AUROBLOCK 2 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. AuroBlock Fast, 2 mg, orally disintegrating tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is AuroBlock Fast and what is it used for
4. Important information before taking AuroBlock Fast
   1. When not to take AuroBlock Fast, 2 mg, orally disintegrating tablets:
   2. Warnings and precautions
   3. Children
   4. AuroBlock Fast and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Pregnancy
   7. Breastfeeding
   8. Driving and using machines
   9. AuroBlock Fast, 2 mg, orally disintegrating tablets contain sodium
5. How to take AuroBlock Fast
   1. Recommended dose:
   2. Children under 15 years
   3. Method of administration
   4. Duration of treatment
   5. Overdose of AuroBlock Fast
   6. Missed dose of AuroBlock Fast
6. Possible side effects
   1. Other side effects include:
   2. Side effects in children:
   3. Reporting side effects
7. How to store AuroBlock Fast
8. Contents of the pack and other information
   1. What AuroBlock Fast, 2 mg, orally disintegrating tablets contain
   2. What AuroBlock Fast looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. This medicine is authorized in the Member States of the European Economic Area under the following names:
   7. Belgium:
   8. France:
   9. Germany:
   10. Poland:
   11. Portugal:
   12. Date of last revision of the leaflet: 01/2023
   13. RECOMMENDATION FOR HEALTH EDUCATION

Leaflet attached to the packaging: information for the user

AuroBlock Fast, 2 mg, orally disintegrating tablets

Loperamide hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 2 days, they should contact a doctor.

Table of contents of the leaflet:

• 1. What is AuroBlock Fast and what is it used for
• 2. Important information before taking AuroBlock Fast
• 3. How to take AuroBlock Fast
• 4. Possible side effects
• 5. How to store AuroBlock Fast
• 6. Contents of the pack and other information

1. What is AuroBlock Fast and what is it used for

The active substance of AuroBlock Fast is loperamide hydrochloride. It belongs to a group of medicines called "anti-diarrheal" used to treat diarrhea. AuroBlock Fast is used to treat the symptoms of acute diarrhea in adults and children from 15 years of age. AuroBlock Fast should not be used for more than 2 days without medical consultation. During treatment, it is essential to drink plenty of fluids and follow dietary recommendations (see section 2 "Warnings and precautions").

2. Important information before taking AuroBlock Fast

When not to take AuroBlock Fast, 2 mg, orally disintegrating tablets:

• if the patient is allergic to loperamide hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• in children under 15 years of age (see also "Children" below)
• in cases where it is necessary to avoid slowing down intestinal peristalsis, such as abdominal distension, constipation, and intestinal obstruction
• AuroBlock Fast should be discontinued immediately in case of constipation, abdominal distension, or intestinal obstruction
• if the patient has diarrhea with fever and (or) bloody stools (acute dysentery)
• if the patient has diarrhea occurring during or after the use of antibiotics
• if the patient has enteritis with diarrhea caused by bacteria (such as Salmonella, Shigella, and Campylobacter)
• if the patient has an acute episode of ulcerative colitis (a form of non-specific colitis).

Warnings and precautions

Before starting to take AuroBlock Fast, the patient should discuss it with a doctor or pharmacist:

• If the patient has AIDS and is taking AuroBlock Fast to treat acute diarrhea. If the first symptoms of abdominal distension occur, the use of AuroBlock Fast should be discontinued.
• If the patient has liver problems. AuroBlock Fast should only be taken after consulting a doctor if liver disease occurs or persists, as the breakdown of loperamide may be delayed, and the risk of side effects may be increased.
• In case of severe thirst, dry mouth. These symptoms indicate the onset of dehydration, i.e., significant fluid loss due to diarrhea. The doctor will then assess the need for hydration, which can be done orally or intravenously.

During treatment, the following dietary rules should be followed:

• Diarrhea can cause significant loss of fluids and salts, so it is essential to ensure adequate fluid replacement by drinking much more fluid than usual, fluids with sugar and salts (electrolytes). This is the most important measure, especially for children and the elderly.
• Avoid consuming milk, green vegetables, raw vegetables, fruits, and spices until the diarrhea subsides.

AuroBlock Fast only suppresses diarrhea, it does not treat its cause. Whenever the cause can be identified, it should be treated accordingly. Therefore, the patient should talk to a doctor. This medicine should not be taken for purposes other than its intended use (see section 1) and never take more than the recommended amount (see section 3). In patients who have taken too much loperamide, the active substance of AuroBlock Fast, serious heart problems have been reported (symptoms of which are rapid or irregular heartbeat). AuroBlock Fast usually stops diarrhea within 48 hours of the first administration. If diarrhea persists after two days of treatment with AuroBlock Fast, the use of AuroBlock Fast should be discontinued, and a doctor should be consulted.

Children

This medicine should not be used in children under 15 years of age.

AuroBlock Fast and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, the patient should discuss with their doctor if it is necessary to regularly or occasionally take one or more of the following medicines:

• ritonavir (a medicine used to treat HIV infection)
• itraconazole or ketoconazole (a medicine used to treat fungal infections)
• quinidine (a medicine used to treat heart rhythm disorders)
• gemfibrozil (a medicine used to treat high blood fat levels)
• desmopressin (a medicine used to treat excessive urination)

It is expected that medicines with a similar mechanism of action to AuroBlock Fast may enhance its effect, and medicines that accelerate gastrointestinal passage may weaken its effect.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.

Pregnancy

The use of AuroBlock Fast is not recommended during pregnancy.

Breastfeeding

The use of this medicine is not recommended during breastfeeding, as small amounts of loperamide may pass into breast milk.

Driving and using machines

During the treatment of acute diarrhea with AuroBlock Fast, dizziness, fatigue, and drowsiness may occur. Therefore, the patient should be cautious when driving or operating machinery.

AuroBlock Fast, 2 mg, orally disintegrating tablets contain sodium

This medicine contains less than 1 mmol (23 mg) of sodium per orally disintegrating tablet, which means it is considered "sodium-free". This medicine contains 5 mg of aspartame per orally disintegrating tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria, a rare genetic disorder, in which phenylalanine accumulates because the body cannot remove it properly. This medicine contains sucrose (a type of sugar). If the patient has been informed by their doctor that they have an intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take AuroBlock Fast

AuroBlock Fast should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult a doctor or pharmacist.

Recommended dose:

• Treatment of acute diarrhea should be started with an initial dose.
• The next dose should be taken after each loose stool.
• The maximum daily dose should not be exceeded.

Children under 15 years

AuroBlock Fast should not be used in children under 15 years of age due to the high content of the active substance. Other medicines are available for this population.

Method of administration

The orally disintegrating tablet should be placed on the tongue. The tablet disintegrates immediately on the tongue and can be swallowed. No liquid is needed to swallow.

Duration of treatment

AuroBlock Fast should not be taken for more than 2 days without medical consultation. If diarrhea persists after two days of treatment with AuroBlock Fast, the use of AuroBlock Fast should be discontinued, and a doctor should be consulted. Treatment with medicines containing loperamide hydrochloride should not last longer than 2 days without medical consultation and monitoring. If the patient feels that the effect of AuroBlock Fast is too strong or too weak, they should consult a doctor or pharmacist.

Overdose of AuroBlock Fast

In case of overdose, the patient should immediately consult a doctor or hospital emergency department for advice. Symptoms may include:

• uncoordinated movements, drowsiness (drowsiness), muscle stiffness, breathing difficulties
• rapid heartbeat, irregular heartbeat, changes in heart rhythm (these symptoms may have potentially serious, life-threatening consequences)
• urination difficulties

Children react more strongly to large amounts of AuroBlock Fast than adults. If a child has taken too much medicine or shows any of the above symptoms, they should immediately consult a doctor. Information for the doctor in case of overdose: Symptoms of loperamide hydrochloride overdose may also occur after relative overdose due to liver function disorders. Treatment depends on the symptoms of overdose and clinical diagnosis. During medical observation, EKG monitoring should be started to check for QT interval prolongation. If symptoms from the central nervous system occur after overdose, the opioid antagonist naloxone can be administered as an antidote. Since loperamide has a longer duration of action than naloxone, it may be necessary to repeat the administration of naloxone. Therefore, the patient should be closely monitored for at least 48 hours to diagnose possible occurrence/recurrence of overdose symptoms.

Missed dose of AuroBlock Fast

A double dose should not be taken to make up for a missed dose. In case of any further doubts about the use of this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, AuroBlock Fast can cause side effects, although not everybody gets them. The most commonly reported side effects in clinical trials were constipation, bloating, headache, nausea, and dizziness. If any of the following symptoms occur, the patient should stop taking AuroBlock Fast and seek medical help immediately:

• allergic reactions, anaphylactic reactions (including anaphylactic shock), anaphylactoid reactions
• severe skin diseases causing blistering (including Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme), skin or mucous membrane edema caused by fluid retention (angioedema)
• loss of consciousness or decreased level of consciousness

Other side effects include:

Frequent (may affect up to 1 in 10 people)

• constipation, nausea, bloating
• dizziness, headache

Uncommon (may affect up to 1 in 100 people)

• drowsiness
• abdominal pain and discomfort, dry mouth
• abdominal pain, vomiting
• indigestion
• skin rash

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

• bloating (swelling) of the abdomen
• body stiffness, abnormal muscle tone, coordination problems
• pupillary constriction (miosis)
• intestinal obstruction (intestinal obstruction, including paralytic), colonic dilatation (megacolon, including toxic megacolon), tongue burning
• hives, itching
• urination difficulties
• fatigue

Frequency not known (frequency cannot be estimated from the available data)

• abdominal pain, abdominal pain radiating to the back, abdominal tenderness, fever, rapid pulse, nausea, vomiting, which may be symptoms of pancreatitis (acute pancreatitis)

Side effects in children:

Frequent (may affect up to 1 in 10 people)

• vomiting

Uncommon (may affect up to 1 in 100 people)

• drowsiness, dizziness, headache
• nausea, abdominal pain, constipation
• skin rash

Certain difficulties may be caused by diarrhea itself: abdominal pain, nausea, vomiting, dry mouth, fatigue, drowsiness, dizziness, constipation, and bloating. After taking AuroBlock Fast tablets, a transient burning or stinging sensation in the tongue may occur.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be gathered on the safety of the medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store AuroBlock Fast

The medicine should be stored out of sight and reach of children. This medicine should not be used after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month. The medicine should not be stored above 25°C. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What AuroBlock Fast, 2 mg, orally disintegrating tablets contain

The active substance is loperamide hydrochloride. Each orally disintegrating tablet contains 2 mg of loperamide hydrochloride. The other ingredients are: sodium croscarmellose, aspartame E 951, fruit flavor (containing: arabic gum E 414, sugar (sucrose), maltodextrin (potato), triacetin, propylene glycol), banana flavor (containing corn maltodextrin), magnesium stearate, mannitol.

What AuroBlock Fast looks like and contents of the pack

Round, white or almost white tablets with a diameter of about 7 mm. AuroBlock Fast, 2 mg, orally disintegrating tablets are available in packs of 6, 10, 12, 20, and 30 orally disintegrating tablets, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o. ul. Sokratesa 13D lokal 27 01-909 Warsaw e-mail: [email protected]

Manufacturer:

Tiofarma B.V. Hermanus Boerhaavestraat 1 3261 ME, Oud-Beijerland Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium:

Loperamide AB 2 mg Orodispergeerbare tabletten/comprimés orodispersibles/Schmelztabletten

France:

LOPERAMIDE ARROW CONSEIL 2 mg, comprimé Orodispersible

Germany:

Loperamide PUREN akut 2mg schmelztabletten

Poland:

AuroBlock Fast

Portugal:

Loperamida Ritisca

Date of last revision of the leaflet: 01/2023

RECOMMENDATION FOR HEALTH EDUCATION

Diarrhea causes loss of fluids and salts. This medicine treats the symptoms of acute diarrhea in adults and children from 15 years of age, but hydration should not be abandoned in combination with a healthy diet. Therefore, it is necessary to drink plenty of sugary drinks (fruit juices) and salty broths to compensate for these losses. The patient should avoid consuming milk, green vegetables, raw vegetables, fruits, and spices until the diarrhea subsides.