Lopedium 2mg 10 Capsules

DESCRIPTION:

LOPEDIUM CAPSULES 2 MG. * 10

CATEGORY: MEDICINES

1. What is Lopedium and what it is used for?

Lopedium is used for the symptomatic treatment of a disorder ( diarrhea ) when it is not possible to treat the cause of diarrhea directly.

Prolonged administration of Lopedium requires medical observation.

2. What you need to know before taking Lopedium?

Do not take Lopedium:

-if you are allergic to looperamide hydrochloride or any of the other ingredients of this medicine (listed in section 6);

-in conditions where obstruction of peristalsis and bowel function should be avoided due to the risk of serious consequences. Such conditions are: feelings of swollen stomach, constipation and intestinal obstruction;

-in children under 2 years of age;

-in a disorder accompanied by fever and feces with impurities of blood and mucus (acute dysentery);

-in acute stroke of ulcerative colitis (ulcerative colitis);

-in bacterial inflammation of the intestines caused by intestinal bacteria that pass through the wall of the intestine (eg Salmonella, Shigella and Campylobacter);

-diarrhea occurring after taking expanse eye spectrum antibiotics (pseudomembranous colitis).

Loperamid hydrochloride should be taken as soon as constipation, abdominal weight, or intestinal obstruction develops.

Warnings and precautions

For certain conditions, Lopedium may only be used after consultation with your doctor. This also applies if you suffer from the aforementioned illnesses.

Talk to your doctor or pharmacist before taking Lopedium:

if the cause of your diarrhea cannot be affected. Lopedium stops diarrhea but does not eliminate the cause of it.

if you suffer from or have had liver disease, you may take Lopedium only after a doctor's consultation as the metabolism of the product is likely to be delayed and signs of relative overdose with the occurance of central nervous system intoxication is possible.

in case of loss of large amounts of fluids and electrolytes, especially in children. Applying an appropriate replacement therapy for liquids and salts (electrolytes) is the most important measure in the presence of diarrhea. Lopedium should not be given to children between 2 and 6 years of age without prescription and supervision.

if you are an AIDS patient and are being treated with Lopedium against diarrhea. At the earliest onset of swelling and abdominal pain, Lopedium should be discontinued and a doctor should be consulted. Separate cases of toxic megacolon have been reported in AIDS patients and infectious colitis, both viral and bacterial, treated with looperamide hydrochloride.

Do not take this product for anything other than that for which it is indicated to be used for (see section 1) and never take more than the recommended amount (see section 3). Serious heart problems (whose symptoms include a rapid or irregular pulse) have been reported in patients who have received too much looperamide, the active ingredient of Lopedium.

In acute diarrhea, if there is no improvement in 48 hours, the administration of Lopedium should be discontinued and medical attention sought.

Lopedium contains lactose. If you are known to be intolerant to some sugars, talk to your doctor before taking this product.

Children and adolescents

Children under 2 years of age should not be treated with looperamide hydrochloride medicines such as Lopedium.

Dosage in children aged between 2 and 6 years should be based on their body weight. Lopedium capsules are not suitable for children in this age group because of the high content of the active ingredient. For this purpose, there are other prescription medicines.

Other medicines and Lopedium

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

Loperamide levels in the blood may increase with concomitant administration with:

-medicines that suppress the body's own P-glycoprotein (eg quinidine, ritonavir, itraconazole and ketoconazole)

-medicines to lower blood lipids (gemfibrozil)

-medicines that suppress the activity of the stomach and intestines.

-Taking quinidine, verapamil or ketoconazole simultaneously with Lopedium causes respiratory depression.

Drugs that accelerate the transport of food or intestinal contents in the gastrointestinal tract may reduce the effect of loperamide.

Concomitant use of Lopedium with oral desmopressin (a synthetic analogue of the urinary depressant hormone vasopressin used in so-called diabetes) results in increased desmopressin concentration in the blood. The dose of desmopressin should be reduced as its effect may become too strong.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, talk to your doctor or pharmacist before taking this medicine.

Pregnancy

Lopedium is not recommended during pregnancy. Women who are pregnant or breast-feeding should consult their physician for appropriate treatment.

Breast-feeding

Do not take Lopedium if you are breast-feeding, as small amounts of loperamide may pass into breast milk. Ask your doctor for appropriate treatment.

Driving and using machines

Lupidity, dizziness or drowsiness may occur along with diarrhea treated with Lopedium. Therefore, caution is advised when driving and operating machines.

3. How to take Lopedium?

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.

The following dosage is recommended if your doctor has not prescribed a different Lopedium course of treatment. You must follow these instructions for use, otherwise Lopedium will not work properly.

Adults

Acute diarrhea: The recommended initial dose is 2 capsules (corresponding to 4 mg looperamide hydrochloride), followed by 1 capsule (2 mg) after each subsequent stool with a rare consistency.

Chronic diarrhea: The recommended initial dose is 2 capsules (4 mg); the initial dose is adjusted until you achieve 1-2 hard stools daily. This is usually achieved with a maintenance dose of 1-6 capsules (2 mg - 12 mg) of looperamide hydrochloride per day.

The maximum dose for acute and chronic diarrhea is 8 capsules (corresponding to 16 mg looperamide hydrochloride) per day and should not be exceeded.

Children and adolescents of 6 to 17 years of age

Acute diarrhea: The recommended initial dose is 1 capsule (corresponding to 2 mg looperamide hydrochloride), followed by 1 capsule (2 mg) after each subsequent stool with a rare consistency.

Chronic diarrhea: The recommended initial dose is 1 capsule (2 mg); the initial dose is adjusted until you achieve 1-2 hard discharges daily. This is usually achieved with a maintenance dose of 1-6 capsules (2 mg - 12 mg) of looperamide hydrochloride per day.

The maximum daily dose for acute and chronic diarrhea is 3 capsules (corresponding to 6 mg looperamide hydrochloride) per 20 kg body weight and should not be exceeded.

The total daily dose should not exceed a maximum of 8 capsules (corresponding to 16 mg looperamide hydrochloride).

Children under 2 years of age

Loperamid hydrochloride should not be used in children below 2 years of age.

Method of administration

For oral use.

Hard gelatin capsules are taken without chewing, along with some water.

If no clinical improvement is detected within 48 hours of starting treatment for acute diarrhea, the administration of Lopedium should be discontinued and a doctor should be consulted.

Lopedium should not be used for more than 4 weeks without medical supervision.

In the case of diarrhea, measures should be taken to recover liquids and electrolytes as the most important treatment method, especially in children.

If you take more Lopedium than you should

If you have received too much Lopedium, contact a doctor or a hospital for immediate medical attention. Symptoms may include: rapid heartbeat, irregular heartbeat, changes in heart rate (these symptoms may have potentially serious, life-threatening effects), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, or shortness of breath. The following complaints may be signs of overdosage with Lopedium (including relative overdose due to impaired liver function): a central nervous system disorder that may manifest itself in delayed thoughts or emotions (stupor) or narrow pupils. You may have constipation or intestinal obstruction.

Children respond more strongly to large amounts of Lopedium than adults. If a child has received too much of a product or has any of the symptoms described above, consult a doctor immediately. Children are more sensitive to the effects on the central nervous system than adults.

If symptoms of overdose occur, a doctor must be consulted. Treatment is directed to overcoming the symptoms of an overdose, with the existing naloxone antidote being used.

Note to the physician

The effect of lomoperamide is longer than that of naloxone, requiring re-administration of naloxone. The patient should be closely monitored for at least 48 hours to detect possible suppression of the central nervous system.

If it is imperative to remove the active ingredient residue from the stomach, a gastric lavage is performed.

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 everyone gets them.

The following undesirable effects have been reported with loperamide usage either in clinical trials or post-marketing.

The frequency of adverse reactions by frequency is as follows:

Very common: may affect more than 1 in 10 patients treated

Common: may affect up to 1 in 10 patients treated

Uncommon: may affect up to 1 in 100 patients treated

Rare: may affect up to 1 in 1,000 patients treated

Very rare: may affect up to 1 in 10,000 treated patients

Common: headache, dizziness, nausea, constipation, gas formation in the intestines.

Uncommon: drowsiness; pain, burning and abdominal discomfort (including cramps), stomach complaints, vomiting (nausea), indigestion, dry mouth, rash.

Rare: hypersensitivity reactions such as skin rashes, edema especially in the face and neck, anaphylactic shock, loss of consciousness, delayed thoughts and emotions (stupor), blurred consciousness, coordination disorder, increased blood pressure, narrow pupils, intestinal obstruction (ileus, paralytic ileus), feeling of weight and swelling of the abdomen, urinary retention, fatigue.

Not known: Allergic reactions, including severe allergic reactions, which cause difficulties in breathing or dizziness; increased muscle tension; abnormal swelling of the colon as a complication of a chronic inflammatory bowel disease (megacolon, toxic megacolon); burning of the tongue; severe skin disease with blistering (such as Steven-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme); swelling of the tongue or mucous membranes due to fluid retention in the tissues (angioedema); itching.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system.

As you report side effects, you can contribute to getting more information on the safety of this medicine.

5. How to store Lopedium

Keep out of the reach and sight of children.

Store in the original packaging in a dry place.

Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Package Contents and Additional Information

What Lopedium contains

The active substance is loperamide hydrochloride. Each hard gelatin capsule contains 2 mg of looperamide hydrochloride.

The other ingredients are: gelatin, lactose monohydrate, magnesium stearate, corn starch, talc, colorants - iron oxide, blue patent, and titanium dioxide.

Note for Diabetics:

1 hard gelatin capsule contains 0.01 carbohydrate units.

What Lopedium looks like and contents of the pack

Original packs containing 10 hard gelatin capsules