Vitaminum A GAL

Główne informacje

  • Nazwa własna:
  • Vitaminum A GAL 6000 j.m. kapsułki miękkie
  • Dawkowanie:
  • 6000 j.m.
  • Forma farmaceutyczna:
  • kapsułki miękkie
  • Używać do:
  • Ludzie
  • Typ medycyny:
  • alopatycznych narkotyków

Dokumenty

Lokalizacja

  • Dostępne w:
  • Vitaminum A GAL 6000 j.m. kapsułki miękkie
    Polska
  • Język:
  • polski

Informacje terapeutyczne

  • Podsumowanie produktu:
  • 60 kaps., 5909990838516, OTC

Inne informacje

Status

  • Źródło:
  • Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
  • Numer pozwolenia:
  • 08385
  • Ostatnia aktualizacja:
  • 17-03-2018

Ulotkę dla pacjenta: substancji czynnych, wskazania, dawkowanie, interakcje, działania niepożądane, ciąża, laktacja

Ulotka doł

czona do opakowania: informacja dla pacjenta

(logo GAL)

VITAMINUM A GAL

(Retinoli palmitas)

6000 IU, kapsułki mi

kkie

NaleŜy uwaŜnie zapoznać się z treścią ulotki przed zaŜyciem leku, poniewaŜ zawiera ona informacje

waŜne dla pacjenta.

Lek ten naleŜy zawsze przyjmować dokładnie tak, jak opisano w ulotce dla pacjenta.

NaleŜy zachować tę ulotkę, aby w razie potrzeby móc ją ponownie przeczytać.

Jeśli potrzebna jest rada lub dodatkowa informacja, naleŜy zwrócić się do farmaceuty.

Jeśli u pacjenta wystąpią jakiekolwiek objawy niepoŜądane, w tym wszelkie moŜliwe objawy

niepoŜądane niewymienione w ulotce, naleŜy powiedzieć o tym lekarzowi lub farmaceucie.

Jeśli nie nastąpiła poprawa lub pacjent czuje się gorzej, naleŜy skontaktować się z lekarzem.

Nie stosowa

u kobiet w ci

ąŜ

Spis tre

ci ulotki:

Co to jest lek V

ITAMINUM

GAL i w jakim celu si

go stosuje

Informacje wa

ne przed zastosowaniem leku V

ITAMINUM

Jak stosowa

lek V

ITAMINUM

liwe działania niepo

Ŝą

dane

Jak przechowywa

lek V

ITAMINUM

Zawarto

ść

opakowania i inne informacje

1. Co to jest lek V

ITAMINUM

A

GAL

i w jakim celu si

go stosuje

ITAMINUM

zawiera palmitynian retynolu (pewna posta

witaminy A).

Witamina A jest niezb

dna do prawidłowego procesu widzenia, rozmna

ania, wzrostu,

regeneracji i ró

nicowania czynno

ci nabłonków, a tak

e do wzrostu i rozwoju ko

ci oraz do

zachowania

integralno

błon

luzowych.

siatkówce

retynol

ulega

przemianie

aldehydu retynowego, który w poł

czeniu z opsyn

tworzy barwnik purpur

wzrokow

(rodopsyn

), konieczn

do adaptacji wzroku w ciemno

Niedobór witaminy A prowadzi do

lepoty zmierzchowej, wysychania spojówek, rozmi

kania

rogówki, a w ci

ęŜ

kich przypadkach do trwałego uszkodzenia oczu i

lepoty.

Niedobór witaminy A mo

e by

powodem zmian skórnych, nadmiernego rogowacenia skóry,

metaplazji nabłonka błon

luzowych (przekształcania tkanki w inn

) oraz zmniejszenia

odporno

ci na zaka

enia.

ITAMINUM

stosowany jest w zapobieganiu i leczeniu nast

pstw stanu niedoboru

witaminy A.

Stosowany bywa równie

jako lek uzupełniaj

cy terapi

chorób skóry (np. rybiej łuski,

dziku pospolitego, łuszczycy, liszaja płaskiego).

2. Informacje wa

ne przed zastosowaniem leku

V

ITAMINUM

A

GAL

Kiedy nie stosować leku V

ITAMINUM

A

GAL

−−

li pacjent jest nadwra

liwy na witamin

A lub inne składniki preparatu;

−−

li u pacjenta wyst

puje hiperwitaminoza A (nadmiar witaminy w organizmie) lub zespół

złego wchłaniania tłuszczów;

−−

li u pacjenta wyst

puje uczulenie na orzeszki ziemne lub soj

(lek zawiera olej

arachidowy).

Kiedy zachować szczególną ostroŜność stosując lek V

ITAMINUM

A

GAL

w chorobach w

troby (marsko

ść

troby, wirusowe zapalenie w

troby), w nadci

nieniu

tniczym (nie nale

y podawa

w du

ych dawkach);

w trakcie podawania innych preparatów zawieraj

cych witamin

A (ze wzgl

du na

liwo

ść

przedawkowania);

w przypadku zaburzenia wchłaniania tłuszczów oraz małego spo

ycia białka (wchłanianie

witaminy A jest zmniejszone).

V

ITAMINUM

A

GAL

a inne leki

Pochodne kwasu retynowego (leki stosowane w chorobach skóry) i witamina A stosowane

jednocze

nie nawzajem zwi

kszaj

swoj

toksyczno

ść

Kolestyramina,

kolestypol,

parafina

płynna

neomycyna

zmniejszy

wchłanianie

witaminy A.

Doustne

rodki antykoncepcyjne zwi

kszaj

ęŜ

enie witaminy A w surowicy krwi.

Nale

y powiedzie

lekarzowi o wszystkich lekach przyjmowanych obecnie lub ostatnio,

a tak

e o lekach, które pacjent planuje przyjmowa

V

ITAMINUM

A

GAL

z jedzeniem i piciem

Lek najlepiej przyjmowa

w czasie posiłku, popijaj

c wystarczaj

płynu.

CiąŜa, karmienie piersią i wpływ na płodność

CiąŜa

Przed zastosowaniem kaŜdego leku naleŜy poradzić się lekarza.

Nie nale

y stosowa

u kobiet w ci

ąŜ

y.

Karmienie piersią

Przed zastosowaniem kaŜdego leku naleŜy poradzić się lekarza.

Witamina A przenika do mleka kobiecego. Nie zaleca si

przyjmowania du

ych dawek ze

wzgl

du na mo

liwo

ść

przedawkowania u dziecka.

Prowadzenia pojazdów i obsługiwanie maszyn

Lek V

ITAMINUM

GAL nie wpływa na zdolno

ść

prowadzenia pojazdów i obsługiwania

maszyn.

3. Jak stosowa

lek V

ITAMINUM

A

GAL

Ten lek nale

y zawsze stosowa

dokładnie tak, jak opisano w ulotce dla pacjenta lub według

zalece

lekarza lub farmaceuty. W razie w

tpliwo

ci nale

y zwróci

do lekarza lub

farmaceuty.

Zalecana dawka leku V

ITAMINUM

GAL profilaktycznie u dorosłych to jedna kapsułka na

w czasie posiłku.

W razie wątpliwości naleŜy zwrócić się do lekarza lub farmaceuty.

Przyjęcie większej niŜ zalecana dawki leku V

ITAMINUM

A

GAL

Nale

y niezwłocznie zwróci

do lekarza lub farmaceuty.

Ostre zatrucie witamin

A objawia si

nadmiern

senno

, zaburzeniami psychicznymi,

zawrotami głowy, nudno

ciami i wymiotami, rumieniem,

dem i złuszczeniem si

skóry.

e wyst

wzrost ci

nienia

ródczaszkowego. Objawy ostrego zatrucia mog

wyst

po dawce 75 000 – 350 000 IU u dzieci, w zale

ci od wieku, i 1 000 000 IU

u dorosłych.

Pominięcie przyjmowania leku V

ITAMINUM

A

GAL

Nie nale

y stosowa

dawki podwójnej w celu uzupełnienia pomini

tej.

Przerwanie przyjmowania leku V

ITAMINUM

A

GAL

W razie jakichkolwiek dalszych w

tpliwo

ci zwi

zanych ze stosowaniem tego leku nale

zwróci

do lekarza lub farmaceuty.

4. Mo

liwe działania niepo

Ŝą

dane

Jak ka

dy lek, lek ten mo

e powodowa

działania niepo

Ŝą

dane, chocia

nie u ka

dego one

wyst

Podczas

długotrwałego

stosowania

leku

dawkach

przekraczaj

cych

zalecane

wyst

hiperwitaminoza A, której objawami s

: złe samopoczucie, osłabienie łaknienia,

nadmierna pobudliwo

ść

lub depresja,

d i sucho

ść

skóry, łamliwo

ść

paznokci, zmiany

zabarwienia skóry, wypadanie włosów, bóle głowy, powi

kszenie w

troby i

ledziony, obrz

tarczy nerwu wzrokowego.

Długotrwałe przyjmowanie witaminy A mo

e by

przyczyn

uszkodzenia w

troby.

Lek mo

e powodowa

reakcje alergiczne.

Zgłaszanie działa

niepo

Ŝą

danych

wyst

jakiekolwiek

objawy

niepo

Ŝą

dane,

wszelkie

objawy

niepo

Ŝą

dane

niewymienione w ulotce, nale

y powiedzie

o tym lekarzowi. Działania niepo

Ŝą

dane mo

zgłasza

bezpo

rednio do Departamentu Monitorowania Niepo

Ŝą

danych Działa

Produktów

Leczniczych Urz

du Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów

Biobójczych

{aktualny adres, nr telefonu i faksu ww. Departamentu}

e-mail: adr@urpl.gov.pl.

ki zgłaszaniu działa

niepo

Ŝą

danych mo

na b

dzie zgromadzi

cej informacji na

temat bezpiecze

stwa stosowania leku.

5. Jak przechowywa

lek V

ITAMINUM

A

GAL

Przechowywa

w temperaturze poni

ej 25°C, w oryginalnym opakowaniu w celu ochrony

przed

wiatłem.

Lek nale

y przechowywa

w miejscu niedost

pnym i niewidocznym dla dzieci.

Nie stosowa

tego leku po upływie terminu wa

ci zamieszczonego na opakowaniu.

6. Zawarto

ść

opakowania i inne informacje

Co zawiera lek V

ITAMINUM

A

GAL

Substancj

czynn

leku jest retynolu palmitynian

Pozostałe

składniki

(substancje

pomocnicze),

olej

arachidowy,

elatyna,

glicerol 99,5%,

etylu

parahydroksybenzoesan,

woda

oczyszczona,

ółcie

pomara

czowa (E 110).

Jak wygląda lek

V

ITAMINUM

A

GAL

i co zawiera opakowanie

60 kapsułek w blistrach z folii Aluminium/PVC i tekturowym pudełku

Podmiot odpowiedzialny i wytwórca

Specjalistyczne Przedsi

biorstwo Rolno-Przetwórcze „GAL”

L.P.M.Ł. Marek s.j.

ul. Krótka 4, 61-012 Pozna

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Warning about Power 1 Walnut

Warning about Power 1 Walnut

The Danish Medicines Agency has been made aware that the Health Sciences Authority in Singapore has confiscated large quantities of the illegal medicinal product Power 1 Walnut, which has been marketed as a potency-enhancing product containing only herbs.

Danish Medicines Agency

30-1-2008

The Danish Medicines Agency and the Danish Veterinary and Food Administration warn against the weight loss product Therma Power

The Danish Medicines Agency and the Danish Veterinary and Food Administration warn against the weight loss product Therma Power

The Danish Medicines Agency strongly warns against Therma Power and products with a similar content and characteristics. Therma Power contains ephedrine or synephrine and is illegal in Denmark.

Danish Medicines Agency

19-10-2007

Warning: Illegal sibutramine-containing weight-loss products sold on the internet

Warning: Illegal sibutramine-containing weight-loss products sold on the internet

The illegal Chinese weight-loss products LiDa (DaiDaiHuaJioaNang) and Miaozi are being sold on the internet, e.g. at the Danish language version of www.hurtigslank.dk (www.fastslim.dk).

Danish Medicines Agency

21-4-2006

Warning: Sale of illegal diet pills

Warning: Sale of illegal diet pills

Illegal diet pills containing the active substances ephedrine and ephedra are sold in a number of shops and on the internet. The illegal products are sold under names such as Therma Power

Danish Medicines Agency

1-1-1970

New EU rules on falsified medicines

New EU rules on falsified medicines

When new EU rules enter into force on 9 February 2019, it will be harder for falsified medicines to reach patients in the EU. The new rules, which introduce new safety features on the packaging of medicines and other measures, are to prevent falsified medicines from entering the legal supply chain of medicines – for example in pharmacies and hospitals.

Danish Medicines Agency

18-2-2019

Australian company pays fine for illegal medicine exports

Australian company pays fine for illegal medicine exports

On 14 December 2018, the TGA issued an infringement notice for export of unlawful medicines from Australia

Therapeutic Goods Administration - Australia

14-2-2019

Today, the @US_FDA issued a warning letter citing safety concerns  regarding an illegally marketed device that claims to prevent and treat  tightening of scar tissue around breast implants. Read the more about  the warning letter here:  https://go.usa.gov

Today, the @US_FDA issued a warning letter citing safety concerns regarding an illegally marketed device that claims to prevent and treat tightening of scar tissue around breast implants. Read the more about the warning letter here: https://go.usa.gov

Today, the @US_FDA issued a warning letter citing safety concerns regarding an illegally marketed device that claims to prevent and treat tightening of scar tissue around breast implants. Read the more about the warning letter here: https://go.usa.gov/xEUks 

FDA - U.S. Food and Drug Administration

24-1-2019

Direction about advertisements: Evolution Supplements

Direction about advertisements: Evolution Supplements

Direction Notice issued to cease advertisement of prescription and illegal products

Therapeutic Goods Administration - Australia

14-12-2018

TGA action against Peptide Clinics Pty Ltd for alleged advertising breaches

TGA action against Peptide Clinics Pty Ltd for alleged advertising breaches

This legal action follows an investigation by the Therapeutic Goods Administration

Therapeutic Goods Administration - Australia

29-11-2018

Company will pay over $25,000 in fines for alleged importation of unapproved therapeutic goods

Company will pay over $25,000 in fines for alleged importation of unapproved therapeutic goods

Operation Antlia targeted the illegal use of therapeutic goods in the cosmetics industry

Therapeutic Goods Administration - Australia

13-11-2018

#DYK November is #DiabetesAwarenessMonth. As the number of people diagnosed with diabetes continues to grow, @US_FDA  encourages patients and caregivers to beware of illegally markets  diabetes treatments. Check out our Consumer Update on this issue  http

#DYK November is #DiabetesAwarenessMonth. As the number of people diagnosed with diabetes continues to grow, @US_FDA encourages patients and caregivers to beware of illegally markets diabetes treatments. Check out our Consumer Update on this issue http

#DYK November is #DiabetesAwarenessMonth. As the number of people diagnosed with diabetes continues to grow, @US_FDA encourages patients and caregivers to beware of illegally markets diabetes treatments. Check out our Consumer Update on this issue https://go.usa.gov/xPfDx  pic.twitter.com/OGwOusdP1w

FDA - U.S. Food and Drug Administration

1-6-2018

#DYK #Opioids are a type of drug that includes the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone (OxyContin®) #FDAInnovationChallenge (1 of 2 messages)

#DYK #Opioids are a type of drug that includes the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone (OxyContin®) #FDAInnovationChallenge (1 of 2 messages)

#DYK #Opioids are a type of drug that includes the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone (OxyContin®) #FDAInnovationChallenge (1 of 2 messages)

FDA - U.S. Food and Drug Administration