Blaston 1 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Blaston 1 mg Tablets

Cinitapride

Read the entire leaflet carefully before starting to take 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, consult 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, since it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.

Leaflet contents:

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 adverse effects
   1. Storage of Blaston 1 mg Tablets
   2. Contents of the container 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 to 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 neuroleptic-induced tardive dyskinesia (repetitive, involuntary movements of the head, neck, trunk, or limbs that may appear months after discontinuation of treatment).

Warnings and precautions

Talk to your doctor or pharmacist before taking Blaston 1 mg Tablets.

• if you are an elderly patient and will be taking the medicine for a prolonged period, as this may lead to tardive dyskinesia (repetitive, involuntary movements of the head, neck, trunk, or limbs that may appear months after discontinuation of treatment).

Taking Blaston 1 mg Tablets with other medicines

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

Blaston may enhance the neurological effects of certain medicines, particularly those used to treat nervous system disorders, insomnia, and moderate to severe pain.

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

Conversely, certain medicines may reduce the action of Blaston. This includes 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

Blaston should not be taken with alcohol, as alcohol enhances its sedative effects.

Pregnancy and breastfeeding

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

Pregnancy

There are no data regarding the use of cinitapride in pregnant women. Animal studies have not shown any direct or indirect harmful effects in terms of reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of cinitapride during pregnancy.

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

Breastfeeding

It is unknown whether the medicine passes into breast milk. As a precautionary measure, it is preferable to avoid using this medicine during breastfeeding.

Driving and using machines

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

Blaston 1 mg Tablets contain lactose

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

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

3. How to take Blaston 1 mg Tablets

Follow exactly the instructions given by your doctor for taking this medicine. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Use in children and adolescents

Administration of Blaston is not recommended in children and adolescents, as there is no experience of use in these age groups.

Use in adults (over 20 years of age)

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

It is neither more effective nor advisable to increase the recommended doses.

Your doctor will determine the duration of your treatment with Blaston. Do not stop the treatment prematurely.

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

If you feel that the effect of Blaston is too strong or too 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 915 620 420, indicating the medicine and the amount taken.

Symptoms of overdose may include: drowsiness, disorientation, and extrapyramidal reactions (involuntary muscle movements of the face, neck, and tongue), which normally resolve upon discontinuation of treatment.

If you forget to take Blaston 1 mg Tablets

Do not take a double dose to make up for forgotten doses. Take the missed dose as soon as you remember, then continue with your regular dosing schedule. However, if it is almost time for your next dose, do not take the missed dose and wait until the next scheduled dose at the usual time.

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

4. Possible adverse effects

Like all medicines, Blaston may cause adverse effects, although not everyone experiences them.

Adverse effects may include:

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

? Some patients may experience mild sedation or drowsiness.

• Frequency unknown (cannot be estimated from available data)

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

? Skin reactions may appear, such as rash, itching, angioedema (swelling of lips and tongue which may affect the larynx), gynecomastia (excessive development of mammary glands), and galactorrhea (milk secretion).

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es

By reporting adverse 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 expiry date stated on the packaging after Exp. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Blaston 1 mg Tablets

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

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

Appearance of the product and contents of the pack

Blaston 1 mg Tablets are round, bevelled, light yellow tablets, scored on one side. 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 most recent revision of this leaflet: March 2019

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/