COMPOSITION :

Each 1 ml of drops  contains : Dimethindene maleate 1   mg.

Each f/c tablet contains          : Dimethindene maleate 1   mg.

DESCRIPTION :

Fenirgic (Dimethindene maleate) is an antihistamine. It blocks histamine receptors which are responsible for causing itching and allergic reactions thus it reduces capillary permeability and itching. After oral administration, the effect of Dimethindene maleate begins after 30-60 minutes, and lasts for 8-12 hours.             

INDICATIONS :

- Symptomatic treatment of pruritus of different origin, such as urticaria, measles, chicken pox , food allergy, drug allergy, eczema, varicella, insect bites, senile pruritus.

- Symptomatic treatment of allergic rhinitis, such as hay fever or perennial rhinitis.

DOSAGE & ADMINISTRATION :

Children                       : Usual daily doses 0.1 mg/ kg .

Children under 1 year ( administered only on medical advice) : 0.15 - 0.5 mg(3-10 drops) 3 times a day .

Children 1-3 years        : 0.5 to 0.75 mg (10 to 15 drops) 3 times a day.

Children 3-12 years      : 0.75 to 1 mg (15 to 20 drops) 3 times a day.

Adults and adolescents : 1- 2 tablets 3 times a day.

- In susceptible patients with a tendency to sedation is recommended 2 tablets at bedtime and 1 tablet at breakfast.

- If the patient after 3 days of treatment shows no improvement, consult the doctor.

RESTRICTIONS ON USE :

Contraindications

- Hypersensitivity to Dimethindene maleate.

- Premature infants and children younger than one month .

- Patients with hypertrophy of the prostate, bladder obstruction  or cardiac arrhythmias.

Precautions

- Caution should be taken in patients with glaucoma, bladder obstruction(e.g prostatic hypertrophy), peptic ulcer, pyloroduodenal obstruction , cardiovascular disease, severe hypertension ,hyperthyroidism or  asthma, chronic pulmonary disease .

- Caution should be taken when taking this drug especially the sedative effect may be associated with episodes of sleep apnea.

- Fenirgic is not effective in itching associated with cholestasis . 

Use in pregnancy and lactation

Fenirgic should be administered during pregnancy only in cases of absolute necessity and only if the desired effect outweigh  the potential risks. The use of Dimethindene maleate during lactation is not recommended.

Effects on the ability to drive vehicles or use machines

Fenirgic can cause drowsiness, so caution is required in case of driving a vehicle or using machines.

DRUG INTERACTIONS :

- Concomitant intake of Fenirgic with tranquilizers, anxiolytics  ,hypnotics and anticonvulsants ,antidepressants (monoamine oxidase inhibitors , tricyclic antidepressants), antihistamine , antiemetics, antipsychotics, the sedative effect of central nervous system can be strengthened.

- Combination of antihistamines with Tricyclic antidepressants or anticholinergics such as bronchodilator and GI spasmolytics can increase the antimuscarinic effects lead to possible worsening of diseases like glaucoma or urinary retention.

SIDE EFFECTS :

Sedative effect, which varies according to individual susceptibility, occurs only at high doses. Drowsiness sometimes observed, particularly in the early treatment .Isolated cases were reported with angioneurotic edema and rare cases of dizziness, headache , anorexia, diarrhea, nausea, dry mouth or throat.

OVERDOSAGE :

Symptoms: CNS depression with drowsiness (especially in adults), CNS stimulation and antimuscarinic effects especially in children including convulsion , urinary retention and fever.

Treatment : There is no specific antidote for Dimethindene maleate. The usual emergency assistance should be taken to treat the symptoms with monitoring the cardiac and respiratory functions.  

STORAGE INSTRUCTIONS :

-Tablets and drops :Store below 30oC, in a dry place and protect from light.         

PRESENTATIONS :

Fenirgic drops   : Bottle of 20 ml. 

Fenirgic tablets : Pack of different sizes