ALLEGRA Allergy Tablets Children 10 mg Melt Tablets, 20 pcs

Instructions for use for ALLEGRA Allergy Tablets Children 10 mg Melt Tablets, 20 pcs

Instructions for use

Children aged 6-11 years (with at least 20 kg body weight)

1 Orodispersible tablet

once daily

before (approx. 1 hour) or after meals (approx. 2 hours)

Indications

Mode of action

How does the active ingredient in the medicine work?

The active ingredient helps with allergies and relieves itching. It suppresses the effect of the body's own substance histamine by displacing it from its binding sites. As a tissue hormone and messenger substance, histamine plays an important role in the development of inflammation and allergic reactions. Blocking its binding sites interrupts the allergic reaction process.

Composition

Contraindications

What speaks against use?

- Hypersensitivity to the ingredients

Which age group should be considered?
- Children under 6 years of age: This medicine must not be used.
- Children under 20 kg body weight: The medicine should not be used in this group.

What about pregnancy and breastfeeding?
- Pregnancy: According to current knowledge, the medicine should not be used.
- Breastfeeding: Based on current knowledge, use is not recommended. Weaning may be considered.

If you have been prescribed the medicine despite a contraindication, talk to your doctor or pharmacist. The therapeutic benefit may outweigh the risk of using it in the presence of a contraindication.

Side effects

What side effects may occur?

Children
- Allergic rhinitis (drug-induced)
- Headache
- Allergic conjunctivitis (drug-induced)
- Abdominal pain
- Dizziness
- Loss of consciousness
- Eye irritation
- Diarrhea
- Nausea
- Swollen lips
- Skin inflammation with itching and redness (eczema)
- Hives (urticaria) caused by medication
- Fatigue

Adolescents and adults
- Gastrointestinal complaints, such as:
- Nausea
- Diarrhea
- Abdominal pain
- Gastritis
- Dry mouth
- Thirst
- Increased appetite
- Weight gain
- Headaches
- Drowsiness
- Insomnia
- Dizziness
- Fatigue
- Anxiety
- Tinnitus (ringing in the ears)
- Attacks of shortness of breath
- Nasal irritation, such as:
- Drying of the nasal mucosa
- Hypersensitivity reactions of the skin, such as:
- Itching
- Abnormalities in EKG (Prolongation of QT-duration)
- Cardiac arrhythmias
- Increased kidney function (creatinine)
- Increased liver function
- Increased blood lipid levels (serum triglycerides)
- Herpes virus infection
- Fever
- General weakness
- Improvement of a pre-existing condition
- EKG- Change (abnormal EKG)

If you notice any discomfort or changes during treatment, contact your doctor or pharmacist.

For the information provided here, we primarily consider side effects that occur in at least one in 1,000 treated patients.

Notes

What should you be aware of?
- Be careful if you are allergic to binding agents (e.g., carboxymethylcellulose with the E number E 466)!
- There may be medications with which interactions occur. Therefore, you should generally inform your doctor or pharmacist about any other medication you are already taking before starting treatment with a new medication. This also applies to medications you buy yourself, use only occasionally, or have used for some time.
- Grapefruit and grapefruit preparations should be avoided completely during treatment with this medication.

Detailed instructions for ALLEGRA Allergy Tablets Children 10 mg Melt Tablets, 20 pcs

Indications

Allegra® Allergy Tablets for Children – Melting Tablets (Pack size: 20) are used to relieve allergic symptoms of the nose, eyes, and skin. Allegra® Allergy Tablets for Children – Melting Tablets (Pack size: 20) are used in children (6-11 years, at least 20 kg) with hay fever, house dust and pet hair allergies, and itching caused by hives.

• Doesn't make you feel drowsy*
• Easy to take - melts on the tongue
• Effective for 24 hours - take only once daily

*Drowsiness & Drowsiness in studies was observed with a comparable frequency to placebo [Novák et al. 2016, Pediatr Allergy Immunol, 27: 493-498].

Mode of action

WIRKSTOFF BILASTIN: Allegra® Allergy Tablets for Children – Melting Tablets (Pack size: 20 tablets) are available over the counter at pharmacies and contain the active ingredient bilastine, a latest-generation antihistamine. This does not affect the sleep center, where tiredness occurs. Therefore, Allegra® with bilastine won't make your child more tired than they may already be due to the allergy*.

*Fatigue & Drowsiness in studies with a comparable frequency to placebo [Novák et al. 2016, Pediatr Allergy Immunol, 27: 493-498].

Active ingredients / Ingredients

Allegra® Allergy Tablets for Children – Orodispersible Tablets (Pack size: 20 tablets) Contains:

The active ingredient is bilastine.
One orodispersible tablet contains 10 mg bilastine.

- The other ingredients are:
Mannitol (E 421), microcrystalline cellulose, croscarmellose sodium (see section 2 "Allegra Allergy Tablets for Children contain sodium"), simaldrate, sucralose, strawberry flavor (main ingredients are maltodextrin, propylene glycol, and gum arabic), magnesium stearate, colloidal silicon dioxide.

Contraindications

This product should not be used in cases of known hypersensitivity to any of the above ingredients.

Dosage

Recommended use of Allegra® Allergy Tablets for Children – Orodispersible Tablets (Pack size: 20 tablets):

The recommended dose for children aged 6 to 11 years with a body weight of at least 20 kg is 1 orodispersible tablet (10 mg bilastine) once daily.

Do not give this medicine to children under 6 years of age or children with a body weight of less than 20 kg, as insufficient data are available.

For adults, including the elderly and adolescents aged 12 years and over, the recommended dose is 20 mg bilastine once daily. Other medicines containing 20 mg bilastine are available for this patient group.

- The orodispersible tablets are for oral use.
- Place the orodispersible tablet in your child's mouth. It will dissolve quickly in saliva and can then be easily swallowed.
- Alternatively, you can dissolve the orodispersible tablet in a teaspoon of water before giving the medicine to your child. Care must be taken to ensure that no sediment remains on the spoon.
- Use only water for dilution. Do not use grapefruit juice or other fruit juices for dissolving.
- Give your child the orodispersible tablet one hour before or two hours after eating or drinking fruit juice.*

Since the duration of treatment depends on your child's condition, your doctor will determine how long your child should take Allegra Allergy Tablets for Children.

* Taking Allegra Allergy Tablets for Children with food and drinks:
These orodispersible tablets should not be taken with food or with grapefruit juice or other fruit juices, as this will reduce the effect of bilastine. To avoid this, you can - wait one hour after giving the orodispersible tablet before giving your child food or fruit juice, or
- if your child has already had food or fruit juice, wait two hours before giving the orodispersible tablet

How to take

• Orodispersible tablets are intended for oral use.
• Place the orodispersible tablet in your child's mouth. It will dissolve quickly in saliva and can then be easily swallowed.
• Alternatively, you can dissolve the orodispersible tablet in a teaspoon of water before giving the medicine to your child. Care must be taken to ensure that no sediment remains on the spoon.
• Use only water for dilution. Do not use grapefruit juice or other fruit juices for dissolving.
• Give your child the orodispersible tablet one hour before or two hours after eating or drinking fruit juice.

Patient Information

• Warnings and Precautions
  • Please talk to your doctor or pharmacist before taking the tablets if your child has moderate to severe kidney or liver impairment or is taking other medications.
  • Children
    • Do not give this medicine to children under 6 years of age or children weighing less than 20 kg, as insufficient data are available.

 

• Driving and using machines
  • 20 Mg of bilastine has been shown to have no effect on the ability to drive in adults. However, each patient's response to the medicine may vary.
  • Therefore, you should check how your child reacts to this medicine before allowing your child to ride a bicycle or other vehicle or operate machinery.

Pregnancy

This medicine is intended for use in children aged 6 to 11 years with a body weight of at least 20 kg. However, the following information should be observed for the safe use of the medicine. There is no or limited data on the use of bilastine in pregnant women and during breastfeeding, or on the effects on fertility.

Notes

Manufacturer:  A. Nattermann & Cie GmbH, Brüningstraße 50