Aremas: detailed information

Package leaflet: Information for the user

AREMAS 0.5 mg/ml oral solution

Generic medicine
Please read 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 others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.

Contents of this leaflet:

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

1. What AREMAS is and what it is used for

AREMAS oral solution is an antiallergic medicine that does not cause drowsiness. It helps control your allergic reaction and its symptoms.
AREMAS oral solution relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or dust mite allergy). These symptoms include sneezing, itching and runny nose, itching of the palate, as well as redness, itching or watery eyes.
AREMAS oral solution is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives (wheals).
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 AREMAS

Do not take AREMAS

if you are allergic (hypersensitive) to desloratadine, loratadine, or any of the excipients of AREMAS

AREMAS oral solution is indicated for children aged between 1 and 11 years, adolescents (aged 12 years and older), and adults, including elderly patients.
Warnings and precautions

if you have reduced kidney function. If this applies to you or if you have any doubts, consult your doctor before taking AREMAS

Other medicines and AREMAS
No interactions between AREMAS and other medicines are known.
AREMAS with food and drink
AREMAS may be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breastfeeding, the use of AREMAS oral solution is not recommended.
Driving and using machines
At the recommended dose, AREMAS is not expected to cause drowsiness or reduce attention levels. However, very rarely, drowsiness has occurred in some individuals, an effect which may impair the ability to drive or operate machinery.
Important information about some of the excipients of AREMAS
AREMAS oral solution contains sorbitol. If your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine.

3. How to take AREMAS

Children aged 1 to 5 years: take 2.5 ml (½ of a 5 ml spoon) of oral solution once daily.
Children aged 6 to 11 years: take 5 ml (one 5 ml spoon) of oral solution once daily.
Adults and adolescents (aged 12 years and older): take 10 ml (two 5 ml spoons) of oral solution once daily.
Swallow the dose of oral solution and then drink a little water. You may take the medicine 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 AREMAS oral solution. 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; therefore, you must follow your doctor's instructions.

If you take more AREMAS than you should
Take AREMAS oral solution only in the amount prescribed for you. No serious problems are expected following accidental overdose. However, if you take more AREMAS oral solution than prescribed, contact your doctor or pharmacist.

If you forget to take AREMAS
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 the missed dose.

4. Possible side effects

Like all medicines, AREMAS oral solution can cause side effects, although not everybody gets them.
In most children and adults, side effects with AREMAS have been found to be similar to those observed with a tablet or solution without active ingredient (placebo). However, common side effects in children under 2 years of age have included diarrhoea, fever and insomnia, while in adults, fatigue, dry mouth and headache have been reported more frequently compared to a tablet without active ingredient (placebo).
During the post-marketing use of AREMAS, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives and swelling) and skin rash have been reported. Furthermore, very rarely, cases of palpitations, increased heart rate, stomach ache, nausea (feeling unwell), vomiting, stomach disturbances, diarrhoea, dizziness, drowsiness, insomnia, muscle pain, hallucinations, seizures, hyperactivity, liver inflammation, and changes in liver function tests have been reported.
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist.

5. How to store AREMAS

Keep out of the sight and reach of children.
Do not freeze. Store in the original packaging.
Do not use AREMAS after the expiry date stated on the carton and on the bottle after "Exp.". The expiry
date refers to the last day of that month.
Inform your pharmacist if you notice any changes in the appearance of the oral solution.
Do not dispose of medicines 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 AREMAS contains
The active substance is desloratadine 0.5 mg/ml.
The other components of the oral solution are:
Liquid sorbitol
(non-crystallizing)
Propylene glycol
Citric acid monohydrate
Sodium citrate
Hypromellose 2910
Sucralose
Disodium edetate
Mixed fruit flavour
Purified water.

Description of the appearance of AREMAS and the contents of the pack
AREMAS oral solution is a clear, colourless solution.
AREMAS 0.5 mg/ml oral solution is available in 100 ml, 120 ml and 150 ml pack sizes and is supplied in amber glass bottles of type III with a volume of 100 ml, 125 ml and 150 ml, closed with a child-resistant screw cap (C/R) with multiple ridges made of polyethylene. The bottles are subsequently packaged in cardboard boxes. All pack sizes include a graduated dosing spoon marked for 2.5 ml and 5 ml.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder
SF GROUP Srl – Via Tiburtina 1143, 00156 Rome (Italy)

Responsible manufacturer for batch release
Specifar S.A
1, 28 Octovriou str.
123 51 Ag. Varvara
Athens
Greece

Portugal: Desloratadine Eurogenus
Italy: AREMAS 0.5 mg/ml oral solution

This leaflet was last approved in: 09/2012

Package leaflet: information for the user

AREMAS 2.5 mg orodispersible tablets, 5 mg orodispersible tablets

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

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

What AREMAS orodispersible tablets are and what they are used for
What you need to know before taking AREMAS orodispersible tablets
How to take AREMAS orodispersible tablets
Possible side effects
How to store AREMAS orodispersible tablets
Package contents and other information

1. What AREMAS orodispersible tablets are and what they are used for

AREMAS orodispersible tablets are an antiallergic medicine that does not cause drowsiness. It helps control your allergic reaction and its symptoms.
AREMAS orodispersible tablets relieve symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or dust mite allergy). These symptoms include sneezing, itching, runny nose, itching of the palate, as well as redness, itching or watering of the eyes.
AREMAS orodispersible tablets are also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). 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 AREMAS orodispersible tablets

Do not take AREMAS orodispersible tablets

if you are allergic (hypersensitive) to desloratadine, loratadine, or any of the excipients in AREMAS orodispersible tablets.

AREMAS 2.5 mg orodispersible tablets are indicated for adults and children (aged 6 years and older).
AREMAS 5 mg orodispersible tablets are indicated for adults and children (aged 12 years and older).
Warnings and precautions

if you have reduced kidney function.

If this applies to you or if you have any doubts, consult your doctor before taking AREMAS.
Other medicines and AREMAS
No interactions between AREMAS and other medicines are known.
AREMAS orodispersible tablets with food and drink
AREMAS orodispersible tablets do not need to be taken with water or any other liquid. Moreover, AREMAS orodispersible tablet may be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, the use of AREMAS is not recommended.
Driving and using machines
At the recommended dose, AREMAS is not expected to cause drowsiness or reduced alertness. However, very rarely, drowsiness has been reported in some individuals, an effect which may affect the ability to drive vehicles or operate machinery.

3. How to take AREMAS orodispersible tablets

Before use, carefully remove the blister backing and take out the orodispersible tablet
without breaking it. Place it in the mouth, where it will disperse immediately. Water or other liquids are not
required to disperse the dose.
Children aged 6 to 11 years: take one AREMAS 2.5 mg orodispersible tablet once daily. Take it immediately
after removal from the blister.
Adults and adolescents (aged 12 years and older): take two AREMAS 2.5 mg orodispersible tablets once daily. Take them immediately after removal from the blister.
Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you have and how long
you should take AREMAS orodispersible tablets. 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; therefore, you must follow your doctor's instructions.
If you take more AREMAS orodispersible tablets than you should
Take AREMAS orodispersible tablets only in the amount prescribed for you. No serious problems are expected following accidental overdose. However, if you take more AREMAS orodispersible tablets than prescribed, contact your doctor or pharmacist.
If you forget to take AREMAS orodispersible tablets
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 the missed dose.

4. Possible side effects

Like all medicines, AREMAS may cause side effects, although not everybody gets them.
In adults, the side effects were found to be similar to those observed with a tablet without active ingredient (placebo). However, fatigue, dry mouth and headache occurred more frequently compared to a tablet without active ingredient (placebo). In adolescents, headache was the most commonly reported adverse effect.
During the post-marketing experience of AREMAS orodispersible tablets, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, urticaria and swelling) and skin rash have been reported. Furthermore, very rarely, cases of palpitations, increased heart rate, stomach ache, nausea (feeling unwell), vomiting, stomach discomfort, diarrhoea, dizziness, drowsiness, insomnia, muscle pain, hallucinations, seizures, hyperactivity, liver inflammation and changes in liver function tests have been reported.
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist.

5. How to store AREMAS orodispersible tablets

Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use AREMAS orodispersible tablets after the expiry date stated on the packaging and blister after "Exp.". The expiry date refers to the last day of that month.
Inform your pharmacist if you notice any changes in the appearance of AREMAS orodispersible tablets.
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 AREMAS orodispersible tablets contain
The active substance is desloratadine 2.5 mg
The active substance is desloratadine 5 mg
The other components are:
Tablet core
Microcrystalline cellulose
Povidone
Methacrylic acid copolymer butylated
Sodium lauryl sulfate
Dibutyl sebacate
Hydrated colloidal silica
Dextrates
Silicified microcrystalline cellulose
Iron oxide red (E172)
Sodium croscarmellose
Sucralose
Fruit flavour
Magnesium stearate

Description of the appearance of AREMAS orodispersible tablets and package contents
AREMAS 2.5 mg orodispersible tablets are pink, round, flat tablets with a diameter of approximately 6.5 mm.
AREMAS 5 mg orodispersible tablets are pink, round, flat tablets with a diameter of approximately 8.0 mm.
AREMAS 2.5 mg orodispersible tablets are packaged in blisters
[OPA/Adhesive/(OPA/Aluminum/PVC)]/[CC kraft paper/PET/Aluminum/hot seal lacquer] containing 18, 20 and 30 tablets.
AREMAS 5 mg orodispersible tablets are packaged in blisters
[OPA/Adhesive/(OPA/Aluminum/PVC)]/[CC kraft paper/PET/Aluminum/hot seal lacquer] containing 20 tablets.
The blisters are subsequently packed into cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorization Holder
SF GROUP SrL – via Tiburtina 1143, 00156 Rome (Italy)

Responsible manufacturer for batch release
Specifar S.A
1, 28 Octovriou str.
123 51 Ag. Varvara
Athens
Greece

Portugal: Desloratadina Eurogenus
Italy: AREMAS 2.5 mg orodispersible tablets
Portugal: Desloratadina Eurogenus
Italy: AREMAS 5 mg orodispersible tablets

This leaflet was last approved on: 09/2012

Patient Information Leaflet: Information for the user

AREMAS 5 mg film-coated tablets

Generic medicine
Please read 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 others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist.

Contents of this leaflet:

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

1. What AREMAS is and what it is used for

AREMAS is an antiallergic medicine that does not cause drowsiness. It helps control your allergic reaction and its symptoms.
AREMAS relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or dust mite allergy). These symptoms include sneezing, itching and a runny nose, itching of the palate, as well as redness, itching or watering of the eyes.
AREMAS is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and wheals (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 AREMAS

Do not take AREMAS

if you are allergic (hypersensitive) to desloratadine or to any of the excipients in AREMAS or to loratadine.

AREMAS is indicated for adults and adolescents (aged 12 years and older).
Warnings and precautions

if you have reduced kidney function.

If this applies to you or if you have any doubts, consult your doctor before taking AREMAS.
Other medicines and AREMAS
No interactions between AREMAS and other medicines are known.
AREMAS with food and drink
AREMAS can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breastfeeding, the use of AREMAS is not recommended.
Driving and using machines
At the recommended dose, AREMAS is not expected to cause drowsiness or reduced alertness. However, very rarely, drowsiness has been reported in some individuals, an effect that may affect the ability to drive vehicles or operate machinery.

3. How to take AREMAS

Adults and adolescents (aged 12 years and older): take one tablet once daily.
Swallow the tablet whole with water, 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 AREMAS. 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; therefore, you must follow your doctor's instructions.
If you take more AREMAS than you should
Take AREMAS only in the amount prescribed for you. Serious problems are not expected following accidental overdose. However, if you take more AREMAS than prescribed, contact your doctor or pharmacist.
If you forget to take AREMAS
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 the missed dose.

4. Possible side effects

Like all medicines, AREMAS may cause side effects, although not everybody gets them.
In adults, side effects were found to be similar to those with a tablet containing no active ingredient (placebo). However, fatigue, dry mouth and headache were reported more frequently compared to a tablet without active ingredient (placebo). In adolescents, headache was the most commonly reported side effect.
During the marketing of AREMAS, very rare cases of serious allergic reactions (difficulty breathing, wheezing, itching, hives and swelling) and skin rash have been reported. Additionally, although very rarely, cases of palpitations, increased heart rate, stomach ache, nausea (feeling of discomfort), vomiting, stomach disturbances, diarrhoea, dizziness, drowsiness, insomnia, muscle pain, hallucinations, seizures, hyperactivity, liver inflammation, and changes in liver function tests have been reported.
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.

5. How to store AREMAS

Keep out of the sight and reach of children.
Do not store above 30°C.
Do not use AREMAS after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Inform your pharmacist if you notice any changes in the appearance of the tablets.
Do not dispose of medicines 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 AREMAS contains
The active substance is desloratadine 5 mg.
The other components of the tablet are:
Tablet core
Isomalt
Pregelatinized starch
Microcrystalline cellulose
Heavy magnesium oxide
Hydroxypropylcellulose
Crospovidone
Magnesium stearate
Tablet film-coating
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol / PEG 3350
Talc
FD & C Blue #2 / Indigo carmine aluminium lake (E132)

Description of the appearance of AREMAS and package contents
AREMAS 5 mg film-coated tablets are blue, round, biconvex film-coated tablets with a diameter of approximately 6.5 mm.
AREMAS 5 mg film-coated tablets are packaged in blister packs made of polychlorotrifluoroethylene (PCTFE)/polyvinyl chloride (PVC)/aluminum.
AREMAS 5 mg film-coated tablets are available in packs containing 7, 20 or 50 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
SF GROUP SrL – Via Tiburtina 1143, 00156 Rome (Italy)

Manufacturer responsible for batch release
Specifar S.A
1, 28 Octovriou str.
123 51 Ag. Varvara
Athens
Greece

This medicinal product is authorized in the European Economic Area countries under the following names:
Portugal: Desloratadina Eurogenus
Italy: AREMAS 5 mg film-coated tablets

This patient information leaflet was last approved in 09/2012