk associated with medicines like Taioma (opioids) and can be fatal after high doses of the medicine.

Other side effects

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

• drowsiness, dizziness, headache.
• constipation, discomfort, nausea, vomiting. Your doctor will prescribe an appropriate 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.
• shakiness or uncontrollable movements in some part of the body, feeling weak.
• low blood pressure, accompanied in rare cases by symptoms such as strong or rapid heartbeat.
• shortness of breath, difficulty breathing or wheezing.
• dry mouth, accompanied in rare cases by thirst and difficulty swallowing, general symptoms of indigestion such as stomach pain, diarrhea, heartburn.
• eruptions, excessive sweating.
• sweating, weakness.

Rare(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.
• dehydration.
• restlessness, mood changes, hallucinations, euphoria, decreased libido, drug dependence.
• amnesia, tingling or numbness (e.g., in the hands or feet), seizures, muscle tone increase or decrease, tics, dizziness, decreased sense of pain or touch, taste alterations.
• visual disturbances, pupil constriction.
• sensation of movement or spinning (vertigo).
• unpleasant sensation of irregular or strong heartbeat, rapid pulse.
• vasodilation causing hypotension.
• shortness of breath, increased cough, throat pain, nasal mucositis, voice alteration.
• difficulty swallowing, oral ulcers, gum inflammation, flatulence (excessive gas in the stomach or intestines), belching, intestinal obstruction (ileus).
• increase in blood concentration of certain liver enzymes.
• dry skin.
• difficulty urinating, frequent urination.
• decreased sexual desire and inability to achieve or maintain an erection during sexual intercourse.
• chills, sensation of dizziness, injuries due to decreased alertness, pain (e.g., chest pain), fluid retention (edema), migraine, thirst, physical dependence with symptoms of dependence, tolerance.

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

• lymph node disease.
• muscle spasms, seizures (attacks), particularly in patients with epilepsy or prone to seizures.
• low blood pressure.
• bleeding gums, decreased appetite, dark stools.
• pruritic urticaria, skin and mucous membrane blisters (oral ulcers or herpes), increased sensitivity to light.
• blood in the urine.
• weight changes (increase or decrease), skin inflammation.

Unknown frequency(cannot be estimated from available data):

• sleep apnea (pauses in breathing during sleep).

• severe allergic reactions.
• aggressiveness.
• increased sensitivity to pain.
• tooth decay.
• bile duct obstruction, biliary colic (causing stomach pain).
• prolonged Taioma treatment during pregnancy can cause withdrawal syndrome in newborns with a threat to their life. Symptoms seen in babies included irritability, hyperactivity, and abnormal sleep pattern, loud crying, tremors, appearance of illness, diarrhea, and weight loss.
• a problem affecting a valve in the intestine, which can cause intense pain in the upper abdomen (Oddi sphincter dysfunction).

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usewww.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children. Store this medication in a secure and closed location where other individuals cannot access it. It may cause severe harm and be fatal to people who have not been prescribed it.

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

Do not store at a temperature above 25°C.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Taioma

• The active principle is hydrochloride of oxicodona. 1 tablet contains 10 mg of hydrochloride of oxicodona equivalent to 8.97 mg of oxicodona.
• The other components are

Core of the tablet : Kollidon SR (formed by polyvinylpyrrolidone (K = 27.0 - 32.4) (E 1201), laurilsulfate, silica), microcrystalline cellulose (E-460), anhydrous colloidal silica, magnesium stearate (E470b).

Covering of the tablet: polyvinyl alcohol, talc (E-553b), titanium dioxide (E-171), macrogol 3350, lecithin (soy) (E-322).

Appearance of Taioma and content of the packaging

Taioma 10 mg are prolonged-release tablets of white color, round and biconvex.

They are presented in blisters of 10, 28, 30, and 56 prolonged-release tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization:

Aristo Pharma Iberia, S.L.

C/ Solana, 26 28850, Torrejón de Ardoz

Madrid. Spain

Responsible for manufacturing

G.L. Pharma GmbH,

Schlossplatz 1, 8502 Lannach,

Austria

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany: Oxycodonhydrochlorid G.L. 10 mg Retardtabletten

France: Oxycodone Viatris 10 mg prolonged-release tablet

Spain: Taioma 10 mg prolonged-release tablets EFG

Date of the last review of this prospectus: April 2024

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/