Binatta

LEAFLET INCLUDED IN THE PACKAGING

Leaflet included in the packaging: patient information

BINATTA, 25 mg, prolonged-release tablets

BINATTA, 50 mg, prolonged-release tablets

BINATTA, 100 mg, prolonged-release tablets

BINATTA, 150 mg, prolonged-release tablets

BINATTA, 200 mg, prolonged-release tablets

BINATTA, 250 mg, prolonged-release tablets

Tapentadol

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is BINATTA and what is it used for
• 2. Important information before taking BINATTA
• 3. How to take BINATTA
• 4. Possible side effects
• 5. How to store BINATTA
• 6. Contents of the pack and other information

1. What is BINATTA and what is it used for

Tapentadol – the active substance of BINATTA – is a strong pain reliever belonging to the opioid group. BINATTA is indicated for the treatment of severe chronic pain in adults, where only opioid pain relief is appropriate.

2. Important information before taking BINATTA

When not to take BINATTA:

• if the patient is allergic to tapentadol or any of the other ingredients of this medicine (listed in section 6),
• in patients with asthma or dangerously slow and shallow breathing (respiratory depression, increased carbon dioxide levels in the blood),
• in patients with intestinal obstruction,
• in case of acute alcohol poisoning, sleeping pills, painkillers, or other psychotropic drugs (mood- and emotion-affecting drugs) (see "BINATTA and other medicines").

Warnings and precautions

Before starting treatment with BINATTA, you should discuss it with your doctor or pharmacist:

• in case of slow or shallow breathing,
• in case of increased intracranial pressure or impaired consciousness up to coma,
• in patients after head injury or with brain tumors,
• in patients with liver or kidney disease (see "How to take BINATTA"),
• in patients with pancreatic or biliary tract diseases, including pancreatitis,
• in patients taking mixed agonist-antagonist opioid receptor drugs (e.g., pentazocine, nalbuphine) or partial opioid receptor agonists (e.g., buprenorphine),
• in patients with a history of seizure or taking other medicines that increase the risk of seizures and may increase the risk of attacks,
• in case of a family history of substance abuse or addiction ("addiction"),
• in patients who smoke tobacco,
• in patients who have ever had mood problems (depression, anxiety disorders, or personality disorders) or have been treated by a psychiatrist for other mental illnesses.

This medicine contains tapentadol, which is an opioid. Repeated use of opioid pain relievers can lead to decreased efficacy of the medicine (tolerance). It can also lead to addiction and abuse, which can result in life-threatening overdose. If you are concerned about addiction to BINATTA, you should consult your doctor. Taking the medicine (even at therapeutic doses) can lead to physical dependence, which can result in withdrawal symptoms and relapse of problems if treatment is suddenly stopped. BINATTA can cause physical and psychological dependence. If there is a tendency to abuse medicines or addiction, treatment should be short-term and under close medical supervision. Sleep apneaBINATTA may cause sleep apnea, such as sleep apnea (pauses in breathing during sleep) and hypoxia during sleep (decreased oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, waking up at night due to shortness of breath, difficulty maintaining sleep continuity, or excessive daytime sleepiness. If you experience these symptoms, you should contact your doctor. Your doctor may consider reducing the dose of the medicine.

BINATTA and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

• The risk of side effects increases if you take medicines that can cause seizures (epileptic seizures), such as antidepressants or antipsychotics. The risk of an attack may increase if you take BINATTA at the same time. Your doctor will inform you whether taking BINATTA is suitable for you.
• Concomitant use of BINATTA and sedatives, such as benzodiazepines or related drugs (some sleeping pills or sedatives, e.g., barbiturates) or painkillers, such as opioids, morphine, and codeine (also as a cough medicine), antipsychotics, antihistamines H1, alcohol, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use of such medicines should only be considered when other treatment options are not possible. However, if your doctor recommends taking BINATTA in combination with sedatives, they should limit the dose and duration of concomitant treatment with such medicines. Concomitant use of opioids and medicines used to treat epilepsy, neuralgia, or anxiety disorders (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression, and can be life-threatening. You should inform your doctor about taking gabapentin, pregabalin, or sedatives and strictly follow their instructions. It is worth informing friends or relatives about the possibility of the above-mentioned symptoms and consulting a doctor if they occur.

