In this manual :
1. WHAT IS LOBAMINE CYSTEINE, capsule AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING LOBAMINE CYSTEINE, capsule?
3. HOW DO I TAKE LOBAMINE CYSTEINE, capsule?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE LOBAMINE CYSTEINE, capsule?
6. ADDITIONAL INFORMATION
1. WHAT IS LOBAMINE CYSTEINE, capsule and WHAT IS IT USED FOR?
Pharmacotherapeutic class
D11AX: Other dermatological drugs.
This medicine contains 2 sulphur-containing amino acids: DL-methionine and cysteine hydrochloride anhydrous. It belongs to the class of dermatological drugs.
It is used in the adjunctive treatment of hair loss in adults.
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING LOBAMINE CYSTEINE, capsule?
List of information needed before taking the medicine
Not applicable.
Never take LOBAMINE CYSTEINE, capsule:
- If you are allergic to DL-Methionine, or cysteine hydrochloride anhydrous or any of the other components contained in 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 your doctor or pharmacist for advice.
Precautions for use; special warnings
Be careful with LOBAMINE CYSTEINE, capsule:
Precautions for use
LOBAMINE CYSTEINE should be used with caution in patients with impaired liver or kidney function. It may aggravate the condition of an already established hepatic encephalopathy in patients with hepatic insufficiency.
In case of doubt, do not hesitate to ask your doctor or pharmacist for advice.
Interactions 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 drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
Pregnancy and lactation
This medicine should be used with caution during pregnancy and lactation.
In general, during pregnancy and lactation, always ask your doctor or pharmacist for advice before using any medication.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with a known effect
Not applicable.
3. HOW TO TAKE LOBAMINE CYSTEINE, capsule
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
For adults only.
4 to 6 capsules per day, in 2 to 3 doses, preferably taken with meals.
Always follow the dosage described in this leaflet. In case of doubt, consult your doctor or pharmacist.
Method and route of administration
ORAL.
Duration of treatment
1 month treatment.
Symptoms and instructions in case of overdose
If you have taken more LOBAMINE CYSTEINE capsule than you should have:
Any overdose may result in worsening of the side effects (nausea, vomiting and irritability). If you think you have taken more LOBAMINE CYSTEINE, capsule than you should have, please contact your doctor or pharmacist.
Instructions in case of missed doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, LOBAMINE CYSTEINE, capsule is likely to have side effects, although not everyone is susceptible.
Headache, nausea, diarrhea and abdominal pain have been reported in post-marketing experience.
These effects are in most cases moderate and transient.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
5. HOW TO STORE LOBAMINE CYSTEINE, capsule
Keep out of the reach and sight of children.
Do not use LOBAMINE CYSTEINE, capsule after the expiry date stated on the outer packaging.
The expiry date refers to the last day of the month.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does LOBAMINE CYSTEINE capsule contain?
The active ingredients are :
DL-methionine................................................................................................................................... 350 mg
Cysteine hydrochloride anhydrous....................................................................................................... 150 mg
For one capsule.
The other components are:
Excipients: colloidal anhydrous silica, magnesium stearate.
Capsule composition: gelatin, titanium dioxide.
Pharmaceutical form and content
What is LOBAMINE CYSTEINE, capsule and what does it contain?
This medicine is presented in capsule form, boxes of 20, 60 or 120.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
PIERRE FABRE DERMATOLOGIE
45, Place Abel Gance
92100 Boulogne
Operator
PIERRE FABRE MEDICAMENT
45, place Abel-Gance
92654 BOULOGNE CEDEX
Manufacturer
LABORATOIRES SIMAPHAC
ZONE INDUSTRIELLE
45220 CHATEAURENARD
OR
PIERRE FABRE MEDICAMENT PRODUCTION
pROGIPHARM site
Rue du Lycée
45500 Gien
Names of the medicinal product in the member states of the European Economic Area
In accordance with the regulations in force.
Date of approval of the package leaflet
The last date on which this leaflet was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
HEALTH EDUCATION ADVICE
a/ What is androgenetic alopecia?
Normally, hair has a lifespan of 3 to 6 years and 50 to 100 hairs fall out per day.
More significant hair loss can occur seasonally (in autumn) or after childbirth: this loss is normal, transitory and there is no need to start 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 of time) can be diffuse or in patches (alopecia) and is most often due to known causes (aggressive hair care, poor general condition, poorly balanced weight loss treatment, certain medications, psychological shock, stress, etc.). These acute alopecias should not be treated with this medicine.
Chronic (long-term) alopecia is almost always diffuse. They are sometimes due to a specific disease (thyroid, metabolic, etc.) and should not be treated with this drug. In the vast majority of cases, these chronic alopecias are of poorly known origin, most often hereditary in nature: 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 becomes progressively thinner from the parting.
* In men: androgenetic alopecia begins with a balding of the temporal gulfs. Then a slight baldness appears at the top of the skull. These two hairless areas will progressively enlarge: androgenetic alopecia progressively evolves towards baldness.
c/ Some additional information
- At the beginning of the treatment, over a short period of time, it is possible that hair loss increases. These hairs were destined to fall out and do so more rapidly. This is a normal phenomenon, continue the treatment.
- The first hair to grow will be soft, fluffy and not very visible. As you continue your treatment, they may change and become thicker.
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