Prospecto:Information for the Patient

Tanonalla 10 mg/5 mg prolonged-release tablets EFG

hydrochloride of oxicodone/hydrochloride of naloxone

Read this prospect carefully before starting to take this medicine,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult yourdoctor or pharmacist.

-This medicine has been prescribedonlyto you, and you must not give it to other people even iftheyhave the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenifthey are not listed in this prospect. See section 4.

1.What is Tanonalla and for what it is used

2.What you need to knowbeforestarting totake Tanonalla

3.How to take Tanonalla

4.Possible adverse effects

5.Storage of Tanonalla

6.Contents of the package and additional information

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

These tablets are only for use in adults.

Pain relief

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

How these tablets work for pain relief

Tanonallacontains as active ingredients hydrochloride of oxycodone and hydrochloride of naloxone. Hydrochloride of oxycodone is responsible for the analgesic effect of Tanonalla, and is a potent opioid analgesic.

The second active ingredient of Tanonalla, hydrochloride of naloxone, has the function of counteracting constipation. Intestinal dysfunction (e.g. constipation) is a common side effect of opioid analgesic treatment.

Do not take Tanonalla:

• if you are allergic tohydrochloride ofoxycodone,hydrochloride ofnaloxone or to any of the other components ofthis medication (listed in section 6),
• if you have respiratory problems, such as slower or weaker breathing than expected (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. This condition consists of the right side of the heart increasing in size due to increased pressure in the blood vessels of the lung, 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 problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tanonalla:

• if you are an elderly or debilitated patient,
• if you have paralytic ileus (a type of intestinal obstruction) caused by opioids,
• if you have kidney problems,
• if you have mild liver disease,
• if you have severe lung disease (e.g. reduced ability to breathe),
• if you have a disease characterized by frequent pauses in breathing during sleep, which may make you feel very drowsy during the day (sleep apnea),
• if you have mixedema (a thyroid disorder characterized by dryness, coldness, and swelling of the skin, affecting the face and extremities),
• if your thyroid gland does not produce enough hormones (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 the sense of reality (psychosis), due to alcoholism or intoxication by other substances (substance-induced psychosis),
• if you have gallstones problems,
• if you have an abnormal enlargement of the prostate (prostatic hypertrophy),
• if you have alcoholism or delirium tremens,
• if you have pancreatitis (inflammation of the pancreas),
• 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 trauma (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, Parkinson's disease or bacterial infections), e.g. medications containing tranilcipromina, fenelzina, isocarboxazida, moclobemida and linezolid,
• if you feel drowsy or if you sometimes fall asleep suddenly.

This medication may cause respiratory problems while sleeping. These problems may include pauses in breathing while sleeping, waking up due to lack of breath, difficulty falling asleep or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Inform 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 Tanonalla.

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

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

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

If you experience intense 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 in the first 3 to 5 days of treatment. If it persists after that 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 Tanonalla, e.g. restlessness, sweating attacks and muscle pain. If you experience any of these symptoms, you may need special monitoring by your doctor.

Like other opioids, oxycodone may affect normal hormone production in the body, such as cortisol or sex hormones, especially if you take high doses for a long period of time. If you notice persistent symptoms such as discomfort (including vomiting), loss of appetite, fatigue, weakness, dizziness, changes in menstrual cycle, impotence, infertility or decreased libido, consult your doctor to monitor your hormone levels.

Surgical intervention

If you need to undergo surgery, inform the doctors who are treating you with Tanonalla.

Long-term treatment

You may experience tolerance if you use Tanonalla for a long time. This means that you may need a higher dose to achieve the desired pain relief. Long-term use of Tanonalla may also cause physical dependence. Withdrawal symptoms may appear if treatment is stopped suddenly (restlessness, sweating attacks, muscle pain). If you no longer need treatment, you should gradually reduce your daily dose, consulting your doctor.

Psychological dependence

The active principle hydrochloride of oxycodone without combination has the same characteristics of abuse as other potent opioids (potent analgesics). It may create psychological dependence. Medications containing hydrochloride of oxycodone should be avoided in patients who have a history of abuse of alcohol, drugs or medications.

Incorrect use of Tanonalla

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

The tabletshould not be broken, chewed or crushed. However, the tablet can be divided into equal doses (see section 3. "Form of administration").

Breaking, chewing or crushing the prolonged-release tablets may lead to potentially fatal absorption of a lethal dose of hydrochloride of oxycodone (see section 3 "If you take more Tanonalla than you should").

You should never abuse Tanonalla, especially if you are addicted to substances. If you are addicted to substances such as heroin, morphine or methadone, you may experience severe withdrawal symptoms if you misuse Tanonalla, because it contains the active principle naloxone. These symptoms may worsen pre-existing withdrawal symptoms.

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

You may see residues of the tablet in your feces. Do not worry, as the active substances (hydrochloride of oxycodone and hydrochloride of naloxone) have been released before while the tablet passed through the stomach and intestine and have begun to be effective in your body.

Doping

The use of this medication may give positive results in antidoping tests. The use of this medication as a doping agent may put your health at risk.

Children and adolescents

Tanonalla has not been studied in children and adolescents under 18 years of age. Its safety and efficacy have not been demonstrated in children and adolescents. Therefore, its use is not recommended in children and adolescents under 18 years of age.

Other medications and Tanonalla

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

The concomitant use of hydrochloride ofoxycodone/hydrochloride of naloxoneand sedative medications such as benzodiazepines or related medications (medications that can affect brain function, see below) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and may put your life at risk. Due to this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes oxycodone/hydrochloride of naloxone together with sedative medications, your doctor should limit the dose and duration of concomitant treatment.

Inform your doctor of all sedative medications you are taking and follow your doctor's recommended doses closely. It may be helpful to inform friends or family members who are aware of the symptoms indicated above. Contact your doctor when you experience these symptoms.

Some examples of medications that can affect brain function are:

• other potent analgesics (opioids),
• medications used to treat epilepsy, pain and anxiety, such as gabapentina and pregabalina,
• somnifacients and tranquilizers (sedative medications, including benzodiazepines, hypnotics, anxiolytics),
• medications used to treat depression,
• 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.

The risk of side effects increases if you use antidepressants (such as citalopram, duloxetina, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, venlafaxina). These medications may interact with oxycodone and you may experience 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.

• If you take these tablets at the same time as other medications, the effects of the tablets or of the other medications described below may change. Inform your doctor if you are taking:
• medications that reduce blood clotting (coumarin derivatives), the speed of clotting may increase or decrease,
• macrolide antibiotics (such as claritromicina, eritromicina or telitromicina),
• azole antifungals (such as ketoconazol, voriconazol, itraconazol or posaconazol),
• a specific type of medication used to treat HIV (protease inhibitors, such as ritonavir, indinavir, nelfinavir or saquinavir),
• cimetidina (a medication used to treat stomach ulcers, indigestion or acid reflux),
• rifampicina (used to treat tuberculosis),
• carbamazepina (used to treat seizures or convulsions and certain painful diseases),
• fenitoína (used to treat seizures or convulsions).
• St. John's Wort (also known as Hypericum perforatum),
• quinidina(a medication used to treat arrhythmias).

Taking Tanonalla with food, drinks and alcohol

Drinking alcohol while taking Tanonalla 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 Tanonalla.

You should avoid drinking grapefruit juice while taking Tanonalla.

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

Breastfeeding

Breastfeeding will be suspended during treatment with Tanonalla.Hidrocloruro de oxicodona passes into breast milk. It is not known if hidrocloruro de naloxona also passes into breast milk. Therefore, the risk to the infant cannot be ruled out, especially if the mother receives several doses of this medication.

Driving and operating machinery

Tanonalla may affect your ability to drive and operate machinery. This occurs especially at the beginning of treatment with this medication, after increasing the dose or after switching from another medication. However, these side effects disappear once the dose of this medication is established.

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

Ask your doctor if you can drive or operate machinery during treatment with this medication.

Tanonalla contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor.This medication is indicated for the treatment of pain.In case of doubt, consult your doctor or pharmacist again.

Tanonalla is a prolonged-release tablet, which means that the active ingredients are released over a prolonged period of time. Its action lasts 12 hours.

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

For the treatment of pain

Adults

The usual initial dose is 10 mg ofhydrochloride ofoxycodone / 5 mg ofhydrochloride ofnaloxone in prolonged-release tablets every 12 hours.

Your doctor will decide the dose of Tanonalla you should take per day and how to divide the total daily dose between the 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 of Tanonalla may be higher.

The maximum daily dose is 160 mg ofhydrochloride ofoxycodone and 80 mg ofhydrochloride ofnaloxone. If you need a higher dose, your doctor may prescribe morehydrochloride ofoxycodone withouthydrochloride ofnaloxone. However, the maximum daily dose ofhydrochloride ofoxycodone should not exceed 400 mg. The beneficial effect ofhydrochloride ofnaloxone on intestinal activity may be affected if the dose ofhydrochloride ofoxycodone is increased without increasing the dose ofhydrochloride ofnaloxone.

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

If you experience pain between two doses of Tanonalla, you may need a rapid-acting analgesic. Tanonalla is not suitable in this case. Consult your doctor.

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

Advanced age

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

Liver or kidney disorder

If you have any degree of kidney disorder or mild liver disorder, your doctor will prescribe this medication with special caution. If you have moderate or severe liver disorder, you should not take Tanonalla (see also the section 2 “Do not take Tanonalla” and “Warnings and precautions”).

Administration form

Oral.

• Take Tanonalla with a glass of water.
• The tablet can be divided into equal doses. The tablet should not be broken, chewed, or crushed.
• You can take the prolonged-release tablets with or without food.

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

[Pliable blister:]

How to remove the tablets from the child-resistant blisters

The tablets are packaged in a single-dose child-resistant blister.

Do not pushthe tabletsthroughthe blister foil.

Remove the tablets as follows:

1. Fold the alveolus along the perforated line.

2. Separate one foil from the blister along the perforation lines.

3.Carefully peel the foil away from the corner.

Remove the tablet.

[Blister by pressure:]

How to remove the tablets from the child-resistant blisters

The tablets are packaged in a single-dose child-resistant blister.

To remove the tablet, press the tablet through the reinforced blister foil.

Treatment duration

Do not take Tanonalla for longer than necessary. If you receive Tanonalla for a long time, your doctor should regularly check that you still need it.

If you take more Tanonalla than you should

If you have taken morehydrochloride ofoxycodone /hydrochloride ofnaloxone than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

A overdose may cause:

• constricted pupils,
• slow and shallow breathing (respiratory depression),
• drowsiness to loss of consciousness,
• low muscle tone (hypotonia),
• reduced heart rate, and
• low blood pressure.

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 forget to take Tanonalla

If you forget to take Tanonallaor if you take a lower dose than prescribed, you may not notice the analgesic effect.

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

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

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

If you interrupt treatment with Tanonalla

Do not stop treatment with Tanonalla without consulting your doctor.

If you no longer need to continue 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 to be aware of, and what to do if you experience them

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

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

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

Frequent(may affect up to 1 in 10 people)

• reduction or loss of appetite,
• difficulty sleeping, fatigue or weakness,
• sensation of dizziness or feeling like "everything is spinning", headache, drowsiness,
• palpitations,
• abdominal pain, constipation, diarrhea, dry mouth, indigestion, nausea, discomfort, flatulence,
• itching, skin reactions, increased sweating,
• unusual feeling of weakness.

Infrequent(may affect up to 1 in 100 people)

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

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

• increased heart rate,
• dependence on the medication,
• yawns,
• oral alterations,
• weight gain.

Frequency not known(cannot be estimated from available data)

• euphoria, hallucinations, nightmares, aggression,
• tingling, intense drowsiness,
• shallow breathing,
• belching,
• difficulty urinating,
• erectile dysfunction,
• breathing problems during sleep (sleep apnea syndrome).

We know that the active ingredient hydrochloride of oxicodone, if not combined with hydrochloride of naloxone, has the following side effects, different from those mentioned:

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

Infrequent(may affect up to 1 in 100 people)

• dehydration,
• agitation, perception disorders (e.g. hallucinations, derealization),
• difficulty concentrating, migraines, increased muscle tension, involuntary muscle contractions, reduced sensitivity to pain or touch, coordination alterations,
• hearing difficulties,
• vasodilation,
• voice alterations (dysphonia),
• difficulty swallowing,
• condition in which the intestine stops functioning correctly (ileus), mouth ulcers, irritated gums,
• dry skin,
• decreased sex hormone levels that can affect sperm production in men or menstrual cycle in women
• water retention swelling, tolerance to the medication.

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

• infections such as oral herpes or herpes (which can cause blisters around the mouth or genital area),
• increased appetite,
• black stools (with tar-like appearance), gingival hemorrhage,
• pruritic eruption (urticaria).

Frequency not known(cannot be estimated from available data)

• acute generalized allergic reactions (anaphylactic reactions),
• increased sensitivity to pain,
• dental caries,
• problems with bile flow, a problem that affects a valve in the intestine, which can cause severe abdominal pain (Oddi sphincter dysfunction),
• amenorrhea,
• withdrawal syndrome in the newborn.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe packaging, bottle or blister after CAD/EXP.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.

Expiration after first opening: 3 months.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Tanonalla

The active principles are hydrochloride of oxycodone and hydrochloride of naloxone.

Each prolonged-release tablet contains 10 mg of hydrochloride of oxycodone (equivalent to 9 mg of oxycodone) and 5 mg of hydrochloride of nal oxone (as 5.45 mg of hydrochloride of naloxone dihydrate, equivalent to 4.5 mg of naloxone).

The other excipients are:

Tablet core:

Acetate of polyvinyl

Povidone K30

Sodium lauryl sulfate

Anhydrous colloidal silica

Microcrystalline cellulose

Magnesium stearate

Tablet coating:

Polyvinyl alcohol

Titanium dioxide (E171)

Macrogol 3350

Talc

Red iron oxide (E172)

Appearance of the product and contents of the package:

Prolonged-release pink, oval, biconvex tablet with grooves on both sides, with a length of 10.2 mm, width of 4.7 mm, and a thickness of 3.0 to 4.0 mm. The tablet can be divided into equal doses.

Tanonalla is available in a child-resistant, pressure-sensitive perforated blister pack or peelable blister pack, aluminum/PVC/PE/PVDC containing 10 x 1 (hospital pack), 14 x 1, 20 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1, 98 x 1, and 100 x 1 prolonged-release tablets or

child-resistant blister pack, aluminum/PVC/PE/PVDC containing 28, 56, and 84 prolonged-release tablets or in HDPE bottles with a child-resistant screw cap containing 50 and 100 prolonged-release tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer:

Develco Pharma GmbH

Grienmatt 27, Baden-Wuerttemberg

D-79650 Schopfheim

Germany

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

This medicinal product is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Germany: Oxycodon comp HEXAL 10 mg/5 mg Retardtabletten

Slovakia: Oxycodone/Naloxone Sandoz 10 mg/5 mg

Slovenia: Codilek Combo 10 mg/5 mg tablete s podaljšanim sprošcanjem

Finland: Tanonalla 10 mg/5 mg depottabletti

Ireland: Dancex SR Plus 10 mg/5 mg Prolonged-release tablets

Iceland: Tanonalla 10 mg/5 mg forðatafla

Italy: Ossicodone e Naloxone Sandoz

Norway: Tanonalla 10 mg/5 mg depottablett

United Kingdom: Doneloxon 10 mg/5 mg Prolonged-release tablets

Czech Republic: Oxycodon/Naloxon Sandoz 10 mg/5 mg

Sweden: Oxycodone/Naloxone Sandoz 10 mg/5 mg depottabletter

Poland: Xanconalon

Portugal: Oxicodona + Naloxona Sandoz 10mg/5 mg comprimidos revestidos por película

Last review date of this leaflet: October 2024.

Detailed 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 /