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Tuesday 19 March 2013

MenoMood Tablets for Hot flushes


The Medicines and Healthcare products Regulatory Agency (MHRA) granted a Traditional Herbal Registration Certificate for the traditional herbal medicinal product MenoMood® Tablets (Traditional Herbal Registration number: THR 23056/0013). 

This product is available without prescription.

The active ingredient of MenoMood® Tablets comes from St. John's wort (Hypericum perforatum L.) aerial parts and Black cohosh (Cimicifuga racemosa L. Nutt) rhizome and root.

MenoMood® Tablets is used for the relief of symptoms of the menopause, such as hot flushes, night sweats, slightly low mood and mild anxiety, based on traditional use only.

Meno Mood St John's Wort and Black Cohosh For Relief of Menopause Symptoms

Before you take this product


DO NOT TAKE this product if:
  • you are under 18 years of age
  • you are pregnant or breast­feeding
  • you are of childbearing potential and do not use adequate contraception
  • you are allergic to any of the ingredients (listed in section 6)
  • your skin is exceptionally sensitive to sunlight (photosensitive)
  • you are having light treatment (phototherapy) for any condition
  • you are suffering from depression (see below)
  • have ever had or are suffering from liver or kidney disease (eg. hepatitis, jaundice or cirrhosis)
  • have ever had or are suffering from an oestrogen dependent tumour
While you are taking this product:

  • avoid excessive sunbathing or the use of sunbeds/ solariums
  • stop using it at least 10 days prior to undergoing any surgery.

Suffering from depression?

Symptoms of depression include feelings of helplessness and hopelessness, loss of interest in daily activities, appetite or weight changes, sleep changes, loss of energy and difficulty concentrating. If your doctor has told you that you are suffering from depression do not use this product. If you think that you may be suffering from depression you should tell your doctor.

Driving and using machines

In rare cases St John’s wort may make you feel dizzy or sleepy. If affected do not drive or operate machines.

Taking other medicines

St John's wort can affect the way some medicines work and reduce their effectiveness. Medicines that can be affected by St John's wort include prescription medicines and those that you may have bought yourself without a prescription.
Therefore it is important that you do not take MenoMood if you are using any of the medicines listed in the table opposite.
DO NOT TAKE THIS PRODUCT IF YOU ARE TAKING ANY OF THE FOLLOWING MEDICINES
All hormonal contraceptivesThe birth control ‘Pill’, emergency contraception, hormonal implants, creams, patches, intra­uterine devices with hormones.
All medicines for depression/anxietyAmitriptyline, clomipramine, moclobemide, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine.
All hormonal replacement therapy (HRT) treatmentsHRT tablets, patches, gels, vaginal rings
All medicines for thinning the blood (anticoagulants)Warfarin, acenocoumarol
All medicines for epilepsyCarbamazepine, phenobarbitone, phenytoin, primidone, sodium valproate
All immunosuppressant medicinesCiclosporin, tacrolimus
All medicines for HIV infectionsAmprenavir, atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir, efavirenz, nevirapine, delavirdine
Some medicines for cholesterolSimvastatin, atorvastatin
Some medicines for cancerIrinotecan, dasatinib, erlotinib, imatinib, sorafenib, sunitinib, etoposide, mitotane
Some medicines for heart diseaseDigoxin, ivabradine, amiodarone
Some medicines for migrainesAlmotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
Some medicines for high blood pressureAmlodipine, nifedipine, felodipine, verapamil
A medicine for regulating moodLithium
A thyroid hormoneThyroxine

Taking other medicines (continued)

St John’s Wort may also affect the following medicines. Therefore do not take this product with these medicines unless a doctor has said it is safe to do so:
  • fentanyl, propofol, sevoflurane, and midazolam (anaesthetics/pre­operative medicines)
  • tramadol (an analgesic)
  • erythromycin, clarithromycin and telithromycin (antibiotics)
  • itraconazole and voriconazole (antifungals)
  • artemether and lumefantrine (antimalarials)
  • rasagiline (an anti­parkinson’s medicine)
  • aripiprazole (an antipsychotic medicine)
  • buspirone (an anxiolytic)
  • aprepitant (used to treat post­operative vomiting)
  • butobarbital and phenobarbital (barbiturates)
  • methyl phenidate (a central nervous system or CNS stimulant)
  • exemestane (a hormone antagonist)
  • eplerenone (a diuretic)
  • lansoprazole and omeprazole (proton pump inhibitors)
  • theophylline (a bronchodilator)
  • gliclazide (an antidiabetic medicine).

Dosage

Take 1 tablet daily. Swallow the tablets whole with some water or other liquid. Do not chew the tablets. The tablets should be taken at the same time of day if possible (morning or evening). Do not exceed the stated dose.
Do not exceed the stated dose.

Side effects

Like all medicines, this product can have side-effects. These are listed below.

Uncommon side-effects (affecting fewer than 1 in 1000 people)

  • digestive upsets such as indigestion or diarrhoea
  • facial swelling
  • allergic skin reactions such as nettle rash, itching of the skin
If these persist for more than a few days, or become troublesome, stop taking this product. These uncommon side-effects are often only temporary. Stop taking this product immediately if you experience any allergic skin reaction.

Other side effects

Black Cohosh may rarely cause liver problems. If you become unwell (yellowing eyes/skin, nausea, vomiting, dark urine, abdominal pain, unusual tiredness) stop taking immediately and seek medical advice.
Tell your doctor or pharmacist if you notice any other side-effect.

Possible side­effects

Like all medicines this product can have side­effects, although these are uncommon. These are listed below.
  • gastrointestinal disorders e.g indigestion, loss of appetite, nausea, diarrhoea, constipation
  • fatigue and restlessness
  • facial swelling, swelling of the feet, ankles or lower leg
  • weight gain
If these persist for more than a few days, or become troublesome, stop taking this product. These sideeffects
are often only temporary.
  • allergic skin reactions such as nettle rash, itching of the skin, hives
Stop taking this product immediately if you experience an allergic reaction.
Other side effects
These include headaches, nerve pain or tingling, anxiety, dizziness, mania.
Also, sunburn like reactions in skin exposed to strong sunlight or strong ultraviolet
(UV) irradiation, e.g solarium, have been reported, particularly in fairskinned
individuals, when taking St John’s Wort.
Black Cohosh may rarely cause liver problems. If you become unwell (yellowing eyes/skin, nausea, vomiting, dark urine, abdominal pain, unusual tiredness) stop taking immediately and seek medical advice.


Product description

Each tablet contains 300 mg of extract (as dry extract) from St John's wort aerial parts (Hypericum perforatum L.) (3.5­6:1) (equivalent to 1050­1800 mg of St John's wort). 
Extraction solvent ethanol 60% m/m; and 6.4 mg of extract (as dry extract) from Black Cohosh rhizome and root (Cimicifuga racemosa (L.) Nutt.) (4.5­8.5:1) (equivalent to 28.80­54.40 mg of Black Cohosh). Extraction solvent ethanol 60% v/v.

MenoMood also contains the following ingredients:

Extract: Maltodextrin, silica colloidal anhydrous, lactose monohydrate
cellulose powdered.
Tablet core: Silica, colloidal anhydrous, cellulose microcrystalline,
croscarmellose sodium, sodium starch glycolate (type A), magnesium stearate.
Coating: Hypromellose, sucrose, talc, calcium carbonate E170, tragacanth,
acacia, liquid glucose, titanium dioxide E171, iron oxide hydrate E172
(= yellow iron oxide), vanillin, beeswax white, carnauba wax, shellac.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product. Each coated tablet contains 234 mg of sucrose, 19 mg of lactose monohydrate and 6 mg glucose.

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