Document: document 0 change

• document 0
• document 1

---

|Previously assessed against UK PIL dated April 2010 |

PATIENT INFORMATION LEAFLET ALDOMET® 250mg TABLETS/ METHYLDOPA 250mg TABLETS ALDOMET® 500mg TABLETS/ METHYLDOPA 500mg TABLETS

D09:Tochange the aic^r^ufed^ure^rdetaihjfrom'Lat^oratorios B^patS.A., Cl Josefa Vc^la^rasl.SS.etSOhrjVladrid^p^ain' to "Iroko ProdUcte °imited,0 no ^eN^f SffeeoUede n^C^SHQ' ,w⁰⁰co aue; que ntia ^f ahan^gs f>^re^fo e^mlea U^eafet.

Variation 00^r0: To aiof ahit heffrod cctdescyi ptksnfrom fellow , nound film-coated tabl ets and are debossed with 'MSD 516' on one side n

reverse', wⁿh conaequeriti aloha. ^Y^^^fo^e^e^,gg^s^^s

^nf 2: Thieve⁰ gizer eftheleefld^thne^oeeacerrec^tedfer ^^f^l1^a31^cnat898 to include both 30 and 60.

No other cha ngeu af3^orgted

oymitemo eic me oemg eo yuuia.

n It one eh tdg oitg gttgcto agto ogniedo, en it eeu neticg one oitg gttgcto net liotgt in tdio Igetlgt, plgeog tgll eeun Secten en pdenmeciot.

In this leoflef:

1.    Wdet Vltemgt Uealgto eng ent Tdet eng tdge uogt ten

2.    Bgteng yeu tekg Vltemgt Uealgto

3.    Hut te tekg Vltemgt Uealgto

4.    Peooialg oitg gttgcto

5.    Hut te oteng Vltemgt Uealgto

6.    Funtdgn intenmetien

1. WHAT ALDOMET TABLETS ARE AND WHAT ARE THEY USED FORl

Vltemgt Uealgto centeino e mgticing cellgt mgtdeltepe. Udio aglenao te e gneup et mgticingo cellgt ‘entidepgntgnoivgo'.

Mgtdeltepe io cdenagt inoitg eeun aete te e netunel ouaotencg tdet leTgno aleet pngooung. Yeun tecten deo pngocniagt Vltemgt Uealgto te tnget digd aleet pngooung (depgntgnoien).

2. BEFORE YOU TAKE ALDOMET TABLETS

Do and foke Aldnmef Tablets if you hove:

n gvgn dot e aet ngectien, oucd eo en ellgnae te mgtdeltepe, en te one et tdg etdgn inangtignto (liotgt in ogctien 6) n gvgn dot livgn tiogeog n gvgn dot Sapreooien

n diad aleet pngooung tug te e tumeun ngen eeun kitnge cellgt ‘pdegecdnemeceteme'. n aggn tekina e tepg et mgticing cellgt e ‘meneeming exiteog indiaiten' (MVO indiaiten)

De net tekg Vltemgt Uealgto it one et tdg eaevg epple te eeu. It eeu eng net oung telk te eeun tecten en pdenmeciot agteng tekina Vltemgt Uealgto.

Toke speciol core with Aldnmef Toblefs

Cdgck Titd eeun tecten agteng tekina tdio mgticing it eeu devg: n en eneeng in eeun temile deo en illngoo cellgt ‘dgpetic penpdenie' n kitnge pnealgmo n dot e otnekg

Cdgck Titd eeun tecten wdilg tekina tdio mgticing it eeu eng aeina te devg: n tieleoio n en epgnetien n e aleet tnenotuoien.

Tesfs you moy hove while fokiag Aldnmef Toblefs

Yeun tecten mee te aleet tgoto te cdgck dew eeun livgn io Tenkina tunina tdg tinot 6 - 12 Tggko. Hl en odg mee uog oimilen taoto it eeu dove e tavan et one time wdila eeu one tekina Vltemat Uealgto. Uall eeun tecten eeu one tekina Vltemat Uealgto it eeu dove e leaenetene taot wdana e unina en aleet oempla io token. Udio io agceuoa Vltemat Uealgto mee effect tda ngoulto et oema tepao et taoto.

It eeu one net ouna it one et tda eaeve epple te eeu, telk te eeun tecten en pdenmeciot aatena tekina Vltemat Uealgto. Tokiag nfher medicines

Plaeoa tall eeun tecten en pdenmeciot it eeu one tekina en dove nacantle token one etdan maticinao, inclutina maticinao eateinct witdeut e pngocniptien eo oema Srdgo mee ettact aecd etdan'o ectien. Udio inclutao denael maticinao.

De net toke Vltemat Uealgto it eeu one tekina o tepa et maticina cellat e ‘meneeming exiteoa indiaiten' (MVO indiaiten) uoat te tnaet tapngooien.

It io penticulenle impentent tdet eeu tall eeun tecten en pdenmeciot it eeu one tekina one et tda tellewina aatena tekina Vltemat Uealgto

n etdan maticinao ten diad aleet pngooung n litdium - uoat te tnaet oema tepao et tapngooien

n maticinao cellat ‘pdanetdiezinao' oucd eo cdlenpnemezina - uoat ten mantel illncoo ent oematimao taalina ent aeina oick

n maticinao cellat ‘tniceclic entitapngooento' - uoat te tnaet tapngooien n ceuad ent celt rematiao tdet centein e tgcenaaotent n inen ent oupplamanto centeinina inen, oucd eo multivitemino witd minanelo

It eeu one net ouna it one et tda eaeve epple te eeu, telk te eeun tecten en pdenmeciot aatena tekina Vltemat Uealgto. Pregnoncy ond breosf-feediag

Yeu odeult cdack witd eeun tecten aatena tekina Vltemat Uealgto it eeu one en tdink eeu mee Il pnaanent, it eeu one plennina te tacema pnaanent en it eeu one angeot-tagtina.

Driving ond using mochines

Yeu mee teal tnewoe en Nadt-dgetat wdila tekina Vltemat Uetlato. It tdio deppano te net tniva en uoa one teelo en mecdinao.

3. HOW TO TAKE ALDOMET TABLETS

Vlweeo toke Vltemat Uetlato axectle eo eeun tecten deo telt eeu. Cdack witd eeun tecten en pdenmeciot it eeu one net ouna.

Toking fhis medicine

Yeu odeult toke tdio maticina te meutd ent axectle eo otviogt te eeun tecten en pdenmeciot. Uda emeunt eeu toke aecd tee will tapant upen eeun centitien. It io vane impentent te centinua tekina Vltemat Uetlato ten eo lena eo eeun tecten deo pngocniagt. De net toke mere en laoo tden eeun tecten deo preochtat.

Uda uouel teoao et Vltemat Uetlato one:

Adulfs

n Uda uouel otentina teoa ten tda tinot twe teeo io 250 ma twe en tdnag timao e tee. n Yeun tecten mee tden cdenaa eeun teoa tapantina en dew eeu ngopent. n Yeu odeult net toke mere tden 3000 ma in e tee.

The elderly

n Uda uouel otentina teoa will net te mere tden 250 ma aecd tee. n Yeun tecten mee tden olewle incnaeog tda teoa. n Yeu odeult net uouelle toke mere tden 2000 ma in e tee.

Children

Uda tecten will wenk eut tda numtan et tetlato. Uda teoa io teogt en tda waiadt et tda cdilt. n Uda uouel otentina teoa io 10 ma ten aecd ka et tete-wgiadt aecd tee. n Udio teoa io token in twe te teun teoao tunina tda tee. n Yeun tecten mee tden cdenaa tda teoa, tapantina en dew tda cdilt ngopento. n V cdilt will net uouelle toke mere tden 65 ma ten aecd ka (en 3000 ma e tee), wdicdavan io laoo.

If you foke more Aldnmef Toblefs fhon you should

It eeu toke tee mene tetlato te mioteka, centect eeun tecten immatietale en oaak maticel ettantien.

If you forgef fo foke Aldomef Toblefs

n It eeu tenaat te toke e teoa, juot cenne en witd tda next teoa eo nenmel. n De net toke e teutla teoa te moke up ten e tenaettan teoa.

If you sfop foking Aldomef Toblefs

De net otep tekina Vltemat Uetlato witdeut telkina te eeun tecten.

It eeu dove one tuntdan quaotieno en tda uoa et tdio pnetuct, eok eeun tecten en pdenmeciot.

Like all medicines, Aldomet Tablets can cause side effects, although not everybody gets them.

Tell your doctor as soon as possible, if you notice any of the following serious side effects such as:

•    chest pain, slow heart rate, or existing angina made worse

•    severe skin reactions (such as painful reddening, followed by blistering and peeling of layers of skin)

•    liver problems, including jaundice and hepatitis - signs include yellowing of your skin and eyes, sometimes with a fever, pale stools and dark urine

•    pain in the gut and diarrhoea caused by inflammation of the bowel (colitis)

•    severe pain in the gut and back caused by inflammation of the pancreas (pancreatitis).

The following reactions have also been reported:

Blood:

•    reduction in red blood cells (anaemia) - this can make your skin pale and make you weak or breathless

•    abnormal blood test causing symptoms such as pale skin, tiredness, fever and sore throat

•    bruising and prolonged bleeding after injury

Nervous system:

•    feeling sleepy or tired - this may happen at the start of treatment or when the dose is increased, and usually goes away

•    headache or feeling weak - this may happen at the start of treatment and usually goes away

•    pins and needles

•    being unable to move part of your face (paralysis)

•    having movements you cannot control

•    confusion

•    frequent dizziness or fainting

•    dizziness due to low blood pressure and light-headedness (particularly when standing up quickly)

Nose and chest:

•    nasal stuffiness

Stomach and gut:

•    feeling sick

•    being sick

•    abdominal pain

•    feeling bloated

•    constipation

•    excess wind

•    diarrhoea

•    dry mouth

•    sore or black tongue

Skin and hair:

•    skin rash or peeling skin

Joints and muscles:

•    painful and/or swollen joints

•    muscle pains

Infections:

•    swelling of salivary glands General:

•    water retention causing swelling and weight gain

•    fever

Sexual:

•    breast enlargement

•    breast development in men

•    loss of periods in women

•    abnormal production of milk

•    changes in sexual function such as impotence and not being able to ejaculate

•    decreased sex drive

Psychiatric:

•    mental changes, including nightmares or depression Laboratory tests:

•    your doctor may need to carry out simple blood tests during the first few months of therapy with Aldomet Tablets. Results could show:

•    a decrease in blood cell production

•    an increase in some white blood cells

•    abnormal levels of prolactin

•    Aldomet Tablets may also interfere with the interpretation of certain blood and urine tests

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE ALDOMET TABLETS

•    Keep out of the sight and reach of children

•    Do not store above 25°C. Store in the original package to protect from light.

•    Do not transfer your medicine into another container, as it might get mixed up.

•    If you have any medicine left over when your doctor tells you to stop using it, return it to the pharmacist.

•    Do not use the medicine past the expiry date, which is clearly marked on the pack.

•    If the tablets become discoloured or show any other signs of deterioration, you should ask your doctor or pharmacist who will advise you what to do.

6. FURTHER INFORMATION

What is in your medicine?

The active ingredient in Aldomet Tablets is methyldopa.

Aldomet Tablets are available as film-coated tablets, which come in two different strengths.

Each Aldomet 250mg Tablets contains methyldopa equivalent to 250mg anhydrous methyldopa. They are yellow-coloured, circular, biconvex tablets and are debossed with ‘ALDOMET' on one side and ‘250' on the reverse.

Each Aldomet 500mg Tablets contains methyldopa equivalent to 500mg anhydrous methyldopa. They are yellow -coloured, circular, biconvex tablets and are debossed with 'ALDOMET' on one side and '500' on the reverse.

Aldomet Tablets contain: cellulose powder, anhydrous citric acid, colloidal anhydrous silica, ethylcellulose, guar gum, magnesium stearate, sodium calcium edetate, hypromellose, propylene glycol. quinoline yellow aluminium lake E104, red iron oxide E172, talc, titanium dioxide (E171).

Aldomet 250mg Tablets are available in blister packs of 60.

Aldomet 500mg Tablets are available in blister packs of 30 and 60.

|POM|    PL No 15814/0897 Aldomet 250mg Tablets/ Methyldopa 250mg Tablets

PL No 15814/0898 Aldomet 500mg Tablets/ Methyldopa 500mg Tablets Who makes your medicine?

Aldomet Tablets are made by Iroko Products Limited, One Silk Street, London EC2Y 8HQ and procured from within the EU and repackaged by the Product Licence Holder OPD Laboratories Limited., Unit 6 Colonial Way, Watford, Herts WD24 4PR.

Leaflet revision and issue date (Ref.) 10.09.2013.

Aldomet is a registered trademark of Iroko Pharmaceuticals, LLC.