Paraffinum liquidum Marco Viti

Liquid Paraffin 40% Oral Emulsion

Package Leaflet

Marco Viti Farmaceutici S.p.A.
Liquid Paraffin Marco Viti 40% Oral Emulsion
Pharmacotherapeutic Category
Emollient laxatives
Therapeutic Indications
Short-term treatment of occasional constipation
Contraindications

• Hypersensitivity to the active substance or to any of the excipients;
• Nausea, vomiting, acute abdominal pain or of unknown origin;
• Intestinal obstruction or stenosis;
• Gastrointestinal disorders such as appendicitis, diverticulitis, ulcerative colitis, rectal bleeding of unknown origin;
• Acute hemorrhoidal crisis with pain and bleeding;
• Severe dehydration;
• Patients with swallowing difficulties or conditions (e.g. hiatal hernia) or situations (e.g. debilitated bedridden patients) that carry a risk of regurgitation;
• Colostomy/ileostomy;
• Children under 6 years of age;
• Concomitant use of other laxatives or stool softeners.

Precautions for Use
Laxatives should be used as infrequently as possible and for no more than seven days. Use for
longer periods requires medical prescription following appropriate individual assessment.
The treatment of chronic or recurrent constipation always requires medical intervention for diagnosis,
prescription of medication, and monitoring during therapy.
In children between 6 and 12 years of age, the medicine may be used only after consulting a doctor.
The medicine should preferably be administered in the evening (or at least one hour before bedtime),
since peristaltic movements are slowed down at night, allowing the laxative to remain in the intestine longer,
thus enhancing its effect.
It is important to avoid lying down or tilting the head backward when taking liquid paraffin to prevent
aspiration of droplets of the medicine. Rarely, especially in younger children, elderly or debilitated patients,
involuntary aspiration of liquid paraffin may cause ab ingestis pneumonia.
Abuse of laxatives (frequent or prolonged use, or excessive doses) may cause persistent diarrhea,
leading to loss of water, electrolytes (especially potassium), and other essential nutrients.
In more severe cases, dehydration or hypokalemia (decreased potassium levels in the blood) may occur,
which can lead to cardiac or neuromuscular dysfunction, particularly if the patient is also receiving treatment
with cardiac glycosides, diuretics, or corticosteroids.
Abuse of laxatives, especially stimulant laxatives (contact laxatives), may lead to dependence (and thus possible
need for progressive dose escalation), chronic constipation, and loss of normal intestinal function (intestinal atony).
Abuse of liquid paraffin-based laxatives may result in reduced absorption of fat-soluble vitamins (A, D, E, K).
In episodes of constipation, it is recommended first to correct dietary habits by increasing daily intake of dietary fiber and water.
When using laxatives, it is important to drink at least 6–8 glasses of water or other fluids daily to help soften stools.
Liquid Paraffin 40% Oral Emulsion

Package leaflet

Marco Viti Farmaceutici S.p.A.
Interactions
Inform your doctor or pharmacist if you have recently taken any other medicines, including those not requiring a prescription.
Laxatives may reduce intestinal transit time, thereby decreasing the absorption of other drugs administered simultaneously by the oral route.
Therefore, avoid taking laxatives and other medicines at the same time; after taking a medicine, wait at least 2 hours before taking the laxative.
In patients treated with cardiac glycosides, diuretics, or corticosteroids, dehydration and potassium loss caused by excessive laxative effect may lead to cardiac or neuromuscular dysfunction.
Do not take a surfactant laxative (e.g. docusate sodium) concurrently, as this may enhance systemic absorption of liquid paraffin, potentially causing chronic foreign body inflammatory reactions in affected tissues (lymph nodes, intestinal mucosa, liver, and spleen).
Concomitant administration of colecalciferol and mineral oil may reduce vitamin D absorption, possibly leading subsequently to hypocalcemia and secondary hyperparathyroidism.
Liquid paraffin may interfere with the absorption of fat-soluble substances such as vitamins A, D, E, and K.

Special warnings
Consult your doctor if the need for a laxative arises from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) lasting more than two weeks, or when use of the laxative fails to produce an effect. Elderly individuals or those in poor health should also consult a doctor before using this medicine.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy
Liquid paraffin should not be used during pregnancy, as it may reduce the absorption of nutrients and vitamins essential for both mother and child.

Breastfeeding
There are no available data on the use of liquid paraffin during breastfeeding, and it is unknown whether this active ingredient passes into breast milk. However, since absorption of the drug is considered negligible, it is highly unlikely that significant amounts would reach breast milk.
Caution is advised when prescribing this medicine during breastfeeding.

Effects on ability to drive and use machines
This medicine does not impair the ability to drive vehicles or operate machinery. However, undesirable effects may occur during treatment; therefore, it is advisable to be aware of your individual response to the medicine before driving or operating machinery.

Important information about certain excipients:
Paraffina liquida Marco Viti contains methylparahydroxybenzoate and propylparahydroxybenzoate: may cause allergic reactions (possibly delayed).
Paraffina liquida Marco Viti contains 1.1 g of sucrose per 5 ml: this should be taken into account in patients with diabetes mellitus. If your doctor has informed you of an intolerance to certain sugars, please consult him/her before taking this medicine.

Health education notes
It should first be recognized that, in most cases, a balanced diet rich in water and fiber (bran, vegetables, and fruit) can provide a lasting solution to constipation.
Many people believe they suffer from constipation if they do not have a bowel movement every day.

Liquid paraffin 40% oral emulsion

Package leaflet

Marco Viti Farmaceutici S.p.A.
This is a mistaken belief, as this condition is completely normal for a large number of individuals.
Instead, constipation should be considered when bowel movements are reduced compared to an individual’s
personal habits and are associated with the passage of hard stools.
If episodes of constipation occur repeatedly, a doctor should be consulted.
Dosage, method and timing of administration
The correct dose is the lowest amount sufficient to produce easy evacuation of soft stools.
It is advisable to initially use the lowest recommended doses.
If necessary, the dose may then be increased, but must never exceed the maximum dose indicated.
Adults and adolescents:
The usual dose ranges from 15 to 45 ml of emulsion per day. The maximum permitted dose is 45 ml per day.
Children from 6 to 12 years of age:
The usual dose is 5–15 ml of emulsion per day. The maximum permitted dose is 15 ml per day.
Liquid paraffin oral emulsion is contraindicated in children under 6 years of age, as children in this age group are more prone to aspirate the emulsion, with a risk of lipoid pneumonia (see Contraindications and Undesirable effects).
Shake the bottle before use. Take the medicine on an empty stomach together with an adequate amount of
water (a full glass), away from 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 longer than seven days (see Precautions for use). A diet rich in fluids supports the effect of the medicine.
Overdose
Abuse of laxatives (frequent or prolonged use, or excessive doses) may cause abdominal pain, persistent diarrhoea leading to loss of water, mineral salts (especially potassium), and other essential nutrients. Losses of fluids and electrolytes must be replaced.
Electrolyte imbalances are characterized by the following symptoms: thirst, vomiting, weakness, oedema, bone pain (osteomalacia), and hypoalbuminemia.
In more severe cases, dehydration or hypokalaemia may occur, which can lead to cardiac or neuromuscular dysfunction, especially if the patient is concurrently being treated with cardiac glycosides, diuretics, or corticosteroids. Abuse of laxatives, particularly stimulant laxatives (contact laxatives), may lead to dependence (and therefore a possible need to progressively increase the dose), chronic constipation, and loss of normal intestinal function (intestinal atony).
Pulmonary aspiration of large amounts of liquid paraffin may lead to potentially fatal lipoid pneumonia, pulmonary fibrosis, and lung carcinoma at fibrotic sites.
Excessive ingestion of liquid paraffin may cause anal incontinence, leakage through the sphincter (dripping), and perianal itching and irritation.
In case of accidental ingestion/overdose of liquid paraffin, contact a doctor immediately or go to the nearest hospital.
IF YOU HAVE ANY DOUBT ABOUT THE USE OF MARCO VITI LIQUID PARAFFIN, CONSULT YOUR DOCTOR OR
PHARMACIST.
Undesirable effects
Like all medicines, liquid paraffin may cause undesirable effects, although not everyone experiences them.
The following are the undesirable effects associated with liquid paraffin. There are insufficient data available to determine the frequency of the individual adverse effects listed.
Liquid paraffin 40% oral emulsion

Package leaflet

Marco Viti Farmaceutici S.p.A.
Immune system disorders
Hypersensitivity reactions, even severe (dyspnea, chest tightness, angioedema).
Rarely, systemic absorption of paraffin may cause chronic inflammatory reactions.
Skin and subcutaneous tissue disorders
Rash, urticaria.
Metabolism and nutrition disorders
Liquid paraffin may interfere with the absorption of fat-soluble substances such as vitamins A, D, E, K, especially following prolonged use of the medicinal product.
Gastrointestinal disorders
Occasional cramp-like pains or abdominal colic, more frequent in cases of severe constipation.
Rectal leakage (loss, dripping) of paraffin with consequent anal irritation and pruritus, rectal bleeding, especially after prolonged use of the medicinal product.
Foreign body reactions (granulomatous reactions – paraffinomas) in the intestinal mucosa due to the absorbed fraction of the medicinal product.
Respiratory, thoracic and mediastinal disorders
Lipoid pneumonia and fat embolism, due to accidental inhalation of the medicinal product.
Following the instructions contained in this leaflet reduces the risk of adverse effects.
If any of the adverse effects worsens, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.
Expiry date and storage
Expiry date: see the date on the packaging
The expiry date refers to the medicinal product in its original, unopened packaging, correctly stored.
WARNING: do not use the medicinal product after the expiry date stated on the packaging.
Storage conditions
Store the bottle tightly closed in the original packaging, protected from light.
After first opening, the medicinal product should be used within 6 months.
After this period, any remaining medicinal product must be discarded.
Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products no longer in use. This will help protect the environment.
Keep the medicinal product out of the reach and sight of children.
Composition
100 g of oral emulsion contain:
Active substance: liquid paraffin 40 g
Excipients: purified water, sucrose, polysorbate 60, sorbitan stearate, glycerol, methylparahydroxybenzoate, propylparahydroxybenzoate, vanillin.
Liquid paraffin 40% oral emulsion

Package leaflet

Marco Viti Farmaceutici S.p.A.
Pharmaceutical form and contents
Oral emulsion.
200 ml glass bottle.
MARKETING AUTHORISATION HOLDER
Marco Viti Farmaceutici S.p.A.
Via Mentana, 38 – 36100 Vicenza
MANUFACTURER
Zeta Farmaceutici S.p.A.
Via Galvani, 10 – 36066 Sandrigo (VI)
AIFA determination of 06 March 2012