Pharmacotherapeutic Classification: Intestinal Disinfectant ( Class A: Gastrointestinal Tract and Metabolism)

Active ingredient: Nifuroxazide 200 mg.

Inactive ingredients: Starch, Sucrose, Croscarmellose Sodium, Magnesium Stearate.

Therapeutic indications:

Nifuroxazide (Antinal ) is an intestinal anti-infectious indicated in the treatment of presumed acute diarrhea of bacterial origin in the absence of suspicion of invasive phenomena (deterioration of the general state, fever, toxi-infectious signs) in adults and adolescents who are 18 years of age and above. Compliance with the appropriate diet, that should be used in cases of diarrhea as well as treatment of dehydration according to patient’s condition during the period of treatment with (Antinal®), must be taken into consideration.

know before taking this medicine?

You must know the following important information before taking this medicine:

- Ask your doctor before taking Antinal® if he had previously told you that you are allergic to some types of sugar.

Contraindications:

Never take Antinal® capsule if you are:

- Allergic to nitrofuran compounds or to any of the other ingredients contained in this medicine.

- Under 18 years of age.

- Antinal® should not be given during pregnancy and while breastfeeding.

For any further questions, ask your doctor or pharmacist

Warnings and special Precautions:

Special warnings

Rehydration should be systematically considered when treating acute diarrhea.

If diarrhea persists after 2 days of treatment, the course of action should be reassessed and the need for rehydration with oral rehydration solution or intravenous should be considered.

In the event of severe and prolonged diarrhea, severe vomiting or refusal to eat, intravenous rehydration should be considered.

In the event of infectious diarrhea with clinical manifestations suggesting an invasive phenomenon, resort to antibacterials with good systemic distribution.

This medicine contains sucrose. Patients with fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency (rare hereditary diseases) should not take this medicine.

Precautions for use

The patient should be informed of the need to:

Rehydrate with abundant drinks, salty or sweet, to compensate for fluid losses due to diarrhea (the average daily water intake for adults is 2 liters);

Feeding time diarrhea,

· by excluding certain intakes and particularly raw vegetables, fruits, green vegetables, spicy dishes, as well as frozen foods or drinks,

· by favoring grilled meats, rice.

Interactions with other drugs:

Not Applicable.

Use during pregnancy and lactation:

pregnancy and lactation:

• Antinal® should not be given during pregnancy and while breastfeeding.

In women of childbearing potential Antinal® should only be used if they are using effective contraception.

Ask your Doctor or Pharmacist for advice before taking any medicine during pregnancy or lactation.

Effects on driving vehicles and machine operation

This drug has no effect on driving vehicles and using machinery

Dosage, route of administration and duration of treatment:

Dosage: this product is to be used only with adults and adolescents who are above 18 years of age: 1 capsule 4 times daily.

Method of administration: Antinal® capsule is administered orally and swallowed whole with some water.

Treatment duration: Treatment with Antinal® should not exceed 3 days.

Symptoms of overdose and how to treat it: Ask your doctor or your pharmacist immediately if you take more dose of (Antinal® capsule 200 mg) than necssary. In case of missing one or more dose of Antinal®; do not compensate for the missed doses.

Description of undesirable side effects:

Taking (Antinal® capsule 200 mg) can generally lead to undesirable side effects in some cases as is the case with all other drugs.

* The serious undesirable effects associated with nifuroxazide are immunoallergic, they are immediate hypersensitivity reactions (anaphylactic shock, angioedema), occurring especially in children and likely to jeopardize the vital prognosis.

Other undesirable effects include eczema-like toxicosis, photosensitivity (skin reactions occurring when exposed to the sun or UV radiation), exceptionally more serious skin damage or even haematological undesirable effects (reduction in the number of platelets (thrombocytopenia), red blood cells (hemolytic anemia) or certain white blood cells. Whenever side effects symptoms are aggravated, inform your doctor or pharmacist. This includes any side effects not listed in this leaflet.

The following table shows the adverse reactions reported with the use of nifuroxazide in clinical trials and in post-marketing experience. Adverse reactions are classified by system organ and frequency using the following convention: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (_ 1/1000 to <1 / 100), rare (≥ 1 / 10,000 to <1 / 1,000), very rare (<1 / 10,000), frequency not known (cannot be estimated from the available data).

To report any side effects:

Saudi Arabia:

The National Pharmacovigilance Centre (NPC):

Fax: +966-11-205-7662 SFDA

Call Center: 19999

E-mail: npc.drug@sfda.gov.sa

Website: https://ade.sfda.gov.sa

Keep this medicine out of the sight and reach of children.

Store in a dry place at a temperature not exceeding 30°C.

Expiry date: Do not use Antinal® capsule after the expiry date which is stated on the package.

Warning of damage signs:

Do not throw away any expired 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 against Chemical contamination .