Aerinaze - patient leaflet, side effects, dosage

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 :

• 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

• – 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. a-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 decreased appetite
• restlessness with increased constipation

body movement

• dry mouth
• dizziness
• sore throat

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

Very rarely: the following other side effects reported during the marketing of desloratadine, may affect up to 1 in 10,000 people

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 inBy 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:

N.V. Organon

Kloosterstraat 6

5349 AB Oss

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

Organon Belgium

Tél/Tel: 0080066550123 (+32 2 2418100)

Etnrapua

OpraHOH (H.A.) E.B. – k.toh Etnrapua

Ten.: +359 2 806 3030

Česká republika

Organon Czech Republic s.r.o.

Tel: +420 233 010 300

Lietuva

Organon Pharma B.V. Lithuania atstovybe

Tel.: +370 52041693

Luxembourg/Lu­xemburg

Organon Belgium

Tel/Tel: 0080066550123 (+32 2 2418100)

Magyarorszag

Organon Hungary Kft.

Tel.: +36 1 766 1963

Danmark

Organon Denmark ApS

Tlf: +45 4484 6800

Deutschland

Organon Healthcare GmbH

Tel.: 0800 3384 726 (+49 (0) 89 2040022 10)

Eesti

Organon Pharma B.V. Estonian RO

Tel: +372 66 61 300

EXXáSa

BLANES A.E.

Tql: +30 210 80091 11

España

Organon Salud, S.L.

Tel: +34 91 591 12 79

France

Organon France

Tél: +33 (0) 1 57 77 32 00

Hrvatska

Organon Pharma d.o.o.

Tel: +385 1 638 4530

Ireland

Organon Pharma (Ireland) Limited

Tel: +353 15828260

Ísland

Vistor hf.

Sími: +354 535 70 00

Italia

Organon Italia S.r.l.

Tel: +39 06 3336407

Kvnpog

Organon Pharma B.V., Cyprus branch

Tql: +357 22866730

Malta

Organon Pharma B.V., Cyprus branch

Tel: +356 2277 8116

Nederland

N.V. Organon

Tel: 00800 66550123

(+32 2 2418100)

Norge

Organon Norway AS

Tlf: +47 24 14 56 60

Österreich

Organon Austria GmbH

Tel: +43 (0) 1 263 28 65

Polska

Organon Polska Sp. z o.o.

Tel.: +48 22 105 50 01

Portugal

Organon Portugal, Sociedade Unipessoal Lda.

Tel: +351 218705500

Romania

Organon Biosciences S.R.L.

Tel: +40 21 527 29 90

Slovenija

Organon Pharma B.V., Oss, podružnica Ljubljana

Tel: +386 1 300 10 80

info.slovenia@or­ganon.com

Slovenská republika

Organon Slovakia s. r. o.

Tel: +421 2 44 88 98 88

Suomi/Finland

Organon Finland Oy

Puh/Tel: +358 (0) 29 170 3520

Sverige

Organon Sweden AB

Tel: +46 8 502 597 00

Latvija Àrvalsts komersanta “Organon Pharma B.V.” pârstâvniecïba Tel: +371 66968876

United Kingdom (Northern Ireland) Organon Pharma (Ireland) Limited Tel: +353 15828260

This leaflet was last revised in

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

26