Goodmood_packHRI Good Mood – SPC

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1. Name of the medicinal product
HRI Good Mood Tablets
2. Qualitative and quantitative composition
Each film coated tablet contains 334 mg of extract (as dry extract) from St John’s Wort aerial parts (Hypericum perforatum L.) (5-7:1) (equivalent to 1670mg – 2338mg of St John’s Wort.)
Extraction solvent: Ethanol 60% V/V
For full list of excipients, see section 6.1.
3. Pharmaceutical form
Film coated tablet.
Pale yellow oval shaped, biconvex film coated tablet.
4. Clinical particulars
4.1. Therapeutic indications
A traditional herbal medicinal product used to relieve the symptoms of slightly low mood and mild anxiety based on traditional use only.
4.2. Posology and method of administration
Adults and the elderly: the recommended dosage is 1 or 2 tablets daily.
The tablets should be swallowed whole with a little water or other liquid. The tablets should not be chewed.
This product is not recommended for children or adolescents under 18 years of age (See Section 4.4. Special Warnings and precautions for use).
If symptoms worsen during the use of the product or persist for more than 6 weeks, a doctor or a qualified healthcare practitioner should be consulted.
4.3. Contraindications
Hypersensitivity to the active substance or any of the excipients.
Patients with known dermal photosensitivity or patients undergoing phototherapy or other photodiagnostic procedures.
This product should not be taken concomitantly with the medicines included in Section 4.5. This is because St John’s wort (Hypericum perforatum) has been shown to induce the cytochrome P450 isoenzymes CYP1A2, CYP2C9, CYP2C19 and CYP3A4 as well as transport protein P-glycoprotein. This results in pharmacokinetic interactions with a large number of medicines including leading to a possible decrease in the effectiveness of those medicines.
In addition, pharmacodynamic interactions have also been identified with antidepressants, particularly the SSRI antidepressants and with the triptan group of medicines.
4.4. Special warnings and precautions for use
Do not exceed the stated dose.
If the condition worsens during the use of the product or if symptoms persist for more than 6 weeks, consult a doctor or qualified healthcare practitioner.
The use of this product in children or adolescents under 18 years of age is not recommended because data are not sufficient and medical advice should be sought.
This product is intended for the relief of symptoms of slightly low mood and mild anxiety. Patients with signs and symptoms of depression should consult a doctor for appropriate treatment.
In very rare cases, particularly in fair-skinned persons, sun burn type reactions on skin areas exposed to strong sunlight may occur due to photosensitisation by St John’s wort. Persons using this product should avoid excessive sunbathing or the use of sunbeds or solariums.
This product should be discontinued at least 10 days prior to elective surgery due to the potential for interactions with medicinal products used during general and regional anaesthesia (see Section 4.5).
4.5. Interaction with other medicinal products and other forms of interaction
Substances in St John’s Wort (Hypericum perforatum) have been shown to induce the cytochrome P450 isoenzymes CYP1A2, CYP2C9, CYP2C19 and CYP3A4 as well as the transport protein P (typo glycoprotein). This results in pharmacokinetic interactions with a large number of medicines leading to a potential decrease in the effectiveness of those medicines.
The concomitant use of ciclosporin, tacrolimus for systemic use, Amprenavir, indinavir and other protease inhibitors, irinotecan and warfarin is contraindicated. Special care should be taken in case of concomitant use of all drug substances the metabolism of which is influenced by CYP1A2, CYP3A4, CYP2C9, CYP2C19 or P-glycopprotein (e.g. amitriptyline, fexofenadine, benzodiazepines, methadone, simvastatin, digoxin, finasteride), because a reduction of plasma concentration is possible.
Users of oral contraceptives taking St John’s Wort (Hypericum perforatum) may experience intracyclic menstrual bleeding and risk of contraception failure is increased.
Clinically significant pharmacodynamic interactions have also been identified with the SSRI antidepressants, and the triptan group of medicines used to treat migraines. Due to the increased risk of undesirable effects associated with these interactions this product should not be used concomitantly with these types of medicines. Therefore this product should not be taken concomitantly with the medicines included in table. Click here to view table.
4.6. Pregnancy and lactation
Safety of the product during pregnancy and lactation has not been established. In the absence of sufficient data the use in pregnancy and lactation is not recommended.
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8. Undesirable effects
Gastrointestinal disorders including dyspepsia, anorexia, nausea, diarrhoea or constipation; allergic skin reactions such as rash, urticaria, pruritis, fatigue and restlessness have been reported. The frequency is not known.
Fair skinned individuals may react with intensified sunburn-like symptoms under intense sunlight or strong ultra-violet (UV) irradiation.
Other adverse reactions that have been reported include headaches, neuropathy, anxiety, dizziness and mania.
If other adverse reactions not mentioned above occur, a doctor, pharmacist or a qualified healthcare practitioner should be consulted.
4.9. Overdose
No case of overdose has been reported. There are no data on human overdose with St. John’s Wort.
After the intake of up to 4.5g dry extract per day for 2 weeks and additionally 15g dry extract just before hospitalisation seizures and confusion have been reported.
When a large overdose has occurred, phototoxic reactions may occur. The skin of the patient should be protected for 1-2 weeks from UV irradiation and sunlight. Outdoor activities should be restricted and clothes and/or sun block preparations used to protect the skin from sunlight. Symptomatic and supportive measures should be taken as appropriate.
5. Pharmacological properties
5.1. Pharmacodynamic properties
The active constituents of St. John’s wort have not been definitively established.
However, hypericin, pseudohypericin, hyperforin and the flavonoids are considered to play a role in its activity.
5.2. Pharmacokinetic properties
No relevant pharmacokinetic data are available.
The active ingredients of St John’s wort can interact with other medicinal agents in two ways. Firstly, active ingredients in St John’s wort that themselves are metabolised in the liver by the CYP3A4 isoenzyme, increase (induce) the activity of this enzyme so that it accelerates the elimination of other medicinal agents which are degraded by the same pathway. This leads to a consequent reduction in the plasma concentration and effectiveness of these other substances. Secondly, the active ingredients in St John’s wort, like other type SRI or SSRI medicinal agents with an antidepressant action, can raise the concentration of serotonin in certain parts of the central nervous system so that this neurotransmitter can sometimes reach toxic levels, particularly when drugs containing St John’s wort are combined with other antidepressants.
5.3. Preclinical safety data
Not required as per Article 16c (1) (a) (iii) of Directive 2001/83/EC as amended, unless necessary for the safe use of the product.
Studies on acute toxicity and repeated dose toxicity did not show signs of toxic effects.
The weak positive results of an ethanolic extract in the AMES-test (Salmonella typhimurium TA 98 and TA 100 with and without metabolic activation) could be assigned to quercetin and are irrelevant to human safety. No signs of muagenicity could be detected in further in-vitro and in-vivo test systems.
Tests on reproductive toxicity revealed equivocal results.
Tests on carcinogenic potential have not been performed.
After oral application of dosages of 1800mg of an extract per day for 15 days the skin sensitivity against UVA was increased, and the minimum dose for pigmentations was significantly reduced. In the recommended dosage, no signs of phototoxicity are reported.
Tests on reproductive toxicity and on carcinogenicity have not been performed.
6. Pharmaceutical particulars
6.1. List of excipients
• Tablet Core
• Dicalcium Phosphate
• Microcrystalline Cellulose
• Croscarmellose Sodium
• Silicon Dioxide
• Magnesium Stearate
• Stearic Acid
• Film Coating
• Hypromellose
• Iron Oxide
• Yellow (E172)
• Titanium Dioxide (E171)
• Purified Talc
6.2. Incompatibilities
None known.
6.3. Shelf life
24 months..
6.4. Special precautions for storage
Do not store above 25 °C. Store in the original packaging.
6.5. Nature and contents of container
Tablets are packed into HDPE bottles with a CRC heat sealed cap containing 30, 60 or 90 Tablets and packed into a Carton.
Tablets are packed into PVC/PVDC blister strips of 15 tablets in the following pack sizes; 30, 60, 90 Tablets and packed into a Carton.
Not all pack sizes may be marketed.
6.6. Instructions for Use/Handling
No special requirements.
7. Traditional registration holder
8. Marketing Authorisation number
THR 02231/0002
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
September 2010