Lopacut

Package Leaflet: Information for the User

Lopacut 2 mg Coated Tablets

Loperamide Hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor, pharmacist, or nurse.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 2 days, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Lopacut and what is it used for
• 2. Important information before taking Lopacut
• 3. How to take Lopacut
• 4. Possible side effects
• 5. How to store Lopacut
• 6. Contents of the pack and other information

1. What is Lopacut and what is it used for

Lopacut contains loperamide hydrochloride. It belongs to a group of anti-diarrheal medicines.
Lopacut is used:

• to relieve the symptoms of sudden, short-term diarrhea (acute diarrhea) in adults and adolescents over 12 years of age.

Lopacut makes the stool harder and reduces the frequency of bowel movements.
A doctor may also prescribe this medicine for other conditions.
If there is no improvement or the patient feels worse after 2 days, they should consult their doctor.

2. Important information before taking Lopacut

When not to take Lopacut

• If the patient is allergic to loperamide or any of the other ingredients of this medicine (listed in section 6).
• If there is blood in the stool or if diarrhea is accompanied by high fever.
• If the patient has inflammatory bowel disease (ulcerative colitis or pseudomembranous colitis after antibiotic treatment).
• If the patient has bacterial enteritis and colitis caused by pathogenic bacteria of the genus Salmonella, Shigella, and Campylobacter.
• If the patient has slowed passage of food through the intestines, e.g., if they have constipation or abdominal distension.
• If the patient has long-term diarrhea (chronic diarrhea).

Warnings and precautions

• Taking Lopacut may mask the symptoms of sudden worsening of long-standing gastrointestinal disease (chronic inflammatory bowel disease).
• Taking Lopacut relieves symptoms but does not treat the cause of diarrhea. Therefore, the underlying disease causing diarrhea should be established before starting long-term treatment for diarrhea.
• If diarrhea does not improve after 2 days of treatment, the use of Lopacut should be discontinued and a doctor consulted.
• If symptoms of constipation or other symptoms of intestinal obstruction occur, the use of Lopacut should be discontinued and a doctor consulted.
• If the patient has liver function disorders, they should consult a doctor before taking Lopacut.
• Diarrhea can cause a significant loss of fluids, which must be replaced by drinking more fluids than usual.
• If the patient has AIDS, they should discontinue Lopacut if they experience the first symptoms of abdominal swelling.
• This product should not be taken for purposes other than its intended use (see section 1) or in doses higher than recommended (see section 3). In patients taking too high doses of loperamide (the active substance of Lopacut), serious heart rhythm disturbances (including accelerated or irregular heart rhythm) have been reported.

Children

Lopacut is not indicated for use in children under 12 years of age.

Lopacut and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may interact with Lopacut, and Lopacut may interact with other medicines if taken at the same time. Examples of such medicines include:

• cholestyramine (reduces serum cholesterol levels) may reduce the absorption of Lopacut.
• quinidine (regulates heart rhythm)
• verapamil (lowers blood pressure)
• ritonavir (a medicine used to treat HIV/AIDS)
• cyclosporine (an immunosuppressive medicine)
• erythromycin and clarithromycin (antibiotics)
• itraconazole and ketoconazole (antifungal medicines)
• desmopressin (used to treat diabetes insipidus and nocturnal enuresis)
• anticholinergic medicines (used to treat Parkinson's disease and asthma) may enhance the effect of Lopacut by slowing gastric and intestinal emptying.

If the patient is taking any of the above medicines, they should consult their doctor before taking Lopacut.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
There is insufficient data on the use of loperamide in pregnancy, so medical consultation is necessary before taking the medicine if the patient is pregnant.
Loperamide passes into breast milk, so it is not recommended for use in breastfeeding mothers. The patient should consult their doctor before taking Lopacut if they are breastfeeding.

Driving and using machines

While taking Lopacut, the patient may experience drowsiness, dizziness, and sleepiness.
The patient should assess whether they can drive or perform tasks that require increased concentration. One of the factors that may affect the ability to drive or use machines is the effect or effects of the medicines being taken. The description of the effect and side effects of the medicine can be found in other sections of this leaflet. The patient should read the entire leaflet to know how to proceed. If the patient thinks the medicine affects their concentration, they should not drive or use machines.
If the patient has any doubts, they should consult their doctor or pharmacist.

3. How to take Lopacut

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Use in adults and adolescents over 12 years of age

Initially 2 tablets, then 1 tablet after each loose stool, but not sooner than 2-3 hours after the initial dose. The maximum daily dose should not exceed 6 tablets in adults (maximum daily dose is 12 mg) and 4 tablets in adolescents (maximum dose is 8 mg). Lopacut should not be taken for more than 2 days without consulting a doctor.

Taking a higher dose of Lopacut than recommended

If the patient has taken too much Lopacut, they should immediately consult a doctor or go to the hospital. The following symptoms may occur: rapid heart rate, irregular heart rhythm, changes in heart rhythm (these symptoms can have severe, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, and shallow breathing.
In children, the reaction to taking too much Lopacut is stronger than in adults. If a child takes too much Lopacut or experiences any of the above symptoms, they should immediately consult a doctor.

Missing a dose of Lopacut

A double dose should not be taken to make up for a missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Lopacut can cause side effects, although not everybody gets them.
The patient should stop taking Lopacut and consult their doctor immediatelyif they experience:

• swelling of the face, lips, tongue, or throat, difficulty swallowing and breathing (angioedema) and (or) hives
• severe irritation, redness, or blisters on the skin, lips, eyelids, and genitals (bullous rash, including Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis).
• abdominal pain, abdominal pain radiating to the back, abdominal tenderness, fever, rapid pulse, nausea, vomiting, which may be symptoms of pancreatitis (acute pancreatitis).

The following list of side effects is presented according to their frequency of occurrence.
Common (may affect up to 1 in 10 people)

• constipation
• bloating with gas
• abdominal cramps and colic
• nausea
• dizziness
• headache

Uncommon (may affect up to 1 in 100 people)

• drowsiness
• dry mouth
• abdominal pain
• abdominal discomfort
• upper abdominal pain
• vomiting
• indigestion
• rash

Rare (may affect up to 1 in 1,000 people)

• loss of consciousness
• impaired critical cognitive function and decreased level of consciousness (stupor)
• decreased level of consciousness
• increased muscle tone (hypertonia)
• coordination disorders
• pupil constriction (miosis)
• urination problems (urinary retention)
• intestinal obstruction
• abdominal distension
• toxic megacolon (toxic dilatation of the colon)
• allergic reactions (hypersensitivity)
• hives
• itching
• rapidly progressing swelling of the face, lips, tongue, and throat (angioedema)
• severe skin and mucous membrane changes (bullous rash)
• fatigue

Not known (frequency cannot be estimated from the available data)

• drowsiness
• acute pancreatitis

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Lopacut

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
The medicine should not be taken after the expiry date stated on the blister and carton after EXP.
The expiry date refers to the last day of the month.
The medicine should not be taken if the tablets are damaged or have an unusual appearance.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Lopacut contains

The active substance of Lopacut is loperamide hydrochloride, 2 mg per tablet.
The other ingredients of the medicine are:
Tablet core: microcrystalline cellulose, pregelatinized starch, sodium croscarmellose, colloidal anhydrous silica, and magnesium stearate.
Tablet coating: Opadry OY-S-28703: polydextrose, hypromellose, titanium dioxide (E 171), and macrogol 4000.

What Lopacut looks like and contents of the pack

Appearance:
The tablets are white, round, and convex with the logo “6”. Diameter 8 mm.
Pack size:
8 and 10 coated tablets in a blister pack (PVC/Aluminum).

Marketing authorization holder and manufacturer

Vitabalans Oy
Varastokatu 8
FI-13500 Hämeenlinna
FINLAND
Phone: +358 (3) 615600
Fax: +358 (3) 6183130

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Lopacut (CZ, DE, DK, EE, FI, HU, LT, LV, NO, PL, SE, SI, SK)

Date of last revision of the leaflet: 04-04-2022