2 mg / 125 mg tablets 
loperamide hydrochloride / dimethicone

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

– Save this information, you may need to read it again.

– Contact the pharmacy staff if you need more information or advice.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

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

In this leaflet: 
1. What Dimor Comp is and what it is used for 
2. What you need to know before you take Dimor Comp 
3. How to take Dimor Comp 
4. Possible side effects 
5. How to store Dimor Comp 
6. Contents of the packaging and other information 

1. What Dimor Comp is and what it is used for

The tablets are used to treat short-term attacks of diarrhea when it occurs together with stomach cramps, bloating, and gas in the intestine.

The tablets contain loperamide hydrochloride, which helps reduce diarrhea by slowing down an overactive gut. It also helps the body absorb more water and salts from the gut.

The tablets also contain dimethicone, which breaks down the gas that is trapped in the intestine and which causes stomach cramps and bloating.

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

2. What you need to know before taking Dimor Comp

Do not take Dimor Comp

• if you are a child under 12 years of age.

If you are allergic (hypersensitive) to loperamide hydrochloride, simethicone, or any of the other ingredients of the tablets (see section 6).

• if you have a high fever (above 38 ° C) or blood in the stool.

• if you have a relapse of inflammatory bowel disease such as ulcerative colitis.

• if you have severe diarrhea after taking antibiotics.

• if you are constipated or your stomach seems swollen.

Warnings and cautions

Talk to a doctor or pharmacist:

Dimor Comp only treats the symptom 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, r 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 powder products that 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 any purpose 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, one of the active ingredients in Dimor Comp.

Other medicines and Dimor Comp

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, as Dimor Comp may or may not affect you.

In particular, tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:

• Quinidine (used to treat abnormal heart rhythms or malaria )

Itraconazole or ketoconazole ( antifungal )

• Gemfibrozil (used to treat high cholesterol )

• Ritonavir (used to treat HIV – infection, and AIDS )

• Desmopressin (used to treat diabetes insipidus and bedwetting)

Pregnancy, breastfeeding, and 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 if you are breast-feeding, as small amounts of the medicine may pass into the milk. Talk to your doctor about appropriate treatment.

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 attention. 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.

Dimor Comp contains sodium.

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

3. How to take Dimor Comp

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

• For oral use (taken by mouth).

• Swallow the tablet whole with liquid.

• The breaker is only there to help you split the tablet if you have difficulty swallowing it whole.

Use for adults over 18 years of age

Take two tablets as a starting dose and then one tablet after each loose stool. Never take more than 4 tablets in one day. If you do not feel better after two days, stop taking the tablets and consult a doctor.

Use for young people between 12 and 18 years

Take one tablet as a starting dose and then one tablet after each loose stool. Never take more than 4 tablets in one day. If you do not feel better after two days, stop taking the tablets and consult a doctor.

Use for children

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

If you take more Dimor Comp than you should

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

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

If you forget to take Dimor Comp

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 including swelling of the face, tongue, or throat, difficulty swallowing, unexplained wheezing, shortness of breath 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 urinating

• Stomach pain or swollen stomach

• Severe constipation

Other side effects that may occur

Common side effects (less than 1 patient in 10 but more than 1 in 100 get these):

• Nausea, or a changed experience of how certain things taste

Uncommon side effects (less than 1 patient in 100 but more than 1 in 1,000 get these):

Drowsiness, constipation, rash

Other side effects:

• Vomiting, indigestion, constipation, flatulence, dizziness, unconsciousness, or decreased consciousness

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

5. How to store Dimor Comp

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 blister and carton. 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 (measured as 125 mg dimethicone per tablet).

The 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 the 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

Nordic Drugs AB

Box 300 35

200 61 Limhamn

Manufacturer

Laboratories Alcala Farma, SL

Avenida de Madrid 82

28802 Alcalá de Henares, Madrid

Spain

Disphar International BV

Winkelskamp 6

7255 PZ Hengelo (Gld)

Netherlands

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

NL: Losibere 2 mg / 125mg, tablets

SE: Dimor Comp 2 mg / 125 mg tablets

Muhammad Nadeem

Leave a Reply