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

Brand name Tapentadol Retard Sandoz 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 88310

Manufacturer Sandoz Farmaceutica S.A.

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

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Tapentadol Retard Sandoz is and what it is used for
2. What you need to know before taking Tapentadol Retard Sandoz
3. How to take Tapentadol Retard Sandoz
4. Possible adverse effects
5. Storage of Tapentadol Retard Sandoz
6. Contents of the pack and other information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tapentadol Retard Sandoz 25 mg prolonged-release tablets EFG

Tapentadol Retard Sandoz 50 mg prolonged-release tablets EFG

Tapentadol Retard Sandoz 100 mg prolonged-release tablets EFG

Tapentadol Retard Sandoz 150 mg prolonged-release tablets EFG

Tapentadol Retard Sandoz 200 mg prolonged-release tablets EFG

Tapentadol Retard Sandoz 250 mg prolonged-release tablets EFG

tapentadol

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, consult 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 could 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.

Contents of the leaflet

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

1. What Tapentadol Retard Sandoz is and what it is used for

Tapentadol – the active substance in Tapentadol Retard Sandoz – is a potent analgesic belonging to the opioid class. Tapentadol Retard Sandoz is used for the treatment of severe chronic pain in adults that can only be adequately managed with an opioid analgesic.

2. What you need to know before taking Tapentadol Retard Sandoz

Do not take Tapentadol Retard Sandoz:

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 have paralytic ileus,
if you have consumed alcohol, sleeping pills, other analgesics, or other psychotropic medicines (medicines that affect mood and emotions) in high doses (see section "Other medicines and Tapentadol Retard Sandoz").

Warnings and precautions

Talk to your doctor or pharmacist before taking tapentadol:

if your breathing is slow or shallow,
if you have increased intracranial pressure or impaired consciousness up to and including coma,
if you have had a head injury or brain tumors,
if you have liver or kidney disease (see section “How to take Tapentadol Retard Sandoz”),
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 the µ-opioid 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 such seizures may increase.

Tolerance, dependence and addiction

This medication 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 reduce the effectiveness of the medicine (your body becomes accustomed to the medicine, known as tolerance). Repeated use of tapentadol may also lead to dependence, abuse, and addiction, which can result in potentially fatal overdose. The risk of adverse 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 a member of your family has a history of alcohol, prescription medicine, or illicit substance abuse or dependence ("addiction"),
you are a smoker,
you have ever had problems with your mood (depression, anxiety, or a personality disorder) or have received treatment from 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 higher doses than recommended,
you may feel that you need to continue taking the medicine, even when it does not help relieve pain,
you are using the medicine for reasons other than prescribed, for example, “to calm down” or “to help you sleep”,
you have made repeated unsuccessful attempts to stop or control the use of the medicine,
you feel unwell when you stop taking the medicine and feel better when you take it again (“withdrawal symptoms”).

If you notice any of these signs, speak with your doctor to discuss the most appropriate treatment strategy for your case, including when it is appropriate to stop taking the medicine and how to do so safely (see section 3 “If you stop taking Tapentadol Retard Sandoz”).

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 oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings 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 Sandoz

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

The risk of adverse 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 if tapentadol is suitable for you.
The concomitant use of tapentadol and sedative medicines such as benzodiazepines or related medicines (certain sleeping or tranquilizing medicines (e.g., barbiturates) or analgesics 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 life-threatening. 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, the dose and duration of concomitant treatment should be limited.

The concomitant use of opioids and medicines used to treat epilepsy, neuropathic 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 listed above. Inform 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. Symptoms include rhythmic, involuntary muscle contractions, including those controlling eye movement, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, and body temperature above 38°C. Your doctor can provide further information.
The co-administration of tapentadol with other types of medicines known as mixed opioid-µ receptor agonists/antagonists (e.g., pentazocine, nalbuphine) or partial opioid-µ agonists (e.g., buprenorphine) has not been studied. Tapentadol may be less effective if taken together with one 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, 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 this other medication. Keep your doctor informed about all medicines you are taking.
Tapentadol must not be taken together with MAO inhibitors (a type of medicine used to treat depression). Inform your doctor if you are taking MAO inhibitors or have taken them within the last 14 days.

If you take Tapentadol Retard Sandoz together with the following medicines that have anticholinergic effects, the risk of side effects may increase:

medicines used to treat depression,
medicines used to treat allergies, dizziness, or nausea (antihistamines or antiemetics),
medicines used to treat psychiatric disorders (antipsychotics or neuroleptics),
muscle relaxants,
medicines used to treat Parkinson's disease.

Taking Tapentadol Retard Sandoz with food, drinks, and alcohol

Do not consume alcohol while taking tapentadol, as some of its adverse effects, such as drowsiness, may increase. Food does not affect the action of this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 instructed you to do so. If used for prolonged periods during pregnancy, tapentadol may cause withdrawal symptoms in the newborn, which can be life-threatening if not detected and treated by a doctor.
during breastfeeding, as it may be excreted in breast milk.

The use of tapentadol is not recommended

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

Driving and using machines

Tapentadol may cause drowsiness, dizziness, and blurred vision, and may impair your reaction ability. This may especially occur at the beginning of tapentadol treatment, after a dose change, or when consuming alcohol or tranquilizers. Ask your doctor whether you can drive or use machines while being treated with tapentadol.

3. How to take Tapentadol Retard Sandoz

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

Before starting treatment and periodically during treatment, your doctor will discuss with you what to expect from the use of Tapentadol Retard Sandoz, 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 Retard Sandoz”).

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

Adults

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

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

Your doctor may prescribe a different and more appropriate dose or dosing schedule if necessary. If you think 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 necessary. However, elimination of tapentadol may be delayed in certain patients in this age group. If this occurs, your doctor may prescribe a different dosing schedule.

Liver and kidney disease (hepatic and renal impairment)

Patients with severe hepatic problems must not take these tablets. If you have moderate hepatic problems, your doctor will prescribe a different dosing schedule. Dose adjustment is not necessary in cases of mild hepatic impairment.

Patients with severe renal problems must not take these tablets. Dose adjustment is not necessary in cases of mild or moderate renal impairment.

Use in children and adolescents

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

How and when to take Tapentadol Retard Sandoz

Tapentadol should be taken orally.

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

The tablet may be divided into equal doses.

The tablet coating may not be completely digested and therefore may appear in the stool. This is not a cause for concern, as the active substance of the tablet will already have been absorbed into your body; what you see is only the empty coating.

Instructions for opening the blister pack

This medicine is packaged in single-dose, child-resistant, pre-perforated blisters. You cannot push the tablet through the blister. Please follow the blister-opening instructions shown below:

Tear a single dose along the perforation line of the blister.

Schematic diagram showing how to separate a section of a leaflet with oval perforations by an arrow indicating the detachment of a piece

In the single-dose unit, an unsealed area can be accessed at the position where the perforation lines intersect.

Pull the unsealed area to remove the cover.

Stylized icon of a sheet of paper with a curved black arrow indicating the folding motion

How long to take Tapentadol Retard Sandoz

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

If you take more Tapentadol Retard Sandoz than you should

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

extremely small pupils,
vomiting,
decreased blood pressure,
rapid heartbeat,
fainting, altered consciousness, or coma (deep loss of consciousness),
seizures,
slow or shallow breathing to dangerous levels or respiratory arrest, which may lead to death.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Poison Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Tapentadol Retard Sandoz

If you forget to take the tablets, you may 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 Sandoz

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

Generally, patients do not experience any adverse effects after stopping treatment, but in rare cases, individuals who have taken the tablets for a long time may feel unwell if they stop taking them suddenly.

Symptoms may include:

restlessness, watery eyes, runny nose, yawning, sweating, chills, muscle aches, and dilated pupils,
irritability, anxiety, backache, 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, consult your doctor.

You must not stop taking 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 on 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 may 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 (a whistling sound when breathing), 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, somnolence, 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, diarrhoea, 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, urticaria, 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,
urticaria,
delayed urination, frequent urination,
sexual dysfunction,
drug withdrawal syndrome (see section “If you stop treatment with Tapentadol Retard Sandoz”), feeling unwell, irritability.

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

drug dependence, thought disturbances, epileptic seizures, feeling faint, impaired coordination,
slow or shallow breathing to dangerous levels (respiratory depression),
delayed gastric emptying,
feeling of drunkenness, sensation 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tapentadol Retard Sandoz

Keep this medicine in a safe and secure place, out of reach of other people. It may cause serious harm or be fatal to individuals who take it accidentally or intentionally when it has not been prescribed for them.

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/CAD. 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. Unused medicines and their packaging should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tapentadol Retard Sandoz

The active substance is tapentadol.

Tapentadol Retard Sandoz 25 mg

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

Tapentadol Retard Sandoz 50 mg

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

Tapentadol Retard Sandoz 100 mg

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

Tapentadol Retard Sandoz 150 mg

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

Tapentadol Retard Sandoz 200 mg

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

Tapentadol Retard Sandoz 250 mg

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

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

Nature of the product and pack contents

Tapentadol Retard Sandoz 25 mg are prolonged-release, oblong, biconvex tablets (6 mm x 12 mm), brown in colour, with score lines on both sides.