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Lobamine Cysteine ??capsules from Pierre Fabre Laboratories belong to the dermatological drug class.
This medication is used as an adjunctive treatment for hair loss in adults.
Composition of Lobamine Cysteine
This medication contains two sulfur-containing amino acids: DL-methionine (350 mg) and anhydrous cysteine ??hydrochloride (150 mg). The excipients are anhydrous colloidal silica and magnesium stearate, while the capsule is composed of gelatin and titanium dioxide.
Dosage and duration of treatment with Lobamine Cysteine ??for hair
The recommended dosage is 4 to 6 capsules per day, taken 2 to 3 times a day for 1 month.
Overdose may increase the risk of adverse effects (nausea, vomiting, irritability).
Precautions and Contraindications for Lobamine Cysteine
This anti-hair loss medication should be used with caution during pregnancy or breastfeeding. Always seek medical advice before use.
In patients with renal or hepatic impairment, Lobamine Cysteine ??should only be used on medical advice due to the risk of worsening existing hepatic encephalopathy.
This medication should not be used for hair loss in cases of metabolic acidosis or homocystinuria.
If you are allergic to any of the ingredients, including the excipients (colloidal anhydrous silica, magnesium stearate, gelatin, titanium dioxide), you should not take Lobamine Cysteine.
Side Effects of Lobamine Cysteine
This medication may cause headaches, nausea, diarrhea, or abdominal pain. Most of the time, these effects are transient and mild.
Packaging: Box of 60 or 120 capsules.
For male androgenic alopecia, Pierre Fabre offers Alopexy 5% minoxidil.
LEAFLET
ANSM - Updated on: 03/30/2023
Name of the medicinal product
LOBAMINE CYSTEINE, capsule
DL-methionine, Anhydrous cysteine ??hydrochloride
Box
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
You must always take this medicine exactly as provided in this leaflet or by your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
Ask your pharmacist for advice or information.
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
You must talk to your doctor if you do not feel better or if you feel worse.
What is in this leaflet? 1. What is LOBAMINE CYSTEINE, capsule and what is it used for?
2. What you need to know before taking LOBAMINE CYSTEINE, capsule?
3. How to take LOBAMINE CYSTEINE, capsule?
4. Possible side effects?
5. How to store LOBAMINE CYSTEINE, capsule?
6. Contents of the pack and other information.
1. WHAT IS LOBAMINE CYSTEINE, capsule AND WHAT IS IT USED FOR?
Pharmacotherapeutic group: AMINO ACIDS INCLUDING COMBINATIONS WITH POLYPEPTIDES - ATC code: V06DD.
This medicine contains two sulfur-containing amino acids: DL-methionine and anhydrous cysteine ??hydrochloride.
It is used as an adjunctive treatment for hair loss in adults.
2. WHAT YOU NEED TO KNOW BEFORE TAKING LOBAMINE CYSTEINE, capsule?
Do not take LOBAMINE CYSTEINE, capsule:
· If you are allergic to DL-methionine, or anhydrous cysteine ??hydrochloride, or to any of the other ingredients of this medicine, listed in section 6.
· If you suffer from metabolic acidosis (abnormal blood acidification due to certain diseases)
· If you suffer from homocystinuria and/or hypermethioninemia (hereditary disorders of amino acid metabolism).
If in doubt, do not hesitate to ask your doctor or pharmacist for advice. Warnings and Precautions
Talk to your doctor or pharmacist before taking LOBAMINE CYSTEINE if you have:
· Liver function impairment (hepatic failure): LOBAMINE CYSTEINE should be used with caution in patients with liver function impairment.
· Kidney function impairment (renal failure): LOBAMINE CYSTEINE should be used with caution in patients with kidney function impairment.
LOBAMINE CYSTEINE may worsen brain function problems caused by liver failure (hepatic encephalopathy), which may already exist in patients with liver failure.
Worsening of hepatic encephalopathy may include:
· Difficulty thinking,
· Confusion,
· Tremors,
· Decreased level of consciousness, possibly leading to coma.
Use in Children
Do not give this medicine to children and adolescents, as its safety and efficacy have not been evaluated. Other medicines and LOBAMINE CYSTEINE, capsule
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
LOBAMINE CYSTEINE, capsule with food and drink
Not applicable.
Pregnancy and breastfeeding
IF YOU ARE PREGNANT OR BREASTFEEDING, THINK YOU MAY BE PREGNANT, OR PLAN TO HAVE A PREGNANCY, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE BEFORE TAKING THIS MEDICINE.
Pregnancy
As a precautionary measure and given the indication, it is preferable to avoid using LOBAMINE CYSTEINE during pregnancy.
Breastfeeding
This medicine passes into breast milk. A risk to newborns/infants cannot therefore be excluded. The decision to discontinue breastfeeding or to discontinue treatment with this medicine must be made taking into account the benefits of breastfeeding for the child and the benefits of treatment for the woman. Driving and using machines
Not applicable.
LOBAMINE CYSTEINE capsule contains
Not applicable.
3. HOW TO TAKE LOBAMINE CYSTEINE capsule?
Dosage
For adults only.
4 to 6 capsules per day, in 2 to 3 doses.
Always follow the dosage instructions in this leaflet. If in doubt, consult your doctor or pharmacist.
Method and route of administration
Oral use.
Preferably take with meals.
Duration of treatment
1-month treatment.
If you take more LOBAMINE CYSTEINE capsule than you should
A possible overdose may cause worsening of side effects (nausea, vomiting, and irritability). If you think you have taken more LOBAMINE CYSTEINE than you should, please contact your doctor or pharmacist. If you forget to take LOBAMINE CYSTEINE, capsule
Do not take a double dose to make up for a forgotten dose.
If you stop taking LOBAMINE CYSTEINE, capsule
Not applicable.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
These side effects occur with an unknown frequency (which cannot be estimated from the available data):
Headache,
Nausea,
Diarrhea,
Abdominal pain.
These effects are mostly mild and transient.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE LOBAMINE CYSTEINE, capsule?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date shown on the outer packaging after EXP. The expiry date refers to the last day of that month.
No special storage conditions are required.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What LOBAMINE CYSTEINE, capsule contains
· The active ingredients are:
DL-methionine...................................................................................................................... 350 mg
Anhydrous cysteine ??hydrochloride.................................................................................. 150 mg
Per capsule.
· The other ingredients are:
Excipients: anhydrous colloidal silica, magnesium stearate.
Capsule composition: gelatin, titanium dioxide.
What LOBAMINE CYSTEINE, capsule looks like and contents of the outer packaging
This medicine comes in the form of a capsule, approximately 22 mm long, opaque white.
Boxes of 20, 60, or 120.
Not all pack sizes may be marketed. Marketing Authorization Holder
PIERRE FABRE MEDICAMENT
LES CAUQUILLOUS
81500 LAVAUR
Marketing Authorization Holder
PIERRE FABRE MEDICAMENT
Parc Industriel de la Chartreuse
81100 CASTRES
Manufacturer
PIERRE FABRE MEDICAMENT PRODUCTION
PROGIPHARM SITE
RUE DU LYCEE
45500 GIEN
Names of the medicinal product in the Member States of the European Economic Area
In accordance with current legislation.
This leaflet was last revised:
[to be completed later by the holder]
Other
Detailed information on this medicinal product is available on the ANSM website (France).
Health Education Council
a/ What is androgenetic alopecia? Normally, hair has a lifespan of 3 to 6 years and 50 to 100 hairs are lost per day.
More significant hair loss may occur seasonally (in the fall) or after childbirth: this loss is normal, transient, and does not require treatment.
Alopecia is defined as hair loss of more than 100 hairs per day.
There are two types of alopecia:
· Acute alopecia
· Chronic alopecia
Acute alopecia (sudden hair loss over a short period) can be diffuse or in patches (alopecia areata) and is most often of known cause (aggressive hair care, poor general health, poorly balanced weight loss program, certain medications, psychological shock, stress, etc.). These acute alopecias should not be treated with this medication.
Chronic alopecia (long-term) is almost always diffuse. They are sometimes due to a specific disease (thyroid, metabolic, etc.) and should not be treated with this medication. In the vast majority of cases, these chronic alopecias are of unknown origin, most often hereditary: this 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 hair density. The hair gradually thins from the parting.
* In men: Androgenetic alopecia begins with a thinning of the temples. Then, a slight tonsure appears on the crown of the head. These two hairless areas will gradually enlarge: androgenetic alopecia gradually progresses to baldness.
c/ Some additional information
· At the beginning of treatment, over a short period of time, an increase in hair loss may occur. This hair was meant to fall out and is now falling out more quickly. This is normal; continue treatment.
· The first hairs that grow will be soft, fluffy, and barely visible. Gradually, as you continue your treatment, they may change and thicken.