Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Pregabalin Sandoz

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HOS-133707 · Präparat HOS-097488

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Pregabalin Sandoz

Pregabalin Sandoz 25 mg hard capsules Pregabalin Sandoz 50 mg hard capsules Pregabalin Sandoz 75 mg hard capsules Pregabalin Sandoz 100 mg hard capsules Pregabalin Sandoz 150 mg hard capsules Pregabalin Sandoz 200 mg hard capsules Pregabalin Sandoz 225 mg hard capsules Pregabalin Sandoz 300 mg hard capsules · Abschnitt 4.5 · PDF-Seite 7

HOS-133708 · Präparat HOS-097488

Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (< 2% of a dose recovered in urine as metabolites), does not inhibit drug metabolism in vitro, and is not bound to plasma proteins, it is unlikely to produce, or be subject to, pharmacokinetic interactions.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Pregabalin Sandoz

Pregabalin Sandoz 25 mg hard capsules Pregabalin Sandoz 50 mg hard capsules Pregabalin Sandoz 75 mg hard capsules Pregabalin Sandoz 100 mg hard capsules Pregabalin Sandoz 150 mg hard capsules Pregabalin Sandoz 200 mg hard capsules Pregabalin Sandoz 225 mg hard capsules Pregabalin Sandoz 300 mg hard capsules · Abschnitt 4.5 · PDF-Seite 7

HOS-133709 · Präparat HOS-097488

In vivo studies and population pharmacokinetic analysis Accordingly, in in vivo studies no clinically relevant pharmacokinetic interactions were observed between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone or ethanol. Population pharmacokinetic analysis indicated that oral antidiabetics, diuretics, insulin, phenobarbital, tiagabine and topiramate had no clinically significant effect on pregabalin clearance.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): lamotrigine (HOS-086242) tiagabine (HOS-112899) topiramate (HOS-110310) phenobarbital (HOS-085617) valproic acid (HOS-088515) carbamazepine (HOS-085618) oxycodone (HOS-109487) lorazepam (HOS-085981) gabapentin (HOS-090745) ethanol (HOS-089988) phenytoin (HOS-084531)

Wechselwirkungen · Pregabalin Sandoz

Pregabalin Sandoz 25 mg hard capsules Pregabalin Sandoz 50 mg hard capsules Pregabalin Sandoz 75 mg hard capsules Pregabalin Sandoz 100 mg hard capsules Pregabalin Sandoz 150 mg hard capsules Pregabalin Sandoz 200 mg hard capsules Pregabalin Sandoz 225 mg hard capsules Pregabalin Sandoz 300 mg hard capsules · Abschnitt 4.5 · PDF-Seite 7

HOS-133717 · Präparat HOS-097488

Oral contraceptives, norethisterone and/or ethinyl oestradiol Co-administration of pregabalin with the oral contraceptives norethisterone and/or ethinyl oestradiol does not influence the steady-state pharmacokinetics of either substance.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Pregabalin Sandoz

Pregabalin Sandoz 25 mg hard capsules Pregabalin Sandoz 50 mg hard capsules Pregabalin Sandoz 75 mg hard capsules Pregabalin Sandoz 100 mg hard capsules Pregabalin Sandoz 150 mg hard capsules Pregabalin Sandoz 200 mg hard capsules Pregabalin Sandoz 225 mg hard capsules Pregabalin Sandoz 300 mg hard capsules · Abschnitt 4.5 · PDF-Seite 7

HOS-133718 · Präparat HOS-097488

Central nervous system influencing medical products Pregabalin may potentiate the effects of ethanol and lorazepam.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): lorazepam (HOS-085981) ethanol (HOS-089988)

Wechselwirkungen · Pregabalin Sandoz

Pregabalin Sandoz 25 mg hard capsules Pregabalin Sandoz 50 mg hard capsules Pregabalin Sandoz 75 mg hard capsules Pregabalin Sandoz 100 mg hard capsules Pregabalin Sandoz 150 mg hard capsules Pregabalin Sandoz 200 mg hard capsules Pregabalin Sandoz 225 mg hard capsules Pregabalin Sandoz 300 mg hard capsules · Abschnitt 4.5 · PDF-Seite 7–8

HOS-133719 · Präparat HOS-097488

In the postmarketing experience, there are reports of respiratory failure, coma and deaths in patients taking pregabalin and opioids and/or other central nervous system (CNS) depressant medicinal products. Pregabalin appears to be additive in the impairment of cognitive and gross motor function caused by oxycodone. 7 Interactions and the elderly No specific pharmacodynamic interaction studies were conducted in elderly volunteers. Interaction studies have only been performed in adults.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): oxycodone (HOS-109487)

Nebenwirkungen · Pregabalin Sandoz

Pregabalin Sandoz 25 mg hard capsules Pregabalin Sandoz 50 mg hard capsules Pregabalin Sandoz 75 mg hard capsules Pregabalin Sandoz 100 mg hard capsules Pregabalin Sandoz 150 mg hard capsules Pregabalin Sandoz 200 mg hard capsules Pregabalin Sandoz 225 mg hard capsules Pregabalin Sandoz 300 mg hard capsules · Abschnitt 4.8 · PDF-Seite 9

HOS-133720 · Präparat HOS-097488

The pregabalin clinical program involved over 8,900 patients exposed to pregabalin, of whom over 5,600 were in double-blind placebo-controlled trials. The most commonly reported adverse reactions were dizziness and somnolence. Adverse reactions were usually mild to moderate in intensity. In all controlled studies, the discontinuation rate due to adverse reactions was 12% for patients receiving pregabalin and 5% for patients receiving placebo. The most common adverse reactions resulting in discontinuation from pregabalin treatment groups were dizziness and somnolence.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Pregabalin Sandoz

Pregabalin Sandoz 25 mg hard capsules Pregabalin Sandoz 50 mg hard capsules Pregabalin Sandoz 75 mg hard capsules Pregabalin Sandoz 100 mg hard capsules Pregabalin Sandoz 150 mg hard capsules Pregabalin Sandoz 200 mg hard capsules Pregabalin Sandoz 225 mg hard capsules Pregabalin Sandoz 300 mg hard capsules · Abschnitt 4.8 · PDF-Seite 9

HOS-133721 · Präparat HOS-097488

In table 2 below all adverse reactions, which occurred at an incidence greater than placebo and in more than one patient, are listed by class and frequency (very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Pregabalin Sandoz

Pregabalin Sandoz 25 mg hard capsules Pregabalin Sandoz 50 mg hard capsules Pregabalin Sandoz 75 mg hard capsules Pregabalin Sandoz 100 mg hard capsules Pregabalin Sandoz 150 mg hard capsules Pregabalin Sandoz 200 mg hard capsules Pregabalin Sandoz 225 mg hard capsules Pregabalin Sandoz 300 mg hard capsules · Abschnitt 4.8 · PDF-Seite 9

HOS-133722 · Präparat HOS-097488

The adverse reactions listed may also be associated with the underlying disease and / or concomitant medicinal products.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Pregabalin Sandoz

Pregabalin Sandoz 25 mg hard capsules Pregabalin Sandoz 50 mg hard capsules Pregabalin Sandoz 75 mg hard capsules Pregabalin Sandoz 100 mg hard capsules Pregabalin Sandoz 150 mg hard capsules Pregabalin Sandoz 200 mg hard capsules Pregabalin Sandoz 225 mg hard capsules Pregabalin Sandoz 300 mg hard capsules · Abschnitt 4.8 · PDF-Seite 9

HOS-133723 · Präparat HOS-097488

In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions in general, CNS adverse reactions and especially somnolence was increased (see section 4.4).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Pregabalin Sandoz

Pregabalin Sandoz 25 mg hard capsules Pregabalin Sandoz 50 mg hard capsules Pregabalin Sandoz 75 mg hard capsules Pregabalin Sandoz 100 mg hard capsules Pregabalin Sandoz 150 mg hard capsules Pregabalin Sandoz 200 mg hard capsules Pregabalin Sandoz 225 mg hard capsules Pregabalin Sandoz 300 mg hard capsules · Abschnitt 4.8 · PDF-Seite 9

HOS-133724 · Präparat HOS-097488

Additional reactions reported from postmarketing experience are included in italics in the list below.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Pregabalin Sandoz

Pregabalin Sandoz 25 mg hard capsules Pregabalin Sandoz 50 mg hard capsules Pregabalin Sandoz 75 mg hard capsules Pregabalin Sandoz 100 mg hard capsules Pregabalin Sandoz 150 mg hard capsules Pregabalin Sandoz 200 mg hard capsules Pregabalin Sandoz 225 mg hard capsules Pregabalin Sandoz 300 mg hard capsules · Abschnitt 4.8 · PDF-Seite 9

HOS-133725 · Präparat HOS-097488

Table 2. Pregabalin Adverse Drug Reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Pregabalin Sandoz

Pregabalin Sandoz 25 mg hard capsules Pregabalin Sandoz 50 mg hard capsules Pregabalin Sandoz 75 mg hard capsules Pregabalin Sandoz 100 mg hard capsules Pregabalin Sandoz 150 mg hard capsules Pregabalin Sandoz 200 mg hard capsules Pregabalin Sandoz 225 mg hard capsules Pregabalin Sandoz 300 mg hard capsules · Abschnitt 4.8 · PDF-Seite 9

HOS-133726 · Präparat HOS-097488

System Organ Class Adverse drug reactions Infections and infestations Common Nasopharyngitis Blood and lymphatic system disorders Uncommon Neutropaenia Immune system disorders Uncommon Hypersensitivity Rare Angioedema, allergic reaction Metabolism and nutrition disorders Common Appetite increased Uncommon Anorexia, hypoglycaemia Psychiatric disorders Common Euphoric mood, confusion, irritability, disorientation, insomnia, libido decreased Uncommon Hallucination, panic attack, restlessness, agitation, depression, depressed mood, elevated mood, aggression, mood swings, depersonalisation, word finding difficulty, abnormal dreams, libido increased, anorgasmia, apathy Rare Disinhibition, suicidal behaviour, suicidal ideation

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Pregabalin Sandoz

Pregabalin Sandoz 25 mg hard capsules Pregabalin Sandoz 50 mg hard capsules Pregabalin Sandoz 75 mg hard capsules Pregabalin Sandoz 100 mg hard capsules Pregabalin Sandoz 150 mg hard capsules Pregabalin Sandoz 200 mg hard capsules Pregabalin Sandoz 225 mg hard capsules Pregabalin Sandoz 300 mg hard capsules · Abschnitt 4.8 · PDF-Seite 9–10

HOS-133727 · Präparat HOS-097488

9 System Organ Class Adverse drug reactions Not known Drug dependence Nervous system disorders Very Common Dizziness, somnolence, headache Common Ataxia, coordination abnormal, tremor, dysarthria, amnesia, memory impairment, disturbance in attention, paraesthesia, hypoaesthesia, sedation, balance disorder, lethargy Uncommon Syncope, stupor, myoclonus, loss of consciousness, psychomotor hyperactivity, dyskinesia, dizziness postural, intention tremor, nystagmus, cognitive disorder, mental impairment, speech disorder, hyporeflexia, hyperaesthesia, burning sensation, ageusia, malaise Rare Convulsions, parosmia, hypokinesia, dysgraphia, parkinsonism Eye disorders Common Vision blurred, diplopia Uncommon Peripheral vision loss, visual disturbance, eye swelling, visual field defect, visual acuity reduced, eye pain, asthenopia, photopsia, dry eye, lacrimation increased, eye irritation Rare Vision loss, keratitis, oscillopsia, altered visual depth perception, mydriasis, strabismus, visual brightness Ear and labyrinth disorders Common Vertigo Uncommon Hyperacusis Cardiac disorders Uncommon Tachycardia, atrioventricular block first degree, sinus bradycardia, congestive heart failure Rare QT prolongation, sinus tachycardia, sinus arrhythmia Vascular disorders Uncommon Hypotension, hypertension, hot flushes, flushing, peripheral coldness Respiratory, thoracic and mediastinal disorders Uncommon Dyspnoea, epistaxis, cough, nasal congestion, rhinitis, snoring, nasal dryness Rare Pulmonary oedema, throat tightness, Not known Respiratory depression Gastrointestinal disorders Common Vomiting, nausea, constipation, diarrhoea, flatulence, abdominal distension, dry mouth Uncommon Gastrooesophageal reflux disease, salivary hypersecretion, hypoaesthesia oral Rare Ascites, pancreatitis, swollen tongue, dysphagia Hepatobiliary disorders

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Pregabalin Sandoz

Pregabalin Sandoz 25 mg hard capsules Pregabalin Sandoz 50 mg hard capsules Pregabalin Sandoz 75 mg hard capsules Pregabalin Sandoz 100 mg hard capsules Pregabalin Sandoz 150 mg hard capsules Pregabalin Sandoz 200 mg hard capsules Pregabalin Sandoz 225 mg hard capsules Pregabalin Sandoz 300 mg hard capsules · Abschnitt 4.8 · PDF-Seite 10–11

HOS-133728 · Präparat HOS-097488

10 System Organ Class Adverse drug reactions Uncommon Elevated liver enzymes* Rare Jaundice Very rare Hepatic failure, hepatitis Skin and subcutaneous tissue disorders Uncommon Rash papular, urticaria, hyperhidrosis, pruritus Rare Toxic epidermal necrolysis, Stevens Johnson syndrome, cold sweat Musculoskeletal and connective tissue disorders Common Muscle cramp, arthralgia, back pain, pain in limb, cervical spasm Uncommon Joint swelling, myalgia, muscle twitching, neck pain, muscle stiffness Rare Rhabdomyolysis Renal and urinary disorders Uncommon Urinary incontinence, dysuria Rare Renal failure, oliguria, urinary retention Reproductive system and breast disorders Common Erectile dysfunction Uncommon Sexual dysfunction, ejaculation delayed, dysmenorrhoea, breast pain Rare Amenorrhoea, breast discharge, breast enlargement, gynaecomastia General disorders and administration site conditions Common Oedema peripheral, oedema, gait abnormal, fall, feeling drunk, feeling abnormal, fatigue Uncommon Generalised oedema, face oedema, chest tightness, pain, pyrexia, thirst, chills, asthenia Investigations Common Weight increased Uncommon Blood creatine phosphokinase increased, blood glucose increased, platelet count decreased, blood creatinine increased, blood potassium decreased, weight decreased Rare White blood cell count decreased * Alanine aminotransferase increased (ALT) and aspartate aminotransferase increased (AST).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Pregabalin Sandoz

Pregabalin Sandoz 25 mg hard capsules Pregabalin Sandoz 50 mg hard capsules Pregabalin Sandoz 75 mg hard capsules Pregabalin Sandoz 100 mg hard capsules Pregabalin Sandoz 150 mg hard capsules Pregabalin Sandoz 200 mg hard capsules Pregabalin Sandoz 225 mg hard capsules Pregabalin Sandoz 300 mg hard capsules · Abschnitt 4.8 · PDF-Seite 11

HOS-133729 · Präparat HOS-097488

After discontinuation of short-term and long-term treatment with pregabalin withdrawal symptoms have been observed . The following symptoms have been reported: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, convulsions, nervousness, depression, suicidal ideation, pain, hyperhidrosis and dizziness. These symptoms may indicate drug dependence. The patient should be informed about this at the start of the treatment.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Pregabalin Sandoz

Pregabalin Sandoz 25 mg hard capsules Pregabalin Sandoz 50 mg hard capsules Pregabalin Sandoz 75 mg hard capsules Pregabalin Sandoz 100 mg hard capsules Pregabalin Sandoz 150 mg hard capsules Pregabalin Sandoz 200 mg hard capsules Pregabalin Sandoz 225 mg hard capsules Pregabalin Sandoz 300 mg hard capsules · Abschnitt 4.8 · PDF-Seite 11

HOS-133730 · Präparat HOS-097488

Concerning discontinuation of long-term treatment of pregabalin, data suggest that the incidence and severity of withdrawal symptoms may be dose-related (see sections 4.2 and 4.4).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Pregabalin Sandoz

Pregabalin Sandoz 25 mg hard capsules Pregabalin Sandoz 50 mg hard capsules Pregabalin Sandoz 75 mg hard capsules Pregabalin Sandoz 100 mg hard capsules Pregabalin Sandoz 150 mg hard capsules Pregabalin Sandoz 200 mg hard capsules Pregabalin Sandoz 225 mg hard capsules Pregabalin Sandoz 300 mg hard capsules · Abschnitt 4.8 · PDF-Seite 11

HOS-133731 · Präparat HOS-097488

Paediatric population

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Pregabalin Sandoz

Pregabalin Sandoz 25 mg hard capsules Pregabalin Sandoz 50 mg hard capsules Pregabalin Sandoz 75 mg hard capsules Pregabalin Sandoz 100 mg hard capsules Pregabalin Sandoz 150 mg hard capsules Pregabalin Sandoz 200 mg hard capsules Pregabalin Sandoz 225 mg hard capsules Pregabalin Sandoz 300 mg hard capsules · Abschnitt 4.8 · PDF-Seite 11–12

HOS-133732 · Präparat HOS-097488

11 The pregabalin safety profile observed in fivepaediatric studies in patients with partial seizures with or without secondary generalisation 12-week efficacy and safety study in patients 4 to 16 years of age, n=295; 14-day efficacy and safety study in patients 1 month to younger than 4 years of age, n=175; pharmacokinetic and tolerability study, n=65; and two 1 year open label follow on safety studies, n=54 and n=431) was similar to that observed in the adult studies of patients with epilepsy. The most common adverse events observed in the 12-week study with pregabalin treatment were somnolence, pyrexia, upper respiratory tract infection, increased appetite, weight increased, and nasopharyngitis. The most common adverse events observed in the 14-day study with pregabalin treatment were somnolence, upper respiratory tract infection, and pyrexia (see sections 4.2, 5.1 and 5.2).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Pregabalin Sandoz

Pregabalin Sandoz 25 mg hard capsules Pregabalin Sandoz 50 mg hard capsules Pregabalin Sandoz 75 mg hard capsules Pregabalin Sandoz 100 mg hard capsules Pregabalin Sandoz 150 mg hard capsules Pregabalin Sandoz 200 mg hard capsules Pregabalin Sandoz 225 mg hard capsules Pregabalin Sandoz 300 mg hard capsules · Abschnitt 4.8 · PDF-Seite 12

HOS-133733 · Präparat HOS-097488

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.