MILDAC 600 MG TABLETS 15 EVENTS depressive

MILDAC 600 MG TABLETS 15 EVENTS depressive View larger

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Mediflor Mildac 600mg 15 Tablets Events depression is a herbal medicine based Wort indicated in the acute treatment of depressive symptoms in mild and transient. Tablets 600mg Mildac Mediflor are reserved for adults.

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Mediflor Mildac 600mg 15 Tablets depressive Events

Description Mediflor mildac 600mg depressive manifestations

Mediflor Mildac 600mg of Merck is a herbal medicine in the form of coated tablets used in the treatment of short duration transient states of sadness and accompanied by declining interest and sleep disorders.

For adults, Mediflor Mildac 600mg Tablets is traditionally used in mild and transient depressive symptoms

Application advice and opinions on mildac 600mg cpr 15

Take 1 tablet of 600mg Mediflor Mildac day, preferably in the morning. Do not exceed 15 days of treatment without medical advice.

For adults only. Medication, carefully read the instructions, ask your pharmacist for advice if symptoms persist consult your doctor. Store at a temperature not exceeding 25 ° C.

Composition mildac 600mg cpr 15

Dry methanol wort 612 mg. Excipients: ascorbic acid, microcrystalline cellulose, croscarmellose sodium, iron oxide (E172), hypromellose, stearic acid, magnesium stearate, saccharin sodium, colloidal silica, titanium dioxide (E 171), talc, vanillin, qs 1 film-coated tablet .


Precaution for use with mildac 600mg cpr 15

This medication is against-indicated in the following situation:

In association with:

  • Oral anti-coagulants
  • Anticonvulsants (ethosuximide, felbamate, fosphenytoin, lamotrigine, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, valpromide) except with carbamazepine (see recommended association), gabapentin and vigabatrin,
  • Oral contraceptives,
  • Digoxin
  • Immunosuppressives (cyclosporine, sirolimus, tacrolimus)
  • Protease inhibitors (amprenavir, atazanavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir),
  • The tyrosine kinase inhibitors
  • Irinotecan,
  • Theophylline.

Precautions:

  • The use of St. John's wort is not recommended during pregnancy or whatsoever in the term and in women of childbearing potential not using contraceptive measures (see Pregnancy and lactation).


Pregnancy:

  • Use of this medicine is not recommended, unless otherwise directed by your doctor during pregnancy. If you discover that you are pregnant during the treatment, consult your doctor promptly, it can only adapt the treatment to your condition.


Breastfeeding:

  • Ask your doctor or pharmacist before taking any medicine

Introducing mildac 600mg cpr 15

Box of 15 tablets

Our expert advice pharmacy

Interaction with other medicinal products and other forms of interaction:


Associations against-indicated:

  • Oral anticoagulant: Decreased plasma concentrations of oral anticoagulant with a risk of reduced efficiency and even reversal of the effect, the consequences can be potentially serious (thrombotic event). In case of fortuitous association, do not stop suddenly taking St. John's Wort but check INR before and after discontinuation of MILLPERTUIS.
  • Anticonvulsants (ethosuximide, felbamate, fosphenytoin, lamotrigine, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, valpromide) except with carbamazepine (see recommended association), gabapentin and vigabatrin: Risk of decreased plasma concentrations and the effectiveness of the anticonvulsant.
  • Oral contraceptives (estrogen-progestogen, progestogen): Decreased plasma concentrations of oral contraceptives, with the risk of reduced efficiency or cancellation of the effect. In case of fortuitous association, do not stop suddenly taking St. John's wort.
  • Digoxin: Decreased digoxin Ave risk of reduced efficiency and even reversal of the effect, the consequences can be potentially serious (decompensated heart failure). In case of fortuitous association, do not stop suddenly taking St. John's wort, but check digoxin before and after stopping St. John's wort.
  • Immunosuppressive drugs (cyclosporine, sirolimus, tacrolimus): Decreased blood levels and efficacy of immunosuppressive (or cancel the effect) with the risk of graft rejection. In case of fortuitous association, do not stop suddenly taking St. John's wort, but controlling blood levels of the immunosuppressant before and after stopping St. John's wort.
  • Protease inhibitors (amprenavir, atazanavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir): Decreased plasma concentrations of the protease inhibitor with a risk of reduced efficiency or cancellation of the effect, which consequences can be potentially serious. In case of fortuitous association, do not stop suddenly taking St. John's wort, but monitor the effectiveness of the protease inhibitor before and after stopping St. John's wort.
  • Tyrosine kinase inhibitors: Decreased plasma concentrations and efficacy of tyrosine kinase inhibitor by increasing its metabolism by St. John's wort.
  • Irrinotécan: Decreased plasma concentrations of the active metabolite of irinotecan with the risk of failure of cytotoxic therapy.
  • Theophylline: Decreased theophylline, with the risk of reduced efficiency and even reversal of the effect, the consequences can be potentially serious (occurrence of obstructive ventilatory disorder). In case of fortuitous association, do not stop suddenly taking St. John's wort, but control theophylline before and after stopping St. John's wort.


Concomitant use not recommended:

  • Cabamazépine: Risk of decreased plasma concentrations and efficacy of the anticonvulsant.
  • Telithromycin: Decreased plasma concentrations of telithromycin, with the risk of failure of anti-infective therapy by increasing the hepatic metabolism of telithromycin by St. John's wort.


Pharmacodynamic interactions:

Combinations requiring precautions for use:

  • Antidepressants reuptake inhibitors of serotonin (citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline): Risk of developing serotonin syndrome: diarrhea, tachycardia, sweating, tremor, confusion and even coma. Regular clinical supervision.
  • Non-selective MAO inhibitors (iproniazid): Risk of developing serotonin syndrome: diarrhea, tachycardia, sweating, tremor, confusion, or clinical coma.Surveillance regular.
  • Selective MAOI (moclobemide, toloxatone): Risk of developing serotonin syndrome: diarrhea, tachycardia, sweating, tremor, confusion, or coma. Regular clinical supervision.
  • Linezolid: Risk of developing serotonin syndrome: diarrhea, tachycardia, sweating, tremor, confusion, or coma. Regular clinical supervision.
  • Propafenone: Decreased plasma concentrations of propafenone by increasing its hepatic metabolism by St. John's wort

Side effects:

  • Some cases of serotonin syndrome with nausea, dizziness, headache, anxiety, abdominal pain, agitation, confusion) have been reported in the literature in elderly patients concomitantly treated with an inhibitor antidepressant of the selective serotonin reuptake and St. John's Wort . Syndrome regressed after stopping St. John's wort (see Interactions with other medicaments and other forms of interaction).
  • Digestive disorders and skin type to photosensitivity reactions have been reported.

Overdose:

No case of overdose has been reported.

VIDAL OF THE FAMILY

MILDAC

Phytotherapy

St. John's wort

. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

MILDAC 300 mg: tablet; box of 40.
-

MILDAC 600 mg: tablet; box of 15.
-

Merck Family Medication Laboratory

COMPOSITION (summary)
p cp p cp
St. John's wort, extract 300 mg 600 mg
Lactose +

INDICATIONS (summary)
This medicine contains an extract of St. John's wort, a plant that has been the subject of scientific research in the treatment of depressive states . Data from these studies indicate that St. John's Wort has activity in the treatment of mild depression. Since these studies have focused on time-limited intake, this drug can not currently be considered a true antidepressant and is recommended only in the treatment of transient depressive states.
It is traditionally used in the treatment of mild and transient depressive manifestations.
CONTRAINDICATIONS (summary)
This medication should not be combined with oral anticoagulants , protease inhibitors, or ciclosporin-containing medicines.
WARNING (Contents)
Depression is a serious illness that warrants medical advice when the state of sadness is not justified by a major event or when it lasts long after a possible triggering event.
Although this drug is over-the-counter and contains only plant extract, it may cause drug interactions, particularly with oral contraceptives (pills). Its effectiveness should not be overestimated and the use of a "classic" antidepressant , prescribed by a physician, combined with psychological support, may be necessary.
DRUG INTERACTIONS (summary)
This medication should not be combined with oral anticoagulants , antiproteases , certain anticonvulsants or ciclosporin: decreased efficacy with St. John's wort, or increased blood levels and risk of overdose if drug is discontinued .
It may interact with oral contraceptives , antidepressants inhibiting serotonin reuptake , triptan antimigraine drugs, and drugs containing digoxin, theophylline, and phenytoin.
PREGNANCY AND BREAST-FEEDING (summary)
The effect of this medication during pregnancy or lactation is not well known: only your doctor can evaluate the possible risk of its use in your case.
DIRECTIONS FOR USE AND DOSAGE (summary)
The tablets should be swallowed with a glass of water, preferably at regular time.

Usual dosage:

  • Adult: 1 tablet 300 mg, 1 to 3 times daily or 1 tablet 600 mg daily, preferably in the morning.
TIPS (summary)
The treatment of a depressive state , even if light, is not just about taking medication. The support of a professional is often a valuable aid to take a difficult course or reflect on the conscious or unconscious causes that are at the origin of this state.
POSSIBLE ADVERSE EFFECTS (summary)
Digestive disorders , photosensitization .


GLOSSARY (summary)


anti coagulants
Medication that prevents blood from coagulating and therefore prevents clots from forming in the blood vessels.
Anticoagulants are used to treat or prevent phlebitis, pulmonary embolism, certain infarcts. They also prevent the formation of clots in the heart during rhythm disorders such as atrial fibrillation or in the case of an artificial heart valve.
There are two main types of anticoagulants:
  • oral anticoagulants, which block the action of vitamin K (antivitamin K, or AVK) and whose effectiveness is controlled by a blood test: INR (formerly TP);
  • injectable anticoagulants derived from heparin, the efficacy of which can be controlled by the blood assay of anti-Xa activity, Howell's Time (TH) or Cephalin Kaolin Time (TCK) depending on the products used. A regular dosage of blood platelets is necessary throughout the life of a heparin derivative.


anticonvulsants
Medication used to treat convulsions and various forms of epilepsy. Anticonvulsants are classified as barbiturates (phenobarbital) and non-barbiturates, which are currently the most widely used.


antidepressant
Medication that works against depression. Some antidepressants are also used to combat obsessive-compulsive disorder, generalized anxiety, certain rebellious pain, enuresis, etc.
Depending on their mode of action and adverse effects, antidepressants are divided into different families: imipraminic antidepressants, serotonin reuptake inhibitors, selective or non-selective MAOIs. Finally, other antidepressants do not belong to any of these families, because they possess original properties.
The mode of action of antidepressants has two main aspects: the relief of moral suffering and the fight against inhibition which removes all will to action from the depressed. There may be a time lag between these two effects: moral suffering may persist, while the capacity for action reappears. During this short period, the risk of suicide in some depressed people can be increased. The physician takes it into account in its prescription (possible association with a tranquillizer) and it must imperatively be respected.


protease inhibitors
An antiretroviral drug which acts by blocking an enzyme (protease) necessary for the maturation of the AIDS virus (HIV) in infected cells. This type of drug blocks one of the stages of reproduction of the virus, but does not allow its eradication. It is most often used in combination with other antiretrovirals.


contraceptives
Who opposes conception: oral contraceptive (pill), local (IUD, spermicide, diaphragm and condom).


depressive states
State of moral suffering associating a demotivation, a fatigue, a feeling of uselessness, of self-depreciation. In the absence of treatment, the depressive state may develop into a serious depression with a feeling of incurability, guilt, and a suicidal risk.


inhibitors of serotonin reuptake
Antidepressant increases the amount of serotonin in the brain, limiting its recapture. Some IRSs are also used for the treatment of obsessive compulsive disorder (OCD) and anxiety.
See also: serotonergic antidepressant.


photosensitivity
Abnormal sensitivity of the skin to light or ultraviolet rays due to a drug or a natural or chemical substance.


overdose
Taking an excessive amount of a drug exposes you to an increase in the intensity of adverse effects, or even to the appearance of particular adverse effects.
This overdose may result from accidental or voluntary poisoning for suicide, so consult your local Poison Control Center (listed in the appendix to the book). However, in most cases, overdose is the result of an error in the understanding of the prescription, or the search for an increase in efficacy by exceeding the recommended dosage. Finally, untimely self-medication may lead to excessive absorption of the same substance contained in different drugs. Some drugs are particularly prone to this risk because they are (wrongly) considered to be harmless: vitamins A and D, aspirin, etc. Stopping or decreasing drug intake helps to remove the disorders associated with an overdose.


triptans
Name of a chemical family of vasoconstrictors used in the treatment of migraine. Compared to vasoconstrictors derived from rye ergot, triptans have the advantage of acting more specifically on the arteries of the brain.


Digestive disorders
Set of symptoms indicating irritation or malfunction of the digestive tract. One or more disorders may be present: nausea, vomiting, aerophagia, abdominal pain, heartburn, bloating, flatulence, diarrhea or constipation, etc. Antibiotics can promote candidiasis, often responsible for digestive disorders.

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Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Last updated: 12/10/2016

Name of the medicinal product

MILDAC 600 mg coated tablet

St. John's wort (dry extract)

framed

Please read this leaflet carefully before you start taking this medicine because it contains important information for you.

You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.

· Keep this leaflet. You might need to read it again.

· Ask your pharmacist for advice or information.

· If you experience any of the 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 experience no improvement or if you feel less well 15 days.

Do not use this medication for children.

What is in this leaflet?

1. What is Mildac 600 mg, coated tablet and in which cases it is used?

2. What should I know before taking Mildac 600 mg coated tablet?

3. How to take Mildac 600 mg, coated tablet?

4. What are the possible side effects?

5. How to store Mildac 600 mg coated tablet?

6. Package contents and other information.

1. WHAT IS MILDAC 600 mg coated tablet AND WHAT IT IS USED FOR?

Pharmacotherapeutic group - ATC code: Herbal medicinal product

Herbal medication traditionally used in the treatment of mild and transient depressive manifestations.

You should contact your doctor if you experience no improvement or feel less well after 15 days.

2. BEFORE YOU TAKE MILDAC 600 mg, coated tablet?

Do not take MILDAC 600 mg, coated tablet:

· if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medication mentioned in section 6.

· In combination with anti-coagulants, anti-epileptics, contraceptives (estrogens and progestins), digoxin (used to treat heart disease), immunosuppressants (used for organ transplantation), protease inhibitors used in the treatment of HIV infection), cobicistat, daclatasvir, ledipasvir and dasabuvir (used in the treatment of hepatitis C), tyrosine kinase inhibitors (used in the treatment of certain cancers) (antimycotic), itraconazole and voriconazole (antifungal), lurasidone (used in schizophrenia), oxycodone (analgesic), rilpivirine (used in the treatment of certain cancers) theophylline and aminophylline (used in the treatment of asthma and certain respiratory diseases), ticagrelor (platelet anti-agregant), vismodegib (used in (see section "Other medicines and MILDAC 600 mg, coated tablet"), verapamil (used in the treatment of heart disease).

Warnings and Precautions

Talk to your doctor or pharmacist before taking MILDAC 600 mg coated tablet .

It is necessary that you take a medical opinion before starting treatment if you are being treated with other medicines (see section "Other medicines").

The antidepressant properties of MILDAC 600 mg coated tablets usually appear within the first 4 weeks after initiation of therapy. If symptoms persist, it is necessary to consult your doctor.

Use in children under 18 years is not recommended due to the lack of sufficient data.

Avoid prolonged exposure to the sun during treatment, due to the risk of skin reactions resembling sunburn (photosensitivity).

If you have to undergo surgery, tell your doctor if you are taking MILDAC 600 mg coated tablet.

Other medicines and MILDAC 600 mg, coated tablet

Inform your doctor or pharmacist if you are taking or have recently taken or may be taking any other medicines.

Inform your doctor or pharmacist if you are taking or have recently taken or may be taking any other medicines, MILDAC 600 mg, coated tablet may cause a decrease in the therapeutic effect of other medicines.

MILDAC 600 mg, coated tablet should not be taken with anticoagulants, antiepileptics, contraceptives (estrogen-progestin and progestin), digoxin (used to treat heart disease), immunosuppressants (used for organ transplants) protease inhibitors (used in the treatment of HIV infection), cobicistat, daclatasvir, ledipasvir and dasabuvir (used in the treatment of hepatitis C), tyrosine kinase inhibitors (used in the (antimycotic), itraconazole and voriconazole (antifungal), lurasidone (used in schizophrenia), oxycodone (analgesic), rilpivirine (used in the treatment of certain cancers) in the treatment of HIV infection), theophylline and aminophylline (used in the treatment of asthma and certain respiratory diseases), ticagrelor (anti-aggregating p vismodegib (used in the treatment of certain cancers), verapamil (used in the treatment of heart disease).

Inform your doctor or pharmacist if you are taking a drug containing any of the active ingredients:

· baedaquilin (used to treat tuberculosis)

· carbamazepine (used to treat epilepsy)

· cyproterone (used to treat certain hormonal diseases),

· dolutegravir (used to treat HIV)

· dronedarone and propafenone (used to treat heart rhythm disorders),

· eribulin (used in the treatment of certain cancers)

· idelalisib (used in the treatment of certain cancers)

· ivabradine (used to treat angina),

· lomitapide (used in some cases of familial hypercholesterolemia)

· macitentan (used in the treatment of pulmonary arterial hypertension)

· maraviroc (used in the treatment of HIV)

· quetiapine (used in the treatment of schizophrenia)

· siméprévir (used in the treatment of hepatitis C)

· simvastatin (used in the treatment of hypercholesterolemia or dyslipidemia)

· sofosbuvir (used in the treatment of hepatitis C)

· telithromycin and linezolid (antibiotics)

· ulipristal (emergency contraceptive).

If your doctor prescribes other medicines for depression, tell your doctor that you are already taking MILDAC 600 mg coated tablets.

MILDAC 600 mg, tablet coated with food, drinks and alcohol

Not applicable.

Pregnancy and breast feeding

If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor for advice or to your pharmacist before taking any medication.

Sport

Not applicable.

Driving and using machines

Not applicable.

MILDAC 600 mg, coated tablet contains

Not applicable.

3. HOW TO TAKE MILDAC 600 mg coated tablet?

Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Reserved for adults (from 18 years) and the elderly.

Always take this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is 1 tablet per day, preferably in the morning.

If you take more than Mildac 600 mg, coated tablet you should:

Immediately consult your doctor or pharmacist.

If you forget to take Mildac 600 mg, coated tablet:

Do not take a double dose to make up for the missed dose .

If you stop taking Mildac 600 mg, coated tablet:

Not applicable.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine may cause side effects, although not everybody gets them.

Like all medicines, Mildac 600 mg, coated tablet is likely to have side effects, although not everyone is subject to it.

Digestive disorders, fatigue, agitation or rash may occur. Possibility of excessive sensitivity to sunlight (photosensitivity) with skin reactions resembling sunburn in case of sun exposure during treatment.

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 via 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 MILDAC 600 mg coated tablet?

Keep this medicine out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.

Do not use this medication if you notice any signs of deterioration.

Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What MILDAC 600 mg contains: coated tablet

· The active substance is:

St. John's wort ( Hypericum perforatum L.) (methanolic dry extract (80% V / V)) 612 mg

· The excipients are: ascorbic acid, microcrystalline cellulose, croscarmellose sodium, iron oxide (E172), hypromellose, stearic acid, magnesium stearate, sodium saccharin, precipitated silica, titanium dioxide (E 171), vanillin.

What Mildac 600 mg coated tablet looks like and contents of the pack

Coated tablet.

Box of 15 and 20 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

DR. WILLMAR SCHWABE GmbH & Co

WILLMAR-SCHWABE Str. 4

76227 KARLSRUHE

GERMANY

Marketing Authorization Operator

MERCK MEDICATION FAMILIALE

18C BOULEVARD WINSTON CHURCHILL

21000 DIJON

LA FRANCE

Maker

DR. WILLMAR SCHWABE GmbH & Co

WILLMAR-SCHWABE Str. 4

76227 KARLSRUHE

GERMANY

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

The last date on which this leaflet was revised is:

[to be completed later by the holder]

Other

Detailed information on this medicine is available on the ANSM website (France).

Sleep disorders can manifest themselves in several ways: difficulty falling asleep, nighttime awakenings, early awakenings. The causes can be diverse: psychological origin (stress, dark thoughts), changing habits (altitude, holidays), alcohol intake, insomnia in the elderly. We offer treatments to address these minor ailments. Most important disorders (sleepwalking, night terrors, bedwetting in children, REM sleep disorder, psychiatric disorders origin or linked to other pathologies) require consulting your doctor.

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