FLATORIL 500 micrograms/200 mg HARD CAPSULES

1. What is Flatoril and what is it used for

Flatoril is composed of clebopride (an antiemetic and prokinetic) and simethicone (an antiflatulent), and belongs to the group of medicines for functional gastrointestinal disorders called propulsives. 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 treatment of functional gastrointestinal motility disorders that occur with flatulence (feeling of gastric discomfort accompanied by a feeling of abdominal fullness) in adults.
• Preventive treatment of excess gas in radiological examinations of the digestive tract in adults.
• Symptomatic treatment of postoperative nausea and vomiting that occur with flatulence in adults.

2. What you need to know before taking Flatoril

Do not take Flatoril:

• If you are allergic to clebopride maleate, simethicone, or any of the other components of this medicine (listed in section 6).
• If you have bleeding, obstruction, or gastrointestinal perforation.
• If you suffer from abnormal and involuntary movements (tardive dyskinesia) that appear in people being treated with a type of medication called neuroleptics.
• If you suffer from seizures (epilepsy).
• If you suffer from Parkinson's disease or other extrapyramidal disorders (which cause alterations in muscle tone, posture, and the appearance of involuntary movements).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Flatoril:

• If you have a severe liver or kidney disease (severe hepatic or renal insufficiency), as it may increase the effect of this medicine.
• If you have certain tumors, such as breast tumors or prolactin-secreting hypophyseal adenocarcinoma, because 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 those recommended may increase the possibility of extrapyramidal reactions (alterations in muscle tone, posture, and the appearance of involuntary movements).

Children

In newborns, cases of acquired methemoglobinemia (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 medicines and Flatoril

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

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

• Phenothiazines, butyrophenones, and other antidopaminergics (used to treat certain mental illnesses) as Flatoril may increase the effect of these medicines on the central nervous system.
• Digoxin (used to treat heart diseases) and cimetidine (used in situations where it is necessary to decrease acid production by the stomach) as Flatoril decreases their effects.
• Hypnotics (medicines 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) or narcotic analgesics (opioids) because they neutralize the action of Flatoril on gastrointestinal motility.
• MAOIs (used to treat depression), as their use with Flatoril may increase the risk of adverse effects.

Taking Flatoril with alcohol

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

Pregnancy and breastfeeding

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

There is not enough information about the use of this medicine in pregnant women or whether it is excreted in breast milk. For this reason, as a precautionary measure, it is preferable to avoid its use during pregnancy, especially during the first three months.

Driving and using machines

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

Flatoril contains sodium

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

3. How to take Flatoril

Follow exactly the administration instructions of the medicine 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 excess gas 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 gastrointestinal motility disorders that occur with flatulence and symptomatic treatment of postoperative nausea and vomiting that occur with flatulence: 1 capsule (500 micrograms of clebopride and 200 mg of simethicone), 3 times a day before meals.

Method of use and administration route

This medicine is for oral administration.

Take your dose with the help of some liquid, preferably water.

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

For the indications of symptomatic treatment of functional gastrointestinal motility disorders that occur with flatulence and symptomatic treatment of postoperative nausea and vomiting that occur with flatulence, take each dose before meals.

If you take more Flatoril than 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 medicine and the amount ingested.

In case of overdose, drowsiness, disorientation, and extrapyramidal reactions (alterations in muscle tone, posture, and the appearance of involuntary movements) may appear, which normally disappear when treatment is discontinued.

If the symptoms persist, consult your doctor.

If you forget to take Flatoril

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

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

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

• Alterations in muscle tone, posture, and the appearance of involuntary movements (extrapyramidal disorders)
• Abnormal involuntary movements (dystonias, most frequently reported in the neck, tongue, or face; dyskinesia; tardive dyskinesia, in elderly patients after prolonged treatments).
• Sedation
• 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)
• Increased breast size in men (gynecomastia)
• Difficulty achieving or maintaining an erection (erectile dysfunction)
• Absence of menstruation (amenorrhea)

These side effects have been reported after prolonged treatments

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

• Gastrointestinal disorders (nausea, vomiting, constipation)
• Immune system disorders (hypersensitivity reactions, such as skin rash, itching, swelling (edema) of the face or tongue, difficulty breathing).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Flatoril

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 that appears on the packaging or on the blister pack after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Flatoril

• The active ingredients are clebopride and simethicone. Each capsule contains 500 micrograms of clebopride (as clebopride maleate) and 200 mg of simethicone.

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), indigo carmine (E-132), and gelatin.

Appearance of the product and package contents

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 packs containing 45 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

Almirall, S.A.

General Mitre, 151

08022 – Barcelona

Manufacturer

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

Date of the last revision of this leaflet: May 2014

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