Loperamide Grindeks

Package leaflet: Information for the user

Loperamide Grindeks 2 mg hard capsules

loperamide hydrochloride
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after 2 days.

Contents of this 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 makes the stools firmer 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 over 12 years of age.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 2 days.

2. What you need to know before taking Loperamide Grindeks

Do not take Loperamide Grindeks hard capsules

• if you are allergic to loperamide hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you are under 2 years of age;
• if you have blood in your stools or high fever;
• if you suffer from ulcerative colitis;
• if you have an intestinal infection caused by bacteria (Salmonella, Shigella, Campylobacter);
• if you have pseudomembranous intestinal inflammation (caused by antibiotic use);
• if you suffer from constipation, stomach bloating, or intestinal obstruction.

If you are unsure whether any of the above conditions apply to you, consult your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Loperamide Grindeks hard capsules.

• Treatment with Loperamide Grindeks is only symptomatic and does not address the underlying cause. Whenever possible, appropriate treatment for the underlying condition should be initiated.
• Diarrhoea is associated with loss of fluids and electrolytes; therefore, special attention should be paid to replacing them, especially in children and frail or elderly individuals. Drink more fluids than usual to compensate for fluid loss and consult your doctor or pharmacist about rehydration therapy to restore lost electrolytes.
• Loperamide Grindeks does not replace antibacterial treatment for infectious diarrhoea.
• In cases of sudden acute diarrhoea, Loperamide Grindeks hard capsules usually relieve symptoms within 48 hours. If symptoms do not improve, stop taking the medicine and consult a doctor.
• Do not take Loperamide Grindeks hard capsules if your doctor has advised you to avoid treatments that slow intestinal motility. This may be the case, for example, if you suffer from constipation or bloating.
• If signs of abdominal distension occur during treatment for diarrhoea in patients with AIDS, stop taking Loperamide Grindeks hard capsules and consult a doctor.
• Consult your doctor if you have liver problems, as this may require closer medical supervision while taking Loperamide Grindeks hard capsules.

Use this medicine only for the specified indication (see section 1) and never take a dose higher than recommended (see section 3). In patients who have taken an excessive dose of loperamide, the active substance in Loperamide Grindeks, serious heart problems (with symptoms including rapid or irregular heartbeat) have been reported.
Other medicines and Loperamide Grindeks hard capsules
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Medicines that speed up or slow down gastrointestinal function may reduce the effect of Loperamide Grindeks.
The effect of desmopressin may be increased when Loperamide Grindeks is taken together with oral desmopressin (a medicine used to treat 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 immunodeficiency)
• 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 anxiety)
• opioid analgesics (used to treat severe pain), as they may increase the risk of severe constipation and central nervous system depression (e.g. drowsiness or reduced level of consciousness).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Loperamide Grindeks should be avoided during pregnancy, especially during the first trimester. If you are known or suspected to be pregnant, consult your doctor, who will decide whether you can take Loperamide Grindeks.
Breastfeeding
Small amounts may pass into breast milk. Talk to your doctor to determine an appropriate treatment.
Driving and using machines
If you feel tired, drowsy, or dizzy while taking Loperamide Grindeks hard capsules (or due to diarrhoea), you must not drive or operate machinery.
Loperamide Grindeks contains lactose
Each Loperamide Grindeks capsule contains 95 mg of lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Loperamide Grindeks

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, 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 stool.
The total daily dose must 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 stool.
The total daily dose must not exceed 4 capsules (8 mg).

Children under 12 years of age
Other loperamide-containing medicines may be more suitable for children aged between 2 and 12 years.
Do not use in children aged between 2 and 12 years without medical prescription.
Loperamide hydrochloride must not be administered to children under 2 years of age.

Elderly
Dose adjustment is not required in elderly patients.

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

Hepatic impairment
Medicines containing loperamide hydrochloride should be used with caution in patients with hepatic impairment. If you suffer from hepatic impairment, inform your doctor before taking Loperamide Grindeks hard capsules.

Method of administration
The capsules must be swallowed whole with liquid. The capsules must not be chewed due to their bitter taste. The capsules may be taken at any time of day, with or without food.

Duration of treatment
You must stop taking the medicine and contact your doctor if symptoms do not resolve within 48 hours.
The maximum duration of treatment is 48 hours.

If you take more Loperamide Grindeks than you should
If you take too much Loperamide Grindeks hard capsules, seek immediate medical advice from a doctor or go to a hospital. Symptoms may include: increased heart rate, irregular heartbeat, changes in heart rhythm (these symptoms may have potentially serious and life-threatening consequences), intestinal obstruction, constricted pupils (miosis), reduced sensitivity and responsiveness to stimuli (stupor), muscle rigidity, uncoordinated movements, drowsiness, dry mouth, abdominal discomfort, nausea, vomiting, constipation, difficulty urinating, and shortness of breath.

Compared to adults, children's reactions to high doses of loperamide hydrochloride are stronger. If a child takes an excessive amount of the medicine or shows any of the symptoms listed above, contact a doctor immediately.

If you forget to take Loperamide Grindeks
Do not take a double dose to make up for the missed capsule.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Treatment with loperamide hydrochloride is generally well tolerated; however, side effects such as constipation, bloating, or difficulty urinating may still occur even when instructions are followed.
Severe abdominal distension and intestinal blockage (ileus) have been reported with the use of loperamide hydrochloride. If you experience any of the symptoms described above, stop taking Loperamide Grindeks hard capsules immediately and consult a doctor.
Upper abdominal pain, abdominal pain radiating to the back, abdominal tenderness, fever, rapid pulse, nausea, and vomiting may occur; these may be symptoms of inflammation of the pancreas (acute pancreatitis). Frequency unknown (frequency cannot be estimated from the available data):
If you experience any of these symptoms, stop using the medicine and seek immediate medical attention.
Isolated cases of hypersensitivity reactions (angioedema) with swelling of the face, tongue, and throat, more severe skin symptoms, and skin disorders have also been reported with loperamide hydrochloride:

• Severe skin disorders with rash, skin peeling, and mucosal ulcers (Stevens-Johnson syndrome and toxic epidermal necrolysis).
• Acute inflammatory skin disease associated with blistering of the mucous membranes of the mouth and lips (erythema multiforme). If you notice any of the symptoms listed above, stop taking Loperamide Grindeks immediately and consult a doctor.

Adverse reactions reported in clinical trials and post-marketing
Common adverse reactions (may affect up to 1 in 10 people):

• headache, dizziness
• constipation, nausea, increased flatulence.

Uncommon adverse reactions (may affect up to 1 in 100 people)

• drowsiness
• abdominal pain, abdominal discomfort, dry mouth, vomiting, indigestion
• skin rash.

Rare adverse reactions (may affect up to 1 in 1,000 people)

• hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock), anaphylactoid reaction, angioedema
• loss of consciousness, reduced sensitivity and response to stimuli (stupor), decreased level of consciousness, increased muscle tone, coordination difficulties
• pupillary constriction
• abdominal distension
• intestinal obstruction (ileus), colon disease (megacolon, including toxic megacolon)
• tongue pain
• urticaria, pruritus
• difficulty urinating
• fatigue.

Various symptoms that may occur during treatment with Loperamide Grindeks are generally difficult to distinguish from symptoms associated with diarrhoea, such as nausea, abdominal pain, vomiting, fatigue, dizziness, drowsiness, dry mouth, flatulence, and loss of appetite.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

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 stated on the cardboard box after "Exp" and on the blister. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Loperamide Grindeks hard capsules contain

• The active substance is loperamide hydrochloride. Each hard capsule contains 2 mg of loperamide hydrochloride.
• The other components are: monohydrate lactose, maize starch, magnesium stearate (E572). Capsule shell: gelatin (E441), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), brilliant blue FCF (E133).

Description of the appearance of Loperamide Grindeks hard capsules and package contents
Hard gelatin capsules size N. 3 (approximately 16 mm × 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/Alu blisters, packed 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 Member States of the European Economic Area 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
Czech Republic Loperamide Grindeks
Croatia Loperamidklorid Grindeks 2 mg tvrde kapsule
Germany Loperamid Grindeks 2 mg Hartkapseln
Finland Loperamide Grindeks 2 mg kapselit, kovat
France LOPERAMIDE GRINDEKS 2 mg, gélule
Greece Loperamide Grindeks 2 mg Σκληρά καψάκια
Ireland Loperamide Grindeks 2 mg hard capsules
Italy Loperamide Grindeks
Netherlands Loperamide Grindeks 2 mg harde capsules
Poland Loperamide Grindeks
Portugal Loperamide Grindeks 2 mg cápsulas duras
Romania Loperamidă Grindeks 2 mg capsule
Slovakia Loperamid Grindeks 2 mg tvrdé kapsuly
Spain Loperamide Grindeks 2 mg cápsulas duras
Sweden Loperamide Grindeks 2 mg hårda kapslar
Hungary Loperamide Grindeks 2 mg kemény kapszula