Leaflet: information for the user

Tapentadol retardStada25 mg prolonged-release tablets EFG

Tapentadol retard Stada 50 mg prolonged-release tablets EFG

Tapentadol retard Stada 100 mg prolonged-release tablets EFG

Tapentadol retard Stada 150 mg prolonged-release tablets EFG

Tapentadol retard Stada 200 mg prolonged-release tablets EFG

Tapentadol retard Stada 250 mg prolonged-release tablets EFG

Read this leaflet carefully before you start 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isTapentadol retard Stadaand what it is used for

2. What you need to know before starting to takeTapentadol retard Stada

3. How to takeTapentadol retard Stada

4. Possible side effects

5. Storage ofTapentadol retard Stada

6. Contents of the pack and additional information

Tapentadol - the active ingredient of Tapentadol retard Stada - is a potent analgesic that belongs to the class of opioids. Tapentadol is used for the treatment of severe chronic pain in adults, which can only be adequately treated with an opioid analgesic.

Do not take Tapentadol retard Stada

• if you are allergic to tapentadol or any of the other ingredients of this medication (listed in section 6)
• if you have asthma or if your breathing is slow or shallow to dangerous levels (respiratory depression, hypercapnia)
• if you have intestinal paralysis
• if you are experiencing acute alcohol intoxication, sleeping pills, analgesics, or other psychoactive medications (medications that affect mood and emotions) (see "Other medications and Tapentadol retard Stada")

Warnings and precautions

Consult your doctor or pharmacist before starting to takeTapentadol retardStada:

• if your breathing is slow or shallow,
• if you have increased intracranial pressure or altered consciousness, even to the point of coma,
• if you have had a head injury or brain tumors,
• if you have liver or kidney disease (see "How to take Tapentadol retard Stada"),
• if you have pancreatitis or pancreatic disease, including bile duct disease,
• if you are taking mixed opioid agonist/antagonist medications (e.g. pentazocine, nalbuphine) or partial opioid mu receptor agonists (e.g. buprenorphine),
• if you are prone to epilepsy or seizures or if you are taking other medications that increase the risk of seizures, as the risk of seizures may increase,
• if you or a family member has a history of alcohol abuse, prescription medication abuse, or illicit substance abuse ("addiction"),
• if you smoke,
• if you have ever had mood problems (depression, anxiety, or personality disorder) or have received psychiatric treatment for other mental health conditions.

This medication contains tapentadol, which is an opioid medication. Repeated use of opioid analgesics may reduce the effectiveness of the medication (you may become accustomed to it). It may also lead to dependence and abuse, which can result in a potentially fatal overdose. It is essential to inform your doctor if you think you may have developed dependence on tapentadol. Your use (even at therapeutic doses) may cause physical dependence, which may lead to withdrawal symptoms and a recurrence of your problems if you stop taking this medication suddenly.

Tapentadol may cause physical and psychological addiction. If you have a tendency to abuse medications or have medication dependence, you should take these tablets only for short periods and under strict medical supervision.

Sleep-related respiratory disorders

Tapentadol may cause sleep-related respiratory disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Other medications and Tapentadol retard Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

• The risk of side effects increases if you are taking medications that may cause seizures (e.g. certain antidepressants or antipsychotics). The risk of seizures increases if you taketapentadolsimultaneously with these medications. Your doctor will tell you if tapentadol retard is suitable for you.

• The concomitant use of tapentadol and sedatives such as benzodiazepines or related medications [certain sleeping pills or tranquilizers (e.g. barbiturates) or analgesics like opioids, morphine, and codeine (also for cough), antipsychotics, H1 antihistamines, alcohol] increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and may be potentially fatal. Due to this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes tapentadol retard along with sedatives, you should limit the dose and duration of concomitant treatment. The concomitant use of opioids and medications used to treat epilepsy, nerve pain, or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression, and may be potentially fatal. Inform your doctor if you are taking gabapentin or pregabalin or any other sedative and strictly follow your doctor's dosage recommendation. It may be helpful to inform your friends and family about the symptoms mentioned above. Contact your doctor if you experience any of these symptoms.

• If you are taking a type of medication that affects serotonin levels (e.g. certain antidepressants), speak with your doctor before taking tapentadol retard as there have been cases of "serotonin syndrome". Serotonin syndrome is a rare but potentially fatal condition. Symptoms may include involuntary muscle contractions, rhythmic muscle movements, including those that control eye movement, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Your doctor may advise you.

• The concomitant administration of tapentadol with other types of medications called mixed opioid agonist/antagonist mu receptor agonists (e.g. pentazocine, nalbuphine) or partial opioid mu receptor agonists (e.g. buprenorphine) has not been studied. Tapentadol may not work as well if taken with one of these medications. Inform your doctor if you are currently being treated with one of these medications.

• The administration of tapentadol with potent inhibitors or inducers (e.g. rifampicin, phenobarbital, or St. John's Wort) of certain enzymes necessary for eliminating tapentadol from your body may affect the efficacy of tapentadol or cause adverse effects, especially when starting or stopping this other type of medication. Please keep your doctor informed about all the medications you are taking.

• Tapentadol should not be taken with MAO inhibitors (certain medications for depression). Inform your doctor if you are taking MAO inhibitors or have taken them in the last 14 days.

Taking Tapentadol retard Stada with food, drinks, and alcohol

Do not consume alcohol while taking tapentadol, as some side effects such as drowsiness may increase. Food intake does not affect the effect of this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take this medication:

• if you are pregnant, unless your doctor has indicated it, as tapentadol may cause withdrawal symptoms in the newborn, which can put the newborn's life at risk if not detected and treated by a doctor.
• during breastfeeding, as it may be excreted in breast milk.

This medication is not recommended for use during delivery, as it may cause slow or shallow breathing in the newborn.

Driving and operating machinery

Ask your doctor if you can drive or operate machinery during treatment with Tapentadol retard. It is essential to observe how this medication affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred vision, or double vision, or have difficulty concentrating. Be particularly cautious at the start of treatment, after a dose change, and when taking it with alcohol or tranquilizers.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will adjust the dose based on the intensity of your pain and your personal sensitivity to pain. Generally, you should take the lowest dose to relieve pain.

Adults

The recommended initial dose is 50 mg twice a day, approximately every 12 hours.

Do not recommend daily total doses exceeding 500 mg of tapentadol.

Your doctor may prescribe a different dose or a more suitable dosing regimen if necessary. If you think the effect of these tablets is too strong or too weak, talk to your doctor or pharmacist.

Older patients

In older patients (over 65 years old), it is usually not necessary to adjust the dose. However, tapentadol elimination may be delayed in some patients in this age group. If this happens to you, your doctor may prescribe a different dosing regimen.

Liver and kidney diseases (insufficiency)

Patients with severe liver problems should not take these tablets. If you have moderate liver problems, your doctor will prescribe a different dosing regimen. In case of mild liver problems, no dose adjustment is necessary.

Patients with severe kidney problems should not take these tablets. In case of mild or moderate kidney problems, no dose adjustment is necessary.

Use in children and adolescents

Tapentadol retard is not indicated in children and adolescents under 18 years old.

How and when to take Tapentadol retard Stada

Tapentadol retard should be taken orally.

Always swallow the tablet with a sufficient amount of liquid. Do not chew or crush it, as this could lead to an overdose because the active ingredient will be released into your body too quickly. You can take the tablets with an empty stomach or with meals.

The tablet can be divided into equal doses.

You may see the coating of the tablet not being fully digested and appearing in the stool. This should not worry you, as the medication (active ingredient) of the tablet has already been absorbed by your body, and what you see is only the empty coating.

Instructions for opening the blister pack

This medication is packaged in pre-cut, child-resistant blister packs. Do not press the tablet out of the blister pack. Please follow the following instructions for opening the blister pack:

1. Cut a dose along the pre-cut lines of the blister pack.

1. Locate the non-sealed area where the pre-cut lines intersect.

1. Peel the laminate

For how long should you take Tapentadol retard Stada

Do not take the tablets for longer than your doctor has indicated.

If you take more Tapentadol retard Stada than you should

After taking very high doses, you may experience some of the following effects:

• Very small pupils
• Vomiting
• Decreased blood pressure
• Accelerated heart rate
• Loss of consciousness or coma (deep loss of consciousness)
• Seizures
• Slow or shallow breathing to dangerous levels or respiratory arrest.

If you experience any of these effects, you should call a doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount used. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to takeTapentadol retard Stada

If you forget to take a tablet, you are likely to feel pain again. Do not take a double dose to compensate for the missed doses, simply continue taking the tablets as before.

If you interrupt treatment with Tapentadol retard Stada

If you interrupt or stop treatment too soon, you are likely to feel pain again. If you want to interrupt treatment, consult your doctor before doing so.

Generally, no withdrawal symptoms are experienced after interrupting treatment, however, in rare cases, people who have taken the tablets for a long time may feel unwell if they stop taking them suddenly.

The symptoms may be:

• Restlessness, tearful eyes, 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, diarrhea, and increased blood pressure, respiratory rate, or heart rate.

If you experience any of these symptoms after interrupting treatment, please consult your doctor.

You should not stop taking this medication abruptly, unless your doctor tells you to. If your doctor wants you to stop taking these tablets, they will indicate how to do it, which may involve a gradual reduction in dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Important side effects or symptoms to be aware of and what to do if you are affected by them:

• This medicine may cause allergic reactions. Symptoms may include wheezing, difficulty breathing, swelling of the eyelids, face, or lips, skin rash or itching, especially if it affects the entire body.
• Another serious side effect is breathing more slowly or more weakly than normal. It occurs mainly in elderly patients or in weakened patients.

If you experience any of these important symptoms, consult your 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 up to 1 in 10 people)

• loss of appetite, anxiety,depression of mood,difficulty sleeping,nervousness, restlessness, alterations in attention,
• shakiness, muscle twitches,
• seizures,
• shortness of breath,
• vomiting, diarrhea, indigestion,
• itching, increased sweating, skin rashes,
• sensation of weakness, fatigue, sensation of change in body temperature, dryness of mucous membranes, accumulation of water in tissues (edema).

