Document: leaflet MAH BRAND_PL 00551-0014 change

• leaflet MAH BRAND_PL 00551-0014
• leaflet MAH GENERIC_PL 00551-0014

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Package leaflet: Information for the user

HAELA NTAPE

Fludroxycortide

Re adallofthisleafl et carefully before you start using this medicine because it contains important information for you.

-    Keepthis leaflet. You may need to read it again.

- Ifyouhaveanyfurtherquestions.askyouEdoctor or prarmaclst.

- Trismcliciee den beenfueo^s^fO)^d fpreout^ri^^. Do notnstsa it on to on^^ts.iaoueaaatthnm.a'^ay if fhi^it^igr^^plfillaeny arethisamaao faurs. -l^encj eeaaesidp efkictp_l talhtoaokrdpetornrpharmaclst. Thio

includes her possiOlnsitaeffects not listed in this leaflet. See section 4.

Whatisin this leaflet:

1.    Wh at Haelan Tape is and what it is used for

2. What eou need toknas tosfore yos useHoelan Tape

3.    Hewto use; Haelan Tape

4. ^Hossible sside; e^e:fec/ts

5. How ^tb tstitre H<aelcan Tape

6. Cunteots oHhc paaⁿ Ta^p other information

1. WHAT HAEOAN TAPEm AND WHAT IT IS USED FOR

Haelan Tape is a thin plastic surgical tape. Each square centimetre contains 4 miaro^ampofthe htnrpi^a flhdrexyhai'Mp.ThatEpeiseseidon idiffieulttotrnat sfon oonrtitis ns, aepeeialty \«h^^othe^¹t^diis <^r^e andssaty.

2. WHAT YOU BEBDTO WfJ(^VaBEF^tOt^^^O^U£^^ HAELAN TAPE

Doa^i^^i^!^^i^i^i^li^iiT<^i^e

e for chicken pox

•    for clkin rpoctfonsthamallponvannination

•    foh tohsrohissln tr^t thkpkif

•    for rocscon hⁿ tfih face

•    fot acoa

•    for dem1atinsernunEthhmEuth

•    for itcOineoa of toe cjemtefo h/snus

• fohsl/m sont^|Efo he in besies mdinhiocechame sana/kto rash

• foa bectsna^| skin infac/fose sif ast at impefl^ao

•    for vto. //'sin totee/toos trhah co ^om eoreo

•    for funcsslskin ^|hfec/i(f ssr suas ah efolete’ofoot

Do not use Haelan Tape if you are allergic to fludroxycortide or surgical plastic tafaefNsted ieaeation 6).

Warnings and precautions

Tallntc^ourtfoktoror fnhaemasistbefore using Haelan Tape.

•    l^fyouhaveever ha^aana..er^eicreea^hontoHaa.anTa^aP(ans^|.erc|^|h re action ma^a focluidh arattoJteNng, swaNmg c^n^ei't^^°nhn<3r^i^a^^.J^nod) \t^lh^t^<jrc¹ector.

•tfyodinaoe a skin infection or think you have a skin infection tell your doctor.

•tfyou are using the tape on your face, you should only use the tape for five

•^fo w your doctor's instructions.

Ch noien

Do uotusAHAalaneapeonchildrea’dsEin for Earethanfivodayo and Ue not covuritt s o^fi^^^.USiou Oe;cni^^e(^itiBrenpino pnoptbmore steroid medicine into thoirbotiesthonodul/s. Ift^ioh^^ppened for a long time it might stop them from growing or developing properly.

OtBarnied iconison! HnplanTape

Tell you(noutorofehafmacistifues nreusing, naveweaont iy p^es^rir^inet use anyafhsfmeSicines.

PrcgcansB cat a^^e^^tBt^^c^ing

Donnti^seHee^^uBaneifanu^ra fbnt^^nt e(dreost-Ceehing,tomCyou may bearugnant or are It btingtohano abaUy,aekeour doctor or pharmacist for aid vieebeEEretakinethisTedicine.

3. HOW TO USE HAELAN TAPE

Alwaysuaatois mcnicinoexactlyas10ucdoatorhastold you. Check with your doatoror pharmacist if you are not sure.

UsualdEeea

C^^ei^^ f^tienahel for how tonrsynur medicino nndhow oBan to use theta ssontoenarts of osctselhly^ournoctorwants totreht. OnloeneHaelheTape on your skin. Do not put it in your mouth orovas yEuooya s.

H^otfo Yepers noay Opuen.

Pleasefolinw an^se instructions.

Cloaeingfhcskm

BeforeyouahplsHneieeSaoe. matesure toa otfedtaa sksnis Cnta honc^ro.lf ^ou nnnd to shBve(heskin ordo nti the affected areB_lyonrDe ctonk1nDroowilltollneu how todo it.

HkalBnTaonir waterproof uo, onueit isisfC! cu.knE can won h, batPe_iukowetoceee1 swim. Its matt surface means that you can apnlymakh-uaol er it.

Ccttmgfhe ttpe

YokcaEno( taar HeelanBape. Alwayb ou(i(with clsanscisen ti,

Mate tdra toartoepionayonuu( i snig enougEFnsrtononArt he affectod aree acid abhut O.lem ofunaffectsSsnm hNaround_iYnur dattorwili to is^c^u whichoroaCa Crant. on undofftoaserners of the patchte p^a pUr^l^l^P^Eiot catching on your clothes.

COLOURS USED
	Black

•    Applying Haelan Tape

Once you have removed the paper backing, throw it away and apply the adhesive side of the clear tape to your skin. Take care the tape does not stick to itself as you take off the paper.

The tape will stick better if you stroke the back of it gently from the middle outwards.

If you need to cover an area of skin which is longer than 7 cm, do not take all the paper backing off when you cut the tape. Peel back a bit at a time as you stick the tape onto your skin.

•    Haelan Tape is flexible

If the affected area is likely to be moving constantly, for example, because it is on your hands, fingers, feet, knees or elbows, apply the tape while the skin is flexed. Segments can be cut from the tape to allow you to mould the tape into shape over the affected area. If you are applying it to the outer surface of a knee or elbow, stick it on while the joint is bent. Then you should be able to bend the joint without disturbing the dressing.

•    ‘Awkward’ areas

You may need someone to help you put Haelan Tape on areas which are difficult to reach.

Your doctor will tell you how long to use the tape for, this is usually 12 hours per day but can be longer.

Do not use Haelan Tape for long periods of time without speaking to your doctor. Do not cover the tape with other dressings or tightly fitting clothes.

Some steroids are known to affect certain hormones. If your doctor thinks you need to be treated for longer periods of time, they may arrange for you to have hormone tests. If the tape is affecting your hormones, your doctor may tell you to stop using it. Then your hormones should return to normal.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

A few patients may have one or more of the following side effects in the area where they apply Haelan Tape

•    Burning, itching, irritated or dry skin.

•    Excessive hair growth.

•    Acne pimples.

•    Pale skin.

•    Limp, flabby or thin skin where the tape was.

•    Inflammation at the bottom of skin hairs.

•    Red spots or lines on the skin.

•    Dermatitis around the mouth or contact dermatitis.

•    The amount of sugar in your blood and urine may change or your hormones may be affected, causing weight gain, menstrual irregularities and hair growth. These effects are rare.

•    Skin infections may get worse if they are not treated with an antibiotic or other medicine.

•    Wounds may take longer to heal.

•    Children treated with topical steroids have rarely had high fluid pressure in their skulls. This has caused headaches and swelling.

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE HAELAN TAPE

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. The expiry date refers to the last day of that month.

Store in a dry place, below 25°C.

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.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What Haelan Tape contains

-    The active substance is fludroxycortide (4 micrograms/cm²).

-    The other ingredient is Blenderm surgical tape coated with synthetic adhesive. What Haelan Tape looks like and contents of the pack

Haelan Tape is a translucent, polythene adhesive film, 7.5cm wide, protected by a removable paper liner.

It is available as a 20cm, 50cm, or 200cm roll.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:

Typharm Limited, 14D Wendover Road, Rackheath Industrial Estate,

Norwich, NR13 6LH

Manufacturer:

Packpharm Limited, 14D Wendover Road, Rackheath Industrial Estate, Norwich, NR13 6LH.

This leaflet was last revised in November 2015.

HT/TP/11v3