NOTICE
ANSM - Updated on : 25/07/2018
Product name
FONCITRIL 4000, granules in dose sachet
Citric acid, potassium citrate, sodium citrate
Enclosed
Please read this leaflet carefully before taking this medicine as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is FONCITRIL 4000, granules in a sachet and what is it used for?
2. What do I need to know before taking FONCITRIL 4000, granules in a sachet?
3. How should FONCITRIL 4000 granules be taken?
4. What are the possible side effects?
5. How should FONCITRIL 4000 granules be stored?
6. Package contents and other information.
1. WHAT IS FONCITRIL 4000, granules in a sachet and WHAT IS IT USED FOR?
Pharmacotherapeutic class: OTHER UROLOGICAL DRUGS (G: genitourinary system and sex hormones)
This drug is indicated to promote urine alkalinization.
You should consult your doctor if you do not feel any improvement or if you feel less well.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING FONCITRIL 4000, granules in sachet-dose?
Never take FONCITRIL 4000, granules in a sachet:
- if you are allergic to citric acid or potassium citrate or sodium citrate, or to any of the other components of this medicine listed in section 6.
- in case of alkalosis (insufficient acidity of the blood).
Warnings and precautions
- Use of this product requires medical supervision.
- Urinary pH should be checked regularly.
- Drink plenty of fluids during treatment.
- Alkalinization of urine can be achieved by a low-protein diet rich in vegetables with alkaline residues, particularly citrus fruits.
- This drug is not recommended for patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare metabolic disorders).
- This medicine contains 5.1 g of sucrose per sachet, which should be taken into account in the daily ration in the case of a low-sugar diet or diabetes.
- This medicine contains 200 mg sodium (main component of table salt) per sachet. This is equivalent to 10% of the recommended maximum daily intake of sodium for an adult. Talk to your doctor or pharmacist if you need 2 or more sachets daily for a prolonged period, especially if you are on a low-salt (sodium) diet.
- This medicine contains potassium. It contains 293 mg potassium per sachet. To be taken into account in patients with renal insufficiency or in patients controlling their dietary intake of potassium.
- This medicine contains an azoic agent (E110, orange-yellow) and may cause allergic reactions.
Ask your doctor or pharmacist before taking FONCITRIL 4000, granules in a sachet.
Children
Not applicable.
Other medicines and FONCITRIL 4000, granules in sachet-dose
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
FONCITRIL 4000, granules in sachet with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
This medicine should only be used during pregnancy on the advice of your doctor.
If you discover that you are pregnant during treatment, consult your doctor, who is the only person who can judge whether it is necessary to continue treatment.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist>for advice before taking this medicine.
Driving and using machines
Not applicable.
FONCITRIL 4000, granules in sachet contains sucrose, sodium, potassium and orange yellow S (E110).
3. HOW DO I TAKE FONCITRIL 4000, granules in a sachet?
Always take this medicine exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
FOR ADULTS ONLY
The recommended dose is :
- Attack treatment: 3 to 4 sachets per day.
- Maintenance treatment: 1 to 2 sachets per day.
Oral use.
The sachet should be dissolved in a large glass of water and taken after meals.
If you have taken more FONCITRIL 4000 granules in a sachet than you should have:
Not applicable.
If you forget to take FONCITRIL 4000, granules in sachet :
Not applicable.
If you stop taking FONCITRIL 4000, granules in a sachet:
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
- Gastrointestinal disorders: digestive disorders such as diarrhoea may occur with high doses of FONCITRIL 4000.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE FONCITRIL 4000, granules in sachet-dose?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging after EXP. The expiration date refers to the last day of that month.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What FONCITRIL 4000 granules in sachet contains
- The active ingredients are :
Citric acid monohydrate
Corresponding quantity of citric acid.............................................................................. 1.189 g
Anhydrous monopotassium citrate........................................................................................... 1.730 g
Anhydrous monosodium citrate................................................................................................ 1.845 g
- Other ingredients: saccharin sodium, concentrated orange juice, sweet orange essential oil, mandarin essential oil, orange yellow S (E110), saccharose.
What FONCITRIL 4000 granules are and what they contain
This medicine comes in the form of granules in a sachet. Box of 30 sachets.
Marketing authorization holder
SOCIETE DETUDES ET DE RECHERCHES PHARMACEUTIQUES (S.E.R.P.)
5, RUE DU GABIAN
IMMEUBLE LE TRITON
98000 MONACO
MONACO
Marketing authorization holder
SOCIETE DETUDES ET DE RECHERCHES PHARMACEUTIQUES (S.E.R.P.)
5, RUE DU GABIAN
IMMEUBLE LE TRITON
98000 MONACO
MONACO
Manufacturer
SOCIETE DETUDES ET DE RECHERCHES PHARMACEUTIQUES (S.E.R.P.)
5, RUE DU GABIAN
IMMEUBLE LE TRITON
98000 MONACO
MONACO
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder]
< {MM/YYYY}>< {month/YYYY}.>
Other
Not applicable.
Detailed information on this drug is available on the ANSM (France) website.