Prospect: information for the patient

Blaston 1 mg Tablets

Cinitaprida

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect.

1.What is Blaston 1 mg Tablets and what is it used for

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

3.How to take Blaston 1 mg Tablets

4.Possible adverse effects

1. Storage of Blaston 1 mg Tablets
2. Contents of the package and additional information

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

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

Do not take Blaston 1 mg Tablets

• if you are allergic to cinitaprida or any of the other ingredients of this medication (listed in section 6).
• if you have gastrointestinal hemorrhage, 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 starting to take Blaston 1 mg tablets.

• if you are an elderly patient and take the medication 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 Medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

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

On the other hand, some medications may decrease the action of Blaston. This is the case for some medications 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

Blaston should not be taken with alcohol as it potentiates its sedative effects.

Pregnancy and Breastfeeding

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

Pregnancy

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

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

Breastfeeding

The medication's passage into breast milk is unknown. As a precaution, it is recommended to avoid the use of this medication during breastfeeding.

Driving and Operating Machinery

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

Blaston 1 mg Tablets contain lactose

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Use in children and adolescents

No administration of Blaston is recommended in children and adolescents, as there is no experience of use in these age groups.

Use in adults (over 20 years)

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

Increasing the recommended doses is not more effective or convenient.

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

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

If you estimate that the action of Blaston is too strong or weak, inform 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 Toxicological Information Service, phone: 915 620 420, indicating the medication and the amount taken.

The symptoms of overdose may be: drowsiness, disorientation, and extrapyramidal reactions (involuntary facial, neck, and tongue muscle movements) that usually disappear when treatment is stopped.

If you forgot to take Blaston 1 mg Tablets

Do not take a double dose to compensate for the missed doses. Take the missed dose when you remember and then continue with your regular schedule. However, if there are only a few hours left before the next dose, do not take the missed dose and wait for the next dose at the scheduled time.

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

Like all medications, Blaston can produce adverse effects, although not all people will experience them.

Adverse effects may include:

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

Some patients may notice mild drowsiness or somnolence.

• Unknown frequency (cannot be estimated from available data)

They may cause extrapyramidal reactions (involuntary facial, neck, and tongue movements).

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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:https://www.notificaram.es

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

No special storage conditions are required.

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.

Unused medications 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 Blaston 1 mg Tablets

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

The other components are sodium carboxymethylcellulose (from potato), powdered cellulose, anhydrous lactose, colloidal silica, and magnesium stearate (E-470b).

Appearance of the product and contents of the packaging

Blaston 1 mg Tablets are presented in the form of round, bisected, light yellow tablets with a scored surface. Each box contains 50 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Lacer, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Responsible for manufacturing

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca – Barcelona (Spain)

Last review date of this leaflet: March 2019

The detailed and updated information on this medication is available on the website of

the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/