Imomed 2 mg (10 tablets)

Side effects:

IMOMED is well tolerated and side effects are unlikely to occur if the product is taken as directed.

Gastrointestinal disorders:

• nausea, abdominal cramps, dry mouth, constipation, flatulence, dyspepsia. Very rare: intestinal obstruction and concomitant colon enlargement as a complication of chronic inflammatory bowel disease (toxic megacolon).

Nervous system disorders:

• headache, fatigue, dizziness.

Immune system disorders:

• hypersensitivity reactions such as skin rash, angioneurotic edema, anaphylactic shock.

Skin and subcutaneous tissue disorders:

• Very rare: bullous rash, including Stephen-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis If you notice side effects not listed in this leaflet, please inform your doctor. He will decide what measures need to be taken.

Before taking:

You should not take Imomed in the following cases:

• hypersensitivity to any of the ingredients;
• conditions in which bowel function should be avoided, such as bloating, constipation and intestinal entanglement;
• disorder accompanied by fever and / or bloody stools;
• a  disorder in which inflammation of the colon has been found (ulcerative colitis or pseudomembranous colitis resulting from antibiotic treatment);
• Imomed is not recommended for use in children under 12 years of age.

Before starting treatment with Imomed, pay special attention:

A significant amount of fluid and electrolytes are lost in the disorder. Therefore, you need to compensate for this loss by drinking a lot more fluids than you would normally. This is especially true for children.

In acute diarrhea, IMOMED is discontinued for up to 48 hours. If there is no effect, stop the medicine and talk to your doctor. In case of impaired liver function, inform your doctor.

You may need strict medical supervision during treatment with Imomed. No dose adjustment is required in patients with renal disease, as most of the drug is excreted in the faeces.

Use in children:

Imomed is given to children over the age of twelve, but not more than 4 tablets in 24 hours.

Pregnant:

There are no adequate data from the use of the product in pregnant women, therefore Imomed should not be used during pregnancy. It is recommended that you do not take Imomed during breast-feeding, as small amounts pass into your breast milk.

Driving and using machines:

To date, no effects on the ability to drive and use machines have been known. Because diarrhea can cause fatigue, dizziness, or drowsiness, caution is advised when driving or using machines.

IMOMED tablets 2 mg * 10 SOPHARMA

Package leaflet: information for the user

IMOMED 2 mg tablets IMOMED 2 mg tablets

Loperamide
hydrochloride

Read all of this leaflet carefully before you start 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 told you.

• Keep this leaflet. You may have to read it again.
• If you need further information or advice, ask your
• pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If after two days you do not feel better or your condition worsens, you should seek medical attention.

What is in this leaflet:

1. What Imomed is and what it is used for

2. What you need to know before you take Imomed

3. How to take Imomed

4. Possible side effects

5. How to store Imomed

6. Contents of the pack and other information

1. What Imomed is and what it is used for

Imomed is an antidiarrheal drug that is used to harden bowel movements and reduce the frequency of defecations. You could take Imomed for sudden (acute) diarrhoea or for long-lasting (chronic) diarrhoea.

It is also used in case of diarrhea after surgical removal of part of the intestine.

2. What you need to know before you take Imomed

Do not take Imomed:

• if you are allergic to the active substance or any of the other ingredients (listed in section 6);
• in a condition called delayed passage through the intestines. An example of such a condition are: swollen abdomen or constipation;
• if blood is present in your stool or if you have a fever; if you have been found to have inflammation of the lower abdomen (such as ulcerative colitis or pseudomembranous colitis after antibiotic treatment);
• in the case of bacterial enterocolitis caused by microorganisms such as salmonella, shigella and campylobacter;
• in children under 6 years.

Warnings and precautions

Although Imomed discontinues diarrhea, the preparation does not eliminate the causes of its occurrence. Whenever possible, it is also necessary to carry out treatment of the causes of diarrhea.

In case you have diarrhea, you should know that you are losing a significant amount of fluid. Therefore, you should compensate for the loss through increased fluid intake. This is especially true for children. Your pharmacist may prescribe a special powder containing sugar and salts. After adding it to water, it will also replace the salt losses incurred due to diarrhea. The solution is especially suitable for children.

In a sudden (acute) attack of diarrhoea, Imomed usually discontinues symptoms for 48 hours. Otherwise, stop taking the medicine and see your doctor.

If you have AIDS and are being treated for diarrhoea with Imomed, if any signs of bloating occur, stop taking Imomed immediately and tell your doctor.

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

If liver function is impaired, tell your doctor. You may need close medical supervision when treated with Imomed.

Children

Children under 6 years of age should not be treated with Imomed due to the high content of loperamide hydrochloride.

Other medicines and Imomed

Tell your doctor in case you are taking medicines that slow down the peristalsis of the stomach and intestines (for example, anticholinergic preparations), as these agents may enhance the effect of Imomed.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This also includes medicines you buy without a prescription, or herbal remedies.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• ritonavir (used to treat HIV);
• quinidine (used to treat heart rhythm disturbances);
• desmopressin oral form (used to treat excessive urination);
• itraconazole or ketoconazole (used to treat fungal infections);
• gemfibrozil (used to lower cholesterol).

Imomed with food, drink and alcohol

Tablets should be taken with liquid.

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.

It is recommended not to take Imomed during breastfeeding, as small amounts pass into breast milk.

Driving and using machines

Imomed has no influence on driving and using machines. Along with diarrhea, fatigue, dizziness or drowsiness may be observed. Therefore, caution should be exercised when driving or using machines.

Imomed contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Imomed

Always take Imomed as recommended in this leaflet. Imomed is available in the form of tablets for oral use. Imomed can be applied at any time of the day. Tablets should be taken with liquid.

If you are not sure, contact your doctor or pharmacist.

Dosage

Acute diarrhoea

Children over 6 years of age – the initial dose is 1 tablet (2 mg) Adults – the starting dose is 2 tablets (4 mg)

Treatment continues by taking 1 tablet (2 mg) after each diluted stool.

Chronic diarrhea

Children over 6 years of age – the initial dose is 1 tablet (2 mg) Adults – the starting dose is 2 tablets (4 mg)

This starting dose can be changed to achieve 1-2 shaped stools per day, which is usually achieved with a maintenance dose of B6 (2-12 mg) tablets daily.

The maximum dose for acute and chronic diarrhea is 8 (16 mg) tablets per day in adults; In children, the dose should be based on body weight (3 tablets/20 kg), but should not exceed the dose of 8 tablets per day.

Caution: do not take more than 8 tablets in 24 hours!

If you take more Imomed than you should

If you take more Imomed than you should, see your doctor, especially if you have any of the following symptoms: fast heartbeat, irregular heartbeat, changes in pulse (these symptoms can have potentially serious life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating or low breathing.

The reaction of children to high doses of Imomed is more pronounced than adults. If your child has taken more or is experiencing any of these symptoms, see your doctor immediately.

Information for the doctor in case of overdose:

• Inject naloxone.
• If necessary, re-inject naloxone after 1-3 hours.
• If necessary, monitor the patient’s condition for at least the next 48 hours.

If you forget to take Imomed

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Seek medical attention immediately in case of:

• Sudden swelling of the face, lips or throat, hoarse voice, shortness of breath, hives (or urticaria), severe irritation, redness or blistering on the skin. These may be signs of severe hypersensitivity or an allergic reaction;
• Excessive fatigue, inability to move in a coordinated way, loss of consciousness;
• Severe stomach pain, bloating, or fever, which may be due to a blockage or enlargement of the intestines.

Not known (cannot be estimated from the available data) Upper abdominal pain, abdominal pain that passes to the back, sensitivity to the touch of the abdomen, fever, rapid heartbeat, nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis).

If you experience any of the side effects listed above, stop taking the medicine and seek medical help immediately.

Consult a doctor as soon as possible in the event of:

• Dry mouth, indigestion, stomach pain, discomfort or bloating, nausea, vomiting, flatulence, constipation;
• Headache, dizziness, drowsiness or fatigue, feeling weak;
• Rash;
• Urinary retention (inability to urinate or empty the bladder completely);
• Shrinkage of the pupils.

Very rare (affects less than 1 in 10,000 people)

Hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock) and anaphylactoid reaction, coordination disorder, depressed level of consciousness, hypertension, loss of consciousness, drowsiness, stupor, myosis (narrowing of the pupil of the eye), ileus (intestinal obstruction), megacolon (enlargement of the large intestine), angiodema (edema), bullous rash including Stephen-Johnson syndrome, toxic epidermal necrolysis (extensive areas of skin necrosis combined with toxic manifestations), urticaria, itching, urinary retention, fatigue.

Reporting of adverse reactions

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Imomed

Keep out of the reach of children.

Store below 25°C.

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Imomed contains

• The active substance is loperamide hydrochloride. Each tablet contains 2 mg loperamide hydrochloride.
• The other ingredients are: cornstarch, lactose monohydrate, povidone, brilliant blue FCF, quinoline yellow, magnesium stearate, talc, silica colloidal anhydrous, sodium starch glycolate.

What Imomed looks like and contents of the pack

Pale green in color, biconvex tablets with a diameter of 7 mm. Original package containing one blister with 10 tablets.

Marketing Authorisation Holder

SOPHARMA AD, Bulgaria

Manufacturer

SOPHARMA AD, Bulgaria