Tapentadol Teva

PACKAGE LEAFLET

Package leaflet: information for the user

Tapentadolo Teva 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

Tapentadol
Generic medicine
Please read this leaflet carefully before taking this medicine as 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 others, 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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Tapentadolo, the active substance contained in Tapentadolo Teva, is a strong pain reliever that belongs to the class of opioids. Tapentadolo Teva is used for the treatment of severe chronic pain in adults which can be adequately managed only with opioid painkillers.

2. What you should know before taking Tapentadolo Teva

Do not take Tapentadolo Teva

• 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 dangerously slow or shallow breathing (respiratory depression, hypercapnia);
• if you have intestinal paralysis;
• if you have acute poisoning due to alcohol, hypnotics, analgesics, or other psychotropic medicines (medicines acting on mood and emotions) (see “Other medicines and Tapentadolo Teva”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Tapentadolo Teva:

• if you have slow or shallow breathing;
• if you have increased intracranial pressure or disturbances of consciousness, up to coma;
• if you have suffered head trauma or have had brain tumours;
• if you have liver or kidney disease (see “How to take Tapentadolo Teva”);
• if you have a disease of the pancreas or biliary tract, including pancreatitis;
• if you are taking medicines called mixed opioid agonist/antagonists (e.g. pentazocine, nalbuphine) or partial agonists of opioid µ (mu) receptors (e.g. buprenorphine);
• if 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;
• if you or a family member has abused or been dependent on alcohol, prescription medicines, or illegal substances (“dependence”);
• if you are a smoker;
• if you have suffered from mood disorders (depression, anxiety, or a personality disorder) or if you 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 reduce the effectiveness of the drug (may lead to tolerance). It may also cause dependence and abuse, which can lead to a life-threatening overdose. If you are concerned about developing dependence on Tapentadolo Teva, it is important to consult your doctor. Use (even at therapeutic doses) may lead to physical dependence, resulting in withdrawal symptoms and recurrence of problems if treatment with this medicine is stopped abruptly.
Tapentadolo Teva may lead to physical and psychological dependence. If you have a tendency to abuse medicines or are drug-dependent, you should take these tablets only for short periods and under strict medical supervision.
Sleep-related breathing disorders
Tapentadolo Teva may cause sleep-related breathing disorders, such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxaemia (low levels of oxygen in the blood). Symptoms may include pauses in breathing during sleep, waking up at night due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.
Other medicines and Tapentadolo Teva
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 can cause seizures (fits), such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take Tapentadolo Teva at the same time. Your doctor will advise you whether Tapentadolo Teva is suitable for you.
• Concomitant use of Tapentadolo Teva and sedative medicines such as benzodiazepines or related substances (some sleeping pills or tranquillisers [e.g. barbiturates] or analgesics such as opioids, morphine and codeine [also used as a cough medicine]), antipsychotics, H1-antihistamines, or alcohol increases the risk of drowsiness, difficulty breathing (respiratory depression), and coma, and can be life-threatening. Concomitant use should therefore be considered only if no alternative treatment options are available. However, if your doctor prescribes Tapentadolo Teva together with sedative medicines, your doctor should also limit the dose 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 and respiratory depression, and can be life-threatening. Inform your doctor if you are taking gabapentin or pregabalin or other sedative medicines and follow carefully his or her dosage recommendations. It may be helpful to inform family members or friends to watch for the signs and symptoms listed above. Contact your doctor if you experience these symptoms.
• If you are taking a type of medicine that affects serotonin levels (e.g. certain medicines for the treatment of depression), consult your doctor before taking Tapentadolo Teva, as cases of “serotonin syndrome” have been observed. Serotonin syndrome is a rare but life-threatening condition. Signs include involuntary rhythmic muscle contractions, including muscles controlling eye movements, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, and body temperature above 38 °C. Your doctor can provide you with further information.
• The concomitant use of Tapentadolo Teva with other types of medicines known as µ (mu) opioid receptor agonist/antagonists (e.g. pentazocine, nalbuphine) or partial agonists of µ (mu) opioid receptors (e.g. buprenorphine) has not been studied. Tapentadolo Teva 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 Tapentadolo Teva together 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 efficacy of tapentadol or cause adverse effects, especially when starting or stopping treatment with these other medicines. Keep your doctor informed about all medicines you are taking.
• Tapentadolo Teva must not be taken together with monoamine oxidase inhibitors (MAOIs) (some medicines for the treatment of depression). Inform your doctor if you are taking MAOIs or if you have taken these medicines within the last 14 days.

