Loperamide grindeks

Patient Information Leaflet

Loperamide Grindeks, 2 mg, hard capsules
Loperamidi hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Always take this medicine exactly as described in this patient leaflet or as your doctor or pharmacist has advised. Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 2 days, or if your condition worsens, you should contact your doctor.

Contents of the leaflet

1. What Loperamide Grindeks is and what it is used for
2. What you need to know before taking 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 Loperamide Grindeks is and what it is used for

Loperamide Grindeks hard capsules contain the active substance loperamide hydrochloride.
Loperamide hydrochloride firms the stool and reduces the frequency and volume of bowel movements.
Loperamide Grindeks is used for the symptomatic treatment of sudden, short-term (acute) episodes of diarrhoea in adults and adolescents above 12 years of age.
If there is no improvement after 2 days, or if you feel worse, you should contact your doctor.

2. Important information before taking Loperamide Grindeks

When not to take Loperamide Grindeks

• if the patient is allergic to loperamide hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• under 2 years of age;
• if the patient has blood in the stool or high fever;
• if the patient has acute ulcerative colitis;
• if the patient suffers from certain bacterial origin intestinal infections ( Salmonella , Shigella , Campylobacter );
• if the patient has pseudomembranous (antibiotic-associated) colitis;
• if the patient has constipation, abdominal distension or intestinal obstruction.

If in doubt whether any of the above points apply to the patient,
consult a doctor or pharmacist.
Warnings and precautions
Before starting to take Loperamide Grindeks hard capsules, discuss this
with a doctor or pharmacist.

• Treatment with Loperamide Grindeks is only symptomatic and does not address the underlying cause. Where possible, in all cases, causal treatment should be pursued.
• Diarrhoea is associated with loss of fluids and electrolytes; therefore, special attention should be paid to their replacement, especially in children, debilitated or elderly patients. Patients should drink more fluids than usual to replace lost fluids and consult a doctor or pharmacist about rehydration therapy to replace lost electrolytes.
• In infectious diarrhoea, Loperamide Grindeks does not replace antibacterial treatment.
• In acute sudden diarrhoea, Loperamide Grindeks hard capsules usually lead to resolution of symptoms within 48 hours. If this does not occur, discontinue use and consult a doctor.
• Do not take Loperamide Grindeks hard capsules if the doctor has advised the patient to avoid treatments that delay defecation. This may be the case, for example, in constipation or abdominal distension.
• If abdominal distension occurs during treatment of diarrhoea in patients with AIDS, discontinue taking Loperamide Grindeks hard capsules and consult a doctor.
• Inform the doctor if the patient has liver problems, as this may require closer medical supervision during treatment with Loperamide Grindeks hard capsules.

This medicine should be used only for the specified indications (see section 1) and should never be used in doses higher than the recommended dose (see section 3). Serious heart problems (symptoms such as rapid or irregular heartbeat) have been reported in patients who took excessive amounts of loperamide, the active substance in Loperamide Grindeks hard capsules.
Loperamide Grindeks and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Medicines that increase gastrointestinal motility may reduce the effect of Loperamide Grindeks.
The effect of desmopressin may be enhanced when Loperamide Grindeks is taken concomitantly with oral desmopressin (a medicine used in the treatment of central diabetes insipidus).
The following active substances may increase blood levels of loperamide hydrochloride:

• quinidine (used in the treatment and prevention of cardiac arrhythmias)
• ritonavir and saquinavir (medicines used in the treatment of immunodeficiency)
• itraconazole, ketoconazole (used in the treatment of fungal skin infections)
• gemfibrozil (used to lower blood lipid levels)
• St John's wort (used to improve mood and treat mild depression)
• valerian (used in the treatment of mild nervousness and anxiety)
• opioid analgesics (used in the treatment of severe pain), as they may increase the risk of severe constipation and central nervous system depression (e.g. drowsiness or reduced consciousness).

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before taking this medicine.
Pregnancy
Loperamide Grindeks should be avoided during pregnancy, especially during the first trimester. If pregnancy is confirmed or suspected, consult a doctor who will decide whether the patient may take Loperamide Grindeks.
Breastfeeding
Small amounts may pass into breast milk. Discuss appropriate treatment with a doctor.
Driving and operating machinery
If the patient experiences fatigue, drowsiness or dizziness while taking Loperamide Grindeks hard capsules (or due to diarrhoea), he or she should not drive or operate machinery.
Loperamide Grindeks contains lactose
Each capsule of Loperamide Grindeks contains 95 mg of lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.

3. How to take Loperamide Grindeks

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose

Adults
The initial dose is 2 capsules (4 mg), followed by 1 capsule (2 mg) after each subsequent loose bowel movement.
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 subsequent loose bowel movement.
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.
Use in children aged 2 to 12 years is not permitted without a doctor's recommendation.
Loperamide must not be given to children under 2 years of age.

Elderly patients
Dose adjustment is not required in elderly patients.

Renal impairment
Dose adjustment is not required in patients with renal impairment.

Hepatic impairment
Loperamide hydrochloride-containing medicines should be used with caution in patients with hepatic impairment. If a patient has hepatic impairment, consult a doctor before taking Loperamide Grindeks hard capsules.

Method of administration
Swallow the capsules whole with liquid. Do not chew the capsules due to their bitter taste. The capsules may be taken at any time of day, with or without food.

Duration of treatment
If symptoms do not resolve within 48 hours, discontinue use and contact your doctor.
The maximum duration of treatment is 48 hours.

Taking more Loperamide Grindeks than recommended
If an excessive amount of Loperamide Grindeks hard capsules has been taken, consult a doctor or go immediately to hospital for advice. Symptoms may include:
increased heart rate, irregular heartbeat, changes in heart rhythm (these effects may have potentially serious, life-threatening consequences), intestinal obstruction, pinpoint pupils (miosis), reduced sensitivity and responsiveness to stimuli (lethargy), muscle rigidity, uncoordinated movements, drowsiness, dry mouth, abdominal discomfort, nausea, vomiting, constipation, difficulty passing urine, and shortness of breath.

Children react more strongly to larger amounts of loperamide hydrochloride than adults. If a child has taken an excessive amount of the medicine or shows any of the above symptoms, contact a doctor immediately.

Missed dose of Loperamide Grindeks
Do not take a double dose to make up for a missed capsule.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Treatment with loperamide hydrochloride is generally well tolerated; however, adverse effects such as constipation, bloating, or difficulty urinating may occur even when following the recommendations.
When using loperamide hydrochloride, constipation, severe abdominal bloating, and intestinal blockage (intestinal obstruction) may occur. If any of the above symptoms occur, treatment with Loperamide Grindeks hard capsules must be stopped immediately and a doctor should be consulted.

Pain in the upper abdomen, abdominal pain radiating to the back, tenderness upon touching the abdomen, fever, rapid heartbeat, nausea, and vomiting may occur, which could be symptoms of pancreatitis (acute pancreatitis). Frequency is unknown (frequency cannot be determined from available data).
If any of these effects occur, treatment must be discontinued and immediate medical assistance sought.

Cases of hypersensitivity reactions (angioedema) with swelling of the face, tongue, and throat, severe skin reactions, and diseases associated with loperamide hydrochloride have also been reported:

• Severe skin disease with rash, skin peeling, and mucosal ulceration (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Acute inflammatory skin disease associated with blister formation on the mucous membranes of the mouth and lips (erythema multiforme). If any of the above symptoms occur, treatment with Loperamide Grindeks must be stopped immediately and a doctor consulted.

Adverse effects reported in clinical trials and after marketing authorization
Common adverse effects (may affect up to 1 in 10 patients)

• headache, dizziness
• constipation, nausea, excessive bloating.

Uncommon adverse effects (may affect up to 1 in 100 patients)

• drowsiness
• abdominal pain, discomfort in the abdominal cavity, dry mouth, vomiting, dyspepsia
• rash.

Rare adverse effects (may affect up to 1 in 1000 patients)

• hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock), anaphylactoid reaction, angioedema
• loss of consciousness, reduced sensitivity and responsiveness to stimuli (stupor), decreased level of consciousness, increased muscle tone, coordination difficulties
• miosis (pupil constriction)
• abdominal distension
• intestinal blockage (intestinal obstruction), disease of the large intestine (acute colonic dilation, including toxic megacolon)
• sore tongue
• urticaria, itching
• difficulty urinating
• fatigue.

During treatment with Loperamide Grindeks, several symptoms may occur which are usually difficult to distinguish from symptoms related to diarrhoea, such as nausea, abdominal pain, vomiting, fatigue, dizziness, drowsiness, dry mouth, bloating, and loss of appetite.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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. Reporting adverse effects helps to collect more information on the safety of using the medicine.
Adverse effects can also be reported to the marketing authorization holder.

5. How to store Loperamide Grindeks

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system 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 Loperamide Grindeks hard capsules contain

• The active substance is loperamide hydrochloride. Each capsule contains 2 mg of loperamide hydrochloride.
• The other ingredients are: monohydrate lactose, maize starch, magnesium stearate (E572). Capsule 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 size 3 (approximately 16 mm x 6 mm) with a pink body and dark green cap, containing white powder. Pack sizes: 6, 8, 10, 12, 16, 18 or 20 capsules in PVC/Aluminium blister packs contained in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53, Rīga, LV-1057, Latvia
Tel: +371 67083205
E-mail: [email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Loperamid Grindeks 2 mg Hartkapseln
Belgium Loperamide Grindeks 2 mg harde 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