Home page Home page
AstraZeneca

Pheburane
sodium phenylbutyrate

Package leaflet: Information for the patient


PHEBURANE 483 mg/g granules

Sodium phenylbutyrate


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


If you experience any of these symptoms, you should immediately contact your doctor or the nearest hospital emergency department for supportive treatment.


If you forget to take PHEBURANE

You should take a dose as soon as possible with your next meal. Make sure that there are at least 3 hours between two doses. Do not take a double dose to make up for a forgotten dose.


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

  1. Possible side effects


    Like all medicines, this medicine can cause side effects, although not everybody gets them. If persistent vomiting occurs, you should contact your doctor immediately.

    Very common side effects (may affect more than 1 in 10 people): irregular menstrual periods and stopping of menstrual periods in fertile women.

    If you are sexually active and your period stops altogether, do not assume that this is caused by PHEBURANE. If this occurs, please discuss it with your doctor, because the absence of your period may be caused by pregnancy (see ‘Pregnancy and breast-feeding’ section above) or by menopause.


    Common side effects (may affect more than 1 in 100 people): changes in number of blood cells (red cells, white cells and platelets), changes in the amount of bicarbonate in the blood, reduced appetite, depression, irritability, headache, fainting, fluid retention (swelling), changes in taste (taste disturbances), stomach ache, vomiting, nausea, constipation, abnormal skin odor, rash, abnormal kidney function, weight gain, altered laboratory test values.


    Uncommon side effects (may affect more than 1 in 1,000 people): deficiency in red blood cells due to failure of the bone marrow, bruising, altered heart rhythm, rectal bleeding, inflammation of the stomach, stomach ulcer, inflammation of the pancreas.


    Reporting of side effects

    image

    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.


  2. How to store PHEBURANE


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


    Do not use PHEBURANE after the expiry date which is stated on the carton and the bottle label after EXP. The expiry date refers to the last day of that month.


    After the first opening, PHEBURANE can be used within 45 days.


    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 protect the environment.


  3. Contents of the pack and other information What PHEBURANE contains

The active substance is sodium phenylbutyrate.

Each gram of granules contains 483 mg of sodium phenylbutyrate.

The other ingredients are: sugar spheres (sucrose and maize starch, see section 2 ‘PHEBURANE contains sucrose), hypromellose, ethylcellulose N7, macrogol 1500, povidone K25.


What PHEBURANE looks like and contents of the pack

PHEBURANE granules are white to off-white.

The granules are packaged in a plastic bottle with child-resistant closure and a dessicant. Each bottle contains 174g of granules.

Each carton contains 1 bottle.


A calibrated measuring spoon is provided.


Marketing Authorisation Holder and Manufacturer

Eurocept International BV Trapgans 5

1244 RL Ankeveen The Netherlands


For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:


België/Belgique/Belgien

Lucane Pharma

Tél/Tel: + 33 153 868 750

info@lucanepharma.com

Lietuva

FrostPharma AB

Tel: +46 775 86 80 02

info@frostpharma.com


България

Lucane Pharma

Teл.: + 33 153 868 750

info@lucanepharma.com

Luxembourg/Luxemburg

Lucane Pharma

Tél/Tel: + 33 153 868 750

info@lucanepharma.com


Česká republika

Lucane Pharma

Tél/Tel: + 33 153 868 750

info@lucanepharma.com

Magyarország

Lucane Pharma

Tel: + 33 153 868 750

info@lucanepharma.com


Danmark FrostPharma AB Tlf: +45 808 20 101

image

info@frostpharma.com

Malta

Lucane Pharma

Tel: + 33 153 868 750

info@lucanepharma.com


Deutschland

Lucane Pharma

Tel: + 33 153 868 750

image

info@lucanepharma.com

Nederland

Eurocept International BV Tel: +31 35 528 39 57

info@euroceptpharma.com


Eesti

FrostPharma AB

Tel: +46 775 86 80 02

info@frostpharma.com

Norge

FrostPharma AB Tlf: +47 815 03 175

info@frostpharma.com


Ελλάδα

Lucane Pharma

Τηλ: + 33 153 868 750

info@lucanepharma.com

Österreich

Lucane Pharma

Tel: + 33 153 868 750

info@lucanepharma.com


España Polska

Lucane Pharma

Tel: + 33 153 868 750

info@lucanepharma.com

Lucane Pharma

Tel: + 33 153 868 750

info@lucanepharma.com


France

Lucane Pharma

Tél: + 33 153 868 750

info@lucanepharma.com

Portugal

Lucane Pharma

Tel: + 33 153 868 750

info@lucanepharma.com


Hrvatska

Lucane Pharma

Tel: + 33 153 868 750

info@lucanepharma.com

România

Lucane Pharma

Tel: + 33 153 868 750

info@lucanepharma.com


Ireland

Lucane Pharma

Tel: + 33 153 868 750

info@lucanepharma.com

Slovenija

Lucane Pharma

Tel: + 33 153 868 750

info@lucanepharma.com


Ísland

FrostPharma AB

Sími: +46 775 86 80 02

info@frostpharma.com

Slovenská republika

Lucane Pharma

Tel: + 33 153 868 750

info@lucanepharma.com


Italia

Lucane Pharma

Tel: + 33 153 868 750

info@lucanepharma.com

Suomi/Finland

FrostPharma AB

Puh/Tel: +35 875 32 51 209

image

info@frostpharma.com


Κύπρος

Lucane Pharma

Τηλ: + 33 153 868 750

info@lucanepharma.com

Sverige

FrostPharma AB

Tel: +46 775 86 80 02

image

info@frostpharma.com


Latvija

FrostPharma AB

Tel: +46 775 86 80 02

image

info@frostpharma.com

United Kingdom

Lucane Pharma

Tel: + 33 153 868 750

info@lucanepharma.com


This leaflet was last revised in:


.


There are also links to other websites about rare diseases and treatments.

image