Olisir 20 mg 10 oro dispersible tablets

Olisir contains the active ingredient bilastine, an antihistamine. Olisir is used to relieve the symptoms of hay fever (sneezing, itchy, runny, stuffy nose and red and watery eyes) and other forms of allergic rhinitis. It can also be used to treat itchy skin rashes (hives or urticaria).

Contraindications

Olisir must not be taken if you are allergic to bilastine or any of the other ingredients of this medicine listed in section 6.

Interactions

Taking Olisir with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

Please talk to your doctor in particular if you are taking any of the following medicines:

• Ketoconazole (a medicine used to treat fungal diseases)
• erythromycin (an antibiotic)
• Diltiazem (a medicine used to treat chest pain or tightness - angina)
• Cyclosporine (a medicine used to reduce the activity of your immune system to prevent transplant rejection or to reduce the severity of autoimmune and allergic diseases such as psoriasis, atopic dermatitis or rheumatoid arthritis)
• Ritonavir (a medicine used to treat AIDS)
• Rifampicin (an antibiotic)

Application

Always take this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist tells you. Check with your doctor or pharmacist if you are unsure.

The recommended dose is 1 orodispersible tablet (20 mg bilastine) once daily for adults, including the elderly and adolescents aged 12 years and over.

• The orodispersible tablet is to be taken orally.
• Please put 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.
• Use only water to dissolve, 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 section 2 “Taking Olisir with food, drink and alcohol”).

Use in children
Other dosage strengths or dosage forms of this medicine - Bilastine 10 mg orodispersible tablets or Bilastine 2.5 mg/ml oral solution - require a prescription and are suitable for children aged 6 to 11 years with a body weight of at least 20 kg. Ask your doctor or pharmacist.

Do not give bilastine to children under 6 years of age or children weighing less than 20 kg as there are insufficient data available.

Side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
You must stop taking the medicine and see a doctor immediately if you experience symptoms of an allergic reaction, which include difficulty breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat and/or swelling and redness of the throat May include skin.

Other side effects that may occur in adults and adolescents include:
Common: may affect up to 1 in 10 people

• Headache
• sleepiness

Uncommon: may affect up to 1 in 100 people

• abnormal ECG changes
• Abnormalities in liver function values ​​in blood tests
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• Weight gain
• nausea
• Angst
• dry or uncomfortable-feeling nose
• stomach pain
• Diarrhea
• Gastritis (an inflammation of the stomach wall)
• Vertigo (a feeling of dizziness or spinning)
• Feeling of weakness
• Durst
• Dyspnea (difficulty breathing)
• dry mouth
• Indigestion
• itching
• cold sores (oral herpes)
• Fever
• Tinnitus (ringing noises in the ears)
• Sleep problems
• Abnormalities in kidney function values ​​in blood tests
• increased blood lipids

Frequency not known (cannot be estimated from available data)

• Heartbeat (palpitations)
• Racing heartbeat (tachycardia)
• Vomit

Side effects that may occur in children include:
Common: may affect up to 1 in 10 people

• Rhinitis (nose infection)
• allergic conjunctivitis (eye inflammation due to an allergic reaction)
• Headache
• Abdominal pain (pain from the lower abdomen to the upper abdomen)

Uncommon: may affect up to 1 in 100 people

• Eye irritation
• dizziness
• Loss of consciousness
• Diarrhea
• nausea
• Lip swelling
• eczema
• Hives (urticaria)
• fatigue

composition

The active ingredient is bilastine.
Each orodispersible tablet contains 20 mg bilastine.

The other ingredients are mannitol (E 421), croscarmellose sodium, sodium stearyl fumarate, sucralose (E 955), red grape flavor (main ingredients: Arabic gum, ethyl butyrate, triacetin, methyl (2-aminobenzoate), ethanol, D-limonene, linalool)

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