Tapentadol Libra-Pharm® retard 50 mg Extended Release Tablets - Patient Information Service (2023)

1. What is Tapentadol Libra-Pharm retard and its uses

Tapentadol - active substance Tapentadol Libra-Pharm retard - is a powerful pain reliever belonging to the opioid class.

Tapentadol Libra-Pharm retard is indicated for the treatment of severe chronic pain in adults who can only be adequately controlled with opioid pain medications.

2. What should you know before starting Tapentadol Libra-Pharm?

Libra-Pharm Delay should not be used with Tapentadol

• If you have an allergy to tapentadol or any other part 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 been acutely intoxicated by alcohol, sleeping pills, pain medicines, or other psychotropic drugs (drugs that affect mood and mood) (see "Taking other medicines and tapentadol Libra-Pharm extended release").

Warnings and Precautions

Talk to your doctor or pharmacist before taking Tapentadol Libra-Pharm retard

• If your breathing is slow or shallow.

• If you have increased intracranial pressure or impaired consciousness until coma.

• After a head injury or brain tumor.

• If you have liver or kidney problems (see "How to take tapentadol Libra-Pharm Delay").

• If you have a disease of the pancreas or bile ducts, including pancreatitis.

• If you are taking a medicine that belongs to a group of medicines called mixed mu-opioid agonists/antagonists (z.B.pentazocine, nalbuphine) or so-called partial mu-opioid receptor agonists (z.B.buprenorphine).

• If you have epilepsy or a tendency to have seizures, as the risk of seizures is higher. Your risk of seizures may be increased if you also take medicines that increase your risk of seizures.

• If you or any member of your household has ever abused or become addicted to alcohol, prescription drugs or illegal drugs (“addiction”).

• If you are a smoker.

• If you have ever had a mental health problem (depression, anxiety, or personality disorder) or been treated by a psychiatrist for another mental health problem.

This medicine contains tapentadol, an opioid. Repeated use of opioids for pain can make the medicine less effective (as you get used to it). It can also lead to addiction and abuse, leading to life-threatening overdoses. Always consult your doctor if you are concerned that you may become addicted to Tapentadol Libra-Pharm retard. Ingestion (even in therapeutic doses) can lead to physical dependence and, if stopped suddenly, withdrawal symptoms and recurring pain.

Tapentadol Libra-Pharm retard can make you physically and mentally dependent. If you are prone to drug abuse or are addicted to drugs, you should take the tablets for a short period of time under close medical supervision.

Sleep-Related Breathing Disorders

Tapentadol Libra-Pharm retard can cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include apnea during sleep, waking up during the night with shortness of breath, trouble sleeping, or excessive daytime sleepiness. If you or anyone else notices these symptoms, please consult your doctor. Your doctor may consider reducing your dose.

Taking Tapentadol Libra-Pharm with other medicines

Tell your doctor or pharmacist if you are taking/using any other medicines, have recently taken/used, or will take them in the near future.

Your risk of side effects increases if you take medicines that can cause seizures, such asz.B.Certain medicines for depression or psychosis. Your risk of seizures may be increased if you take tapentadol Libra-Pharm Delay at the same time. Your doctor can tell you if Tapentadol Libra-Pharm Delay is right for you.

Concomitant administration of tapentadol Libra-Pharm blockers and sedatives such as benzodiazepines or similar drugs (certain sleeping pills or sedatives) [z。 B.barbiturates] or pain relievers such as opioids, morphine, and codeine [also used as antitussives], antipsychotics, H1 antihistamines, alcohol) increase drowsiness, difficulty breathing (respiratory depression), and Risk of coma, which may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available.

However, if your doctor has prescribed Tapentadol Libra-Pharm extended-release with a sedative, your doctor should limit the dose and duration of your concomitant therapy.

Concomitant use of opioids and drugs for epilepsy, neuralgia, or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose and respiratory depression, which can be life-threatening.

Tell your doctor if you are taking gabapentin or pregabalin or other sedatives, and follow your doctor's dosage recommendations closely. It may be helpful to tell friends or relatives to watch for the above signs and symptoms. Contact your doctor if you experience any of these symptoms.

If you are taking certain medications that affect serotonin levels (z.B.certain medicines used to treat depression), talk to your doctor before taking tapentadol Libra-Pharm Delay because of reports of a condition called serotonin syndrome. Serotonin syndrome is a rare but life-threatening condition. Symptoms include involuntary, rhythmic muscle twitches, including eye muscles, restlessness, profuse sweating, tremors, increased reflexes, increased muscle tone, and a temperature above 38 degrees^°C. Your doctor can advise you on this.

Taking Tapentadol Libra-Pharm Delay with other drugs belonging to the mixed µ-opioid agonist/antagonist group (z.B.pentazocine, nalbuphine) or partial mu-opioid receptor agonists (z.B.buprenorphine) has not been studied. Tapentadol Libra-Pharm Delay may not work as well when taken with one of these medicines. Tell your doctor if you are currently being treated with these medicines.

Taking tapentadol Libra-Pharm ER with a strong inhibitor or booster (z.B.rifampicin, phenobarbital, St. John's wort) and certain endogenous enzymes important for clearing tapentadol from the body may affect how tapentadol works or cause side effects. This can happen especially when these other drugs are started or stopped. Tell your doctor about all medicines you are taking.

Tapentadol Libra-Pharm retard should not be taken concomitantlyhair- Are taking depressants (certain medicines used to treat depression). ifhair- You are taking a suppressant or have taken a suppressant within the past 14 days.

Take Tapentadol Libra-Pharm Extended Release with food, drink, and alcohol

Do not drink alcohol during delayed treatment with Tapentadol Libra-Pharm as there are some side effects such asz.B.Drowsiness may be more common. Food does not affect the efficacy of this medicine.

pregnancy and lactation

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

do not use this medicine

• If you are pregnant, unless advised by your doctor. Long-term use of tapentadol during pregnancy can cause withdrawal symptoms in the newborn, which can be life-threatening if not recognized and treated by a doctor.

• During labor, as this can cause dangerously slow or shallow breathing (respiratory depression) in the newborn.

• If you are breastfeeding, as the active substance may be excreted in breast milk.

Ability to drive vehicles and machines

Tapentadol Libra-Pharm Delay can cause drowsiness, dizziness, and blurred vision and affect your ability to react. This may happen especially when you first start taking Tapentadol Libra-Pharm, if your doctor changes your dose, if you drink alcohol or take sedatives. Ask your doctor if you are allowed to drive or operate machinery.

Tapentadol Libra-Pharm Extended Release Lactose

This medicine contains lactose. If you know you have an intolerance to certain sugars, consult your doctor before taking Tapentadol Libra-Pharm Extended Release.

3. How to take Tapentadol Libra-Pharm Extended Release Tablet?

Always use this medicine exactly as your doctor or pharmacist tells you to. If in doubt, ask your doctor or pharmacist.

Your doctor will adjust the dose based on the severity of your pain (pain intensity) and your personal sensitivity to pain. In general, the lowest pain relief dose should be taken.

aldult

The usual starting dose is 50mgEvery 12 hours. Your doctor may prescribe a different, more appropriate dose and/or suggest a different dosing interval. If you think these tablets are too strong or too weak, talk to your doctor or pharmacist.

A total of more than 500mgDaily use of Tapentadol is not recommended.

Elderly patients

Elderly patients (over 65 years) generally do not require dose adjustments. Some patients in this age group may have delayed excretion of the active substance tapentadol. If this applies to you, your doctor may recommend a different dosing regimen.

Liver and kidney dysfunction (deficiency)

Patients with severe liver impairment should not take these tablets. Your doctor may recommend a different dosing regimen if you have moderate liver problems. No dosage adjustment is required in case of mild hepatic impairment.

Patients with severe kidney impairment should not take these tablets. Mild to moderate renal impairment requires no dose adjustment.

Use in children and adolescents

Tapentadol Libra-Pharm retard is not suitable for children and adolescents under the age of 18.

How and when to take Tapentadol Libra-Pharm retard?

Tapentadol Libra-Pharm retard is for oral use.

Always swallow the tablet whole with plenty of liquid.

Tablets should not be chewed, crushed or crushed - this may cause an overdose as the active ingredient is released into your body too quickly.

Tablets may be taken on an empty stomach or with food.

Tablet matrix may not be fully digested and canperhaps.Found in whole or in part in feces, apparently intact. This is nothing to worry about, as the active ingredients in the pill have already been absorbed by the body and all you see is the seemingly intact pill matrix.

How long should you take Tapentadol Libra-Pharm Delay?

Do not take the tablet for longer than your doctor prescribes.

If you take more Tapentadol Libra-Pharm retard than you should

After swallowing very high doses, the following may happen:

• Pupil constriction (pinhead-sized pupils), vomiting, drop in blood pressure, fast heartbeat, circulatory collapse, disturbance of consciousness until coma (deep coma), seizures, dangerously slow or shallow breathing or breathing stops.

If you experience these symptoms, seek medical attention immediately!

What if you forget to take Tapentadol Libra-Pharm sluggish?

If you forget to take your medicine, your pain is likely to return. Do not take a double dose to make up for a missed dose, but continue taking it as before.

If you stop taking Tapentadol Libra-Pharm Delay

Pain may return if you interrupt or stop treatment too soon. If you want to stop treatment, please contact your doctor first.

Generally, there are no consequences for stopping treatment. However, patients who take the drug occasionally for a period of time may experience discomfort if they stop taking it suddenly.

The following symptoms may occur:

• Irritability, tearing, runny nose, yawning, sweating, shaking, muscle aches, and dilated pupils.

• Irritability, anxiety, back pain, joint pain, weakness, abdominal cramping, trouble sleeping, nausea, loss of appetite, vomiting, diarrhea, increased blood pressure, shortness of breath, and fast heartbeat.

Talk to your doctor if you experience any of these symptoms after stopping treatment.

You should not stop taking this medicine suddenly without your doctor's advice. If your doctor tells you to stop taking your medicine, he will explain the procedure to you. It may also mean that the dose is gradually reduced.

If you have any confusion or questions about using this medicine, ask your doctor or pharmacist.

4. What are the possible side effects?

Like all medicines, this medicine can cause side effects, but not everyone experiences them.

Important side effects or symptoms to watch for and how to react:

This drug may cause an allergic reaction. Symptoms may include wheezing, difficulty breathing, swelling of the eyelids, face, or lips, and rash or itching, especially if it affects the whole body.

Another serious side effect is slower or weaker breathing than expected. This is most common in elderly and debilitated patients.

If you experience any of these important side effects, please contact your doctor right away.

Other side 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, low mood, trouble sleeping, nervousness, irritability, trouble concentrating, shaking, muscle twitching, flushing, trouble breathing, vomiting, diarrhea, indigestion, itching, increased sweating, rash, feeling weak, tired, Mood swings Body temperature, dry mucous membranes, fluid buildup in tissues (edema).

Less common (may affect up to 1 in 100 people):

Drug allergy (including swelling of the mucous membranes of the face and mouth and throat [angioedema], and in severe cases, difficulty breathing, drop in blood pressure, collapse, or shock), weight loss, disorientation, confusion, irritability (agitation), sensory disturbances, Unusual dreams, euphoric mood, disturbance of consciousness, memory disturbance, mental disturbance, fainting, sedation, balance disturbance, speech disturbance, numbness, skin paresthesia (z.B.stinging, pins and needles), visual disturbances, fast heart rate, slow heart rate, palpitations, low blood pressure, abdominal discomfort, hives, delayed urination, frequent urination, sexual dysfunction, withdrawal syndrome (see "If you stop taking He Pentadol Libra- Pharm retard"), general health disturbance, irritability.

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

Drug addiction, unusual thinking, seizures, feeling weak, abnormal coordination, slow or dangerously shallow breathing (respiratory depression), abnormal stomach emptying, feeling drunk, feeling relaxed.

Unknown (frequency cannot be estimated from available data):

delirium

In general, patients with chronic pain are more likely to develop suicidal thoughts and behaviors. Also, medications used to treat depression (which affect neurotransmitters in the brain) may increase this risk, especially at the beginning of treatment. Although tapentadol also affects neurotransmitters in the brain, data on the use of tapentadol in humans does not suggest an increased risk.

report side effects

If you notice any side effects, please consult your doctor or pharmacist. This also applies to side effects not listed in these instructions for use. You can also report side effects directly to the Federal Institute for Medicines and Medical Products,ExceedPharmakovigilanz，Kurt-Georg-Kiesinger Allee 3，D-53175Bonn, website: http://www.bfarm.de to sue. By reporting side effects, you can help provide more information about the safety of this drug.

5. How to store Tapentadol Libra-Pharm retard

Keep out of the sight and reach of children.

Do not use this medicine for the time stated on the carton and blister"Require"Do not use specified expiration dates. The validity period refers to the last day of the current month.

This drug does not require any special storage conditions.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to discard medicines you no longer use. You help protect our environment.

6. Package contents and other information

What are the ingredients in Tapentadol Libra-Pharm retard?

ofActive ingredientsMe: He sprayed him too much.

Extended-release tablets contain 50mghe pentadol (and 58.24mgtapentadolhidroklorid)。

dieotherThese components are:

tablet core:

Hypromellose,

microcrystalline cellulose,

colloidal silicon,

Magnesium stearate (Doctor of Philosophy in Europe).

tablet coating:

Hypromellose,

lactose monohydrate,

dialogue,

polyethylene glycol,

polypropylene glycol,

Titanium dioxide (E171).

What Tapentadol Libra-Pharm retard looks like and package contents

White, film-coated, slender, extended-release tablet (6.5mm× 15mm), marked with the Grünenthal logo on one side and "H1" on the other.

Tapentadol Libra-Pharm extended release tablets are available in blister packs in boxes of 20, 24, 50, 54 and 100 tablets.

pharmaceutical entrepreneur

Libra-Pharmaceuticallimited company• Zieglerstraße 6 •52078Akon

Telephone:0241 569-1111

fax:0241 569-1112

manufacturer

Grantaylimited company

Ziegler Strasse 6

52078Akon

The medicine is authorized in the member states of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Spain: YANTIL delayed

Italy: Grünenthal

Sweden: Ationdo Depot

United Kingdom (Northern Ireland): Ationdo SR

This note was last revised October 2022.