Aurogastro

Leaflet accompanying the packaging: patient information

AuroGastro, 10 mg, coated tablets

Hyoscine butylbromide

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 the patient leaflet or as advised by
your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should speak to a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should stop taking the medicine and consult a doctor.

Table of contents of the leaflet:

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

1. What is AuroGastro and what is it used for

AuroGastro contains the active substance hyoscine butylbromide. It belongs to a group of medicines called
"antispasmodics".
AuroGastro is used to relieve cramps of the muscles of:

• the stomach
• the intestines.

2. Important information before taking AuroGastro

When not to take AuroGastro

• if you are allergic (hypersensitive) to hyoscine butylbromide or any of the other ingredients of the medicine (listed in section 6)
• if you have prostate enlargement
• if you have urinary retention or any other urinary tract obstruction
• if you have mechanical obstruction of the gastrointestinal tract (narrowing of the gastrointestinal tract) or pyloric stenosis
• if you have paralytic or obstructive intestinal obstruction (paralytic ileus)
• if you have tachycardia
• if you have glaucoma (an eye problem)
• if you have a condition called "myasthenia gravis" (a rare problem with muscle weakness)
• in patients with colonic dilatation (megacolon, significant widening of a portion of the large intestine)

• if you have a rare hereditary disease that may prevent you from taking any of the excipients contained in it.

You should not take this medicine if any of the above applies to you. If you are unsure, you should consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking the medicine, you should consult your doctor or pharmacist if:

• you have a fast heart rate or other heart problems
• you have thyroid problems, such as hyperthyroidism
• you have difficulty or pain when urinating, for example, men with an enlarged prostate (prostate gland)
• you have constipation
• you have a fever.

If you are unsure whether any of the above applies to you, you should consult your doctor or pharmacist before taking AuroGastro.
You should immediately consult your doctor or pharmacist if you experience unexplained abdominal pain that persists or worsens, or occurs with:

• fever
• malaise
• nausea
• changes in bowel movements
• abdominal tenderness
• low blood pressure
• feeling of fainting or
• blood in the stool.

AuroGastro and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently. This includes medicines available without a prescription and herbal medicines. This is because AuroGastro tablets may affect the action of some other medicines. Also, other medicines may affect the way AuroGastro works.
In particular, you should tell your doctor or pharmacist if you are taking any of the following medicines:

• Medicines used to treat depression called "tricyclic and tetracyclic antidepressants", such as doxepin.
• Medicines for allergies and motion sickness called "antihistamines".
• Medicines that control heart rhythm, such as quinidine or disopyramide.
• Medicines used to treat severe mental illnesses called "antipsychotics", such as haloperidol or fluphenazine.
• Medicines usually used for breathing problems, such as tiotropium, ipratropium, or atropine-like medicines.
• Amantadine - a medicine for Parkinson's disease and flu.
• Metoclopramide - a medicine for nausea (nausea).

If you are unsure whether any of the above applies to you, you should consult your doctor or pharmacist before taking AuroGastro.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

So far, the experience with butylscopolamine in pregnant women is insufficient.
There are no sufficient animal studies that indicate possible undesirable or harmful effects in pregnant women. Therefore, hyoscine butylbromide should not be used during pregnancy.

Breastfeeding

The penetration of hyoscine butylbromide, the active substance of the medicine, into breast milk has not been studied. Medicines of this type may inhibit milk production, and infants may be sensitive to such medicines.
When deciding whether to stop breastfeeding or to take hyoscine butylbromide, the doctor must weigh the benefits of breastfeeding for the baby and the benefits of treatment for the mother.

Driving and using machines

Taking hyoscine butylbromide may cause side effects such as confusion, blurred vision, drowsiness, etc. They can affect your ability to drive and use machines.
No studies have been conducted on the effects of the medicine on the ability to drive and use machines.

AuroGastro contains sucrose

If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.

3. How to take AuroGastro

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
AuroGastro should not be taken continuously for a long time.

Adults and children over 12 years

The usual dose of AuroGastro for adults and children over 12 years is:
1 to 2 tablets (10 mg to 20 mg), 3 to 5 times a day.
Tablets should be swallowed whole (without chewing or breaking), with a drink.
Effects have been observed 15 minutes after administration.
AuroGastro should not be given daily, continuously, or for a long time without examining the causes of abdominal pain.
No dose adjustment is necessary in patients with renal and/or hepatic impairment.

Children from 6 to 12 years

The usual dose is 1 tablet 3 times a day.
AuroGastro is not recommended for children under 6 years of age.

Taking a higher dose of AuroGastro than recommended

You should not take a higher dose of AuroGastro than recommended.
If you take a higher dose of AuroGastro than recommended, you may experience some side effects described in section 4 "Possible side effects".
In this case, you should stop taking AuroGastro and immediately consult your doctor.
Additionally, if necessary, appropriate treatment will be applied.

Missing a dose of AuroGastro

• If you miss a dose, you should take it as soon as possible. However, if it is time for your next dose, you should skip the missed dose.
• You should not take a double dose to make up for a missed dose.

If you have any further questions on the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, AuroGastro can cause side effects, although not everybody gets them. The following side effects may occur when taking this medicine.
Many of the side effects of AuroGastro are related to its anticholinergic properties. They are usually mild and transient. The following may occur:

• Uncommon(affects less than 1 in 100 people):
• rapid heartbeat,
• dry mouth,
• reduced sweating,
• skin reactions (hives, itching).

Rare(affects less than 1 in 1,000 people):

• •urinary retention.

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

• •anaphylactic shock (a sudden and severe allergic reaction characterized by difficulty breathing, circulatory collapse, and sudden swelling),
• •anaphylactic reactions with episodes of respiratory disorders, skin reactions (rash, redness), and other hypersensitivity reactions.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store AuroGastro

The medicine should be stored out of the sight and reach of children.
You should not take AuroGastro after the expiry date stated on the label, carton, and blister after: EXP. The expiry date refers to the last day of the month.
Store in a temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What AuroGastro contains

• The active substance is butylscopolamine/hyoscine butylbromide. Each coated tablet contains 10 mg of butylscopolamine (butylhyoscine bromide).
• The other ingredients of the medicine are: Core:calcium hydrogen phosphate, maize starch, tartaric acid, colloidal anhydrous silica, stearic acid.

Coating:
sucrose, talc (E 553b), hypromellose 2910 (5mPas) (E 464), macrogol 4000 (E 1521),
glycerol monostearate (E 471), medium-chain triglycerides, polysorbate 80 (E 433).

What AuroGastro looks like and contents of the pack

White or almost white, sugar-coated, round, biconvex tablets, smooth on both sides.
AuroGastro coated tablets are available in blisters packed in a cardboard box.

Pack sizes

Blisters of: 10, 20, 30, 40, 50, 60, and 100 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

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

Belgium:
Butylhyoscine bromide AB 10 mg coated tablets / compressimés enrobés / überzogene Tabletten
Germany:
Butylscopolamin PUREN 10 mg überzogene Tabletten
Italy:
Scopolamina Aurobindo
Poland:
AuroGastro
Portugal:
Butilescopolamina Conforpam
Spain:
Butilescopolamina Aurovitas 10 mg clarimidos recubiertos EFG

Date of last revision of the leaflet: