Makatussin Comp. Cough Syrup

Product Name: Makatussin Comp. Cough Syrup

Active Substances (per 5 ml):

• Dihydrocodeine hydrochloride: 10 mg

• Diphenhydramine hydrochloride: 15 mg

Excipients: Sodium benzoate (E211), citric acid, neohesperidin dihydrochalcone, sucrose, cherry flavor, elderberry concentrate, 70% sorbitol solution (non-crystallizable), purified water .

Carbohydrate content: Each 5 ml contains approximately 4 g of carbohydrates (approx. 0.33 UP).

Manufacturer: Gebro Pharma AG, 4410 Liestal, Switzerland .

Legal Category: Prescription-only medication (Category B in Switzerland). In some pharmacies, it may be dispensed after a professional consultation .

Therapeutic Indications:
Makatussin Comp. is indicated for the treatment of cough, particularly dry, irritating cough. It works by:

• Calming the cough reflex

• Loosening mucus

• Reducing swelling of the bronchial and nasal mucosa 

Dosage and Administration:
For adults aged 18 years and older: 5 ml, 2 to 3 times daily. A measuring cup is included for precise dosing. Use the lowest effective dose for the shortest duration necessary .

Contraindications:
Do not use Makatussin Comp. in the following cases:

• Hypersensitivity to any component

• Children and adolescents under 18 years of age

• Known “ultra-rapid metabolizers” of codeine

• Pregnancy

• Breastfeeding women

• Bronchial asthma

• Conditions where respiratory center depression must be avoided

• Chronic constipation (with long-term use)

• Narrow-angle glaucoma

• Prostatic hypertrophy (enlarged prostate)

• Cough with significant mucus production

• After surgical procedures on the intestines or stomach

• Cardiac, duodenal, or pyloric stenosis

• Pheochromocytoma

• Treatment with MAO inhibitors (for depression)

• Opiate dependence 

Warnings and Precautions:

• Addiction and Abuse: Repeated use of opioids like Makatussin Comp. can lead to habituation and physical and/or psychological dependence. Misuse can lead to life-threatening overdose and possible death .

• Respiratory Depression: This medication can cause dangerously slow or shallow breathing. Contact your doctor immediately if this occurs .

• Alcohol and Sedatives: Concurrent use with alcohol or medications that cause drowsiness increases the risk of dangerous, potentially fatal side effects .

• Accidental Use: Accidental ingestion, especially in children, can lead to fatal overdose. Keep out of reach of children .

• Impaired Reactions: This medication may affect the ability to drive or operate machinery, especially when combined with alcohol .

• Sugar Content: Contains sorbitol (a source of fructose) and sucrose. Consult your doctor if you have hereditary fructose intolerance or other sugar intolerances .

• Sodium Benzoate: Contains 3.5 mg of sodium benzoate (E211) per 5 ml .

• Liver or Kidney Disease: Use with caution and only for a few days without medical prescription .

Side Effects:
Common (may affect up to 1 in 10 people):

• Nausea

• Constipation

• Drowsiness

• Headache

• Risk of dependence (with abusive use)

Occasional:

• Shortness of breath (dyspnea)

Rare:

• Fatigue

• Vomiting

• Depression

• Dry mouth

• Central nervous disorders

• Urination disorders

• Visual disturbances

• Glaucoma triggering

• Hypersensitivity reactions (e.g., skin rashes)

• Blood count alterations

• Sleep interruption

• Euphoria 

Storage:
Store at room temperature (15-25°C). Keep out of reach of children .

Available Package Size:
80 ml bottle .

Regulatory Information:
Last updated: May 2024 by Swissmedic (Swiss Agency for Therapeutic Products) .