Tiorfan 100mg, 10 capsules — Made in Irlandia — Free Delivery

Product description

Tiorfan 100 mg is a medicinal product in the form of hard capsules, each containing 100 mg of racecadotril (Racecadotrilum). The size 2 capsules are ivory in color and contain a white powder with a sulfur odor.

Tiorfan preparation- use

Tiorfan is only used in adults for the symptomatic treatment of acute diarrhea (when causal treatment is not possible) or as an adjunct treatment (when causal treatment is available).

Indications

Tiorfan 100 mg capsules are used in adults:

• for symptomatic treatment of acute diarrhea in adults when causal treatment is not possible,
• as supportive care when causal treatment can be used.

Composition

1 capsule contains:

• active ingredient: racecadotril 100 mg,
• excipients (powder): lactose, pregelatinized maize starch, magnesium stearate, colloidal anhydrous silica,
• excipients (capsule shell): gelatin, yellow iron oxide (E172), titanium dioxide (E171).

Action

The effects of using Tiorfan

Tiorfan has an anti-diarrheal effect.

Dosage

Always take Tiorfan exactly as described in the package leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The usual dose is one capsule three times a day. The capsule is swallowed with a glass of water. It is best to take the preparation before main meals, but when starting the treatment, you can take one capsule at any time.

Adults: One capsule initially, regardless of the time of day. Then one capsule three times a day, preferably before main meals. Continue treatment until you pass two normal stools.

Elderly patients: no dose adjustment is required for elderly patients.

Treatment should not exceed 7 days.

Caution is advised in patients with impaired liver and kidney function.

Contraindications

Hypersensitivity to any of the ingredients of the preparation.

Pregnancy and the period of breastfeeding.

Storage

There are no special storage conditions for Tiorfan.

Side effects

Tiorfan, like any other medicine, can cause side effects, although not everybody gets them.

Data are available from clinical trials in 2,193 adult patients with severe diarrhea treated with racecadotril and 282 in the placebo group.

The side effects listed below occurred more frequently with racecadotril treatment than with placebo in clinical trials or from post-marketing experience.

Common (occurs in less than 1 in 10 but more than 1 in 100 patients):

• headaches.

Uncommon (affects less than 1 in 100 but more than 1 in 1,000 patients):

• rash,
• erythema.

Not known (cannot be estimated from the available data)

• tongue swelling, angioedema, eyelid edema, face swelling, lip swelling,
• hives
• erythema nodosum, erythema multiforme,
• itching, itching
• toxic skin eruption,
• papular rash.

Interactions

Tell the doctor or pharmacist about all the preparations that the patient is taking now or recently, and about the preparations that the patient is going to take.

In humans, concomitant treatment with racecadotril and loperamide or nifuroxazide does not change the kinetics of racecadotril.

Interaction of reacecadotril with angiotensin converting enzyme inhibitors

Concomitant use of racecadotril with ACE inhibitors (e.g. captopril, enalapril, lisinopril, perindopril, ramipril) may increase the risk of angioedema.

Warnings and Precautions

Tiorfan contains lactose.

The preparation should not be used in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Skin reactions have occurred with the use of the product. While most of the reactions were mild and did not require treatment, in some cases the reactions were acute or even life-threatening. A link between their occurrence and the use of racecadotril cannot be completely excluded. If severe skin reactions occur during treatment, treatment should be discontinued immediately.

Hypersensitivity and / or angioedema have been reported in patients taking racecadotril. They can occur at any time during therapy. There may be swelling of the face, limbs, lips and mucous membranes. If the swelling is obstructing the upper respiratory tract such as the tongue, glottis and / or larynx, immediate medical attention is needed. If this occurs, discontinue racecadotril therapy, place the patient under close medical supervision and monitor until complete and sustained resolution of symptoms.

Patients with a history of angioedema unrelated to racecadotril therapy may be at increased risk of angioedema.

Concomitant use of racecadotril with angiotensin converting enzyme inhibitors may increase the risk of angioedema, therefore a careful risk / benefit assessment of hypersensitivity should be performed before starting racecadotril therapy in patients treated with ACE inhibitors.

Taking racecadotril has no effect on the usual hydration pattern.

The presence of bloody or purulent stools along with a fever may indicate a bacterial infection causing diarrhea or the presence of other serious illnesses.

The use of racecadotril in antibiotic-induced diarrhea has not been studied and should therefore not be administered in these conditions.

There are insufficient studies on the use of Tiorfan in chronic diarrhea. Only limited data are available in patients with renal or hepatic impairment. Therefore, caution should be exercised when administering the product to these patient groups.

The bioavailability of the product is likely to be reduced in the event of prolonged vomiting.

Pregnancy, breast-feeding and fertility

There are no adequate data on the use of racecadotril in pregnant women. Animal studies do not indicate direct or indirect harmful effects on pregnancy, fertility, embryofoetal development, parturition and postnatal development. However, as specific clinical trials are not available, racecadotril should not be used in pregnant women.

Due to the lack of data on the excretion of racecadotril in human milk, Tiorfan should not be used in breast-feeding women.

Fertility studies in rats did not show such an effect.