Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Taioma 5 mg prolonged-release tablets EFG

Oxycodone hydrochloride

Read the entire 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet.

Leaflet contents:

What Taioma is and what it is used for
What you need to know before taking Taioma
How to take Taioma
Possible adverse effects
How to store Taioma
Contents of the pack and other information

1. What Taioma is and what it is used for

This medicine is a strong opioid analgesic.

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

2. What you need to know before taking Taioma

Do not take Taioma

if you are allergic to oxycodone hydrochloride, peanut, soy, or any of the other ingredients of this medicine (listed in section 6),
if you suffer from severe chronic lung disease associated with narrowing of the airways (COPD = chronic obstructive pulmonary disease),
if you have a certain heart disease called cor pulmonale,
if you have asthma,
if you suffer from breathing problems, such as breathing more slowly or weakly than normal (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 are elderly or weakened,
if the function of your lungs, liver, or kidneys is severely impaired,
if you have a thyroid disorder causing swollen, puffy, cold, and dry skin on the face and limbs,
if you have a certain disorder of the thyroid glands (myxoedema) or if your thyroid glands do 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 suffer from enlargement of the prostate,
if you have a mental disorder caused by alcohol or intoxication with other substances,
if you are in a phase of alcohol withdrawal,
if you have inflammation of the pancreas (pancreatitis) or have problems with the gallbladder,
if you have inflammation of the pancreas that may cause severe pain in the abdomen or back,
if you have inflammatory bowel disease,
if your doctor suspects you have intestinal paralysis (a condition in which the intestine has stopped functioning),
if you have a head injury with severe headache or discomfort – signs of increased intracranial pressure,
if you have low blood pressure or feel dizzy when standing up,
if you suffer from epilepsy or have a tendency to seizures,
if you are taking a type of medicine to treat depression known as MAOIs (such as tranilcipromine, phenelzine, isocarboxazide, moclobemide, or linezolid), or if you have taken such medicines within the last two weeks,
if you suffer from constipation.

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

If any of the above applies to you, please contact your doctor.

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

This medicine is specially formulated to release the active ingredient over a 12-hour period. The prolonged-release tablets must not be broken, split, chewed, or crushed. Doing so would lead to the absorption of a potentially dangerous dose of the active substance oxycodone hydrochloride (see section "If you take more Taioma than you should or if someone accidentally ingests Taioma").

Tolerance, dependence, and addiction

This medicine contains oxycodone, an opioid. It may cause dependence and/or addiction.

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

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

Dependence or addiction may make you feel that you no longer have control over how much medicine you need to take or how often. You may feel that you need to keep taking the medicine, even when it no longer helps 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 has a history of alcohol, prescription medicine, or illicit substance abuse or dependence ("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 illnesses.

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 higher doses than recommended.
You are using the medicine for reasons other than prescribed, for example, "to stay calm" or "to help you sleep."
You have made repeated unsuccessful attempts to stop or control your use of the medicine.
You feel unwell when you stop taking the medicine and feel better once you take it again ("withdrawal symptoms").

If you notice any of these signs, speak with 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-line treatment for non-cancer-related pain and are not recommended as the sole treatment. Other medicines should be used alongside opioids in the treatment of chronic pain. Your doctor should monitor you closely and make necessary dose adjustments while you are taking Taioma to prevent addiction and abuse.

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

The active ingredient, oxycodone hydrochloride, like other potent opioids (strong analgesics), has abuse potential. Psychological addiction may develop. 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, increased sensitivity to pain (hyperalgesia) may occur, which does not respond to increasing the dose of Taioma. Your doctor will then decide whether to reduce the dose or switch to another strong analgesic (opioid).

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

If you are undergoing surgery, inform your doctor that you are taking Taioma.

Contact your doctor if you experience severe upper abdominal pain that may radiate to the back, nausea, vomiting, or fever, as these may be symptoms associated with inflammation of the pancreas (pancreatitis) or the biliary tract system.

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

Paediatric population

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

Anti-doping warning

Athletes are advised that this medicine contains a component that may result in a positive doping test.

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

Sleep-related breathing disorders

Taioma may cause sleep-related breathing disorders, such as sleep apnoea (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 maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing your dose.

Other medicines and Taioma

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

Concomitant use of Taioma and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment option 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.

Inform your doctor about all sedative medicines you are taking and follow your doctor's dosage recommendations. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Consult your doctor if you experience any symptoms.

Side effects of Taioma may be more frequent or more severe if used at the same time as medicines that may affect brain function or are used to treat allergies, dizziness, or vomiting. Side effects may include flattening and slowing of breathing (respiratory depression), constipation, dry mouth, or urinary problems.

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

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

Inform your doctor or pharmacist if you are taking:

medicines that help you sleep or stay calm (e.g. hypnotics or sedatives, including benzodiazepines),
medicines to treat depression (e.g. paroxetine or amitriptyline), including those belonging to the MAOI group (such as tranilcipromine, phenelzine, isocarboxazide, moclobemide, or linezolid),
medicines for allergy, dizziness, or vomiting (antihistamines, antiemetics),
medicines to treat psychiatric or mental disorders (such as psychotropic drugs, phenothiazines, or neuroleptic medicines),
medicines to treat epilepsy, pain, and anxiety, such as gabapentin and pregabalin,
muscle relaxants used to treat muscle spasms (such as tizanidine),
medicines to treat Parkinson's disease,
other strong analgesics (opioids),
cimetidine (a medicine for stomach ulcers, indigestion, or heartburn),
medicines to treat 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 treating HIV (such as boceprevir, ritonavir, indinavir, nelfinavir, or saquinavir),
rifampicin for treating tuberculosis,
carbamazepine (a medicine for treating epilepsy or seizures and certain pain conditions),
phenytoin (a medicine for treating seizures or convulsions),
a herbal medicine called "St. John's wort" (also known as Hypericum perforatum),
quinidine (a medicine for treating rapid heart rate),
certain medicines to prevent blood clotting or thinning the blood (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 serious adverse effects such as shallow breathing with risk of respiratory arrest and fainting. It is recommended not to drink alcohol while taking Taioma.

The use of the tablets should be avoided in patients with a history of or current alcohol or drug abuse.

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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You must not take Taioma during pregnancy. There are insufficient data on the use of oxycodone in pregnant women.

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

Breastfeeding

You must not use Taioma while breastfeeding, as oxycodone passes into breast milk and may cause sedation and slow, shallow breathing (respiratory depression) in the breastfed infant.

Driving and using machines

Taioma may affect your ability to drive and use machines.

This is particularly expected at the beginning of Taioma therapy, after increasing the dose, or after switching formulations, as well as when Taioma interacts with alcohol or drugs that impair brain function.

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

Taioma contains lecithin (from soy).

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

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

3. How to take Taioma

Follow exactly the administration instructions for this medicine as provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Dosage

For doses not achievable/practical with this concentration, other concentrations of this medicine are available.

Your doctor will adjust the dose according to the intensity of 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 previously been treated with opioids, your doctor may initiate your therapy with a higher dose.

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

Speak with your doctor if you experience breakthrough pain despite pain therapy. Your doctor may prescribe an additional analgesic (immediate-release analgesic) or adjust your dose of this medicine to manage breakthrough pain. You must not take this medicine for breakthrough pain.

If your doctor has not instructed otherwise, the recommended dose is

for adults and adolescents (from 12 years of age):

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 possible side effects.

Your doctor will prescribe the dose necessary to treat your pain. If you continue to experience pain while taking these tablets, inform your doctor.

In the treatment of non-malignant pain, 40 mg of oxycodone hydrochloride (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 required. Patients with malignant pain usually require doses of 80 to 120 mg of oxycodone hydrochloride, which may be increased up to 400 mg in individual cases.

Some patients taking Taioma on a fixed schedule may require a fast-acting analgesic as an as-needed medication to control breakthrough pain. Prolonged-release tablets of Taioma are not intended for the treatment of such breakthrough pain.

for children (under 12 years of age):

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

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 impairment, or with low body weight:

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

for other at-risk patients:

If you are small in stature or if your body metabolizes medications more slowly, the initial dose should be half the recommended adult dose.

Method of administration

Oral use.

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 a.m., and the next at 8 p.m.). You may take the tablets with or without food.

Swallow the prolonged-release tablets whole so that the specific release of the active substance over an extended period is not affected. Prolonged-release tablets must be swallowed whole and must not be broken, split, chewed, or crushed.

Duration of treatment

Your doctor will inform you about the duration of your treatment with this medicine.

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

If you take this medicine for a long time, your treatment should be monitored and discussed with your doctor regularly. This is necessary to achieve optimal pain therapy, i.e., to allow timely management of any side effects, as well as decisions regarding dose adjustment and continuation of treatment.

Consult your doctor or pharmacist if you feel that the effect of this medicine 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 prescribed, or call the Toxicology Information Service: 91 562 04 20, indicating the medicine and the amount ingested.

An overdose may cause:

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

In more severe cases, loss of consciousness (coma), water retention in the lungs, and circulatory failure may occur, possibly resulting in death.

Never place yourself in situations requiring high alertness, such as driving a car.

If you forget to take Taioma

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

If you miss a dose, you may take it if the next regular dose is scheduled more than 8 hours later. If less than 8 hours remain until the next dose, take the missed dose and then take the next dose 8 hours later.

Afterward, you may continue with your usual dosing schedule.

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

Consult your doctor or pharmacist if you are unsure.

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

If you stop taking Taioma

Do not stop treatment without first consulting your doctor.

If you stop taking the medicine, withdrawal symptoms may occur (e.g., yawning, dilated pupils, tearing, runny nose, tremors, sweating, anxiety, restlessness, seizures, insomnia, or muscle pain). Therefore, it may be advisable for your doctor to gradually reduce the dose.

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

4. Possible adverse effects

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

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

?Slowing or weakening of breathing (respiratory depression). This is the greatest danger associated with medicines such as Taioma (opioids) and can be fatal following high doses of the medicine.

Other adverse effects

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

numbness, dizziness, headache.
constipation, discomfort, nausea, vomiting. Your doctor will prescribe an appropriate medicine to treat these symptoms.
itching.

Common (may affect up to 1 in 10 people)

mood changes (anxiety, confusion, depression, restlessness), sleep disorders, abnormal thoughts.
tremors or uncontrollable movements in any part of the body, feeling of weakness.
decreased blood pressure, occasionally accompanied by symptoms such as strong or rapid 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.
rashes, excessive sweating.
sweating, weakness.

Uncommon (may affect up to 1 in 100 people)

allergic reactions.
increase in the level of a certain hormone (ADH = antidiuretic hormone) in the blood, with symptoms such as headache, irritability, lethargy, nausea, vomiting, confusion, and altered consciousness.
reduction in body water (dehydration).
restlessness, mood changes, hallucinations, euphoria, decreased libido, drug dependence.
amnesia, tingling or numbness (e.g., in hands or feet), seizures, increased or decreased muscle tone, tics, fainting, reduced sense of pain or touch, taste disturbances.
visual disturbances, reduced pupil size.
sensation of movement or spinning (dizziness).
unpleasant awareness of irregular or strong heartbeat, rapid pulse.
widening of blood vessels causing hypotension.
shortness of breath, increased cough, sore throat, nasal mucus, voice changes.
difficulty swallowing, mouth ulcers, gum inflammation, flatulence (excessive gas in the stomach or intestine), belching, intestinal obstruction (ileus).
increased blood concentration of certain liver enzymes.
dry skin.
difficulty urinating, frequent urination.
reduced sexual desire and inability to achieve or maintain an erection during sexual activity.
chills, dizziness, injuries due to reduced 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 (fits), particularly in patients with epilepsy or a predisposition to seizures.
low blood pressure.
bleeding gums, decreased appetite, dark stools.
itchy rash, blisters on the skin and mucous membranes (mouth 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 (breathing pauses during sleep).
severe allergic reactions.
aggression.
increased sensitivity to pain.
dental caries.
obstruction of bile secretion, biliary colic (causing stomach pain).
prolonged use of Taioma during pregnancy may cause withdrawal syndrome in newborns, which may be life-threatening. Symptoms observed in babies included irritability, hyperactivity, abnormal sleep patterns, high-pitched crying, tremors, appearance of illness, diarrhea, and failure to gain weight.
a condition affecting a valve in the intestine, which may cause severe upper abdominal pain (Oddi sphincter dysfunction).

If treatment is abruptly discontinued, prolonged use of Taioma may lead to dependence and withdrawal syndrome may occur. If you no longer require treatment with Taioma, your doctor will gradually reduce the dose to prevent withdrawal symptoms (see also "Take special care with Taioma").

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Taioma

Keep this medicine out of sight and reach of children. Store this medicine in a safe and secure place, where others cannot access it. It may cause serious harm or be fatal to individuals for whom it has not been prescribed.

Do not use this medicine after the expiry date stated on the blister and outer packaging following EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Taioma

The active substance is oxycodone hydrochloride. One tablet contains 5 mg of oxycodone hydrochloride, equivalent to 4.48 mg of oxycodone.
The other components are

Tablet core: Kollidon SR (composed of 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, lecithin (soy) (E-322), yellow iron oxide (E-172), black iron oxide (E-172), indigo carmine, aluminium lake (E-132).

Appearance of Taioma and contents of the pack

Taioma 5 mg are prolonged-release tablets, light grey in colour, round and biconvex.

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

Only certain 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 medicinal product 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 comprimé à libération prolongée

Spain: Taioma 5 mg comprimidos de liberación prolongada EFG

Date of the most recent review of this leaflet: June 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/