LOPERAMIDA 2 mg Hard Capsules
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How to use LOPERAMIDE GRINDEKS 2 mg HARD CAPSULES
Contents of the leaflet
- Introduction
- What is Loperamide Grindeks and what is it used for
- What you need to know before taking Loperamide Grindeks
- How to Take Loperamide Grindeks
- Possible Side Effects
- Storage of Loperamide Grindeks
- Package Contents and Additional Information
Introduction
Package Leaflet: Information for the User
Loperamide Grindeks 2 mg Hard Capsules
loperamide hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.
- Keep this leaflet, you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.
- You should consult a doctor if it worsens or does not improve after 2 days.
Contents of the Package Leaflet
- What is Loperamide Grindeks and what is it used for
- What you need to know before taking Loperamide Grindeks
- How to take Loperamide Grindeks
- Possible side effects
- Storage of Loperamide Grindeks
- Package Contents and Additional Information
1. What is Loperamide Grindeks and what is it used for
Loperamide Grindeks hard capsules contain the active substance loperamide hydrochloride, which hardens the stools and reduces the frequency and volume of bowel movements.
Loperamide Grindeks is used for the symptomatic treatment of sudden and short episodes of diarrhea (acute) in adults and adolescents over 12 years of age.
If it worsens or does not improve after 2 days, you should consult your doctor.
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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.
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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/
- Country of registration
- Dosage formCAPSULE, 2 mg
- ATC codeA07DA03
- Active substance
- Prescription requiredNo
- Manufacturer
- CompositionLACTOSA MONOHIDRATO (100 mg mg)
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to LOPERAMIDE GRINDEKS 2 mg HARD CAPSULESDosage form: TABLET, 2 mgActive substance: loperamideManufacturer: Uxa Farma S.A.Prescription not requiredDosage form: CAPSULE, 2 mg loperamide hydrochlorideActive substance: loperamideManufacturer: Laboratorios Cinfa S.A.Prescription not requiredDosage form: ORALLY DISINTEGRATING TABLET/LIOTAB, 2 mgActive substance: loperamideManufacturer: Laboratorios Cinfa S.A.Prescription not required
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Frequently Asked Questions
LOPERAMIDE GRINDEKS 2 mg HARD CAPSULES does not require a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
The active ingredient in LOPERAMIDE GRINDEKS 2 mg HARD CAPSULES is loperamide. This information helps identify medicines with the same composition but different brand names.
LOPERAMIDE GRINDEKS 2 mg HARD CAPSULES is manufactured by Grindeks As. Pharmacy brands and packaging may differ depending on the distributor.
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether LOPERAMIDE GRINDEKS 2 mg HARD CAPSULES is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.
You can buy LOPERAMIDE GRINDEKS 2 mg HARD CAPSULES in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.
To obtain a prescription, you can use Oladoctor:
Other medicines with the same active substance (loperamide) include ABECLIN 2 mg TABLETS, DIARFIN 2 mg HARD CAPSULES, DIARFIN FLAS 2 mg ORAL LYOPHILIZED. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
