2

Dogmatil 50mg , Sulpiride : capsules

Fluotin : Indicated for Depression, Bulimia nervosa,  Panic disorder

Primperan : Indicated in adults for Symptomatic treatment of vomiting and nausea

Dogmatil 50mg

COMPOSITION

Active substance is: Sulpiride base 50 mg for one capsule

Excipients: Lactose,methylcellulose,talc,magnesium stearate

The capsule shell: gelatin, titanium dioxide (E171)

Dosage form and presentation

Capsule form Box of TO (2 x 15 capsules)

THERAPEUTIC INDICATIONS

NEUROLEPTIC ANTIPSYCHOTIC

BENZAMIDE

Dogmatil 50mg is used to treat certain forms of anxiety in adults and certain behavioral disorders in adults and children over 6 years of age

POSOLOGY AND METHOD OF ADMINISTRATION

Dosage

For use in adults and children over 6 years of age only.

The dosage is variable and must be adapted to cue h individual case

IN All CASES. Strictly follow your doctor’s PRESCRIPTION

Method of administration

Oral use

Treatment duration

follow your doctor PRESCRIPTION

CONTRA INDICATIONS

Never take Dogmatil 50mg capsules in Ihe following cases in the following case:

hypersensitivity to sulpiride or to one the other ingredients of the product

Diagnosed prolactin- dependent tomors, e.g pituitary gland tumor or breast cancer,

Pheochromocytoma (a condition affecting the adrenal medulla, causing  severe high blood pressure),in minhination wdh dopamine agomsls not lor use

SPECIAL WARNINGS

In the event of unexplained level paleness or heavy sweating, it is essential that you alert a doctor or an emergency medical service immediatlely

Inurdei In detect any potential heart disorders yum dot lot may ask you to undergo an Her In aidiogiain I Ins is this metit me tan used with taulion m pahenls who mulitme dmulii he used with Caution paltertls suffering from dementia.

Dogmatil 50mg should hr used with caution if you or a family member have a history of blood clots since taking antipsychotic drugs has been associated with the formation of blood clots.

In children, regular medical follow- up is essential

Tablets or capsules must not be given to children under 6 years of

age since this may cause choking.

It is inadvisable to use this drug with drinks or medicines containing alcohol, with levodopa, dopamine antiparkinsonian drugs, antiparasitics likely to induce torsades de pointes (serious heart rhythm disorders), methadone, other neuroleptics and drugs likely to induce torsades de pointes (see Section “Taking other medicines”).

Dogmatil 50mg contains lactose and is therefore not recommended if you have galactose intolerance, Lapp lactase deficiency or glucose and galactose malabsorption syndrome (rare hereditary diseases). IF YOU ARE UNSURE OF ANYTHING, IT IS ESSENTIAL THAT YOU ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE

PRECAUTIONS FOR USE

You must inform your doctor if you have any of the following so that he/she can adjust the dosage and/or  treatment monitoring:

– heart disease

– Parkinson’s disease,

– kidney failure.

– a history of seizures (long standing or recent), or epilepsy,

– diabetes or risk factors for diabetes.

IF YOU ARE UNSURE Of ANYTHING. DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE

PREGNANCY AND BREAST-FEEDING

Pregnancy

Dogmatil 50mg should only be used during pregnancy on the advice of your doctor

If you discover that you are pregnant, consult your doctor so that he/she can determine whether it is necessary to continue treatment.

Breast-feeding

Breast-feeding is not recommended during treatment with this medicine. Ask your doctor or pharmacist for advice before taking any medicine

DRIVING AND USING MACHINES

You should be aware, especially il you drive or use machines, that Dogniatil 50 may cause drowsiness

Important information about certain ingredients of Dogniatil 50 mg capsules: lactose

TALKING OTHER MEDICINLS

Dogniatil 50mg MUST NOT TAKEN with cabergoline or quinagolide (medicines used for lactation disoiders) Using Dogniatil 50mg with the billowing substances MUST BE AVOIDED:

– Certain medicines for the treatment of Parkinson’s disease

– Certain medicines that can induce torsades de pointes (serious heart rhythm disorders),

– Drinks or medicines containing alcohol

Please Inform Your Doctor Or Pharmacist If You Are Taking Or Have Recently Taken Any Other Medicines,Including Those Obtained Without A prescription

POSSIBLE SIDE EFECTS

As with all medicines, Dogmatil 50mg capsules can cause side effects although not all patients have them.

– absence of menstrual period, enlarge d breasts, atmoimal svuetum of milk from the nipple

– impotent frigidity

– weight gain

– drowsiness

– shaking, rigidity  and/or abnormal movements including facial ( and tongue ) ovements

– dizziness oil standing hom a lying oi sitting position,

– heart rhythm disorders, which may lead to death (see Section ’ “Special Warnings*)

– seizures

– rash

– increase in liver enzymes

– Venous blood clots, particularly in the legs (symptoms include swelling, pain and redness in the legs) may pass through the blood vessels to reach the lungs, causing chest pain and difficulty breathing If you experience any of these symptoms, see a doctor immediately.

– Neuroleptic malignant syndrome which can be life-threatening unexplained fever, sweating, paleness, change m blood pressure or heart rhythm impaired consciousness, muscle rigidity.

Immediately alert a doctor or an emergency medical service if any of these symptoms develop (see Section “Special Warnings”).

Do not hesitate to ask your doctor or pharmacist for advice and to inform them of any unwanted and unpleasant side effects. particularly those not mentioned in this package leaflet

PHARMACODYNAMIC PROPERTIES

NEUROLEPIIC ANIlPSYCHOTIC BFNZAMIDE

ATC CODE :  N05AL01

Sulpiride interferes in cerebral dopamincigic nerve transmission and exerts an activating action simulating a dopaminomimctic effect at low doses. At higher doses, sulpiride also has an antiprodutive action.

PHARMACOKINETIC PROPERTIES

Following oral administration of one capsule containing 50 mg, the plasma peak for sulpiride is reached m 3 to 6 hours, corresponding to 0.25 mg/l. 1 he bioavailabihty of the oral forms is 25 to 35%, with high inter- individual variability. The kinetic profile of sulpiride remains linear after administration of doses ranging from 50 to 300 mg.

Sulpiride is rapidly distributed into tissue the apparent volume of distribution at the steady state is 0<M 1/kg. Plasma protein binding is approximately 40%. Sulpiride is excreted in breast milk to a limited extent, and crosses the placental harrier

Sulpiride undergoes slight metabolism in man.

Sulpiride mainly undergoes renal excretion, by glomerular filtr.ition.Iot.il c Ivar.tncc is 12b ml/mm The elimination half-life is 7 hours

OVERDOSE

If you take too high a dose ol Ihe medicine, immediately alert a doctor or an emergency medical service because of the risk of serious heart disorders

STORAGE

Keep out of the reach and sight of children

Do not use Dogniatil 50mg capsule’s after The tartly dale printed on the box

Store at a temperature no higher than 30 C

Medicines should not be disposed ol via wastewatei oi with household waste youirphaimatist what to do with unused mvdit me measures will help to protect Ihe environment

shell life 36 months

Prescription only medicine

Read all of this leaflet carefully before you start taking this medicine.

If you have any questions or are unsure of anything, ask your doctor or pharmacist for more information.

Keep this leaflet, You may need to read it again.

Dogmatil 50mg has been prescried for you personally and you should no! pass it on to others. It may harm them, even if their symptoms are the same as yours

If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

Some drugs have composition sulpirid 50mg : Dogatina , Spirilix , Stogurad …

Dogatina-sulpirid-50mg

Spirilix-sulpirid-50mg

Stogurad-sulpirid-50mg

 

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