Palexia

Package leaflet: Information for the patient

Palexia 25 mg prolonged-release tablets

Tapentadol
Please read all of 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, because it could be dangerous.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist (see section 4).

Contents of this leaflet:

1. What Palexia prolonged-release tablets are and what they are used for
2. What you need to know before taking Palexia prolonged-release tablets
3. How to take Palexia prolonged-release tablets
4. Possible side effects
5. How to store Palexia prolonged-release tablets
6. Contents of the pack and other information

1. What Palexia prolonged-release tablets are and what they are used for

Tapentadol, the active substance in Palexia prolonged-release tablets, is a strong painkiller belonging to the opioid class. Palexia prolonged-release tablets are used for the treatment of severe chronic pain in adults who can only be adequately managed with opioid painkillers.

2. What you should know before using Palexia prolonged-release tablets

Do not use Palexia prolonged-release tablets:

• 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 from alcohol, sleeping medicines, painkillers, or other psychotropic medicines (medicines that affect mood and emotions) (see "Other medicines and Palexia prolonged-release tablets").

Warnings and precautions
Talk to your doctor or pharmacist before taking Palexia prolonged-release tablets:

• if you have shortness of breath or weak breathing,
• if you suffer from increased pressure inside the skull or disturbances of consciousness, up to coma,
• if you have had a head injury or a brain tumour,
• if you suffer from liver or kidney disorders (see "How to use Palexia prolonged-release tablets"),
• if you suffer from disorders of the pancreas or biliary tract, including pancreatitis,
• if you are taking medicines called mixed opioid agonist/antagonists (such as pentazocine, nalbuphine) or medicines that are partial agonists at mu-opioid receptors (such as 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 a seizure may increase.

Palexia prolonged-release tablets may lead to physical and psychological dependence. If you have a tendency to misuse medicines or are drug-dependent, you should take this medicine only for short periods and under strict medical supervision.

Sleep-related breathing disorders
Palexia prolonged-release tablets contain an active substance that belongs to the group of opioids.
Opioids can cause sleep-related breathing disorders, such as central sleep apnoea (shallow breathing or breathing pauses during sleep) and sleep-related hypoxaemia (low oxygen levels in the blood).
The risk of central sleep apnoea occurring depends on the dose of opioids. Your doctor may consider reducing the total opioid dosage if central sleep apnoea occurs.

Other medicines and Palexia prolonged-release tablets
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 (fits), such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take Palexia together with these medicines. Your doctor will advise you whether you can take Palexia.

The concomitant use of Palexia and sedative medicines such as benzodiazepines or similar medicines (some sleeping or tranquillising medicines (such as barbiturates), painkillers such as opioids, morphine and codeine (also used in cough preparations)), antipsychotics, H1 antihistamines, or alcohol increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered if no other therapeutic options are possible. However, if your doctor prescribes Palexia together with sedative medicines, they will also determine a reduction in dose and duration of concomitant treatment.

Inform your doctor about all sedative medicines you are taking and follow their dosage recommendations strictly. 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 (such as certain medicines for treating depression), discuss this with your doctor before taking Palexia, as cases of "serotonin syndrome" have been reported. Serotonin syndrome is rare but potentially life-threatening. Symptoms include uncontrollable rhythmic muscle contractions, including those controlling eye movements, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tone, and body temperature above 38°C. Your doctor can inform you about this.

The use of Palexia prolonged-release tablets together with other types of medicines known as mu-receptor agonist/antagonists (such as pentazocine, nalbuphine) or partial mu-opioid receptor agonists (such as buprenorphine) has not been studied. Palexia prolonged-release tablets may not be effective if taken together with any of these medicines. Inform your doctor if you are taking any of these medicines.

Taking Palexia prolonged-release tablets together with certain medicines (such as rifampicin, phenobarbital, St. John’s wort), strong inhibitors or inducers of certain enzymes required to eliminate tapentadol from the body, may affect the effectiveness of tapentadol and may cause side effects, especially at the beginning or end of treatment with these medicines. Keep your doctor informed about all medicines you are taking.

Palexia prolonged-release tablets 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.

Palexia prolonged-release tablets with food, drinks and alcohol
Do not drink alcohol during treatment with Palexia prolonged-release tablets, as certain side 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 if you are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Do not take these tablets:

• if you are pregnant, unless your doctor has specifically instructed you to do so. Prolonged use of tapentadol during pregnancy may lead to withdrawal symptoms in the newborn, which can be life-threatening if not recognised and treated by a doctor.
• during childbirth, because the newborn's breathing may become dangerously slow or weak (respiratory failure),
• while breastfeeding, because the medicine may be excreted in breast milk.

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

Palexia prolonged-release tablets contain lactose
If you have been diagnosed by your doctor with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to use Palexia prolonged-release tablets

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
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 1 tablet every 12 hours. Daily doses of Palexia prolonged-release tablets exceeding 500 mg of tapentadol are not recommended. Your doctor may prescribe a different or more appropriate dose 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, excretion 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 disorders (insufficiency)
Patients with severe liver problems must not take these tablets. If you have mild to moderate liver impairment, your doctor will prescribe an adjusted dosage. In case of mild liver impairment, no dosage adjustment is necessary.
Patients with severe kidney problems must not take these tablets. In case of mild or moderate kidney impairment, no dosage adjustment is necessary.
Use in children and adolescents
Palexia prolonged-release tablets are not suitable for children and adolescents under 18 years of age.
How and when to take Palexia prolonged-release tablets
Palexia prolonged-release tablets are for oral use.
Always swallow the tablets whole with sufficient liquid.
Do not chew, break, or crush the tablets, as this could lead to overdose due to rapid release of the active substance into the body.
You may take the tablets on an empty stomach or with food.
The empty tablet shell may not be completely digested and may appear in the stool. This is not a cause for concern, as the active ingredient of the tablet has already been absorbed by your body; what you see is only the empty shell.
Duration of treatment
Do not take the tablets for longer than prescribed by your doctor.
If you take more Palexia prolonged-release tablets 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 (profound unconsciousness), seizures, dangerously slow and shallow breathing, or respiratory arrest. In such cases, medical help must be sought immediately.

If you forget to take Palexia prolonged-release tablets
If you miss a dose, your pain may 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 Palexia prolonged-release tablets
If you stop or discontinue treatment too early, your pain may return. If you wish to stop treatment, consult your doctor.
Generally, withdrawal effects do not occur when stopping treatment. However, in rare cases, people 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, diarrhea, 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 abruptly, unless your doctor tells you otherwise. If your doctor advises you to stop taking the tablets, they will also instruct 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 everyone experiences them.
Important side effects or symptoms to pay attention to and what to do if they occur:
this medicine may cause allergic reactions. Symptoms may include shortness of breath, wheezing, swelling of the eyelids, face or lips, rash or itching, especially affecting the entire body. Another serious side effect is worsening of breathing or more pronounced shortness of breath than expected. This occurs mainly in elderly or frail patients.
In such cases, contact your doctor immediately.
Other possible side effects are:
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, sleep disturbances, nervousness, restlessness, attention disturbances, tremor, muscle contractions, flushing, 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), disturbances in perception, unusual dreams, euphoria, reduced level of consciousness, memory impairment, mental impairment, fainting, sedation, balance disorders, difficulty speaking, numbness, abnormal skin sensations (e.g. tingling, pruritus), 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 "When stopping treatment with Palexia"), feeling strange, irritability.
Rare (may affect up to 1 in 1,000 people): drug dependence, abnormal thoughts, epileptic seizures, feeling faint, abnormal coordination, dangerously slow breathing or shortness of breath (respiratory depression), problems with gastric emptying, feeling drunk, sensation of relaxation.
Frequency not known: 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 also acts on neurotransmitters, 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 Palexia prolonged-release tablets

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 on the blister. 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 Palexia prolonged-release tablets contain
The active substance is: tapentadol
Each tablet contains 25 mg of tapentadol (equivalent to 29.12 mg of tapentadol hydrochloride).
The other components are:
Tablet core: hypromellose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.
Tablet coating: hypromellose, lactose monohydrate, talc, macrogol 400, macrogol 6000, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

Description of the appearance of Palexia 25 mg prolonged-release tablets and package contents
Oblong, film-coated tablets, light brown-orange in colour (5.5 mm x 10 mm), marked with the Grünenthal logo on one side and "H9" on the other.
Palexia prolonged-release tablets are packaged in blisters, available in pack sizes of 7, 10, 10x1, 14, 14x1, 20, 20x1, 24, 28, 28x1, 30, 30x1, 40, 50, 50x1, 54, 56, 56x1, 60, 60x1, 90, 90x1, 100 and 100x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
GRŰNENTHAL ITALIA S.r.l. Via Vittor Pisani, 16 Milano
Manufacturer
Grünenthal GmbH Zieglerstrasse 6, 52078 Aachen, Germany
Farmaceutici Formenti S.p.A. via Di Vittorio 2 Origgio - Italy

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria, Belgium, Croatia, Cyprus, Czech Republic, Germany, Greece, Luxembourg, Netherlands, Poland, Portugal, Slovakia, Spain: PALEXIA retard
Denmark, Finland, Norway, Sweden: PALEXIA Depot
France: PALEXIA LP
Ireland, United Kingdom, Slovenia: PALEXIA SR
Italy: Palexia

Patient information leaflet

Palexia 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
Please read this entire 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 others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist (see section 4).

Contents of this leaflet:

1. What Palexia prolonged-release tablets are and what they are used for
2. What you need to know before taking Palexia prolonged-release tablets
3. How to take Palexia prolonged-release tablets
4. Possible side effects
5. How to store Palexia prolonged-release tablets
6. Contents of the pack and other information

1. What Palexia prolonged-release tablets are and what they are used for

Tapentadol, the active substance in Palexia prolonged-release tablets, is a strong analgesic belonging to the opioid class. Palexia prolonged-release tablets are used for the treatment of severe chronic pain in adults that can be adequately managed only with opioid analgesics.

2. What you should know before taking Palexia prolonged-release tablets

Do not use Palexia prolonged-release tablets

• 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 Palexia prolonged-release tablets").

Warnings and precautions
Talk to your doctor or pharmacist before taking Palexia prolonged-release tablets:

• if you have shortness of breath or weak breathing,
• if you have increased pressure inside the skull or disturbances of consciousness, up to coma,
• if you have had a head injury or brain tumour,
• if you suffer from liver or kidney problems (see "How to use Palexia prolonged-release tablets"),
• if you suffer from pancreatic or biliary tract disorders, including pancreatitis,
• if you are taking medicines called opioid agonist/antagonists (such as pentazocine, nalbuphine) or medicines that are partial agonists at mu-opioid receptors (such as 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 a seizure may increase.

Palexia prolonged-release tablets may lead to physical and psychological tolerance. If you have a tendency to misuse medicines or are drug-dependent, you should take this medicine only for short periods and under strict medical supervision.
Sleep-related breathing disorders
Palexia contains an active substance belonging to the group of opioids. Opioids may cause sleep-related breathing disorders, such as central sleep apnoea (shallow breathing or breathing pauses during sleep) and sleep-related hypoxaemia (low blood oxygen levels).
The risk of developing central sleep apnoea depends on the dose of opioids. Your doctor may consider reducing the total opioid dose if central sleep apnoea occurs.

Other medicines and Palexia prolonged-release tablets
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 may cause seizures (fits), such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take Palexia together with these medicines. Your doctor will advise you whether you can take Palexia.
The concomitant use of Palexia and sedative medicines such as benzodiazepines or similar medicines (some sleeping medicines or tranquilising medicines (such as barbiturates), painkillers such as morphine and codeine (also used in cough suppressants), antipsychotics, H1 antihistamines, alcohol) increases the risk of drowsiness, difficulty in breathing (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered if no other therapeutic options are available. However, if your doctor prescribes Palexia together with sedative medicines, they will also determine a reduced dose and shorter duration of concomitant treatment. Inform your doctor about all sedative medicines you are taking 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 (such as certain medicines for the treatment of depression), talk to your doctor before taking Palexia, as cases of "serotonin syndrome" have been reported. Serotonin syndrome is rare but potentially life-threatening. Symptoms include uncontrollable rhythmic muscle contractions including muscles controlling eye movements, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tone, and body temperature above 38°C. Your doctor can provide you with further information.
The use of Palexia prolonged-release tablets together with other types of medicines known as mu-receptor agonist/antagonists (such as pentazocine, nalbuphine) or partial mu-opioid receptor agonists (such as buprenorphine) has not been studied. Palexia prolonged-release tablets may not be effective if taken together with one of these medicines. Inform your doctor if you are taking any of these medicines.
Taking Palexia prolonged-release tablets together with certain medicines (such as rifampicin, phenobarbital, St. John’s wort), which are strong inhibitors or inducers of enzymes involved in the elimination of tapentadol from the body, may affect the efficacy of tapentadol and may cause side effects, especially at the beginning or end of treatment with these medicines. Keep your doctor informed about all medicines you are taking.
Palexia prolonged-release tablets 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.

Palexia prolonged-release tablets with food, drinks, and alcohol
Do not drink alcohol during treatment with Palexia prolonged-release tablets, as some side effects, such as drowsiness, may increase. Food does not affect the efficacy of this medicine.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not take these tablets:

• if you are pregnant, unless your doctor has specifically instructed you to do so. Prolonged use of tapentadol during pregnancy may cause withdrawal symptoms in the newborn, which can be life-threatening if not recognised and treated by a doctor.
• during childbirth, because the newborn's breathing may dangerously slow down or become weak (respiratory failure),
• while breastfeeding, because the medicine may be excreted in breast milk.

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

Palexia prolonged-release tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to use Palexia prolonged-release tablets

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
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 1 tablet every 12 hours. Total daily doses of Palexia prolonged-release tablets exceeding 500 mg of tapentadol are not recommended. Your doctor may prescribe a different or more appropriate dose or dosing interval if necessary. If you feel 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, excretion of tapentadolo may be slowed in some patients in this group. If this applies to you, your doctor may prescribe a different dosage.
Liver and kidney disorders (impairment)
Patients with severe liver problems must not take these tablets. If you have mild liver problems, your doctor may prescribe a different dosage. In patients with mild liver impairment, no dosage adjustment is necessary.
Patients with severe kidney problems must not take these tablets. In patients with mild or moderate kidney impairment, no dosage adjustment is necessary.
Use in children and adolescents
Palexia prolonged-release tablets are not suitable for children and adolescents under 18 years of age.
How and when to take Palexia prolonged-release tablets
Palexia prolonged-release tablets are for oral use.
Always swallow the tablets whole with sufficient liquid.
Do not chew, break 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 empty tablet shell may not be completely digested and may therefore be found in the faeces. This is not a cause for concern, as the medicine (active substance) has already been absorbed by your body and what you see is only the empty shell.
Duration of treatment
Do not take the tablets for longer than prescribed by your doctor.
If you take more Palexia prolonged-release tablets 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), epileptic seizures, breathing becoming dangerously slow and shallow, or respiratory arrest. In this case, call your doctor immediately!

If you forget to take Palexia prolonged-release tablets
If you forget to take your tablets, your pain may 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 Palexia prolonged-release tablets
If you stop or discontinue treatment too early, your pain may return. If you wish to stop treatment due to side effects, consult your doctor.
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 treatment is stopped abruptly.
Symptoms may include:

• nervousness, tearing, runny nose, yawning, 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 tells 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 everyone experiences them.
Serious side effects or symptoms to which attention should be paid, and what to do if they occur:
this medicine may cause allergic reactions. Symptoms may include shortness of breath, wheezing, swelling of the eyelids, face or lips, skin rash or itching, especially affecting the entire body. Another serious side effect is slowed breathing or more pronounced shortness of breath than expected. This occurs mainly in elderly or weak patients.
In such 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): decreased appetite, anxiety, depression, sleep disorders, nervousness, restlessness, attention disturbances, tremor, involuntary 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 (edema).
Uncommon (may affect up to 1 in 100 people): allergic reactions to the medicine (including subcutaneous edema, urticaria, and in severe cases, breathing difficulties, drop in blood pressure, collapse or shock), weight loss, disorientation, confusion, excitability (agitation), disturbances in perception, strange dreams, euphoria, reduced level of consciousness, memory impairment, mental dulling, feeling faint, sedation, balance disorders, 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 “When stopping treatment with Palexia”), abnormal sensations, irritability.
Rare (may affect up to 1 in 1,000 people): drug dependence, abnormal thoughts, epileptic seizures, feeling faint, abnormal coordination, dangerous slowing of breathing or shortness of breath (respiratory depression), problems with gastric emptying, feeling drunk, sensation of relaxation.
Frequency not known: delirium.
Generally, the likelihood of having suicidal thoughts or behaviour 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 data on its use 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 may also report side effects directly via the national reporting system at the following website: 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 Palexia prolonged-release tablets

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. The expiry date refers to the last day of the month indicated.
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 no longer required. This will help protect the environment.

6. Package contents and other information

What Palexia prolonged-release tablets contain
The active substance is: tapentadol
Each tablet contains 50 mg of tapentadol (equivalent to 8.24 mg of tapentadol hydrochloride)
Each tablet contains 100 mg of tapentadol (equivalent to 116.48 mg of tapentadol hydrochloride)
Each tablet contains 150 mg of tapentadol (equivalent to 174.72 mg of tapentadol hydrochloride)
Each tablet contains 200 mg of tapentadol (equivalent to 232.96 mg of tapentadol hydrochloride)
Each tablet contains 250 mg of tapentadol (equivalent to 291.20 mg of tapentadol hydrochloride)
The other components are:
[50 mg]:
Tablet core: hypromellose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.
Tablet coating: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene glycol,
titanium dioxide (E 171)
[100 mg]:
Tablet core: hypromellose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.
Tablet coating: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene glycol,
titanium dioxide (E 171), yellow iron oxide (E 172)
[150 mg]:
Tablet core: hypromellose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.
Tablet coating: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene glycol,
titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172)
[200 mg]:
Tablet core: hypromellose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.
Tablet coating: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene glycol,
titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172)
[250 mg]:
Tablet core: hypromellose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.
Tablet coating: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene glycol,
titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172)

Description of the appearance of Palexia prolonged-release tablets and pack sizes
[50 mg]: oval-shaped, film-coated tablets, white in colour (6.5 mm x 15 mm), marked with the Grünenthal logo on one side and “H1” on the other.
[100 mg]: oval-shaped, film-coated tablets, light yellow in colour (6.5 mm x 15 mm), marked with the Grünenthal logo on one side and “H2” on the other.
[150 mg]: oval-shaped, film-coated tablets, light pink in colour (6.5 mm x 15 mm), marked with the Grünenthal logo on one side and “H3” on the other.
[200 mg]: oval-shaped, film-coated tablets, light orange in colour (7 mm x 17 mm), marked with the Grünenthal logo on one side and “H4” on the other.
[250 mg]: oval-shaped, film-coated tablets, reddish-brown in colour (7 mm x 17 mm), marked with the Grünenthal logo on one side and “H5” on the other.
Palexia prolonged-release tablets are packaged in blisters in pack sizes of 7, 10, 10x1, 14, 14x1, 20, 20x1, 24, 28, 28x1, 30, 30x1, 40, 50, 50x1, 54, 56, 56x1, 60, 60x1, 90, 90x1, 100 and 100x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Grünenthal Italia S.r.l. Via Carlo Bo, 11 20143 Milano
Responsible manufacturer for batch release:
Grünenthal GmbH, Zieglerstrasse, 6 Aachen Germany
Farmaceutici Formenti S.p.A., via Di Vittorio 2 Origgio - Italy

This medicinal product is authorised in the European Economic Area member states under the following names:
Austria, Belgium, Croatia, Cyprus, Czech Republic, Germany, Greece, Luxembourg, Netherlands, Poland, Portugal, Slovakia, Spain: PALEXIA retard
Denmark, Finland, Norway, Sweden: PALEXIA Depot
France: PALEXIA LP
Ireland, United Kingdom, Slovenia: PALEXIA SR
Italy: Palexia

Patient information leaflet

Palexia 50 mg film-coated tablets, 75 mg film-coated tablets, 100 mg film-coated tablets

Tapentadol
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, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist (see section 4).

Contents of this leaflet:

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

1. What Palexia is and what it is used for

Tapentadol, the active substance in Palexia, is a strong analgesic belonging to the opioid class.
Palexia is used for the treatment of moderate to severe acute pain in adults which can be adequately managed only with opioid analgesics.

2. What you need to know before using Palexia

Do not use P alexia

• 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 from alcohol, sleeping medicines, painkillers or other psychotropic medicines (medicines that affect mood and emotions) (see "Other medicines and Palexia")

Warnings and precautions
Talk to your doctor or pharmacist before taking Palexia:

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

Palexia may lead to physical and psychological dependence. If you have a tendency to abuse medicines or if you are drug-dependent, you should take this medicine only for short periods and under strict medical supervision.
Sleep-related breathing disorders
Palexia contains an active substance belonging to the group of opioids. Opioids may cause sleep-related breathing disorders, such as central sleep apnea (shallow breathing/pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood).
The risk of central sleep apnea occurring depends on the dose of opioids. Your doctor may consider reducing the total opioid dosage if central sleep apnea occurs.
Other medicines and Palexia
Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines.
The risk of side effects increases if you are taking medicines that can cause seizures (fits), such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take Palexia together with these medicines. Your doctor will advise you whether you can take Palexia.
The concomitant use of Palexia and sedative medicines such as benzodiazepines or similar medicines (some sleeping medicines or tranquilizers (such as barbiturates), painkillers such as opioids, morphine and codeine (also used in cough suppressants), antipsychotics, H1 antihistamines, alcohol) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered if no other therapeutic options are possible. However, if your doctor prescribes Palexia together with sedative medicines, he/she will also determine a reduction in dose and duration of concomitant treatment.
Inform your doctor about all sedative medicines you are taking and follow his/her dosage 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 (such as certain medicines for the treatment of depression), talk to your doctor before taking Palexia, because cases of "serotonin syndrome" have been reported. Serotonin syndrome is rare but potentially life-threatening. Symptoms include uncontrollable rhythmic muscle contractions including those controlling eye movements, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tone and body temperature above 38°C. Your doctor will inform you about this.
The use of Palexia together with other types of medicines known as μ-receptor agonist/antagonists (such as pentazocine, nalbuphine) or partial μ-opioid receptor agonists (such as buprenorphine) has not been studied. Palexia may not be effective if taken together with any of these medicines. Inform your doctor if you are taking any of these medicines.
Taking Palexia together with certain medicines (such as rifampicin, phenobarbital, St. John's wort), strong inhibitors or inducers of certain enzymes needed to eliminate tapentadol from the body, may affect the efficacy of tapentadol and may cause side effects, especially at the beginning or end of treatment with these medicines. Keep your doctor informed about all medicines you are taking.
Palexia 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.
Palexia with food, drinks and alcohol
Do not drink alcohol during treatment with Palexia, as some side effects, such as drowsiness, may increase. Food does not affect the efficacy 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 using this medicine.
Do not take these tablets:

• if you are pregnant, unless your doctor has specifically instructed you to do so; prolonged use of tapentadol during pregnancy may cause withdrawal symptoms in the newborn, which may be life-threatening if not recognized and treated by a doctor.
• during childbirth, because the newborn's breathing may become dangerously slow or weak (respiratory failure),
• during breastfeeding, because the medicine may be excreted in breast milk.

Driving and using machines:
Palexia may cause drowsiness, dizziness and blurred vision and may reduce reaction time. This may especially occur when starting treatment with Palexia, when your doctor changes your dose, or when you drink alcohol or take tranquilizers. Ask your doctor whether you can drive or operate machinery.
Palexia contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to use Palexia

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Your doctor will determine 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 1 tablet every 4–6 hours. Total daily doses of Palexia exceeding 700 mg of tapentadol on the first day of treatment and exceeding 600 mg of tapentadol on subsequent days 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, elimination of tapentadolo may be slowed in some patients in this group. If this applies to you, your doctor may prescribe a different dosage.

Liver and kidney disorders (insufficiency)
Patients with severe liver problems must not take these tablets. If you have mild to moderate liver problems, your doctor will prescribe an adjusted dosage. In patients with mild liver impairment, dosage adjustment is not necessary.

Patients with severe kidney problems must not take these tablets. In patients with mild or moderate kidney impairment, dosage adjustment is not necessary.

Use in children and adolescents
Palexia is not suitable for children and adolescents under 18 years of age.

How and when to take Palexia
Palexia is for oral use.
Always swallow the tablets with sufficient liquid.
You may take the tablets on an empty stomach or with food.

Duration of treatment
Do not take the tablets for longer than prescribed by your doctor.

If you take more Palexia 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, dangerously slow and shallow breathing, or respiratory arrest. In such cases, call your doctor immediately.

If you forget to take Palexia
If you forget to take a dose, your pain may 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 Palexia
If you stop or discontinue treatment too early, your pain may return. If you wish to stop treatment due to side effects, consult your doctor.

Generally, withdrawal effects do not occur when stopping treatment. However, in rare cases, people 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, chills, muscle pain, and dilated pupils,
• Irritability, anxiety, backache, joint pain, weakness, abdominal cramps, difficulty sleeping, nausea, loss of appetite, vomiting, diarrhea, and increased blood pressure, breathing rate, or heart rate.

If you experience any of these symptoms after stopping treatment, consult your doctor. You should not stop taking this medicine abruptly, unless your doctor tells you otherwise. If your doctor advises you to stop taking the tablets, they will instruct 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 everyone will experience them.
Serious side effects or symptoms to pay attention to, and what to do if they occur:
this medicine may cause allergic reactions. Symptoms may include shortness of breath, wheezing, 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 such cases, contact your doctor immediately.
Other possible side effects are:
Very common (may affect more than 1 in 10 people): nausea, vomiting, dizziness, drowsiness, headache
Common (may affect up to 1 in 10 people): loss of appetite, anxiety, confusion, hallucinations, sleep disturbances, strange dreams, tremors, hot flushes, constipation, diarrhoea, indigestion, dry mouth, itching, increased sweating, rash, muscle cramps, feeling weak, fatigue, sensation of temperature fluctuations.
Uncommon (may affect up to 1 in 100 people): depression, disorientation, excitability (agitation), nervousness, restlessness, euphoria, attention disturbances, memory impairment, feeling faint, sedation, difficulty controlling movements, difficulty speaking, numbness, abnormal skin sensations (e.g. tingling, pricking), involuntary muscle contractions, blurred vision, increased heart rate, palpitations, low blood pressure, dangerously slowed breathing or shortness of breath (respiratory depression), reduced oxygen levels in the blood, slowed breathing, abdominal discomfort, urticaria, feeling of heaviness, difficulty urinating, increased frequency of urination, withdrawal syndrome (see “If you stop taking Palexia”), fluid accumulation in tissues (oedema), strange sensations, feeling drunk, irritability, sensation of relaxation.
Rare (may affect up to 1 in 1,000 people): allergic reactions to the medicine, including subcutaneous oedema and urticaria, and in severe cases, difficulty breathing, drop in blood pressure, collapse or shock; strange thoughts, epileptic seizures, reduced level of consciousness, abnormal coordination, slowed heart rate, problems with gastric emptying.
Frequency not known: delirium
Generally, the likelihood of having suicidal thoughts or behaviour 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 on tapentadol 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 Palexia

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the blister. The expiry date refers to the last day of that indicated 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. These measures help protect the environment.

6. Package contents and other information

What Palexia contains
The active substance is: tapentadol
Each tablet contains 50 mg of tapentadol (equivalent to 58.24 mg of tapentadol hydrochloride)
Each tablet contains 75 mg of tapentadol (equivalent to 87.36 mg of tapentadol hydrochloride)
Each tablet contains 100 mg of tapentadol (equivalent to 116.48 mg of tapentadol hydrochloride)
The other components are:
[50 mg]:
Tablet core: microcrystalline cellulose, monohydrate lactose, sodium carmellose, povidone K30,
magnesium stearate.
Tablet coating: polyvinyl alcohol, titanium dioxide, macrogol 3350, talc
[75 mg]:
Tablet core: microcrystalline cellulose, monohydrate lactose, sodium carmellose, povidone K30,
magnesium stearate.
Tablet coating: polyvinyl alcohol, titanium dioxide, macrogol 3350, talc,
yellow iron oxide (E172), red iron oxide (E172)
[100 mg]:
Tablet core: microcrystalline cellulose, monohydrate lactose, sodium carmellose, povidone K30,
magnesium stearate.
Tablet coating: polyvinyl alcohol, titanium dioxide, macrogol 3350, talc,
yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172)

Description of the appearance of Palexia and package contents
[50 mg]: white, round, film-coated tablets, 7 mm in diameter, marked with the Grünenthal logo on one side and “H6” on the other.
[75 mg]: light yellow, round, film-coated tablets, 8 mm in diameter, marked with the Grünenthal logo on one side and “H7” on the other.
[100 mg]: light pink, round, film-coated tablets, 9 mm in diameter, marked with the Grünenthal logo on one side and “H8” on the other.
Palexia prolonged-release tablets are packaged in blisters, in pack sizes of 5, 10, 10x1, 14, 14x1, 20, 20x1, 24, 28, 28x1, 30, 30x1, 40, 50, 50x1, 54, 56, 56x1, 60, 60x1, 90, 90x1, 100 and 100x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder: Grűnenthal Italia S.r.l., Via Carlo Bo, 11, 20142 Milano, Italy
Responsible manufacturer for batch release:
Grünenthal GmbH, Zieglerstrasse, 6, Aachen, Germany
Farmaceutici Formenti S.p.A., via Di Vittorio 2, Origgio, Italy

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany: Palexia Akutschmerz
Austria, Belgium, Croatia, Cyprus, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Norway,
Netherlands, Poland, Portugal, United Kingdom, Czech Republic, Slovakia, Slovenia, Spain, Sweden:
PALEXIA

This leaflet was last updated on:

Package leaflet: Information for the user

Palexia 4 mg/ml oral solution

Tapentadol
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, consult your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist (see section 4).

Contents of this leaflet:

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

1. What PALEXIA is and what it is used for

Tapentadol, the active substance in Palexia, is a strong analgesic belonging to the opioid class.
Palexia is used for the treatment of moderate to severe acute pain in children and adolescents from 2 years of age and in adults who can be adequately treated only with opioid analgesics.

2. What you need to know before taking PALEXIA

Do not take P alexia

• If you are allergic to tapentadol or any of the other ingredients of this medicine (see 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 from alcohol, sleeping medicines, painkillers or other psychotropic medicines (medicines that affect mood and emotions) (see "Other medicines and Palexia")

Warnings and precautions
Talk to your doctor or pharmacist before taking Palexia if:

• you have short or weak breathing
• you suffer from increased pressure in the brain or disturbances of consciousness, up to coma
• you have had head injuries or a brain tumor
• you suffer from liver or kidney problems (see "How to take Palexia")
• you suffer from disorders of the pancreas or biliary tract, including pancreatitis
• you are taking medicines called opioid agonist/antagonists (such as pentazocine, nalbuphine) or partial mu-opioid receptor agonist medicines (such as buprenorphine)
• you are prone to epilepsy or seizures, or if you are taking other medicines known to increase the risk of seizures, because the risk of a seizure may increase
• you or a family member has ever abused or been dependent on alcohol, prescription medicines or illegal substances (“addiction”)
• you are a smoker
• you have had mood disorders (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental illnesses

This medicine contains tapentadol, which is an opioid medicine. Repeated use of opioid painkillers may lead to reduced effectiveness of the medicine (you may become accustomed to it). It may also cause dependence and abuse, which can lead to potentially life-threatening overdose. Ask your doctor for advice if you are concerned about developing dependence on Palexia. Use (even at therapeutic doses) may lead to physical dependence, resulting in withdrawal symptoms and a recurrence of problems if treatment with this medicine is stopped suddenly.
Palexia may lead to physical and psychological dependence. If you have a tendency to abuse medicines or are dependent on medicines, you should take this medicine only for short periods and under strict medical supervision.
Obese children should be closely monitored and the maximum recommended dose must not be exceeded.
Do not give this medicine to children under 2 years of age.
Sleep-related breathing disorders
Palexia may cause sleep-related breathing disorders, such as sleep apnoea (breathing pauses during sleep) and sleep-related hypoxemia (low levels of oxygen in the blood). Symptoms may include breathing pauses during sleep, nighttime awakenings due to breathlessness, 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 Palexia
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 (fits), such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take Palexia together with these medicines. Your doctor will tell you whether you can take Palexia.
• Taking Palexia together with sedative medicines such as benzodiazepines or similar medicines (some sleeping medicines or tranquilizers (such as barbiturates), painkillers such as opioids, morphine and codeine (also used in cough preparations), antipsychotics, H1 antihistamines, alcohol) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and may be life-threatening. For this reason, concomitant use should only be considered if no other therapeutic options are available. However, if your doctor prescribes Palexia together with sedative medicines, he or she will also determine a reduced dose and duration of concomitant treatment.

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 life-threatening.
Inform your doctor if you are taking gabapentin or pregabalin or other sedative medicines and follow
his or her dose recommendations carefully. It may be helpful to inform family members or friends to
pay attention to 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 (such as certain medicines for depression), talk to your doctor before taking Palexia, as cases of "serotonin syndrome" have been reported. Serotonin syndrome is rare but potentially life-threatening. Symptoms include uncontrolled rhythmic muscle contractions including muscles controlling eye movements, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tone and body temperature above 38°C. Your doctor can inform you about this.
• Taking Palexia together with other types of medicines known as mixed mu-receptor agonist/antagonists (such as pentazocine and nalbuphine) or partial mu-opioid receptor agonists (such as buprenorphine) has not been studied. Palexia may not be effective if taken together with one of these medicines. Inform your doctor if you are taking any of these medicines.
• Taking Palexia together with certain medicines (such as rifampicin, phenobarbital, St. John's wort), strong inhibitors or inducers of certain enzymes required to eliminate tapentadol from the body, may affect the effectiveness of tapentadol or may cause side effects, especially at the beginning or end of treatment with these medicines. Keep your doctor informed about all medicines you are taking.
• Palexia 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.

Palexia with food, drinks and alcohol
Do not drink alcohol during treatment with Palexia, as some side effects such as drowsiness may increase. Food does not affect the effectiveness of this medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine:

• if you are pregnant, unless your doctor has specifically instructed you to do so; prolonged use of tapentadol during pregnancy may cause withdrawal symptoms in the newborn, which may be life-threatening if not recognized and treated by a doctor.

Use of Palexia is not recommended

• during childbirth, because the newborn's breathing may slow down or become dangerously weak (respiratory failure)
• during breastfeeding, because tapentadol may be excreted in breast milk.

