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, as it contains important information for you.
1. What isTapentadol retard Stadaand what is it used for
2. What you need to know before you start takingTapentadol 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
Warnings and precautions
Consult your doctor or pharmacist before starting to takeTapentadol retardStada:
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 abruptly.
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.
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 think you may be pregnant, consult your doctor or pharmacist before using this medication.
Do not take this medication:
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 especially careful 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 dose or a different and 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, as the active ingredient will be released in 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 safety blister packs. You cannot push the tablet out of the blister pack. Please follow the following instructions for opening the blister pack:
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:
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 Toxicology 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 taking the treatment too soon, you are likely to feel pain again. If you want to interrupt the treatment, consult your doctor before doing so.
The symptoms may be:
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:
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)
Common(may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Frequency not known (cannot be estimated from available data)
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 prospectus. 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.
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 retard Stada 25 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:
Core tablet : 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
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 notch 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) tablets with a notch on both sides and a notch 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 notch on both sides.
The tablet can be divided into equal doses.
The tablet can be divided into equal doses.
Tapentadol retard Stada 250 mg prolonged-release tablets EFG are brownish-red, oblong, biconvex (9 mm x 18 mm) tablets with a notch 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 Laboratorios, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
Responsible manufacturer
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 under the following names:
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 | |
TAPISTA | |
Denmark | Tapentadol STADA |
Slovakia | Tapestad retard 50 mg, 100 mg, 150 mg, 200 mg, 250 mg |
Tapentadol retard STADA 25 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 | |
Iceland | Tapentadol STADA 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 250 mg; forðahylki |
Italy | Mudol |
Norway | Tapentadol STADA |
Tapentadol retard CF 25 mg, tablets with prolonged release Tapentadol retard CF 50 mg, tablets with prolonged release Tapentadol retard CF 100 mg, tablets with prolonged release Tapentadol retard CF 150 mg, tablets with prolonged release Tapentadol retard CF 200 mg, tablets with prolonged release Tapentadol retard CF 250 mg, tablets with prolonged release | |
Poland | BINATTA |
Czech Republic | Taxemba |
Sweden | Tapentadol Depot STADA 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 250 mg; depottablets |
Last review date of this leaflet: September 2022.
The 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/).
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.