Tapelod

Patient Information Leaflet: Information for the User

Tapelod 25 mg prolonged-release tablets, 50 mg prolonged-release tablets, 100 mg prolonged-release tablets, 150 mg prolonged-release tablets, 200 mg prolonged-release tablets, 250 mg prolonged-release tablets

tapentadol
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Tapelod is and what it is used for
2. What you need to know before taking Tapelod
3. How to take Tapelod
4. Possible side effects
5. How to store Tapelod
6. Contents of the pack and other information

1. What Tapelod is and what it is used for

Tapentadolo, the active substance in Tapelod, is a strong pain reliever belonging to the opioid class.
Tapelod is used for the treatment of severe chronic pain in adults which can be adequately managed only with opioid painkillers.

2. What you should know before taking Tapelod

Do not take Tapelod

• 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 dangerously slow or shallow (respiratory depression, hypercapnia)
• if you have intestinal paralysis
• if you have acute poisoning due to alcohol, sleeping medicines, painkillers, or other psychotropic medicines (medicines acting on mood and emotions) (see "Other medicines and Tapelod")

Warnings and precautions

Talk to your doctor or pharmacist before taking Tapelod if:

• you have shortness of breath or weak breathing,
• you suffer from increased pressure inside the brain or disturbances of consciousness, up to coma,
• you have had a head injury or brain tumour,
• you have liver or kidney problems (see "How to take Tapelod"),
• you suffer from pancreatic or biliary tract disorders, including pancreatitis,
• you are taking medicines called mixed opioid agonist/antagonists (such as pentazocine, nalbuphine) or partial mu-opioid receptor agonists (such as buprenorphine),
• you are prone to epilepsy or seizures, or if you are taking other medicines known to increase the risk of convulsions, as the risk of a seizure may increase.

Tolerance, dependence and abuse
This medicine contains tapentadol, which is an opioid. It may cause dependence and/or
abuse.
This medicine contains tapentadol, which is an opioid medicine. Repeated use of opioids may
lead to reduced effectiveness of the medicine (you become accustomed to it, a phenomenon known as tolerance).
Repeated use of Tapelod may also lead to dependence, abuse and addiction, which may result
in a potentially life-threatening overdose. The risk of these adverse effects may
increase with higher doses and prolonged duration of use.
Dependence or addiction may make you feel that you no longer have control over the amount of
medicine you need or how often you must take it.
The risk of developing dependence or addiction varies from person to person. You may have a
higher risk of becoming dependent or addicted to Tapelod if:

• you or a family member has previously suffered from alcohol, prescription medicine or illegal substance abuse or dependence ("addiction");
• you are a smoker;
• you have previously had mood disorders (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental illnesses. The appearance of any of the following signs during use of Tapelod may be a sign of dependence or addiction:
• You feel the need to use the medicine for a longer period than prescribed by your doctor.
• You feel the need to use a higher dose than recommended.
• You may feel you need to continue using the medicine, even if it does not help relieve your pain.
• You use the medicine for reasons other than those prescribed, for example, “to stay calm” or “to help sleep.”
• You have tried several times to stop or control the use of this medicine without success.
• When you stop treatment with the medicine, you feel unwell, and when you restart it, you feel better (“withdrawal effects”). If you notice any of these signs, talk to your doctor to discuss the best treatment approach for you, including whether it is appropriate to discontinue treatment and how to stop safely (see section 3, If you stop taking Tapelod).

Sleep-related breathing disorders
Tapelod may cause sleep-related breathing disorders, such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low levels of oxygen in the blood). Symptoms
may include pauses in breathing during sleep, nighttime awakenings due to gasping for breath,
difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes
these symptoms, talk to your doctor. Your doctor may consider reducing your dose.

Other medicines and Tapelod
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicine.

• The risk of adverse effects increases if you are taking medicines that can cause seizures (epileptic fits), such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take Tapelod together with these medicines. Your doctor will advise you whether you can take Tapelod.
• The concomitant use of Tapelod and sedatives such as benzodiazepines or related medicines (some sleeping medicines or tranquilizers [such as barbiturates], painkillers such as opioids, morphine and codeine [also used to suppress cough], antipsychotics, H1 antihistamines, alcohol) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and may be potentially life-threatening. Because of this, concomitant use should only be considered when no other treatment options are possible. In any case, if your doctor prescribes Tapelod together with sedative medicines, they will also determine a reduction in dose and duration of concomitant treatment. The simultaneous 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 life-threatening. Inform your doctor if you are taking gabapentin or pregabalin or other sedative medicines and follow their dose recommendations carefully. It may be helpful to inform family members or friends to watch for the signs and symptoms listed above. Contact your doctor if you experience these symptoms.
• If you are taking a type of medicine that affects serotonin levels (e.g. some medicines used to treat depression), talk to your doctor before taking Tapelod, as cases of "serotonin syndrome" have been reported. Serotonin syndrome is a rare but potentially life-threatening condition. Signs include involuntary rhythmic muscle contractions, including muscles controlling eye movements, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle stiffness and body temperature above 38°C. Your doctor can advise you on this.
• The use of Tapelod together with other medicines known as mixed mu-receptor agonist/antagonists (such as pentazocine, nalbuphine) or partial mu-opioid receptor agonists (such as buprenorphine) has not been studied. Tapentadol may not be effective if taken together with one of these medicines. Inform your doctor if you are taking any of these medicines.
• Taking Tapelod together with certain medicines (such as rifampicin, phenobarbital, St. John’s wort), which are strong inhibitors or inducers of enzymes involved in eliminating tapentadol from the body, may affect the effectiveness of tapentadol and may cause adverse effects, especially at the beginning or end of treatment with these medicines. Keep your doctor informed about all medicines you are taking.
• Tapelod 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.

The use of Tapelod with the following medicines that have anticholinergic effects may increase the risk of
adverse effects:

• medicines used to treat depression;
• medicines used to treat allergies, motion sickness or nausea (antihistamines or antiemetics);
• medicines used to treat psychiatric disorders (antipsychotics or neuroleptics);
• muscle relaxants (muscle relaxers);
• medicines used to treat Parkinson’s disease.

Tapelod with food, drinks and alcohol
Do not drink alcohol during treatment with Tapelod, as some adverse effects, such as drowsiness,
may increase. Food does not affect the effectiveness of this medicine.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you may be pregnant or are planning to become pregnant, ask
your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine:

• if you are pregnant, unless your doctor has specifically instructed you to do so. If used for prolonged periods during pregnancy, tapentadol may lead to withdrawal symptoms in the newborn, which could be life-threatening for the infant if not recognised and treated by a doctor.
• while breastfeeding, as the medicine may be excreted in breast milk.

The use of Tapelod is not recommended

• during labour, as it may cause dangerously slow or shallow breathing (respiratory depression) in the newborn.

Driving and using machines
Tapelod may cause drowsiness, dizziness and blurred vision and may reduce reaction time. This may
occur especially when starting treatment with Tapelod, when your doctor changes your dose, or
when you drink alcohol or take tranquilizers. Ask your doctor whether you can drive or operate machinery.

3. How to take Tapelod

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what
to expect from using Tapelod, when and for how long it is necessary to use it, when to contact
your doctor, and when you should stop treatment (see also "If you stop taking
Tapelod" below).
Your doctor will decide the dosage based on the intensity of your pain and your individual sensitivity to pain. In
general, the lowest effective dose that relieves pain should be used.
Adults
The usual dose is 50 mg taken twice daily, approximately every 12 hours.
Daily doses of Tapelod exceeding 500 mg of tapentadol are not recommended.
Your doctor may prescribe a different or more appropriate dosage or dosing interval if necessary. If
you feel that 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), dosage adjustment is generally not required. However,
the elimination of tapentadol may be slowed in some patients in this group. If this applies to you,
your doctor may prescribe a different dosage.
Liver and kidney disease (insufficiency)
Patients with severe liver problems must not take these tablets. If you have moderate liver problems,
your doctor will prescribe a different dosage. In case of mild liver problems, no dosage adjustment is
necessary.
Patients with severe kidney problems must not take these tablets. In case of mild or moderate kidney problems, no dosage adjustment is necessary.
Use in children and adolescents
Tapelod is not suitable for children and adolescents under 18 years of age.
How and when to take Tapelod
Tapelod is for oral use.
Always swallow the tablets whole with sufficient liquid. Do not chew or crush them,
as this could lead to overdose because the medicine would be released into the body too quickly. You may take the tablets on an empty stomach or with food.
The tablet may be divided into equal doses.
The empty tablet coating may not be completely digested and may therefore be found in the
faeces. This is not a cause for concern, as the active substance of the tablet has already been absorbed by your body, and what you see is only the empty coating.
Instructions for opening the blister
This medicine is packaged in a child-resistant, divisible unit-dose blister. It is not
possible to remove the tablets through the blister. Please follow these instructions for
opening the blister:

