Package Leaflet: Information for the User

Taioma Plus20mg/10mg prolonged-release EFG tablets

Oxycodone hydrochloride/naloxone 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 doubts, consult 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, 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. See section 4.

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

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

3. How to take Taioma Plus

4. Possible side effects

5. Storage of Taioma Plus

6. Contents of the pack and additional information

You have been prescribed Taioma Plus for the treatment of intense pain, which can only be adequately treated with opioid analgesics. Hydrochloride of naloxone is added to counteract constipation.

How it worksTaioma Plusfor pain relief

Taioma Pluscontains as active ingredients hydrochloride of oxycodone and hydrochloride of naloxone. Hydrochloride of oxycodone is responsible for the analgesic effect ofTaioma Plus, and is a potent analgesic of the opioid group.

The second active ingredient ofTaioma Plus, hydrochloride of naloxone, has the function of counteracting constipation. Intestinal dysfunction (e.g. constipation) is a common adverse effect of treatment with opioid analgesics.

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

These tablets are only for use in adults.

Do not takeTaioma Plus:

• if you are allergic to oxycodone hydrochloride, naloxone hydrochloride, or any of the other ingredients in this medication (listed in section 6),
• if you have difficulty breathing and are unable to get enough oxygen into your blood or remove carbon dioxide from your body (respiratory depression),
• if you have a severe lung disease associated with narrowing of the airways (chronic obstructive pulmonary disease or COPD),
• if you have a condition called cor pulmonale, which is characterized by an increase in the size of the right side of the heart due to increased pressure in the pulmonary blood vessels, etc. (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 Taioma Plus:

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 Taioma Plus.

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

Tolerance, dependence, and addiction

This medication contains oxycodone, which is an opioid, and may cause dependence and/or addiction.

This medication contains oxycodone, 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 Plus may cause dependence and abuse, which can lead to a potentially life-threatening overdose. It is essential to inform your doctor if you think you may have developed dependence on Taioma Plus.

Dependence or addiction may make you feel like 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 like you need to continue taking the medication, even when it no longer helps alleviate your pain.

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

• if you or a family member has a history of alcohol abuse, prescription medication abuse, or illicit substance abuse ("addiction").
• if you smoke
• if you have ever had problems with your mood (depression, anxiety, or personality disorder) or have received treatment from a psychiatrist for other mental 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 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, for example, "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 (2 symptoms of withdrawal").

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 interrupt treatment with Taioma Plus").

The most severe consequence of opioid overdose is respiratory depression (slow and shallow breathing). This can also cause a decrease in oxygen concentration in the blood, leading to dizziness, etc.

Respiratory disorders related to sleep

Taioma Plus 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 maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.

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

Children and adolescents

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

How to take Taioma Plus correctly

Diarrea

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

Cambio a Taioma Plus

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

Cirugía

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

Tratamiento a largo plazo

You may experience tolerance if you take these tablets for a long time. This means that you will need a higher dose to achieve the desired effect. Prolonged use may also cause physical dependence. Withdrawal symptoms may occur if treatment is stopped abruptly (restlessness, sweating, muscle pain). If you no longer need treatment, you should gradually reduce the daily dose, consulting with your doctor.

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

Uso incorrecto deTaioma Plus

These tablets do not serve as treatment for withdrawal syndrome.

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

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

Abuso

You should never abuse Taioma Plus, especially if you have a history of addiction to any substance. If you are addicted to substances like heroin, morphine, or methadone, you may experience severe withdrawal symptoms if you misuse these tablets, as they contain naloxone. These symptoms may worsen existing withdrawal symptoms.

Uso indebido

You should never dissolve these tablets to inject them (e.g., into a vein). The reason is that they contain talc, which can cause local tissue destruction (necrosis) and pulmonary tissue alterations (pulmonary granuloma). This misuse may also have other severe consequences and even cause death.

Dopaje

The use of Taioma Plus may result in positive tests in antidoping controls. The use of Taioma Plus as a doping agent may put your health at risk.

Other medications and Taioma Plus

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

If you take these tablets at the same time as other medications, the effect of these tablets or the other medication may change. Inform your doctor if you are taking:

• other potent analgesics (opioids),
• sleeping pills and tranquilizers (sedatives, hypnotics),
• medications used to treat depression (antidepressants),
• medications used to treat allergies, dizziness, or nausea (antihistamines or antiemetics),
• medications used to treat psychiatric or mental disorders (phenothiazines, neuroleptics, antipsychotics),
• muscle relaxants
• medications used to treat Parkinson's disease
• medications that reduce blood clotting (coumarin derivatives), may increase or decrease blood clotting speed,
• macrolide antibiotics (such as clarithromycin, erythromycin, or telithromycin),
• azole antifungals (e.g., ketoconazole, voriconazole, itraconazole, or posaconazole),
• a specific type of medication known as a protease inhibitor used to treat HIV (e.g., ritonavir, indinavir, nelfinavir, or saquinavir),
• cimetidine (used to treat stomach ulcers, indigestion, or acid reflux),
• rifampicin (used to treat tuberculosis),
• carbamazepine (used to treat seizures or convulsions and certain painful diseases),
• phenytoin (used to treat seizures or convulsions),
• a medicinal plant called St. John's Wort (also known asHypericum perforatum),
• quinidine (a medication used to treat arrhythmias).

No interactions are expected between Taioma Plus and paracetamol, aspirin, 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 severe 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.

Avoid drinking grapefruit juice while taking Taioma Plus.

Pregnancy and breastfeeding

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

Pregnancy

During pregnancy, these tablets should be avoided as much 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).

Lactancia

Breastfeeding will be suspended during treatment with these tablets. Oxycodone hydrochloride passes into breast milk. It is not known if 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 operating machinery

Taioma Plus may affect your ability to drive and operate machinery. This is especially true at the beginning of treatment with Taioma Plus, after an increase in dose, or after switching from another medication. However, these side effects disappear once you take a stable dose of Taioma Plus.

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

Consult your doctor if you are allowed to drive or operate machinery.

Follow exactly the administration instructions of this medication 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 to stop taking it (also see “If you interrupt treatment with Taioma Plus”).

Taioma Plusis a prolonged-release tablet, meaning that the active ingredients are released over a prolonged period of time. Its action lasts 12 hours.

Do not break, crush, or chew the tablets. If you do, your body may absorb a potentially fatal dose of hydrochloride oxycodone (see section 3 “If you take more Taioma Plusthan you should”).

Unless your doctor tells you otherwise, theusual dose is:

For pain treatment

Adults

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

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 you need to adjust the dose during treatment. Your dose will be adjusted to your level of pain and individual sensitivity. You should receive the minimum dose necessary to relieve pain. If you have already received treatment with opioids, the initial dose ofTaioma Plusmay be higher.

The maximum daily dose is 160mg of hydrochloride oxycodone and 80mg of hydrochloride naloxone. If you need a higher dose, your doctor may prescribe more hydrochloride oxycodone without hydrochloride naloxone. However, the maximum daily dose of hydrochloride oxycodone should not exceed 400mg. The beneficial effect of hydrochloride naloxone on intestinal activity may be affected if the dose of hydrochloride oxycodone is increased without increasing the dose of hydrochloride naloxone.

If you substitute these tabletswith another opioid analgesic, it is likely that your intestinal function will worsen.

If you experience pain between two doses of Taioma Plus, you may need a rapid-acting analgesic. Taioma Plusis not intended for this purpose. For these cases, consult your doctor.

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

Patients over 65 years old

Generally, no dose adjustment is necessary in elderly patients with normal kidney and/or liver function.

Patients with liver or kidney problems

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

Children and adolescents under 18years

Taioma Plushas not been studied in children and adolescents under 18years. Its safety and efficacy have not been demonstrated in these patients. Therefore, the use of Taioma Plusis not recommended in children and adolescents under 18years.

Administration form

Oral

Take thesetablets every 12hours, following a fixed schedule (e.g., at 8in the morning and at 8in the afternoon).

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

Duration of treatment

Generally, you should not take Taioma Plusfor longer than necessary. If you receive these tabletsfor a long time, your doctor will regularly check that you still need them.

If you take more Taioma Plusthan you should

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

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

Aoverdose may cause:

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

You should avoid situations that require a high level of alertness, such as driving.

If you forgot to take Taioma Plus

If you forgot to takeTaioma Plusor if you take a dose lower than prescribed, you may not notice the analgesic effect.

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

• If 8hours or more have passed since the next scheduled dose: Take the missed dose immediately, and continue with the regular schedule.
• If less than 8hours have passed since the next scheduled dose: Take the missed dose.Wait 8hours before taking the next dose. Try to recover the original schedule (e.g., 8in the morning and 8in the afternoon). Do not take more than one dose in an 8hour period.

Do not take a double dose to compensate for missed doses.

If you interrupt treatment with Taioma Plus

Do not interrupt treatmentwithTaioma Pluswithout 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.

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

Important side effects or signs to be aware of, and what to do if you experience them:

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

The 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 severe decrease in blood pressure in susceptible patients.

The side effects listed below are divided into two sections: pain treatment, treatment with the active ingredient hydrochloride of oxicodone only.

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

Frequent(mayaffectup to1in10patients):

• reduced or lost appetite,
• difficulty sleeping, fatigue orexhaustion,unusual feeling of weakness,
• feeling of dizziness or that “everything is spinning”, headache, drowsiness,
• dizziness,
• flushing,
• abdominal pain, constipation, diarrhea, dry mouth, indigestion, vomiting, discomfort, flatulence,
• itching, skin rash, sweating,
• general discomfort.

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

• allergic reactions,
• anxiety, abnormal thoughts, anxiety, confusion, depression, nervousness,
• seizures (especially in people with epilepsy or predisposition to seizures), difficulty concentrating, speech alteration, fainting, tremors,
• vision disorder,
• sensation of chest oppression especially if you already have coronary heart disease, palpitations,
• decrease in blood pressure, increase in blood pressure,
• difficulty breathing, runny nose, cough,
• abdominal distension,
• increase in liver enzymes, biliary colic,
• muscle cramps, muscle contractions, muscle pain,
• increased need to urinate,
• withdrawal symptoms such as agitation, chest pain, chills, general discomfort, pain, inflammation of hands, ankles or feet,
• weight loss,
• accidents,
• decreased libido,
• loss of energy,
• thirst,
• alteration of taste.

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

• increased heart rate,
• yawns,
• dental alterations,
• weight gain.

Unknown frequency (the frequency cannot be estimated from available data):

• euphoria, hallucinations, nightmares,
• tingling in the skin (pinpricks), intense drowsiness,
• shallow breathing,
• belching,
• difficulty urinating,
• erectile dysfunction.
• Sleep apnea (interruptions of breathing during sleep)

The following side effects are known to occur with the active ingredient hydrochloride of oxicodone, if not combined with hydrochloride of naloxone, and are different from those listed:

Oxicodone can cause respiratory problems (respiratory depression), pupil constriction, muscle cramps of the bronchial muscles and smooth muscles, and depression of the cough reflex.

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

• mood alteration and changes in personality (e.g. depression, feeling extremely happy), decreased activity, increased activity,
• hypo,
• difficulty urinating.

Poorly frequent (may affect up to 1 in 100 people):

• dehydration,
• agitation, perception disorders (e.g. hallucinations, derealization),drug dependence,
• difficulty concentrating, migraines, increased muscle tension, involuntary muscle contractions, reduced sensitivity to pain or touch, coordination anomalies,
• hearing difficulties,
• voice alterations (dysphonia),
• difficulty swallowing,state in which the intestine fails to function properly (ileus), mouth ulcers, inflamed gums,
• dry mouth,
• fluid retention inflammation, tolerance to the drug,
• skin redness,
• decrease in sex hormone levels that can affect sperm production in men or menstrual cycle in women.

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

• infections such as herpes labial or herpes (which can cause blisters around the mouth or genital area),
• increased appetite,
• black stools (with tar-like appearance), bleeding gums,
• skin rash with itching (urticaria).

Unknown frequency (the frequency cannot be estimated from available data):

• anaphylactic reactions,
• problems with bile flow,
• absence of menstrual periods,
• withdrawal syndrome in newborns,
• dental caries,
• aggression,
• increased sensitivity to pain.
• a problem that affects a valve in the intestine, which can cause intense pain in the upper abdomen (Oddi sphincter dysfunction).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.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.Conserve this medication in a safe and closed place, where other people cannot access it. It can cause serious harm and be fatal to people when not prescribed.

Do not use this medication after the expiration date that appears on the box and on the blister, after “CAD”. The expiration date is the last day of the month indicated.

Blister: Do not store at a temperature above 25°C.

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

Medications should not be thrown into the drains or trash. Deposit the containers and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition ofTaioma Plus

The active principles are: hydrochloride of oxicodone and hydrochloride of naloxone.

Each prolonged-release tablet contains 20mg of hydrochloride of oxicodone (equivalent to 18mg of oxicodone)and 10 mg of hydrochloride of naloxone (as10,9mg of hydrochloride of naloxone dihydrate, equivalent to 9mg of naloxone).

The other components are:

Tablet core::Polyvinylacetate, Povidone K30, sodium lauryl sulfate, colloidal anhydrous silica, microcrystalline cellulose, and magnesium stearate.

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

Appearance of Taioma Plus and contents of the package

Prolonged-release white, oblong, biconvex tablets, with breaking lines on both faces, 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 blisters of 10, 14, 20, 28, 30, 50, 56, 60, 98and 100prolonged-release tablets or child-resistant bottles of 50, 100, and 250 prolonged-release tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Responsible manufacturer

Develco Pharma GmbH

Grienmatt 27, Schopfheim

79650

Germany

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

Last review date of this leaflet: February 2025

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