Aerinaze 2.5mg/120 mg modified-release tablets

Aerinaze tablets contain a combination of two active ingredients, desloratadine which is an antihistamine and pseudoephedrine 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.

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.

• Do not take Aerinaze if you:
• are allergic (hypersensitive) to desloratadine, loratadine, pseudoephedrine or to any of the other ingredients of Aerinaze
• have high blood pressure, heart or blood vessel disease or a history of stroke
• have glaucoma, difficulty in urinating, urinary tract blockage, or an overactive thyroid
• are taking monoamine oxidase (MAO) inhibitor (a class of antidepressant agents) therapy or have stopped taking these types of medicines within the last 14 days.

Take special care with Aerinaze

Certain conditions may make you unusually sensitive to the decongestant pseudoephedrine contained in this medicine. Before taking Aerinaze, tell your doctor or pharmacist if you:

• are 60 years of age or older. Older adults may be more sensitive to the effects of this medicine
• have eye problems (such as increased pressure in the eye or glaucoma)
• have, diabetes
• have intestinal ulcers leading to the narrowing of the stomach, small intestine or esophagus (stenosing peptic ulcer)
• have intestinal blockage (pyloral or duodenal blockage)
• have bladder neck blockage (vesical cervix blockage)
• have a history of difficulty breathing due to tightening of the lung muscles (bronchospasm)
• have prostate enlargement
• haveproblems with your liver, kidney, or bladder.

In addition, if you experience or are diagnosed with any of the following conditions you should tell your doctor as he 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 are scheduled to have surgery, your doctor may advise you to stop taking Aerinaze for a few days 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.

Laboratory Tests
Stop taking Aerinaze at least 48 hours before you have any skin tests.Athletes taking Aerinaze may have positive doping-tests.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important if you are taking:

• digitalis, a medicine used to treat certain heart disorders
• medicines for blood pressure (e.g. -methyldopa, mecamylamine, reserpine, veratrum alkaloids and guanethidine)
• decongestants (oral or nasal)
• diet pills (appetite suppressants)
• amphetamines
• medicines for migraines e.g. ergot alkaloids (such as, dihydroergotamine, ergotamine, or methylergometrine)
• an antibiotic called linezolide
• 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.

Taking Aerinaze with food and drink
Aerinaze tablets may be taken with or without food.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breast-feeding.
Taking Aerinaze is not recommended if you are pregnant.

Decreased milk production in nursing mothers has been reported with pseudoephedrine, a component of Aerinaze. If you are breast-feeding taking Aerinaze is not recommended.

Driving and using machines
At the recommended dose, Aerinaze is not expected to cause you to be drowsy or less alert. However, very rarely some people experience drowsiness, which may affect their ability to drive or use machines.

Always take Aerinaze tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults and adolescents 12 years of age and over: Take one Aerinaze tablettwice daily with a glass of water, with or without food. Swallow the tablet whole; do not crush, break or chew the tablet before swallowing.

Aerinaze should not be used in children under 12 years of age.

Do not take more Aerinaze tablets than recommended on the label. Do not take Aerinaze 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 or pharmacist 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 have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Aerinaze can cause side effects, although not everybody gets them. The following side effects have been seen in studies:

Common (at least 1 in 100 patients) side effects associated with Aerinaze include:

• fast heartbeat? decreased appetite ? tiredness
• restlessness with increased? constipation ? headache body movement ? sugar in urine ? trouble sleeping
• dry mouth? increased sugar in blood ? nervousness
• dizziness? thirst ? drowsiness
• sore throat

Uncommon (at least 1 in 1,000 patients) side effects include:

• pounding or irregular heart? inflammation of the nose ? problems urinating beat ? runny nose ? changes in frequency of
• increased body movement? inflammation of the sinus urination
• flushing? dry throat ? itching
• hot flushes? stomach pain ? chills
• confusion? stomach flu ? decreased sense of smell
• blurry vision? nausea ? abnormal liver function tests
• dry eyes? abnormal stool ? agitation
• nose bleeds? painful or difficult ? anxiety
• irritated noseurination ? irritability

During the marketing of desloratadine, the following side effects have been reported very rarely:

• severe allergic reactions ? stomach pain ? drowsiness (difficulty in breathing, ? nausea (feeling sick) ? inability to sleep wheezing, itching, hives and ? vomiting ? muscle pain swelling) ? upset stomach ? seizures ? rash ? diarrhoea ? restlessness with increased ? palpitations ? hallucinations body movement ? rapid heartbeat ? dizziness ? liver inflammation
• abnormal liver function tests

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Aerinaze after the expiry date which is stated on the blister.
The expiry date refers to the last day of that month.

Do not store above 30°C. Keep the blisters in the outer carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Aerinaze contains

• The active substances are desloratadine and pseudoephedrine (as sulphate)
• Each tablet contains 2.5 mg desloratadine and 120 mg pseudoephedrine (as sulphate).
• The other ingredients are:
• Inactive ingredients in the blue, immediate-release layer: maize starch, microcrystalline cellulose, edetate disodium, citric acid, stearic acid and colorant (Indigo Carmine E132, Aluminum lake).
• Inactive 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 tablet with ?D12? branded on 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:
SP Europe
Rue de Stalle 73
B-1180 Bruxelles
Belgium.

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:

BelgiëBelgiqueBelgien Rue de StalleStallestraat 73 B-1180 BruxellesBrusselBrüssel TélTel 32-02 370 92 11 LuxembourgLuxemburg Rue de Stalle 73 B-1180 BruxellesBrüssel BelgiqueBelgien TélTel 32-02 370 92 11

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