Dinid

Package Leaflet: Information for the Patient

Dynid, 0.5 mg/ml, Oral Solution

Desloratadine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Dynid and what is it used for

What is Dynid

Dynid contains desloratadine, which is an antihistamine.

How Dynid works

Dynid, oral solution is an anti-allergic medicine that does not cause drowsiness. It helps to control allergic reactions and their symptoms.

When to use Dynid

Dynid, oral solution relieves the symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by an allergy, such as hay fever or allergy to dust mites) in adults, adolescents, and children over 1 year of age. The symptoms include: sneezing, runny or itchy nose, itchy palate, and itchy, red, or watery eyes. Dynid, oral solution is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). The symptoms include skin itching and urticaria. The relief of these symptoms persists throughout the day, making it easier to return to normal daily activities and normal sleep.

2. Important information before taking Dynid

When not to take Dynid

• 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 Dynid, discuss with your doctor, pharmacist, or nurse:

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

Children and adolescents

Do not give this medicine to children under 1 year of age.

Dynid 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, and about any medicines you plan to take.

Taking Dynid with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is not recommended to take Dynid during pregnancy or breastfeeding.

Fertility

There is no data on the effect on fertility in men and women.

Driving and using machines

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

Dynid, oral solution contains sorbitol

The medicine contains 150 mg of sorbitol in each ml of oral solution. Sorbitol is a source of fructose. If you have been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which your body does not break down fructose, you should consult your doctor before taking this medicine or giving it to your child.

Dynid, oral solution contains propylene glycol

The medicine contains 150 mg of propylene glycol in each ml of oral solution.

Dynid, oral solution contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is considered "sodium-free".

3. How to take Dynid

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

Use in children

Children from 1 to 5 years: The recommended dose is 2.5 ml (½ measuring cup of 5 ml) of oral solution once a day. Children from 6 to 11 years: The recommended dose is 5 ml (one measuring cup of 5 ml) of oral solution once a day.

Use in adults and adolescents over 12 years:

The recommended dose is 10 ml (two measuring cups of 5 ml) of oral solution once a day. If a measuring cup or oral syringe is provided with the bottle, it can be used to measure the correct amount of oral solution. This medicine is for oral use only. The dose of oral solution should be swallowed and then followed by water. The medicine can be taken with or without food. The duration of treatment with Dynid will be determined by your doctor, depending on the type of allergic rhinitis you have. If you have intermittent allergic rhinitis (symptoms that occur for less than 4 days a week or for less than 4 weeks), your doctor will recommend a treatment schedule based on your medical history. If you have persistent allergic rhinitis (symptoms that occur for 4 or more days a week and for more than 4 weeks), your doctor will recommend longer-term use of the medicine. In urticaria, the duration of treatment may vary from patient to patient. Therefore, you should follow your doctor's advice.

Taking too much Dynid

Dynid should only be taken as prescribed. If you accidentally take more than the prescribed dose, you should not experience serious disorders. However, if you take more than the recommended dose of Dynid, tell your doctor, pharmacist, or nurse immediately.

Missing a dose of Dynid

If you miss a dose, take it as soon as possible and then continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping Dynid treatment

If you have any further questions about taking this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Dynid can cause side effects, although not everybody gets them. After desloratadine was made available, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, urticaria, and swelling) have been reported. If you experience any of these severe side effects, stop taking the medicine and see a doctor immediately. In clinical trials, the side effects of desloratadine in most children and adults were almost the same as those experienced with a placebo or a tablet that did not contain the active substance. However, in children under 2 years of age, common side effects were diarrhea, fever, and insomnia, while in adult patients, fatigue, dry mouth, and headache were reported more frequently than with a placebo. In clinical trials of desloratadine, the following side effects were reported:

• Frequently:may affect up to 1 in 10 people
• fatigue
• dry mouth
• headache

Children

• Frequently:in children under 2 years of age: may affect up to 1 in 10 people
• diarrhea
• fever
• insomnia

After desloratadine was made available, the following side effects have been reported:

• Very rarely:may affect up to 1 in 10,000 people
• severe allergic reactions
• rash
• palpitations and irregular heartbeat
• rapid heartbeat
• abdominal pain
• nausea (vomiting)
• vomiting
• upset stomach
• diarrhea
• dizziness
• drowsiness
• insomnia
• muscle pain
• hallucinations
• seizures
• restlessness with excessive
• hepatitis
• abnormalities in 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 sunlight, even in cloudy weather and to UV (ultraviolet) radiation, such as in a solarium
• changes in heart rhythm
• abnormal behavior
• aggressive behavior
• weight gain
• increased appetite
• low mood
• dry eyes

Children

• Frequency not known:frequency cannot be estimated from the available data
• slow heartbeat
• change in heart rhythm
• abnormal behavior
• aggressive behavior
• low mood
• dry eyes

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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 Dynid

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton after "EXP" and on the bottle after "EXP". The expiry date refers to the last day of the month. There are no special storage precautions. Store in the original package. Do not use this medicine if you notice a change in the appearance of the oral solution. 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 Dynid contains

• The active substance is desloratadine 0.5 mg per 1 ml.
• The other ingredients are sodium citrate, sorbitol liquid, sucralose, anhydrous citric acid, propylene glycol, hypromellose, Tutti Frutti liquid flavor, and purified water.

What Dynid looks like and contents of the pack

Dynid, oral solution is available in bottles with a child-resistant closure. A measuring cup or oral syringe is provided with the bottle. The measuring cup allows for measurement of 2.5 ml and 5 ml of oral solution. The oral syringe has markings to measure 2.5 ml and 5 ml of oral solution. Pack sizes: 150 ml or 300 ml of oral solution. Not all pack sizes may be marketed.

Marketing authorization holder

Glenmark Pharmaceuticals s.r.o., Hvĕzdova 1716/2b, 140 78 Prague 4, Czech Republic

Manufacturer

Genepharm S.A., 18km Marathon Avenue, 15351 Pallini, Greece, Glenmark Pharmaceuticals s.r.o., Fibichova 143, 566 17 Vysoké Mýto, Czech Republic, Famar A.V.E., 49th km National road Athens-Lamia, Avlona Attiki, 19011, Greece

For more information about this medicine and its names in other EU countries, contact the local representative of the marketing authorization holder:

Glenmark Pharmaceuticals Sp. z o. o., ul. Dziekońskiego 3, 00-728 Warsaw, Email: poland.receptionist@glenmarkpharma.com

Date of last revision of the leaflet: