TAIOMA PLUS 20 mg/10 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Taioma Plus20mg/10mg prolonged-release tablets EFG

Oxycodone hydrochloride/Naloxone 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. See section 4.

Contents of the pack and other information

1. What is Taioma Plus and what is it used for
2. What you need to know before you take 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 is Taioma Plus and what is it used for

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

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

The second active substance of Taioma Plus, naloxone hydrochloride, has the function of counteracting constipation. Bowel dysfunction (e.g. constipation) is a common side effect of treatment with opioid analgesics.

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

Do not take Taioma Plus

• if you are allergic to oxycodone hydrochloride, naloxone hydrochloride or any of the other ingredients of this medicine (listed in section 6),
• if your breathing is too weak to take in enough oxygen or remove carbon dioxide from your 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 condition where the right side of the heart is enlarged due to increased pressure in the blood vessels of the lungs, etc. (e.g. as a result of COPD, see above),
• if you have severe bronchial asthma,
• if you have paralytic ileus (a type of bowel 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 an elderly or debilitated patient (weak),
• if you have paralytic ileus (a type of bowel 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 disease characterized by frequent pauses in breathing during sleep, which can make you feel very sleepy during the day (sleep apnea),
• if you have myxedema (a thyroid disorder characterized by dryness, coldness, and swelling of the skin, affecting the face and limbs),
• if your thyroid gland does not produce enough hormones (underactive thyroid, or hypothyroidism),
• if your adrenal glands do not produce enough hormones (adrenal insufficiency or Addison's disease),
• if you have a mental illness accompanied by a loss (partial) of contact with reality (psychosis), due to alcoholism or intoxication with other substances (substance-induced psychosis),
• if you have problems with gallstones, or if you have 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 history of cardiovascular disease,
• if you have had 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 this type of medicine in the last two weeks, for example, medicines containing tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid,
• if you experience drowsiness or sudden sleep episodes.

Breathing-related sleep disorders

Taioma Plus may cause breathing-related sleep 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 sleepiness during the day. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Tell your doctor if you have had any of these diseases 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 can also cause a decrease in oxygen concentration in the blood, which can lead to fainting, etc.

Swallow the prolonged-release tablet whole, so that the slow release of oxycodone hydrochloride from the prolonged-release tablet is not affected. Do not break, chew, or crush the tablets. Taking them broken, chewed, or crushed can lead to a 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 start of treatment, it may be due to the effect of naloxone. It may be a sign that bowel function is returning to normal. This diarrhea may occur in the first 3 to 5 days of treatment. If it persists after this period of 3 to 5 days, 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, e.g. restlessness, sweating, and muscle pain. If you experience any of these symptoms, you may need special monitoring by your doctor.

Tolerance, dependence, and addiction

This medicine contains oxycodone, which is an opioid, and can cause dependence and/or addiction.

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 Plus can cause dependence and abuse, which can lead to overdose and threaten your life. It is important that you inform your doctor if you think you may have developed dependence on Taioma Plus.

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 Plus:

• if you or a family member have a history of abuse or dependence on alcohol, prescription drugs, or illicit substances ("addiction").
• if you smoke
• if you have ever had problems with your mood (depression, anxiety, or personality disorder) or have received psychiatric treatment for other mental health disorders.

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 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 it 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 it safely (see section 3, "If you stop taking Taioma Plus").

Tell your doctor if you have cancer associated with peritoneal metastasis or initial intestinal obstruction in advanced stages of digestive and pelvic cancers.

If you need to undergo surgery, tell the doctors that you are taking Taioma Plus.

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

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

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

Children and adolescents

The safety and efficacy of Taioma Plus in children and adolescents below 18 years have not been established.

How to take Taioma Plus correctly

Diarrhea

If you experience severe diarrhea at the start of treatment, it may be due to the effect of naloxone. It may be a sign that bowel function is returning to normal. This diarrhea may occur in the first 3 to 5 days of treatment. If it persists after this period of 3 to 5 days, or if you are concerned, contact your doctor.

Switching to Taioma Plus

If you have been receiving another opioid, you may experience withdrawal symptoms shortly after starting treatment with Taioma Plus, e.g. restlessness, sweating, and muscle pain. If you experience any of these symptoms, you may need special monitoring by your doctor. These tablets are not intended as treatment for withdrawal syndrome.

Incorrect use of Taioma Plus

These tablets are not intended as treatment for withdrawal syndrome.

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

Taking the tablets chewed or crushed can lead to a potentially fatal absorption of oxycodone hydrochloride (see section 3 "If you take more Taioma Plus than you should").

Abuse

Never abuse Taioma Plus, especially if you have an addiction to any drug. If you are addicted to substances such as heroin, morphine, or methadone, you may experience severe withdrawal symptoms if you misuse these tablets, as they contain naloxone. They can worsen pre-existing withdrawal symptoms.

Misuse

Never dissolve these tablets to inject them (e.g. into a blood vessel). The reason is that they contain talc, which can cause local tissue destruction (necrosis) and lung tissue changes (pulmonary granuloma). This abuse can also have other serious consequences and even cause death.

Doping

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

Other medicines and Taioma Plus

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

The risk of side effects increases if you are taking antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines can interact with oxycodone and may cause symptoms such as involuntary muscle contractions, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. 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, breathing difficulties (respiratory depression), coma, and can threaten your life. Due to this, concomitant use should only be considered when other treatment options are not possible.

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

Tell your doctor about all sedative medicines you are taking and follow the recommended doses carefully as prescribed by your doctor. It may be useful to inform friends or family members who are aware of the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms. Some examples of sedative medicines or related medicines are:

• other potent analgesics (opioids),
• medicines for treating epilepsy, pain, and anxiety, such as gabapentin and pregabalin;
• sleeping pills and tranquilizers (sedatives, including benzodiazepines, hypnotics, anxiolytics),
• medicines for treating 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 at the same time as other medicines, the effects of the tablets or the other medicines described below may change. Tell your doctor if you are taking:
• medicines that reduce blood clotting (coumarin derivatives), the speed of blood clotting may increase or decrease,
• macrolide antibiotics (such as clarithromycin, erythromycin, or telithromycin),
• azole-type antifungal agents (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 for treating stomach ulcers, indigestion, or heartburn),
• rifampicin (used to treat tuberculosis),
• carbamazepine (used to treat seizures or certain painful conditions),
• phenytoin (used to treat seizures),
• a herbal medicine called St. John's Wort (also known as Hypericum perforatum),
• quinidine (a medicine for treating arrhythmias).

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

Using Taioma Plus with food, drinks, and alcohol

Drinking alcohol while taking Taioma Plus can make you feel more drowsy or increase the risk of serious side effects such as shallow breathing with the risk of stopping breathing, 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

During pregnancy, these tablets should be avoided as far as possible. If used during prolonged periods of pregnancy, oxycodone hydrochloride may cause withdrawal symptoms in the newborn. If oxycodone hydrochloride is administered during delivery, the newborn may experience respiratory depression (slow and shallow breathing).

Breastfeeding

Breastfeeding should 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 breastfed child cannot be excluded, especially if the mother receives multiple doses of Taioma Plus.

Driving and using machines

Taioma Plus may affect your ability to drive or use machines. This is especially true at the start of treatment with Taioma Plus, after a dose increase, or after switching from another medicine. However, these side effects disappear once you take a stable dose of Taioma Plus.

Taioma Plus has been associated with drowsiness and sudden sleep episodes. If you experience these side effects, do not drive or use machinery. If this happens, inform your doctor.

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

3. How to take Taioma Plus

Follow the administration instructions of this medication exactly as indicated by your doctor. In case of 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 the use of 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 ingredients are released over a prolonged period. Its action lasts 12 hours.

You should swallow the prolonged-release tablet whole to avoid affecting 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 oxycodone hydrochloride (see section 3 "If you take more Taioma Plus than you should").

Unless your doctor tells you otherwise, theusual dose is:

For the treatment of pain

Adults

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

Your doctor will decide the dose you should take per day and how to divide it into morning and evening doses. Your doctor will also decide if it is necessary to adjust the dose during treatment. Your dose will be adapted to your degree of pain and individual sensitivity. You should receive the minimum necessary dose to relieve pain. If you have already received treatment with opioids, 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 need a higher dose, your doctor may prescribe more oxycodone hydrochloride without naloxone hydrochloride. However, the maximum daily dose of oxycodone hydrochloride should not exceed 400 mg. The beneficial effect of naloxone hydrochloride on intestinal activity may be affected if the dose of oxycodone hydrochloride is increased without increasing the dose of naloxone hydrochloride.

