Package leaflet: information for the patient

Goldesin alerstop, 5 mg, film-coated tablets
Desloratadinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by a
doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days or if your condition worsens, contact your doctor.

Leaflet contents:

What Goldesin alerstop is and what it is used for
What you need to know before taking Goldesin alerstop
How to take Goldesin alerstop
Possible side effects
How to store Goldesin alerstop
Contents of the pack and other information

1. What Goldesin alerstop is and what it is used for

What Goldesin alerstop is
Goldesin alerstop contains desloratadine, which is an antihistamine medicine.
How Goldesin alerstop works
Goldesin alerstop is an antiallergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.
What Goldesin alerstop is used for
Goldesin alerstop relieves symptoms associated with 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. These symptoms include:
sneezing, itching or watery nasal discharge, itching of the palate, and eye itching, redness or watering.
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 your condition worsens, contact your doctor.

2. Important information before using Goldesin alerstop

When not to use Goldesin alerstop:

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 Goldesin alerstop, consult a doctor or pharmacist:

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

Children and adolescents
This medicine should not be given to children under 12 years of age.
Goldesin alerstop and other medicines
No interactions between Goldesin alerstop and other medicines are known.
You should tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Goldesin alerstop with food, drink and alcohol
Goldesin alerstop can be taken regardless of meals.
Caution should be exercised when taking Goldesin alerstop with alcohol.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Use of Goldesin alerstop during pregnancy or breastfeeding is not recommended.
Fertility
There are no available data on the effect on fertility in men and women.
Driving and operating machinery
Goldesin alerstop, when used at the recommended dose, is not expected to affect the ability to drive or operate machinery. Although most patients do not experience drowsiness, it is recommended to refrain from activities requiring mental alertness, such as driving or operating machinery, until the individual's response to this medicine is known.
3. How to use Goldesin alerstop
This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults and adolescents (aged 12 years and older)
The recommended dose is one tablet once daily, taken with water, with or without food.
This medicine is for oral use.
The tablet should be swallowed whole.
If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.
Do not use this medicine for longer than 10 days without consulting a doctor.
Taking more Goldesin alerstop than recommended
Goldesin alerstop should be taken according to the doctor's instructions or those provided in the leaflet. After accidental overdose, severe disturbances are not expected. However, if a dose higher than recommended has been taken, contact the treating doctor or pharmacist immediately.
Missing a dose of Goldesin alerstop
If a dose is missed, it should be taken as soon as possible, and then continue with the regular dosing schedule. Do not take a double dose to make up for a missed dose.
Stopping Goldesin alerstop
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.
Since the introduction of desloratadine-containing medicines to the market, severe allergic reactions (difficulty breathing, wheezing, itching, urticaria, and swelling) have been reported very rarely. If any of these severe adverse effects occur, treatment should be discontinued immediately and medical advice should be sought without delay.

In clinical trials, adverse effects in adults were almost the same as those observed with placebo tablets (tablets without active ingredient). However, fatigue, dry mouth, and headache were observed more frequently than with placebo tablets. In adolescents, headache was the most commonly reported adverse effect.

The following adverse effects have been reported in clinical studies with desloratadine:

Common: may affect up to 1 in 10 people

fatigue, dry mouth, headache.

After desloratadine was introduced to the market, the following adverse effects have been reported:

Very rare: may affect up to 1 in 10,000 people

severe allergic reactions, rash,
palpitations, irregular heartbeat, rapid heartbeat,
abdominal pain, nausea, vomiting, dyspepsia, diarrhoea,
dizziness, somnolence, insomnia,
muscle pain,
hallucinations, convulsions, restlessness with excessive motor activity,
hepatitis, abnormal liver function test results.

Frequency not known: frequency cannot be estimated from the available data

unusual weakness,
yellowing of the skin and (or) eyes,
increased sensitivity of the skin to sunlight (even on cloudy days) and to UV radiation (ultraviolet), for example UV radiation in a tanning bed,
unusual behaviour,
aggressive behaviour,
change in heartbeat,
weight gain,
increased appetite,
depressed mood,
dry eyes.

Children
Frequency not known:

slow heartbeat,
change in heartbeat,
unusual behaviour,
aggressive behaviour.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 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 to provide more information on the safety of the medicine.

5. How to store Goldesin alerstop

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and on the blister pack after EXP. The expiry date refers to the last day of the stated month.
There are no special storage temperature requirements. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Goldesin alerstop contains

The active substance is desloratadine. Each coated tablet contains 5 mg of desloratadine.
The other ingredients are: microcrystalline cellulose, pregelatinized maize starch, magnesium stearate and colloidal anhydrous silica. The tablet coating additionally contains: Opadry Blue 03A30735 (which consists of: hypromellose 6 cP, titanium dioxide (E 171), microcrystalline cellulose, stearic acid and indigo carmine (E 132)).

What Goldesin alerstop looks like and contents of the pack
Goldesin alerstop 5 mg coated tablets are blue, round and biconvex.
The pack contains 10 coated tablets.
Marketing Authorisation Holder
TACTICA Pharmaceuticals Sp. z o.o.
ul. Królowej Jadwigi 148a/1a
30-212 Kraków
Tel. +48 12 422 04 72
(Logo of the marketing authorisation holder)
Manufacturer
Genepharm S.A.
18km Marathonos Ave
15351 Pallini Attiki, Greece