Imolopesim – Loperamide hydrochloride / Dimethicone uses, dose and side effects


2 mg / 125 mg tablets
loperamide hydrochloride / dimethicone

1. What Imolopesim is and what it is used for

Imolopesim is used to treat temporary diarrhea when the diarrhea is associated with stomach cramps, bloating, and flatulence.

The tablets contain two active substances:

  • loperamide hydrochloride, which helps reduce diarrhea by normalizing excessive bowel movements. It also helps the body absorb more water and salts from the gut.
  • dimethicone, which dissolves the gas that is trapped in the intestine and which causes stomach cramps and bloating.

Imolopesim is used in adults and adolescents over 12 years of age.

You must talk to a doctor if you do not feel better or if you feel worse after two days.

Loperamide hydrochloride/dimethicone (simethicone) contained in Imolopesim may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before taking Imolopesim

Do not take Imolopesim

  • to a child under 12 years of age.
  • if you are allergic to loperamide hydrochloride, dimethicone (simethicone) or any of the other ingredients of this medicine (listed in section 6).
  • if you have a high fever (eg above 38 ° C) or blood in the stool.
  • if you have a flare-up of inflammatory bowel disease such as ulcerative colitis .
  • if you have severe diarrhea after using antibiotics .
  • if you are constipated or your stomach appears to be swollen.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Imolopesim:

  • Imolopesim only treats the symptoms of diarrhea. In some cases, the cause of your diarrhea may require treatment. If symptoms persist or worsen, consult your doctor.
  • If you have severe diarrhea, because your body loses more fluid, sugar and salts than normal. You need to replace the fluid by drinking more fluid than usual. Ask your pharmacy staff about special liquid substitutes to replace sugar and salts.
  • If you have AIDS and your stomach swells, stop taking the tablets immediately and contact your doctor.
  • If you have liver disease, you should consult your doctor before using the tablets. Some of the side effects can be more bothersome.

Do not take this medicine for anything other than its intended use (see section 1) and never take more than the recommended dose (see section 3). Severe heart problems (with symptoms such as fast or irregular heartbeat) have been reported in patients who have taken too much loperamide, the active substance in Imolopesim.

In case of temporary diarrhea, the symptoms usually stop within 2 days. If symptoms persist after that period, discontinue treatment and consult a physician.

Other medicines and Imolopesim

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

  • Quinidine (used to treat abnormal heart rhythm or malaria )
  • Itraconazole or ketoconazole ( antifungal )
  • Gemfibrozil (used to treat high cholesterol )
  • Ritonavir (used to treat HIV – infection and AIDS )
  • Desmopressin (used to control thirst and urine output in patients with diabetes insipidus )

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, as Imolopesim may interact with you.

Pregnancy, fertility

  • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.


  • Do not take this medicine without consulting a doctor if you are breast-feeding, as small amounts of the medicine may pass into the milk.

Driving and using machines

This medicine may make you feel dizzy, tired, or drowsy. If you notice this, do not drive or use any machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Imolopesim contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free.

3. How to take Imolopesim

Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.

  • Swallow the right number of tablets whole with water.
  • Do not use more than the recommended dose .
  • The notch is only for you to be able to divide the tablet if you have difficulty swallowing it whole. 

Use for adults over 18 years

Take 2 tablets first and then 1 tablet after each loose stool. Take a maximum of 4 tablets per day for a maximum of 2 days. If you do not get better after 2 days, stop taking the tablets and contact your doctor.

Use for young people between 12 and 18 years

Take 1 tablet first and then 1 tablet after each loose stool. Take a maximum of 4 tablets per day for a maximum of 2 days. If you do not get better after 2 days, stop taking the tablets and contact your doctor.

Use for children and adolescents under 12 years of age

Do not give the tablets to children under 12 years of age.

If you take more Imolopesim than you should

If you take more Imolopesim than you should, contact your doctor or hospital immediately for advice. Symptoms may include increased heart rate, irregular heartbeat, changes in a heartbeat (these symptoms can potentially have serious, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, or poor breathing. You may become dry in the mouth or have reduced pupils. You may have a stomach ache, feel sick or vomit or become constipated.

Children react more strongly than adults to large amounts of Imolopesim. Contact a doctor immediately if a child has ingested too much of the medicine or has any of the above symptoms.

If you have ingested too much medicine or if e.g. a child inhaled the medicine accidentally contact a doctor, hospital, or the Poison Information Center for risk assessment and advice

If you forget to take Imolopesim

Take one tablet after the next loose stool.

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

If you get any of the following side effects, stop using the medicine and seek medical advice immediately:

Allergic reactions to the symptoms

  • swelling of the face, tongue or throat
  • difficulty swallowing
  • inexplicable hissing sound when breathing, shortness of breath that may be accompanied by skin rash or hives.

If you get any of the following side effects, stop using this medicine and talk to your doctor:

  • Difficulty throwing water
  • Severe abdominal pain, bulging or swollen stomach or fever which may be a sign of blocked or enlarged bowel
  • Severe constipation.

Other side effects that may occur

Common side effects (may affect up to 1 in 10 people):

  • Headache, nausea, or a changed experience of how certain things taste.

Uncommon side effects (may affect up to 1 in 100 people):

  • Drowsiness, dizziness, weakness, constipation. 
  • vomiting, indigestion, flatulence, dry mouth , rash. 

Rare side effects (may affect up to 1 in 1,000 people):

  • Unconsciousness or decreased level of consciousness, small pupils , skin rash that can lead to severe blistering and skin detachment, hives, itching , fatigue. 

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Imolopesim

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. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substances are:

Loperamide hydrochloride (2 mg per tablet) and simethicone equivalent to 125 mg dimethicone per tablet.

Other ingredients are:

microcrystalline cellulose (E460), sodium starch glycolate, hypromellose (E464), povidone (E2101), calcium phosphate (E341), mannitol (E421), and magnesium stearate (E572).

What the medicine looks like and contents of the pack

The tablets are white to off-white capsule-shaped tablets with “LO-SI” debossed on one side and “2” and “125” debossed on the other side, on either side of a breaker.

Each pack contains 6, 8, 10, 12, 15, or 16 tablets in blister strips.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Orifarm Generics A / S

Energivej 15

5260 Odense S


Local representative:

Orifarm Generics AB,

Box 56048

102 17 Stockholm

This medicinal product is authorized under the European Economic Area under the names:

NL: Losidaru

DK: Imolopesim

SE: Imolopesim

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