Uncommon (may affect up to 1 in 100 people)

• allergic reaction to medication (including hives, urticarial rash, and in severe cases difficulty breathing, decreased blood pressure, collapse, or shock),
• weight loss,
• disorientation, confusion, excitability (agitation), alterations in perception, alterations in sleep, mood, depression of consciousness, deterioration of memory, mental deterioration,
• syncope, sedation, balance disorders, difficulty speaking, numbness, abnormal sensations in the skin (e.g., tingling, itching),
• vision changes,
• rapid heart rate, slow heart rate, palpitations, decreased blood pressure,
• abdominal discomfort,
• hives,
• delayed urination, frequent urination,
• sexual dysfunction,
• drug withdrawal syndrome (see "If you stop treatment with Tapentadol retard Stada"), feeling unwell, irritability.

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

• drug dependence, altered thinking, seizures, sensation of impending syncope, altered coordination,
• respiratory depression to dangerous levels,
• gastrointestinal emptying alteration,
• sensation of intoxication, sensation of relaxation.

Frequency not known (cannot be estimated from available data)

• delirium

In general, the possibility of having suicidal thoughts and behaviors increases in patients with

chronic pain. Additionally, some medications for treating depression (affecting the neurotransmitter system in the brain) may increase this risk, especially at the beginning of treatment. Although tapentadol also affects neurotransmitters, through experience in patients it has not been proven to increase this risk.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Tapentadol retard Stada

The active ingredient is tapentadol.

Tapentadol retardStada25 mg prolonged-release tablets EFG

Each prolonged-release tablet contains tapentadol phosphate equivalent to 25 mg of tapentadol.

Tapentadol retard Stada 50 mg prolonged-release tablets EFG

Each prolonged-release tablet contains tapentadol phosphate equivalent to 50 mg of tapentadol.

Tapentadol retard Stada 100 mg prolonged-release tablets EFG

Each prolonged-release tablet contains tapentadol phosphate equivalent to 100 mg of tapentadol.

Tapentadol retard Stada 150 mg prolonged-release tablets EFG

Each prolonged-release tablet contains tapentadol phosphate equivalent to 150 mg of tapentadol.

Tapentadol retard Stada 200 mg prolonged-release tablets EFG

Each prolonged-release tablet contains tapentadol phosphate equivalent to 200 mg of tapentadol.

Tapentadol retard Stada 250 mg prolonged-release tablets EFG

Each prolonged-release tablet contains tapentadol phosphate equivalent to 250 mg of tapentadol.

The other components (excipients) 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 (only in the 25, 100, 150, 200, and 250 mg doses) (E172), yellow iron oxide (only in the 25, 100, and 200 mg doses) (E172), black iron oxide (only in the 25, 100, 150, 200, and 250 mg doses) (E172).

Appearance of the product and contents of the package

Tapentadol retard Stada 25 mg prolonged-release tablets EFG are brownish-colored, oblong, biconvex (6 mm x 12 mm) tablets with a score on both sides.

The tablet can be divided into equal doses.

Tapentadol retard Stada 50 mg prolonged-release tablets EFG are white, oblong, biconvex (6 mm x 13 mm) tablets with a score on both sides.

The tablet can be divided into equal doses.

Tapentadol retard Stada 100 mg prolonged-release tablets EFG are yellowish-colored, oblong, biconvex (7 mm x 14 mm)and scored on both sides..

The tablet can be divided into equal doses.

Tapentadol retard Stada 150 mg prolonged-release tablets EFG are bright reddish-colored, oblong, biconvex (7 mm x 15 mm) tablets with a score on both sides.

The tablet can be divided into equal doses.

Tapentadol retard Stada 200 mg prolonged-release tablets EFG are yellow-colored, oblong, biconvex (8 mm x 16 mm) tablets with a score on both sides.

The tablet can be divided into equal doses.

Tapentadol retard Stada 250 mg prolonged-release tablets EFG are brownish-red-colored, oblong, biconvex (9 mm x 18 mm) tablets with a score on both sides.

The tablet can be divided into equal doses.

Tapentadol retard Stada is available in the following formats:

Tapentadol retard Stada 25 mg prolonged-release tablets EFG

20x1, 30x1, 40x1, 50x1, 54x1, 60x1, or 100x1 tablets in safety-sealed, child-resistant blisters.

Tapentadol retard Stada 50, 100, 150, 200, 250 mg prolonged-release tablets EFG

20x1, 24x1, 30x1, 50x1, 54x1, 60x1, or 100x1 tablets in safety-sealed, child-resistant blisters.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

Develco Pharma GmbH

Grienmatt 27

79650 Schopfheim

Germany

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

Centrafarm Services B.V.,

Van de Reijtstraat 31-E,

4814 NE Breda,

Netherlands

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:September 2022.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).