MSD

Modified release tablet 2.5 mg / 120 mg
(Not provided)(Blue and white two-layer oval tablet with the blue layer marked “D12”)

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Aerinaze is and what it is used for 
2. What you need to know before you use Aerinaze 
3. How to take Aerinaze 
4. Possible side effects 
5. How to store Aerinaze 
6. Contents of the packaging and other information 

1. What Aerinaze is and what it is used for

What Aerinaze is

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 reduce allergic symptoms by counteracting the effects of histamine, a substance that is released into the body’s tissues. Decongestants reduce nasal congestion.

When to use Aerinaze

Aerinaze tablets relieve symptoms of an allergic, seasonal runny nose (hay fever) such as sneezing, runny or itchy nose and eyes, as nasal congestion is also present in adults and adolescents 12 years and older.

2. What you need to know before using Aerinaze

Do not take Aerinaze:

  • if you are allergic to desloratadine, pseudoephedrine sulfate, adrenergic medicines, or any of the other ingredients of this medicine (listed in section 6) or to loratadine.
  • if you have high blood pressure, cardio vascular disease, or previous stroke
  • if you suffer from glaucoma or you have urinary incontinence, urinary retention, or overactive thyroid gland
  • if you are taking monoamine oxidase inhibitors (MAOs) (a group of antidepressants) or if you have stopped taking this type of medicine in the last 14 days.

Warnings and cautions

Some conditions may make you unusually sensitive to the decongestant substance pseudoephedrine sulfate contained in this medicine. Talk to your doctor, pharmacist, or nurse before taking Aerinaze:

  • if you are 60 years or older. Elderly people may be more sensitive to the effect of the medicine.
  • if you have diabetes
  • if you have stomach ulcers that lead to narrowing of the stomach, small intestine, or esophagus (blocking stomach ulcers )
  • if you have an intestinal obstruction ( pylorus – or duodenal stenosis)
  • if you have obstruction of the bladder neck (bladder neck obstruction)
  • if you have previously had difficulty breathing due to contraction of the lung muscles ( bronchospasm )
  • if you have problems with your liver, kidneys, or bladder.

In addition, if you have any of the following conditions or are diagnosed with any of the following conditions, talk to your doctor, pharmacist, or nurse as they may advise you to stop taking Aerinaze:

  • high blood pressure
  • fast or throbbing heartbeat
  • abnormal heart rhythm
  • nausea and headache or increased headache while taking Aerinaze
  • if you or someone in your family has had seizures.
  • severe skin reactions, including signs and symptoms such as redness of the skin, many small rashes, with or without fever.

If you are going to have an operation, your doctor may advise you to stop taking Aerinaze 24 hours in advance.

One of the active substances in Aerinaze, pseudoephedrine sulfate, can be addictive and large doses of pseudoephedrine sulfate can be toxic. Continuous use may result in taking more Aerinaze than the recommended dose to achieve the desired effect, leading to an increased risk of overdose. If you suddenly stop treatment, depression can occur.

Laboratory tests

Discontinue Aerinaze at least 48 hours before undergoing a skin test as antihistamines may affect the results of the skin test.

Athletes taking Aerinaze can receive positive doping tests.

Use for 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 drug used to treat certain heart conditions
  • medicines for blood pressure (eg α-methyldopa, mecamylamine, reserpine, veratrum alkaloids, and guanethidine)
  • oral or nasal decongestants (such as phenylpropanolamine, phenylephrine, ephedrine, oxymetazoline, naphazoline)
  • slimming preparations (appetite suppressants)
  • amphetamine preparations
  • medicines for migraines e.g. ergot alkaloids (such as dihydroergotamine, ergotamine, or methylergotamine)
  • medicines for Parkinson’s disease or infertility such as bromocriptine, cabergoline, lisuride, and pergolide
  • antacids for indigestion or stomach upset
  • a drug for diarrhea called kaolin
  • tricyclic antidepressants (such as nortriptyline), antihistamines (such as cetirizine, fexofenadine).

Aerinaze with alcohol

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

Pregnancy, breastfeeding, 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.

If you are pregnant, taking Aerinaze is not recommended.

Decreased milk production in breastfeeding mothers has been reported with pseudoephedrine sulfate, an ingredient in Aerinaze. Both desloratadine and pseudoephedrine are excreted in human milk. If you are breast-feeding, do not use Aerinaze.

Fertility

There are no fertility data for men and women.

Driving and using machines

At the recommended dose, it is unlikely that this medicine will affect your ability to drive or use machines. Although most people do not feel drowsy, it is recommended that you do not perform activities that require sharp attention, such as driving a vehicle or using machinery until you know how you react to the medicine.

3. How to take Aerinaze

Always take this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.

Adults and children from 12 years

The recommended dose is one tablet twice daily with a glass of water, with or without food.

This medicine should be swallowed.

The tablet should be swallowed whole, must not be crushed, divided, or chewed before swallowing.

Do not take more tablets than recommended in the instructions. Do not take tablets more often than recommended.

Do not take this medicine for more than 10 days in a row, unless your doctor tells you otherwise.

If you take more Aerinaze than you should

If you have taken more Aerinaze than you were told to, contact a doctor, pharmacist, or nurse immediately.

If you forget to take Aerinaze

If you forget to take your tablet at the right time, take it as soon as possible and then go back to your regular dosing one. 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 product, 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 adverse reactions have been reported in clinical trials:

Common: the following may occur in less than 1 in 10 users
fast heartbeat restlessness with increased body movement mouthdizzinesssore throat decreased appetite constipation
fatigueheadachedifficulty sleepinganxietydrowsiness

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Uncommon: the following may occur in less than 1 in 100 users
throbbing or irregular heartbeat increased body movementrednesshemorrhageconfusiondimsyndry eyesnosebleedsirritation of the nose inflammation of the nose runny nose inflammation of the sinuses dryness in the throat stomach ache stomach flunauseaabnormal stool painful or difficult urinationsugar in the murine elevated blood sugarthirsturination problems change in the number of urinations
itchingoverindulgeimpaired odorabnormal liver function testsrestlessnessconcernirritation

Very rare: the following other side effects reported during marketing of desloratadine may occur in less than 1 in 10,000 users
severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling)rash vomitingdiarrheahallucination
muscle painseizureshepatitisabnormal liver function tests

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Has been reported (occurs in an unknown number of users):
deviant behavior weight gain, increased appetite aggression changes in how the heartbeats

Cases of severe skin reactions, including signs and symptoms such as fever, flushing, or many small rashes, have been reported during treatment with products containing pseudoephedrine.

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

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 carton after “EXP” and on the blister after “EXP”.

The expiration date is the last day of the specified month.

Store at a high 30 ° C. Store blisters in the outer carton. Sensitive to 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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances are desloratadine and pseudoephedrine sulfate.
  • Each tablet contains 2.5 mg desloratadine and 120 mg pseudoephedrine sulfate.
  • Other ingredients are:
    • Ingredients in the blue immediate-release layer: corn starch, microcrystalline cellulose, disodium edetate, citric acid, stearic acid, and dye (indigo carmine E132, aluminum lacquer).
    • Ingredients in the white layer with delayed-release: hypromellose 2208, microcrystalline cellulose, povidone K30, silicon dioxide, and magnesium stearate.

What the medicine looks like and the contents of the pack

Blue and white two-layer oval tablet with modified-release with “D12” embossed in the blue layer.

Aerinaze tablets are packaged as 2, 4, 7, 10, 14, or 20 tablets in blisters consisting of laminated blister film with foil lids.

Not all packaging may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Merck Sharp & Dohme BV

Waarderweg 39

2031 BN Haarlem

Netherlands

Manufacturer:

SP Labo NV

Industrial Park 30

B-2220 Heist-op-den-Berg

Belgium.

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienMSD Belgium BVBA / SPRLTel: +32 (0) 2 776 62 11dpoc_belux@merck.com LithuaniaUAB Merck Sharp & DohmeTel. + 370 5 278 02 47msd_lietuva@merck.com
BulgariaMark Harp and Doom Bulgaria BulgariaTel: +359 2 819 3737info-msdbg@merck.com Luxembourg / LuxemburgMSD Belgium BVBA / SPRLTel: +32 (0) 2 776 62 11dpoc_belux@merck.com
Czech RepublicMerck Sharp & Dohme sroTel: +420 233 010 111dpoc_czechslovak@merck.com HungaryMSD Pharma Hungary Kft.Tel .: +36 1 888-5300hungary_msd@merck.com
DenmarkMSD Danmark ApSTel: + 45 4482 4000dkmail@merck.com MaltaMerck Sharp & Dohme Cyprus LimitedTel: 8007 4433 (+356 99917558)malta_info@merck.com
GermanyMSD SHARP & DOHME GMBHTel: 0800 673 673 673 (+49 (0) 89 4561 2612)e-mail@msd.de The NetherlandsMerck Sharp & Dohme BVTel: 0800 9999000(+31 23 5153153)medicalinfo.nl@merck.com
EestiMerck Sharp & Dohme OÜTel: + 372 6144 200msdeesti@merck.com NorwayMSD (Norway) ASTel: +47 32 20 73 00msdnorge@msd.no
GreeceMSD Α.Φ.Β.Ε.Ε.:Ηλ: +30 210 98 97 300dpoc_greece@merck.com AustriaMerck Sharp & Dohme Ges.mbHTel: +43 (0) 1 26 044msd-medizin@merck.com
SpainMerck Sharp & Dohme de España, SATel: +34 91 321 06 00msd_info@merck.com PolandMSD Polska Sp. z ooTel .: +48 22 549 51 00msdpolska@merck.com
FranceMSD FranceTel: + 33 (0) 1 80 46 40 40 PortugalMerck Sharp & Dohme, LdaTel: +351 214465700inform_pt@merck.com
CroatiaMerck Sharp & Dohme dooTel: + 385 1 6611 333croatia_info@merck.com RomaniaMerck Sharp & Dohme Romania SRLTel .: + 40 21 529 2900msdromania@merck.com
IrelandMerck Sharp & Dohme Ireland ( HumanHealth) LimitedTel: +353 (0) 1 2998700medinfo_ireland@merck.com SloveniaMerck Sharp & Dohme, an innovative freelance dooTel: +386 1 5204 201msd.slovenia@merck.com
IcelandVistor hf.Phone: + 354 535 70 00 Slovak RepublicMerck Sharp & Dohme, sroTel: +421 2 58282010dpoc_czechslovak@merck.com
ItalyMSD Italia SrlTel: +39 06 361911medicalinformation.it@merck.com Finland / FinlandMSD Finland OyPuh / Tel: + 358 (0) 9 804 650info@msd.fi
ΚύπροςMerck Sharp & Dohme Cyprus Limited..: Ηλ .: 800 00 673(+357 22866700)cyprus_info@merck.com
LatviaSIA Merck Sharp & Dohme LatvijaTel: + 371 67364224msd_lv@merck.com United KingdomMerck Sharp & Dohme LimitedTel: +44 (0) 1992 467272medicalinformationuk@merck.com

Muhammad Nadeem

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