Summary of Product Characteristics

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Summary of Product Characteristics SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dimenhydrinate [MAH] 6.2 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection contains 6.2 mg dimenhydrinate. 1 ampoule of 10 ml solution for injection contains 62 mg dimenhydrinate. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection Clear, colourless solution with a pH of 6.5 – 7.5 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Dimenhydrinate [MAH] can be used for prophylaxis and symptomatic treatment of nausea and vomiting of different genesis, in particular kinetosis. Note: Dimenhydrinate is not appropriate as a sole agent for treatment of chemotherapy induced nausea and vomiting. 4.2 Posology and method of administration Posology Usual dose for: Adults and adolescents aged 14 years and over: 1 – 3 ampoules (corresponding to 62 – 186 mg dimenhydrinate) per day. The maximum daily dose of 400 mg should not be exceeded. Children aged 6 to 14 years: 1 – 3 times daily 25 – 50 mg dimenhydrinate. The maximum daily dose of 150 mg should not be exceeded. Children ≥ 6 kg bodyweight: 1 – 3 times daily 1.25 mg dimenhydrinate/kg body weight. Method of administration For prophylaxis of motion sickness the first dose is given approx. ½ - 1 hour before start of journey. For the treatment of nausea and vomiting the doses are administered at regularly intervals throughout the day. 1 Dimenhydrinate [MAH] is administered very slowly by intravenous injection (10 ml in not less than 2 min). When applied via an injection port of an i.v. cannula the venous access should be flushed afterwards with Sodium chloride 9 mg/ml (0.9 %) solution for injection or Ringer’s solution. For administration of an intravenous infusion, Dimenhydrinate [MAH] can be added to the following solutions for infusion: Glucose 5 % or 10 % Sodium chloride 9 mg/ml (0.9 %) solution for injection Ringer’s solution Dimenhydrinate [MAH] is intended for short term use only. Therefore, a doctor should be consulted if symptoms persist. At the latest 2 weeks after start of treatment it should be checked whether treatment with Dimenhydrinate [MAH] is still necessary. 4.3 Contraindications Dimenhydrinate [MAH] is contraindicated in patients with: - hypersensitivity to dimenhydrinate or other antihistamines, - acute asthma attack, - narrow-angle glaucoma, - pheochromocytoma, - porphyria, - prostatic hypertrophy with generation of residual urine, - seizures/convulsions (epilepsy, eclampsia). 4.4 Special warnings and precautions for use Dimenhydrinate [MAH] should be used with caution in patients with: - impaired liver function, - hypokalaemia, hypomagnesaemia, - cardiac dysrhythmia/arrhythmia (e.g. tachycardia), - bradycardia, - congenital long QT syndrome or other clinical significant cardiac disorders (particularly coronary heart disease, conduction disturbance), - concomitant treatment with medicinal products that also cause prolongation of the QT interval (e.g. antiarrhythmic drugs class IA or III, antibiotics, malaria drugs, antihistamines, neuroleptics) or lead to hypokalaemia (see section 4.5), - chronic breathing difficulties and asthma, - pyloric stenosis. 4.5 Interaction with other medicinal products and other forms of interaction If used concomitantly, the effects of dimenhydrinate and other CNS depressants (antipsychotic drugs, hypnotics, sedatives, analgesics, narcotics) may be enhanced. The anticholinergic effect of dimenhydrinate (see section 4.8) may be potentiated in a non- predictable way if taken concomitantly with other agents with anticholinergic activity (e.g. atropine, biperiden, or tricyclic antidepressants). When dimenhydrinate is given in conjunction with monoamine oxidase inhibitors enteroparesis that may be life-threatening, urinary retention or an increased intraocular pressure may develop. In addition, a drop in blood pressure may occur and central nervous system and breathing dysfunctions may be enhanced. Therefore, dimenhydrinate must not be used in conjunction with monoamine oxidase inhibitors. 2 The concomitant use of medicinal products that also prolong the QT interval (e.g. antiarrhythmic drugs class IA or III, antibiotics, malaria drugs, neuroleptics) or lead to hypokalaemia (e.g. certain diuretics) should be avoided (see section 4.4, 4.9 and 5.3). The concomitant use of dimenhydrinate with antihypertensive medicinal products can lead to increased tiredness or to increased hypotensive effect. Dimenhydrinate may cause false-negative results in allergy tests. Caution should be used if dimenhydrinate is given during therapy with aminoglycoside antibiotics because it may mask ototoxic symptoms. Alcohol consumption should be avoided during dimenhydrinate treatment because alcohol can change or increase the effects of dimenhydrinate in a non-predictable manner. The ability to drive and use machines is further impaired. 4.6 Fertility, pregnancy and lactation Pregnancy There are inconsistent reports about the safe use of Dimenhydrinate [MAH] during pregnancy. A prospective study on pregnant women did not reveal any evidence for a relationship between dimenhydrinate treatment and malformations. Another study described an association between cardiovascular defects or inguinal hernia with dimenhydrinate exposition during pregnancy. A case-control study included 38,151 new-borns without congenital malformations and 22,843 with congenital malformations of whom a total of 2,640 children were exposed to dimenhydrinate. Dimenhydrinate showed no evidence of teratogenic potential. There are no indications that dimenhydrinate application leads to a higher abortion rate during the first trimester of pregnancy. Dimenhydrinate can stimulate preterm uterine contractions and increases the risk for premature labour. Animal studies with dimenhydrinate are insufficient with respect to reproductive toxicity (see section 5.3). Dimenhydrinate [MAH] should only be used during pregnancy if a therapy without medication or a treatment with other, safe medicinal products were not effective. Dimenhydrinate [MAH] should not be used during the third trimester because it can trigger preterm uterine contractions. Breastfeeding Dimenhydrinate is excreted into human breast milk. There are no data about the use of dimenhydrinate during breast feeding. Because undesirable effects on a nursing infant such as increased irritability cannot be excluded, either Dimenhydrinate [MAH] treatment should be discontinued or breast feeding should be discontinued. Fertility No data are available (see section 5.3). 4.7 Effects on ability to drive and use machines Drowsiness, disturbances of memory and a decreased ability to concentrate may negatively influence the ability to drive and use machines. This has to be considered especially after an insufficient sleeping period, when starting treatment, when changing medication or when concomitantly alcohol is used (see also section 4.5). 4.8 Undesirable effects 3 The frequency of undesirable effects listed in table 1 is classified according to the following convention: 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 Especially at the beginning of the treatment undesirable effects such as somnolence, drowsiness, dizziness, and muscle weakness may occur depending on the individual susceptibility and dose. These side effects can last into the following day. Table 1: Adverse reactions reported with dimenhydrinate System organ class Frequency Blood and lymphatic Not known system disorders In exceptional cases blood cell damages can occur. Psychiatric disorders Common mood swings Not known drug dependence Nervous system Very Common disorders somnolence, drowsiness, dizziness Common restlessness, agitation, insomnia, anxiety, tremor Eye disorders Common visual disturbances, increased intraocular pressure Cardiac disorders Common tachycardia Gastrointestinal Common disorders nausea, pain in the stomach region, vomiting, obstipation, diarrhoea Hepato-biliary Not known disorders liver dysfunction (cholestatic icterus) Skin and subcutaneous Common tissue disorders dryness of mouth, nasal obstruction Not known allergic skin reactions and sensitivity to light (direct sun exposure should be avoided) Musculoskeletal and Very Common connective tissue muscle weakness disorders Renal and urinary Common disorders urinary dysfunctions 4 Sudden discontinuation after long-term daily treatment can temporarily cause insomnia. Therefore, treatment should be discontinued by gradually decreasing the dose in these cases. As with other medicinal products with a hypnotic effect, development of drug dependence cannot be ruled out after long-term therapy. Therefore, the indication for a treatment longer than only short-term should be carefully checked. Paediatric population Particularly in children, there is the possibility of paradoxical reactions such as restlessness, excitation, insomnia, anxiety and shaking (tremor). 4.9 Overdose Intoxications with dimenhydrinate, the active substance of Dimenhydrinate [MAH] can be life-threatening. Children are at special risk. In case of overdose or intoxication with Dimenhydrinate [MAH] immediate medical attention is needed. The signs of overdose with Dimenhydrinate [MAH] are mainly characterised by different stages of impaired consciousness, ranging from strong drowsiness to coma - depending on the applied dose. Apart from this, signs of the anticholinergic syndrome
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