Desloratadine Mylan Pharma

Package leaflet: Information for the patient

Desloratadine Mylan Pharma 5 mg orodispersible tablets

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Desloratadine Mylan Pharma is and what it is used for
2. What you need to know before taking Desloratadine Mylan Pharma
3. How to take Desloratadine Mylan Pharma
4. Possible side effects
5. How to store Desloratadine Mylan Pharma
6. Contents of the pack and other information

1. What Desloratadine Mylan Pharma is and what it is used for

Desloratadine Mylan Pharma is a non-sedating antihistamine medicine. It helps control your allergic reaction and its symptoms.
Desloratadine Mylan Pharma relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by allergies, such as hay fever or dust mite allergy) in adults and adolescents aged 12 years and older. These symptoms include sneezing, runny nose, itchy nose, itchy palate, as well as itchy, red and watery eyes.
Desloratadine Mylan Pharma is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergic reaction). These symptoms include itching and hives.
Relief from these symptoms lasts throughout the day, helping you resume your normal daily activities and sleep.

2. What you need to know before taking Desloratadine Mylan Pharma

Do not take Desloratadine Mylan Pharma

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Desloratadine Mylan Pharma:

• if you or a family member suffers from epilepsy
• if your kidney function is reduced.

Children
Do not give this medicine to children under 12 years of age.
Other medicines and Desloratadine Mylan Pharma
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No interactions between Desloratadine Mylan Pharma and other medicines are known.
Desloratadine Mylan Pharma with food, drinks and alcohol
There is no need to take Desloratadine Mylan Pharma orodispersible tablets with water or any other liquid. Moreover, Desloratadine Mylan Pharma orodispersible tablets can be taken with or without food. Use caution when taking Desloratadine Mylan Pharma with alcohol.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breast-feeding, the use of Desloratadine Mylan Pharma is not recommended.
There are no available data on male/female fertility.
Driving and using machines
At the recommended dose, this medicine is not expected to affect your ability to drive or operate machinery. However, drowsiness has very rarely occurred in some individuals.
Nevertheless, it is recommended not to engage in such activities until you know how you react to this medicine.
Desloratadine Mylan Pharma contains aspartame
This medicine contains 3 mg of aspartame per tablet. Aspartame is a source of phenylalanine.
It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Desloratadina Mylan Pharma

Always take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
This medicine is for oral use.
Before use, remove the blister backing and take out the orodispersible tablet dose
without breaking it. Place it in the mouth, where it will disperse immediately. It is not necessary to use
water or any other liquid to swallow the dose. Take the dose immediately after removing it
from the blister.
Adults and adolescents (aged 12 years and older)
The recommended dose is one tablet once daily, with or without food.
Regarding treatment duration, your doctor will determine the type of allergic rhinitis you have
and how long you should take the medicine.
If your allergic rhinitis is intermittent (symptoms present for less than 4 days per
week or for less than 4 weeks), your doctor will prescribe a treatment regimen based on an assessment of your medical history.
If your allergic rhinitis is persistent (symptoms present for 4 or more days per week
and for more than 4 weeks), your doctor may prescribe long-term treatment.
In the case of urticaria, treatment duration may vary from patient to patient, so you must
follow your doctor's instructions.
If you take more Desloratadina Mylan Pharma than you should
Take Desloratadina Mylan Pharma only if it has been prescribed for you. Serious problems due to accidental overdose are unlikely. However, if you take more
Desloratadina Mylan Pharma than prescribed, contact your doctor or pharmacist.
If you forget to take Desloratadina Mylan Pharma
If you forget to take your dose at the prescribed time, take it as soon as possible, then
continue treatment as usual. Do not take a double dose to make up for the missed dose.
If you stop taking Desloratadina Mylan Pharma
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
In adults, side effects were similar to those observed with a tablet without active ingredient (placebo). However, fatigue, dry mouth, and headache were reported more frequently than with the placebo tablet. In adolescents, headache was the most commonly reported side effect.
During the marketing of desloratadine, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If you notice any of these serious side effects, stop taking the medicine and contact a doctor immediately.
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
In clinical studies with desloratadine, the following side effects were reported as:
Common (may affect up to 1 in 10 people)

