TANONALLA 10 mg/5 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet:information for the patient

Tanonalla 10 mg/5 mg 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.

• 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

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

1. What is Tanonalla and what is it used for

Tanonalla 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 only for use in adults.

Pain relief

You have been prescribed Tanonalla 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

Tanonalla contains the active substances oxycodone hydrochloride and naloxone hydrochloride. Oxycodone hydrochloride is responsible for the analgesic effect of Tanonalla and is a potent analgesic belonging to the opioid group.

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

2. What you need to know before you take Tanonalla

Do not take Tanonalla:

• if you are allergic to oxycodone hydrochloride, naloxone hydrochloride or any of the other ingredients of this medicine (listed in section 6),
• if you have respiratory problems, such as slower or weaker breathing than expected (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 known as cor pulmonale. This condition consists of the right side of the heart becoming 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 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 disorder,
• if you have severe lung disease (e.g. reduced breathing capacity),
• if you have a condition 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 extremities),
• 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 the notion of reality (psychosis), due to alcoholism or intoxication with other substances (substance-induced psychosis),
• if you have problems with gallstones,
• if you have an abnormal increase in the size of the prostate (prostate hypertrophy),
• if you have a history of 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 pre-existing 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, Parkinson's disease, or bacterial infections), e.g. medications containing tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid,
• if you feel drowsy or if you sometimes fall asleep suddenly.

This medicine can cause respiratory problems while you sleep. These problems can include pauses in breathing while you sleep, waking up short of breath, difficulty staying asleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Tell your doctor if you have had any of these conditions in the past. Also, tell your doctor if you develop any of these conditions during treatment with Tanonalla.

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.

Tell 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 radiate to the back, nausea, vomiting, or fever, as these may be symptoms associated with pancreatitis or biliary tract disease.

If you experience intense diarrhea at the start of treatment, it may be due to the effect of naloxone. It can be a sign that bowel function is normalizing. This diarrhea may occur in 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 Tanonalla, e.g. restlessness, sweating, and muscle pain. If you experience any of these symptoms, you may need special monitoring by your doctor.

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 malaise (including vomiting), loss of appetite, fatigue, weakness, dizziness, changes in menstrual cycle, impotence, fertility, or decreased sexual desire, consult your doctor so that they can monitor your hormone levels.

Surgery

If you need to undergo surgery, inform your doctors that you are being treated with Tanonalla.

Long-term treatment

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

Tolerance, dependence, and addiction

Psychological dependence

The active substance oxycodone hydrochloride, when used alone, has the same potential for abuse as other potent opioids (potent analgesics). It can create psychological dependence. Medications containing oxycodone hydrochloride should be avoided in patients with a history of alcohol, drug, or medication abuse.

Incorrect use of Tanonalla

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

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

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

Never abuse Tanonalla, especially if you have a history of drug addiction. If you are addicted to substances such as heroin, morphine, or methadone, you may experience severe withdrawal symptoms if you misuse Tanonalla, as it contains the active substance naloxone. It can worsen pre-existing withdrawal symptoms.

Also, 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 changes in lung tissue (pulmonary granuloma). This abuse can also have other serious consequences and even cause death.

You may see remnants of the tablet in your stool. Do not worry, as the active substances (oxycodone hydrochloride and naloxone hydrochloride) have been released earlier while the tablet passed through the stomach and intestine and have started to take effect in your body.

Doping

The use of this medicine can result in positive doping tests. The use of this medicine as a doping agent can endanger health.

Children and adolescents

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

Other medicines and Tanonalla

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

Concomitant use of oxycodone hydrochloride/naloxone hydrochloride and sedative medicines such as benzodiazepines or related drugs (medicines that affect brain function, see below) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can 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/naloxone hydrochloride together with sedative medicines, your doctor will limit the dose and duration of concomitant treatment.

Tell your doctor about all sedative medicines you are taking and follow your doctor's dose recommendations carefully. It may be useful to inform friends or family members who are aware of the signs and symptoms indicated above. Contact your doctor when you experience these symptoms.

Some examples of medicines that can affect brain function are:

• other potent analgesics (opioids),
• medicines for treating epilepsy, pain, and anxiety, such as gabapentin and pregabalin,
• sleeping pills and sedatives (sedative medicines, 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 (phenothiazines, neuroleptics, antipsychotics),
• muscle relaxants,
• medicines used to treat Parkinson's disease.

The risk of side effects increases if you use 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.

• 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 (such as ketoconazole, voriconazole, itraconazole, or posaconazole),
• a specific type of medicine used to treat HIV (protease inhibitors, such as 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).

Taking Tanonalla with food, drinks, and alcohol

Drinking alcohol while taking Tanonalla 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 Tanonalla.

You should avoid drinking grapefruit juice while taking Tanonalla.

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

This medicine should be avoided during pregnancy if possible. If used during prolonged periods of 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 should be discontinued during treatment with Tanonalla. Oxycodone hydrochloride passes into breast milk. It is not known if naloxone hydrochloride also passes into breast milk. Therefore, a risk to the breastfed child cannot be excluded, especially if the mother receives multiple doses of this medicine.

Driving and using machines

Tanonalla can affect your ability to drive and use machines. This occurs especially at the start of treatment with this medicine, after a dose increase, or after switching from another medication. However, these adverse effects disappear once the dose of this medicine is established.

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

Ask your doctor if you can drive or use machines during treatment with this medicine.

Tanonalla contains sodium

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

3. How to take Tanonalla

Follow your doctor's administration instructions for this medication exactly. If in 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 pain treatment

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 what 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 it is necessary to adjust the dose during treatment. Your dose will be adjusted 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 Tanonalla 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 Tanonalla with 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 fast-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.

Elderly

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 this medication with special caution. If you have moderate or severe liver disorder, you should not take Tanonalla (see also section 2 "Do not take Tanonalla" and "Warnings and precautions").

Method of administration

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).

[Child-resistant blister:]

How to remove the tablets from the child-resistant blisters

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

Do not pushthe tablets throughthe blister sheet.

Remove the tablets as follows:

1. Fold the blister along the perforated line.

1. Separate a sheet from the blister along the perforation lines.

1. Carefully peel off the sheet from the corner.

Remove the tablet.

[Press-through blister:]

How to remove the tablets from the child-resistant blisters

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

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

Duration of treatment

In general, you should 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 more oxycodone hydrochloride/naloxone hydrochloride than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

An overdose can cause:

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

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 Tanonalla

If you forget to take Tanonalla or if you take a lower dose than prescribed, you may not feel the analgesic effect.

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

• If there are 8 hours or more left until the next normal dose: take the missed dose immediately, and continue with the normal schedule.
• If there are less than 8 hours left until 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 Tanonalla more than once in an 8-hour period.

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

If you stop 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 further 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 to which you must pay attention, 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 receiving treatment for pain:

Common(may affect up to 1 in 10 people)

• reduced or lost appetite,
• difficulty sleeping, fatigue, or weakness,
• feeling of dizziness or that "everything is spinning", headache, drowsiness,
• hot flashes,
• abdominal pain, constipation, diarrhea, dry mouth, indigestion, nausea, discomfort, flatulence,
• skin itching, skin reactions, increased sweating,
• unusual feeling of weakness.

Uncommon(may affect up to 1 in 100 people)

• allergic/hypersensitivity reactions,
• decreased sexual desire,
• restlessness, unusual thoughts, anxiety, confusion, depression, nervousness,
• seizures (especially in people with seizure disorders or predisposition to convulsions), difficulty concentrating, altered taste, speech disorders, fainting, tremors, loss of energy.
• vision disorders,
• feeling of chest tightness, especially if you already have coronary artery disease, palpitations,
• decreased blood pressure, increased blood pressure,
• breathing difficulties, runny nose, cough,
• abdominal distension,
• increased liver enzymes, biliary colic,
• muscle cramps, muscle contractions, muscle pain,
• increased need to urinate urgently,
• withdrawal symptoms such as restlessness,
• chest pain,
• chills, feeling of general discomfort, pain, thirst,
• swelling of hands, ankles, or feet,
• weight loss,
• accidental injuries.

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

• increased heart rate,
• drug dependence,
• yawning,
• dental disorders,
• weight gain.

Frequency not known(cannot be estimated from available data)

• euphoria, hallucinations, nightmares, aggression,
• tingling, intense drowsiness,
• shallow breathing,
• belching,
• urination difficulties,
• erectile dysfunction,
• sleep apnea syndrome.

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

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

Common(may affect up to 1 in 10 people)

• mood changes and personality changes (e.g., depression, feeling of extreme happiness), decreased activity, increased activity,
• hypo,
• difficulty urinating.

Uncommon(may affect up to 1 in 100 people)

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

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 a tar-like appearance), gum bleeding,
• itchy rash (urticaria).

Frequency not known(cannot be estimated from available data)

• acute generalized allergic reactions (anaphylactic reactions),
• increased pain sensitivity,
• dental caries,
• bile flow problems, a problem affecting a valve in the intestine, which can cause severe abdominal pain (Oddi sphincter dysfunction),
• absence of menstrual periods,
• withdrawal syndrome in the newborn.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tanonalla

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging, bottle, or blister after CAD/EXP. The expiration date is the last day of the month indicated.

Blister:

Do not store above 25°C.

Bottles:

Do not store above 30°C.

Expiration after first opening: 3 months.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package contents and additional information

Tanonalla composition

The active ingredients are oxycodone hydrochloride and naloxone hydrochloride.

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

The other excipients are:

Tablet core:

Polyvinyl acetate

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)

Product appearance and package contents

Prolonged-release tablet, pink, oblong, biconvex with score lines on both sides, 10.2 mm long, 4.7 mm wide, and 3.0 to 4.0 mm thick. The tablet can be divided into equal doses.

Tanonalla is available in child-resistant single-dose blisters, aluminum/PVC/PE/PVDC, containing 10 x 1 (hospital packaging), 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 blisters, aluminum/PVC/PE/PVDC, containing 28, 56, and 84 prolonged-release tablets, or

HDPE bottles with child-resistant screw caps containing 50 and 100 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

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 medication 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

Date of last revision of this leaflet:May 2025.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/