Tapentadolo Teva with food, drinks and alcohol
Do not drink alcohol during treatment with Tapentadolo Teva, as some adverse 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, planning to become pregnant, or 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 specifically instructed you to do so. If used for prolonged periods during pregnancy, tapentadol may cause withdrawal symptoms in the newborn, which, if not recognised and treated by a doctor, could be life-threatening;
• while breastfeeding, as the medicine may be excreted in breast milk.

Use of Tapentadolo Teva is not recommended

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

Driving and using machines
Tapentadolo Teva may cause drowsiness, dizziness, and blurred vision, and may reduce reaction time. These effects may occur especially when starting treatment with Tapentadolo Teva, when your doctor changes the dose, or when alcohol or tranquillisers are consumed.
Ask your doctor whether you can drive or operate machinery.

3. How to take Tapentadolo Teva

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will adjust the dose according to the intensity of your pain and your individual sensitivity to pain. In general, you should take the lowest effective dose that relieves your pain.
Adults
The usual starting dose is 50 mg taken twice daily, approximately every 12 hours.
Total daily doses of Tapentadolo Teva exceeding 500 mg of tapentadol are not recommended.
If necessary, your doctor may prescribe a different or more appropriate dose or dosing interval. If you feel that 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 usually not required. However, elimination of tapentadol may be slowed in some patients in this age group. If this applies to you, your doctor may recommend a different dosing regimen.
Liver and kidney impairment
Patients with severe liver problems must not take these tablets. If you have moderate liver problems, your doctor will recommend a different dosing regimen. In case of mild liver problems, no dose adjustment is necessary.
Patients with severe kidney problems must not take these tablets. In case of mild or moderate kidney problems, no dose adjustment is necessary.
Use in children and adolescents
Tapentadolo Teva is not suitable for children and adolescents under 18 years of age.
How and when to take Tapentadolo Teva
Tapentadolo Teva is for oral use.
Always swallow the tablets whole with sufficient liquid. Do not chew, break or crush them, as this could lead to overdose due to too rapid release of the medicine into the body. You may take the tablets on an empty stomach or with food.
The tablet may be divided into equal doses.
The empty tablet coating may not be completely digested and may therefore be found in the faeces. This should not concern you, as the medicine (active substance) has already been absorbed by the body and what you see is only the empty coating.
Instructions for opening the blister
This medicine is packaged in child-resistant, perforated, unit-dose blisters. It is not possible to remove the tablets by pressing on the blister. Follow the blister-opening instructions shown below:

1. Detach a single dose by tearing along the perforated line of the blister.

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

3. Pull the unsealed section to remove the sealing foil.

How long to take Tapentadolo Teva
Do not take the tablets for longer than prescribed by your doctor.
If you take more Tapentadolo Teva 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 or shallow breathing or respiratory arrest. In such cases, call a doctor immediately.

If you forget to take Tapentadolo Teva
If you forget to take the tablets, your pain may return. Do not take a double dose to make up for the missed dose, but simply continue taking the tablets as before.
If you stop taking Tapentadolo Teva
If you stop or discontinue treatment too early, your pain may return. If you wish to stop treatment, discuss this with your doctor first.
Generally, withdrawal effects do not occur when stopping treatment. However, in rare cases, individuals who have been taking the tablets for some time may feel unwell if treatment is stopped abruptly.
Symptoms may include:

• restlessness, tearing, runny nose, yawning, sweating, chills, muscle pain and dilated pupils;
• irritability, anxiety, back pain, joint pain, weakness, abdominal cramps, difficulty sleeping, nausea, loss of appetite, vomiting, diarrhoea, and increased blood pressure, respiratory rate or heart rate. If you experience any of these symptoms after stopping treatment, consult your doctor. Do not stop taking this medicine abruptly unless instructed by your doctor. If your doctor advises you to stop taking the tablets, they will explain how to do so. This 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 everyone gets them.

Important side effects or symptoms to pay attention to, and what to do if they occur:

• This medicine can 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 a condition in which breathing is slower or weaker than expected. This condition occurs mainly in elderly and frail patients.

