Diacalm Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
DiaCalm tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains:
56 mg of extract (as dry extract) from Valerian Root (Valeriana officinalis L.) (36:1),
Extraction solvent: ethanol 70% (v/v)
120 mg of extract (as dry extract) from St. John's Wort Herb (Hypericum perforatum L.) (3.5-6:1), Extraction solvent: ethanol 60% (m/m)
Each coated tablet also contains Sucrose (171.4 mg) and glucose (15.9 mg)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablets, green, round, biconvex, smooth and glossy surface
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Traditional herbal medicinal product used to relieve slightly low mood, mild anxiety and sleep disturbances due to mild anxiety, based on traditional use only.
4.2 Posology and method of administration Posology
For oral use only.
Adults and the elderly
To help relieve symptoms of slightly low mood and mild anxiety:
One tablet to be taken one to three times daily.
To relieve sleep disturbances due to mild anxiety:
One tablet to be taken half an hour before going to sleep.
The tablets should be swallowed whole with some liquid.
The maximum recommended daily dose is 3 coated tablets.
This product is not recommended for use in children or adolescents under 18 years of age (see section 4.4 special warnings and precaution for use).
Duration of use
As the effects of this product may not occur immediately, the product should be taken continuously for 2-4 weeks.
If symptoms worsen or persist after using the product for 4 weeks, a doctor or qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to any of the active ingredients or any of the excipients.
This product should not be taken concomitantly with any of the medicines specified in section 4.5.
This is because St. John’s Wort (Hypericum perforatum) has been shown to induce the cytochrome P450 isoenzymes CYP1A2, CYP2C19, CYP2C9, 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 some of these medicines.
In addition, pharmacodynamic interactions have also been identified with antidepressants, particularly the SSRI antidepressants (paroxetine, sertraline), nefazodone, or buspirone and with the triptan group of medicines.
This product should not be taken by patients with known dermal photosensitivity or by patients undergoing phototherapy or any photodiagnostic procedures.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
The use of this product in children and 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 relief of slightly low mood, mild anxiety and of sleep disturbances due to mild anxiety. Patients with signs and symptoms of depression should seek medical advice for appropriate treatment.
In very rare cases, particularly in light-skinned persons, sun burn type reactions on skin areas exposed to strong sunlight may occur due increased sensitivity to sunlight (photosensitization) by St. John’s Wort. Persons using this product should avoid excessive sunbathing or the use of sunbeds or solariums.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency and/ or glucose-galactose malabsorption should not take this medicine.
This product should be discontinued at least 10 days prior to elective surgery due to the potential for St. John’s Wort to interact with drugs used during general and regional anaestesia (see section 4.5).
4.5 Interaction with other medicinal products and other forms of interaction
Only limited data on pharmacological interactions of valerian root with other medicinal products are available. Clinically relevant interactions with drugs metabolised by CYP2D6, CYP3A4/5, CYP1A2 or CYP2E1 pathway has not been observed. Additive effects with hypnotics and other sedative drugs cannot be excluded and therefore co-medication is not recommended as a general precaution.
The effect of Valerian may be potentiated by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided.
Substances in St. John’s Wort have been shown to induce the cytochrome P450 (CYP)- isoenzymes CYP1A2, CYP2C19, CYP2C9, and CYP3A4 and the drug transport protein P-glycoprotein. This results in pharmacokinetic interactions with a large number of medicines leading to a potential decrease in the effectiveness of some of these medicines.
The concomitant use of ciclosporin, tacrolimus for systemic use, amprenavir, indinavir or 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-glycoprotein (e.g. amitriptyline, fexofenandine, benzodiazepines, methadone, simvastatin, digoxin, finasteride) because a reduction in 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 (paroxetine, sertraline), nefazodone, or buspirone 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.
This product should not be taken concomitantly with the medicines included in the table below:
|
Co-administered drug |
Interaction |
Recommendations concerning coadministration |
|
Anaesthetics /pre-operative medicines | ||
|
Fentanyl, propofol, sevoflurane, midazolam |
Reduced blood levels with risk of therapeutic failure. |
Based on the elimination half-lives of hypericin and hyperforin this product should be discontinued at least 10 days prior to elective surgery. |
|
Analgesics | ||
|
Tramadol |
Reduced blood levels with risk of therapeutic failure. |
Do not take with this product. |
|
Antianginals | ||
|
Ivabradine |
Reduced blood levels with risk of therapeutic failure. |
Do not take with this product. |
|
Anti-arrhythmics | ||
|
Amiodarone |
Reduced blood levels with risk of therapeutic failure. |
Do not take with this product. |
|
Antibacterials | ||
|
Erythromycin, clarithromycin, telithromycin |
Reduced blood levels with risk of therapeutic failure. |
Do not take with this product. |
|
Anticoagulants | ||
|
warfarin, acenocoumarol |
Reduced anticoagulant effect and need for increased dose |
Do not take with this product. |
|
Antidepressants | ||
|
Tricyclics eg. amitriptyline, clomipramine |
Increased serotonergic effects with increased incidence of adverse reactions. |
Do not take with this product. |
|
MAOIs eg. moclobemide | ||
|
SSRIs eg. citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, | ||
|
Others eg. duloxetine, venlafaxine | ||
|
Antiepileptics | ||
|
All drugs in this class including: Carbamazepine, phenobarbitone, phenytoin primidone, sodium valproate |
Reduced blood levels with increased risk of frequency and severity of seizures. |
Do not take with this product. |
|
Antifungals | ||
|
Itraconazole, voriconazole |
Reduced blood levels with risk of therapeutic failure. |
Do not take with this product. |
|
Antimalarials | ||
|
Artemether, lumefantrine |
Reduced blood levels with risk of therapeutic failure. |
Do not take with this product. |
|
Anti-parkinsons | ||
|
Rasagiline |
Reduced blood levels with risk of therapeutic failure. |
Do not take with this product. |
|
Antipsychotics | ||
|
Aripiprazole |
Reduced blood levels with risk of therapeutic failure. |
Do not take with this product. |
|
Antivirals | ||
|
HIV protease inhibitors: amprenavir, atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir |
Reduced blood levels with possible loss of HIV suppression. |
Do not take with this product. |
|
HIV nonnucleoside reverse transcriptase inhibitors: efavirenz, nevirapine, delavirdine |
Reduced blood levels with possible loss of HIV suppression |
Do not take with this product. |
|
Anxiolytics | ||
|
Buspirone |
Increased serotonergic effects with increased incidence of adverse reactions. |
Do not take with this product. |
|
Aprepitant |
Reduced blood levels with risk of therapeutic failure. |
Do not take with this product. |
|
Barbiturates | ||
|
Butobarbital, phenobarbital |
Reduced blood levels with risk of therapeutic failure. |
Do not take with this product. |
|
Calcium channel blockers | ||
|
Amlodipine, nifedipine verapamil, felodipine |
Reduced blood levels with risk of therapeutic failure. |
Do not take with this product. |
|
Cardiac glycosides | ||
|
Digoxin |
Reduced blood levels and loss of control of heart rhythm or heart failure. |
Do not take with this product. |
|
CNS Stimulants | ||
|
Methyl phenidate |
Reduced blood levels with risk of therapeutic failure. |
Do not take with this product. |
|
Cytotoxics | ||
|
Irinotecan, dasatinib, erlotinib, imatinib, sorafenib, sunitinib, etoposide, mitotane |
Reduced blood levels with risk of therapeutic failure. |
Do not take with this product. |
|
Hormonal contraceptives | ||
|
Oral contraceptives Emergency Hormonal Contraception Hormonal implants, injections Transdermal patches, creams etc. Intra-uterine devices with hormones |
Reduced blood levels with risk of unintended pregnancy and breakthrough bleeding. |
Do not take with this product. |
|
Hormone Replacement Therapy | ||
|
Hormone Replacement Therapy: Oral Trandermal patches, gels Vaginal rings |
Reduced blood levels with risk of therapeutic failure. |
Do not take with this product. |
|
Hormone antagonists | ||
|
Exemestane |
Reduced blood levels with risk of therapeutic failure. |
Do not take with this product. |
