NOTICE
ANSM - Last updated: 20/01/2017
Name of the medicinal product
LOBAMINE CYSTEINE, capsule
DL-methionine, Anhydrous cysteine hydrochloride
framed
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
This is an authorized and controlled medicinal product (see identification number on the outer packaging):
· This medication can be used for self-medication, ie used without consultation or prescription from a doctor;
· If symptoms persist, worsen or new symptoms appear, seek advice from your pharmacist or doctor;
· This leaflet is designed to help you use this medicine. Keep it, you may need to reread it.
· If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
· Do not use this medication for children.
Review summary
In this notice :
1. WHAT IS LOBAMINE CYSTEINE, capsule AND WHAT CASES IS IT USED FOR?
2. BEFORE YOU TAKE LOBAMINE CYSTEINE, capsule?
3. HOW TO TAKE LOBAMINE CYSTEINE, capsule?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE LOBAMINE CYSTEINE, capsule?
6. ADDITIONAL INFORMATION
1. WHAT IS LOBAMINE CYSTEINE, capsule AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group
D11AX: Other dermatological drugs.
This medicine contains 2 sulfur-containing amino acids: DL-methionine and anhydrous cysteine hydrochloride. It belongs to the class of dermatological drugs.
Therapeutic indications
It is used as an adjunct to adult hair loss.
2. BEFORE YOU TAKE LOBAMINE CYSTEINE, capsule?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take LOBAMINE CYSTEINE, capsule:
· If you are allergic to DL-Methionine, or to anhydrous cysteine hydrochloride or any of the other ingredients of LOBAMINE CYSTEINE capsule.
· If you suffer from metabolic acidosis (abnormal state of blood acidification due to certain diseases).
· If you suffer from homocystinuria (hereditary disorders of amino acid metabolism).
In case of doubt do not hesitate to ask the advice of your doctor or pharmacist.
Precautions for use; special warnings
Take special care with LOBAMINE CYSTEINE, capsule:
Precautions for use
LOBAMINE CYSTEINE should be used with caution in patients with hepatic and renal insufficiency. It may worsen the condition of hepatic encephalopathy already present in patients with hepatic impairment.
In case of doubt do not hesitate to ask the advice of your doctor or pharmacist.
Interaction with other medicines
Taking other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
This medication should be used with caution during pregnancy and lactation.
Generally, during pregnancy and breast-feeding, you should always seek advice from your doctor or pharmacist before using any medication.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO TAKE LOBAMINE CYSTEINE, capsule?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Reserved for adults only.
4 to 6 capsules per day, in 2 to 3 doses, to be taken preferably during the meals.
Always use the dosage described in this leaflet. If in doubt, consult your doctor or pharmacist.
Method and route of administration
Oral use.
Duration of treatment
Treatment of 1 month.
Symptoms and Instructions for Overdose
If you take more LOBAMINE CYSTEINE, capsule than you should:
Possible overdose may lead to worsening of adverse effects (nausea, vomiting and irritability). If you think you may have taken more LOBAMINE CYSTEINE capsule than you should, contact your doctor or pharmacist.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, LOBAMINE CYSTEINE, capsule is likely to have undesirable effects, although not everyone is subject to it.
Cases of headache, nausea, diarrhea and abdominal pain have been reported after the product has been marketed.
These effects are in the majority of moderate and transient cases.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly through the national reporting system : National Agency for the Safety of Medicines and Health Products (Ansm) and network of Regional Centers of Pharmacovigilance. Website: www.ansm.sante.fr . By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE LOBAMINE CYSTEINE, capsule?
Keep out of the reach and sight of children.
Expiration date
Do not use LOBAMINE CYSTEINE capsule after the expiry date which is stated on the outer packaging.
The expiry date refers to the last day of the month.
Storage conditions
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does LOBAMINE CYSTEINE contain, capsule?
The active substances are :
DL-methionine ............................................... .................................................. .................................. 350 mg
Anhydrous cysteine hydrochloride .............................................. .................................................. 150 mg
For a capsule.
The other components are :
Excipients : anhydrous colloidal silica, magnesium stearate.
Composition of the capsule: gelatin, titanium dioxide.
Pharmaceutical form and content
What is LOBAMINE CYSTEINE, capsule and contents of the pack?
This medication is in capsule form, boxes of 20, 60 or 120.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
DUCRAY DERMATOLOGICAL LABORATORIES
45, place Abel Gance
92100 BOULOGNE
exploiting
PIERRE FABRE DERMATOLOGIE
THE CAUQUILLOUS
81506 LAVAUR CEDEX
Maker
SIMAPHAC LABORATORIES
INDUSTRIAL ZONE
45220 CHATEAURENARD
or
PIERRE FABRE MEDICAMENT PRODUCTION
PROGIPHARM website
Street of Lycée
45500 Gien
Names of the medicinal product in the Member States of the European Economic Area
In accordance with the regulations.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Other
SANITARY EDUCATION COUNCILS
a / What is an androgenetic alopecia?
Normally the hair has a lifetime of 3 to 6 years and it drops 50 to 100 hair per day.
A greater fall in hair may occur seasonally (in the fall) or after delivery: this fall is normal, transient and there is no need to start treatment.
Alopecia is defined as hair loss greater than 100 hairs per day.
There are two types of alopecia:
· acute alopecia,
· chronic alopecia.
Acute alopecia (sudden hair loss over a short period of time) may be diffuse or patchy (alopecia areata) and are most often of known cause (aggressive hair care, poor general condition, poorly balanced weight loss, psychic, stress ...). These acute alopecia should not be treated with this medication.
Chronic (long-term) alopecia are almost always diffuse. They are sometimes due to a specific disease (thyroid, metabolic ...) and they should not be treated with this drug. In the vast majority, these chronic alopecia are of poorly known origin, usually of hereditary nature: it is androgenetic alopecia. Only this type of alopecia can be treated with LOBAMINE CYSTEINE.
b / How to recognize androgenetic alopecia?
* In women: Androgenetic alopecia is diffuse: there is an overall decrease in capillary density. The hair gradually clears from the skate.
* In humans: androgenetic alopecia begins with a degeneration of the temporal gulfs. Then a slight tonsure appears at the top of the skull. These two hairless areas will gradually increase: the androgenetic alopecia is gradually evolving towards baldness.
c / Some additional information
· At the beginning of treatment, over a short period, it is possible that an increase in hair loss occurs. These hair were destined to fall and do it more quickly. This is a normal phenomenon, continue treatment.
· The first hair that grows will be soft, fluffy and not very visible. As you continue your treatment, they can change and thicken.