Loperamid Apteo Med

Package Leaflet: Information for the Patient

Loperamid APTEO MED, 2 mg, Hard Capsules

Loperamide Hydrochloride

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Taken Exactly as Described in the Patient Leaflet or as Advised 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 Adverse Reactions, Including any Possible Adverse Reactions not Listed in the Leaflet, They Should Inform their Doctor or Pharmacist. See Section
• 4.
• If After 2 Days There is no Improvement or the Patient Feels Worse, They Should Contact their Doctor.

Table of Contents of the Leaflet:

• 1. What is Loperamid APTEO MED and What is it Used for
• 2. Important Information Before Taking Loperamid APTEO MED
• 3. How to Take Loperamid APTEO MED
• 4. Possible Adverse Reactions
• 5. How to Store Loperamid APTEO MED
• 6. Package Contents and Other Information

1. What is Loperamid APTEO MED and What is it Used for

The Active Substance of Loperamid APTEO MED is Loperamide Hydrochloride, a Substance with Anti-Diarrheal Action. The Medication Prolongs the Time of Passage of Food Through the Intestines, Reduces Water and Electrolyte Excretion, and Reduces the Immediate Need for Defecation.
Loperamid APTEO MED is Used:

• for Symptomatic Treatment of Acute and Chronic Diarrhea in Adults, Children, and Adolescents Over 6 Years of Age;
• for Symptomatic Treatment of Acute Episodes of Diarrhea Associated with Irritable Bowel Syndrome in Adults Over 18 Years of Age, After Initial Diagnosis by a Doctor.

If After 2 Days There is no Improvement or the Patient Feels Worse, They Should Consult their Doctor.

2. Important Information Before Taking Loperamid APTEO MED

When Not to Take Loperamid APTEO MED:

• if the Patient is Allergic to Loperamide Hydrochloride or any of the Other Ingredients of the Medication (Listed in Section 6),
• in Children Under 6 Years of Age,
• in Patients with Diagnosed Irritable Bowel Syndrome (IBS) Under 18 Years of Age,
• in Patients with Acute Dysentery, Characterized by the Presence of Blood in the Stool and High Fever,
• in Patients with Acute Exacerbation of Ulcerative Colitis,
• in Patients with Bacterial Enteritis and Colitis Caused by Pathogenic Bacteria of the Genus Salmonella, Shigellaand Campylobacter,
• in Patients with Pseudomembranous Colitis Associated with the Administration of Broad-Spectrum Antibiotics,
• if the Patient Should Avoid Delaying Intestinal Peristalsis. In Such a Case, there is a Risk of Serious Complications, Including Intestinal Obstruction, Colonic Dilatation, and Toxic Megacolon. The Use of Loperamid APTEO MED Should be Discontinued Immediately in Case of Constipation, Abdominal Distension, or Intestinal Obstruction.

Warnings and Precautions

Before Starting Treatment with Loperamid APTEO MED, the Patient Should Discuss it with their Doctor or Pharmacist.
Treatment of Diarrhea with Loperamid APTEO MED 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.
In Patients with Diarrhea, Especially in Young People, the Elderly, and Weakened Patients, Dehydration and Excessive Electrolyte Loss may Occur. Therefore, During Diarrhea, it is Necessary to Take More Fluids than Usual to Compensate for these Deficiencies.
If After Administration of the Medication in Acute Diarrhea, Symptoms do not Subside Within 48 Hours, the Patient Should Discontinue the Use of Loperamid APTEO MED and Consult their Doctor.
Patients with AIDS Taking Loperamid APTEO MED for Diarrhea Should Immediately Discontinue the Medication and Consult their Doctor if they Experience any Early Symptoms of Abdominal Distension. In Patients with AIDS and Infectious Colitis Caused by Both Viruses and Bacteria, Isolated Cases of Toxic Megacolon have been Reported During the Use of Loperamide.
In Patients with Liver Function Disorders, the Product Loperamid APTEO MED Should be Used with Caution Due to Reduced Metabolism Associated with the First-Pass Effect in the Liver. In these Patients, Relative Overdose of the Medication may Occur, Leading to Toxic Effects on the Central Nervous System.
This Medication Should not be Taken for a Purpose Other than its Indicated Use (See Section 1) or in Higher Doses than Recommended (See Section 3). In Patients Taking Too High Doses of Loperamide (the Active Substance of Loperamid APTEO MED), Serious Heart Rhythm Disorders (Including Accelerated or Irregular Heart Rhythm) have been Noted.
Patients with Diagnosed Irritable Bowel Syndrome (IBS) Should Discuss Treatment with their Doctor or Pharmacist Before Taking the Medication, Especially if:

• the Patient is Over 40 Years Old and it has Been a While Since the Last Episode of IBS Symptoms or if the Symptoms are Different from Those Experienced Previously,
• the Patient has Recently Experienced Rectal Bleeding,
• the Patient has Severe Constipation,
• the Patient has Nausea or Vomiting,
• the Patient has Lost Appetite or Weight Loss,
• the Patient has Difficulty or Pain When Urinating,
• the Patient has a Fever,
• the Patient has Recently Travelled Abroad.

Children and Adolescents

Loperamid APTEO MED Should not be Used in Children Under 6 Years of Age or in Patients with Irritable Bowel Syndrome Under 18 Years of Age.

Loperamid APTEO MED and Other Medications

The Patient Should Inform their Doctor or Pharmacist About all Medications They are Currently Taking or Have Recently Taken, as Well as any Medications They Plan to Take.
It is Especially Important to Inform the Doctor or Pharmacist About the Use of:

• Ritonavir (a Medication Used to Treat HIV Infection),
• Quinidine (a Medication Used to Treat Irregular Heart Rhythm or Malaria),
• Desmopressin Administered Orally (a Medication Used to Treat Excessive Urination),
• Itraconazole or Ketoconazole (Medications Used to Treat Fungal Infections),
• Gemfibrozil (a Medication Used to Treat High Cholesterol Levels).

Using Loperamid APTEO MED with Food, Drinks, and Alcohol

See Section 3.

Pregnancy, Breastfeeding, and Fertility

If the Patient is Pregnant or Breastfeeding, Thinks They May be Pregnant, or is Planning to Have a Child, They Should Consult their Doctor or Pharmacist Before Taking this Medication.
Small Amounts of Loperamide may Pass into Breast Milk, Therefore, it is not Recommended to Use the Medication During Breastfeeding.
Pregnant or Breastfeeding Patients Should Consult their Doctor to Determine the Appropriate Treatment.
The Effect of the Medication on Fertility has not been Studied.

Driving and Operating Machines

During the Treatment of Diarrhea with Loperamide, the Following Symptoms may Occur: Reduced Awareness, Fatigue, Dizziness, or Drowsiness, Therefore, Caution Should be Exercised When Driving or Operating Machines.

Loperamid APTEO MED Contains Lactose

If the Patient has Previously been Diagnosed with Intolerance to Some Sugars, They Should Consult their Doctor Before Taking the Medication.

3. How to Take Loperamid APTEO MED

Loperamid APTEO MED Should be Taken Exactly as Described in the Patient Leaflet or as Advised by a Doctor. In Case of Doubt, the Patient Should Consult their Doctor or Pharmacist.
Loperamid APTEO MED Should be Taken Orally, with a Drink of Fluid.

Dosage

Diarrhea may Subside After a Single Dose. In this Case, the Medication Should not be Continued. During Diarrhea, it is Necessary to Drink More Fluids than Usual. This is Especially Important in the Case of Young People, the Elderly, and Weakened Patients.
Acute and Chronic Diarrhea:
Adults, Children, and Adolescents Over 6 Years of Age
Acute Diarrhea: Initially, the Dose is 2 Capsules (4 mg) for Adults and 1 Capsule (2 mg) for Children, and then 1 Capsule (2 mg) After Each Loose Stool.
Chronic Diarrhea: the Initial Dose is 2 Capsules (4 mg) per Day for Adults and 1 Capsule (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 Capsules (2 mg to 12 mg) per Day.
Maximum Daily Dose in Acute and Chronic Diarrhea: 8 Capsules (16 mg) per Day for Adults and Children; in Children, the Dose Must be Adjusted According to Body Weight (3 Capsules/20 kg Body Weight). The Dose Should not Exceed the Maximum Recommended Dose.
If in the Treatment of Acute Diarrhea, Symptoms Worsen or do not Subside Within 48 Hours of Taking Loperamid APTEO MED, the Patient Should Discontinue the Medication and Consult their Doctor.
Symptomatic Treatment of Acute Episodes of Diarrhea Associated with Irritable Bowel Syndrome:
Adults, Persons Over 18 Years of Age
Initially 2 Capsules (4 mg), and then 1 Capsule (2 mg) After Each Loose Stool or as Advised by a Doctor. The Maximum Daily Dose Should not Exceed 6 Capsules (12 mg).
In the Case of Repeated Episodes of Diarrhea in Irritable Bowel Syndrome, Loperamid APTEO MED can be Used for up to 2 Weeks, but in Each Episode of Diarrhea Lasting Longer than 48 Hours, the Patient Should Consult their Doctor.
Children
Loperamid APTEO MED Should not be Used in Children Under 6 Years of Age, or in Patients with Irritable Bowel Syndrome Under 18 Years of Age.
Using Loperamid APTEO MED in the Elderly
In the Elderly, Dose Adjustment is not Necessary.
Using Loperamid APTEO MED in Patients with Renal Impairment
In Patients with Renal Impairment, Dose Adjustment is not Necessary.
Using Loperamid APTEO MED in Patients with Hepatic Impairment
In Patients with Hepatic Impairment, the Medication Should be Used Under Medical Supervision, as Caution is Advised and Close Monitoring for Signs of Central Nervous System Toxicity is Necessary.

Taking a Higher Dose of Loperamid APTEO MED than Recommended

In Case of Taking a Higher Dose of the Medication than Recommended, the Patient Should Immediately Consult their Doctor or Go to the Nearest Hospital.
In Case of Overdose, the Following Symptoms may Occur:
Accelerated Heart Rate, Irregular Heart Rhythm, Changes in Heart Rhythm (These Symptoms may have Severe, Life-Threatening Consequences), Muscle Stiffness, Uncoordinated Movements, Drowsiness, Pupillary Constriction, Urination Difficulties, Shallow Breathing, Slow Breathing. In Children, the Reaction to Taking High Doses of Loperamid APTEO MED is Stronger than in Adults. If a Child Takes Too High a Dose of the Medication or Experiences any of the Above Symptoms, the Parent or Guardian Should Immediately Consult a Doctor.

Missing a Dose of Loperamid APTEO MED

In Case of Missing a Dose, the Patient Should Take the Next Dose After the Next Loose Stool (Defecation).
The Patient Should not Take a Double Dose to Make up for the Missed Dose.

4. Possible Adverse Reactions

Like all Medications, this Medication can Cause Adverse Reactions, Although not Everybody gets them.

The Patient Should Stop Taking the Medication and Immediately Consult their Doctor if they Experience any of the Following Adverse Reactions. These Require Immediate Medical Attention.

Rare(May Affect up to 1 in 1000 People):

• Hypersensitivity Reactions, Anaphylactic Reaction (Including Anaphylactic Shock), Anaphylactoid Reaction, Angioedema,
• Bullous Skin Reactions, Exfoliative Dermatitis (Including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Erythema Multiforme), Itching, Urticaria,
• Loss of Consciousness, Stupor or Decreased Level of Consciousness, Increased Muscle Tone, Coordination Disorders.

In Case of the Following Adverse Reactions, the Patient Should Stop Taking the Medication and Immediately Consult their Doctor.

Uncommon(May Affect Less than 1 in 100 People):

• Rash,
• Abdominal Pain, Abdominal Discomfort, Nausea, Upper Abdominal Pain Rare(May Affect up to 1 in 1000 People):
• Urinary Retention,
• Severe Constipation,
• Abdominal Distension,
• Pupillary Constriction. Frequency Not Known(Cannot be Estimated from the Available Data): Upper Abdominal Pain, Abdominal Pain Radiating to the Back, Abdominal Tenderness, Fever, Accelerated Heart Rate, Nausea, Vomiting, Which may be Symptoms of Pancreatitis (Acute Pancreatitis).

Other Adverse Reactions that may Occur During Treatment with the Medication:

Common(May Affect Less than 1 in 10 People):

• Constipation, Nausea, Flatulence
• Headache Uncommon(May Affect Less than 1 in 100 People):
• Dizziness, Drowsiness,
• Vomiting, Nausea,
• Dry Mouth Rare(May Affect up to 1 in 1000 People):
• Fatigue.

Reporting Adverse Reactions

If the Patient Experiences any Adverse Reactions, Including any Adverse Reactions not Listed in the Leaflet, They Should Inform their Doctor or Pharmacist. Adverse Reactions can be Reported Directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw. Tel.: +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 will Help to Gather More Information on the Safety of the Medication.

5. How to Store Loperamid APTEO MED

Do not Store Above 25°C.
The Medication Should be Stored in a Place that is Inaccessible to Children.
Do not Use this Medication After the Expiry Date Stated on the Packaging. The Expiry Date Refers to the Last Day of the Specified Month.
Medications Should not be Disposed of via Wastewater or Household Waste. The Patient Should Ask their Pharmacist how to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Loperamid APTEO MED Contains

The Active Substance of the Medication is Loperamide Hydrochloride. Each Capsule Contains 2 mg of Loperamide Hydrochloride.
The Other Ingredients are:
Corn Starch (Dried), Lactose (DCL 21), Polysorbate 80, Talc, Colloidal Silica (Anhydrous), Magnesium Stearate. Capsule Shell: Body: Gelatin, Purified Water, Sodium Lauryl Sulfate, Erythrosine (E 127), Iron Oxide (E 172), Titanium Dioxide (E 171), Cap: Gelatin, Purified Water, Sodium Lauryl Sulfate, Iron Oxide Yellow (E 172), Indigo Carmine (E 132), Titanium Dioxide (E 171); Ink: Shellac, Iron Oxide (E 172), Potassium Hydroxide.

• Shellac, Iron Oxide (E 172), Potassium Hydroxide.

What Loperamid APTEO MED Looks Like and What the Package Contains

Hard Gelatin Capsule, Grey-Green in Colour, Size "4", with the Imprint "24" on the Body and "C" on the Cap, Filled with a White or Almost White Powder.
Package Size:
8, 10 or 20 Capsules in PVC/Aluminium Blister Packs in a Cardboard Box.

Marketing Authorization Holder:

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
tel. 607 696 231
e-mail: [email protected]

Manufacturer/Importer:

Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
Date of Last Update of the Leaflet:August 2024