Goldesin alerstop

Package Leaflet: Information for the Patient

Goldesin alerstop, 5 mg, film-coated tablets

Desloratadine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact a doctor.

Table of Contents of the Leaflet:

• 1. What is Goldesin alerstop and what is it used for
• 2. Important information before taking Goldesin alerstop
• 3. How to take Goldesin alerstop
• 4. Possible side effects
• 5. How to store Goldesin alerstop
• 6. Contents of the pack and other information

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

What is Goldesin alerstop

Goldesin alerstop contains desloratadine, which is an antihistamine.

How Goldesin alerstop works

Goldesin alerstop is an anti-allergic 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 (hay fever or allergy to dust mites) in adults and adolescents 12 years of age and older. These symptoms include: sneezing, runny or itchy nose, itchy palate, and itchy, red, or watery eyes. The relief of these symptoms lasts throughout the day, making it easier to return to normal daily activities and normal sleep. If after 3 days there is no improvement or you feel worse, you should contact a doctor.

2. Important information before taking Goldesin alerstop

When not to take Goldesin alerstop:

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

Warnings and precautions

Before taking Goldesin alerstop, tell your doctor or pharmacist:

• if you have kidney problems,
• if you have a history of seizures or a family history of seizures.

Children and adolescents

Do not give this medicine to children under 12 years of age.

Goldesin alerstop and other medicines

No interactions with other medicines are known. Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.

Goldesin alerstop with food, drink, and alcohol

Goldesin alerstop can be taken with or without food. Be cautious when taking Goldesin alerstop with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is not recommended to take Goldesin alerstop during pregnancy or breastfeeding. FertilityThere are no available data on the effect on fertility in men and women.

Driving and using machines

It is unlikely that Goldesin alerstop will affect your ability to drive or use machines. However, since most people do not experience drowsiness, it is recommended to avoid activities that require concentration, such as driving or operating machinery, until you know how you react to this medicine.

3. How to take Goldesin alerstop

Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist. Adults and adolescents (12 years of age and older) The recommended dose is one tablet once daily, taken with water, with or without food. The medicine is for oral use. Swallow the tablet whole. If after 3 days there is no improvement or you feel worse, you should contact a doctor.

Do not take the medicine for more than 10 days without consulting a doctor.

Overdose of Goldesin alerstop

Take Goldesin alerstop as directed by your doctor or the instructions in the leaflet. In case of accidental overdose, severe disorders are unlikely to occur. However, if you take more than the recommended dose of Goldesin alerstop, contact your doctor or pharmacist immediately.

Missing a dose of Goldesin alerstop

If you miss a dose, take it as soon as you remember, and then continue with your 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 on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. After the marketing of desloratadine, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If you experience any of these severe side effects, stop taking the medicine and contact a doctor immediately. In clinical studies, side effects in adults were almost the same as with placebo tablets. However, fatigue, dry mouth, and headache were observed more frequently than with placebo tablets. In adolescents, the most commonly reported side effect was headache. In clinical studies with desloratadine, the following side effects were reported:

Common:may affect up to 1 in 10 people

• fatigue, dry mouth, headache.

After the marketing of desloratadine, the following side effects have been reported:

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

• severe allergic reactions, rash,
• palpitations and irregular heartbeat, rapid heartbeat,
• abdominal pain, nausea, vomiting, gastrointestinal disorder, diarrhea,
• dizziness, drowsiness, insomnia,
• muscle pain,
• hallucinations, seizures, restlessness with excessive physical activity,
• hepatitis, abnormal liver function tests.

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 sun (even in cloudy weather) and to UV radiation (ultraviolet), for example, to UV radiation in a solarium,
• unusual behavior,
• aggressive behavior,
• change in heart rhythm,
• weight gain,
• increased appetite,
• low mood.
• dry eyes

Children

Frequency not known:

• slow heartbeat,
• change in heart rhythm,
• unusual behavior,
• aggressive behavior.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Goldesin alerstop

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month. There are no special storage instructions. Store in the original package 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 pack and other information

What Goldesin alerstop contains

• The active substance is desloratadine. Each film-coated tablet contains 5 mg of desloratadine.
• The other ingredients are: microcrystalline cellulose, maize starch, magnesium stearate, and silica colloidal anhydrous. The tablet coating also contains: Opadry Blue 03A30735 (which contains 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 film-coated tablets are blue, round, and biconvex. The pack contains 10 film-coated tablets.

Marketing authorization 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 authorization holder)

Manufacturer

Genepharm S.A. 18km Marathonos Ave 15351 Pallini Attiki, Greece

Date of last revision of the leaflet: