BUTILESCOPOLAMINA AUROVITAS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Butylscopolamine Aurovitas 10 mg Coated Tablets EFG

Butylscopolamine Bromide

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Butylscopolamine Aurovitas and what is it used for
2. What you need to know before taking Butylscopolamine Aurovitas
3. How to take Butylscopolamine Aurovitas
4. Possible side effects
5. Storage of Butylscopolamine Aurovitas
6. Package Contents and Additional Information

1. What is Butylscopolamine Aurovitas and what is it used for

Butylscopolamine Aurovitas contains a medicine called "Butylscopolamine". This medicine belongs to a group of medicines called "antispasmodics".

This medication is used to relieve cramps in the muscles of the:

• Stomach.
• Intestine.

2. What you need to know before taking Butylscopolamine Aurovitas

Do not take Butylscopolamine Aurovitas:

• If you are allergic to butylscopolamine bromide or any of the other components of this medication (listed in section 6).
• If you have prostate hypertrophy.
• If you suffer from urinary retention due to any urethro-prostatic pathology.
• If you have mechanical stenosis of the gastrointestinal tract (narrowing of the gastrointestinal tract) or pyloric stenosis (narrowing of the pylorus).
• If you have paralytic or obstructive ileus (intestinal paralysis).
• If you have tachycardia.
• If you suffer from glaucoma (eye problems).
• If you have megacolon (abnormally large colon).
• If you have myasthenia gravis (a chronic disease characterized by varying degrees of muscle weakness).
• If you have a rare hereditary disease that may be incompatible with any excipient of the medication.

Do not take this medication if any of the above points apply to you. If you have doubts, consult your doctor or pharmacist before taking this medication.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medication if:

• You have a very rapid heart rate or other heart problems.
• You have a problem with the thyroid gland, such as an overactive thyroid gland.
• You have difficulty or pain when urinating, such as in men with prostate problems.
• You have constipation.
• You have a fever.

If you are not sure if any of the above points apply to you, consult your doctor or pharmacist before taking this medication.

Consult your doctor or pharmacist immediately if you have unexplained abdominal pain that persists or worsens, or occurs with:

• fever
• feeling unwell
• being sick
• changes in bowel movements
• abdominal tenderness
• low blood pressure
• feeling weak or
• blood in the stool.

Other Medications and Butylscopolamine Aurovitas

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication. This includes medications obtained without a prescription and herbal remedies. This is because butylscopolamine may affect how other medications work. These medications may also affect how butylscopolamine works.

In particular, tell your doctor or pharmacist if you are taking any of the following medications:

• Medications for the treatment of depression called "tricyclic and tetracyclic antidepressants".
• Medications for the treatment of allergies called "antihistamines".
• Medications for the treatment of severe mental illnesses called "antipsychotics", such as haloperidol or flufenazine.
• Medications for controlling heart rhythm, such as quinidine or disopyramide.
• Medications commonly used for respiratory problems, such as tiotropium, ipratropium, or atropine-like medications.
• Amantadine - for Parkinson's disease and flu.
• Metoclopramide - for when you feel nauseous.

If you are not sure if any of the above points apply to you, consult your doctor or pharmacist before taking this medication.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

There is currently not enough experience with the use of butylscopolamine in pregnant women.

There are not enough animal studies available to indicate possible undesirable or harmful effects in pregnant women. Therefore, you should not use this medication if you are pregnant.

Breastfeeding

The transfer of butylscopolamine bromide, the active ingredient of this medication, to breast milk has not been studied.

Medications of this type may inhibit milk production, and babies may be sensitive to these medications.

When deciding whether to stop breastfeeding or receive treatment with butylscopolamine, your doctor must weigh the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and Using Machines

Administration of this medication may produce side effects such as confusion, blurred vision, drowsiness, etc., which may affect the ability to drive and use machines. No studies have been conducted on the ability to drive and use machines.

Butylscopolamine Aurovitas contains Sucrose

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Butylscopolamine Aurovitas

Always take the medication exactly as your doctor or pharmacist has told you. You should consult with your doctor or pharmacist if you have any doubts.

This medication should not be taken continuously for long periods of time.

Adults and Children over 12 years

The usual dose of this medication for adults and children over 6 years is as follows:

1 to 2 tablets (10 mg to 20 mg), 3 to 5 times a day.

The tablets should be swallowed whole (without chewing or breaking) with liquid.

The effect is observed 15 minutes after taking this medication.

This medication should not be administered daily on a continuous basis or for long periods without investigating the causes of abdominal pain.

No dose adjustment is required in patients with renal and/or hepatic insufficiency.

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

Children from 6 to 12 years:

The usual dose is 1 tablet 3 times a day.

This medication is not recommended for children under 6 years.

If you take more Butylscopolamine Aurovitas than you should

Do not take this medication beyond the recommended dose.

If you take more butylscopolamine than you should, you may experience some side effects described in the section "4. Possible side effects".

If this happens, stop taking butylscopolamine and contact your doctor immediately.

In addition, appropriate supportive measures will be applied as needed.

If you have taken more Butylscopolamine Aurovitas than you should, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Butylscopolamine Aurovitas

If you forget a dose, take it as soon as you remember. However, if it is time for the next dose, skip the missed dose.

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

If you have more questions about the use of this medication, consult your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. The following side effects may occur with this medication.

Many of the undesirable effects of this medication are associated with its anticholinergic properties. However, these effects are generally mild and limited.

The following may occur:

Uncommon (may affect up to 1 in 100 people):

• Rapid heartbeats,
• dry mouth,
• reduced sweating,
• skin reactions
• (hives, itching).

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

• urinary retention.

Frequency not known (cannot be estimated from 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 of side effects

If you experience any side effects, consult your doctor, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Butylscopolamine Aurovitas

Keep out of sight and reach of children.

Do not use this medication after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medications should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Butylscopolamine Aurovitas

The active substance is butylscopolamine.

Each coated tablet contains 10 mg of butylscopolamine (butylscopolamine bromide).

Excipients:

Core of the tablet: Dicalcium phosphate dihydrate, corn 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).

Appearance of the Product and Package Contents

White to off-white, circular, biconvex, sugar-coated tablets, smooth on both sides.

Butylscopolamine Aurovitas 10 mg coated tablets EFG are available in blister packs.

Butylscopolamine Aurovitas is available in blister packs.

Package sizes

Blister pack: 10, 20, 30, 40, 50, 60, and 100 coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer:

APL Swift Services (Malta) Ltd,

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000, Malta

Or

Generis Farmacêutica S.A., Portugal

Rua de João de Deus, nº 19,

Venda Nova. Amadora

2700 487, Portugal

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

Belgium: Butylhyoscine bromide AB 10 mg coated tablets/comprimés enrobés/berzogene Tabletten

Germany: Butylscopolamin PUREN 10 mg coated tablets

Italy: Scopolamina Aurobindo

Poland: AuroGastro

Portugal: Butylscopolamine Conforpam

Spain: Butylscopolamine Aurovitas 10 mg coated tablets EFG

Date of the last revision of this package leaflet: January 2021

Other sources of information

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)