BITOSEN 20 mg orodispersible tablets, 20 pcs

Instructions for use for BITOSEN 20 mg orodispersible tablets, 20 pcs

Instructions for use

Adolescents 12 years and older and adults

1 Orodispersible tablet

1 time 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 are the contraindications?

- Hypersensitivity to the ingredients

Which age group should be considered?
- Children under 12 years of age: The medicine should generally not be used in this age group.

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

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

Side effects

What adverse effects may occur?

- 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 (prolonged QT-duration)
- Cardiac arrhythmias
- Increased kidney values (creatinine)
- Increased liver values
- Increased blood lipid levels (serum triglycerides)
- Herpes virus infection
- Fever
- General weakness
- Improvement of a pre-existing condition
- changes EKG(abnormal EKG)

If you notice any discomfort or changes during treatment, consult 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?
- Caution if you are allergic to binding agents (e.g., carboxymethylcellulose with the E number E 466)!
- There may be drug interactions with certain medications. 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 BITOSEN 20 mg orodispersible tablets, 20 pcs

Area of Use

Bitosen 20 mg Allergy Melting Tablets (Pack Size: 20) relieves the symptoms of hay fever (sneezing, itchy, runny, stuffy nose, and red and watery eyes) and other forms of allergic rhinitis (e.g., allergies to house dust mites, pet dander, or mold). Bitosen 20 mg Allergy Melting Tablets (Pack Size: 20) can also be used for itchy skin rashes (hives). The product is indicated for adults and adolescents aged 12 years and older.

Active ingredients / Ingredients

Bitosen 20 mg orodispersible tablets for allergies (pack size: 20 tablets) contains:

The active ingredient is bilastine. Each orodispersible tablet contains 20 mg of bilastine.
– The other ingredients are mannitol (Ph. Eur.)
(E 421), croscarmellose sodium, sodium stearyl fumarate (Ph. Eur.), sucralose (E 955), red grape flavor (main ingredients: gum arabic, ethyl butyrate, triacetin, methyl 2-aminobenzoate, ethanol, (+)-limonene, linalool)

Contraindications

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

Dosage

Recommended use of Bitosen 20 mg Dissolvable Tablets for Allergies (Pack size: 20 pcs):

Dissolve one orodispersible tablet in the mouth once daily or dissolve it in water only. Take Bitosen 20 mg Orodispersible Tablets for Allergies (Pack size: 20 pcs) one hour before or two hours after consuming food or fruit juice.

How to take

• The orodispersible tablet is for oral use.
• Please place the orodispersible tablet in your mouth. It dissolves quickly in saliva and can then be easily swallowed.
• Alternatively, the orodispersible tablet can be dissolved in water before taking it.
  • Use only water to dissolve the tablet, not grapefruit juice or other fruit juices.
• The orodispersible tablet must be taken one hour before or two hours after eating or drinking fruit juice (see instructions for use).

Patient Information

• Warnings and Precautions
  • Please talk to your doctor or pharmacist before taking this medicine if you have moderate to severe kidney impairment and are also taking other medications.
  • Do not take more than the recommended dose. If symptoms persist, consult your doctor.
• Children
  • Do not give this medicine to children under 12 years of age.

 

• 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 you react to this medicine before driving or operating machinery.

Pregnancy

• There are no or limited data on the use of bilastine in pregnant women and during breastfeeding, or on its effects on fertility. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine.
• Consult your doctor or pharmacist before taking any medicine.

Notes

Manufacturer:  BERLIN-CHEMIE AG, Glienicker Weg 125