AERINAZE 2.5 mg/120 mg MODIFIED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Aerinaze 2.5mg/120mg Modified Release Tablets

desloratadine/pseudoephedrine sulfate

Contents of the Package Leaflet

1. What is Aerinaze and what is it used for
2. What you need to know before you take Aerinaze
3. How to take Aerinaze
4. Possible side effects
5. Storage of Aerinaze
6. Contents of the pack and other information

1. What is Aerinaze and what is it used for

What is Aerinaze

Aerinaze tablets contain a combination of two active substances, desloratadine, which is an antihistamine, and pseudoephedrine sulfate, 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 in the body. Decongestants help to relieve nasal congestion (blockage/congestion).

When to take Aerinaze

Aerinaze tablets relieve the symptoms associated with seasonal allergic rhinitis (hay fever) such as sneezing, runny or itchy nose, itchy or watery eyes, when accompanied by nasal congestion in adults and adolescents over 12 years of age.

2. What you need to know before you take Aerinaze

Do not take Aerinaze

• if you are allergic to desloratadine, pseudoephedrine sulfate, adrenergic medications, or any of the other ingredients of this medicine (listed in section 6) or to loratadine

• if you have high blood pressure, heart disease, or blood vessel disease, or have had a stroke in the past

• if you have glaucoma, difficulty urinating, obstruction of the urinary tract, or hyperthyroidism
• if you are receiving treatment with monoamine oxidase inhibitors (MAOIs) (a class of antidepressant medications) or have stopped taking this type of medication in the last 14 days.

Warnings and precautions

Certain conditions may make you unusually sensitive to the decongestant pseudoephedrine sulfate contained in this medicine. Consult your doctor, pharmacist, or nurse before starting to take 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 that lead to narrowing of the stomach, small intestine, or esophagus (peptic ulcer stenosis)
• if you have obstruction of the intestine (pyloric or duodenal obstruction)
• if you have obstruction of the bladder neck (bladder neck obstruction)
• if you have had difficulty breathing in the past due to muscle pressure on the lungs (bronchospasm)
• if you have liver, kidney, or bladder problems.

Additionally, if you experience or are diagnosed with any of the following conditions, you should inform your doctor, pharmacist, or nurse, as they may advise you to stop taking Aerinaze:

• high blood pressure
• rapid or strong heartbeat
• abnormal heartbeat
• nausea and headache or increased headache when using Aerinaze
• if you have a personal or family history of seizures
• severe skin reactions, which include signs and symptoms such as skin redness, many small bumps, with or without fever.

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

One of the active substances of Aerinaze, pseudoephedrine sulfate, has the potential for abuse and large doses of pseudoephedrine sulfate can be toxic. Continuous use can lead to taking more Aerinaze than the recommended dose to achieve the desired effect, increasing the risk of overdose. If treatment is suddenly interrupted, depression may occur.

Laboratory Tests

Stop taking Aerinaze at least 48 hours before undergoing skin tests, as antihistamines may affect the results of skin tests.

Athletes taking Aerinaze may test positive for doping.

Use in Children and Adolescents

Do not give this medicine to children under 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)
• oral or nasal decongestants (such as phenylpropanolamine, phenylephrine, ephedrine, oxymetazoline, naphazoline)
• weight loss medicines (appetite suppressants)
• amphetamines
• medicines for migraines, e.g., ergot alkaloids (such as dihydroergotamine, ergotamine, or methylergometrine)
• medicines for Parkinson's disease or infertility such as bromocriptine, cabergoline, lisuride, and pergolide
• antacids for indigestion or stomach problems
• a medicine for diarrhea called kaolin
• tricyclic antidepressants (such as nortriptyline), antihistamines (such as cetirizine, fexofenadine).

Taking Aerinaze with Alcohol

Talk to your doctor, pharmacist, or nurse about whether you can drink alcohol while taking Aerinaze. It is not recommended to drink alcohol while taking Aerinaze.

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 or pharmacist for advice before taking this medicine.

Aerinaze is not recommended during pregnancy.

Pseudoephedrine sulfate, one of the components of Aerinaze, has been reported to decrease milk production in breast-feeding women. Both desloratadine and pseudoephedrine sulfate are excreted in breast milk. Aerinaze is not recommended during breast-feeding.

Fertility

No data are available on male and 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 that require mental alertness, such as driving a car or operating machinery, until you have determined your own response to the medicine.

3. How to Take Aerinaze

Follow exactly the administration instructions of this medicine given by your doctor, pharmacist, or nurse. If you are unsure, consult your doctor, pharmacist, or nurse again.

Adults and Adolescents from 12 Years of Age

The recommended dose is one tablet twice a day 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 it before swallowing.

Do not take more tablets than recommended in the leaflet. Do not take tablets more frequently than recommended.

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

If You Take More Aerinaze Than You Should

If you take more Aerinaze than you should, inform 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 continue with your regular dosing schedule. Do not take a double dose to make up for forgotten doses.

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 observed in studies:

Frequent: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: the following side effects have been reported during marketing of desloratadine and may affect up to 1 in 10,000 people

Frequency not known: frequency cannot be estimated from the available data

Severe skin reactions, which include signs and symptoms such as fever, skin redness, or many small bumps, have been reported with pseudoephedrine-containing medicines.

Reporting of Side Effects

If you experience 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. Storage of 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 carton and blister after EXP. The expiry date refers to the last day of the month shown.

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

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 protect the environment.

6. Contents of the Pack and Other Information

Composition of Aerinaze

• The active substances are desloratadine and pseudoephedrine sulfate.
• Each tablet contains 2.5 mg of desloratadine and 120 mg of pseudoephedrine sulfate.
• The other ingredients are:
• Ingredients in the blue immediate release layer:corn starch, microcrystalline cellulose, disodium edetate, citric acid, stearic acid, and colorant (aluminum lake carmine indigo E-132).
• Ingredients in the white sustained release layer:hypromellose 2208, microcrystalline cellulose, povidone K30, silicon dioxide, and magnesium stearate.

Appearance of the Product and Contents of the Pack

Aerinaze is a modified release, oval, two-layer tablet (blue and white), with “D12” engraved on the blue layer. Aerinaze tablets are presented in blisters of 2, 4, 7, 10, 14, or 20 tablets formed by a blister pack with an aluminum foil lid.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

Manufacturer:

SP Labo N.V.

Industriepark 30

B-2220 Heist-op-den-Berg

Belgium.

For further information on this medicine, contact the local representative of the Marketing Authorization Holder:

Date of Last Revision of this Leaflet:

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