Pharmaceutical forms present on the market

The pharmaceutical forms of Guttalax® currently authorized in Italy are as follows:

• Guttalax® 2.5 mg soft capsules in packs of 30 units;
• Guttalax®  7.5 mg/mL drops in 15 mL pack.

How much?

Guttalax® is a class C drug that does not require a prescription to be purchased.

To buy Guttalax® we will have to spend:

• 8.90 euros for soft capsules;
• 7.90 euros for the drops.

The prices shown refer to the moment in which the drug guide was written and may be subject to promotions and offers.

How does it work?

Guttalax® is a drug belonging to the category of contact laxatives. Sodium picosulfate is the active ingredient of the drug and it is a locally acting laxative that activates the bacterial flora and stimulates the intestinal mucous membranes by helping peristalsis in the colon by increasing the accumulation of water and electrolytes and thus facilitating the expulsion of faeces .

The drug stimulates defecation , softens the stool and decreases its transit time. As a laxative it acts on the colon and stimulates the evacuation process in the gastrointestinal tract. The drug does not affect digestion in any way and does not interfere with the absorption of nutrients.

Sodium picosulfate reaches the colon without being absorbed, following the transformation only small doses of BHPM are absorbed by the body.

Posology and Method of Use

It is necessary to strictly adhere to the dosage recommended by the doctor or pharmacist or follow the one shown in the package leaflet.

For adults , the dosage for soft capsules is: 2-3 capsules a day;
In children and adolescents over 10 years of age: 2-3 capsules a day;
In children over 4 years up to 10 years: 1 capsule per day;
The drug is not recommended for children under 4 years of age.

For children under the age of 4 it is recommended to use Guttalax® in drops, but always after seeking medical advice.

For adults , the dosage of Guttalax® in drops is: 7-8 drops a day in a glass of water. The dose should be reduced if the effect of the drug is excessive or increased if it is ineffective. Stubborn constipation can be countered with 15-20 drops in water, and it is strongly recommended not to exceed this dose.
In children over 3 years of age: 2-3 drops a day in a glass of water.

It is advisable not to exceed the recommended doses without first consulting your doctor. It is recommended to start with the therapy using the minimum doses and to adjust the therapy afterwards. The exact dose is the minimum that allows you to produce normal stools that are easily evacuated.

The soft capsules should be taken in the evening to help the patient evacuate the following morning. The product should be used not too frequently and for no more than a week. Only the doctor can recommend a longer therapy following a careful analysis.

It is advisable to consult your doctor if the discomfort continues or if it occurs often. It is also advisable to ingest the drug with a glass of water since proper hydration helps improve the effect of the drug and facilitates evacuation.

The recommended doses of the drug, in the case of patients with renal
and hepatic insufficiency, must be prescribed by the doctor since the drug could be contraindicated. For any doubts, it is advisable to seek the advice of your doctor or pharmacist.

Overdose

In case of taking doses higher than those recommended, it is advisable to consult your doctor. High doses of the drug can cause: diarrhea, abdominal cramps, hypokalemia and electrolyte dysfunction. In some cases, ischemia of the colonic mucosa can be found.

Overdose of laxatives can also cause chronic diarrhea, hypokalemia, and secondary hyperaldosteronism as well as the appearance of kidney stones. Chronic laxative abuse can cause renal tubular injury, secondary muscle weakness caused by hypokalemia, and metabolic alkalosis.

In the event of an overdose, immediate action is recommended to reduce drug absorption. Absorption can be minimized by gastric lavage while fluid and electrolyte losses should be replaced as soon as possible. For any doubts, it is advisable to seek the advice of your doctor or pharmacist.

Pregnancy and breastfeeding

Regarding the possibilities of using Guttalax® during pregnancy and breastfeeding, you should always consult your doctor. It is advisable to seek advice from your doctor or pharmacist before taking any medicine during pregnancy or while breastfeeding.

The drug should be taken only after carefully assessing the risk-benefit ratio for both the mother and the fetus. During lactation, data from clinical studies state that sodium picosulfate and glucuronic derivatives are not excreted, in measurable quantities, in the mother’s milk.

Despite this, the drug must be taken during breastfeeding only if there is a real need, and only and only under the supervision of the doctor, also in this case after evaluating the relationship between risk and benefit for both the mother and for the infant.

Contraindications

The use of Guttalax® is contraindicated in the case of overt hypersensitivity to sodium picosulphate or to any of the excipients present in the drug. The excipients contained in the drug in soft capsules are: macrogol 400, purified water, propylene glycol, gelatin and glycerol.

For the drops the excipients are: liquid sorbitol, sodium citrate, purified water, citric acid monohydrate and sodium benzoate. Guttalax® is contraindicated in patients with paralytic ileus or suffering from intestinal obstruction or stenosis or biliary obstruction.

Patients suffering from acute or severe abdominal conditions such as appendicitis should not take the drug. Patients in severe dehydration or suffering from nausea and/or vomiting should not take Guttalax® .

The medicine is also contraindicated in case of acute inflammation of the gastrointestinal tract and in case of rectal bleeding of unknown origin. Do not take the drug in case of gallstone disease and liver failure. Finally, the drug is contraindicated in children under 4 years of age.

Interactions with other drugs

You are advised to tell your doctor or pharmacist if you have taken, are taking and if you need to take any other medicines besides Guttalax® , including over-the-counter medicines without a prescription. Laxatives can reduce the absorption of other drugs taken at the same time.

It is advisable not to ingest laxatives and other drugs in contemporary therapies. After taking a medicine, it is advisable to wait at least two hours before taking the laxative Guttalax®. Milk or antacid drugs may interfere with the effect of the medicine, therefore it is advisable to wait at least 1 hour before taking the laxative.

Guttalax® could enhance the patient’s response to anticoagulant drugs and also modify glucose tolerance. Taking diuretics or adrenocorticosteroids together with Guttalax® may increase the risk of electrolyte imbalance which could consequently increase sensitivity to cardiac glycosides.

Taking antibiotics in the presence of this medicine can cause side effects.

Using the drug for an extended period of time can lead to diarrhea, hypokalemia and even electrolyte imbalance. In some cases, patients receiving treatment with Guttalax® may experience dizziness and/or experience a vasovagal response to pain caused by constipation.

Using laxatives incorrectly and frequently can cause persistent diarrhea with serious health consequences. The risks of laxative abuse are dehydration and/or hypokalemia which can cause cardiac dysfunction or neuromuscular dysfunction.

Abusing laxatives can even cause addiction, chronic constipation and even lead to the loss of natural intestinal functions causing intestinal atony. Guttalax® helps with occasional constipation, but a diet rich in water and fiber helps curb the problem.

It should be remembered that constipation occurs when evacuations are much reduced compared to one’s habits and not when one is unable to evacuate only occasionally. For any doubts regarding the use and intake of the drug, it is advisable to consult your doctor or trusted pharmacist.

Side effects

Guttalax® can also cause serious side effects. In addition to hypersensitivity, the drug can cause with unknown frequency : dizziness, syncope, vasovagal response, skin reactions, rash. Very common
side effects are: diarrhea, abdominal cramps, abdominal pain and discomfort. Uncommon side effects are : vomiting and nausea, abdominal colic.

Undesirable effects due to Guttalax® are generally transient. In the event that they appear, it is advisable to notify your doctor or trusted pharmacist.

If the patient notices even a single side effect not described in the package insert, it is advisable to notify the doctor or pharmacist and communicate the effects found. The doctor or pharmacist will take care of reporting the unknown side effects to the Italian Medicines Agency in order to update the list.