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

2. This will expose an unsealed area located where the perforation lines intersect.

3. Pull the unsealed section to lift the foil.

How long treatment with Tapelod lasts
Do not take the tablets for longer than your doctor has instructed.
If you take more Tapelod than you should
After taking very high doses, the following may occur:

• pinpoint pupils,
• vomiting,
• low blood pressure,
• rapid heartbeat,
• collapse, disturbances of consciousness or coma (deep unconsciousness),
• seizures,
• breathing becoming dangerously slow and shallow or respiratory arrest, which may lead to death.

In such a case, call your doctor immediately.
If you forget to take Tapelod
If you forget to take the tablets, your pain is likely to return. Do not take a double dose to
make up for the missed tablet; simply continue taking the tablets as before.
If you stop taking Tapelod
If you stop or end treatment too early, your pain is likely to return. If you wish to stop treatment due to side effects, consult your doctor.
Generally, withdrawal effects do not occur when stopping treatment, but in rare cases, individuals who have taken the tablets for a prolonged period may feel unwell if treatment is stopped abruptly.
Symptoms may include:

• restlessness, tearing, 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, diarrhoea, and increased blood pressure, breathing rate, or heart rate.

If you experience any of these symptoms after stopping treatment, consult your doctor.
You must not stop taking this medicine suddenly, unless your doctor has instructed you otherwise. If your doctor advises you to stop taking the tablets, they will also tell you how to do so, which may include gradually reducing the dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important side effects or symptoms to which attention should be paid and what to do if they occur:

• this medicine can cause allergic reactions. Symptoms may include wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching, especially affecting the whole body.
• another serious side effect is slowed breathing or more pronounced shortness of breath than expected. This mainly occurs in elderly or weak patients.

In these cases, contact your doctor immediately.
Other possible side effects are:
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, sleep disturbances, nervousness, restlessness, attention disturbances,
• tremor, muscle contractions,
• hot flushes,
• shortness of breath,
• vomiting, diarrhoea, indigestion,
• itching, increased sweating, rash,
• feeling of weakness, fatigue, sensation of body temperature fluctuations, dryness of mucous membranes, fluid accumulation in tissues (oedema).

Uncommon (may affect up to 1 in 100 people):

• allergic reactions to the medicine (including subcutaneous oedema, urticaria, and in severe cases, breathing difficulties, drop in blood pressure, collapse or shock),
• weight loss,
• disorientation, confusion, excitability (agitation), perceptual disturbances, abnormal dreams, euphoria, reduced level of consciousness, memory impairment, mental deterioration,
• fainting, sedation, balance disturbances, difficulty speaking, numbness, abnormal skin sensations (e.g. tingling, pricking),
• blurred vision,
• increased heart rate, slowed heart rate, palpitations, low blood pressure,
• abdominal discomfort,
• urticaria,
• difficulty urinating, increased frequency of urination,
• sexual dysfunction,
• withdrawal syndrome (see “If you stop treatment with Tapelod”), abnormal sensations, irritability.

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

• medicine dependence, abnormal thoughts, epileptic seizures, feeling faint, abnormal coordination,
• dangerous slowing of breathing or shortness of breath (respiratory depression),
• gastric emptying problems,
• feeling drunk, sensation of relaxation.

Frequency not known (frequency cannot be estimated from the available data)

• delirium.

Generally, the likelihood of having suicidal thoughts or behaviours increases in patients suffering from chronic pain. In addition, some medicines used to treat depression (which therefore affect the brain's neurotransmission system) may increase this risk, especially at the beginning of treatment.
Although tapentadol acts on neurotransmission, clinical use data do not show an increased risk.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tapelod

Keep this medicine in a safe and secure place, out of reach of other people. Taking this medicine by someone for whom it has not been prescribed can cause serious harm or be fatal.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tapelod contains

• The active substance is tapentadol.

Tapelod 25 mg prolonged-release tablets
Each prolonged-release tablet contains tapentadol phosphate equivalent to 25 mg of tapentadol.
Tapelod 50 mg prolonged-release tablets
Each prolonged-release tablet contains tapentadol phosphate equivalent to 50 mg of tapentadol.
Tapelod 100 mg prolonged-release tablets
Each prolonged-release tablet contains tapentadol phosphate equivalent to 100 mg of tapentadol.
Tapelod 150 mg prolonged-release tablets
Each prolonged-release tablet contains tapentadol phosphate equivalent to 150 mg of tapentadol.
Tapelod 200 mg prolonged-release tablets
Each prolonged-release tablet contains tapentadol phosphate equivalent to 200 mg of tapentadol.
Tapelod 250 mg prolonged-release tablets
Each prolonged-release tablet contains tapentadol phosphate equivalent to 250 mg of tapentadol.

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

Description of Tapelod and contents of the pack

Tapelod 25 mg are prolonged-release, oblong, biconvex, brownish tablets (6 mm x 12 mm), with score lines on both sides.
The tablet can be divided into equal doses.

Tapelod 50 mg are prolonged-release, oblong, biconvex, white tablets (6 mm x 13 mm), with score lines on both sides.
The tablet can be divided into equal doses.

Tapelod 100 mg are prolonged-release, oblong, biconvex, yellowish tablets (7 mm x 14 mm), with score lines on both sides.
The tablet can be divided into equal doses.

Tapelod 150 mg are prolonged-release, oblong, biconvex, bright reddish tablets (7 mm x 15 mm), with score lines on both sides.
The tablet can be divided into equal doses.

Tapelod 200 mg are prolonged-release, oblong, biconvex, yellow tablets (8 mm x 16 mm), with score lines on both sides.
The tablet can be divided into equal doses.

Tapelod 250 mg are prolonged-release, oblong, biconvex, reddish-brown tablets (9 mm x 18 mm), with score lines on both sides.
The tablet can be divided into equal doses.

Tapelod is available in the following pack sizes:
Tapelod 25 mg
20x1, 30x1, 40x1, 50x1, 54x1, 60x1 or 100x1 prolonged-release tablets in child-resistant, unit-dose divisible blisters.
Tapelod 50 mg – 250 mg
20x1, 24x1, 30x1, 50x1, 54x1, 60x1 or 100x1 prolonged-release tablets in child-resistant, unit-dose divisible blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
Develco Pharma GmbH
Grienmatt 27
79650 Schopfheim
Germany
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1,
39179 Barleben,
Germany

This medicinal product is authorised in the European Economic Area Member States under the following names:
Germany Tapentadol - 1 A Pharma 25 mg Retardtabletten
Tapentadol - 1 A Pharma 50 mg Retardtabletten
Tapentadol - 1 A Pharma 100 mg Retardtabletten
Tapentadol - 1 A Pharma 150 mg Retardtabletten
Tapentadol - 1 A Pharma 200 mg Retardtabletten
Tapentadol - 1 A Pharma 250 mg Retardtabletten
Czech Republic Mabinovan
Italy Tapelod
Netherlands Tapentadol Retard Sandoz 25 mg, tabletten met verlengde afgifte
Tapentadol Retard Sandoz 50 mg, tabletten met verlengde afgifte
Tapentadol Retard Sandoz 100 mg, tabletten met verlengde afgifte
Tapentadol Retard Sandoz 150 mg, tabletten met verlengde afgifte
Tapentadol Retard Sandoz 200 mg, tabletten met verlengde afgifte
Tapentadol Retard Sandoz 250 mg, tabletten met verlengde afgifte
Slovakia MABINOVAN 25 mg
MABINOVAN 50 mg
MABINOVAN 100 mg
MABINOVAN 150 mg
MABINOVAN 200 mg
MABINOVAN 250 mg
Spain Tapentadol Retard Sandoz 25 mg comprimidos de liberación prolongada EFG
Tapentadol Retard Sandoz 50 mg comprimidos de liberación prolongada EFG
Tapentadol Retard Sandoz 100 mg comprimidos de liberación prolongada EFG
Tapentadol Retard Sandoz 150 mg comprimidos de liberación prolongada EFG
Tapentadol Retard Sandoz 200 mg comprimidos de liberación prolongada EFG
Tapentadol Retard Sandoz 250 mg comprimidos de liberación prolongada EFG