Meclizigo Orodispersible films is indicated for:

1. the treatment of nausea and vomiting.
2. adult and adolescent over 12 years old, for the prevention and symptomatic treatment of nausea, vomiting and dizziness associated with travel sickness (motion sickness).
3. Management of vertigo associated with diseases affecting the vestibular system.

Since drowsiness may, on occasion, occur with use of Meclizigo, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery. Patients should avoid alcoholic beverages while taking this drug. Meclizigo should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland.

Composition

Each Meclizigo Orodispersible film contains:

• 25 mg Meclozine Hydrochloride.

Does Meclozine used to treat Nausea and Vomiting?

A pooled data from seven randomized clinical trials have confirmed that antihistamines (including Meclozine) significantly reduce nausea and vomiting in pregnancy. Meclozine is known to have a sedative effect, and thus many women show discomfort in taking these medications throughout the day.

Meclozine is one of the most commonly used antihistamine for NVPs ((nausea and vomiting in pregnancy). Meclozine is generally considered safe to be use in pregnancy.

Method of administration

Meclizigo oral thin films are for oral use and are taken without water.

If desired, Meclizigi oral thin films may also be used with water.

It shoud be placed on the tongue where it dissolved rapidly.

Before taking Meclizigo Orodispersible film

• You should not use Meclizigo if you are allergic to it.
• To make sure Meclizigo is safe for you, tell your doctor if you have any of these conditions:
  • liver disease.
  • kidney disease.
  • asthma.
  • glaucoma.
  • enlarged prostate or urination problems.

Is Meclizigo safe in pregnancy?

• FDA pregnancy category B.
• Meclizigo is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
• Meclizigo, should be used in pregnant women only if absolutely necessary, and duration should be as short as possible and dosage should not exceed two Orodispersible films per day.

Is Meclizigo safe during breast-feeding?

It is not known whether meclizine (Meclizigo) passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Meclizigo Dosage

• For the control of vertigo associated with diseases affecting the vestibular system, the recommended dose is 1 to 4 Meclizigo Orodispersible films daily, in divided dosage, depending upon clinical response.
• For Motion Sickness: The initial dose is 1  Orodispersible film to be taken one hour prior to embarkation for protection against motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.
• For nausea and vomiting in pregnancy: Meclizigo, should be used in pregnant women only if absolutely necessary, and duration should be as short as possible and dosage should not exceed two Orodispersible films per day.

Adverse Reactions of Meclizigo

Undesirable effects are mostly related to CNS depressant or paradoxical CNS stimulation effects, to anticholinergic properties, or to hypersensitivity reactions of Meclozine hydrochloride.

The most common adverse effect of Meclizigo is:

• drowsiness or sedation.
• Dry mouth is a frequent adverse effect.
• Blurred vision0
• Nausea and vomiting occur rarely.
• Headache.
• Tired feeling

Interactions

1. Dosage adjustments may be necessary, in case of concomitant use of alcohol and CNS depressants with Meclozine hydrochloride as the depressant action of these drugs or of Meclozine may increase.
2. The potentiating action of Meclozine hydrochloride must be considered, and dosage should be adapted on an individual basis, while Meclozine is co-administered with anticholinergics, other drugs with anticholinergic effects or MAO inhibitors.
3. Although, no in vitro and no in vivo interaction studies have been performed with Meclozine, there is a potential risk for interaction when Meclozine is administered to patients on drugs known to be inducers or inhibitors of liver enzymes.

NERHADOU International Company – EGYPT  is the company that owns the production and marketing rights for Meclizigo.

Hyperemesis Gravidarum (HG)

• HG defined, based on the symptoms, vomiting exceeding three times a day with significant ketonuria or weight loss more than or equal to 5% of pre pregnancy weight, electrolytic imbalance or fluid depletion, and onset occurs at 4 to 8 weeks of pregnancy till 14 to 16 weeks.
• Nausea and vomiting in pregnancy is of multifarious etiology (fluctuating levels of progesterone, estrogens, Thyroid Stimulating Hormone (TSH), slow peristaltic movement of Gastrointestinal (GI) tract); however, the exact mechanism remains still unclear.
• Both patients and healthcare practitioners often fear the use of antiemetic medications in pregnancy due to the potential risk to fetus and mother. The manifestation of nausea and vomiting in pregnancy is different among each woman, so its management should be tailored similarly.
• An early treatment of nausea and vomiting is important and beneficial since it prevents a more severe form of occurring, or a possible hospitalization, and prevents both emotional and psychological problems.
• It is very important for the women and the healthcare providers to understand that a safe and effective NVP treatment benefits both fetus and mother, thus all the treatment options should be open and considered.
• Nonetheless, given the widespread prevalence of nausea and vomiting, its adverse effects and effects on psychological conditions of pregnant women, it is necessary to be treated effectively and safely during embryonic and fetal developmental stages.

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