BINATTA with food, drink, and alcohol

You should not drink alcohol while taking BINATTA, as some side effects, such as drowsiness, may worsen. The medicine can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine. You should not take BINATTA:

• during pregnancy, unless your doctor decides to prescribe it. Long-term use of tapentadol during pregnancy may cause withdrawal symptoms in newborns, which can be life-threatening if not recognized and treated by a doctor;
• during breastfeeding, as the medicine may be excreted in breast milk.

You should not take BINATTA:

• during childbirth, as it may cause dangerous slowing or shallowing of the newborn's breathing (respiratory depression).

Driving and using machines

BINATTA may cause drowsiness, dizziness, blurred vision, and affect your reaction ability. These symptoms may occur especially at the beginning of treatment with BINATTA, after a dose change prescribed by your doctor, or when taking alcohol or sedatives. You should ask your doctor if you can drive or operate machines after taking BINATTA.

3. How to take BINATTA

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist. The dose should be adjusted according to the severity of the pain and the patient's individual sensitivity to pain. Essentially, the smallest effective dose should be used.

Adults

The usual starting dose is 50 mg, taken twice a day, approximately every 12 hours. Total daily doses of BINATTA greater than 500 mg of tapentadol are not recommended. Your doctor may prescribe a different, more suitable dose or interval between doses if necessary. If you feel that the effect of the medicine is too strong or too weak, you should contact your doctor or pharmacist.

Elderly patients

Dose adjustment is not usually necessary in elderly patients (over 65 years). Tapentadol elimination may be prolonged in this age group, and your doctor may prescribe a different dosing schedule.

Patients with impaired liver or kidney function

Patients with severe liver impairment should not take this medicine. In case of moderate liver impairment, your doctor will prescribe a different dosing schedule. Patients with mild liver impairment do not require dose adjustment. Patients with severe kidney impairment should not take this medicine. In case of mild or moderate kidney impairment, dose adjustment is not required.

Use in children and adolescents

BINATTA should not be used in children and adolescents under 18 years of age.

How to take BINATTA

BINATTA should be taken orally. The tablet should be swallowed, washed down with enough liquid. The tablets should not be chewed or crushed, as this can lead to overdose due to rapid release of the medicine. The medicine can be taken with or without food.

• The tablet can be divided into equal doses. The empty tablet shell may not be completely digested and may be present in the stool. You should not be concerned, as the medicine (active substance) has already been absorbed by the body, and only the tablet shell is present in the stool.

Instructions for opening the blister pack

This medicine is packaged in child-resistant, perforated blister packs, divided into single doses. The tablets cannot be pushed through the blister pack. The blister packs should be opened according to the following instructions:

• 1. Tear off a single dose along the perforated line of the blister pack.

• 2. The area where the lines intersect is an unprotected area.

• 3. Pull the unprotected part to tear off the top protective layer.

Duration of treatment with BINATTA

You should not take the tablets for longer than prescribed by your doctor.

Taking a higher dose of BINATTA than recommended

If you take very high doses, the following symptoms may occur:

• pupil constriction to the size of a pinhead,
• vomiting,
• decreased blood pressure,
• rapid heartbeat,
• collapse, impaired consciousness, or coma (deep state of unconsciousness),
• seizures,
• dangerously slow or shallow breathing or respiratory arrest. In such cases, you should immediately consult a doctor!

Missing a dose of BINATTA

If you forget to take a dose, your pain is likely to return. You should not take a double dose to make up for the missed dose. You should continue with your original dosing schedule.

