Bilastina Amarox
Italy
Table of Contents
Package leaflet: Information for the patient
Bilastina Amarox 20 mg tablets
Bilastina
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Bilastina Amarox is and what it is used for
- What you need to know before taking Bilastina Amarox
- How to take Bilastina Amarox
- Possible side effects
- How to store Bilastina Amarox
- Contents of the pack and other information
1. What Bilastina Amarox is and what it is used for
Bilastina Amarox contains the active substance bilastine, which is an antihistamine. Bilastina Amarox is used to relieve symptoms of hay fever (sneezing, itching, runny nose, nasal congestion, and eye redness and watering) and other forms of allergic rhinitis. It can also be used for the treatment of itchy skin rashes (such as urticaria).
2. What you need to know before taking Bilastina Amarox
Do not take Bilastina Amarox:
if you are allergic to bilastine or to any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking bilastine if you have moderate or severe kidney disease, if you have low levels of potassium, magnesium, or calcium in your blood, if you have or have had heart rhythm problems, if your heart rate is very low, if you are taking medicines that may affect heart rhythm, or if you have or have had a specific heart rhythm disorder (known as QTc interval prolongation on electrocardiogram), which may occur in certain types of heart disease and you are also taking other medicines (see "Other medicines and bilastine").
Children
Bilastina Amarox must not be taken by children under 12 years of age.
Do not exceed the recommended dose. If symptoms persist, consult your doctor.
Other medicines and Bilastina Amarox
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
In particular, consult your doctor if you are taking any of the following medicines:
- Ketoconazole (an antifungal medicine)
- Erythromycin (an antibiotic)
- Diltiazem (used to treat angina)
- Cyclosporine (used to reduce immune system activity to prevent transplant rejection or to reduce the activity of autoimmune and allergic diseases such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
- Ritonavir (used to treat AIDS)
- Rifampicin (an antibiotic)
Bilastina Amarox with food, drinks, and alcohol
The tablets must not be taken with food or grapefruit juice or other fruit juices, as this reduces the effect of bilastine. To avoid this, you may:
- take the tablet and wait one hour before consuming food or fruit juices;
- if you have consumed food or fruit juices, wait two hours before taking the tablet.
Bilastine, at the recommended dose (20 mg), does not increase drowsiness caused by alcohol.
Pregnancy, breastfeeding, and fertility
Data on the use of bilastine in pregnant or breastfeeding women and on the effects of bilastine on fertility are unavailable or limited.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor for advice before taking this medicine. Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
It has been shown that doses of 20 mg of bilastine do not affect driving ability in adults.
However, individual patient response to the medicine may vary. Therefore, it is important to assess how this medicine affects you before driving or operating machinery.
Bilastina Amarox contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially 'sodium-free'.
3. How to take Bilastina Amarox
Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, contact your doctor or pharmacist.
The recommended dose for adults, including the elderly and adolescents aged 12 years and older, is 1
tablet (20 mg) per day.
- The tablet is for oral use.
- The tablet should be taken one hour before or two hours after food or fruit juices (see section 2, “Bilastina Amarox with food, drinks and alcohol”).
- Swallow the tablet with a glass of water.
- The score line is provided only to assist in breaking the tablet if you have difficulty swallowing it whole.
Regarding the duration of treatment, your doctor will assess your condition and decide how long you should take Bilastina Amarox.
Use in children
Other formulations of this medicine – bilastina 10 mg orodispersible tablets or bilastina
2.5 mg/mL oral solution – may be more suitable for children aged 6 to 11 years with a body weight of at least 20 kg; please consult your doctor or pharmacist.
Do not administer this medicine to children under 6 years of age with a body weight
below 20 kg, as sufficient data are not available.
If you take more Bilastina Amarox than you should
If you or someone else has taken an excessive amount of Bilastina Amarox, contact
immediately your doctor, pharmacist, or go to the nearest hospital emergency department.
Remember to bring the pack or the leaflet of this medicine with you.
If you forget to take Bilastina Amarox
Do not take a double dose to make up for the forgotten dose.
If you forget to take a dose, take it as soon as possible and then continue with your regular dosing schedule.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you notice symptoms of allergic reactions, which may include difficulty breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat and/or skin swelling and redness, stop taking the medicine and contact your doctor immediately.
Other side effects that may occur in adults and adolescents are as follows:
Common: may affect up to 1 in 10 people
- headache
- drowsiness
Uncommon: may affect up to 1 in 100 people
- abnormal electrocardiogram (ECG)
- blood tests indicating changes in liver function
- dizziness
- stomach pain
- fatigue
- increased appetite
- irregular heartbeat
- weight gain
- nausea (feeling of sickness)
- anxiety
- sensation of dryness or discomfort in the nose
- panic attacks
- diarrhoea
- gastritis (inflammation of the stomach lining)
- vertigo (a sensation of dizziness)
- feeling of weakness
- thirst
- dyspnoea (difficulty breathing)
- dry mouth
- indigestion
- itching
- cold sores (oral herpes)
- fever
- tinnitus (ringing in the ears)
- difficulty falling asleep
- blood tests indicating changes in kidney function
- increased blood fats
Frequency not known: cannot be estimated based on available data
- palpitations (awareness of heartbeat)
- tachycardia (fast heartbeat)
- allergic reactions whose signs may include difficulty breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat and/or swelling and redness of the skin. If you experience any of these serious side effects, stop taking the medicine and contact a doctor immediately.
- Vomiting
Side effects that may occur in children are as follows:
Common: may affect up to 1 in 10 people
- rhinitis (nasal irritation)
- allergic conjunctivitis (eye irritation)
- headache
- stomach pain (abdominal pain/upper abdominal pain)
Uncommon: may affect up to 1 in 100 people
- eye irritation
- dizziness
- loss of consciousness
- diarrhoea
- nausea (feeling of sickness)
- swelling of the lips
- eczema
- urticaria
- fatigue
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Bilastina Amarox
Keep this medicine out of the sight and reach of children.
Do not use Bilastina Amarox after the expiry date which is stated on the carton and blister after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Bilastina Amarox contains:
The active substance is bilastine.
Each tablet contains 20 mg of bilastine.
The other components are:
Anhydrous colloidal silica, microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate.
Description of the appearance of Bilastina Amarox and pack contents:
Biconvex, oval, white to off-white tablets, 10.0 mm x 5.0 mm, marked with “B” and “H” above and below the break line on one side and “2” on the other side.
The break line is intended only to facilitate tablet splitting for ease of swallowing and not for dividing the tablet into equal doses.
Bilastina Amarox is available in blisters containing 20 tablets.
Marketing Authorization Holder:
Amarox Pharma B.V.
Rouboslaan 32
2252 TR Voorschoten
The Netherlands
Manufacturers:
Amarox Pharma B.V.
Rouboslaan 32
2252 TR Voorschoten
The Netherlands
This medicinal product is authorized in the European Economic Area countries under the
following names:
Deutschland: Bilastin Amarox 20 mg Tabletten
Italia: Bilastina Amarox 20 mg compresse
España: Bilastina Tarbis 20 mg comprimidos EFG