Driving and using machines
Palexia may cause drowsiness, dizziness and blurred vision and may impair reaction time. This may especially occur when starting treatment with Palexia, when your doctor changes your dose, or if you drink alcohol or take tranquilizers. Ask your doctor whether you can drive or operate machinery.
Palexia 4 mg/ml contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per maximum single dose, i.e. essentially "sodium-free".
Palexia 4 mg/ml contains sodium benzoate
This medicine contains 59 mg of sodium benzoate per volume unit, equivalent to 2.4 mg/ml. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).
Palexia 4 mg/ml contains propylene glycol
This medicine contains 48 mg of propylene glycol in 25 ml of solution (maximum single dose), equivalent to 2 mg/ml.

3. How to take PALEXIA

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Your doctor will decide the dosage based on the intensity of the pain and your individual sensitivity to pain.
Generally, the lowest effective dose that relieves pain should be used.
Adults
The usual dose is 50 mg of tapentadol (12.5 ml of oral solution), 75 mg of tapentadol (18.75 ml of oral
solution), or 100 mg of tapentadol (25 ml of oral solution) every 4–6 hours.
Total daily doses exceeding 700 mg of tapentadol on the first day of treatment and exceeding 600 mg of
tapentadol on subsequent days 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 this medicine 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, excretion of
tapentadol may be slowed in some patients in this age group. If this applies to you, your doctor may prescribe
a different dosage.
Hepatic and renal disorders (insufficiency)
Patients with severe liver problems must not take this medicine. If you have mild liver problems, your doctor
will prescribe a different dosage. No dosage adjustment is necessary in patients with mild liver impairment.
Patients with severe kidney problems must not take this medicine. No dosage adjustment is necessary in
patients with mild or moderate renal impairment.
Use in children and adolescents
Palexia should be administered to children only in a hospital setting.
The dosage of Palexia in children and adolescents from 2 years up to but less than 18 years of age is 1.25
mg/kg every 4 hours.
Always wait 4 hours before administering the next dose. The dose may be reduced as acute pain decreases.
The correct dosage will be determined by the doctor.
Hepatic and renal disorders (insufficiency)
Children and adolescents with liver or kidney problems must not take this medicine.
How and when to take Palexia
Palexia is for oral use.
You may take the oral solution on an empty stomach or with food.
A dosing syringe with an attached adapter is included in the package and must be used to withdraw the
exact amount (volume) corresponding to the prescribed dose of tapentadolo from the bottle.
Instructions for opening the bottle and using the dosing syringe

The bottle is equipped with a child-resistant cap. To remove the cap, press firmly downward and
turn counterclockwise. (Fig.1). Remove the cap and discard the seal from the bottle neck. If the
seal is damaged, do not use the medicine and contact your pharmacist.
Place the bottle on a stable, flat surface. Open the plastic pouch containing the

dosing syringe/adapter by tearing along the perforated line and remove the dosing syringe (A)
with the attached adapter (B). Firmly insert the dosing syringe, via the adapter end, into the
bottle neck (Fig.2)

To fill the dosing syringe, invert the bottle. While holding the syringe steady, pull the plunger (C)
downward until the mark corresponding to the dose prescribed by your doctor is reached (see
section “How to use Palexia”). Do not remove the dosing syringe at this point! (Fig.3)

Turn the bottle upright again, carefully remove the dosing syringe from the bottle. After
removing the syringe, carefully check that you have drawn up the correct dose of solution. The
adapter (B), which was previously attached to the dosing syringe, will now remain attached to
the bottle (Fig.4).
Take the medicine by placing the dosing syringe in your mouth and pushing the plunger. Press

the plunger fully to ensure that all the solution is used. If preferred, you may dilute the
medicine in a glass of water or non-alcoholic beverage before taking it; in this case, drink the
entire glass to ensure you receive the full dose of medicine. (Fig.5).
Leave the adapter attached to the bottle, replace the cap tightly, and store the bottle upright. Rinse the dosing
syringe with water after use and allow it to dry thoroughly. When taking the medicine next time, insert the
dosing syringe into the adapter on the bottle neck and follow the instructions above.
How long to take Palexia
Do not take this medicine longer than prescribed by your doctor.
If you take more Palexia 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), epileptic seizures, dangerously slow and shallow breathing, or respiratory arrest.

In such cases, contact your doctor immediately.
If you forget to take Palexia
If you forget to take this medicine, your pain may return. Do not take a double dose to make up for the
missed dose; simply continue taking the medicine as previously scheduled.
If you stop taking Palexia
If you stop or end treatment too early, your pain may return. If you wish to discontinue treatment, consult
your doctor first.
Generally, withdrawal effects do not occur when stopping treatment. However, in rare cases, individuals who
have taken the medicine for some time may feel unwell if treatment is stopped abruptly.
Symptoms may include:

• restlessness, tearing, 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 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 abruptly unless your doctor tells you otherwise. If your doctor decides to discontinue treatment, they will advise you on 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.
Serious side effects or symptoms to which you should pay attention, and what to do if they occur:
This medicine can cause allergic reactions. Symptoms may include shortness of breath, wheezing, swelling of the eyelids, face or lips, skin rash or itching, especially affecting the whole body. Another serious side effect is a condition in which you feel very drowsy and breathe more slowly or more shallowly than expected. This occurs mainly in elderly or weak patients.
In such cases, contact your doctor immediately.
Other possible side effects are:
Very common (may affect more than 1 in 10 people): nausea, vomiting, dizziness, drowsiness, headache
Common (may affect up to 1 in 10 people): decreased appetite, anxiety, confusion, hallucinations, sleep disturbances, unusual dreams, tremors, hot flushes, constipation, diarrhoea, indigestion, dry mouth, itching, increased sweating, rash, muscle cramps, feeling weak, fatigue, sensation of temperature fluctuations.
Uncommon (may affect up to 1 in 100 people): depression, disorientation, excitability (agitation), nervousness, restlessness, euphoria, attention disturbances, memory impairment, feeling faint, sedation, difficulty controlling movements, difficulty speaking, numbness, abnormal skin sensations (e.g. tingling, pricking), involuntary muscle contractions, distorted vision, rapid heartbeat, palpitations, low blood pressure, dangerous slowing or shallow breathing (respiratory depression), reduced oxygen levels in the blood, slowed breathing, abdominal discomfort, urticaria, feeling of heaviness, difficulty urinating, increased frequency of urination, withdrawal syndrome (see "If you stop taking Palexia"), fluid accumulation in tissues (oedema), unusual sensations, feeling drunk, irritability, sensation of relaxation.
Rare (may affect up to 1 in 1,000 people): allergic reactions to the medicine (including swelling under the skin, urticaria, and in severe cases, difficulty breathing, drop in blood pressure, collapse or shock), unusual thoughts, epileptic seizures, reduced level of consciousness, abnormal coordination, slow heartbeat, problems with stomach emptying.
Frequency not known: delirium.
Generally, the likelihood of having suicidal thoughts or behaviour 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 also acts on neurotransmission, clinical use data on tapentadol do not show an increased risk.
No additional side effects have been observed in children and adolescents
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. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store PALEXIA

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 on the bottle after EXP.
The expiry date refers to the last day of that month.
Closed package: this medicine requires no special storage conditions.
After first opening of the bottle, the solution must not be used for more than 6 weeks.
Keep the bottle in an upright position after first opening.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Package contents and other information

What Palexia contains
The active substance is tapentadol.
1 ml of Palexia 4 mg/ml oral solution contains 4 mg of tapentadol (as hydrochloride).
The other components are:
sodium benzoate (E 211),
citric acid monohydrate,
sucralose (E 955),
raspberry flavour containing propylene glycol (E 1520),
purified water.

Description of the appearance of Palexia and contents of the pack
Palexia is a clear, colourless oral solution.
Palexia 4 mg/ml oral solution is supplied in a plastic bottle containing 100 millilitres of solution, with an attached 5 ml dosing syringe graduated in 0.1 ml increments and an adapter inserted into the dosing syringe.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Holder: GRÜNENTHAL ITALIA S.r.l., Vittor Pisani, 16, 20124 Milan (Italy)

Manufacturer responsible for batch release
Grünenthal GmbH,
Zieglerstrasse, 6, Aachen,
Germany

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Belgium, Croatia, Cyprus, Germany, Greece, Ireland, Italy, Luxembourg, Norway, Netherlands, Poland, Portugal, United Kingdom (Northern Ireland), Czech Republic, Slovakia, Slovenia, Spain: PALEXIA

This leaflet was last updated on:

Package leaflet: Information for the user

Palexia 20 mg/ml oral solution

Tapentadol
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet; you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist (see section 4).

Contents of this leaflet:

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

1. What PALEXIA is and what it is used for

Tapentadol, the active substance in Palexia, is a strong analgesic belonging to the opioid class.
Palexia is used for the treatment of moderate to severe acute pain in children and adolescents from 2 years of age with body weight above 16 kg, and in adults who can only be adequately managed with opioid analgesics.

2. What you should know before taking PALEXIA

Do not take P alexia

• If you are allergic to tapentadol or to any of the other ingredients of this medicine (see 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 Palexia")

Warnings and precautions
Talk to your doctor or pharmacist before taking Palexia if:

• you have shortness of breath or weak breathing
• you suffer from increased pressure in the brain or disturbances of consciousness, up to coma
• you have had head injuries or a brain tumor
• you suffer from liver or kidney problems (see "How to take Palexia")
• you suffer from disorders of the pancreas or biliary tract, including pancreatitis
• you are taking medicines called opioid agonist/antagonists (such as pentazocine, nalbuphine) or partial mu-opioid receptor agonist medicines (such as buprenorphine)
• 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 seizure may increase
• you or a family member has ever abused or been dependent on alcohol, prescription medicines, or illegal substances ("addiction")
• you are a smoker
• you have had mood disorders (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses

This medicine contains tapentadol, which is an opioid medicine. Repeated use of opioid painkillers may lead to reduced effectiveness of the drug (you may become accustomed to it). It may also cause dependence and abuse, which could lead to potentially life-threatening overdose. Ask your doctor for advice if you are concerned about developing dependence on Palexia. Use (even at therapeutic doses) may lead to physical dependence, resulting in withdrawal symptoms and recurrence of problems if treatment with this medicine is stopped abruptly.
Palexia may lead to physical and psychological dependence. If you have a tendency to abuse medicines or are dependent on medicines, you should take this medicine only for short periods and under strict medical supervision.
Children affected by obesity should be closely monitored and the recommended maximum dose must not be exceeded.
Do not give this medicine to children under 2 years of age or with a body weight below 16 kg.

Sleep-related breathing disorders
Palexia 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, nighttime awakenings due to breathlessness, 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 Palexia
Inform 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 (fits), such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take Palexia together with these medicines. Your doctor will advise you whether you can take Palexia.
• The concomitant use of Palexia and sedative medicines such as benzodiazepines or similar medicines (some sleeping medicines or tranquilizers (such as barbiturates), painkillers such as opioids, morphine and codeine (also used in cough preparations), antipsychotics, H1 antihistamines, alcohol) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered if no other therapeutic options are available. However, if your doctor prescribes Palexia together with sedative medicines, they will also establish 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 relatives 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 (such as certain medicines for the treatment of depression), discuss this with your doctor before taking Palexia, as cases of "serotonin syndrome" have been reported. Serotonin syndrome is rare but potentially life-threatening. Symptoms include uncontrolled rhythmic muscle contractions including those controlling eye movements, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle stiffness, and body temperature above 38°C. Your doctor can provide further information on this.
• The use of Palexia together with other types of medicines known as mixed mu-receptor agonist/antagonists (such as pentazocine and nalbuphine) or partial mu-opioid receptor agonists (such as buprenorphine) has not been studied. Palexia may not be effective if taken together with any of these medicines. Inform your doctor if you are taking any of these medicines.
• Taking Palexia together with certain medicines (such as rifampicin, phenobarbital, St. John's wort), strong inhibitors or inducers of enzymes necessary for eliminating tapentadol from the body, may affect the effectiveness of tapentadol or may cause side effects, especially at the beginning or end of treatment with these medicines. Keep your doctor informed about all medicines you are taking.
• Palexia 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.

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist 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 cause withdrawal symptoms in the newborn, which may be life-threatening if not recognized and treated by a doctor.

The use of Palexia is not recommended:

• during childbirth, because the newborn's breathing may slow down or become dangerously weak (respiratory failure)
• during breastfeeding, because tapentadol may be excreted in breast milk.

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

Palexia 20 mg/ml contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per maximum single dose, i.e. essentially "sodium-free".

Palexia 20 mg/ml contains sodium benzoate
This medicine contains 5.9 mg of benzoate salt in 5 ml of solution (maximum single dose), equivalent to 1.18 mg/ml.
The benzoate salt may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

Palexia 20 mg/ml contains propylene glycol
This medicine contains 10 mg of propylene glycol in 5 ml of solution (maximum single dose), equivalent to 2 mg/ml.

3. How to take PALEXIA

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Your doctor will determine 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 of tapentadol (2.5 ml of oral solution), 75 mg of tapentadol (3.75 ml of oral solution), or 100 mg of tapentadol (5 ml of oral solution) every 4–6 hours.
Total daily doses exceeding 700 mg of tapentadol on the first day of treatment and exceeding 600 mg of tapentadol on subsequent days are not recommended.
Your doctor may prescribe a different dosage or dosing interval if necessary. If you feel that the effect of this medicine 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, excretion of tapentadolo may be slowed in some patients in this age group. If this applies to you, your doctor may prescribe a different dosage.
Hepatic and renal impairment (insufficiency)
Patients with severe liver problems must not take this medicine. If you have mild liver impairment, your doctor may prescribe a different dosage. No dosage adjustment is necessary for mild liver problems.
Patients with severe kidney problems must not take this medicine. No dosage adjustment is necessary for mild or moderate kidney problems.
Use in children and adolescents
Palexia should be administered to children only in a hospital setting.
Palexia should only be given to children weighing more than 16 kg.
The dosage of Palexia in children and adolescents aged 2 years up to but less than 18 years is 1.25 mg/kg every 4 hours.
Always wait 4 hours before administering the next dose. The dose may be reduced as acute pain decreases.
The correct dosage will be determined by the doctor.
Hepatic and renal impairment (insufficiency)
Children and adolescents with liver or kidney problems must not take this medicine.
How and when to take Palexia
Palexia is for oral use.
You may take the oral solution on an empty stomach or with food.
The package contains a dosing syringe with an attached adapter, which must be used to withdraw the exact amount (volume) corresponding to the prescribed dose of tapentadol from the bottle.
Instructions for opening the bottle and using the dosing syringe

The bottle is equipped with a child-resistant cap. To remove the cap, press down firmly and turn counterclockwise (Fig. 1). Remove the cap and discard the seal from the mouth of the bottle. If the seal is damaged, do not use the medicine and contact your pharmacist.
Place the bottle on a stable, flat surface. Open the plastic pouch containing the

dosing syringe/adapter along the perforated line, and remove the dosing syringe (A) with the attached adapter (B). Firmly insert the dosing syringe, with the adapter end, into the neck of the bottle (Fig. 2).

To fill the dosing syringe, invert the bottle. While holding the dosing syringe steady, pull the plunger (C) down until it reaches the mark corresponding to the dose prescribed by your doctor (see section “How to use Palexia”). Do not remove the dosing syringe at this time! (Fig. 3)

Turn the bottle upright again, carefully remove the dosing syringe from the bottle. After removing the syringe, carefully check that you have drawn up the correct dose of solution. The adapter (B), which was previously attached to the dosing syringe, will now remain on the bottle (Fig. 4).
Take the medicine by placing the dosing syringe in your mouth and pressing the plunger. Press the

plunger fully to ensure that all the solution has been used. If preferred, you may dilute the medicine in a glass of water or non-alcoholic drink before taking it; in this case, drink the entire glass to ensure you receive the full dose of medicine (Fig. 5).
Leave the adapter on the bottle, close it tightly with the cap, and store the bottle upright. Rinse the dosing syringe with water after use and allow it to dry thoroughly. The next time you take the medicine, insert the dosing syringe into the adapter on the bottle neck and follow the instructions above.
How long to take Palexia
Do not take this medicine for longer than prescribed by your doctor.
If you take more Palexia 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, dangerously slow and shallow breathing, or respiratory arrest. In such cases, contact a doctor immediately.

If you forget to take Palexia
If you forget to take this medicine, your pain may return. Do not take a double dose to make up for the missed dose; simply continue taking the medicine as before.
If you stop taking Palexia
If you stop or discontinue treatment too early, your pain may return. If you wish to stop treatment, consult your doctor first.
Generally, withdrawal effects do not occur when stopping treatment. However, in uncommon cases, individuals who have taken the medicine for a prolonged period may feel unwell if treatment is stopped abruptly.
Symptoms may include:

• restlessness, tearing, runny nose, yawning, sweating, chills, muscle aches, and dilated pupils
• irritability, anxiety, back pain, joint pain, weakness, abdominal cramps, difficulty sleeping, nausea, loss of appetite, vomiting, diarrhea, 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 abruptly unless your doctor advises otherwise. If your doctor instructs you to discontinue this medicine, they will advise you on how to do so, which may include gradually reducing the dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Serious side effects or symptoms requiring attention and what to do if they occur:
This medicine may cause allergic reactions. Symptoms may include shortness of breath, wheezing, swelling of the eyelids, face or lips, skin rash or itching, especially widespread over the body. Another serious side effect is a condition in which you feel very drowsy and breathe more slowly or more shallowly than normal. This occurs mainly in elderly or weakened patients.
In such cases, contact your doctor immediately.

Other possible side effects are:

Very common (may affect more than 1 in 10 people): nausea, vomiting, dizziness, drowsiness, headache.

Common (may affect up to 1 in 10 people): decreased appetite, anxiety, confusion, hallucinations, sleep disturbances, strange dreams, tremors, hot flushes, constipation, diarrhoea, indigestion, dry mouth, itching, increased sweating, rash, muscle cramps, feeling weak, fatigue, sensation of temperature fluctuations.

Uncommon (may affect up to 1 in 100 people): depression, disorientation, excitability (agitation), nervousness, restlessness, euphoria, attention disturbances, memory impairment, feeling faint, sedation, difficulty controlling movements, difficulty speaking, numbness, abnormal skin sensations (e.g. tingling, pricking), involuntary muscle contractions, distorted vision, rapid heartbeat, palpitations, low blood pressure, dangerous slowing or shallow breathing (respiratory depression), reduced oxygen levels in the blood, slowed breathing, abdominal discomfort, urticaria, feeling of heaviness, difficulty urinating, increased frequency of urination, withdrawal syndrome (see "If you stop taking Palexia"), fluid accumulation in tissues (edema), unusual sensations, feeling drunk, irritability, sensation of relaxation.

Rare (may affect up to 1 in 1,000 people): allergic reactions to the medicine (including subcutaneous swelling, urticaria, and in severe cases, breathing difficulties, drop in blood pressure, collapse or shock), strange thoughts, epileptic seizures, reduced level of consciousness, abnormal coordination, slower heartbeat, problems with gastric emptying.

Frequency not known: delirium.

Generally, the risk of suicidal thoughts or behaviour increases in patients suffering from chronic pain. In addition, some medicines used to treat depression (which therefore affect the brain's neurotransmitter system) may increase this risk, especially at the beginning of treatment.

Although tapentadol also acts on neurotransmission, clinical use data for tapentadol do not show an increased risk.

No additional side effects have been observed in children and adolescents.

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 PALEXIA

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 bottle after EXP.
The expiry date refers to the last day of that month.
Unopened package: this medicine does not require any special storage conditions.
After first opening the bottle, the solution must not be used for more than 6 weeks.
Keep the bottle in an upright position after first opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and other information

What Palexia contains
The active substance is tapentadol.
1 ml of Palexia 20 mg/ml oral solution contains 20 mg of tapentadol (as hydrochloride).
The other components are:
sodium benzoate (E 211),
citric acid monohydrate,
sucralose (E 955),
raspberry flavour containing propylene glycol (E 1520),
sodium hydroxide (for pH adjustment),
purified water.

Description of the appearance of Palexia and the contents of the pack
Palexia is a clear, colourless oral solution.
Palexia 20 mg/ml oral solution is supplied in a plastic bottle containing 100 millilitres or 200 millilitres of solution, with an attached 5 ml dosing syringe with a scale graduated in 0.1 ml increments. Furthermore, the scale on the right side indicates the single dose for adults.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Marketing Authorisation Holder: GRÜNENTHAL ITALIA S.r.l., Vittor Pisani, 16 - 20124 Milan (Italy)

Responsible manufacturer for batch release
Grünenthal GmbH,
Zieglerstrasse, 6 Aachen
Germany

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Austria, Belgium, Croatia, Cyprus, Germany, Greece, Ireland, Italy, Luxembourg, Norway, Netherlands, Poland, Portugal, United Kingdom (Northern Ireland), Czech Republic, Slovakia, Slovenia, Spain: PALEXIA

This leaflet was last updated on: