Binatta

PACKAGE LEAFLET

Package leaflet: information for the patient

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
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents

1. What BINATTA is and what it is used for
2. What you need to know 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 BINATTA is and what it is used for

Tapentadol, the active substance in BINATTA, is a potent analgesic belonging to the opioid group. BINATTA is indicated for the treatment of severe chronic pain in adults, when only treatment with an opioid analgesic is appropriate for managing the pain adequately.

2. Important information before using the medicine BINATTA

When not to use 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 cases of acute alcohol, sedative, analgesic or other psychotropic drug intoxication (drugs affecting mood and emotions) (see "BINATTA with other medicines").

Warnings and precautions
Before starting treatment with BINATTA, discuss the following with your doctor or pharmacist:

• if you have slow or shallow breathing,
• if you have increased intracranial pressure or impaired consciousness up to coma,
• in patients after head injury or with brain tumours,
• in patients with liver or kidney disease (see "How to take BINATTA"),
• in patients with diseases of the pancreas or biliary tract, including pancreatitis,
• in patients taking medicines with mixed agonist-antagonist properties at "mu" opioid receptors (e.g. pentazocine, nalbuphine) or medicines that are partial agonists of the "mu" opioid receptor (e.g. buprenorphine),
• in patients with a tendency to seizures or convulsions, or when taking other medicines that increase the risk of seizures and may increase the risk of seizure attacks,
• if there is a family history of alcohol, drug or narcotic 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 medicine. Repeated use of opioid
analgesics may lead to reduced effectiveness of the medicine (tolerance).
It may also lead to dependence and abuse, which could result in life-threatening
overdose. If you are concerned about becoming addicted to BINATTA, you should
consult your doctor. Use of the medicine (even at therapeutic doses) may
lead to physical dependence, which could result in withdrawal symptoms and
rebound problems if treatment is stopped abruptly.
BINATTA may cause physical and psychological dependence. In cases of tendency to
drug abuse or history of addiction, treatment should be short-term and carried out
under strict medical supervision.
Sleep-related breathing disorders
BINATTA may cause sleep-related breathing disorders, such as sleep apnoea
(pauses in breathing during sleep) and nocturnal hypoxia (reduced oxygen levels in
the blood). Symptoms may include pauses in breathing during sleep, waking up at night due to
breathlessness, difficulty maintaining continuous sleep or excessive daytime sleepiness. If
these symptoms occur, contact your doctor. The doctor may consider
reducing the dose of the medicine.
BINATTA with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have taken
recently, as well as any medicines you plan to take.

• The risk of adverse effects increases if the patient takes medicines that may provoke seizures (epileptic fits), such as antidepressants or antipsychotics. The risk of seizures may increase if the patient is also taking BINATTA. Your doctor will inform you whether taking BINATTA is appropriate for you.

• Concomitant use of BINATTA and sedative medicines, such as benzodiazepines or related drugs (some sleeping tablets or sedatives (e.g. barbiturates)) or analgesics such as opioids, morphine and codeine (also as cough medicine), antipsychotics, H1 antihistamines, alcohol), increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. Therefore, concomitant use of such medicines should only be considered if no other treatment options are possible. However, if your doctor prescribes BINATTA together with sedative medicines, the dose and duration of concomitant treatment with such medicines should be limited. Concomitant use of opioids and medicines used to treat epilepsy,
  neuropathic pain or anxiety disorders (gabapentin and pregabalin) increases the risk of
  opioid overdose, respiratory depression and may be life-threatening. Inform your doctor if you are taking gabapentin, pregabalin or sedative medicines and strictly
  follow his instructions. It is advisable to inform family members or close friends about the possibility of the above-mentioned objective and subjective symptoms. If such symptoms occur, contact your doctor immediately.

• If the patient is taking medicines that affect serotonin levels (e.g. certain medicines used to treat depression), they should consult their doctor before taking BINATTA due to the risk of developing "serotonin syndrome". Serotonin syndrome is rare but may be life-threatening. Symptoms include: uncontrolled, rhythmic muscle contractions, including eye muscle movements, agitation, excessive sweating, tremor, exaggerated reflexes, including increased muscle tone and body temperature above 38°C. Your doctor can provide appropriate information on this matter.

• Concomitant use of BINATTA with mixed mu-opioid receptor agonist/antagonist medicines (e.g. pentazocine, nalbuphine) or partial mu-opioid receptor agonists (e.g. buprenorphine) has not been studied. It is possible that BINATTA may not work properly if used simultaneously with medicines from the groups listed above. Inform your doctor immediately if you are currently taking any of the medicines mentioned above.

• Concomitant use of BINATTA with strong inhibitors or inducers (e.g. rifampicin, phenobarbital, St. John's wort) of certain enzymes necessary for the elimination of tapentadol from the body may affect the action of tapentadol or may cause adverse effects, especially when starting or stopping their administration. Inform your doctor about all medicines currently being taken.

• BINATTA should not be used concomitantly with MAO inhibitors (medicines used to treat depression). Inform your doctor if these medicines have been used or are being used within the last 14 days.

BINATTA with food, drink and alcohol
Do not drink alcohol while taking BINATTA, as some adverse effects such as drowsiness may be intensified. The medicine can be taken regardless of meals.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor or pharmacist before using this medicine.
BINATTA should not be used:

• during pregnancy, unless the doctor decides it is necessary. Prolonged use of tapentadol during pregnancy may cause withdrawal symptoms in newborns, which may be life-threatening if not recognised and treated by a doctor;
• during breastfeeding, as the medicine may be excreted in breast milk.

Use of BINATTA is not recommended:

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

Driving and operating machinery
BINATTA may cause drowsiness, dizziness, blurred vision and affect reaction ability.
These symptoms may occur especially at the beginning of BINATTA treatment, after a dose adjustment recommended by the doctor, or when alcohol or sedative medicines are used concomitantly. Ask your doctor whether driving and operating machinery are permitted
after taking the medicine.

3. How to use BINATTA

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The dose should be adjusted according to the intensity of pain and individual patient sensitivity to pain.
In general, the lowest effective dose for pain relief should be used.
Adults
The usual starting dose is 50 mg administered twice daily, approximately every 12 hours.
Total daily doses of BINATTA exceeding 500 mg of tapentadol are not recommended.
Your doctor may recommend a different dose or dosing interval if necessary. If you feel the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.
Elderly patients
Dose adjustment is usually not required in elderly patients (over 65 years of age). However, elimination of tapentadol may be prolonged in this age group, and therefore your doctor may recommend an alternative dosing regimen.
Patients with impaired liver or kidney function
Patients with severe liver impairment should not take this medicine. In cases of moderate liver impairment, your doctor will recommend an alternative dosing regimen. Patients with mild liver impairment do not require dose adjustment.
Patients with severe kidney impairment should not take this medicine. In cases of mild or moderate kidney impairment, dose adjustment is not required.
Use in children and adolescents
BINATTA is not recommended for use in children and adolescents under 18 years of age.
How to take BINATTA
BINATTA tablets should be taken orally.
Swallow the tablet whole with sufficient fluid. The tablets must not be chewed or crushed,

• as this may lead to overdose due to rapid release of the drug in the body. The medicine may be taken on an empty stomach or with food.
  The tablet may be divided into equal doses.
  The empty tablet shell may not be completely digested and may appear in the stool. This is not a cause for concern, as the medicine (active substance) has already been absorbed by the body, and only the tablet shell remains in the stool.
  Instructions for opening the blister pack
  This medicine is packaged in child-resistant, perforated blister packs, divided into single doses. Tablets cannot be pushed through the blister. The blister should be opened according to the following instructions:

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

2. At the intersection of the lines there is an unprotected area.

3. Pull the unprotected part to remove the upper protective layer.

Duration of treatment with BINATTA
Do not take the tablets for longer than recommended by your doctor.
Taking more BINATTA than recommended
After taking very large doses, the following symptoms may occur:

• pinpoint constriction of the pupils,
• vomiting,
• drop in blood pressure,
• rapid heartbeat,
• collapse, disturbances of consciousness or coma (deep unconsciousness),
• seizures,
• dangerously slow or shallow breathing or respiratory arrest. In such cases, seek immediate medical attention!

If you forget to take BINATTA
If you miss a dose, pain symptoms may return. Do not take a double dose to make up for the missed dose. Return to your regular dosing schedule.
Stopping BINATTA
If you stop or interrupt treatment before the recommended duration, pain symptoms are likely to return. Consult your doctor before stopping the medicine.
Generally, no adverse effects are observed after discontinuation of the medicine. However, in rare cases, patients who have been taking the medicine for some time and stop abruptly may experience general malaise.
The following symptoms may occur:

• restlessness, lacrimation, runny nose, yawning, sweating, chills, muscle aches, and dilated pupils,
• irritability, restlessness, back pain, joint pain, weakness, abdominal cramps, difficulty sleeping, nausea, loss of appetite, vomiting, diarrhoea, increased blood pressure, respiratory rate, and heart rate. If any of these symptoms occur after stopping treatment, consult your doctor immediately. Do not stop taking the medicine suddenly unless your doctor advises you to do so. Your doctor will inform you how to discontinue the medicine properly. Discontinuation may involve gradually reducing the dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Important adverse effects or symptoms to watch 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, particularly affecting the whole body.
• Another serious adverse effect is excessive slowing and shallowing of breathing. This most commonly occurs in elderly and weakened patients.

If any of these important adverse effects affect you, contact your doctor immediately.
Other adverse 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, depressed mood, sleep disturbances, restlessness, agitation, difficulty concentrating,
• tremor, muscle cramps,
• flushing,
• shortness of breath,
• vomiting, diarrhoea, indigestion,
• itching, excessive sweating, rash,
• feeling weak, fatigue, sensation of body temperature change, dryness of mucous membranes, fluid retention (oedema).

Uncommon (may affect up to 1 in 100 people)

• allergic reactions to the medicine (including skin swelling, urticaria, and in severe cases difficulty breathing, low blood pressure, collapse or shock),
• weight loss,
• disorientation, confusion, agitation (excitement), perceptual disturbances, unusual dreams, euphoric mood, impaired level of consciousness, memory impairment, psychiatric disturbances,
• fainting, excessive sedation, balance disorders, speech disorders, tingling, abnormal skin sensations (e.g. numbness, pricking),
• visual disturbances,
• faster heartbeat, slower heartbeat, palpitations, reduced arterial pressure,
• abdominal discomfort,
• urticaria,
• difficulty passing urine, frequent urination,
• sexual dysfunction,
• withdrawal syndrome (see "Stopping treatment with BINATTA"), feeling of abnormality, irritability.

Rare (may affect up to 1 in 1000 people)

• drug dependence, thinking disorders, seizures, feeling of impending fainting, coordination disturbances,
• dangerously slow or shallow breathing (respiratory depression),
• delayed gastric emptying,
• feeling of alcohol intoxication, feeling of relaxation.

Frequency not known (cannot be estimated from available data)

• hallucinations.

Generally, the likelihood of suicidal thoughts and behaviours 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 obtained from human use of the medicine have not provided evidence of increased risk.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine BINATTA

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What the medicine BINATTA contains

• The active substance 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 components are:
  Tablet core: microcrystalline cellulose (E 460); hypromellose (E 464); colloidal anhydrous silica (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 in strengths 25, 100, 150, 200 and 250 mg); iron oxide yellow (E 172) (only in strengths 25, 100 and 200 mg); iron oxide black (E 172) (only in strengths 25, 100, 150, 200 and 250 mg).

What BINATTA looks like and contents of the pack
BINATTA 25 mg: brownish, prolonged-release, elongated, biconvex tablets (6 mm x 12 mm) with a score line on both sides.
The tablet can be divided into equal doses.
BINATTA 50 mg: white, prolonged-release, elongated, biconvex tablets (6 mm x 13 mm) with a score line on both sides.
The tablet can be divided into equal doses.
BINATTA 100 mg: yellowish, prolonged-release, elongated, biconvex tablets (7 mm x 14 mm) with a score line on both sides.
The tablet can be divided into equal doses.
BINATTA 150 mg: light red, prolonged-release, elongated, biconvex tablets (7 mm x 15 mm) with a score line on both sides.
The tablet can be divided into equal doses.
BINATTA 200 mg: yellow, prolonged-release, elongated, biconvex tablets (8 mm x 16 mm) with a score line on both sides.
The tablet can be divided into equal doses.
BINATTA 250 mg: reddish-brown, prolonged-release, elongated, biconvex tablets (9 mm x 18 mm) with a score line on both sides.
The tablet can be divided into equal doses.

BINATTA is available in packs containing:
BINATTA 25 mg
20x1, 30x1, 40x1, 50x1, 54x1, 60x1 or 100x1 prolonged-release tablets in single-dose, perforated blisters, child-resistant packaging.
BINATTA 50–250 mg
20x1, 24x1, 30x1, 50x1, 54x1, 60x1 or 100x1 prolonged-release tablets in single-dose, perforated blisters, child-resistant packaging.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturers/Importers:
Develco Pharma GmbH
Grienmatt 27
Fahrnau
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
The Netherlands

For further information about this medicine, please contact the representative of the Marketing Authorisation Holder:
Stada Pharm sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

This medicinal product is authorised in the European Economic Area countries 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