Benoboston

ADMINISTRATION

BENOBOSTON is administered orally, after meals and before going to bed.

Dosage

For use only by adults and children over 6 years old.

Usual Dosage:

- Adults and children over 12 years: 3-4 tablets per day. 

- Children 6-12 years: ½  tablet morning and evening.

-It will always be advisable to look for the minimum effective dosage that can be lowered up to 1 tablet every 2 days.

-The usual duration of treatment of acute urticaria will not exceed 10 days. Therefore, when cessation of treatment, there is no need to gradually reduce the dose.

Contraindications

- Hypersensitivity to any component of the drug or to drugs with a similar structure.

Due to the ingredients containing betamethasone, it is contraindicated in the following cases:

- Any infection.

-Viral infections (including hepatitis,  chickenpox, herpes, shingles)

- Psychotic states not controlled by treatment.

- Live vaccines

Due to the ingredients containing dexchlorpheniramine, it is contraindicated in the following cases:

Risk of angle-closure glaucoma.

Risk of urinary retention associated with prostatic urethral disorders.

The dosage form is not suitable for children under 6 years of age.

This drug is not recommended for:

+   Women who are breastfeeding.

+  Combined with drugs that cause torsade de points (except antiarrhythmic drugs (except antiarrhythmic drugs).

WARNINGS AND PRECAUTIONS 

Precautions with betamethasone:

-BENOBOSTON is used with caution in patients with tuberculosis, peptic ulcer, mental illness,  Herpes simplex keratitis, cardiovascular disease including thrombotic hypertension, posterior subcapsular cataract, diabetes mellitus, osteoporosis, liver disease, infection, narrow-angle glaucoma, pyloric obstruction, prostatic hypertrophy or bladder neck obstruction.

-The drug should also be used with caution in patients with prior acute myocardial infarction (cardiac arrest has been reported).

-When discontinuing the drug, the dose should be gradually reduced and a more suitable drug.

-Moderate and high doses of corticosteroids increase blood pressure, salt and water retention, and increase potassium excretion.  A diet that limits salt and provides extra potassium should be considered. All corticosteroids increase calcium excretion.

-When corticosteroids are used in children, complications from severe viral infections such as smallpox and measles may be aggravated by the immunosuppressive effects of the drug.

-During corticosteroid therapy, patients should not be vaccinated against smallpox. Immunosuppressive measures should not be used in patients receiving corticosteroids, especially at high doses, because of possible neurologic complications and lack of antibody response.

-The safety and efficacy of BENOBOSTON have not been established in children younger than 3 years of age. The growth and development of children should be closely monitored because corticosteroids can affect growth rates and inhibit endogenous corticosteroid production in these patients.

-Use of corticosteroids carries a risk of urticaria. Therefore, symptomatic treatment of chronic urticaria has not been shown to be effective.

- Corticosteroid treatment may increase the risk of complications from infections, especially those caused by bacteria, yeast, and parasites. The occurrence of malignant strongyloidiasis is a significant risk. All subjects coming from an endemic area (tropical, subtropical, southern European regions) should have a parasitological examination and systematic eradicative treatment before corticosteroid therapy.

-It is important, before starting treatment, to rule out any possibility of visceral foci, including tuberculosis, and to monitor the appearance of infectious pathologies during treatment.

-In the case of old tuberculosis, prophylactic anti-tuberculosis treatment is necessary if there are significant radiological sequelae and if it cannot be ensured that a well-conducted 6-month treatment with rifampicin has been given.

The use of corticosteroids requires particularly appropriate monitoring, especially in elderly subjects and in cases of ulcerative colitis (risk of perforation), recent intestinal anastomosis, renal failure, liver failure, osteoporosis, myasthenia gravis.

Precautions with dexchlorpheniramine maleate:

Elderly patients in cases of:

+ Easily prone to postural hypotension, dizziness, and drowsiness.

+ Chronic constipation (risk of intestinal paralysis).

+ Prostate enlargement.

-Patients with severe liver or kidney failure, due to the risk of drug accumulation.

-The consumption of alcoholic beverages or drugs containing alcohol is not recommended during treatment.

Precautions with excipients

Products containing lactose: Not recommended for use in patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Products containing maize starch: Suitable for patients with fatty diarrhea. Not recommended for patients allergic to wheat starch (except in cases of fatty diarrhea).

Recommendations for pregnant and lactating women

Because children born to mothers who received corticosteroids during pregnancy have impaired adrenal cortex function and the safety of this drug in pregnancy has not been established, its use in pregnant women, lactating women or women of childbearing age must weigh the benefits of treatment against the potential danger to the mother and the fetus or infant.

Effects of drugs on work (machine operators, driving vehicles, people working at height and other cases)

Due to side effects such as drowsiness, blurred vision, and dizziness, caution should be exercised when driving, operating machinery, working at height or in other cases.

SHELF-LIFE: 

36 months from the manufacturing date.  Do not use after the expiry date

Bottle of 500 tablets

Box of 10 blisters x 10 tablets