Auroblock fast

Package leaflet: Information for the user

AuroBlock Fast, 2 mg, orodispersible tablets
Loperamidi hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 2 days, or if you feel worse, consult your doctor.

Contents of the leaflet:

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

The active substance in AuroBlock Fast is loperamide hydrochloride. It belongs to a group of medicines
called "antidiarrhoeals", which are used to treat diarrhoea.
AuroBlock Fast is used to treat symptoms of acute diarrhoea in adults and children aged 15 years and older.
AuroBlock Fast must not be used for longer than 2 days unless advised by a doctor, under medical supervision and medical control.
During treatment, it is important to drink plenty of fluids and to follow dietary recommendations
(see section 2 "Warnings and precautions").

2. Important information before using AuroBlock Fast

When not to use AuroBlock Fast, 2 mg, orodispersible 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 conditions where slowing of intestinal peristalsis should be avoided, e.g. abdominal distension, constipation and intestinal obstruction
• AuroBlock Fast must be discontinued immediately in case of constipation, abdominal distension or intestinal obstruction
• if the patient has diarrhoea with fever and (or) bloody stools (acute dysentery)
• if the patient has diarrhoea occurring during or after antibiotic treatment
• if the patient has diarrhoea due to intestinal infection caused by bacteria (such as Salmonella, Shigella and Campylobacter)
• if the patient has an acute episode of ulcerative colitis (a form of inflammatory bowel disease).

Warnings and precautions
Before taking AuroBlock Fast, discuss with your doctor or pharmacist:

• If the patient has AIDS and is taking AuroBlock Fast for the treatment of acute diarrhoea. If symptoms of abdominal distension occur, treatment with AuroBlock Fast should be stopped immediately.
• If the patient has liver problems. AuroBlock Fast should be taken only after consultation with a doctor if liver disease is present or persistent, as the metabolism of loperamide may be delayed and the risk of adverse effects may be increased.
• In case of intense thirst or dryness of the mouth. These symptoms indicate the onset of dehydration, i.e. significant loss of fluids due to diarrhoea. Your doctor will then assess the need for rehydration, which can be administered orally or intravenously.

During treatment, the following dietary rules should be observed:

• Diarrhoea may cause significant loss of fluids and electrolytes; therefore, adequate fluid replacement should be ensured by drinking significantly more fluids than usual, including fluids containing sugar and salts (electrolytes). This is the most important measure, especially in children and elderly patients.
• Milk, green vegetables, raw vegetables, fruits and spices should be avoided until diarrhoea resolves.

AuroBlock Fast only suppresses diarrhoea but does not treat its underlying cause. Whenever the cause can be identified, it should be appropriately treated. Therefore, consult your doctor.
Do not take this medicine for any other purpose than intended (see section 1) and never take more than the recommended dose (see section 3). Serious heart problems (manifested as rapid or irregular heartbeat) have been reported in patients who have taken an excessive dose of loperamide, the active substance in AuroBlock Fast.
AuroBlock Fast usually stops diarrhoea within 48 hours after the first dose. If diarrhoea persists after two days of treatment with AuroBlock Fast, discontinue use of the medicine and contact your doctor.
Children
This medicine must not be used in children under 15 years of age.
AuroBlock Fast and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
In particular, talk to your doctor if you need to take regularly or occasionally one or more of the following medicines:

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

Medicines with a similar mechanism of action to AuroBlock Fast may enhance its effect, while medicines that accelerate gastrointestinal transit may reduce its effect.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
The use of AuroBlock Fast during pregnancy is not recommended.
Breastfeeding
The use of this medicine during breastfeeding is not recommended, as small amounts of loperamide may pass into breast milk.
Driving and operating machinery
Dizziness, fatigue and drowsiness may occur during acute diarrhoea treated with AuroBlock Fast. Therefore, caution should be exercised when driving or operating machinery.
AuroBlock Fast, 2 mg, orodispersible tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per orodispersible tablet, meaning the medicine is considered "sodium-free".
This medicine contains 5 mg of aspartame per orodispersible tablet. Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
This medicine contains sucrose (a type of sugar). If you have been told by your doctor that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use AuroBlock Fast

AuroBlock Fast should always be used exactly as described in this patient leaflet or as recommended by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose:

• Acute diarrhoea treatment should be initiated with the initial dose.
• Subsequently, the next dose should be taken after each loose bowel movement.
• The maximum daily dose must not be exceeded.

Children under 15 years of age
AuroBlock Fast should not be used in children under 15 years of age due to the high content of the active substance. Other medicinal products are available for this population.
Method of administration
The orodispersible tablet should be placed on the tongue. The tablet disintegrates immediately on the tongue and can be swallowed. No liquid is required for administration.
Duration of treatment
Do not take AuroBlock Fast for longer than 2 days without consulting a doctor.
If diarrhoea persists after 2 days of treatment with AuroBlock Fast, discontinue use and consult a doctor. Treatment with medicinal products containing loperamide hydrochloride should last longer than 2 days only after medical consultation and under medical supervision.
If you feel that the effect of AuroBlock Fast is too strong or too weak, consult a doctor or pharmacist.
Taking a higher than recommended dose of AuroBlock Fast
If an excessive amount of AuroBlock Fast has been taken, contact a doctor or hospital emergency department immediately for advice.
Symptoms may include:

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

Children react more strongly to large amounts of AuroBlock Fast than adults. If a child has taken too much of the medicine or shows any of the above symptoms, contact a doctor immediately.
Information for the doctor in case of overdose
Symptoms of loperamide hydrochloride overdose may also occur after relative overdose due to impaired liver function. Treatment depends on the symptoms of overdose and clinical diagnosis.
During medical observation, ECG monitoring for QT interval prolongation should be initiated.
If central nervous system symptoms occur following overdose, the opioid antagonist naloxone may be administered as an antidote. Since loperamide has a longer duration of action than naloxone, repeated doses of naloxone may be necessary. Therefore, the patient should be very closely monitored for at least 48 hours to detect possible onset or recurrence of overdose symptoms.
Missed dose of AuroBlock Fast
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
The most commonly reported adverse effects in clinical trials were constipation, bloating,
headache, nausea and dizziness.
If any of the following symptoms occur, stop taking AuroBlock Fast and
seek immediate medical help:

• hypersensitivity 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 mucosal swelling due to fluid retention (angioedema)
• loss of consciousness or reduced level of consciousness

Other adverse effects include:
Common (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
• epigastric pain, vomiting
• dyspepsia
• skin rash

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

• distended (swollen) abdomen
• muscle rigidity, abnormal increase in muscle tone, coordination problems
• constriction of the pupils of the eye (miosis)
• intestinal obstruction (including paralytic ileus), colonic dilation (megacolon, including toxic megacolon), burning sensation of the tongue
• urticaria, itching
• urinary retention
• fatigue

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

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

Adverse effects in children:
Common (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

Diarrhoea itself may cause certain difficulties: abdominal pain, nausea, vomiting, dry mouth,
fatigue, drowsiness, dizziness, constipation and bloating.
Shortly after taking AuroBlock Fast tablets, a transient burning or pricking sensation in the tongue may occur.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.
Adverse effects may also be reported to the marketing authorisation holder.

5. How to store AuroBlock Fast

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What AuroBlock Fast 2 mg orodispersible tablets contain
The active substance is loperamide hydrochloride.
Each orodispersible tablet contains 2 mg of loperamide hydrochloride.
The other ingredients are: sodium croscarmellose, aspartame (E 951), fruit flavour (containing: gum arabic E 414, sugar (sucrose), maltodextrin (potato), triacetin, propylene glycol), banana flavour (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 approximately 7 mm.
AuroBlock Fast 2 mg orodispersible tablets are available in packs of 6, 10, 12, 20 and 30 orodispersible tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
e-mail: [email protected]

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

This medicinal product is authorised in the European Economic Area countries 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 2 mg Schmelztabletten
Poland: AuroBlock Fast
Portugal: Loperamida Ritisca

HEALTH EDUCATION RECOMMENDATION
Diarrhoea causes loss of fluids and electrolytes.
This medicine treats symptoms of acute diarrhoea in adults and children aged 15 years and older, but rehydration combined with a healthy diet should not be neglected.
Therefore, it is important to drink plenty of sweetened fluids (fruit juices) and salty broths to compensate for these losses. Milk, green vegetables, raw vegetables, fruits and spices should be avoided until diarrhoea resolves.