Taioma Plus 30 mg/15 mg prolonged-release tablets EFG

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the user

Taioma Plus 30mg/15mg prolonged-release tablets EFG

Oxycodone hydrochloride/naloxone hydrochloride

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Taioma Plus is and what it is used for

Taioma Plus is a prolonged-release tablet, meaning that its active substances are released over an extended period of time. Its action lasts for 12 hours.

These tablets are intended for use in adults only.

Pain relief

You have been prescribed Taioma Plus for the treatment of severe pain, which can only be adequately managed with opioid analgesics. Naloxone hydrochloride is added to counteract constipation.

How these tablets work for pain relief

These tablets contain as active substances oxycodone hydrochloride and naloxone hydrochloride. Oxycodone hydrochloride is responsible for the analgesic effect of Taioma Plus and is a potent analgesic belonging to the opioid group.

The second active substance in Taioma Plus, naloxone hydrochloride, serves to counteract constipation. Gastrointestinal dysfunction (e.g. constipation) is a common adverse effect of opioid analgesic therapy.

2. What you need to know before starting to take Taioma Plus

Do not take Taioma Plus:

• if you are allergic to oxycodone hydrochloride, naloxone hydrochloride, or any of the other components of this medicine (listed in section 6),
• if your breathing does not provide sufficient oxygen to the blood or remove carbon dioxide produced in the body (respiratory depression),
• if you have severe lung disease associated with narrowing of the airways (chronic obstructive pulmonary disease or COPD),
• if you have a disorder called cor pulmonale. This condition involves enlargement of the right side of the heart due to increased pressure in the blood vessels of the lungs (e.g., as a result of COPD, see above),
• if you have severe bronchial asthma,
• if you have paralytic ileus (a type of intestinal obstruction) not caused by opioids,
• if you have moderate to severe liver disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Taioma Plus:

• if you are elderly or debilitated (weak),
• if you have paralytic ileus (a type of intestinal obstruction) caused by opioids,
• if you have kidney disorder,
• if you have mild liver disorder,
• if you have severe lung disorder (i.e., reduced breathing capacity),
• if you have a condition characterized by frequent breathing pauses during sleep, which may make you feel very sleepy during the day (sleep apnea),
• if you have myxedema (a thyroid disorder characterized by dry, cold, and swollen skin, affecting the face and extremities),
• if your thyroid gland does not produce enough hormones (underactive thyroid, or hypothyroidism),
• if your adrenal glands do not produce sufficient hormones (adrenal insufficiency or Addison's disease),
• if you have a mental disorder accompanied by partial or complete loss of touch with reality (psychosis) due to alcoholism or intoxication with other substances (substance-induced psychosis),
• if you have problems related to gallstones, or any other disorder of the bile ducts (disease affecting the bile ducts, gallbladder, etc.),
• if you have alcoholism or delirium tremens,
• if you have low blood pressure (hypotension),
• if you have high blood pressure (hypertension),
• if you have a previous cardiovascular disease,
• if you have a head injury (due to the risk of increased pressure in the brain),
• if you have epilepsy or are prone to seizures,
• if you are also receiving treatment with MAO inhibitors (used to treat depression or Parkinson's disease), or have taken such medication within the last two weeks, for example, medicines containing tranylcypromine, phenelzine, isocarbazide, moclobemide, or linezolid,
• if you experience drowsiness or sudden episodes of falling asleep.

Sleep-related breathing disorders

Taioma Plus may cause sleep-related breathing disorders 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, nighttime awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Tell your doctor if you have had any of these conditions in the past. Also inform your doctor if you develop any of them during treatment with these tablets.

The most serious consequence of opioid overdose is respiratory depression (slow and shallow breathing). This may also lead to reduced oxygen concentration in the blood, which can cause fainting, etc.

Swallow the prolonged-release tablet whole to ensure the slow release of oxycodone hydrochloride from the tablet. Do not split, chew, or crush the tablets. Taking them split, chewed, or crushed may lead to potentially fatal absorption of oxycodone hydrochloride (see section 3 “If you take more Taioma Plus than you should”).

If you experience severe diarrhea at the beginning of treatment, it may be due to the effect of naloxone. It may be a sign that intestinal function is normalizing. This diarrhea may occur during the first 3 to 5 days of treatment. If it persists beyond this 3- to 5-day period, or if you are concerned, contact your doctor.

If you have been receiving another opioid, you may experience withdrawal symptoms shortly after starting treatment with Taioma Plus, for example, restlessness, sweating episodes, and muscle pain. If you experience any of these symptoms, you may require special monitoring by your doctor.

Tolerance, dependence, and addiction

This medicine contains oxycodone, which is an opioid, and may lead to dependence and/or addiction.

This medicine contains oxycodone, an opioid medicine. Repeated use of opioid analgesics may make the medicine less effective (you become accustomed to it, known as tolerance). Repeated use of Taioma Plus may cause dependence and abuse, which could lead to a life-threatening overdose. It is important that you inform your doctor if you think you may have developed dependence on Taioma Plus.

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 continue taking the medicine, even when it does not help 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 Plus:

• if you or a family member have 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 Plus, 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, e.g., "to stay calm" or "to help you sleep."
• You have made repeated unsuccessful attempts to stop or control the 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 Plus").

Inform your doctor if you have cancer with peritoneal metastases or initial intestinal obstruction in advanced stages of gastrointestinal or pelvic cancers.

If you need to undergo surgery, inform the medical team that you are taking Taioma Plus.

Like other opioids, oxycodone may affect the normal production of hormones in the body, such as cortisol or sex hormones, especially if high doses are taken for long periods. If you notice persistent symptoms such as malaise (including vomiting), loss of appetite, fatigue, weakness, dizziness, changes in menstrual cycle, impotence, infertility, or decreased sexual desire, consult your doctor so they can monitor your hormone levels.

This medicine may increase your sensitivity to pain, especially at high doses. Inform your doctor if this occurs. It may be necessary to reduce the dose or change the medicine.

You may notice remnants of the prolonged-release tablet in your stools. Do not be alarmed, as the active ingredients (oxycodone hydrochloride and naloxone hydrochloride) have already been released in the stomach and intestine and absorbed by your body.

Incorrect use of Taioma Plus

These tablets are not suitable for the treatment of withdrawal syndrome.

The prolonged-release tablet may be divided into equal doses but must not be chewed or crushed.

Taking chewed or crushed tablets may lead to potentially fatal absorption of oxycodone hydrochloride (see section 3 “If you take more Taioma Plus than you should”).

Abuse

Taioma Plus must never be abused, especially if you have a substance addiction. If you are addicted to substances such as heroin, morphine, or methadone, you are likely to experience severe withdrawal symptoms if you misuse these tablets, because they contain naloxone. Pre-existing withdrawal symptoms may worsen.

Misuse

You must never dissolve these tablets for injection (e.g., into a blood vessel). This is because they contain talc, which can cause local tissue destruction (necrosis) and lung tissue abnormalities (pulmonary granuloma). Such abuse may also have other serious consequences and may even cause death.

Doping

The use of Taioma Plus may result in positive anti-doping tests. The use of Taioma Plus as a doping agent may endanger health.

Other medicines and Taioma Plus

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

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 symptoms such as rhythmic, involuntary muscle contractions (including eye movement control muscles), agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C may occur. Contact your doctor if you experience these symptoms.

The concomitant use of opioids, including oxycodone hydrochloride, and sedative medicines such as benzodiazepines or related medicines, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes Targin together with sedative medicines, your doctor must limit the dose and duration of concomitant treatment.

Inform your doctor of all sedative medicines you are taking and carefully follow the recommended doses. It may be helpful to inform friends or family members about the signs and symptoms listed above. Contact your doctor if you experience such symptoms. Examples of sedative or related medicines include:

• other strong painkillers (opioids),
• medicines used to treat epilepsy, pain, and anxiety, such as gabapentin and pregabalin,
• sleeping pills and tranquilizers (sedatives, including benzodiazepines, hypnotics, anxiolytics),
• medicines used to treat depression,
• medicines used to treat allergies, dizziness, or nausea (antihistamines or antiemetics),
• medicines used to treat psychiatric or mental disorders (antipsychotics including phenothiazines and neuroleptics).

If you take these tablets together with other medicines, the effects of the tablets or the other medicines listed below may change. Inform your doctor if you are taking:

• medicines that reduce blood clotting ability (coumarin derivatives), which may increase or decrease clotting speed,
• macrolide antibiotics (such as clarithromycin, erythromycin, or telithromycin),
• antifungal agents of the -azole type (e.g., ketoconazole, voriconazole, itraconazole, or posaconazole),
• a specific type of medicine known as a protease inhibitor used to treat HIV (e.g., ritonavir, indinavir, nelfinavir, or saquinavir),
• cimetidine (a medicine used to treat stomach ulcers, indigestion, or heartburn),
• rifampicin (used to treat tuberculosis),
• carbamazepine (used to treat seizures or convulsions and certain painful conditions),
• phenytoin (used to treat seizures or convulsions),
• a herbal medicine called St. John's wort (also known as Hypericum perforatum),
• quinidine (a medicine used to treat arrhythmias).

No interactions are expected between Taioma Plus and paracetamol, acetylsalicylic acid, or naltrexone.

Use of Taioma Plus with food, drinks, and alcohol

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

You should avoid drinking grapefruit juice while taking Taioma Plus.

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

These tablets should be avoided during pregnancy as much as possible. If used for prolonged periods during pregnancy, oxycodone hydrochloride may cause withdrawal symptoms in the newborn. If oxycodone hydrochloride is administered during labor, the newborn may experience respiratory depression (slow and shallow breathing).

Breastfeeding

Breastfeeding must be discontinued during treatment with these tablets. Oxycodone hydrochloride passes into breast milk. It is not known whether naloxone hydrochloride also passes into breast milk. Therefore, the risk to the infant cannot be ruled out, especially if the mother receives multiple doses of Taioma Plus.

Driving and using machines

Taioma Plus may affect your ability to drive and use machines. This is particularly true at the beginning of treatment with Taioma Plus, after a dose increase, or after switching from another medication. However, these adverse effects usually disappear once you are on a stable dose of Taioma Plus.

Taioma Plus has been associated with drowsiness and sudden episodes of falling asleep. If you experience these adverse effects, you should not drive or operate machinery. If this occurs, inform your doctor.

Consult your doctor to determine whether you are allowed to drive or use machines.

3. How to take Taioma Plus

Follow exactly the instructions for using this medicine as indicated by your doctor. 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 Taioma Plus, 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 treatment with Taioma Plus”).

Taioma Plus is a prolonged-release tablet, which means that the active substances are released over an extended period of time. Its action lasts 12 hours.

You must swallow the prolonged-release tablet whole to avoid interfering with the slow release of oxycodone hydrochloride from the tablet. Do not break, crush, or chew the tablets. If you do, your body may absorb a potentially fatal dose of oxycod0ne hydrochloride (see section 3 “If you take more Taioma Plus than you should”).

Unless your doctor tells you otherwise, the usual dose is:

For pain treatment

Adults

The usual initial dose is 10 mg oxycodone hydrochloride / 5 mg naloxone hydrochloride in prolonged-release tablets every 12 hours.

Your doctor will decide the daily dose you should take and how to divide it into morning and evening doses. Your doctor will also determine whether the dose needs to be adjusted during treatment. Your dose will be adapted to the severity of your pain and your individual sensitivity. You should receive the lowest dose necessary to relieve pain. If you have previously received opioid treatment, the initial dose of Taioma Plus may be higher.

The maximum daily dose is 160 mg of oxycodone hydrochloride and 80 mg of naloxone hydrochloride. If you require a higher dose, your doctor may prescribe additional oxycodone hydrochloride without naloxone hydrochloride. However, the maximum daily dose of oxycodone hydrochloride must not exceed 400 mg. The beneficial effect of naloxone hydrochloride on intestinal function may be reduced if the dose of oxycodone hydrochloride is increased without increasing the dose of naloxone hydrochloride.

If you switch from these tablets to another opioid analgesic, your intestinal function may worsen.

If you experience pain between doses of Taioma Plus, you may need a fast-acting analgesic. Taioma Plus is not suitable for treatment in this case. Speak with your doctor about this.

If you feel the effect of these tablets is too strong or too weak, consult your doctor or pharmacist.

Elderly patients

In general, dose adjustment is not necessary in elderly patients with normal kidney and/or liver function.

Liver or kidney impairment

If you have any degree of kidney impairment or mild liver impairment, your doctor will prescribe these tablets with special caution. If you have moderate or severe liver impairment, you must not take these tablets (see also section 2 “Do not take Taioma Plus” and “Warnings and precautions”).

Children and adolescents under 18 years

Taioma Plus has not been studied in children and adolescents under 18 years of age. Its safety and efficacy have not been established in these patients. Therefore, the use of Taioma Plus is not recommended in children and adolescents under 18 years of age.

Method of administration

Oral use.

Take these tablets every 12 hours, following a fixed schedule (e.g., 8 a.m. and 8 p.m.).

Swallow these tablets with sufficient liquid (half a glass of water). The tablet may be divided into two equal doses. Do not break, chew, or crush the tablets. You may take the prolonged-release tablets with or without food.

Duration of treatment

In general, you should not take these tablets longer than necessary. If you are taking these tablets for a prolonged period, your doctor should regularly check whether you still need them.

If you take more Taioma Plus than you should

If you have taken more tablets than prescribed, inform your doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine package and leaflet to the healthcare professional.

An overdose may cause:

• constricted pupils,
• slow and shallow breathing (respiratory depression),
• drowsiness up to loss of consciousness,
• low muscle tone (hypotonia),
• reduced heart rate, and
• low blood pressure.
• A brain disorder (known as toxic leukoencephalopathy)

In severe cases, loss of consciousness (coma), fluid accumulation in the lungs, and circulatory collapse may occur, which can be fatal in some cases.

You should avoid situations requiring high alertness, for example, driving.

If you forget to take Taioma Plus

If you take a lower dose than prescribed, you may stop feeling the analgesic effect.

If you forget to take a dose, follow the instructions below:

• If 8 hours or more remain until your next scheduled dose: Take the missed dose immediately, and continue with your regular dosing schedule.
• If less than 8 hours remain until your next scheduled dose: Take the missed dose. Wait another 8 hours before taking the next dose. Try to return to your original schedule (e.g., 8 a.m. and 8 p.m.). Do not take more than one dose within an 8-hour period.

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

If you stop treatment with Taioma Plus

Do not stop treatment without consulting your doctor.

If you no longer require treatment, you should gradually reduce the daily dose after discussing it with your doctor. This will help you avoid withdrawal symptoms such as restlessness, episodes of sweating, and muscle pain.

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

4. Possible adverse effects

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

Important adverse effects or signs to be aware of, and what to do if they occur:

If you already experience any of the following serious adverse effects, consult your nearest doctor immediately.

Slow and shallow breathing (respiratory depression) is the main danger in opioid overdose. This occurs particularly in elderly and debilitated patients. Opioids may also cause a marked decrease in blood pressure in susceptible patients.

The following adverse effects have been observed in patients treated for pain:

Frequent (may affect up to 1 in 10 patients):

abdominal pain	malaise	fatigue or exhaustion
constipation	flatulence (gas)	itchy skin
diarrhea	reduced or loss of appetite	skin reactions/rashes
dry mouth	dizziness or sensation that “everything is spinning”	sweating
indigestion	headache	vertigo
vomiting	hot flushes	insomnia
	unusual weakness	drowsiness

Uncommon (may affect up to 1 in 100 people):

flatulence	palpitations	rhinorrhea
abnormal thoughts	biliary colic	cough
anxiety	chest pain	hypersensitivity/allergic reactions
confusion	general malaise	injuries from accidents
depression	pain	increased urgency to urinate
nervousness	swelling of hands, ankles or feet	muscle cramps
feeling of tightness in the chest, especially if you already have coronary heart disease	weight loss	muscle contractions
decrease in blood pressure	difficulty concentrating	muscle pain
withdrawal symptoms such as agitation	speech disturbance	visual disturbance
fainting	tremor	epileptic seizures (especially in people with epileptic disorders or predisposition to seizures)
loss of energy	increase in blood pressure
thirst	difficulty breathing
taste disturbance	restlessness
	chills
	increase in liver enzymes
	decrease in sexual desire

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

increased heart rate	dental abnormalities	weight gain
drug dependence		yawning

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

euphoria	hallucinations	skin tingling
severe sedation	respiratory depression	belching
erectile dysfunction	difficulty urinating	sleep apnea (interruptions in breathing during sleep)
nightmares	aggression

It is known that the active substance oxycodone hydrochloride, when not combined with naloxone hydrochloride, has the following adverse effects, in addition to those mentioned above:

Oxycodone may cause respiratory problems (respiratory depression), decreased pupil size, bronchial and smooth muscle spasms, and suppression of the cough reflex.

Frequent (may affect up to 1 in 10 people):

mood and personality changes (e.g., depression, feeling extremely happy)	decreased activity	difficulty urinating
	increased activity	hiccups

Uncommon (may affect up to 1 in 100 people):

difficulty concentrating	reduced sensitivity to pain or touch	gingivitis
migraine	coordination abnormalities	perception disorders (e.g., hallucinations, derealization)
increased muscle tension	voice alterations (dysphonia)	skin redness
involuntary muscle contractions	water retention	dehydration
condition in which the intestine stops functioning properly (ileus)	hearing difficulties	agitation
dry skin	mouth ulcers	decreased levels of sex hormones which may affect sperm production in men or menstrual cycle in women
drug tolerance	difficulty swallowing

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

itchy rash (urticaria)	increased appetite	bleeding gums
infections such as cold sores or herpes (which may cause blisters around the mouth or genital area)	black stools (resembling tar)

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

generalized acute allergic reactions (anaphylactic reactions)	absence of menstrual periods	problems with bile flow
increased sensitivity to pain	neonatal withdrawal syndrome	dental caries

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is an adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Taioma Plus

Keep this medicine out of the sight and reach of children. Store this medicine in a safe, closed 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 carton and on the blister, following "EXP". The expiry date refers to the last day of the month indicated.

Blister: Do not store above 25 °C.

Bottles: Do not store above 30 °C. Shelf life after first opening: 3 months.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE point located in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Taioma Plus

The active substances are: oxycodone hydrochloride and naloxone hydrochloride.

Each prolonged-release tablet contains 30 mg of oxycodone hydrochloride (equivalent to 27 mg of oxycodone) and 15 mg of naloxone hydrochloride (as 16.35 mg of naloxone hydrochloride dihydrate, equivalent to 13.5 mg of naloxone).

The other components are:

Tablet core: Polyvinyl acetate, povidone K30, sodium lauryl sulfate, anhydrous colloidal silica, microcrystalline cellulose and magnesium stearate.

Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), yellow iron oxide (E172), macrogol 3350 and talc.

Appearance of Taioma Plus and contents of the pack

Yellow, oblong, biconvex prolonged-release tablets with score lines on both sides, measuring 12.2 mm in length, 5.7 mm in width and 3.3 – 4.3 mm in height.

The tablet may be divided into two equal doses.

Taioma Plus is available in:

Child-resistant blisters containing 10, 14, 20, 28, 30, 50, 56, 60, 98 and 100 prolonged-release tablets, or child-resistant bottles containing 50, 100 and 250 prolonged-release tablets.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer

Develco Pharma GmbH

Grienmatt 27, Schopfheim

79650

Germany

Laboratori Fundació DAU

C/ C 12-14, Polígono Industrial Zona Franca,

08040, Barcelona

Spain

Date of the most recent revision of this leaflet: March 2025

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