User Information: Package Insert

Flatoril500 micrograms/200 mgHard Capsules

Clebopride/Simethicone

Read this entire package insert carefully before taking this medicine, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others who may 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 package insert. See section 4.

Flatorilis composed of cleboprida (an antiemetic and prokinetic)and simeticona (an antiflatulent),and belongs to the group of medicationsfor functional gastrointestinal disordersdesignated asprokinetics.It prevents the formation of gases and stimulates gastrointestinal motility, which helps to expel gases from the stomach and intestine.

Flatoril is indicated for:

• Symptomatic treatmentof functional disorders of gastrointestinal motility that are accompanied by flatulence(a sensationof gastric discomfort accompanied by a sensation of abdominal fullness) in adults.
• Preventive treatment ofexcess gasin radiological explorations of the digestive tractin adults.
• Symptomatic treatment of nausea and vomitingpost-operativethat are accompanied by flatulencein adults.

Do not take Flatoril:

• If you areallergicto clebopride maleate, simethicone, or any of the other ingredients of this medication (listed in section 6).
• If you havegastrointestinal bleeding, obstruction, or perforation.
• If you suffer from abnormal and involuntary movements (tardive dyskinesia) that occur in people treated with a type of medication called neuroleptics..
• If you suffer fromseizures (epilepsy).
• If you suffer fromParkinson's disease or other extrapyramidal disorders (which cause muscle tone, posture, and involuntary movement alterations).

Warnings and precautions

Consult your doctor or pharmacist before starting to takeFlatoril:

• If you have severe liver or kidney disease (severe hepatic or renal insufficiency), as it may increase the effect of this medication.
• If you have some tumors, such as breast cancer or prolactin-secreting pituitary adenocarcinoma, as it may increase the level of a hormone called prolactin in the blood.

• In children, adolescents, and the elderly,the use of doses higher than recommended may increase the likelihood ofextrapyramidal reactions(muscle tone, posture, and involuntary movement alterations).

Children

In newborns, cases ofmetahemoglobinemiaacquired (a blood disorder that affects its ability to transport oxygen) due to orthopramides (a group of medications to which Flatoril belongs)have been described.

Other medications andFlatoril

Inform your doctor or pharmacist if you aretaking,have takenrecentlyor may need to take any other medication.

It is especially important to inform your doctor if you are taking any of the following medications:

• Phenothiazines, butyrophenones, and other antipsychotics(used to treat certain mental illnesses) as Flatoril may increase the effect of these medications on the central nervous system.
• Digoxin(used to treat heart diseases)and cimetidine(used in situations where it is necessary to reduce stomach acid production) as Flatoril reduces their effects
• Hypnotics (medications that improve sleep onset and duration), anxiolytics (reduce anxiety) or narcotics (used to treat moderate or severe pain) as Flatoril may potentiate their sedative effects.
• Anticholinergics (such as atropine, used to relieve stomach cramps or spasms, to treat Parkinson's disease, or to prevent travel sickness) oropioid analgesicsbecause they neutralize the action of Flatoril on gastrointestinal motility.
• IMAO (used to treat depression), as its use with Flatoril may increase the risk of adverse effects.

Flatoril and alcohol

Avoid taking alcohol while taking Flatoril, as it may potentiate its sedative effects.

Pregnancy and breastfeeding

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

No sufficient information is available on the use of this medication in pregnant women or if it is excreted in breast milk. For this reason, as a precaution, it is best to avoid its use during pregnancy, especially in the first three months.

Driving and operating machinery

During treatment with Flatoril, you should avoid situations that require a special state of alertness, such as driving or operating hazardous machinery.

Flatoril contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per capsule; that is, it is essentially “sodium-free”.

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

The recommended dose for adults is:

- For the preventive treatment of gas excess in radiological examinations of the digestive tract: 1 capsule (500 micrograms of clebopride and 200 mg of simethicone) 2 hours before the test.

- For the symptomatic treatment of functional disorders of gastrointestinal motility that are accompanied by flatulence and symptomatic treatment of postoperative nausea and vomiting that are accompanied by flatulence: 1 capsule (500 micrograms of clebopride and 200 mg of simethicone), 3 times a day before meals.

Form of use and route of administration

This medication is for oral administration

Take your dose with the help of something liquid, preferably water

For the indication of preventive treatment of meteorism in radiological examinations of the digestive tract, administration should be performed 2 hours before the exploratory procedure

For the symptomatic treatment indications of functional disorders of gastrointestinal motility that are accompanied by flatulence and symptomatic treatment of postoperative nausea and vomiting that are accompanied by flatulencetake each dose before meals

If you take moreFlatorilthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amountingested.

In case ofoverdose, somnolence, disorientation, and extrapyramidal reactions (muscle tone alterations, posture, and appearance of involuntary movements)may appear, which usually disappear when treatment is suspended

Ifsymptomspersist, see your doctor

If you forgot to takeFlatoril

Do not take a double dose to compensate for the missed doses

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

Like all medications,this medicationmay cause adverse effects, although not all people will experience them.

Rare (may affect up to 1 in 1,000 patients)

• Muscle tone, posture alterations, and involuntary movement (extrapyramidal disorders)
• Abnormal involuntary movements (dystonias, more frequently reported in the neck, tongue, or face; dyskinesia; tardive dyskinesia, in elderly patients after prolonged treatment)
• Drowsiness
• Tremor
• Drowsiness

Very rare (may affect up to 1 in 10,000 patients)

• Increased levels of prolactin in the blood (hyperprolactinemia)
• Milk secretion outside the lactation period (galactorrhea)
• Enlargement of the breasts in males (gynecomastia)
• Difficulty achieving or maintaining an erection (erectile dysfunction)
• Absence of menstruation (amenorrhea)

These adverse effects have been reported after prolonged treatment

Unknown frequency (cannot be estimated from available data)

• Gastrointestinal alterations (nausea, vomiting, constipation)
• Immune system alterations (hypersensitivity reactions, such as skin rash, itching, facial or tongue swelling, difficulty breathing)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 on 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 shown on the packaging or blister after CAD. The expiration date is the last day of the month indicated.

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 Flatoril

• The active principles are cleboprida and simeticona.Each capsule contains 500 micrograms of cleboprida (as cleboprida malate)and 200 mg of simeticona

The other components (excipients) are: povidone, sodium lauryl sulfate, colloidal silica, and sodium croscarmellose).Components of the capsule:titanium dioxide (E-171), erythrosine (E-127), indigotin (E-132), and gelatin.

Appearance of the product and contents of the packaging

Flatoril is presented in the form of hard gelatin capsules with a white body and a red cap containing white powder, in PVC/Aluminum blister packscontaining 45 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Almirall, S.A.

General Mitre, 151

08022 – Barcelona

Responsible for manufacturing

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

Local representative

Casen Recordati, S.L.

Autovía de Logroño, Km 13,300

50180 Utebo (Zaragoza)

Spain

Last review date of this leaflet: May 2014

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