Doxylamine 15 mg Viatris - Scored Tablets (10 Tablets)

Relief for Occasional Insomnia

Doxylamine 15 mg tablets are formulated to help manage occasional insomnia in adults and adolescents over 15 years old. This first-generation H1 antihistamine works by promoting drowsiness, making it easier to fall asleep and improve sleep quality.

Key Features

• Fast-Acting Relief: Take 15–30 minutes before bedtime for optimal results.
• Flexible Dosage: Adjust between ½ tablet to 2 tablets per day as needed (consult your doctor for higher doses).
• Safe for Pregnant Women: Can be used during pregnancy under medical advice.
• Convenient Scored Tablets: Easy to break for customized dosing.

Composition

Each scored tablet contains:

• Active Ingredient:

  • Doxylamine hydrogen succinate: 15 mg

• Excipients:

  • Core: Lactose monohydrate, microcrystalline cellulose, magnesium stearate, croscarmellose sodium.
  • Film Coating: Hypromelose (E464), talc, titanium dioxide (E171), macrogol 6000, propylene glycol.

How to Use

• Age: Reserved for adults and adolescents 15 years and older.
• Dosage:
  • Standard: ½ to 1 tablet per day.
  • Maximum: Up to 2 tablets per day if necessary (consult your doctor).
• Administration: Swallow with water in the evening, 15–30 minutes before bedtime.
• Duration: Limit use to 2–5 days. Do not exceed 5 days without consulting a healthcare professional.

Precautions

Contraindications

• Allergies to antihistamines.
• History of acute glaucoma or difficulty urinating (e.g., due to prostate issues).
• Children under 15 years old.

Special Considerations

• Use with caution in elderly individuals due to increased risk of falls and dizziness.
• Not recommended for those with lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
• Avoid combining with alcohol or other sedatives.

Pregnancy and Breastfeeding

• Pregnancy: Safe under normal conditions of use; consult a doctor before use.
• Breastfeeding: Not recommended as it may affect the infant (lethargy, loss of tone, or insomnia).

Side Effects

Common side effects may include:

• Daytime drowsiness.
• Dry mouth, visual disturbances, urinary retention, constipation.
• Heart palpitations, confusion, or muscle pain (rhabdomyolysis).
• Rare cases of dependence have been reported.

Additional Information

• Sleep Apnea: May aggravate symptoms; consult a doctor if you have sleep apnea.
• Packaging: 10 scored, film-coated tablets.
• Storage: Keep in a dry place below 25°C, out of reach of children.

Caution: Doxylamine may impair daytime alertness, especially if sleep duration is insufficient. Avoid operating machinery or driving during treatment. Always consult your doctor or pharmacist if combining with other medications.

Effective relief for occasional insomnia – rest easy with Doxylamine Viatris.

Please read the following full disclosure before purchasing or using this product.

SUMMARY OF PRODUCT CHARACTERISTICS

ANSM - Last updated: 12/05/2023

1. NAME OF THE MEDICINAL PRODUCT

DOXYLAMINE VIATRIS CONSEIL 15 mg, film-coated scored tablet.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Doxylamine hydrogen succinate: 15.00 mg
For one scored film-coated tablet.

Notable excipient: This product contains 76.90 mg of lactose monohydrate per tablet.
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Film-coated scored tablet.
White to off-white, oblong, biconvex tablets with a break line.
The tablet can be divided into equal doses.

4. CLINICAL DATA

4.1 Therapeutic Indications

Treatment of occasional insomnia in adults.

4.2 Posology and Method of Administration

Posology

• Recommended dose: 7.5–15 mg per day (½ to 1 tablet daily).
• Maximum dose: Up to 30 mg per day (2 tablets), if necessary.

For elderly patients or those with renal or hepatic impairment: Dosage reduction is recommended.

Method of Administration

• Oral use.
• Take a single dose per day, in the evening, 15–30 minutes before bedtime.
• Swallow the tablet with a small amount of water.

Duration of Treatment

• The treatment duration is 2 to 5 days.
• If insomnia persists for more than 5 days, reassess the clinical situation.

4.3 Contraindications

Do not use in the following cases:

• Known hypersensitivity to antihistamines, the active substance, or any of the excipients listed in section 6.1.
• Personal or family history of acute angle-closure glaucoma.
• Urethroprostatic disorders at risk of urinary retention.
• Children under 15 years of age.

