Europe — EMA
Hodernal
Hodernal is an oral liquid formulation containing liquid paraffin as its active ingredient. It is marketed in the European Union as an over‑the‑counter (OTC) mineral oil laxative. The product is supplied in a liquid dos…
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What is Liquid Paraffin?
Hodernal is an oral liquid formulation containing liquid paraffin as its active ingredient. It is marketed in the European Union as an over‑the‑counter (OTC) mineral oil laxative. The product is supplied in a liquid dosage form without a specified strength, and it is intended to relieve occasional constipation by lubricating the intestinal tract. It works by reducing water absorption from the stool, helping to soften feces and promote easier passage.
What is Liquid Paraffin used for?
Hodernal is indicated for the temporary relief of constipation in adults and children when a gentle, non‑stimulant laxative is preferred.
- Occasional constipation due to low dietary fiber or fluid intake. - Constipation associated with reduced physical activity or travel. - Softening of hard stools to facilitate bowel movements. - Use as a stool‑softening adjunct before minor surgical or diagnostic procedures requiring clear bowels. - Management of constipation in patients on opioid therapy where a non‑stimulant option is desired. - Support for bowel regularity in elderly individuals prone to hard stools.
What are the side effects of Liquid Paraffin?
Like other mineral oil laxatives, Hodernal may cause unwanted gastrointestinal or systemic reactions, most of which are mild and reversible.
Common: - Mild abdominal cramping or bloating. - Loose stools or mild diarrhea. - Nausea or a feeling of fullness. - Rectal irritation or mild anal discomfort.
Serious: - Persistent diarrhea leading to dehydration. - Severe abdominal pain suggestive of obstruction. - Unexpected weight loss or malnutrition with prolonged use. - Signs of allergic reaction such as rash, itching, or swelling.
What precautions apply to Liquid Paraffin?
Before using Hodernal, consider the following precautions to ensure safe and appropriate use.
- Avoid use in individuals with known hypersensitivity to mineral oil or any component of the product. - Do not use in cases of intestinal blockage, perforation, or severe inflammatory bowel disease. - Limit duration of use; prolonged daily intake may interfere with absorption of fat
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