LIQ MV 40% FL 200G

LIQUID PARAFFIN MARCO VITI 40% ORAL EMULSION

active ingredients

100 g emulsion contain: Active ingredient: Liquid paraffin g 40. For the full list of excipients, see paragraph 6.1.

Excellent

Purified water, sucrose, polysorbate 60, sorbitan stearate, glycerol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, vanillin.

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

– hypersensitivity to the active ingredient or any of the excipients; – nausea, vomiting, acute or unknown abdominal pain; – obstruction or intestinal stenosis; – gastrointestinal disorders such as appendicitis, diverticulitis, ulcerative colitis, rectal bleeding of unknown origin; – acute hemorrhoid crisis with pain and bleeding; – severe dehydration; – subjects with difficulty in ingesting or presenting pathologies (e.g. iatal hernia) or conditions (e.g. debilitated persons forced into bed) which involve the risk of regurgitation; – cholestomy/leostomy; – pregnancy (see paragraph 4.6); – children under the age of 6; – concomitant intake of other laxatives or softeners of feces.

Population

The correct dose is sufficient to produce an easy evacuation of soft feces. It is advisable to initially use the minimum doses provided. When necessary, the dose may be increased, but never exceed the maximum indicated. Adults and teenagers: the usual dose varies from 15 to 45 ml of emulsion per day. The maximum permitted dose is 45 ml per day. Children from 6 years to 12 years: the usual dose is 5–15 ml emulsion per day. The maximum permitted dose is 15 ml per day. The liquid oral emulsion paraffin is contraindicated in children under 6 years of age, as in this age group children are more likely to aspire emulsion, with a risk of lipoidea pneumonia (see paragraphs 4.3 and 4.8). Shake the bottle before use. Take the medicine on an empty stomach together with an adequate amount of water (a plentiful glass) away from meals and preferably in the evening at least an hour before bedtime. Take at least 2 hours before or after meals, as the medicine may interfere with the absorption of nutrients and vitamins. Laxatives must be used as frequently as possible and for no more than seven days (see paragraph 4.4). A fluid-rich diet promotes the effect of the medicine.

Conservation

Store the bottle tightly closed in the original packaging away from light.

Warnings

Laxatives must be used as frequently as possible and for no more than seven days. Use for longer periods requires the doctor’s prescription after adequate evaluation of the individual case. Treatment of chronic or recurring constipation always requires medical intervention for diagnosis, prescription of drugs and surveillance during therapy. The drug should be administered preferably in the evening (however at least an hour before bedtime) since peristaltic movements are slowed down and the laxative may persist in the intestine longer with consequent improvement of its effect. It is important to avoid recurring or reclining the head backwards when taking liquid paraffin to avoid the aspiration of drops of the drug. Rarely, especially in younger children, elderly or debilitated patients, the involuntary suction of liquid paraffin can cause pneumonia ab ingestis. Abuse of laxatives (frequent or prolonged use or excessive doses) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutrients.In more serious cases, dehydration or hypokalemia may occur, which can lead to cardiac or neuromuscular dysfunction, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids.Abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause dependence (and, therefore, the possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).Abuse of laxatives based on liquid paraffin can cause reduced absorption of fat-soluble vitamins (A, D E and K).In episodes of constipation, it is recommended first of all to correct eating habits by integrating the daily diet with an adequate intake of fiber and water.When using laxatives, it is important to drink at least 6–8 glasses of water or other liquids a day to help soften the stool. Important information about some excipients: Liquid paraffin Marco Viti contains methyl parahydroxybenzoate and propyl parahydroxybenzoate: may cause allergic reactions (possibly delayed).Liquid paraffin Marco Viti contains 1.1 g of sucrose per 5 ml: this should be taken into account for patients with diabetes mellitus.Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Interactions

Laxatives can reduce the time of stay in the intestine, and therefore the absorption of other drugs administered at the same time by mouth. Avoid taking laxatives and other drugs at the same time; after taking a medicine let spend a range of at least 2 hours before taking laxative. In patients treated with cardioactive glucosides, diuretics or corticosteroids, dehydration and potassium loss caused by excessive laxative effect can cause heart failure or neuromuscular. Do not simultaneously take a tessioactive laxative (e.g. docusate sodium) as it could promote the systemic absorption of the liquid paraffin, causing reactions of chronic inflammation from foreign body in the affected tissues (linphodes, intestinal mucosa, liver and spleen). Co-administration of cholecalciferol and mineral oil can reduce the absorption of vitamin D and therefore subsequently cause hypocalcemia and secondary hyperparathyroidism. Liquid paraffin can interfere with the absorption of fat-soluble substances, such as vitamins A, D, E, K.

Effects

Below are the undesirable effects of liquid paraffin organized according to the organic system classification MedDRA. No sufficient data is available to determine the frequency of the individual effects listed. Immune system disorders Hypersensitivity reactions, even severe ones (dyspnea, feeling of heaviness in the chest, angioedema).Rarely, systemic absorption of paraffin can cause chronic inflammatory reactions. Pathologies of skin and subcutaneous tissue Rash, hives. Disorders of metabolism and nutrition Liquid paraffin may interfere with the absorption of fat-soluble substances, such as vitamins A, D, E, K, especially following prolonged use of the drug. Gastrointestinal diseases Isolated cramping pain or abdominal colic, more frequent in cases of severe constipation.Rectal oozing (loss, dripping) of paraffin with consequent anal irritation and itching, rectal bleeding, especially following prolonged use of the drug.Foreign body reactions (granulomatous reactions – paraffinomas) in the intestinal mucosa, due to the absorbed portion of the drug. Respiratory, chest and mediastinic pathologies Lipoidea lungitis and oleous embolism due to accidental inhalation of the medicinal product.

Overdosing

Laxative abuse (frequent or prolonged use or excessive doses) can cause abdominal pain, persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutrients.Fluid and electrolyte losses must be replaced.Electrolyte imbalances are characterized by the following symptoms: thirst, vomiting, weakness, edema, bone pain (osteomalacia) and hypoalbuminemia.In more serious cases, dehydration or hypokalemia may occur, which may cause cardiac or neuromuscular dysfunction, especially in the case of concomitant treatment with cardiac glycosides, diuretics or corticosteroids.Laxative abuse, especially contact laxatives (stimulant laxatives), can cause dependence (and, therefore, the possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).Pulmonary aspiration of large amounts of liquid paraffin can cause life-threatening lipoid pneumonia, pulmonary fibrosis, and lung cancer at fibrotic sites.Excessive ingestion of liquid paraffin can cause anal incontinence, leakage through the sphincter (dripping), perianal itching, and irritation.

Pregnancy

For liquid paraffin, there are no clinical data on exposed pregnancies.Liquid paraffin should not be used during pregnancy;it may reduce the absorption of nutrients and vitamins essential for the mother and child.

Food

There are no data available on the use of liquid paraffin during breastfeeding and it is not known whether this active substance passes into breast milk.However, since the absorption of the drug can be considered negligible, it is very unlikely that significant quantities reach breast milk.Caution should be exercised when prescribing the medicine during breastfeeding.

Source: Farmadati