Olisir 20 mg 30 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, even if they are taken without a prescription.

In particular, talk to your doctor if you are using any of the following medicines:

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

Taking Olisir with food, drink and alcohol
These tablets should not be taken with food or with grapefruit juice or other fruit juices as this will reduce the effect of Olisir. To avoid this, you can

• Wait one hour after taking the tablet before consuming food or fruit juice, or
• If you have already eaten food or fruit juice, wait two hours before taking the tablet.

Bilastine does not increase alcohol-induced drowsiness at the recommended dosage of 20 mg.

Pregnancy, breast-feeding and fertility
There are no or limited data on the use of bilastine in pregnant women and during breast-feeding and on the effects on fertility.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Before taking any medicines, ask your doctor or pharmacist for advice.

Driving and using machines
Bilastine 20 mg has been shown to have no effect on the ability to drive in adults. However, each individual patient's reaction to the medicine may vary. Therefore, you should check how you react to this medicine before driving a vehicle or operating machines.

Olisir contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, meaning it is almost “sodium free”.

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 tablet (20 mg bilastine) daily for adults, including the elderly and adolescents aged 12 years and over.

• The tablet is to be taken.
• The 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”).
• Swallow your tablet with a glass of water.
• The score line is only used to split the tablet if you have difficulty swallowing it whole.

If you don't feel better or feel worse after 3 days, contact your doctor. Do not use Olisir for more than 10 days without consulting your doctor.

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

Do not give this medicine 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.

If you experience symptoms of an allergic reaction, which may include difficulty breathing, spinning, collapse or loss of consciousness, swelling of the face, lips, tongue or throat and/or swelling and redness of the skin, you must stop taking the medicine immediately see a doctor.

Other side effects that may occur in adults and adolescents include:

Common: may affect up to 1 in 10 people

• Headache
• Lightheadedness

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 (the feeling of feeling bad)
• Fear
• dry or uncomfortable-feeling nose
• stomach pain
• diarrhea (diarrhea)
• Gastritis (an inflammation of the stomach wall)
• Vertigo (a feeling of dizziness or spinning)
• Feeling of weakness
• thirst
• 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 the 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 (allergic inflammation of the conjunctiva of the eye)
• 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 tablet contains 20 mg bilastine.

The other ingredients are microcrystalline cellulose, carboxymethyl starch sodium (type A) [from potatoes], highly disperse anhydrous silicon dioxide, magnesium stearate.

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