Microser (Drops) Instructions for Use

Marketing Authorization Holder

Prodotti Formenti, S.r.l. (Italy)

Manufactured By

Farmaceutici Formenti, S.p.A. (Italy)

ATC Code

N07CA01 (Betahistine)

Active Substance

Betahistine (Rec.INN registered by WHO)

Dosage Form

Microser

Oral drops 1.25%: bottle 30 ml with dropper

Dosage Form, Packaging, and Composition

Oral drops in the form of a transparent, colorless or light yellow solution with an orange odor.

Excipients: glycerol, ethanol, glycine, sodium saccharin, benzoic acid, sodium edetate, propyl gallate, orange flavor, purified water.

30 ml – dark glass bottles (1) with a dropper – cardboard packs.

Clinical-Pharmacological Group

Drug improving microcirculation of the labyrinth, used for pathology of the vestibular apparatus

Pharmacotherapeutic Group

Histamine preparation

Pharmacological Action

Synthetic analogue of histamine. It acts similarly to histamine, mainly on histamine H₁ receptors. Causes dilation of precapillaries, in particular, facilitates microcirculation in the labyrinth.

In addition, Betahistine regulates endolymph pressure in the labyrinth and cochlea, leading to clinical improvement in vertigo of various etiologies. Reduces the frequency and intensity of dizziness, reduces tinnitus, and helps improve hearing in cases of its decrease.

Increases the tone of the smooth muscles of the bronchi and gastrointestinal tract. May cause increased secretion of gastric juice.

Pharmacokinetics

After oral administration, betahistine dihydrochloride is rapidly and almost completely absorbed from the gastrointestinal tract. Plasma protein binding is low.

It is almost completely eliminated from the body with urine within 24 hours. T_1/2 is 3-4 hours.

Indications

Ménière’s disease; syndromes characterized by dizziness, tinnitus and/or progressive hearing loss, including labyrinthine hydrops of the inner ear, vestibular and labyrinthine disorders (including dizziness, tinnitus and ear pain, headache, nausea, vomiting, hearing loss), vestibular neuritis, labyrinthitis, benign positional vertigo (including after neurosurgical operations); vertebrobasilar insufficiency, post-traumatic encephalopathy, cerebral vascular atherosclerosis (as part of complex therapy).

ICD codes

Dosage Regimen

Administer the medication three times daily.

Take a single dose of 8 to 16 mg.

Use the provided dropper for accurate measurement.

For the 1.25% oral drops solution, a single dose is approximately 20 to 40 drops.

Take the drops with a small amount of water during or after meals to minimize potential dyspeptic symptoms.

Continue treatment for a long duration as prescribed.

Be aware that the desired clinical effect is typically achieved after several months of continuous therapy.

Do not discontinue treatment without consulting your physician.

Adverse Reactions

From the digestive system: slightly pronounced nausea, feeling of heaviness in the epigastrium are possible.

Allergic reactions: in some cases – skin rash, itching, urticaria.

Contraindications

Hypersensitivity to betahistine, pheochromocytoma, gastric and duodenal ulcer in the acute phase, bronchial asthma, first trimester of pregnancy.

With caution second and third trimesters of pregnancy, period of breastfeeding; childhood.

Use in Pregnancy and Lactation

Contraindicated in the first trimester of pregnancy. Should be used with caution in the second and third trimesters of pregnancy. Use during breastfeeding is not recommended.

Pediatric Use

Should be used with caution in children.

Special Precautions

Should be used with caution in patients with a history of gastric or duodenal ulcer, in the second and third trimesters of pregnancy, as well as in children.

It must be taken into account that the desired clinical effect is achieved after several months of treatment.

For dyspeptic symptoms, Betahistine is recommended to be taken during or after meals.

Drug Interactions

Antihistamines, when taken simultaneously, reduce the effect of betahistine.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.