TAPENTADOL EG

Package leaflet: Information for the user

Tapentadolo EG 25 mg prolonged-release tablets, 50 mg prolonged-release tablets, 100 mg prolonged-release tablets, 150 mg prolonged-release tablets, 200 mg prolonged-release tablets, 250 mg prolonged-release tablets

Generic medicine
Please read all of this leaflet carefully before taking 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 they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Tapentadolo EG is and what it is used for

Tapentadolo, the active substance of Tapentadolo EG, is a strong analgesic belonging to the opioid class. Tapentadolo EG is used for the treatment of severe chronic pain in adults that can be adequately managed only with opioid analgesics.

2. What you need to know before taking Tapentadolo EG

Do not take Tapentadolo EG

• if you are allergic to tapentadol or to any of the other ingredients of this medicine (listed in section 6);
• if you have asthma or if your breathing is dangerously slow or shallow (respiratory depression, hypercapnia);
• if you have intestinal paralysis;
• if you have acute poisoning due to alcohol, sleeping medicines, painkillers, or other psychotropic medicines (medicines acting on mood and emotions) (see "Other medicines and Tapentadolo EG").

Warnings and precautions
Talk to your doctor or pharmacist before taking Tapentadolo EG if

• you have short or weak breathing;
• you suffer from increased pressure inside the head or disturbances of consciousness, up to coma;
• you have suffered a head injury or have a brain tumour;
• you suffer from liver or kidney problems (see "How to take Tapentadolo EG");
• you suffer from disorders of the pancreas or biliary tract, including pancreatitis;
• you are taking medicines called mixed opioid agonist/antagonists (such as pentazocine, nalbuphine) or partially mu-opioid receptor agonist medicines (such as buprenorphine);
• you are prone to epilepsy or seizures, or if you are taking other medicines known to increase the risk of seizures, as the risk of a seizure may increase.

Tolerance, dependence and abuse
This medicine contains tapentadol, which is an opioid. It may cause dependence and/or abuse.
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 Tapentadolo EG may also lead to dependence, abuse and addiction, which may result in a potentially life-threatening overdose. The risk of these adverse effects may increase with higher doses and prolonged duration of use.
Dependence or addiction may make you feel that you no longer have control over the amount of medicine you need or how often you use it.
The risk of developing dependence or addiction varies from person to person. You may have a higher risk of becoming dependent or addicted to Tapentadolo EG if:

• you or a family member have previously suffered from alcohol, prescription medicine or illegal substance abuse or dependence ("addiction");
• 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 Tapentadolo EG may be a sign of dependence or addiction:

• 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 those 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 when you restart, you feel better (“withdrawal effects”). If you notice any of these signs, talk to your doctor to discuss the best treatment approach for you, including whether it is appropriate to stop treatment and how to stop safely (see section 3, If you stop taking Tapentadolo EG).

Sleep-related breathing disorders
Tapentadolo EG may cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep-related hypoxaemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, night-time awakenings due to shortness of breath, difficulty staying asleep, or excessive daytime sleepiness. If you or someone else notices the appearance of these symptoms, contact your doctor. Your doctor may consider reducing the dose.

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

• The risk of adverse effects increases if you are taking medicines that may cause seizures (epileptic fits), such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take Tapentadolo EG together with these medicines. Your doctor will tell you whether you can take Tapentadolo EG.
• Concomitant use of Tapentadolo EG and sedative medicines such as benzodiazepines or similar medicines (some sleeping medicines or tranquilisers (such as barbiturates), or painkillers such as opioids, morphine and codeine (also used in cough preparations)), increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other therapeutic options are possible. If your doctor prescribes Tapentadolo EG together with sedatives, your doctor will determine the appropriate dosage and duration of concomitant treatment. 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 life-threatening. Inform your doctor if you are taking gabapentin or pregabalin or any other sedative medicine, and strictly follow the dosage recommendations. It may be helpful for friends or family members to be aware of the signs and symptoms listed above. Contact your doctor if any of these symptoms occur.
• If you are taking a type of medicine that affects serotonin levels (such as certain medicines for depression), talk to your doctor before taking Tapentadolo EG, as cases of "serotonin syndrome" have been reported. Serotonin syndrome is rare but potentially life-threatening. Symptoms include involuntary, rhythmic muscle contractions including those controlling eye movements, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tone, and body temperature above 38°C. Your doctor can provide further information.
• The use of Tapentadolo EG together with certain medicines known as μ-opioid receptor agonist/antagonists (such as pentazocine, nalbuphine) or partial μ-opioid receptor agonists (such as buprenorphine) has not been studied. Tapentadolo EG may not be effective if taken together with one of these medicines. Inform your doctor if you are taking any of these medicines.
• Taking Tapentadolo EG together with certain medicines (such as rifampicin, phenobarbital, St. John’s wort), which are strong inhibitors or inducers of enzymes needed to eliminate tapentadol from the body, may affect the effectiveness of tapentadol or may cause adverse effects, especially at the beginning or end of treatment with these medicines. Keep your doctor informed about all medicines you are taking.
• Tapentadolo EG must not be taken together with MAO inhibitors (a type of medicine used to treat depression). Inform your doctor if you are taking MAO inhibitors or have taken them within the last 14 days.
• The use of Tapentadolo EG 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 relaxers);
  • medicines used to treat Parkinson’s disease.

Tapentadolo EG with food, drinks and alcohol
Do not drink alcohol during treatment with Tapentadolo EG, as some adverse effects, such as drowsiness, may increase. Food does not affect the effectiveness of this medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Do not take these tablets:

• if you are pregnant, unless your doctor has specifically instructed you to do so. If used for prolonged periods during pregnancy, tapentadol may cause withdrawal symptoms in the newborn, which could be life-threatening if not recognised and treated by a doctor;
• while breastfeeding, as the medicine may be excreted in breast milk.

Use of Tapentadolo EG is not recommended:

• during childbirth, because the newborn’s breathing may slow down or become dangerously weak (respiratory depression).

Driving and using machines
Tapentadolo EG may cause drowsiness, dizziness and blurred vision, and may reduce reaction time. This may especially occur when starting treatment with Tapentadolo EG, when your doctor changes your dose, or when you drink alcohol or take tranquilisers. Ask your doctor whether you can drive or operate machinery.

3. How to take Tapentadolo EG

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what
to expect from using Tapentadolo EG, when and for how long it should be used, when to
contact your doctor, and when you should stop treatment (see also “If you stop taking
Tapentadolo EG” below).
The dose should be adjusted according to the intensity of pain and your individual sensitivity to pain. In general,
you should take the lowest dose capable of relieving your pain.
Adults
The usual initial dose is 50 mg twice daily, approximately every 12 hours.
Daily total doses of Tapentadolo EG exceeding 500 mg of tapentadol are not recommended.
Your doctor may prescribe a different or more appropriate dosage or dosing interval if necessary.
Inform your doctor or pharmacist if you feel that the effect of these tablets is too strong or too weak.
Elderly patients
In elderly patients (over 65 years of age), dose adjustment is generally not required. However, excretion
of tapentadol may be slowed in some patients in this group. If this applies to you, your doctor may
prescribe a different dose.
Hepatic and renal impairment (insufficiency)
Patients with severe liver problems must not take these tablets. If you have mild liver problems,
your doctor will prescribe a different dose. Dose adjustment is not necessary in case of mild liver impairment.
Patients with severe kidney problems must not take these tablets. Dose adjustment is not necessary in case of mild or moderate kidney impairment.
Use in children and adolescents
Tapentadolo EG is not indicated for use in children and adolescents under 18 years of age.
How and when to take Tapentadolo EG
Tapentadolo EG is for oral use.
Always swallow the tablets whole with sufficient liquid. Do not chew or crush them: this could cause an overdose, as the medicine would be released into your body too quickly. You may take the tablets either on an empty stomach or after a meal.
The tablet may be divided into two equal doses.
It is possible that the empty tablet shell may not be completely digested and therefore may be visible in the
faeces. This should not concern you, as the medicine (active ingredient) of the tablet has already been
absorbed by your body, and what you see is only the empty shell.
How to open the blister
This medicine is packaged in a child-resistant, unit-dose divisible blister. The tablet cannot be removed through the blister. Follow the instructions below to open the blister:

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

2. This allows access to an unsealed area located at the point where the perforation lines intersect.

3. Pull the unsealed section to remove the cover.

How long should you take Tapentadolo EG
Do not take the tablets for longer than your doctor has instructed.
If you take more Tapentadolo EG than you should
After taking very high doses, the following may occur:

• pinpoint pupils;
• vomiting;
• drop in blood pressure;
• rapid heartbeat;
• collapse, disturbances of consciousness or coma (deep unconscious state);
• seizures;
• dangerously slow or shallow breathing or respiratory arrest, which may lead to death.

In such cases, call your doctor immediately!
If you forget to take Tapentadolo EG
If you forget to take the tablets, your pain is likely to return. Do not take a double dose to make up for the missed dose; simply continue taking the tablets as before.
If you stop taking Tapentadolo EG
If you stop or end treatment too early, your pain is likely to return. If you wish to stop treatment, consult your doctor first.
Generally, withdrawal effects do not occur when stopping treatment, but occasionally people who have taken the tablets for some time may feel unwell if they stop treatment 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, diarrhoea, and increased blood pressure, breathing rate, or heart rate. If you experience any of these symptoms after stopping treatment, consult your doctor. Do not stop taking this medicine suddenly unless instructed by your doctor. If your doctor advises you to discontinue the tablets, they will tell you how to do so, which may include gradually reducing the dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Serious side effects or symptoms to which you should pay attention, 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 entire body.
• Another serious side effect is slowed or more pronounced shortness of breath than expected. This mainly occurs in elderly or weak patients.

In these cases, contact your doctor immediately.
Other possible side effects are:
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 problems, nervousness, restlessness, attention disturbances;
• tremors, muscle contractions;
• hot flushes;
• shortness of breath;
• vomiting, diarrhoea, indigestion;
• itching, excessive sweating, skin rash;
• feeling weak, tiredness, sensation of body temperature fluctuations, dryness of mucous membranes, fluid accumulation in tissues (oedema).

Uncommon (may affect up to 1 in 100 people)

• allergic reaction to medicines (including subcutaneous swelling, hives, and in more severe cases, breathing difficulties, drop in blood pressure, collapse or shock);
• weight loss;
• disorientation, confusion, excitability (agitation), disturbances in perception, abnormal dreams, euphoric mood, depressed level of consciousness, memory impairment, mental impairment;
• fainting, sedation, balance disorders, difficulty speaking, numbness, abnormal skin sensations (e.g. tingling, pricking);
• abnormal vision;
• rapid heartbeat, slow heartbeat, palpitations, decreased blood pressure;
• abdominal discomfort;
• hives;
• urinary hesitation, frequent urination;
• sexual dysfunction;
• drug withdrawal syndrome (see "If you stop taking Tapentadolo EG"), feeling of abnormality, irritability.

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

• drug dependence, abnormal thoughts, epileptic seizure, feeling faint, abnormal coordination;
• dangerously slow or shallow breathing (respiratory depression);
• altered gastric emptying;
• feeling of drunkenness, sensation of relaxation.

Not known (frequency cannot be estimated from the available data)

• delirium.

Generally, the likelihood of having suicidal thoughts or behaviour increases in patients suffering from chronic
pain. In addition, some medicines used to treat depression (which affect brain neurotransmission systems) can
increase this risk, especially at the beginning of treatment. Although tapentadol affects neurotransmission,
clinical use data for tapentadol do not show 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 can 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 Tapentadolo EG

Keep this medicine in a safe and secure place, out of reach of other people. Use by others who have not been prescribed this medicine may cause serious harm or be fatal.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging or blister after the word “Exp.” 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. Package contents and other information

What Tapentadolo EG contains

• The active substance is tapentadol.

Tapentadolo EG 25 mg prolonged-release tablets
Each prolonged-release tablet contains tapentadol phosphate equivalent to 25 mg of tapentadol.
Tapentadolo EG 50 mg prolonged-release tablets
Each prolonged-release tablet contains tapentadol phosphate equivalent to 50 mg of tapentadol.
Tapentadolo EG 100 mg prolonged-release tablets
Each prolonged-release tablet contains tapentadol phosphate equivalent to 100 mg of tapentadol.
Tapentadolo EG 150 mg prolonged-release tablets
Each prolonged-release tablet contains tapentadol phosphate equivalent to 150 mg of tapentadol.
Tapentadolo EG 200 mg prolonged-release tablets
Each prolonged-release tablet contains tapentadol phosphate equivalent to 200 mg of tapentadol.
Tapentadolo EG 250 mg prolonged-release tablets
Each prolonged-release tablet contains tapentadol phosphate equivalent to 250 mg of tapentadol.

• The other components are:
  Tablet core: microcrystalline cellulose (E460), hypromellose (E464), anhydrous colloidal silica (E551); magnesium stearate.
  Tablet coating: hypromellose (E464); glycerol (E422); talc (E553b); microcrystalline cellulose (E460); titanium dioxide (E171); iron oxide red (E172) (only in dosages of 25, 100, 150, 200 and 250 mg); iron oxide yellow (E172) (only in dosages of 25, 100 and 200 mg); iron oxide black (E172) (only in dosages of 25, 100, 150, 200 and 250 mg).

Description of the appearance of Tapentadolo EG and the contents of the pack
Tapentadolo EG 25 mg is available as prolonged-release tablets (6 mm x 12 mm), brownish in colour, oblong, biconvex, with score lines on both sides.
The tablet can be divided into equal doses.
Tapentadolo EG 50 mg is available as prolonged-release tablets (6 mm x 13 mm), white in colour, oblong, biconvex, with score lines on both sides.
The tablet can be divided into equal doses.
Tapentadolo EG 100 mg is available as prolonged-release tablets (7 mm x 14 mm), yellowish in colour, oblong, biconvex, with score lines on both sides.
The tablet can be divided into equal doses.
Tapentadolo EG 150 mg is available as prolonged-release tablets (7 mm x 15 mm), bright red in colour, oblong, biconvex, with score lines on both sides.
The tablet can be divided into equal doses.
Tapentadolo EG 200 mg is available as prolonged-release tablets (8 mm x 16 mm), yellow in colour, oblong, biconvex, with score lines on both sides.
The tablet can be divided into equal doses.
Tapentadolo EG 250 mg is available as prolonged-release tablets (9 mm x 18 mm), reddish-brown in colour, oblong, biconvex, with score lines on both sides.
The tablet can be divided into equal doses.

Tapentadolo EG is available in the following pack sizes:
Tapentadolo EG 25 mg
20x1, 30x1, 40x1, 50x1, 54x1, 60x1 or 100x1 prolonged-release tablets in child-resistant, unit-dose divisible blisters.
Tapentadolo EG 50 mg
20x1, 24x1, 30x1, 50x1, 54x1, 60x1 or 100x1 prolonged-release tablets in child-resistant, unit-dose divisible blisters.
Tapentadolo EG 100 mg
20x1, 24x1, 30x1, 50x1, 54x1, 60x1 or 100x1 prolonged-release tablets in child-resistant, unit-dose divisible blisters.
Tapentadolo EG 150 mg
20x1, 24x1, 30x1, 50x1, 54x1, 60x1 or 100x1 prolonged-release tablets in child-resistant, unit-dose divisible blisters.
Tapentadolo EG 200 mg
20x1, 24x1, 30x1, 50x1, 54x1, 60x1 or 100x1 prolonged-release tablets in child-resistant, unit-dose divisible blisters.
Tapentadolo EG 250 mg
20x1, 24x1, 30x1, 50x1, 54x1, 60x1 or 100x1 prolonged-release tablets in child-resistant, unit-dose divisible blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia 6, 20136 Milano
Manufacturer
Develco Pharma GmbH, Grienmatt 27, 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)

This medicinal product is authorized in the European Economic Area (EEA) 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 Tapentadolo EG
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