Stopping treatment with BINATTA

If you stop or discontinue treatment with BINATTA before the end of the treatment, your pain is likely to return. You should consult your doctor before stopping the medicine. Generally, no side effects are observed after stopping the medicine, although in rare cases, patients who have taken the medicine for some time and stopped it abruptly may experience general malaise. The following symptoms may occur:

• restlessness, tearfulness, runny nose, yawning, sweating, chills, muscle pain, and pupil dilation,
• irritability, restlessness, back pain, joint pain, weakness, abdominal cramps, sleep disturbances, nausea, loss of appetite, vomiting, diarrhea, increased blood pressure, respiratory rate, and heart rate. If you experience any of these symptoms after stopping treatment, you should immediately consult your doctor. You should not stop taking BINATTA abruptly, unless your doctor advises you to do so. Your doctor will inform you how to stop taking the medicine. Stopping the medicine may involve gradually reducing the dose.

If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, BINATTA can cause side effects, although not everybody gets them.

Important side effects or symptoms to watch out for and what to do if they occur:

• This medicine may cause allergic reactions. Symptoms may include wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching, especially affecting the whole body.
• Another serious side effect is excessive slowing and shallowing of breathing. This occurs most commonly in elderly and frail patients.

If any of these important side effects affect you, you should immediately consult your doctor.

Other side effects that may occur:

Very common(may affect more than 1 in 10 people)

• nausea, constipation,
• dizziness, drowsiness, headache.

Common(may affect up to 1 in 10 people)

• loss of appetite, anxiety, depressive mood, sleep disturbances, nervousness, restlessness, concentration disorders,
• tremors, muscle spasms,
• flushing,
• shortness of breath,
• vomiting, diarrhea, indigestion,
• itching, excessive sweating, rash,
• feeling of weakness, fatigue, feeling of temperature change, dryness of mucous membranes, water retention (edema).

Uncommon(may affect up to 1 in 100 people)

• allergic reactions to the medicine (including skin swelling, hives, and in severe cases, difficulty breathing, low blood pressure, collapse, or shock),
• weight loss,
• disorientation, confusion, agitation (excitement), perception disorders, unusual dreams, euphoric mood, decreased level of consciousness, memory impairment, mental disorders,
• fainting, excessive sedation, balance disorders, speech disorders, tingling, abnormal skin sensations (e.g., burning, prickling),
• vision disturbances,
• rapid heartbeat, slow heartbeat, palpitations, decreased blood pressure,
• abdominal discomfort,
• hives,
• urination difficulties, frequent urination,
• sexual dysfunction,
• withdrawal syndrome (see "Stopping treatment with BINATTA"), feeling of abnormality, irritability.

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

• addiction to the medicine, thinking disorders, seizures, feeling of impending fainting, coordination disorders,
• dangerously slow or shallow breathing (respiratory depression),
• gastric emptying disorders,
• feeling of intoxication, feeling of relaxation.

Frequency not known(cannot be estimated from available data)

• delirium.

Generally, the likelihood of suicidal thoughts and behaviors is higher in patients with chronic pain. Additionally, medicines used to treat depression (which affect the neurotransmitter system in the brain) may increase this risk, especially at the beginning of treatment. Although tapentadol also affects neurotransmitters, data from human use of the medicine have not provided evidence of an increased risk.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store BINATTA

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister pack after EXP. The expiry date refers to the last day of the month. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What BINATTA contains

• The active substance of BINATTA is tapentadol.

BINATTA, 25 mg, prolonged-release tablets Each prolonged-release tablet contains 25 mg of tapentadol (as phosphate). BINATTA, 50 mg, prolonged-release tablets Each prolonged-release tablet contains 50 mg of tapentadol (as phosphate). BINATTA, 100 mg, prolonged-release tablets Each prolonged-release tablet contains 100 mg of tapentadol (as phosphate). BINATTA, 150 mg, prolonged-release tablets Each prolonged-release tablet contains 150 mg of tapentadol (as phosphate). BINATTA, 200 mg, prolonged-release tablets Each prolonged-release tablet contains 200 mg of tapentadol (as phosphate). BINATTA, 250 mg, prolonged-release tablets Each prolonged-release tablet contains 250 mg of tapentadol (as phosphate).

• Other ingredients are: Tablet core:microcrystalline cellulose (E 460); hypromellose (E 464); silica, colloidal, anhydrous (E 551); magnesium stearate. Tablet coating:hypromellose (E 464); glycerol (E 422); talc (E 553b); microcrystalline cellulose (E 460); titanium dioxide (E 171); iron oxide, red (E 172) (only for 25, 100, 150, 200, and 250 mg); iron oxide, yellow (E 172) (only for 25, 100, and 200 mg); iron oxide, black (E 172) (only for 25, 100, 150, 200, and 250 mg).

What BINATTA looks like and contents of the pack

BINATTA, 25 mg: brownish, biconvex, prolonged-release tablets, with a longitudinal shape (6 mm x 12 mm) and a dividing line on both sides. The tablet can be divided into equal doses. BINATTA, 50 mg: white, biconvex, prolonged-release tablets, with a longitudinal shape (6 mm x 13 mm) and a dividing line on both sides. The tablet can be divided into equal doses. BINATTA, 100 mg: yellowish, biconvex, prolonged-release tablets, with a longitudinal shape (7 mm x 14 mm) and a dividing line on both sides. The tablet can be divided into equal doses. BINATTA, 150 mg: light red, biconvex, prolonged-release tablets, with a longitudinal shape (7 mm x 15 mm) and a dividing line on both sides. The tablet can be divided into equal doses. BINATTA, 200 mg: yellow, biconvex, prolonged-release tablets, with a longitudinal shape (8 mm x 16 mm) and a dividing line on both sides. The tablet can be divided into equal doses. BINATTA, 250 mg: reddish-brown, biconvex, prolonged-release tablets, with a longitudinal shape (9 mm x 18 mm) and a dividing line on both sides. The tablet can be divided into equal doses. BINATTA is available in packs of: BINATTA, 25 mg 20x1, 30x1, 40x1, 50x1, 54x1, 60x1, or 100x1 prolonged-release tablets in single-dose, perforated, child-resistant blister packs. BINATTA, 50–250 mg 20x1, 24x1, 30x1, 50x1, 54x1, 60x1, or 100x1 prolonged-release tablets in single-dose, perforated, child-resistant blister packs. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder: STADA Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel Germany Manufacturer/importer: Develco Pharma GmbH Grienmatt 27 Farhnau 79650 Schopfheim Germany STADA Arzneimittel AG Stadastrasse 2 – 18 61118 Bad Vilbel Germany Centrafarm Services B.V. Van de Reijtstraat 31-E 4814 NE Breda Netherlands For more information about this medicine, you should contact the representative of the marketing authorization holder: Stada Pharm sp. z o.o. ul. Krakowiaków 44 02-255 Warsaw Tel. +48 22 737 79 20

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

Germany Tapentadol AL 25 mg Retardtabletten Tapentadol AL 50 mg Retardtabletten Tapentadol AL 100 mg Retardtabletten Tapentadol AL 150 mg Retardtabletten Tapentadol AL 200 mg Retardtabletten Tapentadol AL 250 mg Retardtabletten Croatia TAPISTA Czech Republic Taxemba Denmark Tapentadol STADA Iceland Tapentadol STADA 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 250 mg; forðahylki Italy Mudol Netherlands Tapentadol retard CF 25 mg, tabletten met verlengde afgifte Tapentadol retard CF 50 mg, tabletten met verlengde afgifte Tapentadol retard CF 100 mg, tabletten met verlengde afgifte Tapentadol retard CF 150 mg, tabletten met verlengde afgifte Tapentadol retard CF 200 mg, tabletten met verlengde afgifte Tapentadol retard CF 250 mg, tabletten met verlengde afgifte Norway Tapentadol STADA Poland BINATTA Slovakia Tapestad retard 50 mg, 100 mg, 150 mg, 200 mg, 250 mg Spain Tapentadol retard STADA 25 mg comprimidos de liberación prolongada EFG Tapentadol retard STADA 50 mg comprimidos de liberación prolongada EFG Tapentadol retard STADA 100 mg comprimidos de liberación prolongada EFG Tapentadol retard STADA 150 mg comprimidos de liberación prolongada EFG Tapentadol retard STADA 200 mg comprimidos de liberación prolongada EFG Tapentadol retard STADA 250 mg comprimidos de liberación prolongada EFG Sweden Tapentadol Depot STADA 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 250 mg; depottabletter

Date of last revision of the leaflet: