Loperamid Dr. Max

Package Leaflet: Information for the User

Loperamid Dr.Max, 2 mg, hard capsules
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 or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. 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 Loperamid Dr.Max and what is it used for
• 2. Important information before taking Loperamid Dr.Max
• 3. How to take Loperamid Dr.Max
• 4. Possible side effects
• 5. How to store Loperamid Dr.Max
• 6. Contents of the pack and other information

1. What is Loperamid Dr.Max and what is it used for

Loperamid Dr.Max contains the active substance loperamide hydrochloride, which belongs to a group of anti-diarrheal medicines.
Loperamid Dr.Max helps to stop diarrhea by thickening the stool and reducing the number of bowel movements.
Loperamid Dr.Max is used to treat the symptoms of sudden, short-term diarrhea (acute diarrhea).
After consulting a doctor, this medicine can be used to treat chronic (long-term) diarrhea and in cases where the patient has had a part of their intestine removed, which often causes diarrhea.
If there is no improvement or the patient feels worse after 2 days, they should consult their doctor.
Loperamid Dr.Max is intended for adults, adolescents, and children over 6 years of age.

2. Important information before taking Loperamid Dr.Max

When not to take Loperamid Dr.Max

• If the patient is allergic to loperamide hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• Do not give Loperamid Dr.Max to children under 2 years of age.
• In patients who have blood in their stool or a high fever (dysentery).
• In patients with inflammatory bowel disease, such as ulcerative colitis or pseudomembranous colitis (colitis, ulcerative colitis, colitis as a complication of broad-spectrum antibiotic treatment).
• If the doctor has determined that the patient has diarrhea caused by bacteria (such as Salmonella, Shigella, and Campylobacter).
• If the doctor determines that it is not advisable to slow down intestinal peristalsis, e.g., when constipation or bloating occurs.
• If the patient experiences bloating or symptoms of intestinal obstruction.

Warnings and precautions

Before taking Loperamid Dr.Max, the patient should discuss it with their doctor or pharmacist:

• During diarrhea, there may be a significant loss of fluids and electrolytes, so it is necessary to replenish fluids and electrolytes by drinking more than usual, special drinks containing sugars and salts that help with hydration, which is especially important in children and weakened or elderly patients with acute diarrhea.
• Loperamid Dr.Max only stops diarrhea, but does not treat the cause of its occurrence. If possible, the cause of diarrhea should always be treated as well.
• The medicinal product Loperamid Dr.Max usually stops the symptoms of sudden, short-term (acute) diarrhea within 48 hours of the first administration. If the symptoms do not disappear, the patient should stop taking the medicine and consult their doctor immediately.
• If the patient has AIDS and is being treated with Loperamid Dr.Max for diarrhea, and symptoms of abdominal bloating appear, the patient should stop taking the medicine and contact their doctor immediately.
• If the patient has liver function disorders, they should consult their doctor before taking the medicine.
• If intestinal obstruction or constipation occurs, the patient should stop taking the medicine and consult their doctor immediately.
• The patient should not exceed the recommended dose and treatment duration (see section 3). In patients who have taken too much loperamide, the active substance of Loperamid Dr.Max, serious heart problems (symptoms include rapid or irregular heartbeat) have been reported.

Loperamid Dr.Max and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform their doctor or pharmacist if they are taking:

• ritonavir (used to treat HIV) or quinidine (used to treat heart rhythm disorders or malaria)
• itraconazole or ketoconazole (used to treat fungal infections)
• gemfibrozil (used to treat high cholesterol)
• desmopressin taken orally (used to control thirst and urine production in patients with diabetes insipidus)
• other medicines that contribute to slowing down or speeding up intestinal peristalsis

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, or is planning to have a baby, they should consult their doctor before taking this medicine.
The patient should not take this medicine if they are pregnant or breastfeeding, as small amounts may pass into breast milk.

Driving and using machines

During diarrhea, the patient may experience fatigue, dizziness, or drowsiness. Therefore, the patient should be particularly careful when driving or operating machinery.

Loperamid Dr.Max contains lactose

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

Loperamid Dr.Max contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially 'sodium-free'.

3. How to take Loperamid Dr.Max

This medicine should always be taken according to the package leaflet or as directed by a doctor. If the patient is unsure, they should consult their doctor or pharmacist.
The recommended dose depends on the patient's age and the type of diarrhea.
Adults and adolescents over 12 years of age

• When acute (sudden) diarrhea occurs, the patient should take 2 capsules at the same time, then 1 capsule after each subsequent loose stool. If a well-formed or very hard stool occurs, or the patient stops feeling bowel movements, they should stop taking the medicine and consult their doctor immediately.
• For chronic (long-term) diarrhea and in patients who have had a part of their intestine removed, the dose is determined by the doctor. The usual initial dose is 2 capsules per day. The dose can be increased to a maintenance dose of 1 to 6 capsules per day to achieve 1-2 solid stools per day.

Adults: Do not take more than 8 capsules in 24 hours.

Adolescents and children over 6 years of age: Do not take more than 3 capsules per 20 kg of body weight and more than 8 capsules in 24 hours.

Use in children

Loperamid Dr.Max is not recommended for children under 6 years of age.
Children over 6 years of age

• When acute (sudden) diarrhea occurs, the patient should take 1 capsule, then 1 capsule after each loose stool. If a well-formed or very hard stool occurs, or the child experiences nausea that may be caused by bowel movement cessation, they should stop taking the capsules and consult their doctor immediately.
• For chronic (long-term) diarrhea and in patients who have had a part of their intestine removed, the dose is determined by the doctor. The usual initial dose is 1 capsule per day. The maintenance dose should be determined based on body weight (up to 3 capsules/20 kg body weight) to achieve 1-2 solid stools per day.

Note: Never exceed the maximum recommended daily dose per kilogram of body weight of the child!
If the patient is unsure, they should consult their doctor or pharmacist.

If acute diarrhea lasts longer than 48 hours, the patient has recurring acute diarrhea, or other symptoms occur, they should consult their doctor.
For oral use only.
Loperamid Dr.Max can be taken at any time of the day.
The capsules should be swallowed with water.

Use in elderly patients and patients with liver or kidney function disorders

Elderly patients and patients with liver or kidney function disorders do not require dose adjustment.
If the patient has liver function disorders, they should consult their doctor or pharmacist before taking this medicine.

Overdose of Loperamid Dr.Max

If the patient has taken more than the recommended dose of Loperamid Dr.Max, they should contact their doctor or hospital immediately and ask for advice. The following symptoms may occur:
rapid or irregular heartbeat, changes in heart rhythm (these symptoms can have serious, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, and shallow breathing.
Symptoms of overdose of Loperamid Dr.Max may be more severe in children than in adults. If a child takes more capsules than they should or experiences the above symptoms, they should contact their doctor immediately.

Information for doctors in case of overdose:

• Naloxone should be administered by injection.
• If necessary, the injection of naloxone should be repeated after 1-3 hours.
• Monitoring is required for at least 48 hours.

If the patient has further questions about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Loperamid Dr.Max can cause side effects, although not everybody gets them.
The patient should stop taking the medicine and seek medical help immediately if they experience the following side effects:

Rare (may affect up to 1 in 1000 people)

• allergic reaction, including unusual wheezing, shortness of breath, fainting, or swelling of the face and throat
• skin rash, which may be severe and include blisters or peeling of the skin
• loss of consciousness or decreased level of consciousness

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

• abdominal pain, abdominal pain radiating to the back, abdominal tenderness, fever, rapid heartbeat, nausea, vomiting, which may be symptoms of pancreatitis (acute pancreatitis). The patient should stop taking the medicine and consult their doctor if they experience the following side effects:

Common (may affect up to 1 in 10 people)

• headache,
• constipation,
• nausea
• bloating with gas

Uncommon (may affect up to 1 in 100 people)

• dizziness or drowsiness
• nausea, vomiting, indigestion, constipation, and gas
• fatigue
• dry mouth
• abdominal discomfort
• rash

Rare (may affect up to 1 in 1000 people):

• itching or hives
• difficulty urinating
• abdominal pain or abdominal swelling
• severe constipation
• hypertonia (increased muscle tone)
• pupil constriction
• intestinal obstruction (may be caused by paralysis of the intestinal wall)
• colonic dilation (may occur rapidly)

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 Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be gathered on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Loperamid Dr.Max

The medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Loperamid Dr.Max contains

The active substance of the medicine is loperamide hydrochloride. One capsule contains 2 mg of loperamide hydrochloride.
The other ingredients are:
Contents of the capsule:
lactose monohydrate, corn starch, talc, magnesium stearate
Capsule cap:
yellow iron oxide (E172), brilliant blue FCF (E133), titanium dioxide (E171), gelatin, sodium lauryl sulfate, purified water
Capsule body:
yellow iron oxide (E172), black iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), gelatin, sodium lauryl sulfate, purified water

What Loperamid Dr.Max looks like and contents of the pack

Hard gelatin capsules with a green cap and gray body. The capsule is filled with a white or almost white powder.
Aluminum/PVC/PVDC blister pack in a cardboard box.
Pack sizes: 8, 10, 12, 18, or 20 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder:

Dr. Max Pharma s.r.o.
Na Florenci 2116/15
110 00 Prague
Czech Republic

Manufacturer/Importer:

SVUS Pharma a.s.
Smetanovo nábřeží 1238/20a
500 02 Hradec Králové
Czech Republic

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

Czech Republic:
Loperamid Dr.Max
Hungary:
Loperamid SVUS 2 mg hard capsule
Poland:
Loperamid Dr.Max
Slovakia:
Loperamid Dr.Max 2 mg
Romania:
Loperamid Dr.Max 2 mg capsule
Date of last revision of the leaflet:05/2022