Aerinaze

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  • Heiti vöru:
  • Aerinaze
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  • Mannfólk
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Staðsetning

  • Fáanlegt í:
  • Aerinaze
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • NASAL PREPARATIONS
  • Lækningarsvæði:
  • Rhinitis, Allergic, Seasonal
  • Ábendingar:
  • Symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion.
  • Vörulýsing:
  • Revision: 16

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/000772
  • Leyfisdagur:
  • 30-07-2007
  • EMEA númer:
  • EMEA/H/C/000772
  • Síðasta uppfærsla:
  • 07-01-2019

Opinber matsskýrsla

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8416

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

An agency of the European Union

© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.

EMA/817144/2011

EMEA/H/C/000772

EPAR summary for the public

Aerinaze

Desloratadine/pseudoephedrine

This is a summary of the European public assessment report (EPAR) for Aerinaze. It explains how the

Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in

favour of granting a marketing authorisation and its recommendations on the conditions of use for

Aerinaze.

What is Aerinaze?

Aerinaze is a medicine containing the active substances desloratadine (2.5 mg) and pseudoephedrine

(120 mg). It is available as blue and white modified-release tablets. ‘Modified-release’ means that the

tablets have been made to allow one of the active substances to be released immediately and the

other one released over a few hours.

What is Aerinaze used for?

Aerinaze is used to treat the symptoms of seasonal allergic rhinitis (hayfever, inflammation of the

nasal passages caused by an allergy to pollen) in patients who have nasal congestion (a blocked nose).

The medicine can only be obtained with a prescription.

How is Aerinaze used?

In adults and adolescents over 12 years of age, the recommended dose of Aerinaze is one tablet twice

a day, taken whole with a full glass of water. Treatment should continue for as short a time as possible

and should stop when symptoms, chiefly the congestion (blocked nose), have disappeared. Treatment

for more than 10 days is not advisable, as the medicine’s effects on nasal congestion may wear off.

Once the nose has cleared, patients can use desloratadine alone.

How does Aerinaze work?

Aerinaze contains two active substances: desloratadine, an antihistamine, and pseudoephedrine, which

is a nasal decongestant. Desloratadine works by blocking the receptors on which histamine, a

substance in the body that causes allergic symptoms, normally attaches itself. When the receptors are

blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.

Pseudoephedrine works by stimulating nerve endings to release the chemical noradrenaline, which

causes the blood vessels to constrict (narrow). This reduces the amount of fluid released from the

vessels, resulting in less swelling and less mucus production in the nose. In Aerinaze, the two active

substances are used together, since an antihistamine alone may not provide adequate relief for

patients with nasal congestion.

Aerinaze tablets have two layers, one containing desloratadine, and the other containing

pseudoephedrine. Desloratadine is released from its layer immediately after it is taken, while

pseudoephedrine is released slowly over 12 hours. This means that patients only need to take the

tablet twice a day.

Desloratadine has been available in the European Union (EU) since 2001, and pseudoephedrine is

widely used in medicines that have been available over-the-counter for many years.

How has Aerinaze been studied?

The effectiveness of Aerinaze was assessed in two main studies involving a total of 1,248 adult and

adolescent patients. In both studies, Aerinaze was compared with desloratadine alone and with

pseudoephedrine alone. The main measures of effectiveness were the change in the severity of

hayfever symptoms reported by the patients between before treatment started, and over the entire 15

days of treatment. The patients recorded their symptoms in a diary every 12 hours during the study,

scoring on a standard symptom scale how severe the symptoms were over the previous 12-hour

period.

What benefit has Aerinaze shown during the studies?

Aerinaze was more effective in reducing symptoms than either of the two active substances taken

alone. When looking at all hayfever symptoms except for nasal congestion, patients taking Aerinaze

reported a reduction in symptoms of 46.0%, compared with 35.9% in those taking pseudoephedrine

alone. When looking at nasal congestion, patients taking Aerinaze had a reduction in symptoms of

37.4%, compared with 26.7% in those taking desloratadine alone. Similar results were seen in the

second study.

What is the risk associated with Aerinaze?

The most common side effects with Aerinaze (seen in between 1 and 10 patients in 100) are

tachycardia (fast heart rate), dry mouth, dizziness, psychomotor hyperactivity (restlessness),

pharyngitis (sore throat), anorexia (loss of appetite), constipation, headache, fatigue (tiredness),

insomnia (difficulty sleeping), somnolence (sleepiness), sleep disorders and nervousness. For the full

list of all side effects reported with Aerinaze, see the Package Leaflet.

Aerinaze must not be used in people who are hypersensitive (allergic) to desloratadine,

pseudoephedrine or any of the other ingredients, to adrenergic agents or to loratadine (another

medicine used to treat allergies). It should not be used in people who are taking a monoamine oxidase

inhibitor (such as some medicines used to treat depression) or who have stopped taking one of these

medicines within the last two weeks. Aerinaze should also not be taken by people who have narrow-

Aerinaze

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Aerinaze

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angle glaucoma (increased pressure inside the eye), urinary retention (difficulty in passing urine),

heart or blood vessel diseases including hypertension (high blood pressure), hyperthyroidism (an

overactive thyroid gland), or a history or risk of haemorrhagic stroke (stroke caused by bleeding within

the brain).

Why has Aerinaze been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Aerinaze’s benefits are

greater than its risks for the symptomatic treatment of seasonal allergic rhinitis when accompanied by

nasal congestion and recommended that Aerinaze be given marketing authorisation.

Other information about Aerinaze

The European Commission granted a marketing authorisation valid throughout the European Union for

Aerinaze on 30 July 2007.

The full EPAR for Aerinaze can be found on the Agency’s website: ema.europa.eu/Find

medicine/Human medicines/European Public Assessment Reports. For more information about

treatment with Aerinaze, read the package leaflet (also part of the EPAR) or contact your doctor or

pharmacist.

This summary was last updated in 10-2011.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Aerinaze 2.5 mg/120 mg modified-release tablets

desloratadine/pseudoephedrine sulphate

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

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 signs or illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet:

What Aerinaze is and what it is used for

What you need to know before you take Aerinaze

How to take Aerinaze

Possible side effects

How to store Aerinaze

Contents of the pack and other information

1.

What Aerinaze is and what it is used for

What Aerinaze is

Aerinaze tablets contain a combination of two active ingredients, desloratadine which is an

antihistamine and pseudoephedrine sulphate which is a decongestant.

How Aerinaze works

Antihistamines help to reduce allergic symptoms by preventing the effects of a substance called

histamine, which is produced by the body. Decongestants help to clear nasal congestion

(blocked/stuffy nose).

When Aerinaze should be used

Aerinaze tablets relieve symptoms associated with seasonal allergic rhinitis (hay fever), such as,

sneezing, runny or itchy nose, and eyes, when accompanied by nasal congestion in adults and

adolescents 12 years of age and older.

2.

What you need to know before you take Aerinaze

Do not take Aerinaze:

if you are allergic to desloratadine, pseudoephedrine sulphate, adrenergic medicines, or any of

the other ingredients of this medicine (listed in section 6) or to loratadine

if you have high blood pressure, heart or blood vessel disease or a history of stroke

if you have glaucoma, difficulty in urinating, urinary tract blockage, or an overactive thyroid

if you are taking monoamine oxidase (MAO) inhibitor (a class of antidepressant medicines)

therapy or have stopped taking these types of medicines within the last 14 days.

Warnings and precautions

Certain conditions may make you unusually sensitive to the decongestant pseudoephedrine sulphate

contained in this medicine. Talk to your doctor, pharmacist or nurse before taking Aerinaze:

if you are 60 years of age or older. Older adults may be more sensitive to the effects of this

medicine

if you have diabetes

if you have intestinal ulcers leading to the narrowing of the stomach, small intestine or

esophagus (stenosing peptic ulcer)

if you have intestinal blockage (pyloral or duodenal blockage)

if you have bladder neck blockage (vesical cervix blockage)

if you have a history of difficulty breathing due to tightening of the lung muscles

(bronchospasm)

if you have problems with your liver, kidney, or bladder.

In addition, if you experience or are diagnosed with any of the following conditions you should talk to

your doctor, pharmacist or nurse as they may advise you to stop taking Aerinaze:

high blood pressure

a fast or pounding heart beat

abnormal heart rhythm

feeling sick and headache or increase headache while using Aerinaze.

if you have medical of familial history of seizures

severe skin reactions, including signs and symptoms such as reddening of the skin, many small

pimples, with or without fever

If you are scheduled to have surgery, your doctor may advise you to stop taking Aerinaze 24 hours

beforehand.

One of the active ingredients in Aerinaze, pseudoephedrine sulphate, has the potential to be abused

and large doses of pseudoephedrine sulphate can be toxic. Continuous use may lead to taking more

Aerinaze than the recommended dose to get the desired effect, resulting in an increased risk of

overdosing. If you suddenly stop treatment, depression may occur.

Laboratory tests

Stop taking Aerinaze at least 48 hours before you have any skin tests since antihistamines may

influence the result of the skin test.

Athletes taking Aerinaze may have positive doping-tests.

Use in children and adolescents

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

Other medicines and Aerinaze

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other

medicines. This is especially important if you are taking:

digitalis, a medicine used to treat certain heart disorders

medicines for blood pressure (e.g. α-methyldopa, mecamylamine, reserpine, veratrum alkaloids

and guanethidine)

decongestants by oral or nasal route (such as phenylpropanolamine, phenylephrine, ephedrine,

oxymetazoline, naphazoline)

diet pills (appetite suppressants)

amphetamines

medicines for migraines e.g. ergot alkaloids (such as, dihydroergotamine, ergotamine, or

methylergometrine)

medicines for Parkinson’s disease or for infertility e.g. bromocriptine, cabergoline, lisuride and

pergolide

antacids for indigestion or stomach problems

a medicine for diarrhoea called kaolin.

tricyclic antidepressants (such as nortriptyline), antihistamines (such as cetirizine,

fexofenadine)

Aerinaze with alcohol

Speak with your doctor, pharmacist or nurse regarding whether you can drink alcohol while taking

Aerinaze. Drinking alcohol while taking Aerinaze is not recommended.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor, pharmacist or nurse for advice before taking this medicine.

Taking Aerinaze is not recommended if you are pregnant.

Decreased milk production in nursing mothers has been reported with pseudoephedrine sulphate, a

component of Aerinaze. Desloratadine and pseudoephedrine sulphate are both excreted in human

milk. If you are breast-feeding taking Aerinaze is not recommended.

Fertility

There is no data available on male/female fertility.

Driving and using machines

At the recommended dose, this medicine is not expected to affect your ability to drive or use

machines. Although most people do not experience drowsiness, it is recommended not to engage in

activities requiring mental alertness, such as driving a car or operating machinery until you have

established your own response to the medicinal product.

3.

How to take Aerinaze

Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your

doctor, pharmacist or nurse if you are not sure.

Adults and adolescents 12 years of age and over

The recommended dose is one tablet twice daily with a glass of water, with or without food.

This medicine is for oral use.

Swallow the tablet whole; do not crush, break or chew the tablet before swallowing.

Do not take more tablets than recommended on the label. Do not take tablets more often than

recommended.

Do not take this medicine for more than 10 days continuously unless your doctor tells you to do so.

If you take more Aerinaze than you should

If you take more Aerinaze than you were told to, tell your doctor, pharmacist or nurse immediately.

If you forget to take Aerinaze

If you forget to take your dose on time, take it as soon as possible and then go back to your regular

dosing schedule. Do not take a double dose to make up for a forgotten dose.

If you stop taking Aerinaze

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The

following side effects have been seen in studies:

Common: the following may affect up to 1 in 10 people

fast heartbeat

restlessness with increased

body movement

dry mouth

dizziness

sore throat

decreased appetite

constipation

tiredness

headache

trouble sleeping

nervousness

drowsiness

Uncommon: the following may affect up to 1 in 100 people

pounding or irregular heart

beat

increased body movement

flushing

hot flush

confusion

blurry vision

dry eye

nose bleeds

irritated nose

inflammation of the nose

runny nose

inflammation of the sinus

dry throat

stomach ache

stomach flu

feeling sick (nausea)

abnormal stool

painful or difficult

urination

sugar in urine

increased sugar in blood

thirst

problems urinating

changes in frequency of

urination

itching

chills

decreased sense of smell

abnormal liver function tests

agitation

anxiety

irritability

Very rarely: the following other side effects reported during the marketing of desloratadine, may

affect up to 1 in 10,000 people

severe allergic reactions

(difficulty in breathing,

wheezing, itching, hives and

swelling)

rash

vomiting

diarrhoea

hallucination

muscle pain

convulsion

liver inflammation

abnormal liver function tests

Not known: frequency cannot be estimated from the available data

abnormal behaviour

aggression

changes in the way the heart

beats

weight increased, increased

appetite

Cases of severe skin reactions, including signs and symptoms such as fever, reddening of the skin, or

many small pimples, have been reported with pseudoephedrine-containing products.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side

effects not listed in this leaflet. You can also report side effects directly via the national reporting

system listed in Appendix V. By reporting side effects you can help provide more information on the

safety of this medicine.

5.

How to store Aerinaze

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 outer carton and blister after

EXP.

The expiry date refers to the last day of that month.

Do not store above 30°C. Keep the blisters in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Aerinaze contains

The active substances are desloratadine and pseudoephedrine sulphate.

Each tablet contains 2.5 mg desloratadine and 120 mg pseudoephedrine sulphate.

The other ingredients are:

Ingredients in the blue, immediate-release layer: maize starch, microcrystalline

cellulose, edetate disodium, citric acid, stearic acid and colorant (Indigo Carmine E132,

Aluminum lake).

Ingredients in the white, sustained-release layer: hypromellose 2208, microcrystalline

cellulose, povidone K30, silicon dioxide and magnesium stearate.

What Aerinaze looks like and contents of the pack

Aerinaze is a blue and white oval bilayer modified-release tablet with “D12” debossed in the blue

layer. Aerinaze tablets are packed as 2, 4, 7, 10, 14, or 20 tablets in blisters comprised of laminate

blister film and foil lidding.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

Manufacturer:

SP Labo N.V.

Industriepark 30

B-2220 Heist-op-den-Berg

Belgium.

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

MSD Belgium BVBA/SPRL

Tél/Tel : 0800 38 693

+32 (0)2 776 62 11

dpoc_belux@merck.com

Lietuva

UAB Merck Sharp & Dohme

Tel. + 370 5 278 02 47

msd_lietuva@merck.com

България

Мерк Шарп и Доум България ЕООД

Тел.: +359 2 819 3737

info-msdbg@merck.com

Luxembourg/Luxemburg

MSD Belgium BVBA/SPRL

Tél/Tel :

0800 38 693

+32 (0)2 776 62 11

dpoc_belux@merck.com

Česká republika

Merck Sharp & Dohme s.r.o.

Tel: +420 233 010 111

dpoc_czechslovak@merck.com

Magyarország

MSD Pharma Hungary Kft.

Tel.: +36 1 888-5300

hungary_msd@merck.com

Danmark

MSD Danmark ApS

Tlf: + 45 4482 4000

dkmail@merck.com

Malta

Merck Sharp & Dohme Cyprus Limited

Tel: 8007 4433 (+356 99917558)

malta_info@merck.com

Deutschland

MSD SHARP & DOHME GMBH

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)

e-mail@msd.de

Nederland

Merck Sharp & Dohme BV

Tel:

0800 9999000

(+31 23 5153153)

medicalinfo.nl@merck.com

Eesti

Merck Sharp & Dohme OÜ

Tel: + 372 6144 200

msdeesti@merck.com

Norge

MSD (Norge) AS

Tlf: +47 32 20 73 00

msdnorge@msd.no

Ελλάδα

MSD Α.Φ.Β.Ε.Ε.

Τηλ: +30 210 98 97 300

dpoc_greece@merck.com

Österreich

Merck Sharp & Dohme Ges.m.b.H.

Tel: +43 (0) 1 26 044

msd-medizin@merck.com

España

Merck Sharp & Dohme de España, S.A.

Tel: +34 91 321 06 00

msd_info@merck.com

Polska

MSD Polska Sp. z o.o.

Tel.: +48 22 549 51 00

msdpolska@merck.com

France

MSD France

Tél: + 33 (0)1 80 46 40 40

Portugal

Merck Sharp & Dohme, Lda

Tel: +351 214465700

clic@merck.com

Hrvatska

Merck Sharp & Dohme d.o.o.

Tel: + 385 1 6611 333

croatia_info@merck.com

România

Merck Sharp & Dohme Romania S.R.L.

Tel.: + 40 21 529 2900

msdromania@merck.com

Ireland

Merck Sharp & Dohme Ireland (Human Health)

Limited

Tel: +353 (0)1 2998700

medinfo_ireland@merck.com

Slovenija

Merck Sharp & Dohme, inovativna zdravila

d.o.o.

Tel: +386 1 5204 201

msd.slovenia@merck.com

Ísland

Vistor hf.

Sími: + 354 535 70 00

Slovenská republika

Merck Sharp & Dohme, s. r. o.

Tel: +421 2 58282010

dpoc_czechslovak@merck.com

Italia

MSD Italia S.r.l.

Tel: +39 06 361911

medicalinformation.it@merck.com

Suomi/Finland

MSD Finland Oy

Puh/Tel: + 358 (0)9 804 650

info@msd.fi

Κύπρος

Merck Sharp & Dohme Cyprus Limited.

Τηλ.: 800 00 673

(+357 22866700)

cyprus_info@merck.com

Sverige

Merck Sharp & Dohme (Sweden) AB

Tel: +46 77 5700488

medicinskinfo@merck.com

Latvija

SIA Merck Sharp & Dohme Latvija

Tel: + 371 67364224

msd_lv@merck.com

United Kingdom

Merck Sharp & Dohme Limited

Tel: +44 (0) 1992 467272

medicalinformationuk@merck.com

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.