A. LABELLING
|
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
{NATURE/TYPE}
|
1. NAME OF THE MEDICINAL PRODUCT |
{(Invented) name <strength> <pharmaceutical form>}
{Active substance}
2. STATEMENT OF ACTIVE SUBSTANCE(S) |
4. PHARMACEUTICAL FORM AND CONTENTS |
5. METHOD AND ROUTE(S) OF ADMINISTRATION |
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN |
Keep out of the reach and sight of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY |
[For terms on Batch number and Expiry date see Appendix IV]
9. SPECIAL STORAGE CONDITIONS |
[For Storage condition statements see Appendix III]
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE |
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER |
12. MARKETING AUTHORISATION NUMBER(S) |
EU/0/00/000/000
13. MANUFACTURER'S BATCH NUMBER |
[For terms on Batch number and Expiry date see Appendix IV]
14. GENERAL CLASSIFICATION FOR SUPPLY |
<Medicinal product subject to medical prescription.>
<Medicinal product not subject to medical prescription.>
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS |
1. NAME OF THE MEDICINAL PRODUCT |
{(Invented) name, strength and pharmaceutical form}
{Active substance}
2. NAME OF THE MARKETING AUTHORISATION HOLDER |
{Name}
[For terms on Batch number and Expiry date see Appendix IV]
[For terms on Batch number and Expiry date see Appendix IV]
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {NATURE/TYPE} |
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION |
{(Invented) name, strength and pharmaceutical form}
{Route of administration}
2. METHOD OF ADMINISTRATION |
[For terms on Batch number and Expiry date see Appendix IV]
[For terms on Batch number and Expiry date see Appendix IV]
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT |
B. PACKAGE LEAFLET
PACKAGE LEAFLET
<Read all of this leaflet carefully before you start <taking> <using> this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.>
<Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. Nevertheless you still need to use X carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must see a doctor if your symptoms worsen or do not improve <after {number of} days.>
In this leaflet:
1. What X is and what it is used for
2. Before you <take> <use> X
3. How to <take> <use> X
4. Possible side effects
5 Storing X
6. Further information
{(Invented) name strength and pharmaceutical form}
{Active substance}
- The active substance is…
- The other ingredients are...
{Marketing Authorisation Holder}
<{Manufacturer}>
1. WHAT X IS AND WHAT IT IS USED FOR
<This medicinal product is for diagnostic use only.>
2. BEFORE YOU <TAKE> <USE> X
Do not <take> <use> X:
- <if you are hypersensitive (allergic) to {active substance} or any of the other ingredients of X.>
- <if you...>
Take special care with X:
- <if you...>
- <when...>
<Taking> <Using> X with food and drink:
Pregnancy
<Ask your doctor or pharmacist for advice before taking any medicine.>
Breast-feeding
<Ask your doctor or pharmacist for advice before taking any medicine.>
Driving and using machines:
<Do not <drive because...>
<Do not operate any tools or machines.>
Important information about some of the ingredients of X:
<Taking> <Using> other medicines:
<Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.>
3. HOW TO <TAKE> <USE> X
<Always <take> <use> X exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.> <The usual dose is...>
<If you have the impression that the effect of X is too strong or too weak, talk to your doctor or pharmacist.>
If you <take> <use> more X than you should:
If you forget to <take> <use> X:
<Do not take a double dose to make up for forgotten individual doses.>
Effects when treatment with X is stopped:
4. POSSIBLE SIDE EFFECTS
Like all medicines, X can have side effects.
[Describe, if necessary, the actions to be taken. If the patient needs to seek help urgently use the term <immediately>; for less urgent conditions use the phrase <as soon as possible>.]
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
5. STORING X
[For Storage condition statements see Appendix III]
6. FURTHER INFORMATION
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
België/Belgique/Belgien
{Nom/Naam/Name}
<{Adresse/Adres/Anschrift }
B-0000 {Localité/Stad/Stadt}>
Tél/Tel: + {N° de téléphone/Telefoonnummer/ Telefonnummer}
<{e-mail}> |
Luxembourg/Luxemburg
{Nom}
<{Adresse}
L-0000 {Localité/Stadt}>
Tél/Tel: + {N° de téléphone/Telefonnummer}
<{e-mail}> |
Česká republika
{Název}
<{Adresa}
CZ {město}>
Tel: +{telefonní íslo}
<{e-mail}> |
Magyarország
{Név}
<{Cím}
H-0000 {Város}>
Tel.:{Telefonszám}
<{e-mail}> |
Danmark
{Navn}
<{Adresse}
DK-0000 {by}>
Tlf: + {Telefonnummer}
<{e-mail}> |
Malta
{Isem}
<{Indirizz}
MT-0000 {Belt/Rahal}>
Tel: + {Numru tat-telefon}
<{e-mail}> |
Deutschland
{Name}
<{Anschrift}
D-00000 {Stadt}>
Tel: + {Telefonnummer}
<{e-mail}> |
Nederland
{Naam}
<{Adres}
NL-0000 XX {stad}>
Tel: + {Telefoonnummer}
<{e-mail}> |
Eesti
(Nimi)
<(Aadress)
EE - (Postiindeks) (Linn)>
Tel: +(Telefoninumber)
<{e-mail}> |
Norge
{Navn}
<{Adresse}
N-0000 {poststed}>
Tlf: + {Telefonnummer}
<{e-mail}> |
Ελλάδα
{Όνοµα}
<{Διεύθυνση}
GR-000 00 {πόλη}>
Τηλ: + {Αριθµός τηλεφώνου}
<{e-mail}> |
Österreich
{Name}
<{Anschrift}
A-00000 {Stadt}>
Tel: + {Telefonnummer}
<{e-mail}> |
España
{Nombre}
<{Dirección}
E-00000 {Ciudad}>
Tel: + {Teléfono}
<{e-mail}> |
Polska
{Nazwa/Nazwisko:}
<{Adres:}
PL - 00 000{Miasto:}>
Tel.: + {Numer telefonu:}
<{e-mail}> |
France
{Nom}
<{Adresse}
F-00000 {Localité}>
Tél: + {Numéro de téléphone}
<{e-mail}> |
Portugal
{Nome}
{Morada}
P-0000-000 {Cidade}
Tel: + {Número de telefone}
{e-mail} |
Ireland
{Name}
<{Address}
IRL - {Town} {Code for Dublin}>
Tel: + {Telephone number}
<{e-mail}> |
Slovenija
{Ime}
<{Naslov}
SI-0000 {Mesto}>
Tel: + {telefonska številka}
<{e-mail}> |
Ísland
{Nafn}
<{Heimilisfang}
IS-000 {Borg/Bær}>
Tel: + {Símanúmer}
<{e-mail}> |
Slovenská republika
{Meno}
<{Adresa}
SK-000 00 {Mesto}>
Tel: + {Telefónne číslo}
<{e-mail}> |
Italia
{Nome}
<{Indirizzo}
I-00000 {Località}>
Tel: + {Numero di telefono}>
<{e-mail}> |
Suomi/Finland
{Nimi/Namn}
<{Osoite/Adress}
FIN-00000
{Postitoimipaikka/Stad}>
Puh/Tel: + {Puhelinnumero/Telefonnummer}
<{e-mail}> |
Κύπρος
{Όνοµα}
<{Διεύθυνση}
CY-000 00 {πόλη}>
Τηλ: + {Αριθµός τηλεφώνου}
<{e-mail}> |
Sverige
{Namn}
<{Adress}
S-000 00 {Stad}>
Tel: + {Telefonnummer}
<{e-mail}> |
Latvija
{Nosaukums}
<{Adrese}
{Pilsēta}, LV{Pasta indekss }>
Tel: + {Telefona numurs}
<{e-mail}> |
United Kingdom
{Name}
<{Address}
{Town}
{Postal code} - UK>
Tel: + {Telephone number}
<{e-mail}> |
Lietuva
{pavadinimas}
<{adresas}
LT {pašto indeksas} {miestas}>
Tel. +370{telefono numeris}
<{e-mail}> |
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This leaflet was last approved on {date}
The following information is intended for medical or healthcare professionals only:>
[Version 6.1, 07/2004]
Chargement en cours...