• fatigue
• dry mouth
• headache

Adults
During the marketing of desloratadine, the following side effects have been reported as:
Very rare (may affect up to 1 in 10,000 people)

• severe allergic reactions
• rapid heartbeat
• vomiting
• dizziness
• muscle pain
• restlessness with increased body movement
• skin rash
• stomach ache
• stomach discomfort
• drowsiness
• hallucinations
• liver inflammation
• pounding or irregular heartbeat
• feeling unwell (nausea)
• diarrhoea
• difficulty sleeping
• seizures
• changes in liver function tests

Not known (frequency cannot be estimated from the available data)

• abnormal behaviour
• aggression
• unusual weakness
• yellowing of the skin and/or eyes
• increased sensitivity of the skin to sunlight, even on cloudy days, and to UV (ultraviolet) light, for example from UV lamps in sunbeds
• changes in heart rhythm
• weight gain, increased appetite

Additional side effects in children
Not known (frequency cannot be estimated from the available data)

• slowing of the heartbeat
• changes in heart rhythm
• abnormal behaviour
• aggression

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Desloratadine Mylan Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister. Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Desloratadina Mylan Pharma contains

• The active substance is desloratadine 5 mg.
• The other components are potassium polyacrylate, citric acid monohydrate, red iron oxide (E172), magnesium stearate, sodium croscarmellose, tutti frutti flavour (also containing propylene glycol), aspartame (E951), microcrystalline cellulose, mannitol, and potassium hydroxide (to adjust pH).

Description of the appearance of Desloratadina Mylan Pharma and contents of the pack
Desloratadina Mylan Pharma orodispersible tablets 5 mg are brick-red, round, flat tablets with bevelled edges and engraved with "5".
Blister packs containing 7 or 20 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan, Italy

Manufacturer
Genepharm S.A., 18 Km Marathon Avenue, 15351 Pallini, Greece

Patient Information Leaflet

Desloratadine Mylan Pharma 2.5 mg orodispersible tablets

Generic medicine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Desloratadine Mylan Pharma is and what it is used for
2. What you need to know before taking Desloratadine Mylan Pharma
3. How to take Desloratadine Mylan Pharma
4. Possible side effects
5. How to store Desloratadine Mylan Pharma
6. Contents of the pack and other information

1. What Desloratadine Mylan Pharma is and what it is used for

Desloratadine Mylan Pharma is a non-sedating antihistamine medicine. It helps control your allergic reaction and its symptoms.
Desloratadine Mylan Pharma relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by allergies, such as hay fever or dust mite allergy) in adults, adolescents, and children aged 6 years and older. These symptoms include sneezing, runny nose, itchy nose, itchy palate, and itchy, red or watery eyes.
Desloratadine Mylan Pharma is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergic reaction). These symptoms include itching and hives.
Relief from these symptoms lasts throughout the day, helping you resume your normal daily activities and sleep.

2. What you need to know before taking Desloratadine Mylan Pharma

Do not take Desloratadine Mylan Pharma

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Desloratadine Mylan Pharma:

• if you or a family member suffers from epilepsy
• if your kidney function is reduced.

Children
Do not give this medicine to children under 6 years of age.
Other medicines and Desloratadine Mylan Pharma
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions between Desloratadine Mylan Pharma and other medicines are known.
Desloratadine Mylan Pharma with food, drinks and alcohol
There is no need to take Desloratadine Mylan Pharma orodispersible tablets with water or any other liquid. Moreover, Desloratadine Mylan Pharma orodispersible tablets can be taken with or without food. Use caution when taking Desloratadine Mylan Pharma with alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, the use of Desloratadine Mylan Pharma is not recommended.
There are no available data on male/female fertility.
Driving and using machines
At the recommended dose, this medicine is not expected to affect your ability to drive or operate machinery. However, drowsiness has very rarely occurred in some individuals. Nevertheless, it is recommended not to undertake such activities until you know how you react to this medicine.
Desloratadine Mylan Pharma contains aspartame
This medicine contains 1.5 mg of aspartame per tablet. Aspartame is a source of phenylalanine.
It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Desloratadine Mylan Pharma

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
This medicine is for oral use.
Before use, remove the blister backing and take out the orodispersible tablet without breaking it.
Place it in the mouth, where it will disperse immediately. There is no need to use water or any other
liquid to swallow the dose. Take the dose immediately after removing it from the blister.
Adults and adolescents (12 years of age and older)
The recommended dose is two orodispersible tablets once daily, with or without food.
Children aged 6 to 11 years
The recommended dose is one orodispersible tablet once daily, with or without food.
Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you have
and how long you should take this medicine.
If your allergic rhinitis is intermittent (symptoms present for less than 4 days per week or for less than
4 weeks), your doctor will prescribe a treatment regimen based on an assessment of your medical
history.
If your allergic rhinitis is persistent (symptoms present for 4 or more days per week and for more than
4 weeks), your doctor may prescribe long-term treatment.
In the case of urticaria, the duration of treatment may vary from patient to patient, so you must follow
your doctor's instructions.
If you take more Desloratadine Mylan Pharma than you should
Take Desloratadine Mylan Pharma only if it has been prescribed for you. Serious problems following
accidental overdose are unlikely. However, if you take more Desloratadine Mylan Pharma than
prescribed, contact your doctor or pharmacist.
If you forget to take Desloratadine Mylan Pharma
If you forget to take your dose at the prescribed time, take it as soon as possible, then continue your
treatment as usual. Do not take a double dose to make up for a forgotten dose.
If you stop taking Desloratadine Mylan Pharma
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
In adults, side effects were similar to those observed with a tablet containing no active ingredient (placebo). However, fatigue, dry mouth and headache were reported more frequently than with the placebo tablet. In adolescents, headache was the most commonly reported side effect.
During post-marketing experience with desloratadine, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives and swelling) have been reported. If you experience any of these serious side effects, stop taking the medicine and contact a doctor immediately.
If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet.
In clinical studies with desloratadine, the following side effects were reported as:
Common (may affect up to 1 in 10 people)

• fatigue
• dry mouth
• headache

Adults
During post-marketing experience with desloratadine, the following side effects have been reported as:
Very rare (may affect up to 1 in 10,000 people)

• severe allergic reactions
• rapid heartbeat
• vomiting
• dizziness
• muscle pain
• restlessness with increased body movement
• skin rash
• stomach ache
• stomach discomfort
• somnolence
• hallucinations
• liver inflammation
• pounding or irregular heartbeat
• feeling unwell (nausea)
• diarrhoea
• difficulty sleeping
• seizures
• changes in liver function tests

Not known (frequency cannot be estimated from the available data)

• abnormal behaviour
• aggression
• unusual weakness
• yellowing of the skin and/or eyes
• increased sensitivity of the skin to sunlight, even on cloudy days, and to UV (ultraviolet) light, for example UV lamps in sunbeds
• change in heartbeat rhythm
• weight gain, increased appetite

Additional side effects in children
Not known (frequency cannot be estimated from the available data)

• slow heartbeat
• change in heartbeat rhythm
• abnormal behaviour
• aggression

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Desloratadine Mylan Pharma

Keep this medicine out of the reach and sight 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 that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Desloratadine Mylan Pharma contains

• The active substance is desloratadine 2.5 mg.
• The other components are polyacrylic acid potassium, citric acid monohydrate, red iron oxide (E172), magnesium stearate, sodium croscarmellose, tutti frutti flavour (also containing propylene glycol), aspartame (E951), microcrystalline cellulose, mannitol, and potassium hydroxide (to adjust pH).

Description of the appearance of Desloratadine Mylan Pharma and pack contents
Desloratadine Mylan Pharma 2.5 mg orodispersible tablets are reddish-brown, round, flat tablets with bevelled edges and engraved with "2.5".
Blister packs containing 18 orodispersible tablets.
Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan, Italy
Manufacturer
Genepharm S.A., 18 Km Marathon Avenue, 15351 Pallini, Greece