SIKLOS 1000 MG TABLETS - patient leaflet, side effects, dosage

Siklos-IOOOmg

filmovertrukket tablet – Hydroxycarbamid

Les den ne indlegsseddel grundigt, inden De begynder at tage medicinen.

• Gem indlegssedlen. De kan fS brug for at l ese den igen.
• Sp0rg legen, apoteketspersonalet eller sygeplejersken, hvis der er mere, De vil vide
• Legen har ordineret Siklos til Dem personligt. Lad derfor vere med at give medicinen til andre. Det kan vere skadeligt for andre, selvom de har de samme symptomer, som De har.
• Tal med legen, apotekspersonalet eller sygeplersken, hvis De fSr bivirkninger, som ikkeer nevnt i denne indlegsseddel. Se afsnit4.

— Oversigt over indlegssedlen:

• 1. Virkning og anvendelse

• 2. Det skal De vide, f0r De begynder at tage Siklos

• 3. SSdan skal De tage Siklos

• 4. Bivirkninger

• 5. Opbevaring

• 6. Pakningsst0rrel­ser og yderligere oplysninger

• 1.VIRKNING OG ANVENDELSE

Siklos bruges til at forebygge smertefulde kriser, der skyldes seglcellesygdom, sSsom pludselige brystsmerter, hos voksne, unge og b0rn, der er eldre end 2 Sr.

Seglcellesygdom er en arvelig blodlidelse, der pSvirker de runde, r0de blodlegemer i blodet. Nogle celler bliver unormale, stive og fSr halvmSne-eller seglfacon, hvilket f0rer til anemi. Seglcellerne setter sig endvidere fast i blodkarrene og blokerer blodgennemstr0mnin­gen. Dette kan medf0re akutte smertefulde kriser og beskadige organerne.

I de mest alvorlige kriser skal de fleste patienter hospitalsindlegges. Siklos nedsetter antallet af smertefulde kriser og behovet for indleggelse i forbindelse med sygdommen.

Det aktive stof i Siklos, hydroxycarbamid, er et stof, som hemmer veksten og formeringen af visse celler sSsom blodlegemer. Disse virkninger f0rer til en reduktion af cirkulerende r0de og hvide blodlegemer samt blodplader (en hemning af knoglemarven). Ved seglcellesygdom er hydroxycarbamid med til at forhindre, at de r0de blodlegemer fSr en unormal form.

• 2. DET SKAL DE VIDE, F0R DE BEGYNDER AT TAGE SIKLOS

• hvis De er overf0lsom over for hydroxycarbamid eller et af de 0vrige indholdsstoffer i dette legemiddel (se afsnit 6),
• hvis De lider af alvorlig leversygdom,
• hvis De lider af alvorlig nyresygdom,
• hvis De har nedsat produktion af r0de, hvide eller koagulerende blodlegemer som beskrevet i afsnittet 3 “SSdan skal De tage Siklos”, Behandlingsop­f0lgning",
• hvis De ammer (se afsnittet “Graviditet, amning og frugtbarhed”).

— Advarsler og forsigtighedsre­gler

Kontakt legen, apoteket eller sundhedspersonalet, f0r De tager Siklos

• hvis De har en leversygdom,
• hvis De har en nyresygdom,
• hvis De har bensSr,
• hvis De tager anden medicin, som nedsetter produktionen af r0de, hvide eller koagulerende blodlegemer, eller hvis De fSr strSlebehandling,
• hvis De ved, at De lider af vitamin B-mangel eller folinsyremangel.

Giv Deres lege besked, hvis St eller flere af ovenstSende punkter g0r sig geldende (eller har gjort sig geldende) for Dem. Sp0rg legen, apoteket eller sundhedspersonalet, hvis der er mere, De vil vide.

Patienterne og/eller foreldrene eller den juridisk ansvarlige person skal vere i stand til at f0lge anvisningerne vedr0rende indgivelse af dette legemiddel samt overvSgningen og plejen af patienterne.

— Brug af anden medicin sammen med Siklos

Fortel det altid til legen eller apotekspersonalet, hvis De tager anden medicin, for nylig har taget anden medicin eller planlegger at tage anden medicin.

Udveksling af oplysninger er specielt n0dvendig for

• visse antiretrovirale legemidler (midler, som hemmer eller 0delegger en retrovirus sSsom HIV), fx didanosin, stavudin og indinavir (der kan opstS et fald i de hvide blodlegemer),
• legem idler, der hemmer knoglemarvens blodcelle-dannende effekt (nedsetter produktionen af r0de, hvide eller koagulerende blodlegemer) og strSlebehandling,
• visse vacciner.

— Graviditet, amning og frugtbarhed

Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlegger at blive gravid, skal De sp0rge Deres lege eller apotekspersonalet til rSds, f0r De tager dette legemiddel.

Siklos b0r ikke anvendes under graviditet. Kontakt 0jeblikkeligt din lege, hvis De har mistanke om, at De er gravid.

Anvendelse af effektiv antikonception anbefales pS det kraftigste.

Hvis De bliver gravid eller planlegger at blive gravid, mens De tager Siklos, vil Deres lege tale med Dem om de potentielle fordele og risici ved at fortsette med at tage Siklos.

For mandlige patienter, der tager Siklos: Hvis Deres partner bliver gravid eller planlegger at blive gravid, vil Deres lege tale med Dem om de potentielle fordele og risici ved at fortsette med at tage Siklos.

Det aktive stof i Siklos passerer ind i menneskets modermelk. De mS ikke amme, mens De tager Siklos.

Hydroxycarbamid kan nedsette sedproduktionen hos mandlige patienter, mens de bliver behandlet.

