Tapentadol krka 100 mg comprimidos de liberacion prolongada efg
Introduction
Package Leaflet: Information for the User
Tapentadol Krka 50 mg prolonged-release tablets EFG
Tapentadol Krka 100 mg prolonged-release tablets EFG
Tapentadol Krka 150 mg prolonged-release tablets EFG
Read this package leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this package 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 package leaflet. See section 4.
1. What is Tapentadol Krka and what is it used for
Tapentadol -the active ingredient of Tapentadol Krka- 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.
2. What you need to know before starting to take Tapentadol Krka
Do not take Tapentadol Krka
- if you are allergic to tapentadol or any of the other ingredients in this medicine (listed in section 6),
- if you have asthma or if your breathing is slow or shallow to dangerous levels (respiratory depression, hypercapnia (elevated carbon dioxide levels in the blood)),
- if you have not had bowel movements that manifest with severe constipation and bloating that may be accompanied by abdominal pain or discomfort,
- if you have consumed alcohol, sleeping pills, other painkillers, or medications that affect mood and emotions in high doses (see section "Other medicines and Tapentadol Krka").
Warnings and precautions
Consult your doctor or pharmacist before starting to take Tapentadol Krka if:
- your breathing is slow or shallow,
- you have increased intracranial pressure or altered consciousness,
- you have had a head injury or brain tumors,
- you have liver or kidney disease (see section “How to take Tapentadol Krka ”),
- you have pancreatitis or biliary tract disease,
- you are taking mixed agonist/antagonist opioid medications (e.g., pentazocine, nalbuphine) or partial agonists of the µ opioid receptors (e.g., buprenorphine),
- you are prone to epilepsy or seizures, or if you are taking other medications that are known to increase the risk of seizures, as the risk of seizures may increase,
- you have a tendency to abuse medications or are dependent on medications, as tapentadol may cause addiction. In this case, you should only take these tablets for short periods of time and under strict medical supervision.
- you or a family member has a history of alcohol, prescription medication, or illicit substance abuse (“addiction”).
- you smoke.
- you have had problems with your mood (depression, anxiety, or personality disorder) or have received treatment from a psychiatrist for other mental health conditions.
This medicine contains tapentadol, 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 may have developed dependence on tapentadol. Its 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.
Respiratory problems related to sleep
Tapentadol may cause respiratory problems related to sleep 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.
Children and adolescents
Tapentadol is not indicated in children and adolescents under 18 years of age.
Other medicines and Tapentadol Krka
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Your doctor will inform you about which medications are safe to take with tapentadol.
- 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 take tapentadol simultaneously with these medications. Your doctor will tell you if tapentadol 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 such as opioids, morphine, and codeine (also for cough) increases the risk of somnolence, respiratory difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes tapentadol 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 sedative medication you are taking and strictly follow your doctor's recommended dose. It may be helpful to inform your friends and family about the symptoms mentioned above. Inform 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, as there have been cases of "serotonin syndrome". Serotonin syndrome is a rare but potentially fatal condition. Symptoms may include involuntary muscle contractions, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Your doctor may provide additional information.
- Tapentadol may not have the same effectiveness if administered with other types of opioid medications (e.g., those containing pentazocine, nalbuphine, or buprenorphine). 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, St. John's wort) of certain enzymes necessary for the elimination of tapentadol from the body may affect the efficacy of tapentadol or cause adverse effects, especially when starting or stopping this other type of medication.
- Tapentadol should not be taken with MAO inhibitors (medications for depression treatment). Inform your doctor if you are taking MAO inhibitors or have taken them in the last 14 days.
Inform your doctor about all the medications you are taking.
Taking Tapentadol Krka with alcohol
Do not consume alcohol while taking tapentadol, as some of its adverse effects, such as somnolence, may increase.
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 may 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.
- if you become pregnant during treatment with this medication. Consult your doctor.
- during delivery, as it may cause slow or shallow breathing to dangerous levels (respiratory depression) in the newborn.
Driving and operating machinery
Do not drive or use tools or machines if you feel drowsy, dizzy, have blurred vision, or have slow reaction times while taking tapentadol.
Be especially careful at the start of treatment, after a dose change, and when taking it with alcohol or tranquilizers.
Ask your doctor if you can drive or use machines.
Tapentadol Krka contains lactose
If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.
3. How to take Tapentadol Krka
Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
Your doctor will adjust the dose and the time between doses of tapentadol based on the intensity of your pain and your needs. Generally, the minimum effective dose should be taken to relieve pain.
Adults
The initial dose is usually 50 mg twice a day, approximately every 12 hours.
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, consult your doctor or pharmacist.
Tapentadol should be taken twice a day, approximately every 12 hours.
Daily total doses of tapentadol should not exceed 500 mg.
How and when to take Tapentadol Krka
Tapentadol should be taken orally.
Always take the whole tablets with a glass of water. You can take them on an empty stomach or with meals.Do not chew, break, or crushthem, as this could lead to an overdose because the active ingredient will be released in your body quickly.
The coating of the tablet may not be completely digested and may appear in the stool. This should not concern you, as the active ingredient of the tablet will have already been absorbed by the body, and what you see is only the empty coating.
For how long should Tapentadol Krka be taken
Do not take the tablets for longer than your doctor has indicated.
Older patients
In older patients (over 65 years old), the dose usually does not need to be adjusted. However, your doctor may prescribe a different dosing regimen.
Liver or kidney impairment
Patients with severe liver or kidney problems should not take this medication.
If you have moderate liver problems, your doctor will prescribe a different dosing regimen.
If you have mild or moderate liver or kidney problems, the dose does not need to be adjusted.
Use in children and adolescents
Tapentadol is not indicated for children and adolescents under 18 years old.
If you take more Tapentadol Krka than you should
Taking too much tapentadol can put your life in danger.
You must seek immediate medical attention in case of an overdose, even if you feel well.
After taking very high doses of this medication, you may experience some of the following effects:
- very small pupils
- feeling sick (vomiting)
- decreased blood pressure
- rapid heart rate
- altered consciousness, fainting, or deep loss of consciousness (coma)
- seizures
- slow or shallow breathing to dangerous levels or respiratory arrest
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 forgot to take Tapentadol Krka
If you forget to take a tablet, it is likely that you will feel pain again. Do not take a double dose to compensate for the missed doses, but continue taking the tablets as before.
If you interrupt the treatment with Tapentadol Krka
If you interrupt or stop taking the treatment too soon, it is likely that you will feel pain again. If you want to interrupt the treatment, consult your doctor before doing so.
Generally, patients do not experience any adverse effects 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:
- anxiety, irritability, anxiety, weakness or discomfort (nausea), loss of appetite, feeling sick (vomiting), diarrhea,
- tearful eyes, runny nose, increased pupil size (dilated pupils),
- difficulty sleeping, yawning,
- sweating, chills,
- muscle or joint pain, back pain, abdominal cramps,
- increased blood pressure, respiratory rate, or heart rate.
If you experience any of these symptoms after interrupting treatment with this medication, 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. This may involve a gradual reduction in dose.
If you have any other doubts about the use of this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
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, including swelling under the skin, hives, and in severe cases, difficulty breathing, a drop in blood pressure, collapse, or shock (rare). Symptoms may include wheezing, difficulty breathing, inflammation of the eyelids, face, or lips, skin rash, or itching, which can affect the entire body.
- Another serious side effect is breathing more slowly or more weakly than normal (rare). It occurs mainly in elderly patients or 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):
- feeling sick (nausea)
- constipation
- dizziness, drowsiness, headache
Common(may affect up to 1 in 10 people):
- decreased appetite, anxiety, feeling sick (vomiting), diarrhea, poor digestion
- difficulty sleeping, fatigue, feeling weak, trembling, muscle tics, shortness of breath
- depression of mood, nervousness, restlessness, attention disturbances
- headaches, increased sweating, sensation of change in body temperature, dryness of mucous membranes such as nasal passages, mouth, lips, eyelids, ears, genitals, and anus
- itching, skin rashes
- fluid accumulation in tissues (edema)
Uncommon(may affect up to 1 in 100 people):
- weight loss
- disorientation, confusion, agitation, perception disturbances, abnormal dreams, memory deterioration, mental deterioration
- euphoric mood, depression of consciousness, fainting, sedation, balance disorders, speech difficulties, numbness
- abnormal skin sensations (e.g., tingling, itching), skin reactions (hives)
- vision disturbances
- rapid heartbeats, slow heartbeats, palpitations, decreased blood pressure
- abdominal discomfort, delayed urination, frequent urination
- sexual dysfunction
- drug withdrawal syndrome (see section “If you stop treatment with Tapentadol Krka”)
- feeling unwell, irritability
Rare(may affect up to 1 in 1,000 people):
- drug dependence
- thought disorder, seizures, feeling of impending fainting, coordination disturbances, feeling of intoxication, feeling of relaxation
- gastrointestinal emptying disorder
Frequency not known:
- delirium
In general, the possibility of having suicidal thoughts and behaviors increases in patients with chronic pain. Additionally, some medications for treating depression (affecting neurotransmitters 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 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:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Tapentadol Krka
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.
This medication does not require special conditions for conservation.
Medicines should not be thrown down the drains or in the trash.Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy.Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.
6. Content of the packaging and additional information
Composition of Tapentadol Krka
- The active ingredient is tapentadol.
Tapentadol Krka 50 mg prolonged-release tablets EFG
Each prolonged-release tablet contains tapentadol maleate hemihydrate equivalent to 50 mg of tapentadol.
Tapentadol Krka 100 mg prolonged-release tablets EFG
Each prolonged-release tablet contains tapentadol maleate hemihydrate equivalent to 100 mg of tapentadol.
Tapentadol Krka 150 mg prolonged-release tablets EFG
Each prolonged-release tablet contains tapentadol maleate hemihydrate equivalent to 150 mg of tapentadol.
- The other components (excipients) are:
- hypromellose, microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate in the core of the tablet.
- hypromellose, lactose monohydrate, titanium dioxide (E171), macrogol, triacetin, yellow iron oxide (E172) ( only for 100 mg, 150 mg ), red iron oxide (E172) ( only for 150 mg ) in the tablet coating. See section 2: “Tapentadol Krka contains lactose”.
Appearance of the product and contents of the package
Tapentadol Krka 50 mg prolonged-release tablets EFG: Prolonged-release tablets, white or almost white, oval, biconvex, coated, with the mark T1 on one face. Tablet dimensions: approximately 16 mm x 8.5 mm.
Tapentadol Krka 100 mg prolonged-release tablets EFG : Prolonged-release tablets, pale yellowish-brown, oval, biconvex, coated, with the mark T2 on one face. Tablet dimensions: approximately 16 mm x 8.5 mm.
Tapentadol Krka 150 mg prolonged-release tablets EFG: Prolonged-release tablets, pale pink, oval, biconvex, coated, with the mark T3 on one face. Tablet dimensions: approximately 16 mm x 8.5 mm.
Tapentadol Krka prolonged-release tablets are available in packages of 20 ( only for 50 mg ), 30, 60 (2 x 30) or 100 prolonged-release tablets in a polyethylene terephthalate (PET) bottle with a polypropylene (PP) closure resistant to tampering and child-resistant.
Only some package sizes may be marketed.
Marketing authorization holder and responsible manufacturer
Marketing authorization holder:
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
Responsible manufacturer:
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
or
TAD Pharma GmbH
Heinz-Lohmann-Straße 5
27472 Cuxhaven
Germany
You can request more information about this medicine by contacting the local representative of the marketing authorization holder:
KRKA Farmacéutica, S.L., C/Anabel Segura 10, 28108 Alcobendas, Madrid, Spain
This medicine is authorized in the member states of the European Economic Area with the following names:
| Member state name | Medicine name |
| Slovenia | Apeneta 50 mg tablete s podaljšanim sproščanjem Apeneta 100 mg tablete s podaljšanim sproščanjem Apeneta 150 mg tablete s podaljšanim sproščanjem |
| Czech Republic | Apeneta |
| Germany | Tapendolor 50 mg Retardtabletten Tapendolor 100 mg Retardtabletten Tapendo lor 150 mg Retardtabletten |
| Denmark | Tapentadol Krka |
| Spain | Tapentadol Krka 50 mg prolonged-release tablets EFG Tapentadol Krka 100 mg prolonged-release tablets EFG Tapentadol Krka 150 mg prolonged-release tablets EFG |
| Croatia | Apeneta 50 mg tablete s produljenim oslobadanjem Apeneta 100 mg tablete s produljenim oslobadanjem Apeneta150 mg tablete s produljenim oslobadanjem |
| Hungary | Adoben 50 mg retard tabletta Adoben 100 mg retard tabletta Adoben 150 mg retard tabletta |
| Ireland | Apeneta 50 mg prolonged-release tablets Apeneta 100 mg prolonged-release tablets Apeneta 150 mg prolonged-release tablets |
| Italy | Tapentadolo Krka |
| Norway | Tapenadol Krka |
| Poland | Adoben |
| Portugal | Tapentadol Krka |
| Sweden | Tapentadol Krka 50 mg depottabletter Tapentadol Krka 100 mg depottabletter Tapentadol Krka 150 mg depottabletter |
| Slovakia | Apeneta 50 mg tablety s predlženým uvolnovaním Apeneta 100 mg tablety s predlženým uvolnovaním Apeneta 150 mg tablety s predlženým uvolnovaním |
Last review date of this leaflet: February 2023
Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/ )
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