NOTICE
ANSM - Updated on : 29/01/2024
Product name
SULFARLEM S 25 mg, coated tablet
Anetholtrithione
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You must always take this medicine exactly as instructed in this leaflet or by your doctor 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.
What does this leaflet contain?
1. What is SULFARLEM S 25 mg, coated tablet and what is it used for?
2. What do I need to know before taking SULFARLEM S 25 mg, coated tablet?
3. How do I take SULFARLEM S 25 mg, coated tablet?
4. What are the possible side effects?
5. How do I keep SULFARLEM S 25 mg, coated tablet?
6. Package contents and other information.
1. WHAT IS SULFARLEM S 25 mg AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: SALIVARY AND LACRYMAL SUBSTITUTE, ATC code: A: digestive system and metabolism/stomatology, S: sense organs/ophthalmology.
Recommended for dry mouth and eyes.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING SULFARLEM S 25 mg, coated tablet?
Never take SULFARLEM S 25 mg, coated tablet
- if the patient is a child under 6 years of age
- in case ofbiliary tract obstruction(notably gallstones).
- if you are allergic (hypersensitive) to wheat, due to the presence of wheat starch.
Warnings and precautions
Talk to your doctor or pharmacist before taking SULFARLEM S 25 mg, coated tablet.
Darker coloration of urine is normal during treatment.
This medicine contains azoic colouring agents (orange yellow S (E110) and cochineal red A (E124)) and may cause allergic reactions.
This medicine may be administered in the event of clique disease. Wheat starch may contain gluten, but only in trace amounts, and is therefore considered safe for people with celiac disease.
This medicine is not recommended for patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
In case of gall-bladder stones, consult your doctor.
This medicine is not recommended for patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases).
Children and adolescents
Not applicable.
Other medicinal products and SULFARLEM S 25 mg, coated tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
SULFARLEM S 25 mg, coated tablet with food and alcohol
Not applicable.
Pregnancy and breast-feeding
The use of this drug should generally be avoided during pregnancy.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
This drug should not be used during breast-feeding.
As a general rule, always ask your doctor or pharmacist before taking any medication during pregnancy or while breast-feeding.
Driving and use of machinery
Not applicable.
SULFARLEM S 25 mg, coated tablet contains wheat starch, lactose, orange yellow S (E110), cochineal red A (E124) and sucrose.
This medicine contains azo colouring agents (orange yellow S (E110) and cochineal red A (E124)) and may cause allergic reactions.
This medicine contains a very low level of gluten (from wheat starch) and is therefore unlikely to cause problems in the case of celiac disease. If you have an allergy to wheat (other than cliquish disease), you should not take this medicine.
If your doctor has informed you that you are intolerant to certain sugars, contact him/her before taking this medicine.
3. HOW DO I TAKE SULFARLEM S 25 mg, coated tablet?
The recommended dose is 1 tablet 3 times a day with meals.
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Oral administration.
If you have taken more SULFARLEM S 25 mg, coated tablet than you should have
Consult your doctor or pharmacist immediately.
If you forget to take SULFARLEM S 25 mg, coated tablet
Not applicable.
If you stop taking SULFARLEM S 25 mg, coated tablet
Not applicable.
If you have any further questions about the use of this medicine, please ask your 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:
- mild digestive disorders (diarrhoea, flatulence, meteorism), which subside with reduced doses.
- SULFARLEM may darken the color of urine.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effect 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: https://signalement.social-sante.gouv.fr/.
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE SULFARLEM S 25 mg, coated tablet?
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 SULFARLEM S 25 mg coated tablet contains
- The active substance is :
Anetholtrithione .......................................................................................................... 25.00 mg
For one coated tablet.
- Other excipients include:
Lactose monohydrate, gum arabic, wheat starch, sucrose, guar gum, colloidal silica hydrate, magnesium stearate, gelatin, talc, titanium dioxide (E171), orange yellow S (E110), cochineal red A (E 124), carnauba wax.
What is SULFARLEM S 25 mg, coated tablet and what does it contain?
This medicine comes in coated tablet form. Each box contains 60 or 90 coated tablets.
Not all presentations may be marketed.
Marketing authorization holder
EXOD
6 PARC DE MONTRETOUT
92210 SAINT-CLOUD
Marketing authorization holder
EG LABO - LABORATOIRES EUROGENERICS
CENTRAL PARK
9-15 RUE MAURICE MALLET
92130 ISSY-LES-MOULINEAUX
Manufacturer
inPHARMAsci
ZI N° 2 DE PROUVY - ROUVIGNIES
1 RUE DE NUNGESSER
59121 PROUVY
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
< {MM/YYYY}>.
Other
Not applicable.
Detailed information on this drug is available on theANSM (France) website.