2 mg film-coated tablets 
loperamide hydrochloride

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

Some packs of this medicine are over-the-counter so that you can counteract minor ailments without medical attention. Dimor must nevertheless be used with caution to achieve the best result.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. See section 4.
  • If you buy Dimor without a prescription, you must talk to a doctor if you do not feel better or if you feel worse after 2 days.

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

1. What Dimor is and what it is used for

Dimor normalizes bowel movements, counteracts fluid loss, and increases the ability to hold stools.

Dimor is used in temporary ( acute ) diarrhea. Dimor can also be prescribed by a doctor for other uses such as prolonged ( chronic ) diarrhea and in the “bag on the stomach” ( stoma ) after certain gastrointestinal surgeries or in case of inability to hold the stool (feces incontinence).

If you bought Dimor without a prescription, you must talk to a doctor if you do not feel better or if you feel worse after 2 days.

2. What you need to know before you take Dimor

Do not take Dimor

  • if you are allergic to loperamide or any of the other ingredients of this medicine (listed in section 6),
  • to children under 12 years,
  • if you have a high fever or blood in the stool ( acute dysentery),
  • in acute symptoms of inflammation of the colon ( ulcerative colitis ),
  • in inflammation of the small and large intestine caused by invasive bacteria, including Salmonella, Shigella, and Campylobacter,
  • in inflammation-like conditions of the colon caused by antibiotics(pseudomembranous colitis ),
  • if the passage of food through the intestine is already slow, for example in case of constipation or distended abdomen.

Warnings and cautions

– 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 rapid or irregular heartbeat) have been reported in patients taking too much loperamide, the active substance in Dimor.

– Treatment with Dimor relieves symptoms but does not cure the cause. Before long-term treatment, the underlying disease must therefore be investigated and treatment against this put in the first place.

– If temporary diarrhea has not stopped after 2 days of treatment, discontinue treatment and consult a doctor.

– If you have impaired liver function, you should consult a doctor before starting treatment with Dimor.

– In diarrhea, the body loses more fluid and salts than normal. Children, in particular, are susceptible to dehydration. Replace fluid loss by drinking plenty of fluids. Do not give Dimor to children under 12 years of age without a doctor’s prescription.

– If you have AIDS and your stomach swells, stop taking the tablets immediately and contact a doctor.

Children

Dimor should not be given to children under 12 years of age.

Other medicines and Dimor

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

Some medicines can affect or be affected by treatment with Dimor if taken at the same time. Examples of such drugs are

  • quinidine ( antiarrhythmic agent),
  • ritonavir (anti-HIV / AIDS drug),
  • itraconazole and ketoconazole ( antifungal ),
  • gemfibrozil and cholestyramine (antihypertensive agents),
  • desmopressin (anti-bedwetting agent and disease caused by a lack of production of antidiuretic hormone, so-called diabetes insipidus ).

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

Experience with the use of Dimor during pregnancy is limited. Talk to your doctor before using Dimor during pregnancy.

Breast-feeding

Do not take Dimor if you are breast-feeding. Small amounts of the drug may pass into breast milk.

Driving and using machines

Fatigue, dizziness, and drowsiness may occur during treatment with Dimor.

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.

Dimor contains lactose

Dimor contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Dimor

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.

In case of temporary diarrhea

The usual dose for adults: Start with 2 tablets. If diarrhea has not stopped within 2-3 hours, take 1 tablet after each loose stool. Take a maximum of 8 tablets per day. Use Dimor for a maximum of 2 days in a row. Doctors may have prescribed another dosage 

In chronic diarrhea

Dose one is determined by the doctor, who adjusts it individually for you.

The usual dose for adults: 1-8 tablets per day. Take a maximum of 8 tablets per day.

The tablets should be swallowed whole with half a glass of water.

Use for children

Dimor should not be given to children under 12 years of age.

If you take more Dimor 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. 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

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

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.

Stop taking Dimor and contact a doctor immediately if you get any of the following symptoms:

  • swelling of the face, tongue, or throat, difficulty swallowing or hive,s and difficulty breathing. This is a sign of angioedema.
  • extreme fatigue, coordination problems, and loss of consciousness or loss of consciousness.
  • severe abdominal pain and/or swollen stomach which may be a sign of blocked or enlarged bowel.
  • Lyell’s syndrome ( toxic epidermal necrolysis ): Severe widespread skin damage (dermal detachment of the epidermis and superficial mucous membranes).
  • Stevens-Johnson syndrome: An extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as genitals.

The following adverse reactions have been reported from clinical trials:

Common (affects more than 1 user in 100): constipation, nausea, flatulence/gas, headache, and dizziness.

Uncommon (affects less than 1 in 100 people): abdominal pain or discomfort, dry mouth, vomiting, indigestion, and rash.

The following side effects are reported after marketing:

Hypersensitivity reactions (such as anaphylactic shock ), drowsiness, muscle stiffness, high blood pressure, small pupils, itching, hives, and difficulty urinating.

5. How to store Dimor

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 expiry date refers to the last day of that month.

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 substance is loperamide hydrochloride. Each tablet contains 2 mg of loperamide hydrochloride.
  • The other ingredients are maize starch, lactose monohydrate 42.8 mg, microcrystalline cellulose, copovidone, colloidal anhydrous silica, magnesium stearate, hypromellose, macrogol 6000, simethicone emulsion (containing dimethicone, silicon dioxide, methylcellulose, sorbic acid, and water).

What the medicine looks like and the contents of the pack

Dimor tablets are white and round, marked with an “L” on one side. Diameter: 7 mm.

Blister packs: 16, 40 x 1 and 100 x 1 tablets.

Plastic jar: 500 tablets (only for dose dispensing and hospital use).

Marketing Authorisation Holder

Nordic Drugs AB

Box 300 35

200 61 Limhamn

Manufacturer

Merckle GmbH, Blaubeuren, Germany

Muhammad Nadeem

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