If you replace these tablets with another opioid analgesic, your intestinal function may worsen.

If you experience pain between two doses of Taioma Plus, you may need a fast-acting analgesic. Taioma Plus is not suitable for treatment in this case. For these cases, talk to your doctor.

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

Elderly patients

In general, it is not necessary to adjust the dose in elderly patients with normal kidney and/or liver function.

Liver or kidney disorder

If you have kidney disorder of any degree or mild liver disorder, your doctor will prescribe these tablets with special caution. If you have moderate or severe liver disorder, you should 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. Its safety and efficacy have not been demonstrated in these patients. For this reason, the use of Taioma Plus is not recommended in children and adolescents under 18 years.

Method of administration

Oral route.

Take these tablets every 12 hours, following a fixed schedule (e.g., at 8 am and 8 pm).

Swallow these tablets with sufficient liquid (half a glass of water). The tablet can be divided into two equal doses. Donot break, chew, or crush the tablets. You can take the prolonged-release tablets with or without food.

Duration of treatment

In general, you should not take these tablets for longer than necessary. If you receive these tablets for a long time, your doctor should regularly check that you still need them.

If you take more Taioma Plus than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to take the medication package and leaflet to the healthcare professional.

An overdose can cause:

• contraction of the pupils,
• slow and shallow breathing (respiratory depression),
• drowsiness leading to loss of consciousness,
• low muscle tone (hypotonia),
• reduction in heart rate, and
• decrease in 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 that require a high level of alertness, such as driving.

If you forget to take Taioma Plus

Or if you take a lower dose than prescribed, you may stop noticing the analgesic effect.

If you forget to take a dose, follow these instructions:

• If there are 8 hours or more left before the next normal dose: Take the missed dose immediately, and continue with the normal schedule.
• If there are less than 8 hours left before the next normal dose: Take the missed dose. Wait another 8 hours before taking the next dose. Try to recover the original schedule (e.g., 8 am and 8 pm). Do not take more than one dose in an 8-hour period.

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

If you stop treatment with Taioma Plus

Do not stop treatment without consulting your doctor.

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

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

4. Possible side effects

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

Important side effects or signs to consider, and what to do if you experience them:

If you already have any of the following important side effects, consult your doctor immediately.

Slow and shallow breathing (respiratory depression) is the main danger of opioid overdose. It occurs mainly in elderly and debilitated patients. Opioids can also cause a significant decrease in blood pressure in susceptible patients.

The following side effects have been observed in patients for the treatment of pain:

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

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

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

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

It is known that the active ingredient oxycodone hydrochloride, if not combined with naloxone hydrochloride, has the following side effects, different from those mentioned:

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

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

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

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

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are 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 Plus

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 for people who have not been prescribed it.

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

Blister pack: Do not store above 25°C.

Bottles: Do not store above 30°C. Validity period after first opening: 3 months.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. 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

Composition of Taioma Plus

The active ingredients are oxycodone hydrochloride and naloxone hydrochloride.

Each prolonged-release tablet contains 20 mg of oxycodone hydrochloride (equivalent to 18 mg of oxycodone) and 10 mg of naloxone hydrochloride (as 10.9 mg of naloxone hydrochloride dihydrate, equivalent to 9 mg of naloxone).

The other ingredients are:

Tablet core: Polyvinyl acetate, Povidone K30, sodium lauryl sulfate, colloidal silicon dioxide, microcrystalline cellulose, and magnesium stearate.

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

Appearance of Taioma Plus and package contents

Prolonged-release tablets are white, oblong, biconvex, with break lines on both sides, with a length of 11.2 mm, width 5.2 mm, and height of 3.3 - 4.3 mm.

The tablet can be divided into two equal doses.

Taioma Plus is available in:

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer

Develco Pharma GmbH

Grienmatt 27, Schopfheim

79650

Germany

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

Date of last revision of this leaflet: March 2025

"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/ "