Histafree Raspberry & Vanilla Flavour Suspension 60ml

INTRODUCTION

HISTAFREE contains Fexofenadine which belongs to the group of medicine called Antihistamines. It is used to provide relief from symptoms associated with seasonal allergic rhinitis in children (aged 2 to 11 years). It is also used to manage uncomplicated skin manifestations of chronic idiopathic urticaria in children (aged 6 months to 11 years of age).

Seasonal allergic rhinitis is an inflammatory condition of the upper airways that occurs in response to exposure to airborne allergens (such as tree, grass, and weed pollens) in sensitized individuals, generally characterized by symptoms such as nasal stuffiness, itchy nose/throat/eyes, headache, and weakness. Chronic idiopathic urticaria is a disturbing allergic condition of the skin that recurs without any known cause which is generally characterized by symptoms such as raised/swollen wheals on skin, itching, and swelling of the lips, eyelids, or throat.

Avoid giving fruit juices (such as grapefruit, orange and apple juice) to your child while taking HISTAFREE since it may reduce the effect of this medicine. Before administering HISTAFREE, inform child’s doctor if your child has liver, kidney, or heart problems. HISTAFREE is not recommended for use in children who are allergic to fexofenadine.

It is not indicated for use in pregnant and breastfeeding women since it is recommended for use only in children. The most common side effects of taking HISTAFREE are headache, back pain, dizziness, stomach discomfort, pain in extremity, fever, middle ear infection, and vomiting. Contact child’s physician if any of the symptoms worsen.

USES OF HISTAFREE

• Relives symptoms associated with seasonal allergic rhinitis in children (aged 2 to 11 years)
• Manages uncomplicated skin manifestations of chronic idiopathic urticaria in children (aged 6 months to 11 years)

HOW HISTAFREE WORKS

HISTAFREE works by blocking the actions of H1 histamine receptors (chemical substance responsible for allergic reactions) that results in preventing the occurrence of seasonal allergic rhinitis and idiopathic urticaria thus providing relief from the symptoms associated with both conditions.

DIRECTIONS FOR USE

Give HISTAFREE to your child as advised by the physician. Shake well before each use. Your doctor will decide the correct dose and duration for your child depending upon age, body weight and severity of the condition.

SIDE EFFECTS OF HISTAFREE

HOW TO MANAGE SIDE EFFECTS

Headache:

Apply hot or cold-water bag on your child’s head. Advise your child to take rest in a quiet room. Massage child’s scalp or head with mild pressure for relieving effect. Consult child’s doctor if the symptom does not improve.

Nausea and vomiting:

Try to give HISTAFREE to your child with or just after a meal or a snack. Follow simple meal plan for your child. Avoid giving foods that are oily, fried or spicy foods. Consult child’s doctor if the symptom does not improve.

Diarrhea:

Advise your child to drink plenty of water and stay hydrated. Try to avoid giving any medicine on your own to your child to manage diarrhea. Consult child’s doctor if the symptom gets worse.

Indigestion:

Advise your child to have smaller and more frequent meals and drink slowly. Avoid giving foods that are oily, fried or spicy foods. Consult child’s doctor if the symptom does not improve.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug - Drug interactions:

Before giving HISTAFREE to your child, inform to child’s doctor if your child is taking any of the following medicines:

• aluminum and magnesium gel (medicines used to relieve symptoms of heart burn or indigestion)  
• ketoconazole (medicine used to manage fungal infections)
• erythromycin (medicine used to manage and prevent bacterial infections)
• omeprazole (medicine used to manage gastric and duodenal ulcers)

B. Drug – Food interactions:

Avoid giving fruit juices (such as grapefruit, orange and apple juice) to your child while taking HISTAFREE since it may reduce the effect of this drug.

Overdosage:

If your child accidentally takes too much of HISTAFREE, consult your doctor immediately or visit the nearby hospital. Signs of overdose includes dizziness, drowsiness, fatigue and dry mouth.

SYNOPSIS

MORE INFORMATION

• Store at room temperature

FAQs ABOUT HISTAFREE

What is HISTAFREE and why is it given?

HISTAFREE contains fexofenadine, which is an antihistamine agent, used in children to provide relief from symptoms associated with seasonal allergic rhinitis in children (aged 2 to 11 years) which is also used to manage uncomplicated skin manifestations of chronic idiopathic urticaria in affected children (aged 6 months to 11 years).

What common side effects are seen with HISTAFREE?

The most common side effects of taking HISTAFREE are headache, back pain, dizziness, stomach discomfort, pain in extremity, fever, middle ear infection, and vomiting. Contact child’s physician if the symptoms worsen over the period of time.

Does HISTAFREE causes headache?

Yes, HISTAFREE can cause headache in your child. To manage this effect, apply hot or cold-water bag on your child’s head. Advise your child to take rest in a quiet room. Massage child’s scalp or head with mild pressure for relieving effect. Consult child’s doctor if the symptom does not improve.

Can HISTAFREE be used in children with kidney problems?

HISTAFREE should be used with caution in children having kidney problems such as decreased kidney function. Doctor may adjust the dose depending upon kidney function. Consult child’s doctor before giving HISTAFREE to your child.

What precautions should I follow while giving HISTAFREE to my child?

Avoid giving fruit juices (such as grapefruit, orange and apple juice) to your child while taking HISTAFREE since it may reduce the effect of this medicine. Inform child’s doctor about previous allergy, medical and medication history to avoid unusual interactions or problems in your child.

REFERENCES

1. KD. Tripathi. Histamine and Antihistaminics. Essentials of medical pharmacology. Eighth edition. 2019. Page – 166.

2. Kari L. Craun, Mark P. Schury. Fexofenadine. NIH National Library of Medicine. National center for biotechnology information. May 2022. [Accessed on 9th June 2022] https://www.ncbi.nlm.nih.gov/books/NBK556104/

3. Sanofi. Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients with Perennial Allergic Rhinitis (PAR). NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in 2013] [Accessed on 9th June 2022] https://clinicaltrials.gov/ct2/show/NCT01244217
4. Sanofi-Aventis U.S. LLC. U.S. Food & Drug Administration (FDA). [Revised in July 2007] [Accessed on 9th June 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020872s018,021963s002lbl.pdf

5. Ciplamed Ltd. Fexigra Oral Suspension (Fexofenadine hydrochloride). Ciplamed [Revised in January 2020] [Accessed on 9th June 2022] https://www.ciplamed.com/content/fexigra-oral-suspension

USEFUL DIAGNOSTIC TESTS

• Complete blood count