Tapentadol Retard Stada 100 mg prolonged-release tablets EFG: detailed information

Brand name Tapentadol Retard Stada 100 mg prolonged-release tablets EFG

Form tablets, prolonged-release

Active substance / Dosage

TAPENTADOL PHOSPHATE · 153,13 mg

Prescription type Prescription Only Medicine. Narcotic

ATC code

N02A N02AX N02AX06

Registration number 88288

Manufacturer Laboratorio Stada S.L.

Tapentadol Retard Stada 100 mg prolonged-release tablets EFG tablets, prolonged-release

Table of Contents

Patient Information Leaflet
Introduction
1. What Tapentadol retard Stada is and what it is used for
2. What you need to know before taking Tapentadol retard Stada
3. How to take Tapentadol retard Stada
4. Possible adverse effects
5. Storage of Tapentadol retard Stada
6. Contents of the pack and other information

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

Read the entire 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, ask your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

What Tapentadol retard Stada is and what it is used for
What you need to know before taking Tapentadol retard Stada
How to take Tapentadol retard Stada
Possible side effects
How to store Tapentadol retard Stada
Contents of the pack and other information

1. What Tapentadol retard Stada is and what it is used for

Tapentadol – the active substance in Tapentadol retard Stada – is a strong analgesic that belongs to the opioid class of medicines. Tapentadol is used for the treatment of severe chronic pain in adults, which can only be adequately managed with an opioid analgesic.

2. What you need to know before taking Tapentadol retard Stada

Do not take Tapentadol retard Stada

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 slow or shallow to dangerous levels (respiratory depression, hypercapnia).
if you suffer from intestinal paralysis.
if you have acute intoxication with alcohol, sleeping pills, painkillers, or other psychotropic medicines (medicines that affect mood and emotions) (see “Other medicines and Tapentadol retard Stada”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tapentadol retard Stada:

if your breathing is slow or shallow,
if you have increased intracranial pressure or altered consciousness up to 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 a disease of the pancreas or bile ducts, including pancreatitis,
if you are taking medicines called mixed opioid agonist/antagonists (e.g., pentazocine, nalbuphine) or partial mu-opioid receptor agonists (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 such seizures may increase.

Tolerance, dependence, and addiction

This medicine contains tapentadol, which is an opioid. It may cause dependence and/or addiction.

This medicine contains tapentadol, which is an opioid medicine. Repeated use of opioids may cause the medicine to become less effective (you get used to it, known as tolerance). Repeated use of tapentadol may also lead to dependence, abuse, and addiction, which may result in potentially fatal overdose. The risk of these side effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you no longer have control over how much medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a higher risk of becoming dependent or addicted to tapentadol if:

You or someone in your family has ever abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
You are a smoker.
You have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs while taking tapentadol, it could be a sign that you have become dependent or addicted:

You need to take the medicine for longer than recommended by your doctor.
You need to take more than the recommended dose.
You may feel that you need to keep taking your medicine, even when it does not help relieve your pain.
You are using the medicine for reasons other than prescribed, for example, "to stay calm" or "to help you sleep."
You have made repeated unsuccessful attempts to quit or control the use of the medicine.
When you stop taking the medicine, you feel unwell and feel better again once you take the medicine again ("withdrawal effects").

If you notice any of these signs, speak with your doctor to discuss the best course of treatment for you, including when it is appropriate to stop taking it and how to stop safely (see section 3, If you stop taking tapentadol).

Sleep-related breathing disorders

Tapentadol may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low levels of oxygen in the blood). Symptoms may include pauses in breathing during sleep, waking up at night due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Other medicines and Tapentadol retard Stada

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

The risk of side effects increases if you are taking medicines that may cause seizures (fits), such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tapentadol at the same time as these medicines. Your doctor will tell you whether tapentadol is suitable for you.
The concomitant use of tapentadol and sedative medicines such as benzodiazepines or related medicines [certain sleeping or tranquilizing tablets (e.g., barbiturates) or painkillers such as opioids, morphine, and codeine (also as a cough medicine)], antipsychotics, H1 antihistamines, or alcohol increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Because of this, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes tapentadol together with sedative medicines, they will limit the dose and duration of concomitant treatment. The 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 potentially fatal. Inform your doctor if you are taking gabapentin or pregabalin or any other sedative medicine and strictly follow your doctor's dosing recommendations. It may be helpful to inform your friends and family about the signs and symptoms mentioned above. Contact your doctor if you experience any of these symptoms.
If you are taking a type of medicine that affects serotonin levels (e.g., certain medicines to treat depression), talk to your doctor before taking tapentadol, as cases of "serotonin syndrome" have been reported. Serotonin syndrome is a rare but potentially life-threatening condition. Signs may include involuntary, rhythmic muscle contractions, including muscles controlling eye movement, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Your doctor can advise you.
The concomitant administration of tapentadol with other types of medicines known as mixed mu-opioid receptor agonist/antagonists (e.g., pentazocine, nalbuphine) or partial mu-opioid agonists (e.g., buprenorphine) has not been studied. Tapentadol may not work as well if taken together with any of these medicines. Inform your doctor if you are currently being treated with any of these medicines.
The administration of tapentadol together with strong inhibitors or inducers (e.g., rifampicin, phenobarbital, or St. John's wort) of certain enzymes required to eliminate tapentadol from your body may affect the efficacy of tapentadol or may cause adverse effects, especially when starting or stopping such medication. Please keep your doctor informed about all medicines you are taking.
Tapentadol must not be taken together with MAO inhibitors (certain medicines used to treat depression). Inform your doctor if you are taking MAO inhibitors or if you have taken them within the last 14 days.
If you use tapentadol together with the following medicines that have anticholinergic effects, the risk of adverse effects may increase:
medicines to treat depression
medicines used to treat allergies, dizziness, or nausea (antihistamines or antiemetics)
medicines to treat psychiatric disorders (antipsychotics or neuroleptics)
muscle relaxants
medicines to treat Parkinson's disease.

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. Taking food does not affect the action of this medicine.

Pregnancy and breastfeeding

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

Do not take this medicine:

if you are pregnant, unless your doctor has specifically instructed you to do so, as prolonged use of tapentadol during pregnancy may cause withdrawal symptoms in the newborn, which may be life-threatening if not detected and treated by a doctor.
during breastfeeding, as it may be excreted in breast milk.

Tapentadol is not recommended:

during childbirth, as it may cause slow or shallow breathing to dangerous levels (respiratory depression) in the newborn.

Driving and using machines

Ask your doctor whether you can drive or use machines while being treated with tapentadol. It is important that before driving or using machines, you observe how this medicine affects you. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision or double vision, or have difficulty concentrating. Take particular care at the beginning of treatment, after a dose change, and when taking it together with alcohol or tranquilizers.

3. How to take Tapentadol retard Stada

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from using tapentadol, when and for how long you should take it, when to contact your doctor, and when you should stop taking it (see also "If you stop taking tapentadol" below).

Your doctor will adjust the dose according to the intensity of your pain and your individual sensitivity to pain. Generally, you should take the lowest effective dose needed to relieve your pain.

Adults

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

Total daily doses exceeding 500 mg of tapentadol are not recommended.

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

Elderly patients

In elderly patients (over 65 years of age), dose adjustment is usually not necessary. However, elimination of tapentadol may be delayed in some patients in this age group. If this applies to you, your doctor may prescribe a different dosage regimen.

Liver and kidney disease (impaired function)

Patients with severe hepatic impairment must not take these tablets. If you have moderate hepatic impairment, your doctor will prescribe a different dosage regimen. In cases of mild hepatic impairment, dose adjustment is not necessary.

Patients with severe renal impairment must not take these tablets. In cases of mild or moderate renal impairment, dose adjustment is not necessary.

Use in children and adolescents

Tapentadol is not indicated for use in children and adolescents under 18 years of age.

How and when to take Tapentadol retard Stada

Tapentadol must be taken by mouth.

Always swallow the tablet with sufficient liquid. Do not chew or crush the tablet, as this could lead to overdose because the active substance would be released too quickly into your body. You may take the tablets on an empty stomach or with food.

The tablet may be divided into equal doses.

The tablet coating may not be completely digested and may therefore be visible in the stool. This is not a cause for concern, as the medicine (active substance) has already been absorbed by the body; what you see is only the empty coating.

Instructions for opening the blister pack

This medicine is packaged in child-resistant, single-dose safety blister packs. The tablet cannot be pushed out through the blister. Please follow the instructions below for opening the blister:

Cut one dose along the pre-perforated lines of the blister.

Diagram showing how to separate a square module from a sheet of multiple modules using a dashed line and a black arrow

Locate the unsealed area where the pre-perforated lines intersect.

Pull the unsealed area to peel off the foil.

Stylized icon of a sheet of paper with the letter L

How long to take Tapentadol retard Stada

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

If you take more Tapentadol retard Stada than you should

After taking very high doses, you may experience one or more of the following effects:

extremely small pupils
vomiting
low blood pressure
rapid heartbeat
fainting, altered consciousness, or coma (profound loss of consciousness)
epileptic seizures
slow or shallow breathing up to dangerous levels or respiratory arrest, which could result in death.

If you experience any of these effects, you must call a doctor immediately!

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, stating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Tapentadol retard Stada

If you forget to take a tablet, you may start to feel pain again. Do not take a double dose to make up for missed doses; simply continue taking the tablets as before.

If you stop taking Tapentadol retard Stada

If you stop or interrupt treatment too early, you may start to feel pain again. If you wish to stop treatment, consult your doctor first.

Generally, withdrawal symptoms do not occur when stopping treatment. However, in rare cases, people who have taken the tablets for a prolonged period may feel unwell if they stop suddenly.

Symptoms may include:

restlessness, watery 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 increases in blood pressure, respiratory rate, or heart rate.

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

You must not stop this medicine abruptly unless your doctor instructs you to do so. If your doctor wants you to stop taking these tablets, they will advise you how to do so, which may involve gradually reducing the dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Important adverse effects or symptoms to watch for and what to do if you experience 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 affecting the whole body.
Another serious adverse effect is breathing more slowly or more weakly than normal. This occurs mostly in elderly or weakened patients.

If you experience any of these serious symptoms, consult your doctor immediately.

Other possible adverse 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)

loss of appetite, anxiety, depressed mood, difficulty sleeping, nervousness, restlessness, attention disturbances,
tremors, muscle tics,
hot flushes,
shortness of breath,
vomiting, diarrhea, indigestion,
itching, increased sweating, skin rashes,
feeling of weakness, fatigue, sensation of change in body temperature, dryness of mucous membranes, fluid accumulation in tissues (edema).

Uncommon (may affect up to 1 in 100 people)

allergic reaction to medicines (including swelling under the skin, urticarial rash, and in severe cases difficulty breathing, decreased blood pressure, collapse or shock),
weight loss,
disorientation, confusion, excitability (agitation), disturbances in perception, sleep disturbances, euphoric mood, decreased level of consciousness, memory impairment, mental deterioration,
fainting, sedation, balance disorders, speech difficulties, numbness, abnormal sensations in the skin (e.g., tingling, itching),
visual disturbances,
rapid heartbeat, slow heartbeat, palpitations, decreased blood pressure,
abdominal discomfort,
rash,
delayed urination, frequent urination,
sexual dysfunction,
drug withdrawal syndrome (see “If you stop taking Tapentadol retard Stada”), feeling unwell, irritability.

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

drug dependence, disturbance in thinking, epileptic seizures, feeling faint, impaired coordination,
slow or shallow breathing to dangerous levels (respiratory depression),
delayed gastric emptying,
sensation of drunkenness, feeling of relaxation.

Frequency not known (cannot be estimated from available data)

delirium

In general, the likelihood of having suicidal thoughts and behaviors increases in patients with chronic pain. In addition, some medicines used to treat depression (which affect the brain's neurotransmitter system) may increase this risk, especially at the beginning of treatment. Although tapentadol also affects neurotransmitters, experience in patients has not shown that it increases this risk.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tapentadol retard Stada

Keep this medicine in a secure storage place, out of reach of others. It may cause serious harm or be fatal to individuals for whom it has not been prescribed.

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tapentadol retard Stada

The active substance 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:

Tablet core: microcrystalline cellulose (E460), hypromellose (E464), colloidal anhydrous silica (E551), magnesium stearate.

Tablet coating: hypromellose (E464), glycerol (E422), talc (E553b), microcrystalline cellulose (E460), titanium dioxide (E171), iron oxide red (only in the 25, 100, 150, 200 and 250 mg strengths) (E172), iron oxide yellow (only in the 25, 100 and 200 mg strengths) (E172), iron oxide black (only in the 25, 100, 150, 200 and 250 mg strengths) (E172).

Appearance of the product and pack contents

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