Butylescopolamine Aurovitas 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Butilescopolamine Aurovitas 10 mg coated tablets EFG

Butylscopolamine bromide

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Leaflet contents

1. What Butilescopolamine Aurovitas is and what it is used for
2. What you need to know before taking Butilescopolamine Aurovitas
3. How to take Butilescopolamine Aurovitas
4. Possible side effects
5. How to store Butilescopolamine Aurovitas
6. Contents of the pack and other information

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

Butilescopolamina Aurovitas contains a drug called "Butilescopolamina". This drug belongs to a group of medicines known as "antispasmodics".

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

• Stomach.
• Intestine.

2. What you need to know before taking Butilescopolamine Aurovitas

Do not take Butilescopolamine Aurovitas:

• If you are allergic to butylscopolamine bromide or to any of the other ingredients of this medicine (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 gastrointestinal tract obstruction (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 have glaucoma (eye problems).
• If you have megacolon (abnormally enlarged colon).
• If you have myasthenia gravis (a chronic disease characterized by variable degrees of muscle weakness).
• If you have a rare hereditary disease that may be incompatible with any of the excipients in the medicine.

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

Warnings and precautions

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

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

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

Seek immediate medical advice from your doctor or pharmacist if you have unexplained abdominal pain that persists or worsens, or occurs with:

• fever
• feeling unwell
• nausea or vomiting
• changes in bowel movements
• abdominal tenderness
• low blood pressure
• feeling weak
• blood in stools

Other medicines and Butilescopolamine Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because butylscopolamine may affect how other medicines work. Likewise, these medicines may affect how butylscopolamine works.

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

• Medicines used to treat depression called "tricyclic and tetracyclic antidepressants".
• Medicines used to treat allergies called "antihistamines".
• Medicines used to treat serious mental illnesses called "antipsychotics", such as haloperidol or flufenazine.
• Medicines used to control heart rhythm, such as quinidine or disopyramide.
• Medicines generally used for respiratory problems such as tiotropium, ipratropium, or medicines similar to atropine.
• Amantadine – for Parkinson's disease and influenza.
• Metoclopramide – for nausea.

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

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 medicine.

Pregnancy

There is currently insufficient experience with the use of butylscopolamine in pregnant women.

There are not enough animal studies available to indicate potential adverse or harmful effects in pregnant women. Therefore, you should not use this medicine if you are pregnant.

Breastfeeding

The passage of butylscopolamine bromide, the active ingredient in this medicine, into breast milk has not been studied.

Medicines of this type may inhibit milk production, and infants may be sensitive to these medicines.

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

Driving and use of machines

This medicine may cause adverse effects such as confusion, blurred vision, drowsiness, etc., which may impair the ability to drive and operate machinery. No studies have been conducted on the ability to drive or operate machinery.

Butilescopolamine Aurovitas contains sucrose

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Butilescopolamine Aurovitas

Always take this medicine exactly as your doctor or pharmacist has instructed you. You should consult your doctor or pharmacist if you have any doubts.

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

Adults and children over 12 years of age

The usual dose of this medicine for adults and children over 6 years of age 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 occurs within 15 minutes after taking this medicine.

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

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

Follow exactly the administration instructions provided in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

Children from 6 to 12 years of age:

The usual dose is 1 tablet three times a day.

This medicine is not recommended for children under 6 years of age.

If you take more Butilescopolamine Aurovitas than you should

Do not take more of this medicine than the recommended dose.

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

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

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

If you have taken more Butilescopolamine Aurovitas than you should, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20.

If you forget to take Butilescopolamine Aurovitas

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

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

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. The following adverse effects may occur with this medicine.

Many of the undesirable effects of this medicine 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 heartbeat,
• Dry mouth,
• Reduced sweating,
• Skin reactions
• (Urticaria, pruritus).

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 adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Butylescopolamine Aurovitas

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Butilescopolamina Aurovitas

The active substance is butylscopolamine.

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

Excipients:

Tablet core: Dicalcium hydrogen phosphate dihydrate, corn starch, tartaric acid, colloidal anhydrous silica, stearic acid.

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

Appearance of the product and contents of the pack

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

Butilescopolamina Aurovitas 10 mg coated tablets EFG is available in blister packs.

Butilescopolamina Aurovitas is available in blister packs.

Pack sizes:

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 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 medicinal product is authorised in the European Economic Area member states under the following names:

Belgium: Butylhyoscine bromide AB 10 mg omhulde tabletten/comprimés enrobés /berzogene Tabletten

Germany: Butylscopolamin PUREN 10 mg überzogene Tabletten

Italy: Scopolamina Aurobindo

Poland: AuroGastro

Portugal: Butilescopolamina Conforpam

Spain: Butilescopolamina Aurovitas 10 mg coated tablets EFG

Date of the most recent review of this leaflet: January 2021

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)