Opium (Granules) Instructions for Use

Marketing Authorization Holder

Boiron (France)

Contact Information

Boiron (France)

ATC Code

V30 (Not assigned)

Dosage Forms

	Opium	Homeopathic granules C5: 4 g tube with granule counter
		Homeopathic granules C9: 4 g tube with granule counter
		Homeopathic granules C15: 4 g tube with granule counter
		Homeopathic granules C30: 4 g tube with granule counter

Dosage Form, Packaging, and Product Composition

Excipients: sucrose, lactose.

4 g – tubes with granule counter (1) – cardboard packs.

Clinical-Pharmacological Group

Single-component homeopathic preparation of plant origin

Pharmacotherapeutic Group

Homeopathic agent

Pharmacological Action

Opium poppy is an annual herbaceous plant with a height from 30 cm to 1.50 m, cultivated since ancient times. The milky sap is collected after the petals fall but before the seed capsule ripens, at a stage called “technical maturity”. It is from this thick milky sap that the mother tincture of Opium^* is prepared.

Its composition is complex; the mother tincture contains simple substances such as glucose, pectins, resins, fats, enzymes, etc.; organic acids such as meconic acid, as well as lactic, oxaloacetic, succinic, malic, fumaric, citric, and tartaric acids; mineral acids; a lactone – meconin, present in goldenseal; and especially numerous alkaloids, which are divided into several groups depending on the core structure.

The most significant in terms of quantity and pharmacological action are the alkaloids derived from morphine: morphine; codeine; thebaine, which primarily affect the central nervous system, pain sensitivity centers, and the respiratory center; and the isoquinoline derivatives: papaverine and other alkaloids derived from benzylisoquinoline – laudanine, laudanosine; noscapine and narceine, derivatives of phthalideisoquinoline, which primarily affect smooth muscle (depressant and antispasmodic action); papaverine, among other things, has a vasodilatory effect.

Other alkaloids constitute 1% of the total alkaloid complex.

In therapy, Opium is used as a sedative and analgesic; and as a muscle relaxant (relaxes the smooth muscles of the respiratory and digestive organs).

Indications

Key symptoms for prescribing the drug

• Absence of pain: the patient does not suffer, does not complain, does not want anything during the illness, despite the intensity of general symptoms;
• Increased sensitivity of all senses, especially hearing: the patient wakes up in the middle of the night from the slightest noise (increased hearing sensitivity can also be combined with nausea and dizziness) or the patient dozes but cannot fall asleep;
• Intense thirst.

Main cases of clinical application

Anesthesiology

• Prolonged confusion after general anesthesia;
• Intestinal atony due to intestinal paresis after laparotomy¹.

Sleep disorders

• Sleep apnea syndrome;
• Insomnia due to increased hearing sensitivity;
• Insomnia due to overexcitement, fear: the patient cannot get rid of the feeling of horror for a long time.

Gastroenterology

• Constipation without the urge to defecate due to intestinal atony.

Dosage Regimen

Sublingually.

The granules should be dissolved in the mouth 30 minutes before a meal or 60 minutes after a meal.

For children from 0 to 3 years old, the granules are first diluted by shaking in 10-15 ml of water at room temperature and given to drink.

The optimal amount per dose is 5 granules.

Consultation with a doctor is necessary to determine the potency, frequency, and duration of administration.

Adverse Reactions

None described to date.

Contraindications

• Individual sensitivity to the drug;
• Lactose intolerance.

Special Precautions

The dosage regimen and frequency of administration are determined by the doctor.

If there is no therapeutic effect within 3 days, or if adverse reactions occur, you should consult a doctor.

Overdose

No information on overdose cases has been received to date.

Drug Interactions

Other medications can be used concomitantly with Opium treatment.

Storage Conditions

At a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 5 years.

Dispensing Status

The drug is available without a prescription.

* Labmer J., Markel J., “Homeopathic Preparations: Opium, Secale cornutum”. Boiron Institute, Commission “Reliability of Medical Raw Materials”, volume 2, Boiron, 1991.

¹ A meta-analysis of the results of 6 controlled clinical trials on postoperative ileus showed the effectiveness of homeopathic preparations compared to placebo (Barnes J., Resch K-L., Ernst E., “Homeopathy for Postoperative Ileus. A Meta-Analysis” / Gastroenterology, 1997. 25, 4: pp. 628-633).

Another meta-analysis of the results raised the question of the identical effects of homeopathic remedies and placebo in controlled clinical trials of homeopathic preparations (when mixing clinical indications). A difference between placebo and homeopathic remedies was identified, but effectiveness in treating diseases was not established (Linde et al. “Are the Clinical Effects of Homeopathy Placebo Effects? A Meta-Analysis of Placebo-Controlled Trials”, The Lancet 1997, 350: pp. 834-843).

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.