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Fortecal for kids 2,5 mg / ml. 100 ml.

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What is Fortecal for children and what it is used for

For children, the forteal contains the active substance, which is antihistamine.
Fortecal for children is used to relieve the symptoms of hay fever (sneezing, itching, runny or stuffy nose, and reddening eyes) and other forms of allergic rhinitis. It is also used to treat skin rashes with pruritus (hives or urticaria).

Pediatric forate 2.5 mg / ml oral solution is indicated in children aged 6 to 11 years and weighing more than 20 kg.

2. What you need to know before using Forteal for children

Do not use Fortecal for children:
- if your child is allergic to feline or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
If your child has moderate to severe renal or hepatic impairment or is taking other medicines, talk to your doctor or pharmacist before using Fortecal for children (see "Other medicines and Forteal for Children").

Do not give this medicine to children under 6 years of age under 20 kg due to the lack of enough information.

Other Drugs and Forteal for Children

Tell your doctor or pharmacist if your child is taking, has recently taken or is likely to start taking other medicines, including medicines obtained without a prescription. Some medicines should not be taken together, others may need to be changed 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 a Forteal for children:
• ketoconazole (an antifungal medicine);
• erythromycin (antibiotic);
• diltiazem (for the treatment of angina);
• cyclosporine (to reduce immune system activity, thus avoiding rejection in transplantation or reducing disease activity in autoimmune and allergic diseases such as psoriasis, atopic dermatitis or rheumatoid arthritis);
• ritonavir (for AIDS treatment);
• rifampicin (an antibiotic).

Forteal for children with food, beverages and alcohol

Oral solution should not be taken with food or with grapefruit juice or other fruit juices, as this will reduce the effect of a feline. To avoid this, you can:
• give your child the oral solution and wait one hour before your child receives food or fruit juice, or
• if your child has taken food or fruit juice, you should wait 2 hours before giving it the oral solution.

Bilastin at the recommended adult dose (20 mg) does not increase alcohol-induced drowsiness.

Pregnancy, breastfeeding and fertility
This medicine is for use in children aged 6 to 11 years and weighing more than 20 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 feline in pregnant women during breast-feeding and on the effects on fertility.

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

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

Driving and using machines

It has been shown that 20 mg of felindine does not affect the ability to drive in adults. However, each patient's reaction to the drug 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.

Forteal for children contains methylparahydroxybenzoate (E218) and propylparahydroxybenzoate (E216), which can cause allergic reactions (possibly delayed type).

3. How to use Forteal 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 6 to 11 years weighing more than 20 kg is 10 mg rabbit (4 ml oral solution) once a day to relieve the symptoms of allergic rhinoconjunctivitis and urticaria.

Do not give this medicine to children under 6 years of age below 20 kg, due to lack of data.

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

• The oral solution is for oral use.
• The bottle of the oral solution is fitted with a child-resistant cap. To open, push the plastic cap down and at the same time rotate counterclockwise
• With the oral solution, a 4 ml dose vial (= 10 mg dosing drops) is provided to help you dosing the oral solution properly.
• Pour 4 ml oral solution into the vial.
• Apply
If you use more than the appropriate dose of Fortecal for children
If your child or someone else has taken too much, tell your doctor immediately or go to the emergency room of the nearest hospital. Do not forget 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 a daily dose in time, give it to you the same day as soon as you remember. Then give the next dose the next day at the usual time prescribed by your doctor.
Under no circumstances, give a double dose to make up for the missed dose.

If you stop using Forteal for children
Generally, there are no follow-up effects when stopping treatment with Fortekal 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 everyone gets them.

Adverse reactions 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.

Adverse reactions 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 abnormalities (electrocardiogram);
• blood tests that show changes in liver function;
• dizziness;
• stomachache;
• fatigue;
• increased appetite;
• uneven heart rate;
• increased body weight;
• nausea (feeling sick);
• anxiety;
• dryness or discomfort in the nose;
• stomach ache;
• diarrhea;
• gastritis (inflammation of the stomach lining);
• vertigo (feeling dizzy or dizzy);
• a feeling of weakness;
• thirst;
• dyspnoea (difficulty in breathing);
• dry mouth;
• stomach upset;
• itching;
• Herpes of the lips (oral herpes);
• fever;
• tinnitus (tinnitus);
• sleep disturbances;
• blood tests that show changes in kidney function;
• increased levels of lipids in the blood.

Not known: can not be estimated from the available data
• palpitations (feeling palpitations);
• tachycardia (rapid heartbeat);
• allergic reactions, which may include difficulty in breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or body and swelling and redness of the skin. If you notice any of these serious side effects, stop taking the medicine and seek immediate medical attention immediately.
How to Store Forteal 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 the bottle after EXP. The expiry date refers to the last day of that month.

Store below 30 ° C.

Shelf life after first opening is 6 months.

Do not use the medicine if you notice visible traces of visible particles.

Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information

What contains Fortecal for children
- The active substance is bilastine. One milliliter of the oral solution contains 2.5 mg of rabbit.
- The other ingredients are: beta-lactose, hydroxyethylcellulose, methylparahydroxybenzoate (E218), propylparahydroxybenzoate (E216), sucralose, raspberry flavor (essential ingredients: ethanol, triacetin, water, ethylbutyrate, of pH), sodium hydroxide (to adjust pH), purified water.

What the Fortecal looks like for children and what the pack contains
Oral for oral solution for children is a clear, colorless, slightly viscous aqueous solution with a pH of 3.0-4.0 without any visible particles.

Children's oral foral 2.5 mg / ml oral solution is packed in a dark glass bottle sealed with an aluminum screw cap or a child-resistant polypropylene cap and is provided with a 15 ml or 25 ml 4 ml dose dispenser. Each bottle contains 120 ml of oral solution.







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