Package Insert: Information for the Patient

Butilescopolamina Aurovitas 10 mg Coated Tablets EFG

Butilescopolamine bromide

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor, even if they are not listed in this package insert. See section 4.

Butilescopolamina Aurovitas contains a medication called "Butilescopolamina". This medication belongs to a group of medications called "antispasmodics".

This medication is used to relieve muscle cramps in the:

• Stomach.

• Intestine.

Do not take Butilescopolamina Aurovitas:

• If you are allergic to butilescopolamina bromide or any of the other components of this medication (listed in section 6).
• If you have an enlarged prostate.
• If you suffer from urinary retention due to any uretro-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 excipients 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 fast heart rate or other heart problems.
• You have a thyroid gland problem, such as an overactive thyroid gland.
• You have difficulty or pain urinating, such as in men with prostate problems.
• You have constipation.
• You have a fever.

If you are unsure 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 nauseous
• Changes in bowel movements
• Abdominal sensitivity
• Low blood pressure
• Feeling weak or,
• Blood in the stool.

Other Medications and Butilescopolamina Aurovitas

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes over-the-counter medications and herbal medications. This is because butilescopolamina may affect how other medications work. These medications may also affect how butilescopolamina works.

Particularly, inform your doctor or pharmacist if you are taking any of the following medications:

• Depression medications called "tricyclic and tetracyclic antidepressants".
• Allergy medications called "antihistamines".
• Mental illness medications called 'antipsychotics', such as haloperidol or flufenazine
• Medications for controlling heart rate, such as quinidine or disopyramide.
• Medications generally used for respiratory problems, such as tiotropium, ipratropium, or medications similar to atropine.
• Amantadine - for Parkinson's disease and flu.
• Metoclopramide - for nausea.

If you are unsure 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 butilescopolamina in pregnant women.

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

Breastfeeding

The transfer of butilescopolamina bromide, the active ingredient in 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.

Your doctor must weigh the benefits of breastfeeding for the baby and the benefits of treatment for the mother when deciding whether to stop breastfeeding or receive treatment with butilescopolamina.

Driving and Operating Machines

The administration of this medication may produce adverse effects such as confusion, blurred vision, drowsiness, etc., that may affect the ability to drive and operate machines.No studies have been conducted on the ability to drive and operate machines.

Butilescopolamina Aurovitas contains saccharose

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

Always take the medication as directed by your doctor or pharmacist. 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 old

The usual dose of this medication for adults and children over 6 years old 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 in a continuous or prolonged manner without investigating the causes of abdominal pain.

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

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

Children from 6 to 12 years old:

The usual dose is 1 tablet 3 times a day.

This medication is not recommended for children under 6 years old.

If you take more Butilescopolamina Aurovitas than you should

Do not take this medication beyond the recommended dose.

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

Stop taking butilescopolamine and contact your doctor immediately.

Additionally, appropriate supportive measures will be applied as needed.

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

If you forgot to take Butilescopolamina Aurovitas

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

Do not take a double dose to compensate for a missed dose.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.The following adverse 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 moderate and limited.

The following may occur:

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

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

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

• Urinary retention.

Unknown frequency (cannot be estimated from available data):

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Butilescopolamina Aurovitas

The active substance is butilescopolamina.

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

Excipients:

Core of the tablet:Calcium dihydrogen phosphate, cornstarch, tartaric acid, anhydrous colloidal silica, stearic acid.

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

Appearance of the product and contents of the package

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

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

Butilescopolamina Aurovitas is available in blister packs.

Pack sizes

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

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization 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 responsible:

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 authorized in the member states of the European Economic Area with the following names:

Belgium:Butylhyoscine bromide AB 10 mg coated tablets/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

Last review date of this leaflet: January 2021

Other sources of information

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)