Change to section 4.4 - Special warnings and precautions for use

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

smpc Zutectra

human hepatitis b immunoglobulin

Biotest (UK) Ltd

Updated 20-Jul-18

Document history

Improved presentation of SPC

Change to section 10 - Date of revision of the text

Change to section 2 - Qualitative and quantitative composition

Change to section 4.1 - Therapeutic indications

Change to section 4.2 - Posology and method of administration

Change to section 4.3 - Contraindications

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 4.8 - Undesirable effects - how to report a side effect

Change to section 4.9 - Overdose

Change to section 5.1 - Pharmacodynamic properties

Change to section 5.2 - Pharmacokinetic properties

Change to other sources of information section

Change to other sources of information section

Change to other sources of information section

Change to section 4.2 - Posology and method of administration

Change to section 5 - how to store or dispose

Change to section 6 - what the product looks like and pack contents

Change to section 6.3 - Shelf life

New SPC for new product

Change to section 5 - how to store or dispose

Change to section 6 - what the product looks like and pack contents

pil Gentamicin Intrathecal 5mg/ml

gentamicin sulfate

Zentiva

Updated 20-Jul-18

Document history

Change to section 1 - what the product is

Change to section 1 - what the product is used for

Change to section 2 - driving and using machines

Change to section 2 - excipient warnings

Change to section 2 - interactions with other medicines, food or drink

Change to section 2 - pregnancy, breast feeding and fertility

Change to section 2 - use in children/adolescents

Change to section 2 - what you need to know - contraindications

Change to section 2 - what you need to know - warnings and precautions

Change to section 3 - dose and frequency

Change to section 3 - duration of treatment

Change to section 3 - how to take/use

Change to section 3 - overdose, missed or forgotten doses

Change to section 3 - use in children/adolescents

Change to section 4 - how to report a side effect

Change to section 4 - possible side effects

Change to section 5 - how to store or dispose

Change to section 6 - manufacturer

Change to section 6 - marketing authorisation holder

Change to section 6 - marketing authorisation number

Change to section 6 - what the product contains

Change to section 6 - what the product looks like and pack contents

pil Gentamicin Paediatric 20mg/2ml

gentamicin sulfate

Zentiva

Updated 20-Jul-18

Document history

Change to section 1 - what the product is

Change to section 1 - what the product is used for

Change to section 2 - driving and using machines

Change to section 2 - excipient warnings

Change to section 2 - interactions with other medicines, food or drink

Change to section 2 - pregnancy, breast feeding and fertility

Change to section 2 - use in children/adolescents

Change to section 2 - what you need to know - warnings and precautions

Change to section 3 - dose and frequency

Change to section 3 - duration of treatment

Change to section 3 - how to take/use

Change to section 3 - overdose, missed or forgotten doses

Change to section 3 - use in children/adolescents

Change to section 4 - how to report a side effect

Change to section 4 - possible side effects

Change to section 5 - how to store or dispose

Change to section 6 - date of revision

Change to section 6 - manufacturer

Change to section 6 - marketing authorisation holder

Change to section 6 - what the product contains

Change to section 4 - possible side effects

Change to section 6 - date of revision

Change to name of medicinal product

Change to section 2 - excipient warnings

Change to section 4 - how to report a side effect

Change to section 6 - what the product looks like and pack contents

Change to section 2 - interactions with other medicines, food or drink

Change to section 2 - interactions with other medicines, food or drink

Change to section 2 - interactions with other medicines, food or drink

Change to section 2 - interactions with other medicines, food or drink

Change to section 2 - interactions with other medicines, food or drink

Change to section 2 - interactions with other medicines, food or drink

pil Fluticasone Propionate 0.05% cream

fluticasone propionate

Aspire Pharma Ltd

New 20-Jul-18

New PIL for eMC ie a PIL for an existing product but one that is new to the eMC

New PIL for eMC ie a PIL for an existing product but one that is new to the eMC

New PIL for eMC ie a PIL for an existing product but one that is new to the eMC

Change to section 2 - pregnancy, breast feeding and fertility

Change to section 2 - what you need to know - warnings and precautions

Change to section 3 - overdose, missed or forgotten doses

Change to section 6 - date of revision

Change to section 2 - pregnancy, breast feeding and fertility

Change to section 2 - what you need to know - warnings and precautions

Change to section 3 - overdose, missed or forgotten doses

Change to section 6 - date of revision

Change to section 2 - pregnancy, breast feeding and fertility

Change to section 2 - what you need to know - warnings and precautions

Change to section 3 - overdose, missed or forgotten doses

Change to section 6 - date of revision

Change to section 2 - pregnancy, breast feeding and fertility

Change to section 2 - what you need to know - warnings and precautions

Change to section 3 - overdose, missed or forgotten doses

Change to section 6 - date of revision

Change to information for healthcare professionals

Change to other sources of information section

Change to section 2 - pregnancy, breast feeding and fertility

Change to section 3 - dose and frequency

Change to section 6 - date of revision

pil Palladone capsules 2.6mg

hydromorphone hydrochloride

Napp Pharmaceuticals Limited

Updated 20-Jul-18

Document history

Change to section 2 - interactions with other medicines, food or drink

Change to section 4 - how to report a side effect

Change to section 6 - date of revision

pil Palladone capsules 1.3 mg

hydromorphone hydrochloride

Napp Pharmaceuticals Limited

Updated 20-Jul-18

Document history

Change to section 2 - interactions with other medicines, food or drink

Change to section 4 - how to report a side effect

Change to section 6 - date of revision

Change to section 10 - Date of revision of the text

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.6 - Fertility, pregnancy and lactation

Change to section 5.2 - Pharmacokinetic properties

Change to section 10 - Date of revision of the text

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.6 - Fertility, pregnancy and lactation

Change to section 5.2 - Pharmacokinetic properties

Change to section 10 - Date of revision of the text

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.6 - Fertility, pregnancy and lactation

Change to section 5.2 - Pharmacokinetic properties

Change to section 10 - Date of revision of the text

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.6 - Fertility, pregnancy and lactation

Change to section 5.2 - Pharmacokinetic properties

pil Palladone SR capsules 4 mg

hydromorphone hydrochloride

Napp Pharmaceuticals Limited

Updated 20-Jul-18

Document history

Change to section 2 - interactions with other medicines, food or drink

Change to section 2 - what you need to know - warnings and precautions

Change to section 4 - how to report a side effect

Change to section 6 - date of revision

pil Palladone SR capsules 8 mg

hydromorphone hydrochloride

Napp Pharmaceuticals Limited

Updated 20-Jul-18

Document history

Change to section 2 - interactions with other medicines, food or drink

Change to section 2 - what you need to know - warnings and precautions

Change to section 4 - how to report a side effect

Change to section 6 - date of revision

pil Palladone SR capsules 24 mg

hydromorphone hydrochloride

Napp Pharmaceuticals Limited

Updated 20-Jul-18

Document history

Change to section 2 - interactions with other medicines, food or drink

Change to section 2 - what you need to know - warnings and precautions

Change to section 4 - how to report a side effect

Change to section 6 - date of revision

pil Palladone SR capsules 16 mg

hydromorphone hydrochloride

Napp Pharmaceuticals Limited

Updated 20-Jul-18

Document history

Change to section 2 - interactions with other medicines, food or drink

Change to section 2 - what you need to know - warnings and precautions

Change to section 4 - how to report a side effect

Change to section 6 - date of revision

pil Palladone SR capsules 2 mg

hydromorphone hydrochloride

Napp Pharmaceuticals Limited

Updated 20-Jul-18

Document history

Change to section 2 - interactions with other medicines, food or drink

Change to section 2 - what you need to know - warnings and precautions

Change to section 4 - how to report a side effect

Change to section 6 - date of revision

smpc Palladone SR capsules 2 mg

hydromorphone hydrochloride

Napp Pharmaceuticals Limited

Updated 20-Jul-18

Document history

Change to section 10 - Date of revision of the text

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 4.8 - Undesirable effects

Change to section 5.1 - Pharmacodynamic properties

smpc Palladone SR capsules 8 mg

hydromorphone hydrochloride

Napp Pharmaceuticals Limited

Updated 20-Jul-18

Document history

Change to section 10 - Date of revision of the text

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 4.8 - Undesirable effects

Change to section 5.1 - Pharmacodynamic properties

smpc Palladone SR capsules 16 mg

hydromorphone hydrochloride

Napp Pharmaceuticals Limited

Updated 20-Jul-18

Document history

Change to section 10 - Date of revision of the text

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 4.8 - Undesirable effects

Change to section 5.1 - Pharmacodynamic properties