FORTECAL 20mg x 20 tabl
PACKAGE LEAFLET: INFORMATION FOR THE USER
FORTECAL 20 MG TABLETS
FORTECAL 20 MG TABLETS
bilastine
Read all of this leaflet carefully before you start taking this medicine.
medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor has told you.
your doctor or pharmacist told you.
· Keep this leaflet. You may need to read it again.
· If you have any further questions, ask your doctor or pharmacist.
If you experience any side effects, tell your doctor.
or pharmacist. This also includes any possible side effects not listed in
this leaflet. See section 4.
You should consult a doctor if you do not feel better or if
Your condition worsened after 3 days.
What this leaflet contains:
1. What Fortecal is and what it is used for
2. What you need to know before you take Fortecal
3. How to take Fortecal
4. Possible side effects
5. How to store Fortecal
6. Contents of the pack and other information
1. What Fortecal is and what it is used for
Fortecal contains bilastine as the active substance, which is an antihistamine. Fortecal is used to relieve the symptoms of hay fever (sneezing, itching, runny or stuffy nose).
stuffy nose and red and watery eyes) and other forms of allergic rhinitis. It is used
also for the treatment of itchy skin rashes (hives or urticaria).
2. What you need to know before you take Fortecal Do not take Fortecal:
Do not take Fortecal:
- if you are allergic to bilastine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Fortecal if you suffer from:
moderate to severe kidney damage low levels of potassium, magnesium, calcium in the blood,
if you have or have had heart rhythm problems or if your heart rate is very low, if you are taking medicines that may affect your heart rhythm, if
you have or have had a certain change in your heart rhythm (known as prolongation
of the QTc interval on an electrocardiogram), which can occur in some forms of heart disease, and if you are also taking other medicines (see “Other
medicines and Fortekal").
Children
Do not give this medicine to children under 12 years of age.
Do not exceed the recommended dose. If symptoms persist, consult your doctor.
Other medicines and Fortecal
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
In particular, please discuss with your doctor if you are taking any of the following medications:
ketoconazole (an antifungal medicine)
· erythromycin (antibiotic)
· diltiazem (for the treatment of angina pectoris)
· ciclosporin (to reduce the activity of the immune system, thus
way to avoid rejection during transplantation or reduce morbidity
activity in autoimmune and allergic diseases such as psoriasis, atopic dermatitis or rheumatoid arthritis)
ritonavir (for the treatment of HIV)
· rifampicin (antibiotic)
Fortecal 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 bilastine. To avoid this, you
you can:
· take the tablet and wait one hour before consuming food or fruit juice
or
· if you have taken food or fruit juice, you should wait 2 hours before taking the tablet.
Bilastine at the recommended dose (20) mg does not increase alcohol-induced drowsiness.
Pregnancy, breastfeeding and fertility
There are no or limited data from the use of bilastine in pregnant women during pregnancy.
of breastfeeding and the effects on fertility.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant
pregnancy, consult your doctor before using this medicine.
Ask your doctor or pharmacist for advice before using any medicine.
medicine.
Driving and using machines
Bilastine 20 mg has been shown not to affect the ability to drive in adults. However
Again, each patient's response to the medication may be different. Therefore, you should check how this medication affects you before driving or operating machinery.
Fortecal contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, i.e. essentially 'sodium-free'.
3. How to take Fortecal
Always take this medicine exactly as described in this leaflet or as your doctor has told you.
your doctor or pharmacist has told you. If you are not sure about anything, ask your doctor
or pharmacist.
The recommended dose for adults, including the elderly, and adolescents aged 12 years and over is 1 tablet (20 mg) per day.
The tablet is taken orally.
The tablet should be taken one hour before or two hours after a meal.
or fruit juice (see section 2, "Fortecal with food, drink and alcohol").
The tablet is swallowed with a glass of water.
The score line is only to make breaking easier if you have difficulty swallowing the tablet whole.
Regarding the duration of treatment, your doctor will determine the type of your illness and determine how long you should take Fortecal.
Use in children
Other forms of this medicine bilastine 10 mg orodispersible tablets or bilastine 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 - ask your doctor or pharmacist.
Do not give bilastine to children under 6 years of age with a body weight of less than 20 kg, as there is no
enough data.
If you take more Fortecal than you should
If you or someone else has taken too much Fortecal, contact your doctor immediately.
Your doctor or pharmacist or go to the emergency department of your nearest hospital. Please remember to take the medicine pack or the package leaflet with you.
If you forget to take Fortecal
Do not take a double dose to make up for a missed dose.
If you miss a dose, take it as soon as possible.
and then return to your usual dosing regimen.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
that not everyone gets them.
If you experience symptoms of an allergic reaction, signs of which 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, stop taking the medicine and seek emergency medical attention immediately.
Other side effects that may occur in adults and adolescents are:
Common: may affect up to 1 in 10 people
headache
drowsiness
Uncommon: may affect up to 1 in 100 people
· ECG (electrocardiogram) abnormalities
blood tests that show changes in liver function
· dizziness
stomach pain
· fatigue
· increased appetite
· irregular heartbeat
· increased body weight
nausea (feeling sick)
· anxiety
· dryness or discomfort in the nose
abdominal pain
diarrhea gastritis (inflammation of the stomach lining)
· vertigo (feeling of dizziness or spinning)
feeling weak
· thirst
· dyspnea (difficulty breathing)
· dry mouth
· stomach upset
itching
· herpes on the lips
fever
Tinnitus (ringing in the ears)
· sleep disorders
blood tests that show changes in kidney function
· increased levels of lipids in the blood
Not known: frequency cannot be estimated from the available data:
· palpitations (feeling of a pounding heart)
tachycardia (rapid heartbeat)
vomiting
Side effects that may occur in children are:
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
diarrhea
nausea (feeling sick)
· swelling of the lips
eczema
· urticaria (hives)
· fatigue
Reporting side effects
If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the national reporting system.
notification system:
Executive Agency for Medicines
8 Damyan Gruev Street
1303 Sofia
tel.: +359 28903417
website: www.bda.bg
By reporting side effects, you can contribute to getting
more information about the safety of this medicine.
5. How to store Fortecal
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton.
packaging and blisters after "Expiry date:". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
6. Contents of the pack and other information
What Fortecal contains:
- The active substance is bilastine. Each tablet contains 20 mg bilastine.
- The other ingredients are microcrystalline cellulose, sodium starch glycolate type A (derived from potato), colloidal silicon dioxide, magnesium stearate.
What Fortecal looks like and contents of the pack
Fortecal are white, oval, biconvex tablets with a score line (10 mm long, 5 mm wide).
The tablets are available in blister packs of 10, 20, 30, 40 or 50 tablets.
Not all types of packaging can be released for sale.
Marketing Authorisation Holder
Menarini International Operations Luxembourg SA,
1, Avenue de la Gare, L-1611, Luxembourg
Manufacturer
Faes Farma SA
Maximo Aguirre, 14
Leioa (Vizcaya)
Spain
or
Faes Farma, SA,
Scientific and Technological Park of Bizkaia,
Ibaizabal Bidea, Edificio 901, 48160 Derio
Spain
or
A.Menarini Manufacturing Logistics and Services Srl
Pile Field
L'Aquila
Italy
or
Menarini - Von Heyden GmbH
Leipziger Strasse 7-13; 01097
Dresden
Germany
This medicinal product is authorised for use in the Member States of
The European Economic Area and the United Kingdom (Northern
Ireland) under the following names:
Austria: Olisir 20 mg Tabletten
Belgium: Bellozal 20 mg Tablet
Bulgaria: Fortecal 20 mg tablet
Cyprus: Bilaz 20 mg Δισκίο
Czech Republic: Xados 20 mg Tablety
Denmark: Revitelle tabletter 20 mg
Estonia: Walnut
Finland: Revitelle 20 mg Tabletti
France: Bilaska 20 mg Comprimé
Germany: Bilaxten 20 mg Tabletten
Greece: Bilaz 20 mg Aikio
Hungary: Lendin 20 mg tabletta
Iceland: Bilaxten 20 mg tablets
Ireland: Drynol 20 mg tablets
Italy: Bysabel 20 mg Compressa
Latvia: Opexa 20 mg tabletes
Lithuania: Orexa 20 mg Tabletis
Luxembourg: Bellozal 20 mg Tablet
Malta: Gosall 20 mg tablets
Norway: Zilas 20 mg tablet
Poland: Clatra Allergy
Portugal: Lergonix 20 mg Tablet
Romania: Borenar 20 mg Comprimate
Slovakia: Omarit
Slovenia: Bilador 20 mg tablete
Spain: Ibis 20 mg Comprimido
Sweden: Bilaxten 20 mg Tablet
United Kingdom (Northern Ireland): Ilaxten 20 mg tablets
Date the leaflet was last revised
