The active substance	The active substance is loperamide hydrochloride ( Loperamidi hydrochloridum ) 2 mg.
the other ingredients	lactose monohydrate, corn starch, talc, magnesium stearate, gelatin capsule composition: gelatin, erythrosine (E127), patent blue (E131), titanium dioxide (E171), quinoline yellow (E104)

Action

Stoperan is a drug against diarrhea. It inhibits increased bowel movements and also increases water absorption. As a result, it reduces the frequency and number of bowel movements, and causes the reabsorption of water in the large intestine, changes the consistency of the stool. It is intended for the treatment of adults and children from 6 years of age.

Dosage

Stopoperan should be used according to the recommendations provided in the leaflet. If in doubt, consult your doctor.

Stoperan should be used orally.

Adults and children over 12 years of age:

• Acute diarrhea:first dose 2 capsules (4 mg), then 1 capsule (2 mg) after each loose bowel movement. Do not take more than 8 capsules (16 mg) a day.
• Chronic diarrhea:initially, 1 capsule (2 mg) 2 times a day, if necessary, the dose can be increased to 4-6 capsules (8-12 mg) a day.

Children from 9 to 12 years of age:

• Acute diarrhea:1 capsule (2 mg) after each loose bowel movement. Do not take more than 3 capsules (6 mg) a day.
• Chronic diarrhea:1 capsule (2 mg) after each loose bowel movement. Do not take more than 3 capsules (6 mg) a day.

Children 6 to 8 years of age:

• Acute diarrhea:1 capsule (2 mg) after each loose bowel movement. Do not take more than 3 capsules (6 mg) a day.
• Chronic diarrhea:1 capsule (2 mg) after each loose bowel movement. Do not take more than 2 capsules (4 mg) a day.

No dosage adjustment is necessary in patients with impaired renal function and in elderly patients.

The diarrhea may go away after one dose. Then the drug should not be used any longer.

If you have the impression that the effect of Stoperan is too strong or too weak, please consult your doctor.

Use of the drug in children and adolescents

Stoperan is contraindicated in children under 6 years of age.

Contraindications

Do not use Stoperan:

• if you are allergic to loperamide or any of the other ingredients of this medicine,
• in conditions where it is undesirable to slow down intestinal peristalsis due to the possible risk of severe complications, including intestinal obstruction, giant colon and toxic colon enlargement, stop using Stoperan immediately in the event of constipation, abdominal distension or intestinal obstruction,
• in intestinal obstruction, acute ulcerative colitis, acute haemorrhagic colitis, pseudomembranous enteritis, especially associated with the administration of broad-spectrum antibiotics,
• in bacterial enteritis and colitis caused by pathogenic bacteria of the genera Salmonella, Shigella and Campylobacter,
• in acute dysentery with blood in the stool and with increased body temperature,
• in children under 6 years of age.

Storage method

15°C-25°C

Manufacturer

US PHARMACIA

Warnings

Caution should be exercised when using Stoperan in bacterial diarrhea.

In patients with impaired hepatic function, the drug should be used with caution because of the possibility of toxic effects of the drug on the central nervous system.

Dehydration and electrolyte depletion may occur in patients with diarrhea, especially in children. Therefore, during diarrhea, you should supplement the deficiencies of water and mineral salts.

The administration of the drug should be discontinued in the event of constipation, flatulence or developing intestinal obstruction.

In patients with fever and blood in the stool, the causes of diarrhea should be investigated before starting loperamide administration.

In AIDS patients treated with Stoperan for diarrhea, treatment should be discontinued at the earliest signs of abdominal distension. In patients with AIDS and concomitant infectious colitis caused by both viruses and bacteria, isolated cases of toxic dilatation of the colon have been reported with the use of loperamide.

Stoperan contains lactose. If the patient has been diagnosed with an intolerance to some sugars, the patient should consult a doctor before taking the drug.

Pregnancy and breastfeeding

Ask your doctor for advice before using the drug.

Driving vehicles

In the course of diarrhea treated with loperamide, fatigue, dizziness or somnolence may occur. Therefore, caution should be exercised when driving a car or operating machinery.

Overdosage

In case of overdose, constipation, intestinal obstruction, urinary retention and symptoms of CNS depression (increased muscle tone, stupor, confusion, drowsiness, impaired neuromuscular coordination, miosis, apnea, respiratory depression) may occur. Children are more sensitive than adults to side effects of the drug on the central nervous system.

If you have taken too much Stoperan, contact your doctor or hospital for advice immediately. The following symptoms may occur: increased heart rate, irregular heart beat, changes in heart rhythm (these symptoms can have serious, life-threatening consequences), muscle stiffness, uncoordinated movement, sleepiness, difficulty urinating and shallow breathing.

In children, the response to large amounts of Stoperan is stronger than in adults. If a child takes too much of this medicine or develops any of the symptoms listed above, consult a doctor immediately.

Management of an overdose
In case of taking a larger dose of the drug than recommended, immediately consult a doctor or pharmacist.

If symptoms of overdose occur, your doctor may prescribe naloxone as an antidote. Since the duration of action of Stoperan is longer than that of naloxone (1 to 3 hours), a re-administration of naloxone may be indicated. Therefore, the patient should be under close medical supervision for at least 48 hours in order to detect any possible depression of the central nervous system.

Interactions with other drugs

Tell your doctor about all the drugs you are taking or are taking.

Concomitant administration of loperamide (16 mg as a single dose) with quinidine (a drug to treat arrhythmias) or ritonavir (used to treat HIV infection), which are P-glycoprotein inhibitors, increases the plasma levels of loperamide. The clinical significance of these interactions is unknown.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.