Bilastina hitaxa
Poland
Table of Contents
Package leaflet: Information for the patient
Bilastyna Hitaxa, 20 mg, tablets
Bilastinum
Please read this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement after 3 days or if you feel worse, contact your doctor.
Table of contents:
- What Bilastyna Hitaxa is and what it is used for
- Important information before taking Bilastyna Hitaxa
- How to use Bilastyna Hitaxa
- Possible side effects
- How to store Bilastyna Hitaxa
- Contents of the pack and other information
1. What Bilastyna Hitaxa is and what it is used for
Bilastyna Hitaxa contains the active substance bilastinum, which has antihistamine properties.
Bilastyna Hitaxa is used in adults and adolescents aged 12 years and older to relieve symptoms of
seasonal allergic rhinitis (sneezing, itching, runny nose, nasal congestion, and red, watery eyes) and
other forms of allergic rhinitis. The medicine may also be used to treat itchy skin rashes (urticaria).
If there is no improvement after 3 days or if you feel worse, consult your doctor.
2. Important information before taking Bilastyna Hitaxa
When not to use Bilastyna Hitaxa
- if you are allergic to bilastinum or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting treatment with Bilastyna Hitaxa, consult your doctor or pharmacist if you have
moderate to severe kidney impairment, low blood levels of potassium, magnesium, or calcium,
if you have or have had heart rhythm disorders or very slow heart rate, if you are taking medicines
that may affect heart rhythm, if you have or have had an abnormal heart rhythm pattern (known as
QTc prolongation on electrocardiogram), which may occur in certain types of heart disease, and
especially if you are taking other medicines (see "Bilastyna Hitaxa and other medicines").
Children
Do not give this medicine to children under 12 years of age.
Do not exceed the recommended dose.
Bilastyna Hitaxa and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken,
or plan to take, including over-the-counter medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:
- ketoconazole (an antifungal medicine)
- erythromycin (an antibiotic)
- diltiazem (a medicine used for coronary heart disease)
- cyclosporine (a medicine used to suppress the immune system to prevent transplant rejection or to reduce the severity of symptoms in autoimmune and allergic diseases such as psoriasis, atopic dermatitis, and rheumatoid arthritis)
- ritonavir (used in the treatment of AIDS)
- rifampicin (an antibiotic).
Bilastyna Hitaxa, food, drink, and alcohol
Do not take this medicine with food, grapefruit juice, or other fruit juices, as this may reduce
the effectiveness of Bilastyna Hitaxa. To avoid reduced effectiveness, you should:
- swallow the tablet and wait one hour before eating a meal or drinking fruit juice, or
- wait two hours after eating or drinking fruit juice before taking the tablet.
Bilastinum at the recommended dose (20 mg) does not increase alcohol-induced drowsiness.
Pregnancy, breastfeeding, and fertility
There are no data or limited data on the use of bilastinum in pregnant or breastfeeding women,
or on its effect on fertility.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby,
you should consult your doctor before using this medicine.
Your doctor will decide whether Bilastyna Hitaxa can be used during pregnancy or while
breastfeeding.
Driving and operating machinery
It has been shown that taking bilastinum at a dose of 20 mg does not affect the ability to drive
in adults. However, individual response to treatment may vary.
Therefore, before driving or operating machinery, you should assess your reaction to the medicine.
3. How to take Bilastyna Hitaxa
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose for adults, including elderly people, and adolescents aged 12 years and
older, is 1 tablet (20 mg) once daily.
- Tablet for oral administration.
- The tablet should be taken one hour before or two hours after any meal or drinking fruit juice (see section 2, "Bilastyna Hitaxa with food, drink and alcohol").
- Swallow the tablet with a glass of water.
- The break line on the tablet is intended only to facilitate breaking the tablet if the patient has difficulty swallowing it whole.
Do not use Bilastyna Hitaxa for longer than 10 days without consulting a doctor.
If there is no improvement after 3 days, or if symptoms worsen, consult your doctor.
The duration of treatment depends on the type of illness and will be determined by your doctor.
Use in children
This medicine should not be given to children under 12 years of age.
If you take more Bilastyna Hitaxa than you should
If you take more than the recommended dose of Bilastyna Hitaxa, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department. Take the medicine pack or this leaflet with you.
If you forget to take Bilastyna Hitaxa
Do not take a double dose to make up for a missed dose.
If you miss a dose, take it as soon as possible, then return to taking your regular dose at the usual time.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
If the patient experiences symptoms of an allergic reaction (frequency unknown), including:
difficulty breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat
and (or) swelling and redness of the skin, administration of the medicine should be discontinued and immediate
medical advice should be sought.
Adverse reactions that may occur in adults and adolescents are:
Common: occurring more frequently than in 1 in 100 but less frequently than in 1 in 10 patients treated
- headache
- somnolence.
Uncommon: occurring more frequently than in 1 in 1,000 but less frequently than in 1 in 100 patients treated
- abnormal ECG recording
- blood test abnormalities indicating liver function disorders
- dizziness
- stomach pain
- fatigue
- increased appetite
- heart rhythm disorders
- weight gain
- nausea
- anxiety
- dryness or discomfort in the nose
- abdominal pain
- diarrhoea
- gastritis
- vertigo (dizziness or sensation of spinning)
- weakness
- excessive thirst
- dyspnoea (difficulty breathing)
- dry mouth
- indigestion
- itching
- facial rash
- fever
- tinnitus (ringing in the ears)
- sleep disorders
- blood test abnormalities indicating kidney function disorders
- increased blood lipid concentration.
Frequency unknown: cannot be estimated from the available data
- palpitations (awareness of heartbeat)
- tachycardia (rapid heartbeat)
- vomiting.
Adverse reactions that may occur in children are:
Common: occurring less frequently than in 1 in 10 patients treated
- rhinitis (nasal irritation)
- allergic conjunctivitis (eye irritation)
- headache
- stomach ache (abdominal pain, epigastric pain).
Uncommon: occurring less frequently than in 1 in 100 patients treated
- eye irritation
- dizziness
- loss of consciousness
- diarrhoea
- nausea
- lip swelling
- rash
- urticaria
- fatigue.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions may be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Bilastyna Hitaxa
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP".
The expiry date refers to the last day of the mentioned month.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the package and other information
What Bilastyna Hitaxa contains
- The active substance is bilastine. Each tablet contains 20 mg of bilastine.
- The other ingredients are: microcrystalline cellulose, crospovidone (type A), magnesium stearate, colloidal anhydrous silica.
What Bilastyna Hitaxa looks like and contents of the pack
Bilastyna Hitaxa tablets are white, round, with a diameter of 7 mm.
The tablets are packed in PA/Aluminum/PVC/Aluminum blisters.
Pack sizes: 10 or 20 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. Mariana Adamkiewicza 6A
05-152 Czosnów
tel.: +48 22 732 77 00
Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
NOUCOR HEALTH, S.A.
Avda. Camí Reial 51-57
08184 Palau-Solità i Plegamans (Barcelona)
Spain