Fortecal for children 10 mg. 30 tablets

1. What Fortecal for children is and what it is used for

Fortecal for children contains the active substance bilastine, which is an antihistamine. Fortecal for children is used to relieve the symptoms of hay fever (sneezing, itchy, runny or blocked nose and red and watery eyes) and other forms of allergic rhinitis. It is also used to treat itchy skin rashes (hives or urticaria).

Fortecal for children is indicated in children aged 2 to 11 years with a body weight of more than 15 kg.

2. What you need to know before you use Fortecal for children

Do not use Fortecal for children:

if your child is 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 using Fortecal for children if your child has moderate or severe kidney or liver impairment, low blood levels of potassium, magnesium, calcium, if your child has or has had heart rhythm problems or a very low heart rate, if your child is taking medicines that can affect the heart rhythm, if your child has or has had a certain abnormal heart rhythm pattern (known as QTc prolongation of the electrocardiogram), which can occur with some forms of heart disease, or if your child is taking other medicines (see "Other medicines and Fortecal for children").

Children

Do not give this medicine to children under 2 years of age or weighing less than 15 kg, due to a lack of sufficient information.

Other medicines and Fortecal for children

Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines, including medicines obtained without a prescription. Some medicines should not be taken together, and for others, a change in dose may be necessary when taken at the same time.

Always tell your doctor or pharmacist if your child is using or taking any of the following medicines in addition to Fortecal for children:

ketoconazole (an antifungal medicine)

erythromycin (an antibiotic)

diltiazem (for the treatment of angina pectoris - pain or heaviness in the chest area)

ciclosporin (to reduce the activity of the immune system, thus avoiding rejection in transplants or reducing the activity of the disease in autoimmune and allergic diseases such as psoriasis, atopic dermatitis or rheumatoid arthritis)

ritonavir (for the treatment of HIV)

rifampicin (an antibiotic)

Fortecal for children with food, drink and alcohol

These orodispersible 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 can:

give your child the orodispersible tablet and wait one hour before your child has food or fruit juice, or

if your child has had food or fruit juice, you should wait 2 hours before giving him the orodispersible tablet.

Bilastine at the recommended adult dose (20 mg) does not increase the drowsiness caused by alcohol.

Pregnancy, breast-feeding and fertility

This medicine is intended for use in children aged 2 to 11 years with a body weight of more than 15 kg. However, the information below should be considered with regard to the safe use of the medicine. There are no or limited data on the use of bilastine in pregnant women, during breast-feeding and on the effects on fertility.

If you are pregnant, breast-feeding or planning to become pregnant, it is advisable to consult your doctor before taking this medicine.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Bilastine 20 mg has not been shown to affect the ability to drive in adults. However, each patient's reaction to the medicine may be different. Therefore, you should check how the medicine affects your child before allowing him to ride a bicycle, drive other vehicles or operate machinery.

Fortecal for children contains ethanol and sodium

This medicine contains 0.0015 mg of alcohol (ethanol) in each orodispersible tablet, which is equivalent to 1 mg/100 g (0.001% w/w). The amount in one orodispersible tablet is equivalent to less than 0.00004 ml of beer or 0.00002 ml of wine.

The small amount of alcohol in this medicine will not have any noticeable effects.

This medicine contains less than 1 mmol sodium (23 mg) per orodispersible tablet, i.e. essentially 'sodium-free'.

3. How to use Fortecal for children

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Use in children

The recommended dose for children aged 2 to 11 years weighing more than 15 kg is 10 mg bilastine (1 orodispersible tablet) once a day to relieve the symptoms of allergic rhinitis.

activitis and urticaria.

Do not give this medicine to children under 2 years of age or weighing less than 15 kg due to lack of sufficient data.

The recommended dose for adults, including the elderly and adolescents over 12 years of age, is 20 mg bilastine once daily. A more suitable dosage form, a tablet, is available for this patient population, which you should ask your doctor or pharmacist about.

The orodispersible tablet is for oral use.

Please place the orodispersible tablet in your child’s mouth. It will dissolve quickly in the saliva and can then be easily swallowed.

Alternatively, dissolve the orodispersible tablet in a teaspoon of water before giving it to your child. This is recommended for children under 6 years of age, as they are at increased risk of inhaling foreign bodies when taking tablets. You should make sure that no part of the medicine remains in the spoon.

You should only use water for the dissolution; do not use grapefruit juice or other fruit juices.

You should give the orodispersible tablet to your child one hour before or two hours after your child has taken food or fruit juice.

Since the duration of treatment depends on your child’s underlying condition, your doctor will decide for how long your child should take Fortecal for children.

If you use more Fortecal for children than you should

If your child or someone else has taken too much of the medicine, tell your doctor immediately or go to the emergency department of your nearest hospital. Remember to take the pack of this medicine or this leaflet with you.

If you forget to use Fortecal for children

If you forget to give your child the daily dose on time, give it on the same day as soon as you remember. Then give the next dose the next day at the usual time prescribed by the doctor. Never give a double dose to make up for a forgotten dose.

If you stop using Fortecal for children

In general, there are no after-effects when stopping treatment with Fortecal for children.

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 everybody gets them.

If your child experiences symptoms of an allergic reaction, the 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 giving your child this medicine and seek emergency medical attention immediately.

Other side effects that may occur in children are

Common: may affect up to 1 in 10 people

allergic conjunctivitis (eye irritation)

headache

Uncommon: may affect up to 1 in 100 people

eye irritation

dizziness

loss of consciousness

diarrhoea

nausea (feeling sick)

swelling of the lips

eczema

urticaria (hives)

tiredness

rhinitis (nasal irritation)

stomach pain (abdominal pain/upper abdominal pain)

Side effects that may occur in adults and adolescents are:

Common: may affect up to 1 in 10 people

Headache

Sleepiness

Uncommon: may affect up to 1 in 100 people

Abnormal ECG (electrocardiogram)

Blood tests showing changes in liver function

Dizziness

Stomach pain

Fatigue

Increased appetite

Irregular heart rate

Weight gain

Nausea (feeling sick)

Anxiety

Dryness or discomfort in the nose

Stomach pain

Diarrhoea

Gastritis (inflammation of the stomach lining)

Vertigo (feeling dizzy or spinning)

Feeling weak

Thirst

Dyspnoea (difficulty breathing)

Dry mouth

Indigestion

Itching

Cold sores (oral herpes)

Fever

Tinnitus (ringing in the ears)

Disorders of the sleep

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 your heart beating)

tachycardia (rapid heartbeat)

vomiting

Reporting side effects

If your child gets 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

By reporting side effects, you can help to provide more information on the safety of this medicine.

5. How to store Fortecal for children

Keep out of the reach and sight of children.

Do not use this medicine 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 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 for children contains

The active substance is bilastine. Each orodispersible tablet contains 10 mg bilastine.

The other ingredients are mannitol (E421), croscarmellose sodium, sodium stearyl fumarate, sucralose (E955), red grape flavour (main ingredients: gum arabic, ethyl butyrate, triacetin, methyl anthranilate, ethanol, d-limonene, linalool)

What Fortecal for children looks like and contents of the pack

Fortecal for children orodispersible tablets are round, slightly biconvex, white and 8 mm in diameter.

The orodispersible tablets are available in blister packs of 10, 20, 30 or 50 tablets

Not all pack sizes may be marketed.