Package leaflet: Information for the patient

LOPERAMID WZF, 2 mg, tablets
Loperamidi hydrochloridum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What is Loperamid WZF and what is it used for
Important information before taking Loperamid WZF
How to take Loperamid WZF
Possible side effects
How to store Loperamid WZF
Contents of the pack and other information

1. What is Loperamid WZF and what is it used for

Loperamid WZF is an antidiarrheal medicine.
The medicine prolongs the transit time of food through the gastrointestinal tract, reduces the excretion of water
and electrolytes, and decreases the immediate urge to defecate. As a result, the frequency and amount of bowel movements are reduced.
Loperamid WZF is used:

for symptomatic treatment of acute and chronic diarrhoea;
to reduce the number and volume of stools and to increase their consistency in patients with an ileostomy.

2. Important information before using Loperamid WZF

When not to use Loperamid WZF:

if the patient is allergic to loperamide hydrochloride or any of the other ingredients of this medicine (listed in section 6);
in children under 6 years of age;
if the patient has severe diarrhoea with blood and high fever (dysentery);
if the patient has ulcerative colitis;
if the patient has acute diarrhoea caused by pathogenic bacteria or antibiotic-associated pseudomembranous colitis;
in situations where reduction of intestinal peristalsis should be avoided due to possible risk of serious complications, including intestinal obstruction, colonic dilatation, and toxic megacolon. Loperamid WZF must be discontinued immediately if the patient develops constipation or abdominal distension.

Warnings and precautions
Before starting treatment with Loperamid WZF, consult a doctor or pharmacist
if the patient has previously been diagnosed with liver function disorders.
Treatment of diarrhoea with Loperamid WZF is purely symptomatic. In every case where the cause of diarrhoea can be identified and appropriate treatment is indicated (or justified), the doctor should recommend specific therapy.
This medicine should not be used for purposes other than those indicated (see section 1) or in doses higher than recommended (see section 3). Severe cardiac disorders (including rapid or irregular heartbeat) have been reported in patients taking excessive doses of loperamide (the active substance in Loperamid WZF).
In patients with diarrhoea, especially in children, debilitated patients, and elderly individuals, fluid (water) and electrolyte losses should be replenished during treatment.
In patients with AIDS treated with loperamide for diarrhoea, treatment should be discontinued at the first sign of abdominal distension and medical advice should be sought.
If there is no improvement within 48 hours after starting loperamide for acute diarrhoea, treatment should be stopped and the patient should consult a doctor.
If the patient is using Loperamid WZF to treat diarrhoea associated with diagnosed irritable bowel syndrome and no improvement occurs within 48 hours, the medicine should be discontinued and medical advice should be sought. Patients should also consult a doctor if symptoms change or if recurrent diarrhoea persists for more than two weeks.

Children
Loperamid WZF should not be given to children under 6 years of age.

Loperamid WZF and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. In particular, inform if the patient is taking:

ritonavir (used in the treatment of HIV);
quinidine (used to treat heart rhythm disorders or malaria);
oral desmopressin (used to treat frequent urination);
itraconazole or ketoconazole (used to treat fungal infections);
gemfibrozil (used to treat high blood cholesterol levels).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Use of this medicine during pregnancy (particularly in the first trimester) and while breastfeeding is not recommended. Small amounts may pass into breast milk. Consult a doctor to determine which medicine may be used during this period.

Driving and operating machinery
During treatment of diarrhoea with Loperamid WZF, symptoms such as loss of consciousness, reduced level of consciousness, fatigue, dizziness, or drowsiness may occur. Therefore, caution should be exercised when driving or operating machinery.

Loperamid WZF contains 100 mg of monohydrate lactose
If the patient has been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Loperamid WZF

This medicine should always be used according to the instructions given by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Adults and children aged 6 years and above
Acute diarrhoea
Initial dose – 2 tablets (4 mg) for adults and 1 tablet (2 mg) for children, followed by
1 tablet (2 mg) after each subsequent loose stool.
The maximum dose is 8 tablets (16 mg) per day for adults; in children the dose must be
adjusted according to body weight (3 tablets/20 kg body weight per day).
If there is no clinical improvement within 48 hours of treatment for acute diarrhoea,
administration of Loperamid WZF should be discontinued and the patient should consult
a doctor.
Chronic diarrhoea
Initial dose – 2 tablets (4 mg) per day for adults and 1 tablet (2 mg) per day for children;
this initial dose should be adjusted until 1 to 2 normal stools per day are achieved, which is usually
accomplished by using a maintenance dose of 1 to 6 tablets (2 to 12 mg) per day.
The maximum dose is 8 tablets (16 mg) per day for adults; in children the dose must be
adjusted according to body weight (3 tablets/20 kg body weight per day).
Since prolonged diarrhoea may be a symptom of more serious diseases, loperamide should not be used
long-term until the cause of the diarrhoea has been established.
In elderly patients and in patients with impaired kidney function, dosage adjustment is not necessary.
Use of a higher than recommended dose of Loperamid WZF
If a patient has taken too high a dose of Loperamid WZF, seek immediate medical advice
from a doctor or hospital. The following symptoms may occur: rapid heartbeat, irregular
heart rhythm, changes in heart rhythm (these may have serious, life-threatening consequences),
muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating and shallow breathing.
Children react more strongly to an overdose of Loperamid WZF than adults. If a child takes too high a dose
of the medicine or develops any of the above-mentioned symptoms, contact a doctor immediately.
Other symptoms of overdose may also occur, such as: stupor, constipation, pinpoint pupils,
intestinal obstruction manifested by abdominal pain, nausea and vomiting.
Missed dose of Loperamid WZF
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should stop taking the medicine and consult a doctor immediately if any of the
following symptoms occur. These require immediate treatment.

Sudden swelling of the face, lips or throat – these may be symptoms of a severe allergic reaction;
Skin changes such as rash, severe irritation, redness, blisters, erosions on the skin, in the mouth, eyes and genital organs, fever and joint pain, or skin peeling;
Abdominal pain, nausea and vomiting, severe abdominal distension, which may result from weakened intestinal motility (intestinal obstruction);
Upper abdominal pain, abdominal pain radiating to the back, abdominal tenderness, fever, rapid heartbeat, nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis).

During use of loperamide hydrochloride, the following have been reported:
Common (occur less frequently than in 1 in 10 patients):

headache, constipation, nausea, abdominal distension.

Uncommon (occur less frequently than in 1 in 100 patients):

dizziness, drowsiness, abdominal pain, discomfort in the abdominal cavity, dry mouth, epigastric pain, vomiting, dyspepsia;
rash.

Rare (occur less frequently than in 1 in 1,000 patients):

hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock), anaphylactoid reaction, angioedema – see symptoms listed above;
loss of consciousness, stupor, decreased level of consciousness, increased muscle tone, coordination disorders;
miosis (constriction of the pupils);
intestinal obstruction (including paralytic ileus), colonic dilatation (including toxic megacolon), abdominal distension;
bullous rash (including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) – see symptoms listed above;
pruritus (itching), urticaria (hives);
urinary retention;
fatigue.

Frequency not known (cannot be estimated from available data):

acute pancreatitis – see symptoms listed above.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows additional information on the safety of the medicine to be collected.

5. How to store Loperamid WZF

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following EXP.
The expiry date refers to the last day of the stated month.
The packaging label following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Loperamid WZF contains

The active substance is loperamide hydrochloride. Each tablet contains 2 mg of loperamide hydrochloride.
The other ingredients are: monohydrate lactose, maize starch, povidone K-25, stearic acid.

What Loperamid WZF looks like and contents of the pack
Loperamid WZF is a white or almost white, biconvex tablet with bevelled edges.
The pack contains 15 or 30 tablets in aluminium/PVC blisters, packed in a cardboard box.
Marketing Authorisation Holder
POLPHARMA Pharmaceutical Works S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01
Manufacturer
POLPHARMA Pharmaceutical Works S.A.
Production Plant in Nowa Dęba
Metalowca Street 2, 39-460 Nowa Dęba