PAGRENTIL RETARD 200 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Pagrentil Retard 25 mg prolonged-release tablets EFG

Pagrentil Retard 50 mg prolonged-release tablets EFG

Pagrentil Retard 100 mg prolonged-release tablets EFG

Pagrentil Retard 150 mg prolonged-release tablets EFG

Pagrentil Retard 200 mg prolonged-release tablets EFG

Pagrentil Retard 250 mg prolonged-release tablets EFG

tapentadol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

Tapentadol - the active substance of Pagrentil Retard - is a potent analgesic belonging to the class of opioids. Pagrentil Retard 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 you take Tapentadol Retard Sandoz

Do not take Pagrentil Retard:

• if you are allergic to tapentadol or any of the other ingredients of this medicine (listed in section 6),
• if you have asthma or if your breathing is slow or too shallow (respiratory depression, hypercapnia),
• if you have intestinal paralysis,
• if you have consumed alcohol, sleeping pills, other analgesics or other psychotropic medicines (medicines that affect mood and emotions) at high doses (see section "Other medicines and Pagrentil Retard”).

Warnings and precautions

Tell your doctor or pharmacist before you start taking tapentadol:

• if your breathing is slow or too 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 section “How to take Pagrentil Retard”),
• 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 agonists of opioid receptors µ (e.g. buprenorphine),
• if you are prone to epilepsy or convulsive seizures, or if you are taking other medicines with a known risk of increasing seizures, as the risk of these seizures may increase,
• if you or a family member have a history of abuse or dependence on alcohol, prescription medicines or illegal substances (“addiction”),
• if you are a smoker,
• if you have ever had problems with your mood (depression, anxiety or personality disorder) or have received psychiatric treatment for other mental illnesses.

This medicine contains tapentadol, an opioid medicine. Repeated use of opioid analgesics may lead to a decrease in their effectiveness (you may get used to it). It can also lead to dependence and abuse, which can result in a potentially life-threatening overdose. It is important that you inform your doctor if you think you may have developed dependence on tapentadol. Its use (even at therapeutic doses) can cause physical dependence, which may cause you to suffer from withdrawal symptoms and a recurrence of your problems if you stop taking this treatment suddenly.

Tapentadol can cause physical and psychological addiction. If you tend to abuse medicines or are dependent on medicines, you should only take these tablets for short periods of time under strict medical supervision.

Respiratory disorders related to sleep

Tapentadol may cause respiratory disorders related to sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen level 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 observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Other medicines and Pagrentil Retard

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

• The risk of side effects increases if you are taking medicines that can cause seizures (attacks), 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.

• Taking tapentadol with sedative medicines such as benzodiazepines or related medicines (certain sleeping pills or tranquilizers (e.g. barbiturates) or analgesics such as opioids, morphine and codeine (also as a cough medicine), antipsychotics, antihistamines-H1, alcohol), increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and can be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes tapentadol with sedative medicines, you should limit the dose and duration of concomitant treatment.

Taking opioids with medicines used to treat epilepsy, neuropathic pain or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression and can be potentially life-threatening.

Tell your doctor if you are taking gabapentin or pregabalin, or any other sedative medicine, and follow your doctor's dosage recommendation strictly. It may be helpful to inform your friends and family about the signs and symptoms indicated above. Tell 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 for treating depression), talk to your doctor before taking tapentadol, as there have been cases of "serotonin syndrome". Serotonin syndrome is a rare but potentially life-threatening disorder. Symptoms include involuntary rhythmic muscle contractions, including muscles that control eye movement, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension and body temperature above 38 °C. Your doctor can give you more information.

• The concomitant administration of tapentadol with other types of medicines called mixed opioid agonist/antagonists (e.g. pentazocine, nalbuphine) or partial agonists of opioid receptors µ (e.g. buprenorphine) has not been studied. It is possible that tapentadol may not have the same effectiveness if administered with one of these medicines. Tell your doctor if you are currently being treated with one of these medicines.

• Taking tapentadol with potent inhibitors or inducers (e.g. rifampicin, phenobarbital, St. John's Wort) of certain enzymes that are necessary to eliminate tapentadol from your body may affect the effectiveness of tapentadol or may cause side effects, especially when starting or stopping this other type of medication. Keep your doctor informed about all the medicines you are taking.

• Tapentadol should not be taken with MAO inhibitors (a type of medicine for treating depression). Tell your doctor if you are taking MAO inhibitors or if you have taken them in the last 14 days.

Taking Pagrentil Retard with food, drinks and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take this medicine:

• if you are pregnant, unless your doctor has told you to. If used during 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.
• while breastfeeding, as it can be excreted in breast milk.

The use of tapentadol is not recommended

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

Driving and using machines

Tapentadol may cause drowsiness, dizziness and blurred vision, and may affect your ability to react. This may occur especially at the start of treatment with tapentadol, after a change in dose, or when drinking alcohol or taking tranquilizers. Ask your doctor if you can drive or use machines while taking tapentadol.

3. How to take Tapentadol Retard Sandoz

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Your doctor will adjust the dose according to the intensity of your pain and your personal sensitivity to pain. The minimum effective dose should usually be taken to relieve pain.

Adults

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

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

Your doctor may prescribe a different dose or dosing regimen, and more suitable if necessary. If you think that the effect of these tablets is too strong or too weak, talk to your doctor or pharmacist.

Elderly patients

In elderly patients (over 65 years of age), the dose does not usually need to be adjusted. However, the elimination of tapentadol 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 disease (hepatic and renal 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. If you have mild liver problems, no dose adjustment is necessary.

Patients with severe kidney problems should not take these tablets. If you have mild or moderate kidney problems, no dose adjustment is necessary.

Use in children and adolescents

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

How and when to take Pagrentil Retard

Tapentadol should be taken orally.

Always swallow the tablet whole with a sufficient amount of liquid. Do not chew or crush it - this could lead to an overdose because the active substance will be released in your body too quickly. You can take the tablets on an empty stomach or with food.

The tablet can be divided into equal doses.

The tablet coating may not be completely digested and therefore appear in the feces. This should not worry you, as the active substance of the tablet will have already been absorbed in your body, and what you see is only the empty coating.

Instructions for opening the blister

This medicine is packaged in child-resistant unit dose blisters. You cannot push the tablet through the blister. Note the instructions for opening the blister shown below:

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

1. In the single dose, you can access an unscaled area that is located in the position where the perforation lines cross.

1. Pull the unscaled area to remove the cover.

How long to take Pagrentil Retard

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

If you take more Pagrentil Retard than you should

After taking very high doses, you may experience some of the following effects:

• very small pupils,
• vomiting,
• decreased blood pressure,
• rapid heartbeat,
• fainting, altered consciousness or coma (deep loss of consciousness),
• seizures,
• slow or shallow breathing or respiratory arrest.

If you experience any of these effects, contact 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 medicine and the amount taken.

If you forget to take Pagrentil Retard

If you forget to take the tablets, you will probably feel pain again. Do not take a double dose to make up for forgotten doses, simply continue taking the tablets as before.

If you stop taking Pagrentil Retard

If you stop or discontinue treatment too early, you will probably feel pain again. If you want to stop treatment, consult your doctor before doing so.

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

Symptoms may be:

• restlessness, tearful 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 increased blood pressure, respiratory rate or heart rate.

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

You should not stop taking this medicine suddenly, unless your doctor tells you to. If your doctor wants you to stop taking these tablets, they will tell you how to do it, which may involve gradually reducing the dose.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Adverse effects or important symptoms to be aware of and what to do if you are affected by them:

• This medicine may cause allergic reactions. The symptoms may consist of wheezing (a kind of whistling when breathing), difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching, especially if they affect the whole body.
• Another serious adverse effect is breathing more slowly or more weakly than normal. It occurs mostly in elderly patients or in weakened patients.

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

Other adverse effects that may occur:

Very common(may affect more than 1 in 10 people)

• nausea, constipation,
• dizziness, drowsiness, headache.

Common(may affect up to 1 in 10 people)

• decreased appetite, anxiety, depressed mood, difficulty sleeping, nervousness, restlessness, attention disorders,
• tremors, muscle twitches,
• hot flashes,
• shortness of breath,
• vomiting, diarrhea, indigestion,
• itching, increased sweating, skin rashes,
• feeling of weakness, fatigue, feeling of change in body temperature, dryness of the mucous membranes, water retention in the tissues (edema).

Uncommon(may affect up to 1 in 100 people)

• allergic reaction to medicines (including swelling under the skin, hives, and in severe cases difficulty breathing, decreased blood pressure, collapse or shock),
• weight loss,
• disorientation, confusion, excitability (agitation), altered perception, sleep disorders, 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),
• vision changes,
• rapid heartbeat, slow heartbeat, palpitations, decreased blood pressure,
• abdominal discomfort,
• hives,
• delayed urination, frequent urination,
• sexual dysfunction,
• drug withdrawal syndrome (see section "If you stop treatment with Pagrentil Retard"), feeling of discomfort, irritability.

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

• drug dependence, altered thinking, epileptic seizures, feeling of being about to faint, altered coordination,
• slow or shallow breathing to dangerous levels (respiratory depression),
• altered gastric emptying,
• feeling of intoxication, feeling of relaxation.

Frequency not known(cannot be estimated from available data)

• delirium.

In general, the possibility of having suicidal thoughts and behaviors increases in patients with chronic pain. Additionally, some medications for treating depression (with an impact on the brain's neurotransmitter system) may increase this risk, especially at the start of treatment. Although tapentadol also affects neurotransmitters, experience in patients has not proven 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 that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Tapentadol Retard Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and the blister after CAD/EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and the medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Pagrentil Retard

• The active ingredient is tapentadol.

Pagrentil Retard 25 mg

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

Pagrentil Retard 50 mg

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

Pagrentil Retard 100 mg

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

Pagrentil Retard 150 mg

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

Pagrentil Retard 200 mg

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

Pagrentil Retard 250 mg

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

• The other ingredients are:

Core of the tablet:microcrystalline cellulose (E460), hypromellose (E464), anhydrous colloidal silica (E551), magnesium stearate.

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

Appearance of the Product and Package Contents

Pagrentil Retard 25 mg are prolonged-release tablets, oblong, biconvex (6 mm x 12 mm), brown in color, with scored lines on both sides.

The tablet can be divided into equal doses.

Pagrentil Retard 50 mg are prolonged-release tablets, oblong, biconvex (6 mm x 13 mm), white in color, with scored lines on both sides.

The tablet can be divided into equal doses.

Pagrentil Retard 100 mg are prolonged-release tablets, oblong, biconvex (7 mm x 14 mm), yellowish in color, with scored lines on both sides.

The tablet can be divided into equal doses.

Pagrentil Retard 150 mg are prolonged-release tablets, oblong, biconvex (7 mm x 15 mm), bright reddish in color, with scored lines on both sides.

The tablet can be divided into equal doses.

Pagrentil Retard 200 mg are prolonged-release tablets, oblong, biconvex (8 mm x 16 mm), yellow in color, with scored lines on both sides.

The tablet can be divided into equal doses.

Pagrentil Retard 250 mg are prolonged-release tablets, oblong, biconvex (9 mm x 18 mm), reddish-brown in color, with scored lines on both sides.

The tablet can be divided into equal doses.

Pagrentil Retard is available in the following package sizes:

Pagrentil Retard 25 mg

Child-resistant unit dose blisters of 20, 30, 40, 50, 54, 60, or 100 (clinical package) prolonged-release tablets.

Pagrentil Retard 50 - 250 mg

Child-resistant unit dose blisters of 20, 24, 30, 50, 54, 60, or 100 (clinical package) prolonged-release tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Develco Pharma GmbH

Grienmatt 27

DE-79650 Schopfheim

Germany

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

DE-39179 Barleben

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this prospectus:February 2023.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/