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

Other possible side effects:

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

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

Common (may affect up to 1 in 10 people)

• reduced appetite, anxiety, depressed mood, sleep disturbances, nervousness, restlessness, attention disturbances;
• tremor, involuntary muscle contractions;
• flushing;
• shortness of breath;
• vomiting, diarrhoea, indigestion;
• itching, increased sweating, rash;
• feeling weak, fatigue, sensation of body temperature changes, dryness of mucous membranes, fluid accumulation in tissues (oedema).

Uncommon (may affect up to 1 in 100 people)

• allergic reactions to medicines (including swelling under the skin, urticaria, and in severe cases, difficulty breathing, low blood pressure, collapse or shock);
• weight loss;
• disorientation, confusion, excitability (agitation), perceptual disturbances, unusual dreams, euphoric mood, reduced level of consciousness, memory impairment, mental deterioration;
• fainting, sedation, balance disorders, difficulty speaking, numbness, abnormal skin sensations (e.g. tingling, pricking);
• blurred vision;
• fast heartbeat, slow heartbeat, palpitations, low blood pressure;
• abdominal discomfort;
• urticaria;
• difficulty urinating, increased frequency of urination;
• sexual dysfunction;
• substance abuse withdrawal syndrome (see "If you stop taking Tapentadolo Teva"), feeling of abnormality, irritability.

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

• substance abuse dependence, abnormal thoughts, epileptic seizure, near-fainting, abnormal coordination;
• dangerous slowing or weakening of breathing (respiratory depression);
• impaired gastric emptying;
• feeling of drunkenness, sensation of relaxation.

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

• delirium.

Generally, the likelihood of experiencing suicidal thoughts or behaviour is increased in patients suffering from chronic pain. In addition, some medicines used to treat depression (which affect the brain's neurotransmission system) may increase this risk, especially at the beginning of treatment. Although tapentadolo also affects neurotransmitters, data from human use 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 Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp. The expiry date refers to the last day of that month.
This medicine requires no 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 Teva contains

• The active substance is tapentadolo.

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

• 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), red iron oxide (E172) (only in 25, 100, 150, 200 and 250 mg strengths), yellow iron oxide (E172) (only in 25, 100 and 200 mg strengths), black iron oxide (E172) (only in 25, 100, 150, 200 and 250 mg strengths).

Description of the appearance of Tapentadolo Teva and package contents
Tapentadolo Teva 25 mg consists of prolonged-release, biconvex, brownish, oblong tablets (6 mm x 12 mm) with a notch on both sides.
The tablet can be divided into equal doses.
Tapentadolo Teva 50 mg consists of prolonged-release, biconvex, white, oblong tablets (6 mm x 13 mm) with a notch on both sides.
The tablet can be divided into equal doses.
Tapentadolo Teva 100 mg consists of prolonged-release, biconvex, yellowish, oblong tablets (7 mm x 14 mm) with a notch on both sides.
The tablet can be divided into equal doses.
Tapentadolo Teva 150 mg consists of prolonged-release, biconvex, bright reddish, oblong tablets (7 mm x 15 mm) with a notch on both sides.
The tablet can be divided into equal doses.
Tapentadolo Teva 200 mg consists of prolonged-release, biconvex, yellow, oblong tablets (8 mm x 16 mm) with a notch on both sides.
The tablet can be divided into equal doses.
Tapentadolo Teva 250 mg consists of prolonged-release, biconvex, reddish-brown, oblong tablets (9 mm x 18 mm) with a notch on both sides.
The tablet can be divided into equal doses.
Tapentadolo Teva is available in the following pack sizes:
Tapentadolo Teva 25 mg
20x1, 30x1, 40x1, 50x1, 54x1, 60x1 or 100x1 prolonged-release tablets in perforated, divisible, unit-dose blisters with child-resistant packaging.
Tapentadolo Teva 50-250 mg
20x1, 24x1, 30x1, 50x1, 54x1, 60x1 or 100x1 prolonged-release tablets in perforated, divisible, unit-dose blisters with child-resistant packaging.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milano, Italy
Manufacturer
Develco Pharma GmbH, Grienmatt 27, DE-79650 Schopfheim, Germany