PACKAGE LEAFET: INFORMATION FOR THE USER _

Ambroxol hydrochloride30mg/Sml

Active substance: Ambroxol hydrochloride

BoehringerIngelheim

-Read all of this leaflet carefully because it contains important information for you.

• Keep this leaflet. You may need to read it again.• Ask your pharmacist if you need more information or advice.• You must contact a doctor if your symptoms worsen or do not improve after 4 - :: cays.• If any of the side effects gets serious, or if yOU notice any side effects not listed -: IS lea let, please tell yourd aci

In this leaflet:

1. What MUCOSOLVAN syrup 30 mg/S ml is and w a'is used for

2. Before you take MUCOSOLVAN syrup 30 mg/S m3. How to take MUCOSO VA syrup 30 mg/S ml4. Possible side effects5. How to store MUCOSOLVAN syrup 30 mg/S ml6. Further information

1. What MUCOSOLVAN syrup 30 mg/S ml is andwhat it is used for

MUCOSOLVAN syrup 30 mg/S m san e oectorant whichis used to thin the mucus in acute and c-'or c bronchialand lung diseases where thick, tenaci s - c sa problem.

2. Before you take MUCOSOLVAN syrup 30 m .5

Do not take MUCOSOLVAN syrup 30 mg/S ml:

• if you are hypersensitive (allergic) to the ac I esubstance (ambroxol hydrochloride) or to an heother ingredients of MUCOSOLVAN syrup 30...,g 5 ml,

Special care must be taken with MUCOSOLVAN syrup30 mg/5 ml in the following circumstances:

In a very sma I number of cases, there have been reportsof severe skin reactions such as Stevens-Jo-hnsonsyndrome and oxic epidermal necrolys s EN) occurr ngin temporal association with the use o' expectorantssuch as ambroxol hydrochloride. os o" hese caseswere attributable 0 he undertyi g a sease and/or 0other medication being taken conco tantly, In add' 0during the early p ase of stevens-Jonnson syndrome orTEN, patients may I I a Iy experie cen -specificinfluenza-like symptoms such as e er, 0 nt pain, rhl • scough and sore hroa Because o' ese non-specif cinfluenza-like initial sympto s. symp oma ic reatme 'with cough and cold medications, which is inappropriate,may be started. If new skin or mucosal lesions appear,therefore, medical advice should be sought immediatelyand the use of ambroxol hydrochloride discontinued.

-Patients with impaired kidney or liver 'unctionIf you have impaired kidney function or severe liverdisease, you must not take MUCOSO VAN cou-gh syrup30 mg/S ml except on medical advice, With ambroxol,as with any medicine which is broke down in the liverand then eliminated via the kidneys, accumulation of thebreakdown products which are formed in the liver canbe expected to occur in patients with severely impairedkidney function.

In some rare bronchial diseases which are associated withexcessive accurr-., a: - o· sec-e 0 s (such as pnrnarvciia s g Ishould only be used unoa ec.ce supervision becauseof the risk that secretions ma acc mu ate.

MUCOSOLVAN syrup 3 mg 5 ml must not ce sed Inchildren under 2 years 0 age except on mea C3 advice.

Taking other medicines

Please tell your doctor or p arrnacist if yOu are ta ins/usrnq or have recently ta"e sed any 0 er me-o CI es,ncluding medicines obta ed Without a prescrrption

Ambroxol and cough suppressantsSimultaneous use of MUCOSOLVAN syrup 30 mg/S mland coug suppres s may ead to the developmentof a dangerous acc - • t.or- of secretions OWing'reduction o· --3 C e 3 3-::: s ould be" de akenonly a er C3-a--_ s -oene'rt =

Pregnancy a <east-feed"

eresst-reea ngAmbroxol has been shown to pass into breast milk inanimal studies. Use while breast-feeding is notreco e ded

Driving and using machines

There is no evidence of any effect on the ability to driveor use machines. No relevant studies have beenperformed.

Important information about some of the ingredients ofMUCOSOLVAN syrup 30 mg/5 ml

This medicine contains approximately 1.2 9 sorbitol per5 ml (equivalent to 4.9 9 if the maximum recommendeddaily dose is taken). f you have been told that you havean intolerance to some sugars, please consult yourdoctor before taking UCOSOLVAN syrup 30 mg/5 ml.

3. How to take MUCOSOLVAN syrup 30 mg/S ml

Always take MUCOSOL syrup 30 mg 5 m exactly asdescribed in this pac age eaflet. You sod check withyour doctor or pharmac s: you are no: sure

Unless otherwise prescnbed by the doc or, therecommended doses are as follows:

Children from 2 to 5 years of age:1.25 ml three times daily (equivalent to 22.5 mg ambroxolhydrochloride per day)

Children from 6 to 12years 0' age;2.5 ml two to three times da :I {equivalent to 30 - 45 mgambroxol hydrochloride per aay

Adults and adolescents over '2 years of age:The usual dosage is 5 ml three c mes daily (equivalent to90 mg ambroxol hvdrochlor.ce per day) for the first2 - 3 days and 5 J twice da eo a e-- - 60ambroxol hydrochlor ae cer ca, t ereafter.

For adults and adolescents over 12 years of age, thel"lo:-.-;th"e,rageutic effect may be enhanced by increasing the

dosage to 10 ml twice daily (equivalent to 120 mgambroxol hydrochloride per day).

Route and method of administration and duration oftreatment

MUCOSOLVAN syrup 30 mg/5 ml is for ora use.

MUCOSOLVAN syrup 30 mg/5 ml can be taxen thor without food and is dispensed with t e aid 0 hemeasuring cup provided.

Please clean the measuring cup after eac use by rinsingwith warm water.

You should contact a doctor 'f your s~ otorns orsenor do oot ire a e<'<i - - ..;"

If you feel that the effect of MUCOSOLVAN syrup30 mg/5 ml is too strong or too weak, talk to yourdoctor or pharmacist.

If you take more MUCOSOLVAN syrup 30 mg/5 ml thanyou should

No specific symptoms of overdose have been reportedto date. The symptoms observed In cases of accidentaloverdose or medication error are co sistent with theside effects which may occur at recommended doses(see section 4). In case of overdose p ease consulta r as sy a ic trea e<'-.a

If you forget to take MUCOSOLVAN syrup 30 mg/5 ml

If you forget to take MUCOSOLVAN syrup 30 mg/5 mlor take too small a dose, wait until it is time to take yournext dose and then continue taking MUCOSOLVANsyrup 30 mg/5 ml as described in the dosageinstructions above.

If you stop taking MUCOSOLVAI'oI syrup 30 mg/5 ml

If you stop treatment early, your symptoms may getorse

4. Possible side effects

·e all rnedici es ~UCOSOLVAN syrup 30 mg/S ml cana e Side effects art 0 9 ot everybody gets them.

- e '0 lowing ca:egor es are orma Iy used whenrePO'" g the freq eoc es 0' s de e ec s:

ery common: More than 1 in 10 patients

Common: Between 1 in 10 and 1 in 100 patients

Uncommon: Between 1 in 100 and 1 in 1000 patients

Between 1 in 1000 and 1 in 10.000 patients

=e er than 1 in 10,000 patients

Frequency cannot be estimated fromhe available data

Side ef4ects

S In rash, urticaria (nettle rash)Swelling of the skin and mucousmembranes, itching, anaphylacticreactions (severe allergic reactions)including shock, other hypersensitivityreactions

Nervous system disorders

Common: Taste d s:~' ances

Rare:Not known:

Gastrointestinal disorders

Common:Uncommon:

Nausea, 'ee og of numbness in the mouthVomiting a arrhoea, indigestion,abdorn a pain, dry mouthDry throaCo+snoet on. ncreased sa ivation

rac c and mediastinal disorders

Rare:Very rare:

::Cesp ret ry; t:Common.Very rare:Not known:

Feeling of numbness in the throatIncreased nasal dischargeShortness of breath (as symptom ofa hypersensitivity reaction)

Renal and urinary disorders

Very rare: Difficulty urinating

General disorders and administration site conditions

Uncommon: Fever, mucous membrane reactions

Action to be taken in the event of side effects

At the first signs of a hypersensitivity reaction, stoptaking MUCOSOLVAN syrup 30 mg/5 ml.

If any of the side effects gets serious, or if you noticeany side effects no lis ed in this leaflet, please tell yourdoc or or pharmacist.

5. How to store MUCOSOLVAN syrup 30 mg/5 ml

Keep out of the reach and sight of children.

Do not use MUCOSOLVAN syrup 30 mg/5 ml after theexpiry date which is stated on the carton and the abel.

Storage conditions

Do not store above 25°C

Shelf life after first opening the bottle

Use MUCOSOLVAN syrup 30 mg/5 ml within 6 monthsof first opening the bottle.

Medicines should not be disposed 0 a aste ter syour pharmacist how to dispose of med c es no longerrequired. These measures will help 0 protect theenvironment.

6. Further information

What MUCOSOLVAN syrup 30 mg/5 ml contains:

The active substance 's ambroxol hydrochloride.

5 ml of the syrup contains 30 mg ambroxolhydrochloride.

The other ingredients are:Benzoic acid, liquid sorbitol (non-crystallising).hydroxye y ce lulose. 9 cero. 85 - a,•...,,..,,ol ••.•.,•• _potassium. tlavounnc agents, punfieo ware

Notes:MUCOSOLVA syru 30 5 ~ s e ,~.diabetics; 5 ml contains 1.2 g of carbohydrates.MUCOSOLVAN syrup 30 mg/5 ml does not conta ~alcohol.

What MUCOSOLVAN syrup 30 mg/5 ml looks Ii e andcontents of the pack:

MUCOSOLVAN syrup 30 mg/5 ml is a colour ess liquidwith a fruity odou r.

MUCOSOLVAN syrup 30 mg/5 ml is available in originalpacks containing 100 ml and 250 ml.

ot all pack sizes may be marketed

Marketing Authorisatio 0 derBoehringer Inge e -e .; c-Binger StraBe 17355216 Ingelheim a e Germa

ManufacturerDelpharm Relms10. Rue Colonel C aroonneaux51100 ReimsFrance

For any information about this medicine. please contactt e ocal representative of the MarketingAu horisation Holder:

Boehringer IngelheimMiddle East & North Africa(Scientific Office) FZ-LLC=.o. Box 505123

"f,ca eCDuba ••UAETel: +971 4 <1230400Fax: +971 4) 423 3637

To report any side effect's:• Saudi Arabia:- National Pharmacovig a e Center (NPC)• Fax: +966-11-205-7662• Toll-free: 800249000• E-mail: npc.drug@sfda ;; sa• Website: www.sfda.g sa '1pC

• Other countries:• Plea "'e a"'· au

This leaflet was last revised in March 2013

This is a Medicament

- Medicament is a product which affects your healthand its consumption contrary to an Instruction isdangerous for you.

- Follow strictly the doctor's prescrip ion. the methodof use and the instructions of the Pharmacist whosold the medicament.

- The doctor and the pharmaclst are the experts inmedicines. their benefits and risks.

- Do not b, y "Se < p- - e period of treatment

w.thout

315393-001