Loperamide Grindeks

Package Leaflet: Information for the User

Loperamide Grindeks, 2 mg, Hard Capsules

Loperamide Hydrochloride

Read All of This Leaflet Carefully Before Taking This Medicine.

• Always Take This Medicine Exactly as Described in This Leaflet or as Directed by Your Doctor or Pharmacist. Keep This Leaflet. You May Need to Read It Again.
• If You Have Any Further Questions, Ask Your Pharmacist.
• If You Get Any Side Effects, Talk to Your Doctor or Pharmacist. This Includes Any Possible Side Effects Not Listed in This Leaflet. See Section 4.
• If After 2 Days You Do Not Feel Better or If You Feel Worse, You Should Contact Your Doctor.

Contents of the Pack and Other Information

• 1. What is Loperamide Grindeks and What is It Used For
• 2. Before You Take Loperamide Grindeks
• 3. How to Take Loperamide Grindeks
• 4. Possible Side Effects
• 5. How to Store Loperamide Grindeks
• 6. Contents of the Pack and Other Information

1. What is Loperamide Grindeks and What is It Used For

Loperamide Grindeks Hard Capsules Contain the Active Substance Loperamide Hydrochloride.
Loperamide Hydrochloride Hardens the Stool and Reduces the Frequency and Volume of Bowel Movements.
Loperamide Grindeks is Used for the Symptomatic Treatment of Acute Diarrhea in Adults and Adolescents Over 12 Years of Age.
If After 2 Days You Do Not Feel Better or If You Feel Worse, You Should Contact Your Doctor.

2. Before You Take Loperamide Grindeks

When Not to Take Loperamide Grindeks

• If You Are Allergic to Loperamide Hydrochloride or Any of the Other Ingredients of This Medicine (Listed in Section 6);
• Below 2 Years of Age;
• If You Have Blood in Your Stool or a High Fever;
• If You Have Acute Ulcerative Colitis;
• If You Have Certain Bacterial Infections of the Gut (Such as Salmonella, Shigella, Campylobacter);
• If You Have Pseudomembranous Colitis (Antibiotic-Associated Colitis);
• If You Have Constipation, Abdominal Distension or Intestinal Obstruction.

In Case of Doubt Whether Any of the Above Applies to You, Consult Your Doctor or Pharmacist.

Warnings and Precautions

Before Taking Loperamide Grindeks Hard Capsules, Discuss This with Your Doctor or Pharmacist.

• Treatment with Loperamide Grindeks is Only Symptomatic, But Does Not Address the Cause. Whenever Possible, All Cases Should Be Treated Causally.
• Diarrhea is Associated with Loss of Fluid and Electrolytes, So Particular Attention Should Be Paid to Their Replacement, Especially in Children, Weakened Patients or the Elderly. You Should Drink More Fluids Than Usual to Replace Lost Fluids and Ask Your Doctor or Pharmacist About Rehydration Therapy to Replace Lost Electrolytes.
• In Infectious Diarrhea, Loperamide Grindeks Does Not Replace Antibacterial Treatment.
• In Case of Acute Diarrhea, Loperamide Grindeks Hard Capsules Usually Relieve Symptoms Within 48 Hours. If Not, You Should Stop Taking the Medicine and Consult Your Doctor.
• You Should Not Take Loperamide Grindeks Hard Capsules if Your Doctor Has Told You to Avoid Treating Slowed Gut Movements. This May Be the Case, for Example, in Constipation or Abdominal Distension.
• If You Experience Symptoms of Abdominal Distension During Diarrhea Treatment in Patients with AIDS, You Should Stop Taking Loperamide Grindeks Hard Capsules and Consult Your Doctor.
• You Should Tell Your Doctor if You Have Liver Problems, as This May Require Closer Medical Supervision When Taking Loperamide Grindeks Hard Capsules.

This Medicine Should Only Be Used in the Indicated Cases (See Section 1) and Never in Higher Doses Than Recommended (See Section 3). Serious Heart Problems (Such as Rapid or Irregular Heartbeat) Have Been Reported in Patients Who Have Taken Too Much Loperamide, the Active Substance of Loperamide Grindeks Hard Capsules.

Loperamide Grindeks and Other Medicines

Tell Your Doctor or Pharmacist About All Medicines You Are Taking or Have Recently Taken, as Well as Any Medicines You Plan to Take.
Medicines That Speed Up Gut Movement May Weaken the Effect of Loperamide Grindeks.
The Effect of Desmopressin May Be Enhanced When Loperamide Grindeks is Taken Together with Oral Desmopressin (a Medicine Used to Treat a Condition Called Central Diabetes Insipidus).
The Following Active Substances May Increase the Blood Levels of Loperamide Hydrochloride:

• Quinidine (Used to Treat and Prevent Heart Rhythm Disorders)
• Ritonavir and Saquinavir (Medicines Used to Treat Immune System Disorders)
• Itraconazole, Ketoconazole (Used to Treat Fungal Skin Infections)
• Gemfibrozil (Used to Lower Blood Fat Levels)
• St. John's Wort (Used to Improve Mood and Treat Mild Depression)
• Valerian (Used to Treat Mild Nervousness and Restlessness)
• Opioid Painkillers (Used to Treat Very Severe Pain), as They May Increase the Risk of Severe Constipation and Depression of the Central Nervous System (Such as Drowsiness or Decreased Awareness).

Pregnancy, Breast-Feeding and Fertility

If You Are Pregnant or Breast-Feeding, Think You May Be Pregnant or Are Planning to Have a Baby, Ask Your Doctor or Pharmacist for Advice Before Taking This Medicine.
Pregnancy
You Should Avoid Taking Loperamide Grindeks During Pregnancy, Especially in the First Trimester of Pregnancy. If You Are Pregnant or Think You May Be Pregnant, Consult Your Doctor, Who Will Decide Whether You Can Take Loperamide Grindeks.
Breast-Feeding
Small Amounts May Pass into Breast Milk. You Should Discuss This with Your Doctor.
Fertility
There is No Information to Suggest that Loperamide Grindeks Affects Fertility.

Driving and Using Machines

If You Feel Drowsy, Dizzy or Experience Dizziness While Taking Loperamide Grindeks Hard Capsules (or Due to Diarrhea), You Should Not Drive or Operate Machinery.

Loperamide Grindeks Contains Lactose

Each Loperamide Grindeks Capsule Contains 95 mg of Lactose. If You Have Been Told by Your Doctor That You Have an Intolerance to Some Sugars, Contact Your Doctor Before Taking This Medicinal Product.

3. How to Take Loperamide Grindeks

This Medicine Should Always Be Taken Exactly as Described in This Leaflet or as Directed by Your Doctor or Pharmacist. If You Are Not Sure, Consult Your Doctor or Pharmacist.
Recommended Dose
Adults
The Initial Dose is 2 Capsules (4 mg), Followed by 1 Capsule (2 mg) After Each Loose Stool.
The Total Daily Dose Should Not Exceed 6 Capsules (12 mg).
Adolescents Over 12 Years of Age
The Initial Dose is 2 Capsules (4 mg), Followed by 1 Capsule (2 mg) After Each Loose Stool. The Total Daily Dose Should Not Exceed 4 Capsules (8 mg).
Children Under 12 Years of Age
Other Loperamide-Containing Medicines May Be More Suitable for Children Aged 2 to 12 Years.
Loperamide Grindeks Should Not Be Used in Children Under 12 Years of Age Without Medical Advice.
Loperamide Should Not Be Given to Children Under 2 Years of Age.
Elderly Patients
No Dose Adjustment is Required in Elderly Patients.
Renal Impairment
No Dose Adjustment is Required in Patients with Renal Impairment.
Hepatic Impairment
Loperamide-Containing Medicines Should Be Used with Caution in Patients with Hepatic Impairment. If You Have Hepatic Impairment, Consult Your Doctor Before Taking Loperamide Grindeks Hard Capsules.
Method of Administration
The Capsules Should Be Swallowed Whole with a Drink of Water. The Capsules Should Not Be Chewed Due to the Bitter Taste. The Capsules Can Be Taken at Any Time of the Day, With or Without Food.
Duration of Treatment
If Symptoms Do Not Improve Within 48 Hours, You Should Stop Taking the Medicine and Consult Your Doctor.
The Maximum Duration of Treatment is 48 Hours.

If You Take More Loperamide Grindeks Than You Should

If You Have Taken More Loperamide Grindeks Hard Capsules Than You Should, Consult Your Doctor or Go to the Hospital for Advice. Symptoms May Include:
Increased Heart Rate, Irregular Heartbeat, Changes in Heart Rhythm (These Symptoms May Have Potentially Serious, Life-Threatening Consequences), Intestinal Obstruction, Constriction of the Pupils (Miosis), Decreased Sensitivity and Reaction to Stimuli (Stupor), Muscle Stiffness, Uncoordinated Movements, Drowsiness, Dryness of the Mouth, Abdominal Discomfort, Nausea, Vomiting, Constipation, Difficulty Urinating and Shortness of Breath.
Children React More Strongly to Higher Amounts of Loperamide Hydrochloride Than Adults. If a Child Has Taken Too Much Medicine or Shows Any of the Above Symptoms, You Should Immediately Consult Your Doctor.

If You Forget to Take Loperamide Grindeks

Do Not Take a Double Dose to Make Up for a Forgotten Capsule.
If You Have Any Further Questions on the Use of This Medicine, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medicines, This Medicine Can Cause Side Effects, Although Not Everybody Gets Them.
Loperamide Hydrochloride Treatment is Generally Well Tolerated, But Side Effects Such as Constipation and Abdominal Distension or Difficulty Urinating May Occur Even When Following the Recommendations.
During Treatment with Loperamide Hydrochloride, Constipation, Severe Abdominal Distension and Intestinal Obstruction (Intestinal Obstruction) May Occur. If You Experience Any of These Symptoms, You Should Immediately Stop Taking Loperamide Grindeks Hard Capsules and Consult Your Doctor.
Abdominal Pain, Abdominal Pain Radiating to the Back, Tenderness on Abdominal Palpation, Fever, Rapid Heart Rate, Nausea, Vomiting, Which May Be Symptoms of Pancreatitis (Acute Pancreatitis), Have Been Reported. The Frequency is Unknown (Frequency Cannot Be Estimated from the Available Data).
If You Experience Any of These Side Effects, You Should Stop Taking the Medicine and Seek Medical Attention Immediately.
There Have Also Been Reports of Single Cases of Hypersensitivity Reactions (Angioedema) with Facial, Tongue and Throat Swelling, Severe Skin Symptoms and Diseases Associated with the Use of Loperamide Hydrochloride:

• Severe Skin Disease with Rash, Peeling and Ulceration of Mucous Membranes (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis).
• Acute Inflammatory Skin Disease Associated with the Formation of Blisters on the Mucous Membranes of the Mouth and Lips (Erythema Multiforme). If You Experience Any of These Symptoms, You Should Immediately Stop Taking Loperamide Grindeks and Consult Your Doctor.

Side Effects Reported in Clinical Trials and Post-Marketing

Common Side Effects (May Affect Up to 1 in 10 People)

• Headache, Dizziness
• Constipation, Nausea, Abdominal Distension.

Uncommon Side Effects (May Affect Up to 1 in 100 People)

• Drowsiness
• Abdominal Pain, Abdominal Discomfort, Dryness of the Mouth, Vomiting, Nausea
• Rash.

Rare Side Effects (May Affect Up to 1 in 1000 People)

• Hypersensitivity Reaction, Anaphylactic Reaction (Including Anaphylactic Shock), Anaphylactoid Reaction, Angioedema
• Loss of Consciousness, Decreased Sensitivity and Reaction to Stimuli (Stupor), Decreased Level of Consciousness, Increased Muscle Tone, Difficulty in Coordination
• Constriction of the Pupils
• Abdominal Distension
• Intestinal Obstruction, Large Intestine Disease (Acute Colonic Distension, Including Toxic Megacolon)
• Painful Tongue
• Urticaria, Itching
• Difficulty Urinating
• Fatigue.

During Treatment with Loperamide Grindeks, Several Symptoms May Occur That Are Usually Difficult to Distinguish from Symptoms Associated with Diarrhea, Such as Nausea, Abdominal Pain, Vomiting, Fatigue, Dizziness, Drowsiness, Dryness of the Mouth, Abdominal Distension, Loss of Appetite.

Reporting of Side Effects

If You Get Any Side Effects, Talk to Your Doctor or Pharmacist. This Includes Any Possible Side Effects Not Listed in This Leaflet. You Can Also Report Side Effects 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, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. By Reporting Side Effects, You Can Help Provide More Information on the Safety of This Medicine.
You Can Also Report Side Effects to the Marketing Authorization Holder.

5. How to Store Loperamide Grindeks

Keep This Medicine Out of the Sight and Reach of Children.
Do Not Use This Medicine After the Expiry Date Which is Stated on the Carton After “Expiry Date” and on the Blister. The Expiry Date Refers to the Last Day of the Month.
There Are No Special Storage Conditions for This Medicine.
Medicines Should Not Be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medicines No Longer Required. These Measures Will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Loperamide Grindeks Hard Capsules Contain

• The Active Substance is Loperamide Hydrochloride. Each Capsule Contains 2 mg of Loperamide Hydrochloride.
• The Other Ingredients Are: Lactose Monohydrate, Corn Starch, Magnesium Stearate (E572). Cap Shell:Gelatin (E441), Titanium Dioxide (E171), Iron Oxide Red (E172), Iron Oxide Yellow (E172), Brilliant Blue FCF (E133).

What Loperamide Grindeks Hard Capsules Look Like and Contents of the Pack

Hard Gelatin Capsules No. 3 (Approximately 16 mm x 6 mm) with a Pink Body and a Dark Green Cap, Filled with a White Powder. Pack Sizes: 6, 8, 10, 12, 18 or 20 Capsules in PVC/Aluminum Blister Packs Packaged in a Cardboard Box.
Not All Pack Sizes May Be Marketed.

Marketing Authorization Holder and Manufacturer

AS GRINDEKS.
Krustpils iela 53, Rīga, LV-1057, Latvia
Phone: +371 67083205
Fax: +371 67083505
Email: [email protected]

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Austria
Loperamid Grindeks 2 mg Hartkapseln
Belgium
Loperamide Grindeks 2 mg hard capsules
Bulgaria
Loperamide Grindeks 2 mg hard capsules
Лоперамид Гриндекс 2 mg твърди капсули
Croatia
Loperamidklorid Grindeks 2 mg tvrde kapsule
Czech Republic
Loperamide Grindeks
Finland
Loperamide Grindeks 2 mg kapselit, kovat
France
LOPERAMIDE GRINDEKS 2 mg, gélule
Greece
Loperamide Grindeks 2 mg Σκληρά καψάκια
Spain
Loperamide Grindeks 2 mg cápsulas duras
Netherlands
Loperamide Grindeks 2 mg harde capsules
Ireland
Loperamide Grindeks 2 mg hard capsules
Germany
Loperamid Grindeks 2 mg Hartkapseln
Poland
Loperamide Grindeks
Portugal
Loperamide Grindeks 2 mg cápsulas duras
Romania
Loperamidă Grindeks 2 mg capsule
Slovakia
Loperamid Grindeks 2 mg tvrdé kapsuly
Sweden
Loperamide Grindeks 2 mg hårda kapslar
Hungary
Loperamide Grindeks 2 mg kemény kapszula
Italy
Loperamide Grindeks

Date of Last Revision of the Leaflet: