Flatoril 500 micrograms/200 mg hard capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Flatoril 500 micrograms/200 mg Hard capsules
Clebopride/Simethicone
Read the entire leaflet carefully before you start taking this medicine, because 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, because it could harm them.
- If you experience adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Flatoril is and what it is used for
- What you need to know before taking Flatoril
- How to take Flatoril
- Possible side effects
- How to store Flatoril
- Contents of the pack and other information
1. What Flatoril is and what it is used for
Flatoril contains clebopride (an antiemetic and prokinetic agent) and simeticone (an antiflatulent), and belongs to the group of gastrointestinal functional disorder medications known as propulsives. It prevents gas formation and stimulates gastrointestinal motility, helping to expel gas from the stomach and intestines.
Flatoril is indicated for:
- Symptomatic treatment of functional gastrointestinal motility disorders associated with flatulence (gastric discomfort accompanied by a sensation of abdominal fullness) in adults.
- Preventive treatment of excess gas in radiological examinations of the gastrointestinal tract in adults.
- Symptomatic treatment of postoperative nausea and vomiting associated with flatulence in adults.
2. What you need to know before taking Flatoril
Do not take Flatoril:
- If you are allergic to clebopride malate, simethicone, or any of the other ingredients of this medicine (listed in section 6).
- If you have gastrointestinal bleeding, obstruction, or perforation.
- If you suffer from abnormal and involuntary movements (tardive dyskinesia) occurring in people being treated with a group of medicines called neuroleptics.
- If you have seizures (epilepsy).
- If you have Parkinson's disease or other extrapyramidal disorders (which cause disturbances in muscle tone, posture, and the appearance of involuntary movements).
Warnings and precautions
Talk to your doctor or pharmacist before taking Flatoril:
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If you have severe liver or kidney disease (severe hepatic or renal insufficiency), as this may increase the effect of this medicine.
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If you have certain tumors, such as breast tumors or prolactin-secreting pituitary adenocarcinoma, because it may increase blood levels of a hormone called prolactin.
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In children, adolescents, and elderly patients, using doses higher than recommended may increase the likelihood of extrapyramidal reactions (alterations in muscle tone, posture, and appearance of involuntary movements).
Children
In newborns, cases of acquired methemoglobinemia (a blood disorder affecting the blood's ability to carry oxygen) have been reported due to orthopramides (a group of medicines to which Flatoril belongs).
Other medicines and Flatoril
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
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 enhance the effects of these medicines on the central nervous system.
- Digoxin (used to treat heart conditions) and cimetidine (used when reduction of stomach acid production is required), as Flatoril may reduce their effects.
- Hypnotics (medicines that improve sleep onset and duration), anxiolytics (reduce anxiety), or narcotics (used to treat moderate to severe pain), as Flatoril may enhance their sedative effects.
- Anticholinergics (such as atropine, used to relieve stomach cramps or spasms, to treat Parkinson's disease, or to prevent motion sickness) or narcotic analgesics (opioids), as they may neutralize Flatoril's effect on gastrointestinal motility.
- MAOIs (monoamine oxidase inhibitors, used to treat depression), as their use together with Flatoril may increase the risk of adverse effects.
Taking Flatoril with alcohol
Avoid alcohol while taking Flatoril, as it may enhance 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.
There is insufficient information on 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, and especially during the first three months.
Driving and using machines
During treatment with Flatoril, you should avoid situations requiring special alertness, such as driving vehicles or operating dangerous machinery.
Flatoril contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per capsule; thus, it is essentially "sodium-free".
3. How to take Flatoril
Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose for adults is:
- For the preventive treatment of excess gas in gastrointestinal X-ray examinations: 1 capsule (500 micrograms of clebopride and 200 mg of simethicone) 2 hours before the procedure.
- For the symptomatic treatment of functional gastrointestinal motility disorders associated with flatulence, and for the symptomatic treatment of postoperative nausea and vomiting associated with flatulence: 1 capsule (500 micrograms of clebopride and 200 mg of simethicone), 3 times a day before meals.
Method of administration and route
This medicine is for oral use.
Take your dose with a drink, preferably water.
For the indication of preventive treatment of meteorism in gastrointestinal X-ray examinations, administration must be performed 2 hours before the diagnostic procedure.
For the indications of symptomatic treatment of functional gastrointestinal motility disorders associated with flatulence and symptomatic treatment of postoperative nausea and vomiting associated with flatulence, take each dose before meals.
If you take more Flatoril than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 915 620 420, stating the medicine and the amount ingested.
In case of overdose, symptoms such as somnolence, disorientation, and extrapyramidal reactions (alterations in muscle tone, posture, and involuntary movements) may occur, which normally resolve upon discontinuation of treatment.
If symptoms persist, consult your doctor.
If you forget to take Flatoril
Do not take a double dose to make up for missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Rare (may affect up to 1 in 1,000 patients)
- Disorders of muscle tone, posture, and involuntary movements (extrapyramidal disorders)
- Abnormal involuntary movements (dystonias, more frequently reported in the neck, tongue, or face; dyskinesia; tardive dyskinesia in elderly patients after prolonged treatment)
- Sedation
- Tremor
- Somnolence
Very rare (may affect up to 1 in 10,000 patients)
- Increased levels of prolactin in the blood (hyperprolactinaemia)
- Milk secretion outside the lactation period (galactorrhoea)
- Enlargement of the breasts in males (gynaecomastia)
- Difficulty achieving or maintaining an erection (erectile dysfunction)
- Absence of menstruation (amenorrhoea)
These adverse effects have been reported after prolonged treatment.
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 (oedema) of the face or tongue, breathing difficulties)
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging or on the blister after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Flatoril
- The active substances are clebopride and simethicone. Each capsule contains 500 micrograms of clebopride (as clebopride malate) and 200 mg of simethicone.
The other components (excipients) are: povidone, sodium lauryl sulfate, colloidal silica and sodium croscarmellose. Capsule components: titanium dioxide (E-171), erythrosine (E-127), indigo carmine (E-132) and gelatin.
Appearance of the product and contents of the pack
Flatoril is presented as hard gelatin capsules with a white body and red cap containing white powder, packed in PVC/Aluminum blister packs containing 45 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 most recent revision of this leaflet: May 2014
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)