TAPENTADOL 75mg

SUMMARY OF PRODUCT CHARACTERISTICS 
1 
NAME OF THE MEDICINAL PRODUCT 
Tapentadol 75 mg film-coated tablets 
2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each Tapentadol 75 mg film-coated tablet contains 87.36 mg Tapentadol hydrochloride 
equivalent to 75 mg Tapentadol. 
Excipients with known effect: 
Tapentadol 75 mg film-coated tablet contains 37.50 mg lactose monohydrate. 
For the full list of excipients, see section 6.1. 
3 
PHARMACEUTICAL FORM 
Film-coated tablet 
Tapentadol 75 mg appears yellow, round, convex, film-coated tablets plain on both sides, 
with diameter 8.0 mm. 
4 
4.1 
CLINICAL PARTICULARS 
Therapeutic indications 
Tapentadol is indicated for the relief of moderate to severe acute pain in adults, which can be 
adequately managed only with opioid analgesics. 
4.2 
Posology and method of administration 
Posology 
The dosing regimen should be individualised according to the severity of pain being treated, 
the previous treatment experience and the ability to monitor the patient. 
Patients should start treatment with single doses of 50 mg tapentadol as film-coated tablet 
administered every 4 to 6 hours. Higher starting doses may be necessary depending on the 
pain intensity and the patient’s previous history of analgesic requirements. 
On the first day of dosing, an additional dose may be taken as soon as one hour after the 
initial dose, if pain control is not achieved. The dose should then be titrated individually to a 
level that provides adequate analgesia and minimises undesirable effects under the close 
supervision of the prescribing physician. 
Total daily doses greater than 700 mg tapentadol on the first day of treatment and 
maintenance daily doses greater than 600 mg tapentadol have not been studied and are 
therefore not recommended. 
Duration of treatment 
The film-coated tablets are intended for acute pain situations. If longer term treatment is 
anticipated or becomes necessary and effective pain relief in the absence of intolerable 
adverse events was achieved with tapentadol, the possibility of switching the patient to 
therapy with tapentadol prolonged release tablets should be considered. As with all 
symptomatic treatments, the continued use of tapentadol must be evaluated on an ongoing 
basis. 
Discontinuation of treatment 
Withdrawal symptoms could occur after abrupt discontinuation of treatment with tapentadol 
(see section 4.8). When a patient no longer requires therapy with tapentadol, it may be 
advisable to taper the dose gradually to prevent symptoms of withdrawal. 
Renal impairment 
In patients with mild or moderate renal impairment a dosage adjustment is not required (see 
section 5.2). Tapentadol has not been studied in controlled efficacy trials in patients with 
severe renal impairment, therefore the use in this population is not recommended (see sections 
4.4 and 5.2). 
Hepatic impairment 
In patients with mild hepatic impairment a dosage adjustment is not required (see section 5.2). 
Tapentadol should be used with caution in patients with moderate hepatic impairment. 
Treatment in these patients should be initiated at the lowest available dose strength, i.e. 50 mg 
tapentadol as film-coated tablet, and not be administered more frequently than once every 8 
hours. At initiation of therapy a daily dose greater than 150 mg tapentadol as film-coated 
tablet is not recommended. Further treatment should reflect maintenance of analgesia with 
acceptable tolerability, to be achieved by either shortening or lengthening the dosing interval 
(see sections 4.4 and 5.2). 
Tapentadol has not been studied in patients with severe hepatic impairment and therefore, use 
in this population is not recommended (see sections 4.4 and 5.2). 
Elderly patients (persons aged 65 years and over) 
In general, a dose adaptation in elderly patients is not required. However, as elderly patients 
are more likely to have decreased renal and hepatic function, care should be taken in dose 
selection as recommended (see sections 4.2 and 5.2). 
Paediatric population 
The safety and efficacy of tapentadol in children and adolescents below 18 years of age has 
not yet been established. Therefore tapentadol is not recommended for use in this population. 
Method of administration 
Tapentadol should be taken with sufficient liquid. Tapentadol can be taken with or without 
food. 
4.3 
Contraindications 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
In situations where active substances with mu-opioid receptor agonist activity are 
contraindicated, i.e. patients with significant respiratory depression (in unmonitored settings 
or the absence of resuscitative equipment), and patients with acute or severe bronchial asthma 
or hypercapnia. 
In any patient who has or is suspected of having paralytic ileus. 
In patients with acute intoxication with alcohol, hypnotics, centrally acting analgesics, or 
psychotropic active substances (see section 4.5). 
4.4 
Special warnings and precautions for use 
Tolerance and Opioid Use Disorder (abuse and dependence) 
Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may 
develop 
upon repeated administration of opioids. Abuse or intentional misuse of opioids may result in 
overdose and/or death. The risk of developing OUD is increased in patients with a personal or 
a family history (parents or siblings) of substance use disorders (including alcohol use 
disorder), in current tobacco users or in patients with a personal history of other mental 
health disorders (e.g. major depression, anxiety and personality disorders). 
Patients will require monitoring for signs of drug-seeking behaviour (e.g. too early requests 
for refills). This includes the review of concomitant opioids and psycho-active drugs (like 
benzodiazepines). For patients with signs and symptoms of OUD, consultation with an 
addiction specialist should be considered. 
Risk from concomitant use of sedating medicinal products such as benzodiazepines or related 
substances 
Concomitant use of tapentadol and sedating medicinal products such as benzodiazepines or 
related substances may result in sedation, respiratory depression, coma and death. Because of 
these risks, concomitant prescribing with these sedating medicinal products should be 
reserved for patients for whom alternative treatment options are not possible. If a decision is 
made to prescribe tapentadol concomitantly with sedating medicinal products, the reduction 
of dose of one or both agents should be considered and the duration of the concomitant 
treatment should be as short as possible. 
The patients should be followed closely for signs and symptoms of respiratory depression and 
sedation. In this respect, it is strongly recommended to inform patients and their caregivers to 
be aware of these symptoms (see section 4.5). 
Respiratory depression 
At high doses or in mu-opioid receptor agonist sensitive patients, tapentadol may produce 
dose-related respiratory depression. Therefore, tapentadol should be administered with 
caution to patients with impaired respiratory functions. Alternative non-mu-opioid receptor 
agonist analgesics should be considered and tapentadol should be employed only under 
careful medical supervision at the lowest effective dose in such patients. If respiratory 
depression occurs, it should be treated as any mu-opioid receptor agonist-induced respiratory 
depression (see section 4.9). 
Head injury and increased intracranial pressure 
Tapentadol should not be used in patients who may be particularly susceptible to the 
intracranial effects of carbon dioxide retention such as those with evidence of increased 
intracranial pressure, impaired consciousness, or coma. Analgesics with mu-opioid receptor 
agonist activity may obscure the clinical course of patients with head injury. Tapentadol 
should be used with caution in patients with head injury and brain tumors. 
Seizures 
Tapentadol has not been systematically evaluated in patients with a seizure disorder, and such 
patients were excluded from clinical trials. However, like other analgesics with mu-opioid 
agonist activity tapentadol is not recommended in patients with a history of a seizure disorder 
or any condition that would put the patient at risk of seizures. In addition, tapentadol may 
increase the seizure risk in patients taking other medicinal products that lower the seizure 
threshold (see section 4.5). 
Renal impairment 
Tapentadol has not been studied in controlled efficacy trials in patients with severe renal 
impairment, therefore the use in this population is not recommended (see section 4.2 and 5.2). 
Hepatic impairment 
Subjects with mild and moderate hepatic impairment showed a 2-fold and 4.5-fold increase in 
systemic exposure, respectively, compared with subjects with normal hepatic function. 
Tapentadol should be used with caution in patients with moderate hepatic impairment (see 
section 4.2 and 5.2), especially upon initiation of treatment. 
Tapentadol has not been studied in patients with severe hepatic impairment and therefore, use 
in this population is not recommended (see sections 4.2 and 5.2). 
Use in pancreatic/Biliary tract disease 
Active substances with mu-opioid receptor agonist activity may cause spasm of the sphincter 
of Oddi. 
Tapentadol should be used with caution in patients with biliary tract disease, including acute 
pancreatitis. 
Sleep-related breathing disorders 
Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and 
sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. 
In patients who present with CSA, consider decreasing the total opioid dosage. 
Mixed opioid agonists/antagonists 
Care should be taken when combining tapentadol with mixed mu-opioid agonist/antagonists 
(like pentazocine, nalbuphine) or partial mu-opioid agonists (like buprenorphine). In patients 
maintained on buprenorphine for the treatment of opioid dependence, alternative treatment 
options (like e.g. temporary buprenorphine discontinuation) should be considered, if 
administration of full mu-agonists (like tapentadol) becomes necessary in acute pain 
situations. On combined use with buprenorphine, higher dose requirements for full mu
receptor agonists have been reported and close monitoring of adverse events such as 
respiratory depression is required in such circumstances. 
This medicine contains lactose. Patients with rare hereditary problems of galactose 
intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this 
medicine. 
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially