Butilscopolamine Aurobindo

Package leaflet: Information for the patient

Butilscopolamine Aurobindo 10 mg coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days. Contents of this leaflet :
  1. What Butilscopolamine Aurobindo is and what it is used for
  2. What you need to know before taking Butilscopolamine Aurobindo
  3. How to take Butilscopolamine Aurobindo
  4. Possible side effects
  5. How to store Butilscopolamine Aurobindo
  6. Contents of the pack and other information

1. What Butilscopolamina Aurobindo is and what it is used for

Butilscopolamina Aurobindo contains a substance called "butilscopolamine". This belongs to a group of medicines known as "antispasmodics".
Butilscopolamina Aurobindo is used to relieve cramps in the muscles of the:

• stomach;
• intestine;

2. What you need to know before taking Butilscopolamina Aurobindo

Do not take Butilscopolamina Aurobindo:

• if you are allergic (hypersensitive) to butylscopolamine or to any of the other ingredients of this medicine (listed in section 6);
• if you have prostate enlargement (benign prostatic hyperplasia);
• if you suffer from urinary retention due to any urethro-prostatic disorder;
• if you have mechanical obstruction 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 have glaucoma (an eye condition);
• if you suffer from a condition called "myasthenia gravis" (a very rare muscle weakness disorder);
• if you have a markedly distended bowel (megacolon);
• if you suffer from a rare hereditary condition that might be incompatible with any excipient in this medicine.

Do not take this medicine if any of the above apply to you. If you are unsure, speak with your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if:

• you have a very rapid heartbeat or other heart problems;
• you have a thyroid gland disorder, such as an overactive thyroid;
• you have difficulty or pain when urinating, as may occur in men with prostate problems;
• you suffer from constipation;
• you have a fever.

If you are unsure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before taking Butilscopolamina Aurobindo.

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

• fever;
• feeling unwell;
• malaise;
• changes in bowel movements;
• abdominal tenderness;
• low blood pressure;
• feeling faint;
• blood in the stools.

Other medicines and Butilscopolamina Aurobindo

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Butilscopolamina Aurobindo tablets may affect how some medicines work. At the same time, other medicines may affect how butylscopolamine works.

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

• antidepressant medicines called "tetracyclic antidepressants" or "tricyclic antidepressants", such as doxepin;
• medicines for allergies and motion sickness called "antihistamines";
• medicines to control heart rhythm, such as quinidine or disopyramide;
• medicines for severe mental illnesses called "antipsychotics", such as haloperidol or flufenazine;
• medicines usually used for respiratory problems, such as tiotropium, ipratropium, or drugs similar to atropine;
• amantadine – for Parkinson's disease and influenza;
• metoclopramide – for feelings of nausea.

If you are unsure whether any of the above apply to you, speak with your doctor or pharmacist before taking Butilscopolamina Aurobindo.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:

Experience with the use of butylscopolamine in pregnant women is currently limited. There are insufficient animal studies to indicate possible adverse or harmful effects in pregnant women. Therefore, butylscopolamine should not be used during pregnancy.

Breastfeeding:

Excretion of butylscopolamine bromide, the active ingredient of butylscopolamine, into breast milk has not been studied. Compounds of this type may inhibit milk production, and therefore newborns may be sensitive to such medicines. When deciding whether to discontinue breastfeeding or treatment with butylscopolamine, your doctor must weigh the benefits of breastfeeding for the child against the benefits of treatment for you.

Driving and using machines

Administration of butylscopolamine may cause adverse effects such as confusion, blurred vision, drowsiness, etc. These may affect your ability to drive vehicles or operate machinery.
No studies have been conducted on the ability to drive or use machinery.

Butilscopolamina Aurobindo contains sucrose

If your doctor has informed you that you have an intolerance to certain sugars, consult him/her before taking this medicine.

3. How to take Butilscopolamine Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Butilscopolamine Aurobindo must not be taken continuously for long periods of time.
Adults and children over 12 years of age
The usual dose of Butilscopolamine Aurobindo for adults and children over 6 years of age is as follows:
1-2 tablets (10 mg or 20 mg), 3 to 5 times daily.
The tablets should be taken whole (without chewing or breaking them), with an adequate amount of
liquid. The effect is observed 15 minutes after administration.
Do not take Butilscopolamine Aurobindo daily on a regular basis or for prolonged periods without
undergoing investigations to determine the causes of abdominal pain.
No dosage adjustment is required in patients with impaired renal and/or hepatic function.
Children from 6 to 12 years of age
The usual dose is 1 tablet three times daily.
Butilscopolamine Aurobindo is not recommended for children under 6 years of age.
If you take more Butilscopolamine Aurobindo than you should
Do not exceed the recommended doses of Butilscopolamine Aurobindo.
If you take more Butilscopolamine Aurobindo than you should, you may experience some of the adverse
events described in section 4, “Side effects”.
If this occurs, stop taking Butilscopolamine Aurobindo and contact your doctor immediately.
Additionally, if necessary, appropriate supportive treatments will be administered.
If you forget to take Butilscopolamine Aurobindo

• If you forget a dose, take it as soon as you remember. However, if it is almost time for the 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, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Butilscopolamine Aurobindo may cause side effects, although not everybody gets
them. The following side effects may occur with this medicine.
Many of the side effects of Butilscopolamine Aurobindo are related to its anticholinergic properties.
However, these effects are generally mild and transient. The following may occur:
Uncommon (may affect up to 1 in 100 people):

• fast heartbeat;
• dry mouth;
• reduced sweating;
• skin reactions (urticaria, itching).

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

• urinary retention.

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

• anaphylactic shock (a sudden and severe allergic reaction characterized by breathing difficulties, circulatory collapse, and sudden edema);
• anaphylactic reactions with episodes characterized by respiratory disturbances, skin reactions (rash, redness), and other hypersensitivity reactions.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Butilscopolamine Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after "Exp".
The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Butilscopolamina Aurobindo contains

• The active substance is butylscopolamine / hyoscine butylbromide. Each coated tablet contains 10 mg of butylscopolamine (hyoscine butylbromide).
• The other ingredients are:
  Tablet core: Calcium hydrogen phosphate anhydrous, maize starch, tartaric acid, colloidal anhydrous silica, stearic acid.
  Tablet coating: Sucrose, talc (E553b), hypromellose 2910 (5 mPa·s) (E464), macrogol 4000 (E1521), glycerol monostearate (E471), medium-chain triglycerides, polysorbate 80 (E433).

Description of the appearance of Butilscopolamina Aurobindo and contents of the pack
White to almost white, circular, sugar-coated, biconvex tablets, smooth on both sides.
Butilscopolamina Aurobindo coated tablets are available in blister packs.
Pack sizes
Blister packs: 10, 20, 30, 40, 50, 60 and 100 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102
21047 - Saronno (VA)
Manufacturer
APL Swift Services (Malta) Limited
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 medicinal product is authorized in the European Economic Area countries under the following
names:
Belgium: Butylhyoscine bromide AB 10 mg omhulde tabletten/comprimés enrobés/überzogene Tabletten
Germany: Butylscopolamin PUREN 10 mg überzogene Tabletten
Italy: Butilscopolamina Aurobindo
Poland: AuroGastro
Portugal: Butilescopolamina Conforpam
Spain: Butilescopolamina Aurovitas 10 mg comprimidos recubiertos EFG