PRESCRIBING INFORMATION

Presentation
Mintol: Each liquid-filled enteric coated hard gelatin capsule contains Peppermint Oil USP 0.2 ml as the active ingredient.

Pharmacological Action
Peppermint oil can ease everything from headaches and menstrual cramps to digestive problems and mental fatigue. It also helps tone the stomach, liver and intestine while strengthening and toning the nervous system. Peppermint oil's double action helps relive both the painful abdominal spasm and uncomfortable bloating of IBS. Firstly Peppermint oil has a relaxing effect in the bowel muscle to relieve the knotted feeling and cramping pain in the stomach. At the same time Peppermint oil helps disperse the pockets of trapped wind that can cause the uncomfortable bloating feeling.

Mechanism of Action
Studies have demonstrated that Peppermint oil is able to cause direct relaxation of smooth muscles found in the gut and gallbladder wall too by blocking the so called calcium channels that help in the contraction of these muscles. Peppermint & Peppermint oil are well-accepted carminatives. Although the exact mechanism of action has not been determined, one proposed mechanism is by relaxation of the esophageal sphincter, leading to released gas pressure in the stomach. Peppermint and its main active agent, menthol are effective decongestants. Because menthol thins mucus, it is also a good expectorant, meaning that is helps loosen and breaks up coughs with phlegm.

Pharmacokinetic Properties
Peppermint oil is relatively rapidly absorbed after oral administration and eliminated mainly via the bile. The major biliary metabolic is menthol glucuronide which undergoes enterohepatic circulation. The urinary metabolites result from hydroxylation at the C-7 methyl group at C-8 and C-9 of the isopropyl moiety forming a series of mono and dihydroxymenthols and carboxylic acids, some of which are excreted in part as glucuronic acid conjugates.

Indications
Mintol (Peppermint Oil) is use for the symptomatic relief of abdominal pain, distension, flatulence and gas associated with the irritable bowel syndrome (IBS). Because it has a calming and numbing effect, it has been used to treat headaches, menstrual cramps and flatulence. It is also widely used to treat symptoms of the common cold & coughs with phlegm. Peppermint oil may help the body break down gallstones.

Dosage and Administration
Adults: Take 1 capsule 3 times a day with a small quantity of water. Increase dosage to 2 capsules 3 times a day if required. Take 30 to 60 minutes before meals. Do not chew. Do not take immediately after meals or with food.
Children over 8 years: 1 capsule 3 times a day swallowed whole with a small quantity of water.

Contraindications
Do not administer with meals or to patients with achlorhydria.

Side Effects
Peppermint oil is usually well tolerated, though very occasionally heartburn and irritation can occur.

Precautions
Peppermint oil should not be administered to patients with heartburn or active gastric ulcers as symptoms may be exacerbated. Do not administer to patients allergic to peppermint, menthol, arachis (peanut) oil or similar essential oils. Do not chew or break the capsules as local irritation of the mouth, esophagus and stomach may occur.

Drug Interactions
The capsules should not be taken immediately after food. Indigestion remedies not are taken at the same time as Peppermint oil.

Use in Pregnancy and Lactation
There are no data available to establish the safety of Peppermint oil in pregnancy; therefore it should be used only if in the option of the physician the possible benefits of treatment outweigh the possible hazards. Levels of menthol were not detectable in plasma or saliva following administration of Peppermint oil indicating rapid first pass metabolism. Significant levels of menthol in breast milk are thought to be unlikely.

Overdose & Treatment
No specific antidote is known and thus conventional management of symptoms should be instituted. Gastric lavage with tap water or weak sodium bicarbonate solution may be performed.

Storage Conditions
Store in a cool and dry place. Keep away from light and out of the reach of Children.

Commercial Pack
Mintol: Each air tight container contains 30 Liquid-Filled Enteric Coated Hard Gelatin Capsule.