LOPERAMIDE GRINDEKS 2 mg HARD CAPSULES

2. What you need to know before taking Loperamide Grindeks

Do not take Loperamide Grindeks

• if you are allergic to loperamide hydrochloride or to any of the other components of this medicine (listed in section 6).
• in the case of children under 2 years of age.
• if you have blood in your stools or high fever.
• if you have acute ulcerative colitis.
• if you have certain types of bacterial intestinal inflammation (Salmonella, Shigella, Campylobacter).
• if you have pseudomembranous intestinal inflammation (induced by antibiotics).
• if you have constipation, stomach swelling, or intestinal obstruction.

If you are not sure if you meet any of the above points, consult your doctor or pharmacist.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Loperamide Grindeks hard capsules.

• Treatment with Loperamide Grindeks is only symptomatic and does not solve the underlying cause. Whenever possible, the cause should be treated in all cases.
• Diarrhea is associated with loss of fluid and salts, so you should be careful to replace them, especially in children and fragile or elderly people. To replace fluids, drink them more frequently than usual, and ask your doctor or pharmacist for a rehydration treatment to replace lost salts.
• In infectious diarrhea, loperamide does not replace antibiotic treatment.
• In the case of sudden acute diarrhea, Loperamide Grindeks usually resolves symptoms within 48 hours. If not, stop taking the medicine and consult a doctor.
• Do not take Loperamide Grindeks hard capsules if your doctor has recommended avoiding treatments that reduce bowel movements. This could be the case, for example, if you experience constipation or abdominal fullness.
• In the event of signs of abdominal swelling during diarrhea treatment in patients with AIDS, it is recommended to interrupt treatment with loperamide Grindeks hard capsules and consult a doctor.
• If you have liver problems, inform your doctor, as you may need closer medical supervision while taking Loperamide Grindeks hard capsules.

Use the medicine only for the specified indication (see section 1) and never take a dose higher than the recommended dose (see section 3). There have been reports of serious heart problems (symptoms including rapid or irregular heartbeat) in patients who took too much loperamide, which is the active substance of Loperamide Grindeks hard capsules.

Other Medicines and Loperamide Grindeks

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Medicines that accelerate gastrointestinal activity may reduce the effect of loperamide.

The effect of desmopressin may increase when taking Loperamide Grindeks with oral desmopressin (a medicine used to treat a disease called central diabetes insipidus).

The following active substances may increase the blood concentration of loperamide hydrochloride:

• quinidine (used to treat and prevent heart rate problems)
• ritonavir and saquinavir (medicines used to treat immunodeficiency)
• itraconazole, ketoconazole (used to treat fungal skin infections)
• gemfibrozil (used to reduce blood lipids)
• St. John's Wort (hypericum; 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 decreased consciousness)

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

The use of loperamide should be avoided during pregnancy, especially during the first trimester. If you are pregnant or think you may be pregnant, consult your doctor. He will decide if you can take Loperamide Grindeks.

Breast-feeding

Loperamide may be excreted in breast milk in small amounts. Consult your doctor to find a suitable treatment.

Driving and Using Machines

If you feel tired, drowsy, or dizzy while taking Loperamide Grindeks hard capsules (or as a result of diarrhea), do not drive or use machines.

Loperamide Grindeks contains Lactose

Each Loperamide Grindeks capsule contains 95 mg of lactose. If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicine.

3. How to Take Loperamide Grindeks

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Recommended Dose

Adults

The initial dose is 2 capsules (4 mg), followed by 1 capsule (2 mg) after each diarrheal bowel movement.

The total daily dose should not exceed 6 capsules (12 mg).

Adolescents over 12 years

The initial dose is 2 capsules (4 mg), followed by 1 capsule (2 mg) after each diarrheal bowel movement. The total daily dose should not exceed 4 capsules (8 mg).

Children under 12 years

In the case of children between 2 and 12 years old, other medicines containing loperamide may be more suitable.

The use in children between 2 and 12 years old should be done under medical prescription.

The use of loperamide is not recommended in children under 2 years of age.

Elderly Patients

No dose adjustment is required in elderly patients.

Renal Impairment

No dose adjustment is necessary in patients with renal impairment.

Hepatic Impairment

Medicines containing loperamide 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 some liquid. The capsules should not be chewed due to their bitter taste. The capsules can be taken at any time of the day with or without food.

Duration of Treatment

If the symptoms do not resolve 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 take too much Loperamide Grindeks hard capsules, inform your doctor or go to the hospital immediately for assistance, you can also call the Toxicology Information Service, Phone 91 562 04 20 (indicating the medicine and the amount ingested). The symptoms may include: increased heart rate, irregular heartbeat, changes in heartbeat (these symptoms can have serious and potentially fatal consequences), intestinal obstruction, pupil constriction (miosis), decreased sensitivity and response to stimuli (stupor), muscle rigidity, lack of coordination, drowsiness, dry mouth, abdominal discomfort, nausea, vomiting, constipation, difficulty urinating, and shortness of breath.

Children respond more expressively to large amounts of loperamide hydrochloride than adults. If a child has taken too much medicine or shows any of the above symptoms, call a doctor immediately.

If you forget to take Loperamide Grindeks

Do not take a double dose to make up for the forgotten dose.

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.

Generally, treatment with loperamide is well tolerated. However, side effects may occur, such as constipation, flatulence, or difficulty urinating, even if the instructions are followed.

With the use of loperamide, constipation, more severe abdominal distension, and intestinal obstruction (ileus) may occur. If you experience any of the above symptoms, stop taking Loperamide Grindeks hard capsules immediately and contact a doctor.

Upper abdominal pain, abdominal pain radiating to the back, abdominal tenderness, fever, rapid pulse, nausea, vomiting may occur, which can be symptoms of pancreatitis (acute pancreatitis). The frequency is unknown (the frequency cannot be estimated from the available data).

If you experience any of these symptoms, stop taking the medicine and seek medical attention immediately.

Isolated cases of hypersensitivity reactions (angioedema) have also been reported, accompanied by swelling of the face, tongue, and throat, and more severe skin diseases and symptoms with the use of loperamide:

• Severe skin disease with rash, skin peeling, and ulcers in the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Acute inflammatory skin disease associated with the formation of blisters in the mucous membranes of the mouth and lips (erythema multiforme).

If you experience any of the above symptoms, stop taking Loperamide Grindeks immediately and contact a doctor.

Side Effects Reported in Clinical Trials and Post-Marketing

Common Side Effects (may affect up to 1 in 10 patients)

• headache, dizziness
• constipation, nausea, increased flatulence

Uncommon Side Effects (may affect up to 1 in 100 patients)

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

Rare Side Effects (may affect up to 1 in 1,000 patients)

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

During treatment with Loperamide Grindeks, several symptoms may appear that are difficult to distinguish from the symptoms associated with diarrhea, such as nausea, abdominal pain, vomiting, fatigue, dizziness, drowsiness, dry mouth, flatulence, and loss of appetite.

Reporting of Side Effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 ‘EXP’ and on the blister. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist or local waste disposal facilities. If you are unsure, ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Package Contents and Additional Information

Composition of Loperamide Grindeks

• The active substance is loperamide hydrochloride. Each hard capsule contains 2 mg of loperamide hydrochloride.
• The other ingredients are lactose monohydrate, corn starch, and magnesium stearate (E-572).

Capsule Shell: gelatin (E-441), titanium dioxide (E-171), red iron oxide (E-172), yellow iron oxide (E-172), brilliant blue FCF (E-133).

Appearance of the Product and Package Contents

Hard gelatin capsules No. 3 (approximately 16 mm × 6 mm), with a pink body and dark green cap, containing white powder.

Package sizes: cardboard box with PVC/Alu blisters of 6, 8, 10, 12, 18, or 20 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

AS GRINDEKS.

Krustpils iela 53, Riga, LV-1057, Latvia

Phone: (+371) 67083205

Fax: (+371) 67083505

Email: [email protected]

You can request more information about this medicine from the local representative of the Marketing Authorization Holder

Grindeks Kalceks España, S.L.

C/ José Abascal, 58 – 2º Dcha.

28003, Madrid, Spain

This medicine 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

????????? ???????? 2 mg ?????? ???????

Czech Republic Loperamide Grindeks

Croatia Loperamidklorid Grindeks 2 mg tvrde kapsule

Germany Loperamid Grindeks 2 mg Hartkapseln

Slovakia Loperamid Grindeks 2 mg tvrdé kapsuly

Spain Loperamida Grindeks 2 mg cápsulas duras

Finland Loperamide Grindeks 2 mg kapselit, kovat

France LOPERAMIDE GRINDEKS 2 mg, gélule

Greece Loperamide Grindeks 2 mg Σκληρ? καψ?κια

Netherlands Loperamide Grindeks 2 mg harde capsules

Hungary Loperamide Grindeks 2 mg kemény kapszula

Ireland Loperamide Grindeks 2 mg hard capsules

Italy Loperamide Grindeks

Poland Loperamide Grindeks

Portugal Loperamide Grindeks 2 mg cápsulas duras

Romania Loperamida Grindeks 2 mg capsule

Sweden Loperamide Grindeks 2 mg hårda kapslar

Date of the Last Revision of this Leaflet:April 2023.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/