Taboxea

Patient Information Leaflet: Information for the User

Taboxea 25 mg film-coated tablets, 50 mg film-coated tablets, 75 mg film-coated tablets, 100 mg film-coated tablets

tapentadol
Generic medicine
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Taboxea is and what it is used for

Tapentadol, the active substance of Taboxea, is a strong pain reliever belonging to the class of opioids.
Taboxea is used for the treatment of moderate to severe acute pain in adults which can only be adequately managed with an opioid analgesic.

2. What you need to know before taking Taboxea

Do not take Taboxea

• If you are allergic to the active substance tapentadol or to any of the other ingredients of this medicine (listed in section 6).
• If you suffer from asthma or if your breathing is dangerously slow or weak (respiratory depression, hypercapnia).
• If you have intestinal paralysis.
• If you have acute intoxication from alcohol, sleeping medicines, painkillers, or other psychotropic medicines (medicines that affect mood and emotions) (see "Other medicines and Taboxea").

Warnings and precautions
Talk to your doctor or pharmacist before taking Taboxea if:

• You have shortness of breath or weak breathing.
• You suffer from increased pressure inside the skull or disturbances of consciousness, up to coma.
• You have had a head injury or brain tumours.
• You suffer from liver or kidney problems (see "How to take Taboxea").
• You suffer from pancreatic or biliary tract disorders, including pancreatitis.
• You are taking medicines called mixed opioid agonist/antagonists (e.g., pentazocine, nalbuphine) or partial mu-opioid receptor agonists (e.g., buprenorphine).
• You have a predisposition to epilepsy or seizures, or you are taking other medicines that may increase the risk of seizures, as the risk of seizures may increase.

Tolerance, dependence and misuse
This medicine contains tapentadol, which is an opioid. It may cause dependence and/or
misuse.
This medicine contains tapentadol, an opioid medicine. Repeated use of opioids may
make the medicine less effective (you become accustomed to it, a phenomenon known as tolerance). Repeated use of Taboxea may also lead to dependence, abuse and misuse, which may
cause a potentially life-threatening overdose. The risk of these adverse effects may increase with higher doses and prolonged duration of use.
Dependence or misuse may make you feel as though you no longer have control over the amount of medicine you need or how often you need to take it.
The risk of developing dependence or misuse varies from person to person. You may have a
higher risk of becoming dependent on or misusing Taboxea if:

• You or a family member have previously suffered from alcohol, prescription medicine, or illegal substance abuse or dependence ("substance dependence");
• You are a smoker;
• You have previously had mood disorders (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

The appearance of any of the following signs during use of Taboxea may be a sign of
dependence or misuse:

• You feel the need to use the medicine for a longer period than prescribed by your doctor.
• You feel the need to use a higher dose than recommended.
• You may feel you need to continue using the medicine, even if it does not help relieve your pain.
• You use the medicine for reasons other than prescribed, for example, “to stay calm” or “to help sleep”.
• You have tried several times to stop or control the use of this medicine without success.
• When you stop taking the medicine, you feel unwell and feel better when you start taking it again (“withdrawal symptoms”). If you notice any of these signs, talk to your doctor to discuss the best treatment approach for you, including when it may be appropriate to stop treatment and how to stop safely (see section 3, If you stop taking Taboxea).

Sleep-related breathing disorders
Taboxea may cause sleep-related breathing disorders, such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low levels of oxygen in the blood). Symptoms may include pauses in breathing during sleep, night awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, talk to your doctor. Your doctor may consider reducing the dose.
Other medicines and Taboxea
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
The risk of side effects increases if you are taking medicines that may cause seizures (fits), such as certain antidepressants or antipsychotics. The risk of seizures may increase if you take Taboxea at the same time. Your doctor will tell you whether Taboxea is suitable for you.
Concomitant use of Taboxea and sedative medicines such as benzodiazepines or similar medicines (some sleeping or tranquilising medicines (e.g., barbiturates) or painkillers such as opioids, morphine and codeine (also used as a cough medicine), antipsychotics, anti-H\ antihistamines, alcohol) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes Taboxea together with sedative medicines, the dose and duration of concomitant treatment must be determined by your doctor.
Concomitant use of opioids and medicines used to treat epilepsy, nerve pain or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression and may be potentially life-threatening.
Inform your doctor if you are taking gabapentin or pregabalin or other sedative medicines and carefully follow your doctor's recommendations regarding dosage. It may be helpful to inform friends or family members about the signs and symptoms listed above. Talk to your doctor if you experience such symptoms.
If you are taking a medicine that affects serotonin levels (e.g., certain medicines for depression), consult your doctor before taking Taboxea, as cases of "serotonin syndrome" have been reported. Serotonin syndrome is a rare but life-threatening condition. Symptoms include involuntary and rhythmic muscle contractions, including muscles controlling eye movements, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tension and body temperature above 38°C. Your doctor can inform you about this.
Taking Taboxea together with other medicines belonging to the group of mixed μ-opioid receptor agonist/antagonists (e.g., pentazocine, nalbuphine) or partial μ-opioid receptor agonists (e.g., buprenorphine) has not been studied. Taboxea may not be effective if taken together with one of these medicines. Inform your doctor if you are currently being treated with any of these medicines.
Taking Taboxea with strong inhibitors or inducers (e.g., rifampicin, phenobarbital, St. John’s wort) of certain enzymes required to eliminate tapentadol from the body may affect the effectiveness of tapentadol and may cause adverse effects, especially at the beginning or end of treatment with these medicines. Keep your doctor informed about any medicines you are taking.
Taboxea must not be taken together with MAO inhibitors (some medicines for depression). Inform your doctor if you are taking MAO inhibitors or have taken them within the last 14 days.
The use of Taboxea with the following medicines that have anticholinergic effects may increase the risk of adverse effects:

