Deslodyna fast
Poland
Table of Contents
Package leaflet: Information for the patient
Deslodyna fast, 5 mg, orodispersible tablets
Desloratadine
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, pharmacist, or nurse.
- Keep this leaflet so that it can be read again if necessary.
- If advice or further information is needed, please consult a pharmacist.
- If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
- If there is no improvement after 3 days or the patient feels worse, contact a doctor.
Table of contents
- What Deslodyna fast is and what it is used for
- Important information before taking Deslodyna fast
- How to take Deslodyna fast
- Possible side effects
- How to store Deslodyna fast
- Contents of the pack and other information
1. What Deslodyna fast is and what it is used for
What Deslodyna fast is
Deslodyna fast orodispersible tablet contains desloratadine, which is an antihistamine medicine.
How Deslodyna fast works
Deslodyna fast is an antiallergy medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.
When to use Deslodyna fast
Deslodyna fast relieves symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by allergy, such as hay fever or allergy to house dust mites) in adults and adolescents aged 12 years and older. Symptoms include: sneezing, watery or itchy nose, itchy palate, and itchy, red, or watery eyes.
Deslodyna fast is also used to relieve symptoms associated with urticaria (a skin condition caused by allergy). Symptoms of this condition include: skin itching and hives.
Relief from these symptoms lasts throughout the day, helping the patient return to normal daily activities and sleep normally.
If there is no improvement after 3 days or the patient feels worse, contact a doctor.
2. Important information before using Deslodyna fast
When not to use Deslodyna 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 Deslodyna fast, please consult your doctor, pharmacist, or nurse:
- if the patient has kidney function disorders,
- if the patient has a personal or family history of seizures.
Children and adolescents
This medicine should not be given to children under 12 years of age.
Deslodyna fast and other medicines
Please inform your doctor or pharmacist about any other medicines the patient is currently taking, has recently taken, or plans to take.
No interactions between Deslodyna fast and other medicines are known.
Deslodyna fast with food, drink and alcohol
It is not necessary to take Deslodyna fast with water or any other liquid. Deslodyna fast may be taken with or without food. Caution is advised when taking Deslodyna fast 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. The use of Deslodyna fast is not recommended during pregnancy or breastfeeding.
Fertility
There is no available data on the effect on fertility in men and women.
Driving and operating machinery
It is not expected that this medicine, when used at the recommended dose, affects the ability to drive or operate machinery. Although most people do not experience drowsiness, it is recommended to refrain from activities requiring mental alertness, such as driving or operating machinery, until the patient knows how they react to this medicine.
Deslodyna fast contains mannitol, aspartame (E 951), propylene glycol, benzyl alcohol and sodium
Deslodyna fast contains 3 mg of aspartame in each orodispersible tablet. Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.
Deslodyna fast contains 0.00562 mg of benzyl alcohol in each orodispersible tablet. Benzyl alcohol may cause allergic reactions. Pregnant or breastfeeding women should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis). Patients with liver or kidney disease should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Deslodyna fast contains less than 1 mmol (23 mg) of sodium per orodispersible tablet, meaning the medicine is considered "sodium-free".
3. How to use Deslodyna fast
This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is intended for oral use.
Before use, carefully open the blister by tearing it. Remove the orodispersible tablet without crushing. Place the tablet in the mouth, where it will disintegrate immediately. Water or any other liquid is not required to swallow the dose. Take the dose immediately after opening the blister.
Do not take this medicine for longer than 10 days without consulting a doctor.
If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.
Adults and adolescents aged 12 years and older
The recommended dose is one tablet once daily, taken with or without food.
Taking more Deslodyna fast than recommended
Deslodyna fast should only be taken as described in this leaflet or as directed by a doctor or pharmacist. Serious adverse effects are not expected after accidental overdose. However, if a higher than recommended dose of Deslodyna fast has been taken, inform a doctor, pharmacist, or nurse immediately.
If you forget to take Deslodyna fast
If a dose has been missed, take it as soon as possible, then return to the regular dosing schedule. Do not take a double dose to make up for a missed dose.
Stopping Deslodyna fast
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Very rarely, severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported since desloratadine has been marketed. If any of these severe adverse reactions occur, you should stop taking the medicine and contact your doctor immediately.
In clinical trials in adult patients, adverse reactions were almost the same as those observed with placebo (inactive tablet). However, fatigue, dry mouth, and headache were reported more frequently than with placebo. In adolescents, the most commonly reported adverse reaction was headache.
The following adverse reactions have been reported in clinical trials with desloratadine:
Common (may occur in fewer than 1 in 10 patients):
- fatigue
- dry mouth
- headache
After desloratadine has been marketed, the following adverse reactions have been reported:
Very rare (may occur in fewer than 1 in 10,000 patients):
- severe allergic reactions – somnolence
- rash – insomnia
- palpitations and irregular heartbeat – muscle pain
- fast heartbeat – hallucinations
- abdominal pain – convulsions
- nausea – restlessness with excessive motor activity
- vomiting – hepatitis
- stomach discomfort – abnormal liver function test results
- diarrhea
- dizziness
Frequency not known (frequency cannot be estimated from available data):
- unusual weakness – changes in heart rhythm
- jaundice (yellowing of the skin and/or eyes) – unusual behaviour
- increased sensitivity of the skin to sunlight, even on cloudy days, and increased exposure to UV (ultraviolet) radiation, for example in solariums – aggressive behaviour
- weight gain, increased appetite
- low mood
- dry eyes
Children
Frequency not known (frequency cannot be estimated from available data):
- slow heartbeat
- change in heart rhythm
- unusual behaviour
- aggressive behaviour
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring of 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Deslodyna fast
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must 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 Deslodyna fast contains
- The active substance is desloratadine. One orodispersible tablet contains 5 mg of desloratadine.
- The other ingredients (excipients) are: potassium polyacrylate, citric acid monohydrate (for pH adjustment), potassium hydroxide 50% (for pH adjustment), mannitol, microcrystalline cellulose, sodium croscarmellose, aspartame (E 951), iron oxide red (E 172), Tutti-Frutti SD 0272 flavour (containing, among others, propylene glycol, benzyl alcohol, citral, geraniol, farnesol, linalool, d-limonene), magnesium stearate.
What Deslodyna fast looks like and contents of the pack
Deslodyna fast is pink orodispersible tablets with red-pink specks, round, smooth, biconvex, with bevelled edges and engraved with the letter "D" on one side, approximately 8 mm in diameter.
One pack contains 10 orodispersible tablets in blisters OPA/Aluminium/PVC/Aluminium, packed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
ul. Żmigrodzka 242 E, 51-131 Wrocław, Poland
Information enquiries
tel.: (22) 742 00 22
email: [email protected]