Fenistil oral drops 15 ml

Fenistil oral drops 15 ml

Composition:

Each 1 ml (20 drops) contains:

Dimetindene maleate 1 mg

Inactive ingredients:

Purified Water, Propylene Glycol (100mg/ml), Disodium Phosphate dodecahydrate, Citric Acid Monohydrate, Benzoic acid (1 mg/ml), Disodium edetate, Saccharin sodium

Properties:

Antipruritic, antihistamine and anti allergic.

Dimethindene is a competitive inhibitor of the histamine H1 receptors. At a low concentration, it stimulates histamine-methyltransferase, causing deactivation of histamine. It has a strong affinity for H1 receptors and is a powerful mastocyte stabilizer.

It also has a local anesthetic effect. It has no effect on H2 receptors. Dimethindene also has an agonistic effect on bradykinin, serotonin, and acetylcholine. It is a racemic mixture in which R-(-dimethindene presents the most powerful H1 antihistaminic effect. It leads to decreased capillary hyperpermeability associated with immediate hypersensitivity reactions.

In association with an H2, antihistamine, it suppresses practically all the circulatory effects of histamine.

Indications:

– Symptomatic treatment of allergic skin reactions: hives and itching associated with eczema and dermatitis, if your doctor has previously diagnosed these conditions;

– Symptomatic treatment of pruritus of various etiologies: endogenous pruritus, eruptive diseases, such as chickenpox, with prior medical diagnosis;

– Insect bites;

– Symptomatic treatment of perennial or seasonal allergic rhinitis, if your doctor has previously diagnosed this condition.

Direction for use:

• Adults and adolescents over 12 years of age:

The daily recommended dose is 3 to 6 mg of dimethindene maleate divided into 3 doses; this corresponds to 20-40 drops, 3 times per day.

In patients with a tendency to drowsiness, it is recommended to prescribe 40 drops before bedtime, and 20 drops in the morning at breakfast.

• Children:

In small children from 1 month to 1 year of age, Fenistil Drops should only be used according to a doctor’s recommendations and upon strict medical indication for antihistamines. The recommended dose should not be exceeded.

• Caution should be used when administering drops to children under 1 year of age. The sedative effect may be associated with episodes of sleep apnoea.

The recommended daily dose is 0.1 mg/kg of body weight per day (this corresponds to 2 drops per kg of body weight per day, divided into 3 doses).

• The usual daily doses for children from 1 month to 12 years of age and based on body weight, are therefore the following:

1 month to 1 year(4.5-15 kg) 0.15-0.5 mg

(3-10 drops) three times per day

1-3 years(15-22.5 kg) 0.5-0.75 mg (10-15 drops) three times per day

3-12 years(22.5-30 kg) 0.75-1 mg (15-20 drops) three times per day

• 20 drops = 1 mL=1 mg of dimethindene maleate.
• 1 drop = 0.05 mg of dimethindene maleate.
• Fenistil Drops cannot withstand high temperatures; before feeding, pour them directly into a warm feeding bottle. If the baby is already eating with a spoon, give the drops in a teaspoon; they have a pleasant taste.
• Maximum duration of use: Fenistil drops must not be taken for more than 14 days without approval from a doctor.

Side effects:

Undesirable effects include drowsiness occurring in particular at the start of treatment.

Allergic reactions occur very rarely..

-Immune system disorders:

Very rare: anaphylactic reaction, including facial oedema, pharyngeal oedema, skin rash, muscle spasms, and dyspnoea.

-Psychiatric disorders

Rare: agitation.

-Nervous system disorders

Very common: fatigue.

Common: drowsiness, nervousness.

Rare: headaches, dizziness.

-Gastrointestinal disorders:

Rare: gastrointestinal disorders, nausea, dry mouth/throat.

Contraindications

-Hypersensitivity to the active substance or to one of the excipients in the composition.

-Newborn under 1 month old, in particular premature babies.

Warnings and precautions

• Follow the usual precautions in case of glaucoma, urinary retention, for example associated with prostatic hypertrophy, chronic obstructive pulmonary disease.

• Like all H1 and H2 receptor agonists, caution should be used in patients with epilepsy.
• Antihistamines may cause excitation in young children.
• Caution should be used when administering drops to children under 1 year of age: the sedative effect may be associated with episodes of sleep apnoea.
• In small children from 1 month to 1 year of age, Fenistil Drops should only be administered after a medical consultation and upon strict medical indication for antihistamines. The recommended dose should not be exceeded.

• Use with caution in elderly patients, as this age group is more susceptible to undesirable effects such as agitation and fatigue. Use in confused elderly patients should be avoided. The recommended dose and duration of use must not be exceeded without a doctor’s approval.
• Drug interactions:

-It is expected that the concomitant use of two or more medicinal products with a sedative effect on the central nervous system leads to increased depression of the CNS. This may have undesirable, even fatal consequences. These medicinal products are, in particular, analgesics (opioids), anticonvulsants, antidepressants (tricyclic antidepressants and MAO inhibitors), antihistamines, antiemetics, antipsychotics, anxiolytics, hypnotics, scopolamine and alcohol.

-Tricyclic antidepressants and anticholinergics (for example, bronchodilators, gastrointestinal spasmolytics, mydriatics, urological antimuscarinics) may cause an additional antimuscarinic effect with antihistamines, and increase the risk of exacerbation of glaucoma or urinary retention.

• In order to reduce the risks of CNS depression or possible potentiation, caution must be exercised when administering procarbazine and antihistamines concomitantly.
• Pregnancy:

In animal studies with dimethindene maleate, no teratogenic potential and no direct or indirect toxicity with an impact on pregnancy, embryonic development, the development of the fetus, and/or postnatal development was revealed.

There is no available clinical data concerning use in pregnant women. During pregnancy, Fenistil Drops should only be used under a strict indication.

• Lactation

It is likely that dimethindene maleate is excreted in human milk. Taking Fenistil Drops is not recommended while breastfeeding.

• Effect on the ability to drive and use machines:

Use of Fenistil Drops can affect reactions. Caution should be used when driving a vehicle or performing tasks requiring machines.

Storage:

Store at a room temperature (15-25°C).

After initial opening, may be used for 6 months.

Package:

Carton box holds a dropper bottle 15 ml and paper instructions.