Loperamid Vzf

Package Leaflet: Information for the Patient

LOPERAMID WZF, 2 mg, tablets

Loperamide hydrochloride

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

Loperamid WZF is an anti-diarrheal medicine.
The medicine prolongs the transit time of food through the digestive tract, reduces water and electrolyte excretion, and reduces the immediate need for bowel movements. As a result of the medicine's action, the frequency and number of bowel movements are reduced.
Loperamid WZF is used:

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

2. Important information before taking Loperamid WZF

When not to take Loperamid WZF:

• if you are 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 you have bloody diarrhea and high fever (dysentery);
• if you have ulcerative colitis;
• if you have acute diarrhea caused by bacteria or pseudomembranous colitis associated with antibiotic use;
• in cases where it is necessary to avoid slowing down intestinal peristalsis, due to the possible risk of serious complications, including intestinal obstruction, colon dilation, and toxic colon dilation. Loperamid WZF should be discontinued immediately if the patient experiences constipation or abdominal distension.

Warnings and precautions

Before starting treatment with Loperamid WZF, discuss it with your doctor or pharmacist if you have previously been diagnosed with liver function disorders.
Treatment of diarrhea with Loperamid WZF is only symptomatic. In every case where it is possible to determine the cause of diarrhea, when justified (or indicated), the doctor will prescribe appropriate treatment.
Do not take this medicine for a purpose other than its intended use (see section 1) or in larger doses than recommended (see section 3). In patients taking too high doses of loperamide (the active substance of Loperamid WZF), serious heart rhythm disorders (including accelerated or irregular heart rhythm) have been reported.
In patients with diarrhea, especially in children, weakened patients, and the elderly, during treatment with the medicine, fluid and electrolyte deficiencies should be supplemented.
In patients with AIDS being treated for diarrhea with loperamide, the treatment should be discontinued at the first signs of abdominal distension and medical attention should be sought.
If, after taking loperamide for acute diarrhea, there is no improvement within 48 hours, the medicine should be discontinued and the patient should consult a doctor.
If the patient is taking Loperamid WZF to treat diarrhea associated with a diagnosed irritable bowel syndrome and there is no improvement within 48 hours, the medicine should be discontinued and the patient should consult a doctor. Patients should also consult a doctor if symptoms change or if recurring diarrhea lasts longer than two weeks.

Children

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

Loperamid WZF and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. In particular, tell them if you are taking:

• ritonavir (used to treat 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 cholesterol levels in the blood).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
This medicine should not be used during pregnancy (especially in the first trimester) and during breastfeeding. Small amounts may pass into breast milk. Ask your doctor which medicine can be used during this period.

Driving and using machines

During treatment with Loperamid WZF for diarrhea, the following may occur: loss of consciousness, decreased level of consciousness, fatigue, dizziness, or drowsiness. Therefore, be careful when driving vehicles and operating machines.

Loperamid WZF contains 100 mg of lactose monohydrate

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Loperamid WZF

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Adults and children over 6 years of age
Acute diarrhea
initial dose - 2 tablets (4 mg) for adults and 1 tablet (2 mg) for children, then 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 of the medicine must be adjusted according to body weight (3 tablets/20 kg body weight per day).
If, during treatment of acute diarrhea, there is no improvement in the patient's condition within 48 hours, the administration of Loperamid WZF should be discontinued and the patient should consult a doctor.
Chronic diarrhea
initial dose - 2 tablets (4 mg) per day for adults and 1 tablet (2 mg) per day for children;
this initial dose should be modified until 1 to 2 normal stools per day are achieved, which is usually achieved by taking 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 of the medicine must be adjusted according to body weight (3 tablets/20 kg body weight per day).
Since prolonged diarrhea can be a symptom of more serious diseases, loperamide should not be taken for a long time until the cause of diarrhea is determined.
In the elderly and in patients with renal impairment, no dose adjustment is necessary.

Taking a higher dose of Loperamid WZF than recommended

If you have taken more Loperamid WZF than recommended, seek medical advice immediately. The following symptoms may occur: rapid heart rate, irregular heart rhythm, changes in heart rhythm (these symptoms can have serious, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, and shallow breathing.
In children, the reaction to taking too high a dose of Loperamid WZF is stronger than in adults. If a child takes too high a dose of the medicine or experiences any of the above symptoms, seek medical attention immediately.
Other overdose symptoms may also occur, such as: stupor, constipation, miosis, intestinal obstruction with abdominal pain, nausea, and vomiting.

Missing a dose of Loperamid WZF

Do not take a double dose to make up for a missed dose.

4. Possible side effects

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

Stop taking the medicine and seek medical attention immediately if you experience any of the following symptoms. They require immediate treatment.

• Sudden swelling of the face, lips, or throat - these may be symptoms of a severe allergic reaction;
• Changes on the skin such as rash, severe irritation, redness, blisters, ulcers on the skin, in the mouth, eyes, and genitals, fever, and joint pain or skin peeling;
• Abdominal pain, nausea, and vomiting, severe abdominal distension, which may be a sign of reduced intestinal motility (intestinal obstruction);
• Upper 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 have been reported during treatment with loperamide hydrochloride:
Common (occurring in less than 1 in 10 patients):

• headache, constipation, nausea, bloating.

Uncommon (occurring in less than 1 in 100 patients):

• dizziness, drowsiness, abdominal pain, abdominal discomfort, dry mouth, upper abdominal pain, vomiting, indigestion;
• rash.

Rare (occurring in less than 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;
• intestinal obstruction (including paralytic ileus), colon dilation (including toxic colon dilation), abdominal distension;
• bullous rash (including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) - see symptoms listed above;
• pruritus, urticaria;
• urinary retention;
• fatigue.

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

• acute pancreatitis - see symptoms listed above.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Loperamid WZF

Store in a temperature below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP.
The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will 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: lactose monohydrate, corn starch, povidone K-25, stearic acid.

What Loperamid WZF looks like and contents of the pack

Loperamid WZF is a white or almost white, flat, beveled-edged tablet.
The pack contains 15 or 30 tablets in aluminum/PVC blisters, in a cardboard box.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba
Date of last revision of the leaflet:December 2024