4.4 Special Warnings and Precautions for Use

Special Warnings

• Insomnia may have various causes that do not necessarily require medication.
• Doxylamine hydrogen succinate, like any sedative or hypnotic, may worsen pre-existing sleep apnea syndrome (increased frequency and duration of apnea episodes).
• Although the risk of abuse or dependence is low, cases have been reported. Monitoring is necessary for signs of misuse or dependence.
• Treatment duration should not exceed 5 days. Use in individuals with a history of substance abuse is discouraged.

Accumulation Risk

• As with all medications, doxylamine hydrogen succinate persists in the body for approximately 5 half-lives (see section 5.2).
• Elderly or patients with renal or hepatic impairment may have prolonged half-lives, requiring dosage adjustment.

Elderly Patients

• Use with caution due to risks of cognitive impairment, sedation, slow reaction times, dizziness, and increased fall risk, particularly with nocturnal awakenings.

Precautions for Use

• Renal or Hepatic Impairment: Reduced clearance and increased plasma concentrations may occur; lower doses are recommended.
• Excipients:
  • Contains lactose; not suitable for patients with rare hereditary disorders such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
  • Contains less than 1 mmol of sodium (23 mg) per tablet, considered "essentially sodium-free."

4.5 Interactions with Other Medicines and Other Forms of Interaction

Discouraged Associations

• Alcohol: Increases the sedative effect of H1 antihistamines. Avoid alcohol consumption and medicines containing alcohol.
• Sodium Oxybate: Enhances central nervous system depression.

Cautionary Combinations

• Other Sedatives: Including benzodiazepines, barbiturates, and opioids.
• Anticholinergics: Risk of additive side effects such as dry mouth, constipation, and urinary retention.

4.6 Fertility, Pregnancy, and Lactation

Pregnancy

• Based on available data, doxylamine use is possible during pregnancy.
• In late pregnancy, monitor the newborn for sedative or anticholinergic effects.

Breastfeeding

• Not recommended during breastfeeding, as the potential effects (e.g., sedation or paradoxical excitation) on the infant are unknown.

Fertility

• Not applicable.

4.7 Effects on Ability to Drive and Use Machines

• Warn patients about potential daytime drowsiness.
• Avoid driving or operating machinery when combining doxylamine with other sedatives or alcohol.
• Insufficient sleep duration increases the risk of impaired alertness.

4.8 Undesirable Effects

Common Side Effects:

• Anticholinergic effects: dry mouth, constipation, urinary retention, visual disturbances, palpitations, confusion.
• Daytime drowsiness requiring dose adjustment.

Rare Effects:

• Rhabdomyolysis and elevated creatine phosphokinase (CPK) levels.
• Cases of abuse and dependence reported.

4.9 Overdose

Symptoms:

• Drowsiness, anticholinergic effects (e.g., dry mouth, tachycardia, agitation, hallucinations), and rare complications such as convulsions or rhabdomyolysis.
• Management: Early administration of activated charcoal is recommended. Treatment is symptomatic.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic Properties

• ATC Code: R06AA09.
• Class: H1 antihistamine (ethanolamine class).
• Reduces sleep onset time and improves sleep duration and quality.

5.2 Pharmacokinetic Properties

• Absorption: Maximum plasma concentration is reached approximately 2 hours after administration.
• Elimination Half-Life: Average of 10 hours.
• Metabolized in the liver; approximately 60% excreted unchanged in the urine.

6. PHARMACEUTICAL DATA

6.1 List of Excipients

Core: Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate.
Coating: Hypromellose (E464), talc, titanium dioxide (E171), macrogol 6000, propylene glycol.

6.3 Shelf Life

• 3 years.

6.5 Packaging

• 10 scored film-coated tablets in a polypropylene tube with a polyethylene cap.

7. MARKETING AUTHORISATION HOLDER

VIATRIS SANTE
1 Rue de Turin
69007 Lyon, France.

8. MARKETING AUTHORISATION NUMBER

34009 266 899 5 7.

9. DATE OF LAST AUTHORISATION UPDATE

[To be completed by the marketing authorisation holder.]

Conditions of Prescription and Dispensation: Non-prescription medication.