Puncto Sleeptight Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Puncto SleepTight tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains:
75 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (5-6:1), Extraction solvent: ethanol 70 % (v/v),
45 mg of extract (as dry extract) from Lemon balm leaf (Melissa officinalis L.) (4-6:1), Extraction solvent: water, and
23 mg of extract (as dry extract) Hop strobile (Humulus lupulus L.) (4-8:1), Extraction solvent: methanol 40 % (v/v).
Each coated tablet also contains 3.09 mg glucose and 121.56 mg sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet.
Light blue, bright, biconvex coated tablet with smooth surface.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the temporary relief of sleep disturbances due to symptoms of mild anxiety, based on traditional use only.
4.2 Posology and method of administration
For oral short term use only.
The tablets should be swallowed whole with some liquid. Do not chew the tablets.
Adults and the elderly
2 tablets, 1/2 to 1 hour before going to sleep.
Duration of use
As treatment effects may not be apparent immediately, this product should taken for 2-4 weeks continuously.
If symptoms worsen or do not improve after 4 weeks a doctor or qualified healthcare practitioner should be consulted.
Children and adolescents under 18 years of age
The use in children or adolescents under 18 years of age is not recommended (See Section 4.4 Special warnings and precautions for use)
4.3 Contraindications
Hypersensitivity to any of the ingredients or any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed stated dose.
If symptoms worsen or do not improve after 4 weeks a doctor or qualified healthcare practitioner should be consulted.
The use of this product is not recommended in children or adolescents under 18 years of age because data are not sufficient and medical advice should be sought.
This product contains dehydrated glucose syrup and sucrose. Patients with rare hereditary problems of fructose intolerance or glucose-galactose malabsorption should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
Valerian extract: Only limited data on pharmacological interactions with other medicinal products are available. Clinically relevant interactions with drugs metabolized by the CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 pathway has not been observed.
Lemon balm extract and Hops extract: None known.
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 the product may be potentiated by alcohol. Excessive alcohol consumption should therefore be avoided.
4.6 Fertility, Pregnancy and lactation
The safety of this product during pregnancy and lactation has not been established, therefore the use of this product during pregnancy and lactation is not recommended.
Studies on fertility have not been carried out.
4.7 Effects on ability to drive and use machines
May impair the ability to drive and use machines. Affected patients should not drive or operate machines.
4.8 Undesirable effects
Gastrointestinal symptoms such as nausea and abdominal cramps may occur after ingestion of Valerian root preparations. The frequency is not known. There are no known adverse reactions with Hops or Lemon Balm.
If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.
4.9 Overdose
Valerian root at a dose of approximately 20 g caused benign symptoms (fatigue, abdominal cramp, chest tightness, lightheadedness, hand tremor and mydriasis), which disappeared within 24 hours.
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.
No cases of overdose have been reported for Hops extract and Lemon balm extract..
Supportive and symptomatic treatment should be provided as appropriate.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not required as per Article 16c(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
Melissa extract: Data from in vitro animal studies indicate that a water extract of Melissa officinalis may inhibit the activity of thyroid stimulating hormone (TSH).
The clinical relevance of these findings is not known.
Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed with Valerian root, Hops and Lemon Balm extract.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Extract excipients:
maltodextrin,
colloidal anhydrous silica.
Tablet core:
microcrystalline cellulose,
Copovidone (64),
Povidone (90), stearic acid 50, talc.
Tablet coating: carmellose sodium,
Capol 600, consisting of Carnauba wax, Cera alba,
Shellac,
spray-dried glucose liquid, Indigotine lacquer E 132, maize starch,
Povidone (25), sucrose,
colloidal anhydrous silica, talc,
Titanium dioxide E171, Polysorbate 80.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
39 months.
6.4 Special precautions for storage
Do not store above 30°C. Store in the original package.
6.5 Nature and contents of container
PVC/PVDC-Al blister strips in cardboard carton.
Packs of 60 or 100 coated tablets per package.
6.6 Special precautions for disposal and other handling
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Grunwalder Gesundheitsprodukte GmbH,
Ruhlandstr. 5,
83646 Bad Tolz,
Germany.
8 MARKETING AUTHORISATION NUMBER(S)
THR 18457/0020
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
10/02/2012
10 DATE OF REVISION OF THE TEXT
05/04/2016