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Aerinaze (desloratadine / pseudophedrine sulphate) – Package leaflet - R01BA52

Updated on site: 05-Oct-2017

Medication nameAerinaze
ATC CodeR01BA52
Substancedesloratadine / pseudophedrine sulphate
ManufacturerMerck Sharp

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:

1.What Aerinaze is and what it is used for

2.What you need to know before you take Aerinaze

3.How to take Aerinaze

4.Possible side effects

5.How to store Aerinaze

6.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

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 fluoxetine), 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

decreased appetite

tiredness

restlessness with increased

constipation

headache

body movement

 

trouble sleeping

dry mouth

 

nervousness

dizziness

 

drowsiness

sore throat

 

 

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

 

pounding or irregular heart

dry throat

itching

beat

stomach ache

chills

increased body movement

stomach flu

decreased sense of smell

flushing

feeling sick (nausea)

abnormal liver function tests

hot flush

abnormal stool

agitation

confusion

painful or difficult

anxiety

blurry vision

urination

irritability

dry eye

sugar in urine

 

nose bleeds

increased sugar in blood

 

irritated nose

thirst

 

inflammation of the nose

problems urinating

 

runny nose

changes in frequency of

 

inflammation of the sinus

urination

 

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

vomiting

muscle pain

(difficulty in breathing,

diarrhoea

convulsion

wheezing, itching, hives and

hallucination

liver inflammation

swelling)

 

abnormal liver function tests

rash

 

 

Not known: frequency cannot be estimated from the available data

 

abnormal behaviour

aggression

changes in the way the heart

 

 

beats

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 bi-layer 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 Ltd

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

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

Lietuva

MSD Belgium BVBA/SPRL

UAB Merck Sharp & Dohme

Tél/Tel : 0800 38 693

Tel. + 370 5 278 02 47

+32 (0)2 776 62 11

msd_lietuva@merck.com

dpoc_belux@merck.com

 

България

Luxembourg/Luxemburg

Мерк Шарп и Доум България ЕООД

MSD Belgium BVBA/SPRL

Тел.: +359 2 819 3737

Tél/Tel : 0800 38 693

info-msdbg@merck.com

+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

Danmark

MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com

Deutschland

MSD SHARP & DOHME GMBH

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612) e-mail@msd.de

Eesti

Merck Sharp & Dohme OÜ Tel: + 372 6144 200 msdeesti@merck.com

Ελλάδα

MSD Α.Φ.Β.Ε.Ε.

Τηλ: +30 210 98 97 300 dpoc_greece@merck.com

España

Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 msd_info@merck.com

France

MSD France

Tél: + 33 (0)1 80 46 40 40

Hrvatska

Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333 croatia_info@merck.com

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700 medinfo_ireland@merck.com

Ísland

Vistor hf.

Sími: + 354 535 70 00

Magyarország

MSD Pharma Hungary Kft. Tel.: +36 1 888-5300 hungary_msd@merck.com

Malta

Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) malta_info@merck.com

Nederland

Merck Sharp & Dohme BV Tel: 0800 9999000

(+31 23 5153153) medicalinfo.nl@merck.com

Norge

MSD (Norge) AS Tlf: +47 32 20 73 00 msdnorge@msd.no

Österreich

Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044 msd-medizin@merck.com

Polska

MSD Polska Sp. z o.o. Tel.: +48 22 549 51 00 msdpolska@merck.com

Portugal

Merck Sharp & Dohme, Lda Tel: +351 214465700 clic@merck.com

România

Merck Sharp & Dohme Romania S.R.L. Tel.: + 40 21 529 2900 msdromania@merck.com

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Tel: +386 1 5204 201 msd.slovenia@merck.com

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

Κύπρος

Merck Sharp & Dohme Cyprus Limited. Τηλ.: 800 00 673

(+357 22866700) cyprus_info@merck.com

Latvija

SIA Merck Sharp & Dohme Latvija Tel: + 371 67364224 msd_lv@merck.com

This leaflet was last revised in

Suomi/Finland

MSD Finland Oy

Puh/Tel: + 358 (0)9 804 650 info@msd.fi

Sverige

Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 medicinskinfo@merck.com

United Kingdom

Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com

Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.

ANNEX IV

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS

OF THE MARKETING AUTHORISATION(S)

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR(s) for desloratadine / pseudoephedrine, the scientific conclusions of CHMP are as follows:

Two literature reports identified a possible relationship between aggressive reaction/abnormal behaviour and desloratadine use with supportive temporal relationships, positive dechallenges and some with positive rechallenges. Similar cases were reported in Eudravigilance for the reference period. Considering the potential seriousness of these events in children, and the number of reported cases with positive dechallenge and rechallenge, the ‘abnormal behaviour’ and ‘aggression’ should be added to the list of adverse drug reactions (ADRs) of desloratadine.

A literature article published during the reference period describes 4 cases of epilepsy in children with a family history of epilepsy or relevant medical history. The causality was assessed as possible for each case, based on temporal association and positive dechallenge. Based on these new data, it could be concluded that desloratadine may aggravate pre-existing seizures in patients (and mainly in children) with medical history of seizures, and that caution should be recommended in treating epileptic patients or those susceptible to convulsions with desloratadine.

Based on 4 new publications regarding a possible association between desloratadine and QT prolongation were reported in the literature and the fact that ‘QT prolongation’ is already listed as an ADR of desloratadine-containing products, this adverse reaction should be listed as an ADR of any desloratadine-containing product.

Therefore, in view of the data presented in the reviewed PSURs, the PRAC considered that changes to the product information of medicinal products containing desloratadine were warranted.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the Marketing Authorisation(s)

On the basis of the scientific conclusions for desloratadine / pseudoephedrine the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing desloratadine / pseudoephedrine is unchanged subject to the proposed changes to the product information

The CHMP recommends that the terms of the marketing authorisation(s) should be varied.

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