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• Cetirizin Mylan film-coated tablet ENG PL

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PACKAGELEAFLET

Packageleaflet:Informationforthepatient

CetirizinMylan 10 mg film-coated tablets

cetirizinedihydrochloride

Read allofthisleafletcarefully beforeyou starttaking thismedicine because it contains important information for you.

− Keep thisleaflet. You mayneed to read itagain.

− Ifyou haveanyfurtherquestions, askyourdoctororpharmacist.

− Thismedicinehasbeen prescribed foryou. Do notpassiton to others. Itmayharmthem, even if theirsigns of illnessarethesameasyours.

− Ifyou get anysideeffects, talk toyourdoctororpharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in thisleaflet:

1. WhatCetirizin Mylanisand whatitisused for

2. What you need to know beforeyou takeCetirizin Mylan

3. Howto takeCetirizin Mylan

4. Possiblesideeffects

5. Howto storeCetirizin Mylan

6. Contents of the pack and otherinformation

1. What Cetirizin Mylan is and what it is used for

CetirizinedihydrochlorideistheactiveingredientofCetirizin Mylan. CetirizinMylan isan antiallergic medication.

In adultsand children aged 6 yearand above, CetirizinMylan isindicated

-forthereliefofnasaland ocularsymptomsofseasonaland perennialallergicrhinitis.

-forthereliefofchronicnettlerash (chronicidiopathicurticaria).

2. What you need to know before you take Cetirizin Mylan

Do nottakeCetirizin Mylan

-ifyou haveaseverekidneydisease(creatinineclearancebelow10ml/min);

-ifyou areallergic to cetirizine dihydrochloride or anyofthe other ingredients of this medicine (listed in section 6), tohydroxyzineortopiperazinederivatives(closelyrelatedactivesubstancesof othermedicines).

Warnings and precautions

Talk to your doctor or pharmacist before taking Cetirizin Mylan

- Ifyouhave kidney problems. You may need to takealowerdose. Thenewdosewillbedetermined byyourdoctor.

-If you have problems passing urine (like spinal cord problems or prostate or bladder problems), ask your doctor for advice.

-Ifyou haveepilepsy or you areatriskofconvulsions (fits).

Skin test

Ifyou need askin (allergy)test, tellthedoctoryou aretakingthesetablets asthis medicinecan affectskin testresults. You willneed to stop treatmentthreedaysbeforethetest.

Children

This medicine isnotrecommended forchildren aged lessthan 6 years.

Othermedicines and Cetirizin Mylan

Tellyourdoctororpharmacistifyou aretaking, haverecentlytaken or might take any other medicines.

Cetirizin Mylanwith alcohol

It is recommended to avoid the consumption of alcohol while taking this medicine.

Pregnancy and breast-feeding

Cetirizin Mylan should be avoided in pregnant women, since the experience of treatment of pregnant women is limited.

You should nottakeCetirizinMylan duringbreast-feedingbecausecetirizinepassesinto breastmilk.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, askyourdoctoror pharmacist foradvicebeforetakingthismedicine.

Driving and using machines

There is no evidenceofimpaired attention, alertnessand drivingcapabilities aftertakingCetirizinMylan attherecommended dose.

You should closelyobserveyourresponseto themedicine after you have taken Cetirizin Mylan ifyou areintendingto drive, engagein potentiallyhazardousactivitiesoroperatemachinery. You should notexceed therecommended dose.

Cetirizin Mylan contains lactose

Ifyou havebeen told byyourdoctorthatyou havean intoleranceto somesugars, contactyourdoctorbeforetakingthismedicinalproduct.

3. How to take Cetirizin Mylan

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Howand when should you takeCetirizin Mylan

Theseguidelinesapplyunlessyourdoctorhasgiven you differentinstructionson howto use

Cetirizin Mylan.

Pleasefollowtheseinstructions, otherwiseCetirizin Mylanmaynotbefullyeffective. Tabletsneed to beswallowed with aglassofliquid.

The tablet can be divided into equal doses.

Adultsand adolescentsabove12 yearsold:

The recommended dose is 10 mgoncedailyasone tablet.

Children between 6 and 12 yearsold:

The recommended dose is 5 mgtwicedailyasahalftablettwicedaily.

Patientswith kidneyimpairment

For patients with kidney impairment, the dose will be determined byyourdoctor based on your kidney function.

Duration oftreatment:

Theduration oftreatmentdependson thetype, duration and courseofyourcomplaintsand is determined byyourdoctor or pharmacist.

Ifyou takemoreCetirizin Mylanthan you should

Ifyou thinkyou havetaken an overdoseofCetirizin Mylanpleaseinformyourdoctor. Yourdoctorwillthen decidewhatmeasures, ifany, should betaken.Afteran overdose, thesideeffectsdescribed belowmayoccurwith increased intensity. Adverse effectssuch asconfusion, diarrhoea, dizziness, tiredness, headache, ailing, dilatingofpupil, itching, restlessness, sedation, somnolence, stupor, abnormalrapid heartrate, tremorsand urinaryretention havebeen reported.

Ifyou forgetto takeCetirizin Mylan

Do nottakeadoubledoseto makeup for aforgotten dose.

4. Possiblesideeffects

Like allmedicines, this medicinecan causesideeffects, although noteverybodygetsthem.

Some side effects could be serious:

Very rare(may affect up to 1 in 10,000 people)

Not known (frequency cannot be estimated from the available data)

• Thoughts of committing suicide

• Unable to pass urine.

If any of the above occurs, tell your doctor straight away.

Other possible side effects

Common(may affect up to 1 in 10 people)

• Tiredness

• Dry mouth

• Feeling sick

• Dizziness

• Headache

• Sleepiness

Sore throat and discomfort when swallowing

Uncommon(may affect up to 1 in 100 people)

• Weakness

• Generally feeling unwell

• Tingling or numbness of the hands or feet

• Agitation

• Itching

• Rash

• Diarrhoea

• Stomach pain

Rare(may affect up to 1 in 1,000 people)

• Fast heart beat

• Abnormal liver function tests

• Increase in weight

• Convulsions (fits)

• Aggression

• Confusion

• Depression

• Seeing, feeling or hearing things that are not there

• Inability to sleep

• Hypersensitivity (usually occurs with skin reaction like rash, itchy red skin)

• Swelling, fluid retention (oedema)

Very rare(may affect up to 1 in 10,000 people)

• Bleeding or bruising more easily than normal

• Blurred vision, eyes having uncontrolled circular movements

• Fainting

• Shaking

• Taste disturbance or loss of taste

• Uncontrolled body movements

• Difficult, painful or involuntary urination

Not known(frequency cannot be estimated from the available data)

• Loss of memory

• Increased appetite

• Vertigo (spinning sensation)

Side effects in children and adolescents

In children and adolescents, the following side effects occur more commonly and can affect up to 1 in 10 people:

• Runny or blocked nose

• Diarrhoea

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via [To be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine.

5. How tostoreCetirizinMylan

Keep outofthesight and reachofchildren.

Do not useCetirizin Mylan afterthe expirydatewhich isstated on thelabel and carton. The expiry date refers to the last day of that month.

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 protect the environment.

Thismedicinedoesnotrequireanyspecial storageconditions.

6. Contents of the pack and otherinformation

WhatCetirizin Mylancontains

-TheactivesubstanceofCetirizin Mylaniscetirizinedihydrochloride. Eachfilm-coated tabletcontains

10 mgcetirizinedihydrochloride.

-Theotheringredientsarelactosemonohydrate (see section 2 “Cetirizin Mylan contain lactose”), pregelatinisedmaizestarch, povidone, magnesium stearate, hypromellose(E464), macrogol, titaniumdioxide(E171)and talc.

WhatCetirizinMylan lookslikeand contentsofthepack

Thetabletsarewhiteand capsule-shaped with ‘CZ10’on onesideand ‘G’on theother. Alltablets haveabreakline.

Packed in bottlesof30, 100 and 250 tabletsand blisterpacksof2, 7, 10, 14, 15, 20, 30, 50, 60, 90 and 100 tablets.

Notallpacksizesmaybemarketed

Marketing Authorisation Holder

[To becompleted nationally]

Manufacturer

McDermottLaboratoriesLimited (t/aGerard Laboratories)

35-36 BaldoyleIndustrialEstate

GrangeRoad

Dublin 13

Ireland

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten

The Netherlands

Thismedicinalproductisauthorised in theMemberStatesoftheEEAunderthefollowingnames:

Austria:Cetirizindihydrochlorid “Arcana”10 mgFilmtabletten Belgium:CetirizineMylan 10 mgfilmomhuldetabletten Denmark:Cetirizin Mylan

Italy:CetirizinaMylan Generics10 mgcompresserivestitecon film

Luxumbourg:Cetirizine-Mylan 10 mg

Netherlands:CetirizinediHClMylan 10 mgfilmomhuldetabletten

Norway:Cetirizin Mylan

Portugal:CetirizineMylan Genericos10 mgcomprimidosrevestidos

Spain:CetirizinaMylan 10 mg, comprimidosrecubiertos Sweden:Cetirizin Mylan 10 mgfilmdragerad tablett United Kingdom:Cetirizine10 mgFilm-coated Tablets

Thisleafletwaslastrevisedin 2016-09-26