Paraffin Liq Mv*40% Fl 200g

NAME
MARCO VITI LIQUID PARAFFIN 40% ORAL EMULSION

PHARMACOTHERAPEUTIC CATEGORY
Constipation medications.

ACTIVE PRINCIPLES
Liquid paraffin.

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

INDICATIONS
Short-term treatment of occasional constipation.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance or to any of the excipients; nausea, vomiting, abdominal pain that is acute or of unknown origin; intestinal obstruction or stricture; disorders affecting the gastrointestinal system such as appendicitis, diverticulitis, ulcerative colitis, rectal bleeding of unknown origin; acute hemorrhoidal crisis with pain and bleeding; severe state of dehydration; subjects with difficulty in swallowing or who have pathologies (for example hiatal hernia) or conditions (for example debilitated subjects confined to bed) that carry the risk of regurgitation; colostomy / ileostomy; pregnancy; children under the age of 6; concomitant intake of other laxatives or stool softeners.

DOSAGE
The correct dose is the minimum sufficient to produce an easy evacuation of soft faeces. It is advisable to initially use the minimum doses provided. When necessary, the dose can then be increased, but without ever exceeding the maximum indicated. Adults and adolescents: the usual dose ranges from 15 to 45 ml of emulsion per day. The maximum allowable dose is 45 ml per day. Children from 6 to 12 years: the usual dose is 5-15 ml of emulsion per day. The maximum allowable dose is 15 ml per day. The oral liquid paraffin emulsion is contraindicated in children younger than 6 years, as in this age group children are more likely to aspirate the emulsion, with a risk of lipoid pneumonia. Shake the bottle before use. Take the drug on an empty stomach together with an adequate quantity of water (a large glass) between meals and preferably in the evening at least one hour before going to bed. Take at least 2 hours before or after meals, as the medicine may interfere with the absorption of nutrients and vitamins. Laxatives should be used as infrequently as possible and for no more than seven days. A diet rich in liquids favors the effect of the medicine.

STORAGE
Keep the bottle tightly closed in the original package away from light.

WARNINGS
Laxatives should be used as infrequently as possible and for no more than seven days. The use for longer periods of time requires a medical prescription after adequate evaluation of the individual case. The treatment of chronic or recurrent constipation always requires the intervention of the doctor for the diagnosis, the prescription of drugs and the surveillance during the course of therapy. The drug should preferably be administered in the evening (in any case at least one hour before bedtime) since the peristaltic movements are slowed down and the laxative can remain in the intestine longer with consequent improvement of its effect. It is important to avoid lying down or tilting your head back when taking liquid paraffin to avoid aspiration of drops of the medicine. Rarely, particularly in younger children, the elderly or disabled patients, involuntary aspiration of liquid paraffin can cause aspiration pneumonia. The abuse of laxatives (frequent or prolonged use or in excessive doses) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors. In the most severe cases the onset of dehydration or hypokalaemia is possible which can cause cardiac or neuromuscular dysfunction, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause addiction (and, therefore, possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). The abuse of liquid paraffin-based laxatives can cause a reduced absorption of fat-soluble vitamins (A, DE and K). In episodes of constipation, it is advisable 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, in order to help soften the stool. The product contains methyl parahydroxybenzoate and propyl parahydroxybenzoate: it can cause allergic reactions (possibly delayed); contains 1.1 g of sucrose per 5 ml: this should be considered for patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose and galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

INTERACTIONS
Laxatives can reduce the time spent in the intestine, and therefore the absorption of other drugs administered simultaneously orally. Therefore, avoid taking laxatives and other drugs at the same time; after taking a medicine leave an interval of at least 2 hours before taking the laxative. In patients treated with cardioactive glucosides, diuretics or corticosteroids, dehydration and potassium loss caused by an excessive laxative effect can cause cardiac or neuromuscular dysfunction. Do not take a surfactant laxative (e.g. docusate sodium) at the same time as it could promote the systemic absorption of liquid paraffin, causing chronic foreign body inflammation reactions in the affected tissues (lymph nodes, intestinal mucosa, liver and spleen). The 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.

SIDE EFFECTS
The following are the side effects of liquid paraffin organized according to the MedDRA system organ classification. Insufficient data are available to establish the frequency of the individual effects listed. Immune system disorders: hypersensitivity reactions' even severe (dyspnoea, feeling of heaviness in the chest, angioedema). Rarely, systemic absorption of paraffin can cause chronic inflammatory reactions. Skin and subcutaneous tissue disorders: rash, urticaria. Metabolism and nutrition disorders: liquid paraffin can interfere with the absorption of fat-soluble substances, such as vitamins A, D, E, K, especially following prolonged use of the drug. Gastrointestinal disorders: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation. Rectal oozing (loss, dripping) of paraffin resulting in 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 amount of the drug. Respiratory, thoracic and mediastinal disorders: lipoid pneumonia and oily embolism, due to accidental inhalation of the drug.

PREGNANCY AND BREASTFEEDING
For liquid paraffin no clinical data on exposed pregnancies are available. Liquid paraffin should not be used during pregnancy; it can reduce the absorption of essential nutrients and vitamins for the mother and the baby. There are no data on the use of liquid paraffin during breastfeeding and it is not known whether this active ingredient 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 in prescribing the medicine during breastfeeding.