Patient Information Leaflet

Hitaxa Fast, 5 mg, orodispersible tablets
Desloratadine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has advised.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if you feel worse, contact your doctor.

Contents of this leaflet:

What Hitaxa Fast is and what it is used for
Important information before taking Hitaxa Fast
How to take Hitaxa Fast
Possible side effects
How to store Hitaxa Fast
Contents of the pack and other information

1. What Hitaxa Fast is and what it is used for

What Hitaxa Fast is
Hitaxa Fast contains desloratadine, which is an antihistamine medicine.
How Hitaxa Fast works
Hitaxa Fast is a non-sedating antiallergic medicine. It helps control allergic reactions and their symptoms.
When Hitaxa Fast should be used
Hitaxa Fast relieves symptoms of allergic rhinitis (inflammation of the nasal mucosa caused by allergy, such as hay fever or dust mite allergy) in adults and adolescents aged 12 years and older. Symptoms of this condition include sneezing, itching or runny nose, itching of the palate, and itchy, red or watery eyes.
Hitaxa Fast orodispersible tablets are also used to relieve symptoms associated with urticaria (an allergic skin condition). Symptoms of this condition include skin itching and hives.
Relief from these symptoms lasts throughout the day, helping patients return to normal daily activities and sleep normally.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before using Hitaxa Fast

When not to use Hitaxa Fast

if the patient is allergic to desloratadine or to any of the other ingredients of this medicine (listed in section 6), or to loratadine.

Warnings and precautions
Before starting treatment with Hitaxa Fast, consult your doctor or pharmacist:

if the patient has kidney function disorders,
if the patient has a history or family history of seizures.

Children and adolescents
This medicine must not be given to children under 12 years of age.
Interaction of Hitaxa Fast with other medicines
No interactions between Hitaxa Fast and other medicines are known.
Hitaxa Fast with food, drink and alcohol
Hitaxa Fast does not need to be taken with water or any other liquid. Moreover, Hitaxa Fast
may be taken with or without food. Caution should be exercised when taking Hitaxa Fast with alcohol.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
Use of Hitaxa Fast is not recommended during pregnancy or breastfeeding.
Fertility
There are no available data on the effect on fertility in men and women.
Driving and operating machinery
It is not expected that Hitaxa Fast, when used at the recommended dose, affects the ability
to drive or operate machinery. Although drowsiness does not occur in most people, it is recommended
to refrain from activities requiring mental alertness, such as driving or operating machinery, until the
individual response to this medicine is known.
Hitaxa Fast orally disintegrating tablets contain aspartame.
The medicine contains 3 mg of aspartame in each 5 mg dose. Aspartame is a source of
phenylalanine. It may be harmful for people with phenylketonuria. This is a rare genetic disorder
in which phenylalanine accumulates in the body due to impaired excretion.
Hitaxa Fast orally disintegrating tablets contain sodium.
The medicine contains less than 1 mmol (23 mg) of sodium per orally disintegrating tablet, which
means the medicine is considered "sodium-free".

3. How to take Hitaxa Fast

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Recommended dose

Adults and adolescents (aged 12 years and older): one 5 mg orodispersible tablet of Hitaxa Fast once daily. The tablet should be taken immediately after opening the blister pack.

This medicine is intended for oral use.
Carefully open the blister pack and remove the orodispersible tablet without crushing it. Place the tablet in the mouth, where it will disintegrate immediately. Water or any other liquid is not required to swallow the dose. The tablet should be taken immediately after opening the blister pack.

Duration of treatment
Treatment of allergic rhinitis and urticaria with desloratadine, without medical consultation, should not last longer than 10 days.

Taking more than the recommended dose of Hitaxa Fast
Hitaxa Fast should only be taken as described in this patient leaflet or as directed by your doctor or pharmacist. Serious adverse effects are not expected after accidental overdose. However, if you have taken more than the recommended dose of Hitaxa Fast, contact your doctor or pharmacist.

Missed dose of Hitaxa Fast
If you miss a dose at the scheduled time, take it as soon as possible and then return to your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping Hitaxa Fast
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Very rarely, serious allergic reactions have been reported since the medicine has been marketed
(difficulty breathing, wheezing, itching, hives, and swelling). If any of these serious adverse effects occur,
you should stop taking the medicine immediately and consult a doctor without delay.
In adults, adverse effects were almost the same as those observed with the placebo tablet. However,
fatigue, dry mouth, and headache occurred more frequently than with the placebo tablet.
In adolescents, headache was the most commonly reported adverse effect.
The following adverse effects have been reported in clinical trials with desloratadine:
Common (may affect up to 1 in 10 patients):

fatigue
dry mouth
headache

After desloratadine was introduced to the market, the following adverse effects have been reported:
Very rare adverse effects (affecting fewer than 1 in 10,000 patients treated):

severe allergic reactions • rash • palpitations and irregular heartbeat
rapid heartbeat • abdominal pain • nausea
vomiting • stomach discomfort • diarrhoea
dizziness • drowsiness • insomnia
muscle pain • hallucinations • seizures
restlessness with increased motor activity • hepatitis • abnormal liver function tests

Adverse effects with unknown frequency (frequency cannot be estimated from the available data):

unusual weakness • weight gain, increased appetite
increased skin sensitivity to sunlight
yellowing of the skin and (or) eyes even when the sun is obscured, and • aggressive behaviour due to exposure to UV (ultraviolet) radiation, for example in a tanning bed • low mood • dry eyes
unusual behaviour
changes in heartbeat

Additional adverse effects in children:
Frequency unknown: frequency cannot be estimated from the available data

slow heartbeat • changes in heartbeat
unusual behaviour • aggressive behaviour

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Hitaxa Fast

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 pack following EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Do not use this medicine if you notice any changes in the appearance of Hitaxa Fast.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Hitaxa Fast contains

The active substance is desloratadine, 5 mg per tablet.
Other ingredients are: potassium polacrilin, monohydrate citric acid, red iron oxide (E 172), magnesium stearate, sodium croscarmellose, Tutti Frutti flavouring (also contains propylene glycol), aspartame (E 951), microcrystalline cellulose, mannitol (spray-dried), potassium hydroxide (for pH adjustment).

What Hitaxa Fast looks like and contents of the pack
Hitaxa Fast 5 mg, orodispersible tablets, are brick-red, round, flat tablets with bevelled edges, embossed with the number "5".
Hitaxa Fast is available in packages containing 10 or 20 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturers:
Genepharm S.A.
18km Marathon Avenue
15351 Pallini
Greece
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. BOX 3012 Larisa Industrial Area
Larisa, 41004
Greece
Pharmapath S.A.
28is Oktovriou 1,
Agia Varvara, 123 51
Greece