|
Diuretics | ||
|
Eplerenone |
Reduced blood levels with risk of therapeutic failure. |
Do not take with this product. |
|
5HT agonists | ||
|
Almotriptan,eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan |
Increased serotonergic effects with increased incidence of adverse reactions. |
Do not take with this product. |
|
Immunosuppressants | ||
|
Ciclosporin, tacrolimus |
Reduced blood levels with risk of transplant rejection. |
Do not take with this product. |
|
Lipid regulating drugs | ||
|
Simvastatin, atorvastatin |
Reduced blood levels with risk of therapeutic failure. |
Do not take with this product. |
|
Lithium |
Reduced blood levels with risk of therapeutic failure. |
Do not take with this product. |
|
Proton pump inhibitors | ||
|
Lansoprazole, omeprazole |
Reduced blood levels with risk of therapeutic failure. |
Do not take with this product. |
|
Theophylline |
Reduced blood levels and loss of control of asthma or chronic airflow limitation. |
Do not take with this product. |
|
Thyroid hormones | ||
|
Thyroxine |
Reduced blood levels with risk of therapeutic failure. |
Do not take with this product. |
|
Oral hypoglycaemic drugs | ||
|
Gliclazide |
Reduced blood levels with risk of therapeutic failure. |
Do not take with this product. |
4.6 Fertility, Pregnancy and lactation
Safety during pregnancy and lactation has not been established. In the absence of sufficient data, use of this product during pregnancy and lactation is not recommended.
4.7 Effects on ability to drive and use machines
This product may impair the ability to drive and use machines. If affected, patients should not drive or operate machinery.
4.8 Undesirable effects
Gastrointestinal disorders (e.g. dyspepsia, anorexia, nausea, diarrhoea, constipation and abdominal cramps); allergic skin reaction (e.g. rash, urticaria, pruritis); fatigue and restlessness may occur. 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 occur, a doctor or qualified healthcare practitioner should be consulted.
4.9 Overdose
There are no reported cases.
There are no data on human overdose with St. John’s Wort.
After intake of up to 4.5 g dry extract per day for 2 weeks and additionally 15 g dry extract just before hospitalisation seizures and confusion have been reported.
Where 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.
Valerian root at a dose of approximately 20 g caused benign symptoms (fatigue, abdominal cramp, chest tightness, light-headedness, hand tremor and mydriasis), which disappeared within 24 hours. If symptoms arise, treatment should be supportive.
After intake of very high doses of Valerian root over several years (daily consumption corresponding to approximately 30 g of the drug) withdrawal symptoms (delirium) have been reported.
Symptomatic and supportive measures should be taken as appropriate.
5 PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic properties
Not required as per Article 16 c (1) (a) (iii) of Directive 2001/83/EC as amended.
5.2 Pharmacokinetic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
5.3 Preclinical safety data
The extracts of St. John's Wort and Valerian root were not mutagenic in a bacterial mutation assay.
Reproductive toxicity and carcinogenicity studies have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Extract excipients:
maltodextrin
liquid glucose, spray-dried silica, colloidal anhydrous
Tablet core:
cellulose microcrystalline cellulose, powdered croscarmellose sodium silica, colloidal anhydrous stearic acid 50 talc
Tablet coating:
sucrose
talc
calcium carbonate E170 acacia, spray dried tragacanth
titanium dioxide E171 liquid glucose, spray dried iron(III)-oxide hydrate E172 (= yellow iron oxide) iron(II,III)-oxide 80 E172 (= black iron oxide) camauba wax
6.2 Incompatibilities
Not applicable
6.3 Shelf life
18 months
6.4 Special precautions for storage
Do not store above 30°C. Keep the blister in the outer carton.
6.5 Nature and contents of container
PVC/PVDC-aluminium blisters. Original packs of 30, 60, 90, or 100 coated tablets.
Not all pack size may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Diapharm GmbH & Co. KG Hafenweg 18-20 48155 Munster Germany
8 MARKETING AUTHORISATION NUMBER(S)
THR 42340/0021
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
03/10/2011
DATE OF REVISION OF THE TEXT
01/08/2013
10