Prospect: information for the user

Cinitaprida Kern Pharma 1 mg tablets EFG

Read this prospect carefully before starting to take this medicine, because 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 medicine has been prescribed only for 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 are not listed in this prospect.

1.What is Cinitaprida Kern Pharma and for what it is used

2.What you need to know before starting to take Cinitaprida Kern Pharma

3.How to take Cinitaprida Kern Pharma

4.Possible adverse effects

5.Storage of Cinitaprida Kern Pharma

6.Contents of the package and additional information

Cinitaprida Kern Pharma belongs to a group of medications known as prokinetics, which act by stimulating gastrointestinal motility.

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

Do not take Cinitaprida Kern Pharma

• If you are allergic (hypersensitive) to cinitaprida or to any of the other components of Cinitaprida Kern Pharma.
• 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 starting to take Cinitaprida Kern Pharma if you are an elderly patient and taking the medication for a prolonged period, as it could cause tardive dyskinesia (rapid and repetitive movements of the head, neck, trunk, or limbs that may appear months after treatment has been discontinued).

Taking Cinitaprida Kern Pharma with other medications

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

Cinitaprida Kern Pharma may increase the neurologic effects of some medications, especially those used to treat nervous system disorders, insomnia, and moderate or intense pain.

Cinitaprida Kern Pharma may decrease the effect of digoxin, a medication used to treat certain heart function abnormalities (heart failure).

On the other hand, some medications may decrease the action of Cinitaprida Kern Pharma. In the case of some medications used to treat Parkinson's disease, abdominal pain, or respiratory diseases such as chronic bronchitis.

Taking Cinitaprida Kern Pharma with food, drinks, and alcohol

Cinitaprida Kern Pharma should not be taken with alcohol as it potentiates its sedative effects.

Pregnancy, breastfeeding, and fertility

Pregnancy:

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. Cinitaprida Kern Pharma should not be administered in the first trimester of pregnancy.

Breastfeeding:

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

Do not drive or operate hazardous machinery during treatment with Cinitaprida Kern Pharma.

Cinitaprida Kern Pharma contains 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.

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

Administration of Cinitaprida Kern Pharma is not recommended in children and adolescents due to lack of experience in these age groups.

Use in adults (over 20 years)

The usual 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 Cinitaprida Kern Pharma. Do not discontinue treatment before.

Tablets should be taken orally with a glass of water.

If you estimate that the action of Cinitaprida Kern Pharma is too strong or weak, inform your doctor or pharmacist.

If you take more Cinitaprida Kern Pharma than you should

If you have taken more Cinitaprida Kern Pharma 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.

Symptoms of overdose may include: drowsiness, disorientation, and extrapyramidal reactions (involuntary facial, neck, and tongue muscle movements) that usually disappear when treatment is discontinued.

If you forgot to take Cinitaprida Kern Pharma

Do not take a double dose to compensate for the missed dose. 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 product, ask your doctor or pharmacist.

If you interrupt treatment with Cinitaprida Kern Pharma

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

Like all medications, Cinitaprida Kern Pharma may produce adverse effects, although not everyone will experience them. Adverse effects may include:

• Rarely, extrapyramidal reactions (involuntary facial, neck, and tongue muscle movements).
• Some patients may notice mild sedation or drowsiness.
• In very rare cases, skin reactions such as rash, itching, and occasionally angioedema (swelling of the lips and tongue that may affect the larynx) and gynecomastia (excessive development of the breast glands) may appear.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: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.

Store below 30°C.

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.

Medicinesshould not be disposed of through drains or in thetrash. Dispose of the packaging and medicines you no longer need at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Cinitaprida Kern Pharma

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

The other components (excipients) are: anhydrous lactose, microcrystalline cellulose, sodium glycolate starch, colloidal silica, and magnesium stearate.

Appearance of the product and content of the packaging

Cinitaprida Kern Pharma 1 mg is presented in the form of tablets. They are yellow-colored, round, biconvex, and have a breaking bar on one face. Each package contains 50 tablets.

Holder of the marketing authorization

Kern Pharma, S.L.

Pol.Ind.Colón II, C/Venus 72

08228 Terrassa (Barcelona)

Spain

Responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This prospectus was approved in December 2013

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