BLASTON 1 mg TABLETS

Introduction

Patient Information Leaflet

Blaston 1 mg Tablets

Cinitapride

Read this leaflet carefully before you start taking this medicine, as 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. Do not give it to others, as it may harm them, even if they have the same symptoms as you.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Contents of the Leaflet:

1. What Blaston 1 mg Tablets are and what they are used for
2. What you need to know before taking Blaston 1 mg Tablets
3. How to take Blaston 1 mg Tablets
4. Possible side effects
   1. Storage of Blaston 1 mg Tablets
   2. Package contents and additional information

1. What Blaston 1 mg Tablets are and what they are used for

Blaston belongs to a group of medicines called prokinetics, which work by stimulating gastrointestinal motility.

Blaston is indicated for the treatment of gastroesophageal reflux to enhance the effect of proton pump inhibitors (medicines that reduce gastric acid production) and for mild to moderate functional disorders of gastrointestinal motility.

2. What you need to know before taking Blaston 1 mg Tablets

Do not take Blaston 1 mg Tablets

• if you are allergic to cinitapride or any of the other ingredients of this medicine (listed in section 6).
• if you have gastrointestinal bleeding, obstruction, or perforation.
• if you have a history of tardive dyskinesia induced by neuroleptics (rapid and repetitive movements of the head, neck, trunk, or limbs that may appear months after treatment has been discontinued).

Warnings and precautions

Consult your doctor or pharmacist before taking Blaston 1 mg Tablets.

• if you are an elderly patient and take the medicine for a prolonged period, as it may cause tardive dyskinesia (rapid and repetitive movements of the head, neck, trunk, or limbs that may appear months after treatment has been discontinued).

Taking Blaston 1 mg Tablets with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Blaston may increase the neurological effects of some medicines, especially those used to treat nervous system disorders, insomnia, and moderate to severe pain.

Blaston may decrease the effect of digoxin, a medicine used to treat heart failure.

On the other hand, some medicines may decrease the action of Blaston. This is the case with some medicines used to treat Parkinson's disease, abdominal pain, or respiratory diseases such as chronic bronchitis.

Taking Blaston 1 mg Tablets with food, drinks, and alcohol

Do not take Blaston with alcohol, as it may enhance its sedative effects.

Pregnancy and breastfeeding

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

Pregnancy

There are no data on the use of cinitapride in pregnant women. Animal studies do not suggest any direct or indirect harmful effects on reproduction. As a precaution, it is recommended to avoid the use of cinitapride during pregnancy.

Your doctor will decide whether you should take Blaston or not.

Breastfeeding

It is not known whether the medicine passes into breast milk. As a precaution, it is recommended to avoid the use of this medicine during breastfeeding.

Driving and using machines

Do not drive or operate hazardous machinery during treatment with Blaston.

Blaston 1 mg Tablets contain lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to take Blaston 1 mg Tablets

Follow the administration instructions for this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

Remember to take your medicine.

Use in children and adolescents

The administration of Blaston is not recommended in children and adolescents, as there is no experience with its use in these age groups.

Use in adults (over 20 years old)

The recommended dose for adults (over 20 years old) is 1 tablet, 3 times a day, 15 minutes before each meal.

It is not more effective or convenient to increase the recommended doses.

Your doctor will indicate the duration of your treatment with Blaston. Do not stop treatment before then.

The tablets should be taken orally with a glass of water.

If you think the action of Blaston is too strong or too weak, tell your doctor or pharmacist.

If you take more Blaston 1 mg Tablets than you should

If you have taken more Blaston than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 915 620 420, indicating the medicine and the amount taken.

The symptoms of overdose may be: drowsiness, disorientation, and extrapyramidal reactions (involuntary muscle movements of the face, neck, and tongue) that normally disappear when treatment is discontinued.

If you forget to take Blaston 1 mg Tablets

Do not take a double dose to make up for forgotten doses. Take the forgotten dose when you remember and then follow your regular schedule. However, if it is almost time for your next dose, do not take the forgotten dose and wait for the next scheduled dose.

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

4. Possible side effects

Like all medicines, Blaston can cause side effects, although not everyone gets them.

Side effects may be:

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

Some patients may notice mild sedation or drowsiness.

• Frequency not known (cannot be estimated from available data)

Extrapyramidal reactions (involuntary muscle movements of the face, neck, and tongue) may occur.

Skin reactions such as rash, itching, angioedema (swelling of the lips and tongue that may affect the larynx), gynecomastia (excessive development of breast tissue), and galactorrhea (milk secretion) may appear.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Blaston 1 mg Tablets

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Blaston 1 mg Tablets

The active ingredient is cinitapride (as tartaric acid). Each tablet contains 1 mg of cinitapride.

The other ingredients are sodium carboxymethyl starch (potato), microcrystalline cellulose, anhydrous lactose, colloidal silicon dioxide, and magnesium stearate (E-470b).

Appearance of the product and package contents

Blaston 1 mg Tablets are presented as round, bisected, light yellow tablets with a score line on the upper surface. Each box contains 50 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Lacer, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca – Barcelona (Spain)

Date of the last revision of this leaflet: March 2019

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