• Medicines used to treat depression;
• Medicines used to treat allergies, motion sickness or nausea (antihistamines or antiemetics);
• Medicines used to treat psychiatric disorders (antipsychotics or neuroleptics);
• Muscle relaxants (muscle relaxants);
• Medicines used to treat Parkinson’s disease.

Taboxea with food, drinks and alcohol
Do not drink alcohol while taking Taboxea, as some side effects, such as drowsiness, may increase. Food does not affect the action of this medicine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take these tablets:

• If you are pregnant, unless your doctor has told you to, as prolonged use of tapentadol during pregnancy may cause withdrawal symptoms in the newborn, which may be life-threatening if not recognised and treated by a doctor.
• During childbirth, as it may cause dangerously slow or weak breathing (respiratory depression) in the newborn.
• During breastfeeding, as it may be excreted in breast milk.

Driving and using machines
Taboxea may cause drowsiness, dizziness and blurred vision and may reduce reaction time. This may occur especially when starting treatment with Taboxea, when your doctor changes your dose, or when you drink alcohol or take tranquilisers. Ask your doctor whether you can drive or operate machinery.
Taboxea contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Taboxea contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially ‘sodium-free’.

3. How to take Taboxea

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what you can expect from using Taboxea, when and for how long it should be used, when to contact your doctor, and when treatment should be stopped (see also "If you stop taking Taboxea" below).
Your doctor will decide the dosage based on the intensity of your pain and your individual sensitivity to pain.
In general, the lowest effective dose that relieves pain should be used.

Adults
The usual starting dose is 50 mg every 4 to 6 hours.
Total daily doses exceeding 700 mg of tapentadol on the first day of treatment and daily doses exceeding 600 mg of tapentadol on subsequent treatment days are not recommended.
Your doctor may prescribe a different or more appropriate dosage or dosing interval if necessary. If you feel the effect of these tablets is too strong or too weak, consult your doctor or pharmacist.

Elderly patients
In elderly patients (over 65 years of age), dose adjustment is generally not required. However, excretion of tapentadolo may be slowed in some patients in this group. If this applies to you, your doctor may prescribe a different dosage.

Liver and kidney disorders (impairment)
Patients with severe liver problems must not take these tablets.
If you have mild liver problems, your doctor will prescribe a different dosage.
In case of mild liver impairment, no dosage adjustment is necessary.
Patients with severe kidney problems must not take these tablets.
In case of mild or moderate kidney impairment, no dosage adjustment is necessary.

Use in children and adolescents
Taboxea is not suitable for children and adolescents under 18 years of age.

How and when to take Taboxea?
Taboxea is for oral use.
Always swallow the tablets with sufficient liquid. You may take the tablets on an empty stomach or with food.

How long should you take Taboxea?
Do not take the tablets for a longer period than prescribed by your doctor.

If you take more Taboxea than you should
After taking very high doses, the following may occur:

• Pinpoint pupils, vomiting, low blood pressure, rapid heartbeat, collapse, disturbances of consciousness or coma (deep unconsciousness), seizures, dangerously slow and shallow breathing, or respiratory arrest which may lead to death. If any of these occur, call a doctor immediately!

If you forget to take Taboxea
If you forget to take the tablets, your pain may return. Do not take a double dose to make up for a missed dose; simply continue taking the tablets as previously directed.

If you stop taking Taboxea
If you stop or discontinue treatment too early, your pain may return. If you wish to stop treatment, inform your doctor first.
Generally, withdrawal effects do not occur when stopping treatment. However, in rare cases, people who have taken the tablets for some time may experience unwanted effects if they stop taking them abruptly.
Symptoms may include:

• Restlessness, tearing, runny nose, yawning, sweating, chills, muscle pain, and dilated pupils.
• Irritability, anxiety, backache, joint pain, weakness, abdominal cramps, difficulty sleeping, nausea, loss of appetite, vomiting, diarrhea, and increased blood pressure, respiration, or heart rate.

If any of these symptoms occur after stopping treatment, consult your doctor.
You must not suddenly stop taking this medicine unless your doctor tells you otherwise. If your doctor wants you to stop taking the tablets, they will advise you on how to do so, which may involve gradually reducing the dose.
If you have any doubts about using 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 which you should pay attention and what to do if they occur:

• This medicine can cause allergic reactions. Symptoms may include shortness of breath, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching, especially if affecting the whole body.
• Another serious side effect is slowed breathing or more pronounced shortness of breath than expected. This mainly occurs in elderly or weak patients.

If 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, vomiting, dizziness, drowsiness, headache
Common (may affect up to 1 in 10 people):
Loss of appetite, anxiety, confusion, hallucinations, sleep disorders, abnormal dreams, tremor, hot flushes, constipation, diarrhoea, indigestion, dry mouth, itching, increased sweating, skin rash, muscle cramps, feeling of weakness, fatigue, sensation of change in body temperature
Uncommon (may affect up to 1 in 100 people):
Depressed mood, disorientation, excitability (agitation), nervousness, restlessness, euphoric mood, attention disturbance, memory impairment, near-fainting, sedation, difficulty controlling movements, difficulty speaking, numbness, abnormal skin sensations (e.g., tingling, pricking), muscle spasms, abnormal vision, rapid heartbeat, palpitations, decreased blood pressure, dangerously slow or shallow breathing (respiratory depression), low oxygen levels in the blood, shortness of breath, abdominal discomfort, urticaria, feeling of heaviness, delayed urination, frequent urination, drug withdrawal syndrome (see "If you stop treatment with Taboxea"), fluid accumulation in tissues (oedema), feeling of abnormality, sensation of drunkenness, irritability, feeling of relaxation, dependence on substances of abuse
Rare (may affect up to 1 in 1,000 people):
Allergic reaction to medicines (including swelling under the skin, urticaria, and in severe cases, difficulty breathing, drop in blood pressure, collapse or shock), abnormal thinking, epileptic seizures, decreased level of consciousness, abnormal coordination, slower heartbeat, altered gastric emptying
Not known (frequency cannot be estimated from the available data):
Delirium

In general, the likelihood of having suicidal thoughts and behaviour increases in patients suffering from chronic pain. In addition, some 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, clinical data on the use of tapentadol in humans do not provide evidence of an increased risk.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Taboxea

Keep this medicine out of the sight and reach of children.
Store this medicine in a safe and secure place, inaccessible to other people. Taking this medicine by
individuals for whom it has not been prescribed may cause serious harm or be fatal.
Do not use this medicine after the expiry date stated on the carton and on the blister. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Taboxea contains
The active substance is tapentadol.
Each tablet contains tapentadol tartrate, equivalent to 25 mg of tapentadol.
Each tablet contains tapentadol tartrate, equivalent to 50 mg of tapentadol.
Each tablet contains tapentadol tartrate, equivalent to 75 mg of tapentadol.
Each tablet contains tapentadol tartrate, equivalent to 100 mg of tapentadol.

The other components are:
Tablet core: microcrystalline cellulose, monohydrate lactose, sodium croscarmellose,
povidone, magnesium stearate.

Tablet coating:
[25 mg]: hypromellose, polydextrose, titanium dioxide (E171), maltodextrin, medium-chain triglycerides, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172).
[50 mg]: hypromellose, polydextrose, titanium dioxide (E171), maltodextrin, medium-chain triglycerides.
[75 mg]: hypromellose, polydextrose, titanium dioxide (E171), maltodextrin, medium-chain triglycerides, yellow iron oxide (E172).
[100 mg]: hypromellose, polydextrose, titanium dioxide (E171), maltodextrin, medium-chain triglycerides, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172).

Description of the appearance of Taboxea and contents of the pack
[25 mg]: Film-coated beige tablets, round and biconvex, marked with "25" on one side, with a diameter of 6 mm and a thickness of 3 mm.
[50 mg]: Film-coated tablets from white to whitish, round and biconvex, marked with "50" on one side, with a diameter of 7 mm and a thickness of 4 mm.
[75 mg]: Film-coated yellow tablets, round and biconvex, marked with "75" on one side, with a diameter of 8 mm and a thickness of 5 mm.
[100 mg]: Film-coated pink tablets, round and biconvex, marked with "100" on one side, with a diameter of 9 mm and a thickness of 5 mm.

Taboxea is available in packs containing:
Film-coated tablets are packaged in PVC/PVDC/PVC/Aluminum blisters or Aluminum/Aluminum blisters and dispensed in boxes of 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany: Tadomon 25 mg Film Tablets
Tadomon 50 mg Film Tablets
Tadomon 75 mg Film Tablets
Tadomon 100 mg Film Tablets
Italy: Taboxea