BIODRAMINA Medicated chewing-gum Ref.[51123] Active ingredients: Dimenhydrinate

• Do not exceed the maximum daily dose (see section 4.2. Posology and method of administration).
• Caution should be exercised in patients with chronic bronchitis or emphysema, as well as in asthma patients with a history of respiratory alterations after the use of antihistamines.
• The physician shall assess the convenience of treating patients with narrow angle glaucoma, pyloroduodenal obstruction, stenosing peptic ulcer, obstruction of the urinary bladder neck, symptomatic prostatic hypertrophy, urinary retention, hyperthyroidism, cardiovascular alterations, epilepsy, liver disorders and hypertension, since dimenhydrinate, due to its anticholinergic effects, can aggravate these illnesses.
• Administer with caution to patients who are under treatment with ototoxic medicinal products (see section 4.5. Interaction with other medicinal products and other forms of interaction)
• Due to its antiemetic action, dimenhydrinate can hinder the diagnosis of illnesses such as appendicitis and mask the toxicity signs induced by overdoses of other medicinal products.
• Alcoholic beverages should not be consumed during treatment (see section 4.5. Interaction with other medicinal products and other forms of interaction).
• Caution should be exercised in the elderly because they are more sensitive to the adverse effects.

Excipient warning:

• This product contains a source of phenylalanine. May be harmful for people with phenylketonuria.
• Patients with rare hereditary problems of glucose-galactose malabsorption should not take this medicine.

Alcohol and other central nervous system (CNS) depressants: there are studies reporting enhanced toxicity, with alteration of intellectual and psychomotor abilities.

Medicinal products with anticholinergic activity (such as tricyclic antidepressants, MAOIs, neuroleptic agents, antiparkinsonian agents, etc.): anticholinergic effects may be enhanced when dimenhydrinate and medicinal products with anticholinergic action are administered simultaneously. Patients should be advised to report the onset of gastrointestinal problems quickly, since paralytic ileus may occur in the case of co-administration.

The concomitant use of ototoxic medications with antihistamines can mask the symptoms of ototoxicity, such as tinnitus or vertigo. It can enhance the photosensitising effect associated with other medicinal products.

Dimenhydrinate can alter the values of the following analytical assays: false negative of skin tests in which allergen extracts are used. Treatment should be discontinued 3 days before starting the test.

Pregnancy

There are no adequate, well-controlled studies in humans (FDA Pregnancy Category B). Although the possibility of foetal damage appears to be remote, this product should only be used when clearly needed.

Lactation

Dimenhydrinate is excreted in small amounts in breast milk. This medicinal product should not be administered to breastfeeding mothers due to the risk of harmful effects in infants (excitation, irritability).

Patients treated with dimenhydrinate should not drive or use hazardous machinery since dimenhydrinate causes drowsiness.

The most typical adverse effects are:

Common (1-9%): drowsiness, dry mouth/nose/throat, blurred vision.

Uncommon, rare or very rare (<1%): constipation, diarrhoea, mydriasis, tinnitus, anorexia, accommodation disorders, mental confusion in the elderly, excitation and insomnia in small children, urinary retention, palpitations, hypotension, headache, exanthematous eruptions, hives, photodermatitis.

In the event of adverse reactions, treatment must be discontinued and the pharmacovigilance systems must be notified.

None.