— Trafik- og arbejdssikkerhed

Nogle personer kan opleve svimmelhed, nSr De tager Siklos. De mS ikke k0re bil eller arbejde med verktq eller maskiner, hvis De oplever svimmelhed, mens De tager Siklos.

3.SADAN skal de tage siklos

Tag altid Siklos n0jagtigt efter legens anvisning. Er De i tvivl, sS sp0rg legen eller apotekspersonalet.

— Doseringer

Deres lege vil fortelle Dem, hvor meget Siklos De skal tage hver dag og angive doseringen i hele, halve eller kvarte tabletter.

Den ordinerede dosis af Siklos skal tages Sn gang om dagen – helst om morgenen inden morgenmaden.

Medicinen kan tages sammen med et glas vand eller en meget lille portion mad.

Hvis De ikke kan sluge tabletterne, kan De opl0se dem i vand umiddelbart inden brug:

• Placer den 0nskede dosis (helst brudt, hvis Siklos 1 000 mg tabletten anvendes) i en teske og tilf0r lidtvand.
• SS snart tabletten er opl0st, synkes teskeens indhold. De kan komme en drSbe sirup i indholdet eller blande indholdet med mad for at skjule en mulig bitter smag.
• Drik derefter et stort glas vand eller anden veske.

— HSndtering

Siklos er et cytotoksisk legemiddel, som skal hSndteres med forsigtighed.

Alle personer, som ikke bruger Siklos, herunder iser gravide kvinder, skal undgS at komme i direkte kontakt med medicinens dele, nSr en tablet brekkes over. Vask hender inden og efter bearing af tabletterne.

Hvis den ordinerede dosis krever, at tabletten deles i halve eller kvarte, skal dette g0res vek fra madvarer. Pulver, der spildes fra den brudte tablet, skal t0rres op med en fugtig engangsklud, som efterf0lgende kasseres. Se afsnittet "Opbevaring” vedr0rende opbevaring af ubrugte, brudte tabletter, se afsnit 5 "Opbevaring”.

• — Behandlingsop­f0lgning

Deres l ege vil fortelle Dem, hvor l enge De skal tage Siklos.

NSr De tager Siklos, vil De regelmessigt fS taget blodprover og fS kontrolleret Deres lever og nyrer. Disse pr0ver vil blive gennemf0rt hver eller hver anden mSned afhengigt af den dosis, De tager.

Deres l ege vil justere Deres dosis af Siklos afhengigt af disse resultater.

• — Hvis De har taget for meget Siklos

Hvis De tager mere Siklos, end De b0r, eller hvis et barn har taget noget af medicinen, skal De straks kontakte Deres lege eller det nermeste hospital, da der kan vere behov for akut behandling. De mest almindelige symptomer pS overdosering med Siklos er:

• R0dmen af huden,
• 0mhed (ber0ring g0r ondt) og hevelse i hSndfladerne og pS fodsSlerne, hvorefter der kommer skel pS hender og f0dder,
• Huden bliver kraftigt farvet (lokale pigmenteret),
• 0mhed eller hevelse i munden.

— Hvis De har glemt at tage Siklos

De mS ikke tage en dobbeltdosis som erstatning for den glemte tablet. Fortset som ellers, nSr det er tid at tage den neste dosis, som Deres lege har ordineret det.

— Hvis De holder op med at tage Siklos

De mS ikke standse Deres behandling, medmindre Deres lege har rSdet Dem til det.

Sp0rg legen eller apotekspersonalet, hvis der er noget, De er i tvivl om, eller f0ler Dem usikker pS.

4.BIVIRKNINGER

Dette legemiddel kan som al anden medicin give bivirkninger, men ikke alle fSr bivirkninger.

Fortel det straks til Deres lege, hvis De oplever en eller flere af f0lgende alvorlige bivirkninger:

• En alvorlig infektion,
• Trethed og/eller bleghed,
• Uforklarlige blS merker (samling af blod under huden) eller bl0dning,
• Usedvanlig hovedpine,
• Problemer med at trekke vejret.
• Feber eller kulderystelser,
• De har kvalme eller en generel f0lelse af utilpashed,
• Kl0ende r0de udbrud i huden (udslet),
• SSr pS benene,
• 0mhed i huden (Sben hudinfektion),
• Desorientering (forvirring) og svimmelhed.

• ■ ANGIVELSE AF BIVIRKNINGER

— Meget almindelige bivirkninger (kan pSvirke flere end 1 ud af 10 brugere):

Lave blodlegemetellin­ger, forst0rrelse af r0de blodlegemer.

Mangel pS spermatozoer eller nedsat mengde spermatozoer i seden (azoospermia eller oligozoospermia). Siklos kan dermed nedsette mends evne til at fS b0rn.

— Almindelige bivirkninger (kan pSvirke op til 1 ud af 10 brugere):

Reduceret antal r0de blodlegemer (anemi), lave bl od pla detell in ger, hovedpine, hudreaktioner, betendelse eller sSrdannelse i munden (oral mucositis).

— Ikke almindelige bivirkninger (kan pSvirke op til 1 ud af 100 brugere):

Svimmelhed, kvalme, kl0ende r0de udbrud i huden (udslet), sortfarvning af neglene (melanonychia), og hSrtab.

— Sjeldne bivirkninger (kan pSvirke op til 1 ud af 1 000 brugere): BensSr, endret leverfunktion.

— Meget sjeldne bivirkninger (kan pSvirke op til 1 ud af 10 000 brugere) eller bivirkninger af ukendt hyppighed (hyppigheden kan ikke estimeres ud fra forhSndenverende data):

Hudbetendelse, der giver r0de afskallende pletter, evt. sammen med ledsmerter.

Enkelte tilfelde af ondartet sygdom i blodlegemerne (leukemi), hudkreft hos eldre patienter, bl0dning, forstyrrelser i mave-tarm-kanalen, opkastning, hudt0rhed, feber, udeblevne menstruationscyklus-ser (amenorrS) samt vegt0gning.

— Indberetning af bivirkninger

Hvis De oplever bivirkninger, b0r De tale med Deres lege, apotekspersonalet eller sygeplejersken. Dette gelder ogsS mulige bivirkninger, som ikke er medtaget i denne indlegsseddel. De eller Deres pSr0rende kan ogsS indberette bivirkninger direkte til Legemiddelstyrelsen via det nationale rapporteringssys­tem: Legemiddelstyrelsen Axel Heides Gade 1

DK-2300 K0benhavn S

Websted:

Ved at indrapportere bivirkninger kan De hjelpe med at fremskaffe mere information om sikkerheden af dette legemiddel.

5.OPBEVARING

Opbevar dette legemiddel utilgengeligt for b0rn.

Brug ikke Siklos efter den udl0bsdato, der stSr pS esken og tabletbeholderen efter EXP.

Opbevares ved temperaturer under 30 °C.

Ubrugte, brudte tabletter skal legges tilbage i flasken og skal bruges inden for 3 mSneder.

Sp0rg apotekspersonalet, hvordan De skal bortskaffe medicinrester. Af hensyn til milj0etmS De ikke smide medicinrester i afl0bet, toiletteteller skraldespanden.

6. PAKNINGSST0RREL­SER OG YDERLIGERE OPLYSNINGER

— Siklos indeholder

• Aktivt stof: hydroxycarbamid.

Hver filmovertrukne Siklos 100 mg tablet indeholder 100 mg hydroxycarbamid.

Hver film over trukne Siklos 1 000 mg tablet indeholder 1 000 mg hydroxycarbamid.

• 0vrige indholdsstoffer: Natriumstearyl­fumarat, silicificeret mikrokrystal-linsk cellulose og grundbutyleret methacrylatco­polymer.

• — Udseende og pakningsst0rrelser

Siklos 100 mg filmovertrukne tabletter er rShvide, aflange tabletter med en delekerv pS begge sider.Tabletten kan deles i to lige store dele. Hver halve tablet er preget med ”H” pS den ene side.

Siklos 100 mg leveres i plastikflasker, der indeholder 60, 90 eller 120 tabletter.

Siklos 1 000 mg filmovertrukne tabletter er rShvide, kapselformede tabletter med tre delekerve pS begge sider. Tabletten kan deles i fire lige store dele.

Hver kvarte tablet er preget med “T” pS den ene side.

Siklos 1 000 mg leveres i flasker med 30 tabletter.

Ikke alle pakningsst0rrelser er n0dvendigvis markedsf0rt.

• — Indehaver af markedsf0ringsti­lladelsen Addmedica

37 rue de Caumartin

75009 Paris

Frankrig

— Fremstiller

Delpharm Lille

Parc d’ActivitSs Roubaix-Est

• 22 rue de Toufflers

CS 50070

59452 Lys-lez-Lannoy

Frankrig

Denne indlegsseddel blev senest revideret d. 08/2021.

De kan finde yderligere yderligere om Siklos pS Det Europeiske Legemiddelagenturs hjemmeside.

Der er ogsS links til andre websteder om sjeldne sygdomme og om, hvordan de behandles.

English

PACKAGE LEAFLET: INFORMATION FOR THE USER

• SIH S- 50 mg ®

film-coated tablet – hydroxycarbamide

Siklos*

film-coated tablet – hydroxycarbamide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

• 1. What Siklos is and what it is used for

• 2. What you need to know before you take Siklos

• 3. How to take Siklos

• 4. Possible side effects

• 5. How to store Siklos

• 6. Contents of the pack and other information

1.what siklos is and what it is used for

Siklos is used to prevent painful crises, including sudden chest pain, caused by sickle cell disease, in adults, adolescents and children older than 2 years.

Sickle cell disease is an inherited blood disorder that affects the disc shaped red cells of the blood.

Some cells become abnormal, rigid and take a crescent or sickle shape which leads to anemia.

The sickle cells also get stuck in blood vessels, blocking blood flow. This can cause acute pain crises and organ damage.

For severe painful crises, most patients require hospitalisation. Siklos will decrease the number of painful crises as well as the need for hospitalisation linked with the disease.

The active substance of Siklos, hydroxycarbamide, is a substance which inhibits growth and proliferation of some cells, such as blood cells. These effects lead to a reduction of circulating red, white and coagulation blood cells (myelosuppressive effect). In sickle cell disease, hydroxycarbamide helps also to prevent red blood cells from taking abnormal shape.

2.what you need to know before you take siklos

— Do not take Siklos

• if you are allergic to hydroxycarbamide or any of the other ingredients of this medicine (listed in section 6),
• if you suffer from severe liver disease,
• if you suffer from severe kidney disease,
• if you are myelosuppressed (if you have decreased production of red, white, or coagulating blood cells) as described in section 3 “How to take Siklos, Treatment follow-up”,
• if you are breast-feeding (see section “Pregnancy, breast-feeding and fertility”).

— Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Siklos

• if you have a liver disease,
• if you have a kidney disease,
• if you have leg ulcers,
• if you are taking other myelosuppressive medicines (decrease production of red, white, or coagulating blood cells) or receiving radiation therapy,
• if you have a known lack of vitamin B or folate.

If you experience (or have experienced) any of the above, please tell your doctor. If you have any question, please ask your doctor or pharmacist or nurse.

Patients and/or parents or the legal responsible person must be able to follow directions regarding the administration of this medicine, their monitoring and care.

— Other medicines and Siklos

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Information sharing is especially required for

• some antiretroviral medicines (those that inhibit or destroy a retrovirus such as HIV), e.g. didanosine, stavudine and indinavir (a drop in your white cell count may occur),
• myelosuppressive medicines (those that decrease production of red, white, or coagulating blood cells) and radiation therapy,
• some vaccines.

— Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Siklos is not recommended during pregnancy. Please contact your doctor immediately if you think you may be pregnant. The use of effective contraception is strongly recommended.

If you become pregnant or plan to become pregnant while taking Siklos, your doctor will discuss with you the potential benefits and risks of continuing using Siklos.

For male patients taking Siklos, if your partner becomes pregnant or plans to become pregnant, your doctor will discuss with you the potential benefits and risks of continuing using Siklos.

The active substance of Siklos passes into human breast-milk. You must not breast-feed while taking Siklos.

Hydroxycarbamide may decrease sperm production in male patients while they are being treated.

— Driving and using machines

Some people may experience dizziness when using Siklos. Do not drive or use any tools or machines if you experience dizziness whilst taking Siklos.

3.HOW TO TAKE SIKLOS

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

— Dose

Your doctor will tell you how much of Siklos to take each day and will describe the dose in whole, half or quarter tablets.

The prescribed dose of Siklos must be taken once daily, preferably in the morning before breakfast.

It can be taken with a glass of water or a very small amount of food.

If you cannot swallow the tablets, you can disintegrate them in water immediately before use:

• Place the required dose (preferably broken if Siklos 1 000 mg tablet is used) in a teaspoon and add some water.
• As soon as the tablet is disintegrated, swallow the content of the teaspoon. You can add a drop of syrup or mix the content with food to mask a possible bitter taste.
• Then drink a large glass of water or any other drink.

— Handling

Siklos is a cytotoxic medicine that must be handled with care.

Any person, in particular pregnant women, who are not taking Siklos should avoid direct contact with the parts when breaking a tablet. Wash your hands before and after contact with the tablets.

In case the prescribed dose requires breaking the tablet in halves or quarters, this should be done out of the reach of food. Powder spilled from the broken tablet should be wiped up with a damp disposable towel which must be thrown out. For the storage of unused broken tablets, see section 5 “How to store Siklos”.

— Treatment follow-up

Your doctor will tell you how long to take Siklos.

When taking Siklos you will have regular blood tests and check your liver and kidney. Depending on the dose you take, these tests may be performed monthly or every two months.

Depending on these results your doctor will adjust your dose of Siklos.

If you take more Siklos than you should

If you take more Siklos than you should or if a child has taken any, contact your doctor or the nearest hospital immediately as you may need urgent medical treatment. The most common symptoms of overdose with Siklos are:

• Redness of the skin,
• Soreness (touch is painful) and swelling of the palms of hands and soles of feet followed by the hands and feet becoming scaly,
• Skin becoming strongly pigmented (locally changes of colour),
• Soreness or swelling in the mouth.

— If you forget to take Siklos

Do not take a double dose to make up for a forgotten tablet. Continue as normal when it is time to take the next dose as prescribed by your doctor.

— If you stop taking Siklos

Do not stop your treatment unless advised by your doctor.

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

4. possible side effects

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

Tell your doctor immediately if you notice any of the following serious side effects:

• A severe infection,
• Tiredness and/or looking pale,
• Unexplained bruising (accumulation of blood under the skin) or bleeding,
• Unusual headache,
• Difficulties in breathing.

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

• Fever or chills,
• Feeling sick, or a general feeling of being unwell,
• Rash (itching red eruption of the skin),
• Ulcers or wounds on your legs,
• Sore (open skin infection) on your skin,
• Disorientation (confusion) and dizziness.

■ DETAILS OF SIDE EFFECTS

— Very common side effects (may affect more than 1 in 10 people):

Low blood cell counts (myelosuppression), enlargement of red blood cells,

Absence or low amount of sperm in the semen (azoospermia or oligospermia). Siklos may hence decrease the ability of men to father children.

— Common side effects (may affect up to 1 in 10 people):

Reduced number of red blood cells (anaemia), low platelet count, headache, skin reactions, inflammation or ulceration of the mouth (oral mucositis).

— Uncommon side effects (may affect up to 1 in 100 people):

Dizziness, nausea, itching red eruption of the skin (rash), black nails (melanonychia), and hair loss.

— Rare side effects (may affect up to 1 in 1 000 people):

Wounds on the legs (leg ulcers), and modification of liver function.

— Very rare side effects (may affect up to 1 in 10 000 people) or unknown frequency (frequency cannot be estimated from the available data):

Inflammation of the skin causing red scaly patches and possibly occurring together with pain in the joints.

Isolated cases of malignant disease of blood cells (leukaemia), skin cancer in elderly patients, bleeding, gastrointestinal disturbances, vomiting, skin dryness, fever, absence of menstrual cycles (amenor-rhoea), and weight gain.

— Reporting of side effects

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

You can also report side effects directly via the national reporting system:

Ireland

HPRA Pharmacovigilance. Website:

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

5. how to store siklos

Keep this medicine out of the sight and reach of children.

Do not use Siklos after the expiry date which is stated on the carton and the bottle after EXP.

Store below 30°C.

Unused broken tablets must be replaced in the bottle and must be used within three months.

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 to protect the environment.

6. contents of the pack and other information

— What Siklos contains

• The active substance is hydroxycarbamide.

Each Siklos 100 mg film-coated tablet contains 100 mg hydroxycarbamide.

Each Siklos 1 000 mg film-coated tablet contains 1 000 mg hydroxycarbamide.

• The other ingredients are sodium stearyl fumarate, silicified microcrystalline cellulose and basic butylated methacrylate copolymer.

— What Siklos looks like and contents of the pack

Siklos 100 mg film-coated tablets are off-white, oblong-shaped tablets with a break line on both sides. The tablet can be divided into two equal parts.

Each half of tablet is embossed “H” on one side.

Siklos 100 mg is supplied in plastic bottles containing 60, 90 or 120 tablets.

Siklos 1 000 mg film-coated tablets are off-white, capsule-shaped tablets marked with three score lines on both sides. The tablet can be divided into four equal parts.

Each quarter of tablet is embossed “T” on one side.

Siklos 1 000 mg is supplied in plastic bottles containing 30 tablets.

All pack sizes may not be marketed.

— Marketing Authorisation Holder

Addmedica

37 rue de Caumartin

75009 Paris

France

— Manufacturer

Delpharm Lille

Parc d’Activites Roubaix-Est

• 22 rue de Toufflers

CS50070

59452 Lys-lez-Lannoy

France

This leaflet was last revised in 08/2021.

Detailed information on this medicine is available on the European Medicines Agency website. There are also links to other websites about rare diseases and treatments.

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Siklos* 1000mg

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• Eav sxsts nspaitspu anopi'sp putfots to Yiatpo, f tov 'papppKonoio f tov voooKopo oat.
• H ouvtaYf Yi’ auto to pappaKo xopnYfPnKs anoKXsiotiKa Yia oat. Asv npsnsi va Suosts to pappaKo os aXXout. Mnopsi' va tout npoKaXsosi pXapn, aKopa Kai otav ta onpsta tnt aoPsvsiat tout swai ^Sla ps ta SiKa oat.
• Eav napatnpfosts Kanoia avsniPupntn svspYsia, svnpspuots tov Yiatpo, f tov pappaKonoio f tov voooKopo oat. Auto ioxusi Kai Yia KaPs niPavf avsniPupntn svspYsia nou Ssv avapspstai oto napov puXXo oSnYiuv xpfont. BXsns napaYpapo 4.

• 1. Ti swai to Siklos Kai noia si'voi n xpfon tou

• 2. Ti npsnsi va Yvupi'Zsts npiv napsts to Siklos

• 3. nut va napsts to Siklos

• 4. niPavst avsniPupntst svspYsist

• 5. nut va puXaoosts to Siklos

• 6. nspisxopsva tnt ouoKsuaotat Kai Xoinst nxnpopopi'st.

• 1. TI EINAI TO SIKLOS KAI nOIA EINAI H XPHZH TOY

To Siklos xpno'ponoisi'tai Yia tnv npoXn®n snuSuvuv Kpi'osuv, oupnspiXappavopsvou oipvi'Siou novou oto Pupa Ka, nou npoKaXouvtai ano SpsnavoKuttapiKo ouvSpopo, os naiSia nx'Kiat psYaXutspnt tuv 2 stuv, svfXiKst Kai spnpoup

H SpsnavoKuttapiKf vooot staai pita KXnpovopiKf Siatapaxf tou a^paTot nou nXfttsi ta SiOKosiSf spuPpa alpoopa^pla. Opiopsva spuPpa aipoopai'pia KaPtatavtai naPoXoYiKa, OKXnpa Kai na'pvouv pnvosiSst oxfpa f to oxfpa Spsnaviou, YsYovot nou oSnYsi' os avaq^a. Ta spuPpa aipoopai'pia os oxfpa Spsnaviou KoXXavs ota aipopopa a/psi'a Kai pnXoKapouv tn pof tou ai'patop Auto pnopsi' va npoKaXsosi Kposit o?so< novou Kai pXapn opYavou.

Itit nspintuosit svtovuv snuSuvuv Kpi'osuv, oi nspioootspoi aoPsvsta npsnsi va voonXsuovtai.

To Siklos Pa psiuosi tov apiPpo tuv snuSuvuv Kptasuv KaPut Kai tnv avaYKn voonXstat Xoyu tnt aoPsvsiat.

H SpaotiKf ouo^a tou Siklos,n uSpoSuKappap^Sn, swai pia ouo^a n onota avaotsXXsi tnv avantuSn Kai tov noXXanXaoiaopo pspiKuv Kuttapuv, onut ta aipoopai'pia. Autst oi sniSpaosit oSnYouv os psuon tuv KuKXopopouvtuv spuPpuv, XsuKuv Kai aipoopaipwv nfSnt (pusXoKataotaXtiKo anotsXsopa). Itn SpsnavoKuttapiKf vooo, n uSpoSuKappap^Sn ponPa, sni'ont, otnv npoXn®n tnt napapoppuont tuv spuPpuv aipoopaipwv.

• 2. TI nPEnEI NA FNOPIZETE nPIN nAPETE TO SIKLOS

— Mqv ndpcTE to Siklos

• os nsptntuon PAAspYi'at otnv uSpoPuKPppapi'Sn f os onoioSfnots aXXo ouotatiKo autou tou pappaKou (avapspovtai otnv napaYpapo 6),
• os nspi'ntuon nou naoxsts ano oopapf nnatiKf vooo,
• os nspi'ntuon nou naoxsts ano oopapf vsppiKf vooo,
• os nspi'ntuon nou sots os pusXoKataotoXf (sav sxsts psiupsvn napaYuYf spuPpuv, XsuKuv f aipoopaipuv nfpnt) onut nspiYpapstai otnv napaYpapo 3 «nut va napsts to Siklos, napaKoXouPnon Pspans^at»,
• os ns.pi'ntuon nou PnXaZsts (pX. napaYpapo “Kunon PnXaopot Kai Yovipotnta”).

— nposiSonoifosic Kai npo^uAd^ctc

AnsuPuvPs^ts otov Yiatpo f tov pappaKonoio f tov voooKopo oat npiv napsts to Siklos

• sav naoxsts ano nnatiKf vooo,
• sav naoxsts ano vsppiKf vooo,
• sav sxsts sXKn ota Katu aKpa,
• sav npi'pvs.ts. aXXa pusXoKaTaotaXtiKa pappaKsutiKa npoiovta (psiupsvn napaYuYf spuPpuv, XsuKuv f aipoopaipi'uv nfpnt) f sav Xappavsts ok tuoPspans^a,
• sav sxsts Yvuotf sXXsiⁿ p'tap^vnt B12 f puXXiKou opsot.

Eav sppavosts (f sxsts sppav^osi) onoioSfnots ano ta oupntupata auta, napaKaXoups svnpspuots tov Yiatpo oat. Eav sxsts Kanoia sputnon, napaKaXoups ansuPuvPs^ts otov Yiatpo oat f tov pappaKonoio oat f tov voooKopo oat.

Oi aoPsvsh; Kai/f Yovsu't f to vopiKa unsuPuvo atopo npsnsi va s^vpi os Pson va aKoXouPfoouv tit oSnY^st oxstiKa ps tn xopfYnon autou tou pappaKsutiKou npoiovtot, tnv napaKoXouPnon Kai tn ppovnSa tuv aoPsvuv.

— AAAa ^dppaKa Kai Siklos

napaKaXoups svnpspuots tov Yiatpo f tov pappaKonoio oat, sav Xappavsts, sxsts npoopata Xapsi f pnopsj va Xapsts Kanoio aXXo pappaKo.

H avtaXXaYf nXnpopopiuv iSioj'tspo. anaitsj'tpi Yia

• opiopsva avtipstpoi'Ka pappaKa (s.ksj'vp nou avaotsXXouv f Kataotpspouv sva pstpoio onut o HIV), n.x. SiSavooi'vn, otapouSNn Kai lvSlvap^pn (svSsxstai va sppavlOTs^ pia ntuon otov apiPpo tuv XsuKuv pipooppipi'uv),
• pusXoKaTaotaXtiKa pappaKa (psiupsvn napaYuYf spuPpuv, XsuKuv f aipoopaipi'uv nfpnt) Kai PKtivoPspans^a,
• pspiKa sppoXia.

— KOqaq, SqAaopOc Kai YovipOTqTa

Eav swts sYKuot f PnXaZsts, vop^ZsTs oti pnopsj' va stats sYKuot f oxsSiaZsts va anoKtfosts naiSL Zntfots tn ouppouXf tou Yiatpou npiv napsts auto to pappaKo.

To Siklos Ss ouviotatai Kata tn SiapKsia tnt Kunont.

napaKaXu svnpspuots apsout tov Yiatpo oat sav unapxsi niPavotnta va spots. sYKuot.

H xpfon anotsXsopatiKft avtiouXXn^nt ouviotatai iSip^tspa.

Eav pstasts sYKuot f OKonsusts va pstasts sYKuot svu nu'pvs.ts. to Siklos, o Yiatpot oat Pa ouZntfosi paZ^ oat ta niPava opsXn Kai tout KivSuvout tnt ouvsxiont tnt Pspans^Pt ps to Siklos.

ria tout appsvst aoPsvsta sav n ouvtpopot oat ps^si sYKuot f OKonsusi va pstasi sYKuot, o Yiatpot oat Pa ouZntfosi paZ^ oat ta niPava opsXn Kai tout KivSuvout tnt ouvsxiont tnt Pspans^at ps to Siklos.

H SpaotiKf ouo^a tou Siklos nspva otov avPpunivo YaXa ps to PnXaopo. Asv Pa npsnsi va PnXaZsts svu nppvsts to Siklos.

H uSpofuKsjppsjpi'Sn pnopsi' va psiuosi tnv napaYuYf onsppatot otout appsvst aoPsvsta svu ppOKovtai uno Pspans^a

— OSnYnaq Kai xapia^Oc pnxavqpdtuv

Kanoioi avPpunoi sppsjvi'Zouv ZaXn Kata tn Pf'pn tou Siklos. Mnv oSnYsi'ts f pn xpnoiponoisi'ts spYaXsta f pnxavfpata, sav viuosts ZaXn svu nppvsts to Siklos.

• 3. nnz NA nAPETE TO SIKLOS

navtots va nu'pvsts to Siklos auotnpa ouppuva ps tit oSn'Y'st tou Yiatpou oat. Eav sxsts appipoji'st, putfots tov Yiatpo f tov pappaKonoio oat.

— AoaoAoY^a

O YiaTpOc 0a aac nci nOao Siklos npSnsi va ^a^pvsTS Kd9s nff^pa Kai 0a op^asl Tn 6Oon as oAOKAnpa, piiad Siataa n TfrapTo Tou Siataou.

H ouvtaYoYpapnpsvn Soon tou Siklos npsnsi va Xappavstai p^a popa tnv npspa, Kata npoti'pnon to npu', npiv ano to npuivo.

iMnopsi' va XnpPs^ ps sva notfpi vspo f ps noXu piKpf noootnta tpopft.

Eav Ssv pnopsi'ts va Katpnuj'ts ta Siotaa, pnopsi'ts va ta SiaXuosts os vspo apiSaoic npiv anO Tn Xpnan:

• TonoPstfots tnv anaitoupsvn Soon (Kata npoti'pnon os Koppatia sav xpnoiponoisi'tpi SiOKto Siklos 1 000 mg) os sva KoutaXaKi toaYiou Kai npooPsots p^yo vspo.
• MoXit to Siok^o SuAuPsi', Ksjtpnisi'ts to nspisxopsvo tou KoutaXiou. iMnopsi'ts va npooPsosts p^a otaYova oiponi f va avaps^sts to nspisxopsvo ps tpopf uots va sniKPA.upPs^ n niPavf niKpf Ysuon.
• Itn ouvsxsia nisi'ts sva psYaXo notfpi vspo f onoioSfnots aXXo popnpa.

— XsipiapO

• To Siklos staai sva KuttapotoSiKo pappaKo to onoio Pa npsnsi va xsip^Zstpi Ksjvsj't ps npoooxf.
• Atopa, Kai iSioj'tspo. sYKust Yuv<u'Kst, nou Ss Xappavouv to Siklos Pa npsnsi va anopsuYouv va spxovtai os apson snapf ps ta pspn svot Siotaou, otav Ytastai n Ppauon tou. nXsvsts ta xspia oat npiv Kai psta tnv snapf ps ta Siotaa.
• Is nsptntuon nou n ouvtaYoYpapnpsvn Soooaoyip anpits^ Ppauon tou Siokou ota Suo f ota tsoospa, auto Pa npsnsi va Yi'vstpi paKpia ano tpopst. iKovn nou sxsi xuPs^ ano to Siaipspsvo Sipk^o Pa npsnsi va OKouni'Zstpi ps sva sXapput uYpo pavtiXaKi p^at xpfont, to onoYj otn ouvsxsia anoppfrtstai. ria tov tpono puXaSnt tuv pn xpnoiponoinpsvuv, Siaipspsvuv SiOKi'uv, avatpspts otnv svotnta 5 «nut Na OuXaoostai to Siklos».

— napaKoAoO0nan 0spansIac

• H SiapKsia tnt Pspsjnsjpt sjnotspsj' suPuvn tou Pspanovta Yiatpou oat.

OTav ^a^pve^c to Siklos, 0a unopdAAcaTC as auxvSc c^erdacic a^Toc Kai 6oKi|ja^sc nnariKfjc Kai vappiKfjc AsiroupY^. AvdAoYa ps rn SOan nou ^a^pve^s, aurSc oi s^srdasic 0a npSnsi va sKTsAoOvrai K<®s pnva n Kd3s S0o pqvsc.

• Ms paon ta anotsXsopata, o Yiatpot oat Pa puPp^Zsl tn Soon tou Siklos.

— Edv ndpsrs psYaAOrspn SOan Siklos anO Tnv KavoviKf

• Eav napsts nspioootspo Siklos ano to kovoviko f av napsi sva npiS^ to pappaKo, sniKOivuvfots apsout ps tov Yiatpo oat f to nXnoisotspo voooKopsi'o Sioti svSsxstai va xpsiaZsots snsiYovtut pappaKsutiKf aYuYf. Ta nio ouxva oupntupata unspSoooAOYiat ps Siklos s^val:
• KoKKtaiopa tou Ssppatot,
• novot (to aYYiYpa sj'vpi oSuvnpo) Kai oi'Snpsj otit naXapst tuv xspiuv Kai otit natouost tuv noSiuv Kai otn ouvsxsia ta xspia Kai ta noSia nu'pvouv poXiSuSn sppavion,
• To Ssppa napouoiaZsi svtovn xpuon (toniKst aXXaYst xpupatot), novot f o^Snpa oto otopa.

Mnv napsts SinXf Soon Yia va avanXnpuosts to SipkO nou psxaoats. luvsx^ots KavoviKa otav s^vpi upa va napsts tnv snopsvn Soon onut avapspstai otn ouvtaYf tou Yiatpou oat.

— Edv aTapiaTifasTs va na^vsrs to Siklos

Mnv otapatfosts tn Pspans^a oat sKtot Kai av oat to ouotfosi o Yiatpot oat.

Eav sxsts nspioootspst sputfosit oxstiKa ps tn xpfon autou tou npoiovtot, putfots tov Yiatpo f tov pappaKonoio oat.

• 4. nIQANEZ ANEnIQYMHTEZ ENEPFEIEZ

Onut oXa ta pappaKa, stoi Kai to Siklos pnopsi' va npoKaXsosi avsniPupntst svspYsist av Kai Ssv napouoiaZovtai os oXout tout avPpunout.

— Evnpsptaars apSaoc rov YiarpO aac, av napouaidasrs Kdnoia anO Tic napaKdto aopapSc avsni0Opnrsc svSpYsisc :

• lopapf Aoi'puSn,
• Konuon f/Kai uxpotnta,
• AvspfYntout puXunst (ouooupsuon sji'pptot Katu ano to Ssppa) f alpoppaY^a,
• AouvfPiotn KspaXaXyia,
• AuoKoX^st otnv avanvof.

— Evnpsptaars to YiarpO aac to auvropOrspo SuvarOv, sdv naparnpfacrs onoiaSfnoTs anO Tic aKOAou0sc avsni0Opnrsc svSpYsisc:

• nupsto f p^Yn,
• AtaPnpa aSiaPsotat f ysviko ataPnpa aSiaPsotap
• ESavPnpa (kokkivo spavPnpa tou Ssppatot ps Kvnopo),
• 'EXKn f nXnYst ota Katu aKpa oat,
• novo (Ao^punn avoixtou Ssppatot) otov Ssppa oat,
• AnonpooavatoXiopot (ouYxuon) Kai ZaXn.

■ AEnTOMEPEIEZ HA TIZ ANEnIQYMHTEZ ENEPrEIEZ

— noAO auxvSc avsni0Opnrsc svSpYsisc (p^ops^ va auppouv as nspiaaOrepa anO 1 ara 10 dropa):

XapnXst tipst aipooptjipi'uv (pusXoKataotoXf), SioYKuon tuv spuPpuv aipoopaipuv.

Anououj f xapnXf noootnta onsppptoZuap^uv oto onsppa pjZuoonsppYj f OAiYOonsppujp Enopsvut, to Siklos svSsxstai va psiuosi tnv iKavotnta tuv avSpuv Yia ts.Kvonoi'non.

— ZuxvSc avsni0Opnrsc svtpYasc (pnopsi va auppouv as

AiYOrspa anO 1 ara 10 dropa):

Msiupsvot apiPpot spuPpuv aipoopaiptav (ava^a), xapnXot apiPpot tjiponstpAi'uv, KspaXaXY^a, aXXspYiKst SsppatiKst avtiSpaosit, pAsYpovf f sXKOt oto otopa (otopatiKf pXsvvoYovitiSa).

— Oxi auxvSc avsni0Opnrsc svSpYsisc (p^ops^ va auppouv as

AiYOrspa anO 1 ara 100 dropa):

ZaXn, vauna, Kvnopot, kokkivo spavPnpa tou Ssppatot ps Kvnopo (spavPnpa), paupa vuxia (psAavuvux^P), anuXsia tpixuv.

— Zndvisc avsni0upnrsc svSpYsisc (p^ops^ va auppoOv as

AiYOrspa anO 1 ara 1 000 dropa):

nXnYst ota noSia (sXKn ota Katu aKpa), tpononoi'non tnt AsitoupYujt tou fnatot.

— noAO andvisc avsni0Opnrsc svSpYsisc (p^ops^ va auppoOv as AiYOrspa anO 1 ara 10 000 dropa) n dYvoarnc auxvOrnra (n auxvOrnra Ss p^ops^ va sKTipn^ pdasi rov Sia0Saipuv SsSopSvov):

OXsYpovf tou Ssppatot nou npOKtasi' spuPpst, poXiSutst nXaKst Kai sppav^ZsTal niPavut paZ^ ps novo otit apPpuosit.

Mspovupsvst nspintuosit KaKofPout vooou tuv aipoopaiptaiv (Xsuxa^a), KjpKi'vou tou Ssppatot os nXiKiupsvout sioPsvsj't, tapopptJYYj, YaotpsvtspiKst Siatapaxst, spstot, SsppatiKf Snpotnta, nupstot, pnououj sppfvuv kukXuv (apnvoppoia) Kai auSnon papout.

— Ava^opd avsni0Opnrov svspYsitav

Eav napatnpfosts Kanoia avsniPupntn svspYsia, svnpspuots tov Yiatpo f tov pappaKonoio f tov voooKopo oat. Auto ioxusi Kai Yia KaPs niPavf avsniPupntn svspYsia nou Ssv avapspstai otov napov puxxo oSnYiuv xpfont.

Mnopsi'ts sni'ont va avapspsts avsniPupntst svspYsist ansuPs^at, psou tou sPvikou ouotfpatot avapopat:

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lototonot:

Msou tnt avapopat avsniPupntuv svspYsiuv pnopsi'ts va ponPfosts otn ouXXoYf nspioootspuv nXnpopopiuv oxstiKa ps tnv aopaXsia tou napovtot pappaKou.

• 5. nOZ NA WYAAZZETE TO SIKLOS

To pappaKo auto npsnsi va puXaoostai os pspn nou Ssv to pXsnouv Kai Ssv to pPavouv ta naiSia.

Na pn xpnoiponoisi'ts to Siklos psta tnv npspopnvYj XfSnt nou avapspstai otnv sniofpavon otn piaXn Kai to kouti' psta ano to «EXP».

®uxaoosts os PsppOKptJOlYj piKpotspn tuv 30°C.

Ta pn xpnoiponoinpsva, Siaipspsva sjokYj npsnsi va snavatonoPstouvtai otn piaXn Kai va xpnoiponoiouvtai svtot tpiuv pnvuv.

Ta pappaKa Ssv npsnsi va anopprntovtai otov vspo tnt anoxstsuont f ta OKouni'Su. Putfots tov pappaKonoio oat nut va nstapsts ta pappaKa nou Ss xpsiaZovtai nia. Auta ta pstpa Pa ponPfoouv otnv npootpoip tou nspipaXXovtot.

• 6. nEPIEXOMENA THZ ZYZKEYAZIAZ KAI AOInEZ nAHPOWOPIEZ

— Ti nspiSxsi ro Siklos

• H SpaotiKf ouo^a staai n uSpoSuKappap^Sn.

KaPs sniKaXuppsvo ps Xsnto upsvio Siotao Siklos 100 mg nspisxsi 100 mg uSpoSuKappap^Snt.

KaPs sniKaXuppsvo ps Xsnto upsvio sjipk^Oi Siklos 1 000 mg nspisxsi 1 000 mg uSpoSuKappap^Snt.

• Ta aXXa ouotatiKa sj'vpi poupapiKo otsatiKo vatpio, nupitiupsvn piKpOKpuotaXXiKf Kuttaptan Kai paoiKo poutuXiupsvo psPaKpuXiKo oupnoXupspst.