NOTICE
ANSM - Updated on : 14/02/2024
Product name
MILDAC 300 mg, coated tablet
St John's wort (dry extract of flowering top)
Box
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as your doctor or pharmacist tells you.
- 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 of the side effects listed above, please tell 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 after 15 days.
What does this leaflet contain?
1. What is MILDAC 300 mg, coated tablet and what is it used for?
2. What do I need to know before taking MILDAC 300 mg, coated tablet?
3. How do I take MILDAC 300 mg, coated tablet?
4. What are the possible side effects?
5. How do I keep MILDAC 300 mg, coated tablet?
6. Package contents and other information.
1. WHAT IS MILDAC 300 mg, coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code: N06AX.
Herbal medicine traditionally used in the treatment of mild, transient depressive symptoms.
You should consult your doctor if you do not feel any improvement or if you feel less well after 15 days.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING MILDAC 300 mg, coated tablet?
Strict compliance with recommended doses is essential.
Never take MILDAC 300 mg, coated tablet:
- if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine, as listed in section 6.
- if you are pregnant
- In association with anti-coagulants, anti-epileptics, contraceptives (stroprogestogens and progestogens), digoxin and verapamil (used to treat heart disease), immunosuppressants (used in organ transplants), drugs used to treat HIV infections including protease inhibitors and others, drugs used to treat hepatitis C infections, drugs used to treat certain cancers (tyrosine kinase inhibitors, lirinotecan, vinca alkaloids, taxanes, eribulin, letoposide, idelalisib, vismodegib and cyclophosphamide), antimycotics, lurasidone (used in schizophrenia), loxycodone (analgesic), theophylline and laminophylline (used in the treatment of asthma and certain respiratory diseases) and ticagrelor (anti-platelet agent) (see "Other drugs and MILDAC 300 mg, coated tablet").
- If you are already taking other antidepressants (iproniazid, nialamide, methylene blue, linezoline, moclobemide, toloxatone, citalopram, dapoxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline).
Warnings and precautions
Talk to your doctor or pharmacist before taking MILDAC.
If your doctor has informed you that you are intolerant to certain sugars, contact him/her before taking this medicine.
If you are taking other medications, consult your doctor before starting treatment (see "Other drugs and MILDAC").
The antidepressant properties of MILDAC usually become apparent within the first 4 weeks of treatment. If symptoms persist, consult your doctor.
Avoid prolonged exposure to the sun during treatment, as there is a risk of skin reactions resembling sunburn (photosensitivity).
If you are due to undergo surgery, inform your doctor if you are taking MILDAC.
Children
Use in children and adolescents under 18 years of age is not recommended in the absence of sufficient data.
Other drugs and MILDAC 300 mg, coated tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicine. MILDAC may reduce the therapeutic effect of other medicines.
MILDAC should not be taken with anticoagulants, antiepileptics, contraceptives (stroprogestogens and progestogens), digoxin and verapamil (used to treat heart disease), immunosuppressants (used in organ transplants), antidepressants (non-selective MAOIs, selective A MAOIs and selective serotonin reuptake inhibitors), drugs used in the treatment of HIV infection (e.g. protease inhibitors, protease inhibitors, antidepressants).e.g. protease inhibitors, cobicistat, dolutegravir, nevirapine and rilpivirine), drugs used in the treatment of hepatitis C (daclatasvir, dasabuvir, ledipasvir, sofosbuvir), drugs used in the treatment of certain cancers (tyrosine kinase inhibitors, irinotecan, letoposide, vinca alkaloids, vismodegib and cyclophosphamide), antimycotics (isavuconazole, itraconazole and voriconazole), theophylline and laminophylline (used in the treatment of asthma and certain respiratory diseases), ticagrelor (anti-platelet agent), buspirone (used to treat anxiety disorders), methadone (used in opiate dependence).
Tell your doctor or pharmacist if you are taking or have recently taken any medicine containing any of the following active ingredients:
- bedaquiline(used to treat tuberculosis)
- benzodiazepines and derivatives such as midazolam (used to treat anxiety disorders)
- carbamazepine (used to treat epilepsy )
- clozapine
- dronedaroneand propafenone (used to treat heart rhythm disorders)
- fexofenadine (antihistamine)
- finasteride(testosterone 5α-reductase enzyme inhibitor)
- ivabradine (used to treat langor) ,
- lomitapide(used in certain cases of familial hypercholesterolemia)
- macitentan (used to treat pulmonary arterial hypertension)
- maraviroc
- ninedanib
- quetiapine (used to treat schizophrenia)
- regorafenib
- simeprevir
- simvastatin (used to treat hypercholesterolemia or dyslipidemia)
- telithromycin and linezolid (antibiotics)
- ulipristal (emergency contraceptive).
If your doctor prescribes other medications for depression, tell him/her that you are already taking MILDAC.
MILDAC 300 mg, coated tablet with food, drink and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
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.
MILDAC should not be used during pregnancy.
MILDAC should not be used during breast-feeding.
Driving and use of machinery
Not applicable.
MILDAC 300 mg, coated tablet contains lactose.
3. HOW DO I TAKE MILDAC 300 mg, coated tablet?
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.
Dosage
Adults and the elderly.
The recommended dose is 1 to 3 tablets a day, divided into 3 doses during the day.
Use in children and adolescents
This drug is not recommended for children and adolescents under 18 years of age.
Method of administration
Oral administration. Preferably taken at the same time each day.
Duration of treatment
The first effects occur within the first 4 weeks of treatment. If symptoms persist during treatment, consult a doctor.
If you have taken more MILDAC than you should have
Consult your doctor or pharmacist immediately.
If you miss a dose
Do not take a double dose to make up for the one you forgot to take;
If you stop taking MILDAC 300 mg, coated tablet
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.
Digestive disorders, fatigue, restlessness or allergic reactions may occur.
Excessive sensitivity to sunlight (photosensitivity) with skin reactions resembling sunburn may occur in the event of sun exposure during treatment.
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: https://signalement.social-sante.gouv.fr
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE MILDAC 300 mg, coated tablet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Do not use if you notice any visible signs of deterioration.
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 MILDAC 300 mg coated tablet contains
- The active substance is :
St John's wort(Hypericum perforatum L.) (quantified dry extract of flowering tops of)............ 312 mg
Quantified :
o 0.1 to 0.3% total hypericins expressed as hypericin,
o at least 6% flavonoids (corresponding to at least 1.5% rutin)
o maximum 6% hyperforin.
o Extraction solvent: 80% V/V methanol.
o Drug:native extract ratio: 3-7:1
For one coated tablet.
- The other components are:
Microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, precipitated silica, magnesium stearate, hypromellose, macrogol 4000, lactose monohydrate, vanillin, saccharin sodium, yellow iron oxide (E 172), titanium dioxide (E 171), talc, simethicone, methylcellulose, sorbic acid, ascorbic acid.
What MILDAC 300 mg, coated tablet is and what it contains
Coated tablet.
Boxes of 15, 20, 30, 40 or 45 tablets in blister packs.
Not all presentations may be marketed.
Marketing authorization holder
DR. WILLMAR SCHWABE GmbH & Co
WILLMAR-SCHWABE-Str. 4
76227 KARLSRUHE
GERMANY
Marketing authorization holder
MENARINI France
1-7 Rue du Jura
94633 Rungis Cedex
Manufacturer
DR. WILLMAR SCHWABE GmbH & Co
WILLMAR-SCHWABE-Str. 4
76227 KARLSRUHE
GERMANY
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is :
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Other
Detailed information on this drug is available on the ANSM (France) website.