Aerinaze
desloratadine, pseudoephedrine
desloratadine/pseudoephedrine sulphate
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 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
Aerinaze tablets contain a combination of two active ingredients, desloratadine which is an antihistamine and pseudoephedrine sulphate which is a decongestant.
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).
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.
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.
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.
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.
Do not give this medicine to children less than 12 years of age.
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)
Speak with your doctor, pharmacist or nurse regarding whether you can drink alcohol while taking Aerinaze. Drinking alcohol while taking Aerinaze is not recommended.
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.
There is no data available on male/female fertility.
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.
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.
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 were told to, tell your doctor, pharmacist or nurse immediately.
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 have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
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
depressed mood
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.
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.
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.
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.
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:
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:
Organon Belgium
Tél/Tel: 0080066550123 (+32 2 2418100)
Organon Pharma B.V. Lithuania atstovybė Tel.: +370 52041693
Органон (И.А.) Б.В. - клон България Тел.: +359 2 806 3030
Organon Belgium
Tél/Tel: 0080066550123 (+32 2 2418100)
Organon Czech Republic s.r.o. Tel: +420 233 010 300
Organon Hungary Kft.
Tel.: +36 1 766 1963
Organon Denmark ApS Tlf: +45 4484 6800
Organon Pharma B.V., Cyprus branch Tel: +356 2277 8116
Organon Healthcare GmbH
Tel.: 0800 3384 726 (+49 (0) 89 2040022 10)
N.V. Organon
Tel: 00800 66550123
(+32 2 2418100)
Organon Pharma B.V. Estonian RO Tel: +372 66 61 300
Organon Norway AS Tlf: +47 24 14 56 60
BIANEΞ Α.Ε.
Τηλ: +30 210 80091 11
Organon Austria GmbH Tel: +43 (0) 1 263 28 65
Organon Salud, S.L.
Tel: +34 91 591 12 79
Organon Polska Sp. z o.o. Tel.: +48 22 105 50 01
Organon France
Tél: +33 (0) 1 57 77 32 00
Organon Portugal, Sociedade Unipessoal Lda.
Tel: +351 218705500
Organon Pharma d.o.o. Tel: +385 1 638 4530
Organon Biosciences S.R.L. Tel: +40 21 527 29 90
Organon Pharma (Ireland) Limited Tel: +353 15828260
Organon Pharma B.V., Oss, podružnica Ljubljana
Tel: +386 1 300 10 80
Vistor hf.
Sími: +354 535 70 00
Organon Italia S.r.l.
Tel: +39 06 3336407
Organon Finland Oy
Puh/Tel: +358 (0) 29 170 3520
Organon Pharma B.V., Cyprus branch Τηλ: +357 22866730
Organon Sweden AB Tel: +46 8 502 597 00
Ārvalsts komersanta “Organon Pharma B.V.” pārstāvniecība
Tel: +371 66968876
Taking into account the PRAC Assessment Report on the PSUR(s) for desloratadine / pseudoephedrine, the scientific conclusions of the CHMP are as follows:
In view of available data from the literature including in some cases a close temporal relationship, a positive de-challenge and/or re-challenge, and in view of a plausible mechanism of action, the PRAC considers a causal relationship between desloratadine and depressed mood is at least a reasonable possibility. The PRAC concluded that the product information (PI) of products containing desloratadine / pseudoephedrine should be amended accordingly.
The CHMP agrees with the scientific conclusions made by the PRAC.
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.