You can take Imodium and Amoxicillin together

Imodium acute lingual

Patient information for Imodium acute lingual

1. What is Imodium acute lingual and what is it used for?

1.1 What are the properties of the medicinal product?

Imodium akut lingual contains the active ingredient loperamide, a drug from the group of so-called antidiarrheal and motility inhibitors.

Loperamide is usually used in salt form as loperamide hydrochloride.

Imodium akut lingual is only available in pharmacies and without a prescription.

1.2 Effective strength and dosage form of Imodium acute lingual

- Orodispersible tablets containing 2 mg loperamide hydrochloride.

Your doctor or your pharmacist will advise you whether this strength and dosage form are suitable for your treatment.

1.3 Imodium acute lingual is used for

2. What should you watch out for before you take Imodium acute lingual?

2.1 Imodium acute lingual must not be taken

- if you are allergic to loperamide hydrochloride, levomenthol or any of the other ingredients of this medicine.

- by children under 12 years of age.

- if you suffer from conditions in which slow bowel movements should be avoided, e.g. B. distended abdomen, constipation and intestinal obstruction suffer. Imodium akut lingual must be discontinued immediately if constipation, distended abdomen or intestinal obstruction (ileus) occurs.

- if you have diarrhea with a fever and / or bloody stool.

- if you have diarrhea that occurs while or after taking antibiotics.

- if you suffer from chronic diarrheal diseases. (These diseases may only be treated with loperamide hydrochloride if prescribed by a doctor.)

- if you have an acute flare-up of ulcerative colitis (inflammation of the colon).

2.2 Special care is required when taking Imodium acute lingual

Imodium akut lingual may only be taken as directed by a doctor if there is a liver disease or has been through it, because severe liver disease can delay the breakdown of loperamide and increase the risk of side effects.

Talk to your doctor or pharmacist before taking Imodium acute lingual if you have AIDS and take Imodium acute lingual to treat diarrhea for acute diarrhea. You should stop taking Imodium akut lingual in acute diarrhea at the first signs of a bloated body and consult your doctor. There are individual reports of constipation with an increased risk of severe inflammatory enlargement of the colon (toxic megacolon) in AIDS patients. These suffered from an infectious colon inflammation (colitis) caused by viral and bacterial pathogens and were treated with loperamide hydrochloride.

if you suffer from liver disease, consult your doctor before taking.

Make sure there is sufficient replacement of liquids and salts (electrolytes). This is the most important treatment measure for diarrhea, as it can lead to a large loss of fluid and salt. This is especially true for children.

Imodium akut lingual leads to the termination of the diarrhea, whereby the cause is not eliminated. If possible, the cause should also be treated. Therefore speak to your doctor.

The recommended dosage of Imodium acute lingual and the duration of use of 2 days must not be exceeded because severe constipation can occur.

If the diarrhea persists after 2 days of treatment with Imodium acute lingual, Imodium acute lingual must be discontinued and a doctor must be consulted.

Note on excipients: This medicine contains aspartame as a source of phenylalanine and can be harmful if you have phenylketonuria.

2.2.a) Children

Children under 2 years of age must not be treated with drugs containing loperamide.

Children between 2 and 12 years of age may only be treated with drugs containing loperamide as prescribed by a doctor. Due to its high active ingredient content, Imodium acute lingual is not suitable for this age group for acute diarrhea. For this purpose, other dosage forms are available according to a doctor's prescription.

2.2.b) Elderly patients

There are no special precautions.

2.2.c) Pregnancy

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

Even if no clear indications of a teratogenic effect were found in a limited number of women (approx. 800) who took the active ingredient of Imodium acute lingual during pregnancy, you should not take Imodium acute lingual during pregnancy.

2.2.d) Breastfeeding

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

Since small amounts of the active ingredient in Imodium Akut can pass into breast milk lingually, you should not take Imodium Akut lingually during breastfeeding.

2.2.e) Ability to drive and use machines

Diarrhea or as a result of taking Imodium acute lingual can lead to dizziness, tiredness and sleepiness. Therefore, caution is advised in traffic and when working with machines.

2.3 Which interactions with other medicinal products have to be considered?

Please inform your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines, including medicines obtained without a prescription.

In particular, please talk to your doctor if you have to take one or more of the following active ingredients regularly or occasionally:

- ritonavir (used to treat HIV infection),

- itraconazole, ketoconazole (medicines used to treat a fungal infection),

Quinidine (used to treat irregular heartbeat),

- gemfibrozil (medicine used to treat high blood lipids),

- Desmopressin (used to treat excessive urination).

It is to be expected that drugs with a mechanism of action similar to Imodium Akut can increase its effect lingually and drugs that accelerate gastrointestinal transit may reduce its effect.

2.4 What should be thought of when taking Imodium akut lingually together with food, beverages and tobacco?

There are no special precautions.

3. How to take Imodium acute lingually?

Always take Imodium acute lingual exactly as your doctor has told you. Please ask your doctor or pharmacist if you are not sure.

3.1 Type and duration of application

Imodium akut lingual is placed on the tongue. The orodispersible tablet dissolves immediately on the tongue and is swallowed with the saliva. No further fluid intake is required.

To remove the orodispersible tablet, completely remove the foil strip on the back of the blister. Do not push the orodispersible tablet through the blister as this may damage it.

Do not take Imodium acute lingual for more than 2 days without medical advice.

If the diarrhea persists after 2 days of treatment with Imodium acute lingual, Imodium acute lingual must be discontinued and a doctor should be consulted.

Treatment with drugs containing loperamide for more than 2 days may only be carried out under medical prescription and monitoring of the course.

Please talk to your doctor or pharmacist if you have the impression that the effect of Imodium acute lingual is too strong or too weak.

3.2 Unless otherwise prescribed by the doctor, the usual dose is

3.2.a) Adults

At the beginning of the treatment of acute diarrhea, 2 orodispersible tablets (equivalent to 4 mg loperamide hydrochloride), then 1 orodispersible tablet (equivalent to 2 mg loperamide hydrochloride) after each unformed stool:

First dose: 2 orodispersible tablets (= 4 mg loperamide hydrochloride) 1 orodispersible tablet.

Repeat dose: 1 orodispersible tablet (= 2 mg loperamide hydrochloride).

A daily dose of 6 orodispersible tablets (equivalent to 12 mg loperamide hydrochloride) must not be exceeded.

3.2.b) Young people aged 12 and over

At the beginning of the treatment of acute diarrhea and after each unformed stool 1 orodispersible tablet (equivalent to 2 mg loperamide hydrochloride):

First dose: 1 orodispersible tablet (= 2 mg loperamide hydrochloride) 1 orodispersible tablet.

Repeat dose: 1 orodispersible tablet (= 2 mg loperamide hydrochloride).

A daily dose of 4 orodispersible tablets (equivalent to 8 mg loperamide hydrochloride) must not be exceeded.

3.3 If you have taken more Imodium lingually than you should

See a doctor as soon as possible, especially if you experience any unusual symptoms (see notes for the doctor).

Notes to physician: CNS depression such as stupor (rigidity of the body), abnormal coordination, somnolence (sleepiness), miosis (pupil constriction), increased muscle tone and respiratory depression may be signs of loperamide hydrochloride overdose (including relative overdose due to hepatic dysfunction) (Decreased breathing) as well as constipation, ileus and urinary retention occur. Children may be more sensitive to the effects of the CNS than adults.

The treatment depends on the symptoms of overdose and the clinical picture.

With medical follow-up, the opioid antagonist naloxone can be used as an antidote. Since loperamide has a longer duration of action than naloxone, repeated administration of naloxone may be indicated. The patient should therefore be closely monitored for at least 48 hours in order to detect a possible (re) occurrence of overdose symptoms. Gastric lavage can be carried out if necessary to remove any drug residues that are still in the stomach.

3.4 If you forget to take Imodium acute lingual

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

3.5 Effects of acute lingual discontinuation of Imodium treatment

If you want to stop the treatment, please discuss this with your doctor or pharmacist beforehand.

4. What are the possible side effects?

Like all medicines, Imodium acute can cause lingual side effects, although not everybody gets them.

When evaluating side effects, the following frequencies are used as a basis:

- very common: more than 1 in 10 people

- common: less than 1 in 10, but more than 1 in 100 patients

- uncommon: less than 1 in 100, but more than 1 in 1,000 patients

- rarely: less than 1 in 1,000 but more than 1 in 10,000 people treated

- very rare: less than 1 in 10,000 patients, including isolated cases

- Frequency not known: frequency cannot be calculated from the available data

4.1 Which side effects can occur in detail?

Clinical Trial Data: The most commonly reported adverse reactions in clinical trials were constipation, gas, headache, nausea, and dizziness.

The following side effects have been observed in clinical trials and in the post-marketing setting:

4.1.a) Often

Constipation, nausea, gas, dizziness, headache.

4.1.b) Occasionally

Drowsiness, gastrointestinal pain and discomfort, dry mouth, upper abdominal pain, vomiting, indigestion, rash.

4.1.c) Rarely

Hypersensitivity reactions, anaphylactic reactions (including anaphylactic shock), anaphylactoid reactions, unconsciousness, rigidity of the body, clouding of consciousness, hypertension, muscle stiffness, incoordination, pupillary constriction, intestinal obstruction (ileus, including paralytic ileus), enlargement of the large intestine (megacolon, including toxic pain), megacolon, including pain on the surface of the tongue, bloated stomach, blistering skin diseases (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme), swelling of the skin or mucous membranes due to fluid accumulation in the tissue (angioedema), hives, itching, urinary retention, tiredness.

Some patients reported a temporary burning or tingling sensation on the tongue immediately after taking Imodium akut lingual.

4.2 What countermeasures should be taken if side effects occur?

Let your doctor know if you experience any side effects. He will decide on possible measures.

If you experience a sudden or severe side effect, inform a doctor immediately, as certain drug side effects (e.g. excessive drop in blood pressure, hypersensitivity reactions) can under certain circumstances have serious consequences. In such cases, do not continue to take the medicine without doctor's advice.

Tell your doctor or pharmacist if you notice any side effects not listed here or in the package insert.

5. How should Imodium be stored acute lingually?

Store the medicine at normal room temperature and keep the medicine in the original packaging away from light and moisture.

Medicines should generally be kept out of the reach of children.

Do not use the medicine after the expiry date stated on the pack.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer need. This measure helps to protect the environment.

6. Source and processing status

Information from the SCHOLZ database based on the data approved by the Federal Office for Drugs and Medical Devices

Copyright by ePrax GmbH, Munich; November 2013