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 all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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

Leaflet 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 management of severe chronic pain in adults, when treatment with an opioid analgesic is considered appropriate for pain severe enough to require continuous, long-term opioid therapy.

2. Important information before using the medicine BINATTA

When not to use the medicine BINATTA:

• if the patient is allergic to tapentadol or any of the other components 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, hypnotic, 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 who have sustained head injury or have brain tumours,
• in patients with liver or kidney disease (see "How to use BINATTA"),
• in patients with diseases of the pancreas or biliary tract, including pancreatitis,
• in patients taking drugs with mixed agonist/antagonist properties at the "mu" opioid receptors (e.g. pentazocine, nalbuphine) or drugs 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 convulsive episodes,
• if there is a family history of alcohol, drug or 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 medicine. Repeated use of opioid
analgesics may lead to reduced effectiveness of the medicine (drug 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 this medicine (even at therapeutic doses) may
lead to physical dependence, which could result in withdrawal symptoms and
recurrence of problems if treatment is stopped abruptly.
BINATTA may cause physical and psychological dependence. In patients with a tendency to
drug abuse or history of addiction, treatment should be short-term and conducted
under strict medical supervision.

Sleep-related breathing disorders
BINATTA may cause breathing disorders during sleep, such as sleep apnoea
(periods of stopped 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
shortness of breath, difficulty maintaining continuous sleep, or excessive daytime sleepiness. If
these symptoms are observed, contact your doctor. The doctor may consider
reducing the dose of the medicine.

BINATTA with other medicines
You must 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 adverse effects increases if the patient is taking 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 (certain sleeping tablets or sedatives (e.g. barbiturates)) or analgesics such as opioids, morphine and codeine (including as cough medicine), antipsychotics, H1 antihistamines, or 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 when other treatment options are not possible. If your doctor prescribes BINATTA to be used together with sedative medicines, the dose and duration of concomitant treatment 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 or her instructions. It is advisable to inform family members or close friends about the possibility of the above-mentioned subjective and objective symptoms. If such symptoms occur, contact your doctor.

• 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 possibility of developing "serotonin syndrome". Serotonin syndrome is rare but may be life-threatening. Symptoms include: uncontrolled, rhythmic muscle contractions, including those affecting eye movement, agitation, excessive sweating, tremor, exaggerated reflexes, including increased muscle tone and body temperature above 38°C. Your doctor can provide appropriate information on this.

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

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

BINATTA with food, drink and alcohol
Do not drink alcohol while taking BINATTA, as certain 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. Long-term use of tapentadol during pregnancy may cause withdrawal symptoms in newborns, which may be life-threatening if not diagnosed and treated by a doctor;
• during breastfeeding, as the medicine may be excreted in breast milk.

Use of BINATTA is not recommended:

• during labour, as it may cause dangerous slowing or depression 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 treatment with BINATTA, after a dose change 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 this medicine.

3. How to take BINATTA

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The dosage should be adjusted according to the intensity of pain and individual patient sensitivity to pain.
In general, the lowest effective dose that adequately relieves pain 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.
The doctor may recommend a different dose or dosing interval if necessary. If you feel the medicine is too strong or too weak, contact your doctor or pharmacist.
Elderly patients
Dosage adjustment is usually not required in elderly patients (over 65 years of age). However, elimination of tapentadol may be prolonged in patients in this age group, and therefore the doctor may recommend an alternative dosing regimen.
Patients with impaired liver or kidney function
This medicine should not be used by patients with severe liver impairment. In cases of moderate liver impairment, the doctor will recommend an adjusted dosing regimen. Patients with mild liver impairment do not require dose adjustment.
This medicine should not be used by patients with severe renal impairment. In cases of mild or moderate renal impairment, dose adjustment is not required.
Use in children and adolescents
The use of BINATTA is not recommended 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 too rapid release of the medicine 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 must not be pushed through the blister. The blister packs 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 top protective layer.

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

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

If you miss a dose of BINATTA
If the patient forgets to take the medicine, pain symptoms may return. Do not take a double dose to make up for the missed dose. Resume the regular dosing schedule.
Stopping treatment with BINATTA
If treatment is interrupted or discontinued before completion, pain symptoms are likely to return. Consult your doctor before stopping the medicine.
Generally, no adverse effects are observed upon 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 falling asleep, nausea, loss of appetite, vomiting, diarrhoea, increased blood pressure, respiratory rate, and heart rate. If any of the above symptoms occur after stopping treatment, consult a doctor immediately. Do not stop taking the medicine suddenly unless instructed by a doctor. The doctor will advise the patient on how to discontinue the medicine. 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 side effects

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

Important side 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, especially affecting the whole body.
• Another serious side effect is excessive slowing and shallowing of breathing. This occurs most frequently in elderly and weakened patients.

If any of these important side effects occur, contact a doctor immediately.

Other side effects that may occur:

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

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

Common (may affect less than 1 in 10 people)

• loss of appetite, anxiety, depressed mood, sleep disturbances, restlessness, motor agitation, difficulty concentrating,
• tremor, muscle spasms,
• flushing,
• shortness of breath,
• vomiting, diarrhoea, indigestion,
• itching, excessive sweating, rash,
• feeling of weakness, fatigue, sensation of body temperature changes, dryness of mucous membranes, fluid retention (oedema).

Uncommon (may affect less than 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, perceptual disturbances, unusual dreams, euphoric mood, impaired level of consciousness, worsening of memory, psychiatric disturbances,
• fainting, excessive sedation, balance disorders, speech disorders, tingling, abnormal skin sensations (e.g. numbness, prickling),
• visual disturbances,
• faster heartbeat, slower heartbeat, palpitations, decreased blood 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 less than 1 in 1,000 people)

• drug dependence, thinking disturbances, seizures, feeling of impending fainting, coordination disturbances,
• dangerously slow or shallow breathing (respiratory depression),
• impaired gastric emptying,
• sensation 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. In addition, medicines used in the treatment of 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 an increased risk.

Reporting of side effects

If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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 authorisation holder.

Reporting side effects helps provide more information on the safety of the medicine.

5. How to store the medicine BINATTA

Keep this 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. Such measures help protect the environment.

6. Contents of the packaging and other information

What 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 ingredients 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 for strengths 25, 100, 150, 200 and 250 mg); iron oxide yellow (E 172) (only for strengths 25, 100 and 200 mg); iron oxide black (E 172) (only for strengths 25, 100, 150, 200 and 250 mg).

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

Binatta is available in the following pack sizes:
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/Importer
Marketing Authorisation 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
The Netherlands

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

This medicinal product is authorised in the European Economic Area member states 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