Instructions for Alluna film-coated tablets 1000 mg No. 10
Composition
active ingredients: 1 film-coated tablet contains:
375 mg of dry native extract from Valeriana officinalis L., radix (valerian root) (5-8:1),
84 mg of dry native extract from Humulus lupulus L., flos (hop cones) (7-10:1),
extractant: methanol 45% w/w;
excipients: colloidal anhydrous silica, croscarmellose sodium, hypromellose, indigo carmine (E 132), polyethylene glycol 20000, magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid, titanium dioxide (E 171).
Dosage form
Film-coated tablets.
Main physicochemical properties: pale blue tablets, with a characteristic smell of valerian, oblong in shape, convex on both sides, approximately 7 x 20 mm, with a break line on both sides. The tablet can be divided into equivalent doses.
Pharmacotherapeutic group
Sleeping pills and sedatives. Other sleeping pills and sedatives.
ATX code N05C M.
Pharmacological properties
Pharmacodynamics.
The sedative effects of preparations containing valerian root and hop cones have long been empirically recognized and have been confirmed for preparations containing valerian root in preclinical trials and controlled clinical trials. To date, no clinical trials have been conducted on hop cone extracts as active medicinal products for insomnia, but at least four randomized, placebo- or comparator-controlled prospective clinical trials have been conducted with fixed combinations of dry extracts obtained from valerian root and hop cones with 45% (w/w) methanol.
Oral administration of fixed combinations of these extracts at recommended doses has shown improvements in sleep latency and quality. These effects cannot be attributed with high confidence to any known components. Several mechanisms of action of various valerian root constituents (sesquiterpenoids, lignin, flavonoids) have been identified as possible contributors to the clinical effect, including interaction with the GABA system, agonism at the A-1 adenosine receptor, and binding to the 5-HT1A receptor. Several mechanisms of action of various hop cone constituents (bitter acids, flavonoids) have also been identified, including interaction with the GABA system, agonism at melatonin receptors (ML1 and ML2), and binding to serotonin receptor subtypes (5-HT4e, 5-HT6, and 5-HT7).
It is currently unknown whether hop cone extract acts alone as a mild sedative or as a synergist for valerian root extract.
Pharmacokinetics.
Data not provided.
Indication
A herbal medicine for the treatment of sleep disorders such as difficulty falling asleep, insomnia, and restless sleep.
Contraindication
Hypersensitivity to the active substances or to any of the excipients of this drug.
Depression and other conditions accompanied by suppression of the central nervous system.
Interaction with other medicinal products and other types of interactions
Limited data are available on pharmacological interactions with other medicinal products.
No clinically significant interactions with drugs metabolized by CYP2D6, CYP3A4/5, CYP1A2, or CYP2E1 have been observed. Combination with synthetic sedatives requires medical diagnosis and supervision.
Valerian preparations may enhance the effects of alcohol, sedatives, hypnotics, analgesics, antispasmodics, and anxiolytics.
Application features
Patients with severe liver dysfunction or a history of severe liver disease should be cautious when taking the drug. Alcohol should be avoided while taking the drug.
There may be a specific sensitivity to the smell of valerian.
This medicinal product contains less than 1 mmol (23 mg) sodium/dose, i.e. essentially 'sodium-free'.
Use during pregnancy or breastfeeding
The safety of the medicine during pregnancy or breastfeeding has not been evaluated. It is not recommended to use any medicine during pregnancy or breastfeeding without consulting a doctor.
Ability to influence reaction speed when driving vehicles or other mechanisms
Do not take this medicine before driving or operating potentially dangerous machinery.
Method of administration and doses
Dosage
Adults
Adults take 1 film-coated tablet 1 hour before bedtime with water. If necessary, the dose can be increased to 1 ½ film-coated tablets.
Due to the gradual onset of efficacy, the fixed combination of valerian root and hop cones is not used for acute interventional treatment of mild nervous tension or sleep disorders. The herbal medicine should be taken for at least 2 weeks to restore normal sleep. To achieve optimal treatment effect, further use for 4 weeks is recommended.
If symptoms persist or worsen after 4 weeks of continuous use, you should consult a doctor.
Method of application
For oral use.
Children.
Not recommended for use.
Overdose
A dose of valerian root of approximately 20 g causes mild symptoms (fatigue, abdominal cramps, chest tightness, dizziness, hand tremor and mydriasis) that resolve within 24 hours. Limited information is available on overdose with a fixed combination of valerian root and hop cones. Isolated cases of up to 30 tablets per day have been reported without any adverse reactions. In isolated cases, symptoms of atypical abdominal sounds, drowsiness, tachycardia, anxiety and dizziness have been reported with doses up to 25 tablets per day.
If symptoms recur, treatment should be supportive.
Treatment: symptomatic.
Side effects
The frequency of adverse reactions is determined based on the following incident reports:
Very common (≥ 1/10)
Common (≥ 1/100 to < 1/10)
Uncommon (≥ 1/1000 to < 1/100)
Rare (≥ 1/10,000 to < 1/1,000)
Very rare (< 1/10,000)
The unknown cannot be estimated based on the available data.
Gastrointestinal disorders: gastrointestinal disorders such as nausea, vomiting, diarrhea and abdominal cramps. The frequency of occurrence is not established.
Skin and subcutaneous tissue disorders: Skin reactions. Occur very rarely.
From the side of the central and peripheral nervous system: dizziness, drowsiness, inhibition of emotional reactions, depression, general weakness, decreased mental and physical performance.
Immune system disorders: hypersensitivity reactions including rash, itching, flushing, skin oedema.
If you experience any side effects not described in the instructions for use, you should inform your doctor.
Expiration date
3 years.
Storage conditions
Store at a temperature of up to 25 °C in a dry, dark place out of the reach of children.
Packaging
10 tablets in a blister, 1 or 3 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Max Zeller Sohne AG, Switzerland.
Location of the manufacturer and address of its place of business.
Seeblickstrasse 4, 8590 Romanshorn, Switzerland.
Applicant
Amaxa LTD, United Kingdom.
Location of the applicant.
31 John Islip Street, London SW1P 4FE, United Kingdom.
