Laremid

Package Leaflet: Information for the Patient

LAREMID, 2 mg, 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 this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 2 days or if the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is Laremid and what is it used for

Laremid is an anti-diarrheal medicine.
The medicine prolongs the transit time of food through the digestive tract, reduces water and electrolyte loss, 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.
Laremid 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 Laremid

When not to take Laremid:

• 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 bloody diarrhea with high fever (dysentery),
• if the patient has ulcerative colitis,
• if the patient has 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. Laremid should be discontinued immediately if constipation or abdominal distension occurs.

Warnings and precautions

Before starting to take Laremid, the patient should discuss it with their doctor or pharmacist if they have previously had liver function disorders.
Treatment of diarrhea with Laremid 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.
This medicine should not be taken for a purpose other than its intended use (see section 1) or in doses larger than recommended (see section 3). In patients taking too high doses of loperamide (the active substance of Laremid), 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 mineral salt losses should be supplemented.
In patients with AIDS being treated for diarrhea with loperamide, the medicine should be discontinued at the first signs of abdominal distension and the patient should consult a doctor.
If, after taking loperamide in 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 Laremid 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

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

Laremid and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, they should mention if they 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 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.
This medicine is not recommended during pregnancy (especially in the first trimester) and during breastfeeding. Small amounts may pass into breast milk. The patient should consult their doctor about which medicine can be used during this period.

Driving and using machines

During the treatment of diarrhea with Laremid, the following may occur: loss of consciousness, decreased level of consciousness, fatigue, dizziness, or drowsiness. Therefore, caution should be exercised when driving vehicles and operating machines.

Laremid contains 100 mg of lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Laremid

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their 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 the treatment of acute diarrhea, there is no improvement in the patient's condition within 48 hours, the administration of Laremid 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 Laremid than recommended

If the patient has taken too much Laremid, they should immediately consult a doctor or go to the hospital. The following symptoms may occur: accelerated 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 much Laremid is stronger than in adults. If a child takes too much Laremid or experiences any of the above symptoms, they should immediately consult a doctor.
Other symptoms of overdose may also occur, such as: stupor, constipation, narrowing of the pupils, intestinal obstruction manifested by abdominal pain, nausea, and vomiting.

Missing a dose of Laremid

A double dose should not be taken 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.

The patient should stop taking the medicine and immediately consult a doctor if they 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 result of weakened intestinal motility (intestinal obstruction); pain in the upper abdomen, abdominal pain radiating to the back, abdominal tenderness, fever, rapid heartbeat, 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;
• pupil constriction;
• intestinal obstruction (including paralytic ileus), colon dilation (including toxic colon dilation), abdominal distension;
• blistering rash (including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) - see symptoms listed above;
• itching, urticaria;
• urinary retention;
• fatigue.

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

• acute pancreatitis - see symptoms listed above.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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, more information can be collected on the safety of the medicine.

5. How to store Laremid

Store in a temperature below 25°C.
The medicine should be stored out of 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.
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 Laremid contains

• The active substance of Laremid 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 Laremid looks like and contents of the pack

Laremid is a white or almost white, flat, beveled-edged tablet.
The pack contains 10 or 20 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