What is Ameluz used for?

Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation, heartburn, indigestion (occurring due to the reflux of stomach contents), for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy, accompanying reflux oesophagitis, including symptoms of laryngopharyngeal reflux such as hoarseness and other voice disorders, sore throats and cough. Can also be used to treat the symptoms of gastro-oe

How does Ameluz work?

ATC Code: A02BX13 Pharmaceutical group: Other drugs for peptic ulcer and gastro-oesophageal reflux On ingestion the suspension reacts with gastric acid to rapidly form a raft of alginic acid gel having a near-neutral pH which floats on the stomach contents effectively impeding gastro-oesophageal reflux for up to 4 hours, and protecting the oesophagus from acid, pepsin and bile.

What is the active ingredient in Ameluz?

Acidum 5-aminolevulinicum hydrochloridum (Acidum 5-aminolevulinicum hydrochloridum)

What pharmaceutical form is Ameluz available in?

Ameluz: Żel 78 mg/g (na skórę)

Is Ameluz OTC or prescription only?

Ameluz requires a doctor's prescription.

What are the side effects of Ameluz?

Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and < 1/100), rare (≥1/10,000 and <1, 1000), very rare (<1/10,000 cases), and not known (cannot be estimated from the available data). System Organ Class Frequency Adverse Event Immune System Disorders Very Rare Anaphylactic and anaphylactoid reactions. Hypersensitivity reactions such as urticaria. Respiratory, Thoracic

Who should NOT take Ameluz?

This medicinal product is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients, or any of the excipients listed in section 6.1, including ethyl parahydroxybenzoate (E214) and propyl Parahydroxybenzoate (E216) (see section 4.4) .

Does Ameluz interact with other medications?

A time-interval of 2 hours should be considered between Acidex Advance intake and the administration of other medicinal products, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates, and estramustine.

Can Ameluz be used during pregnancy?

Pregnancy: Clinical studies in more than 500 pregnant women as well as a large amount of data from post-marketing experience indicate no malformative nor foeto/neonatal toxicity of the active substances. Acidex Advance can be used during pregnancy, if clinically needed. Breast feeding: No known effect on breast fed infants. Acidex Advance can be used during breast feeding. Fertility No known effect on human fertility.

Who manufactures Ameluz?

Biofrontera Bioscience GmbH (Niemcy)

What ATC class does Ameluz belong to?

Ameluz: ATC L01XD04. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Ameluz

78 mg/g, Żel

INN: Acidum 5-aminolevulinicum hydrochloridum

Data updated: 2026-04-13

Available in:

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Form

Żel

Dosage

78 mg/g

Route

na skórę

Storage

—

About This Product

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