Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - pheburane

Document Subject

Generated Narrative: MedicinalProductDefinition mp1d04d08431237504735e48c47e138afc

identifier: http://ema.europa.eu/identifier/EU/1/13/822/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: PHEBURANE 483 mg/g granules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-1d04d08431237504735e48c47e138afc

identifier: http://ema.europa.eu/identifier/EU/1/13/822/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - pheburane

Attesters

What is in this leaflet:

1. What PHEBURANE is and what it is used for
2. What you need to know before you take PHEBURANE
3. How to take PHEBURANE
4. Possible side effects
5. How to store PHEBURANE
6. Contents of the pack and other information

PHEBURANE contains the active substance sodium phenylbutyrate which is used to treat patients of all ages with urea cycle disorders. These rare disorders are due to a deficiency of certain liver enzymes which are necessary to eliminate waste nitrogen in the form of ammonia.

Nitrogen is a building block of proteins, which are an essential part of the food we eat. As the body breaks down protein after eating, waste nitrogen, in the form of ammonia, accumulates because the body cannot eliminate it. Ammonia is especially toxic for the brain and leads, in severe cases, to reduced levels of consciousness and to coma.

This medicine helps the body to eliminate waste nitrogen, reducing the amount of ammonia in your body. However PHEBURANE must be used along with a diet reduced in proteins, designed especially for you by the doctor and the dietician. You must follow this diet carefully.

Do not take PHEBURANE if you:

are allergic to sodium phenylbutyrate or any of the other ingredients of this medicine (listed in section 6).

are pregnant.

are breast-feeding.

Warnings and precautions Talk to your doctor or pharmacist before taking PHEBURANE if you:

suffer from congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body) or a decrease in your kidney function.

have decreased kidney or liver function, since PHEBURANE is eliminated from the body through the kidney and liver. PHEBURANE will not prevent the occurrence of an acute excess of ammonia in the blood, a condition which usually constitutes a medical emergency. If this happens you will develop symptoms such as feeling sick (nausea), being sick (vomiting), confusion and will need to get urgent medical help.

If you need laboratory tests, it is important to remind your doctor that you are taking PHEBURANE, since sodium phenylbutyrate may interfere with certain laboratory test results (such as blood electrolytes or protein, or liver function tests)

In case of any doubt, ask your doctor or pharmacist.

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

It is especially important to tell your doctor if you are taking medicines containing:

valproate (an antiepileptic medicine).

haloperidol (used in certain psychotic disorders).

corticosteroids (medicines that are used to provide relief for inflamed areas of the body),

probenecid (for treatment of hyperuricaemia, high levels of uric acid in the blood, associated with gout).

These medicines may change the effect of PHEBURANE and you will need more frequent blood tests. If you are uncertain if your medicines contain these substances, you should check with your doctor or pharmacist.

Pregnancy and breast-feeding Do not use PHEBURANE if you are pregnant, because this medicine can harm your unborn baby.

If you are a woman who could get pregnant, you must use reliable contraception, during treatment with PHEBURANE. Talk to your doctor for the details.

Do not use PHEBURANE if you are breast-feeding, because this medicine can pass into the breast milk and may harm your baby.

Driving and using machines PHEBURANE is unlikely to affect your ability to drive and use machines.

PHEBURANE contains sodium and sucrose This medicine contains 124 mg (5.4 mmol) sodium (main component of cooking/table salt) in each gram granules. This is equivalent to 6,2% of the recommended maximum daily dietary intake of sodium for an adult.
The maximum daily dose of this medicine contains 2.5 mg sodium per 20 gram granules. This is equivalent to 125% of the recommended maximum daily dietary intake of sodium for an adult. Talk to your doctor or pharmacist if you need 3 or more grams daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.

This medicine contains 768 mg sucrose in each gram granules. This should be taken into account if you have diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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

Dose The daily dose of PHEBURANE will be based on your body weight or body surface and adjusted according to your protein tolerance and diet. You will need regular blood tests to determine the correct daily dose. Your doctor will tell you the amount of granules you should take.

Method of administration You should take PHEBURANE by mouth. Because it dissolves slowly, PHEBURANE should not be administered through a gastrostomy (tube that goes through the abdomen to the stomach) or through a nasogastric tube (tube that goes through the nose to the stomach).

PHEBURANE must be taken with a special diet reduced in protein.

You should take PHEBURANE with each meal or feeding. In small children this can be 4 to 6 times per day.

The doses of PHEBURANE prescribed by your doctor are expressed in grams of sodium phenylbutyrate. A calibrated measuring spoon which dispenses up to 3 g of sodium phenylbutyrate at a time is provided with the medicine. Only use this measuring spoon to measure out the dose of PHEBURANE. The measuring spoon must not be used for any other medicine.

To measure the dose:

Lines on the spoon indicate the amount of PHEBURANE in gram of sodium phenylbutyrate. Take the correct amount as prescribed by your doctor.

Pour granules directly into the spoon as shown by the picture (on the outer carton and in this leaflet).

Tap the spoon once on a table to give a horizontal level of granules and continue filling if necessary.

The granules can be directly swallowed with a drink (water, fruit juices, protein-free infant formulas) or sprinkled on to a spoonful of solid foods (mashed potatoes or apple sauce). If you mix them with food, it is important that you take it immediately. This will keep the granules from producing any taste.

You will need to take this medicine and to follow a diet throughout your life.

If you take more PHEBURANE than you should Patients who have taken very high doses of sodium phenylbutyrate experienced:

sleepiness, tiredness, light-headedness and less frequently confusion;

headache;

changes in taste (taste disturbances);

decrease in hearing;

disorientation;

impaired memory;

worsening of existing neurological conditions.

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.

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 odour, 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 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.

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.

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 calibrating measuring spoon is provided.

Marketing Authorisation Holder
Eurocept International BV Trapgans 5 1244 RL Ankeveen The Netherlands

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:

Belgi /Belgique/Belgien Lucane Pharma T l/Tel: + 33 153 868 info@lucanepharma.com

Lietuva
FrostPharma AB Tel: +46 775 86 80 info@lucanepharma.com

Lucane Pharma Te .: + 33 153 868 info@lucanepharma.com

Luxembourg/Luxemburg Lucane Pharma T l/Tel: + 33 153 868 info@lucanepharma.com esk republika Lucane Pharma T l/Tel: + 33 153 868 info@lucanepharma.com

Magyarorsz g Lucane Pharma Tel: + 33 153 868 info@lucanepharma.com Danmark FrostPharma AB Tlf: +45 808 20 info@frostpharma.com

Malta Lucane Pharma Tel: + 33 153 868 info@lucanepharma.com Deutschland Lucane Pharma Tel: + 33 153 868 info@lucanepharma.com

Nederland Lucane Pharma (Eurocept International BV) Tel: +31 35 528 39 info@euroceptpharma.com Eesti FrostPharma AB Tel: +46 775 86 80 info@frostpharma.com Norge FrostPharma AB Tlf: +47 815 03 info@frostpharma.com

Lucane Pharma : + 33 153 868 info@lucanepharma.com

sterreich Lucane Pharma Tel: + 33 153 868 info@lucanepharma.com Espa a Lucane Pharma Tel: + 33 153 868 info@lucanepharma.com

Polska Lucane Pharma Tel: + 33 153 868 info@lucanepharma.com France Lucane Pharma T l: + 33 153 868 info@lucanepharma.com

Portugal Lucane Pharma Tel: + 33 153 868 info@lucanepharma.com Hrvatska Lucane Pharma Tel: + 33 153 868 info@lucanepharma.com

Rom nia Lucane Pharma Tel: + 33 153 868 info@lucanepharma.com

Ireland Lucane Pharma Tel: + 33 153 868 info@lucanepharma.com

Slovenija Lucane Pharma Tel: + 33 153 868 info@lucanepharma.com sland Lucane Pharma S mi: + 33 153 868 info@lucanepharma.com

Slovensk republika Lucane Pharma Tel: + 33 153 868 info@lucanepharma.com Italia Lucane Pharma Tel: + 33 153 868 info@lucanepharma.com Suomi/Finland FrostPharma AB Puh/Tel: +35 875 32 51 info@frostpharma.com

Lucane Pharma : + 33 153 868 info@lucanepharma.com

Sverige FrostPharma AB
Tel: +46 775 86 80 info@medicalneed.com Latvija FrostPharma AB Tel: +46 775 86 80 info@frostpharma.com United Kingdom (Northern Ireland) Lucane Pharma Tel: + 33 153 868 info@lucanepharma.com

This leaflet was last revised in:

Detailed information on this medicine is available on the European Medicines Agency web site: