Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Sulpiride 200mg Tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Sulpiride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for The name of your medicine is Sulpiride Tablets. It contains sulpiride. This belongs to a group of medicines called benzamides. It works by blocking the effect of a chemical in the brain. Sulpiride is used for treating acute and chronic schizophrenia.
What you need to know before you take it
e Sulpiride Tablets Do not take Sulpiride Tablets: ,IRXDUHDOOHUJLFWRVXOSLULGHRUDQRWKHU ingredients of this medicine (listed in Section 6). The signs of an allergic reaction include a rash, swallowing or breathing problems, swelling of your lips, throat or tongue. ,IRXKDYHDWXPRXURQWKHDGUHQDOJODQG called 'phaeochromocytoma' ,IRXKDYHDUDUHLOOQHVVFDOOHGμSRUSKULD¶ which affects your metabolism ,IRXKDYHEUHDVWFDQFHURUFDQFHULQWKH pituitary gland ,IRXDUHWDNLQJ/HYRGRSDRUURSLQLUROHXVHG for Parkinson's Disease 'RQRWWDNHWKLVPHGLFLQHLIDQRIWKHDERYH apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine. Warnings and precautions Talk your doctor or pharmacist before taking Sulpiride Tablets: ,IRXKDYHERXWVRIDJJUHVVLYHEHKDYLRXURU agitation ,IRXKDYHNLGQHSUREOHPV ,IRXKDYHKHDUWSUREOHPVRUDIDPLOKLVWRU of heart problems. Your doctor may test your heart function before you take this medicine. ,IRXKDYHHYHUKDGDVWURNH ,IRXRUVRPHRQHHOVHLQRXUIDPLOKDVD history of blood clots, as medicines like WKHVHKDYHEHHQDVVRFLDWHGZLWKIRUPDWLRQ of blood clots ,IRXKDYHORZOHYHOVRISRWDVVLXPLQRXU body (hypokalaemia) ,IWKHSHUVRQLVHDUVRIDJHRUROGHU ,IRXKDYHGHPHQWLD ,IRXKDYH3DUNLQVRQ¶V'LVHDVH ,IRXKDYHORZEORRGOHYHOVRISRWDVVLXP calcium and magnesium. Your doctor may do blood tests to check on these ,IRXKDYHHSLOHSVRUKDYHKDGILWV VHL]XUHV ,IRXKDYHDORZQXPEHURIZKLWHEORRG cells (agranulocytosis). This means you may get infections more easily than usual ,IRXKDYHIUHTXHQWLQIHFWLRQVVXFKDVIHYHU VHYHUHFKLOOVVRUHWKURDWRUPRXWKXOFHUV These could be signs of a blood problem called 'leukopenia' ,IRXKDYHKLJKEORRGSUHVVXUH ,IRXKDYHSDLQIXOHHVZLWKEOXUUHGYLVLRQ (glaucoma) ,IRXKDYHDWSHRIERZHOREVWUXFWLRQ LOHXV ,IRXKDYHGLIILFXOWSDVVLQJZDWHU XULQH ,IRXKDYHDQHQODUJHGSURVWDWH ,IRXKDYHDGLJHVWLYHSUREOHPFDOOHG FRQJHQLWDOGLJHVWLYHVWHQRVLV ,IRXRUVRPHRQHHOVHLQRXUIDPLOKDVD history of breast cancer ,IRXDUHQRWVXUHLIDQRIWKHDERYHDSSOWR you, talk to your doctor or pharmacist before taking Sulpiride Tablets. Other medicines and Sulpiride Tablets Tell your doctor or pharmacist if you are WDNLQJKDYHUHFHQWOWDNHQRUPLJKWWDNHDQ other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Sulpiride Tablets can affect the way some other medicines work. Also, some medicines can affect the way Sulpiride Tablets work. In particular, do not take this medicine and tell your doctor if you are taking: /HYRGRSDRUURSLQLUROHXVHGIRU3DUNLQVRQ¶V disease Tell your doctor if you are taking any of the following medicines; 0HGLFLQHVWRFRQWURORXUKHDUWEHDWVXFKDV DPLRGDURQHVRWDOROGLVRSUDPLGHRUTXLQLGLQH 0HGLFLQHVIRUKLJKEORRGSUHVVXUHRUKHDUW disorders, such as clonidine, diltiazem, YHUDSDPLORUGLJLWDOLV 2WKHUPHGLFLQHVIRUVFKL]RSKUHQLDVXFKDV pimozide, haloperidol, thioridazine /LWKLXPXVHGIRUVRPHWSHVRIPHQWDOLOOQHVV 6RPHPHGLFLQHVWRKHOSRXVOHHSRUORZHU your anxiety 2WKHUPHGLFLQHVXVHGWRFDOPHPRWLRQDODQG mental problems
:DWHUWDEOHWV GLXUHWLFV WKDWFDQORZHUWKH OHYHOVRISRWDVVLXPLQRXUEORRG 6RPHPHGLFLQHVXVHGIRUFRQVWLSDWLRQ OD[DWLYHV WKDWFDQORZHUWKHOHYHOVRI potassium in your blood 6RPHPHGLFLQHVXVHGIRULQIHFWLRQV (antibiotics) such as pentamidine, erythromycin or amphotericin B 7HWUDFRVDFWLGHXVHGWRWHVWWKHIXQFWLRQRI your adrenal gland 6WHURLGVXVHGWRORZHULQIODPPDWLRQVXFKDV prednisolone, betamethasone, dexamethasone 6RPHPHGLFLQHVIRUGHSUHVVLRQVXFKDV imipramine 0HGLFLQHVIRULQGLJHVWLRQDQGKHDUWEXUQ 6XFUDOIDWHXVHGIRUVWRPDFKXOFHUV 0HGLFLQHVIRUSDLQUHOLHI7KHVHPDDOVREH included in medicines for colds and flu 6RPHPHGLFLQHVXVHGIRUDOOHUJLHV (anti-histamines that make you sleepy) such as chlorphenamine, promethazine, ketotifen 0HWKDGRQHXVHGIRUSDLQUHOLHIDQGDVD drug substitute +DORIDQWULQHXVHGIRUPDODULD ,IRXDUHQRWVXUHLIDQRIWKHDERYHDSSOWR you, talk to your doctor or pharmacist before taking Sulpiride Tablets Sulpiride Tablets with alcohol Do not drink alcohol or take medicines that contain alcohol while being treated with Sulpiride Tablets. This is because alcohol can increase the effects of Sulpiride Tablets. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think RXPDEHSUHJQDQWRUDUHSODQQLQJWRKDYH DEDEDVNRXUGRFWRUIRUDGYLFHEHIRUH taking this medicine. Pregnancy Sulpiride Tablets are not recommended during pregnancy and in women of childbearing SRWHQWLDOQRWXVLQJHIIHFWLYHFRQWUDFHSWLRQ If you use Sulpiride Tablets during the last three months of pregnancy, your baby may suffer from agitation, increased muscle WHQVLRQLQYROXQWDUWUHPEOLQJRIWKHERG somnolence, respiratory distress, or feeding disorder. Talk to your doctor, if your baby GHYHORSVDQRIWKHVHVPSWRPV Breast-feeding Do not breast-feed if you are taking Sulpiride Tablets. This is because small amount may pass into mothers' milk. If you are breast-feeding or planning to breast-feed talk to your doctor or pharmacist before taking this medicine. The following symptoms may occur in QHZERUQEDELHVRIPRWKHUVWKDWKDYHXVHG Sulpiride Tablets in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in IHHGLQJ,IRXUEDEGHYHORSVDQRIWKHVH symptoms you may need to contact your doctor. Driving and using machines You may feel sleepy after taking this medicine. ,IWKLVKDSSHQVGRQRWGULYHRUXVHDQWRROV or machines. Sulpiride Tablets contain lactose 7KLVPHGLFLQHFRQWDLQVODFWRVH,IRXKDYH EHHQWROGERXUGRFWRUWKDWRXKDYHDQ intolerance to some sugars, contact your doctor before taking this medicine.
How to take it
Sulpiride Tablets Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Taking this medicine 7DNHWKLVPHGLFLQHEPRXWK Swallow the tablets whole with a drink of water. ,IRXIHHOWKHHIIHFWRIRXUPHGLFLQHLVWRR weak or too strong, do not change the dose yourself, but ask your doctor Adults: The recommended dose is 400mg twice daily 7KHGRFWRUPDUHGXFHWKHGRVHWRPJ twice daily or increase it to a maximum of 1200mg twice daily Patients with Kidney Disease 7KHVWDUWLQJGRVHPDEHORZHUDQGWKHUDWH of increasing the dose slower. Use in Children: This medicine is not recommended for children under the age of 14. If you take more Sulpiride Tablets than you should If you take more Sulpiride Tablets than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor NQRZVZKDWRXKDYHWDNHQ7KHIROORZLQJ effects may happen: feeling restless, FRQIXVHGRUDJLWDWHGKDYLQJDUHGXFHGOHYHO of consciousness, trembling, muscle stiffness 103297/7
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PRODUCT : CUSTOMER : FP CODE: PLANT LOCATION : DIMENSIONS : PHARMACODE No. : SAP CODE No. : TEXT FONT SIZE : FILE NAME : SOFTWARE : TYPEFACES : ARTWORK (DETAILS) RECEIVED ON : PROOF REVISION :
Sulpiride 200 & 400mg – 30 Tabs Wockhardt UK FP2025; FP2026 Daman (Bhimpore) X Y I NN 9 pt. 4VMQJSJEF@-FBøFU@BJ Adobe Illustrator CS5 Arial Regular / Bold UIUI4FQUFNCFS
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Sulpiride 400mg )LOP&RDWHG7DEOHWV 7KLVLVDVHUYLFHSURYLGHGEWKH5RDO 1DWLRQDO,QVWLWXWHRI%OLQG3HRSOH This leaflet was last revised in 10/2019.
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Possible side effects
not listed in this leaflet. <RXFDQDOVRUHSRUWVLGHHIIHFWVGLUHFWOYLD the Yellow Card Scheme at: ZZZPKUDJRYXNHOORZFDUG or search for 0+5$<HOORZ&DUGLQWKH*RRJOH3ODRU Apple App Store. By reporting side effects you FDQKHOSSURYLGHPRUHLQIRUPDWLRQRQWKH safety of this medicine.
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RUVSDVPGLIILFXOWLQPRYHPHQWPRYHPHQWV that you cannot control (for example of the eyes, neck, arms and legs), producing more VDOLYDWKDQXVXDO,QVRPHFDVHVGL]]LQHVV lightheadedness, fainting (due to low blood SUHVVXUH DQGFRPDKDYHKDSSHQHG If you forget to take Sulpiride Tablets ,IRXIRUJHWDGRVHWDNHDQRWKHUDVVRRQDV you remember. If it is almost time for your next dose, do not take the missed dose at all. 'RQRWWDNHDGRXEOHGRVHWRPDNHXSIRUD forgotten dose. If you stop taking Sulpiride Tablets Keep taking Sulpiride Tablets until your doctor tells you to stop. Do not stop taking Sulpiride Tablets just because you feel better. If you stop taking Sulpiride Tablets suddenly, your LOOQHVVPDFRPHEDFNDQGRXPDKDYH other unwanted effects such as feeling or being sick, sweating and difficulty sleeping. In some cases you may also feel restless or KDYHPRYHPHQWVWKDWRXFDQQRWFRQWURO IRU example of the eyes, neck, arms and legs). Your doctor will gradually lower your dose XQWLORXVWRSRXUPHGLFLQHWRSUHYHQWWKHVH effects happening ,IRXKDYHDQIXUWKHUTXHVWLRQVRQWKHXVHRI this medicine, ask your doctor or pharmacist.
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How to store it
Sulpiride Tablets .HHSWKLVPHGLFLQHRXWRIWKHVLJKWDQG reach of children 'RQRWVWRUHDERYH& 6WRUHLQWKHRULJLQDOSDFNDJHLQRUGHUWR protect from light 'RQRWWUDQVIHU6XOSLULGH7DEOHWVWRDQRWKHU container 'RQRWXVHWKLVPHGLFLQHDIWHUWKHH[SLU date which is stated on the label and carton ([S PRQWKHDU 7KHH[SLUGDWHUHIHUVWRWKHODVWGDRIWKDW month 'RQRWXVH6XOSLULGH7DEOHWVLIRXQRWLFHD change in the appearance or smell of the medicine. Talk to your pharmacist. 'RQRWWKURZDZDPHGLFLQHVYLD wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will KHOSSURWHFWWKHHQYLURQPHQW
(26.25mm)
4. Possible side effects /LNHDOOPHGLFLQHVWKLVPHGLFLQHFDQFDXVH VLGHHIIHFWVDOWKRXJKQRWHYHUERGJHWVWKHP Stop taking Sulpiride Tablets and see a doctor or go to a hospital straight away if; Common (may affect up to 1 in 10 people) <RXKDYHWUHPRUVWLIIQHVVDQGVKXIIOLQJ (parkinsonism) <RXKDYHWUHPEOLQJPXVFOHVSDVPVRUVORZ PRYHPHQWV H[WUDSUDPLGDOGLVRUGHUV Rare (may affect up to 1 in 1,000 people) <RXKDYHYHUIDVWRUYHUVORZXQHYHQRU IRUFHIXOKHDUWEHDWV<RXPDDOVRKDYH breathing problems such as wheezing, shortness of breath, tightness in the chest and chest pain Not known IUHTXHQFFDQQRWEHHVWLPDWHG IURPWKHDYDLODEOHGDWD <RXKDYHDVHYHUHDOOHUJLFUHDFWLRQ (anaphylactic reaction or anaphylactic shock). The signs may include shock such as difficulty in breathing, dizziness, cold clammy skin, pale skin colour and racing heart beat /RZEORRGSUHVVXUH $OWHUDWLRQRIWKHKHDUWUKWKP FDOOHG 3URORQJDWLRQRI47LQWHUYDO VHHQRQ(&* HOHFWULFDODFWLYLWRIWKHKHDUW <RXKDYHILWV <RXKDYHDKLJKWHPSHUDWXUHVZHDWLQJVWLII muscles, fast heartbeat, fast breathing and feel confused, drowsy or agitated. These could be signs of a serious but rare side effect called 'neuroleptic malignant syndrome' <RXKDYHEORRGFORWVLQWKHYHLQVHVSHFLDOO in the legs (symptoms include swelling, pain DQGUHGQHVVLQWKHOHJ ZKLFKPDWUDYHO WKURXJKEORRGYHVVHOVWRWKHOXQJVFDXVLQJ chest pain and difficulty breathing. If you notice any of these symptoms seek medical DGYLFHLPPHGLDWHO <RXKDYHDOLIHWKUHDWHQLQJLUUHJXODU heartbeat (Torsade de pointes) <RXKDYHDFDUGLDFDUUHVW <RXJHWPRUHLQIHFWLRQVWKDQXVXDO7KLV could be because of a blood disorder (agranulocytosis) or a decrease in the number of white blood cells (neutropenia) 6KRUWQHVVRIEUHDWKRUGLIILFXOWEUHDWKLQJ <RXKDYHDQLQIHFWLRQRIWKHOXQJV SRVVLEO DVDUHVXOWRILQKDOLQJIRRGOLTXLGRUYRPLW into the lungs) Tell a pharmacist or doctor as soon as possible if you have any of the following side effects: Common (may affect up to 1 in 10 people) )HHOLQJUHVWOHVVDQGQRWEHLQJDEOHWRNHHS still (akathisia) Uncommon (may affect up to 1 in 100 people) )HHOLQJGL]]OLJKWKHDGHGRUIDLQWZKHQRX VWDQGRUVLWXSTXLFNO GXHWRORZEORRG pressure) $EQRUPDOLQFUHDVHLQPXVFOHWHQVLRQDQG reduced ability to stretch (hypertonia) ,QYROXQWDUDQGXQFRQWUROODEOHPRYHPHQWV (dyskinesia) Rare (may affect up to 1 in 1,000 people) 5ROOLQJRIWKHHHV Not known IUHTXHQFFDQQRWEHHVWLPDWHG IURPWKHDYDLODEOHGDWD <RXUQHFNEHFRPHVWZLVWHGWRRQHVLGH <RXUMDZLVWLJKWDQGVWLII 'HFUHDVHGERGRUPXVFOHPRYHPHQW (hypokinesia) )HHOLQJFRQIXVHG +LJKEORRGSUHVVXUH Talk to your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days: Common 0DDIIHFWXSWRLQSHRSOH $EQRUPDOSURGXFWLRQRIEUHDVWPLONLQPHQ and women :HLJKWJDLQ 3DLQIXOEUHDVWVLQPHQDQGZRPHQ )HHOLQJGURZVRUVOHHS 'LIILFXOWVOHHSLQJ LQVRPQLD 6NLQUDVKHV &RQVWLSDWLRQ Uncommon (may affect up to 1 in 100 people) %UHDVWHQODUJHPHQWLQZRPHQ /RVVRIPHQVWUXDOSHULRGV 'LIILFXOWLQJHWWLQJRUNHHSLQJDQHUHFWLRQRU in ejaculating (impotence) or being unable to KDYHDQRUJDVP
3URGXFLQJPRUHVDOLYDWKDQXVXDO <RXKDYHPRYHPHQWVWKDWRXFDQQRW control, mainly of the tongue, mouth, jaw, arms and legs (dystonia) Not known IUHTXHQF cannot be estimated IURPWKHDYDLODEOH data) %UHDVWHQODUJHPHQW in men 8QFRQWUROODEOH PRYHPHQWVRIWKH mouth, tongue and OLPEV WDUGLYH dyskinesia) 7LUHGZHDN FRQIXVHGDQGKDYHPXVFOHVWKDWDFKHDUH stiff or do not work well. This may be due to ORZVRGLXPOHYHOVLQRXUEORRG )HHOLQJXQZHOOFRQIXVHGDQGRUZHDN feeling sick (nausea), loss of appetite, feeling irritable. This could be something called a syndrome of inappropriate anti-diuretic hormone secretion (SIADH) 7KHUHKDYHEHHQYHUUDUHUHSRUWVRIVXGGHQ death with sulpiride. These are possibly caused by heart problems. In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotics FRPSDUHGZLWKWKRVHQRWUHFHLYLQJ antipsychotics. Blood tests 6XOSLULGH7DEOHWVFDQLQFUHDVHWKHOHYHOVRI OLYHUHQ]PHVVKRZQXSLQEORRGWHVWV7KLV FDQPHDQWKDWRXUOLYHULVQRWZRUNLQJ properly. Reporting of side effects If you get any side effects, talk to your doctor pharmacist or nurse. This includes any
Contents of the pack and other information
What Sulpiride Tablets contain 7KHDFWLYHLQJUHGLHQWLVVXOSLULGH7KHWDEOHWV come in two strengths of 200mg and 400mg. 7KHRWKHULQJUHGLHQWVLQ6XOSLULGHPJ Tablets are lactose, microcrystalline FHOOXORVHSRYLGRQH.VRGLXPVWDUFK glycollate and magnesium stearate. 7KHRWKHULQJUHGLHQWVLQ6XOSLULGHPJ )LOP&RDWHG7DEOHWVDUHODFWRVH PLFURFUVWDOOLQHFHOOXORVHSRYLGRQH. sodium starch glycollate, magnesium stearate and tablet coating made from WLWDQLXPGLR[LGH ( hydroxypropylmethylcellulose and polyethylene glycol. What Sulpiride Tablets look like and contents of the pack Sulpiride 200mg tablets are white, circular tablets marked S200 on one face and CP on WKHUHYHUVH 6XOSLULGHPJ)LOP&RDWHG7DEOHWVDUH ZKLWHRYDOILOPFRDWHGWDEOHWVPDUNHG6 and breakline on one face and CP on the UHYHUVH 6XOSLULGHWDEOHWVDUHDYDLODEOHLQEOLVWHUVWULS packs of 30 tablets. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: :RFNKDUGW8./LPLWHG$VK5RDG1RUWK :UH[KDP// 8)8. Manufacturer: &33KDUPDFHXWLFDOV/LPLWHG $VK5RDG1RUWK:UH[KDP// 8)8. Other formats: 7ROLVWHQWRRUUHTXHVWDFRSRIWKLVOHDIOHWLQ Braille, large print or audio please call, free RIFKDUJH 8.2QO 3OHDVHEHUHDGWRJLYHWKHIROORZLQJ information: Product name Reference number Sulpiride 200mg Tablets 29831/0193
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Frequently asked questions about Sulpiride 200mg Tablets
How do I take Sulpiride 200mg Tablets?
Sulpiride 200mg Tablets comes as tablet containing 200mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Sulpiride 200mg Tablets?
The active substance in Sulpiride 200mg Tablets is sulpiride.
Are there equivalent medicines to Sulpiride 200mg Tablets?
Medicines with the same active substance, strength and form include: Sulpiride Grindeks 200 mg Tablets. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Sulpiride 200mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Sulpiride 200mg Tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: sulpiride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
The treatment of acute and chronic schizophrenia.
4.2. Posology and method of administration
Posology
Adults
A starting dose of 400mg to 800mg daily, given as one or two tablets twice daily (morning and early evening) is recommended.
Predominantly positive symptoms (formal thought disorder, hallucinations, delusions, incongruity of affect) respond to higher doses, and a starting dose of at least 400mg twice daily is recommended, increasing if necessary up to a suggested maximum of 1200mg twice daily. Increasing the dose beyond this level has not been shown to produce further improvement.
Predominantly negative symptoms (flattening of affect, poverty of speech, anergia, apathy, as well as depression) respond to doses below 800mg daily; therefore, a starting dose of 400mg twice daily is recommended. Reducing this dose towards 200mg twice daily will normally increase the alerting effect of sulpiride.
Patients with mixed positive and negative symptoms, with neither predominating, will normally respond to a dose of 400mg-600mg twice daily.
Elderly
The same dose ranges are applicable in the elderly, but the dose should be reduced if there is evidence of renal impairment.
Paediatric population
Clinical experience in children under 14 years of age is insufficient to permit specific recommendations.
Method of administration
For oral use.
4.3. Contraindications
Phaeochromocytoma and acute porphyria.
Hypersensitivity to sulpiride or to any of the excipients listed in section 6.1.
Concomitant prolactin-dependent tumours e.g. pituitary gland prolactinomas and breast cancer (See section 4.8 Undesirable effects).
Association with levodopa or antiparkinsonian drugs (including ropinirole) (See section 4.5 Interactions with other medicinal products and other forms of interaction).
4.4. Special warnings and precautions for use
Warnings:
Increased motor agitation has been reported at high dosage in a small number of patients: in aggressive, agitated or excited phases of the disease process, low doses of sulpiride may aggravate symptoms. Care should be exercised where mania or hypomania is present.
Extrapyramidal reactions, principally akathisia have been reported in a small number of cases. If warranted, reduction in dosage or anti-parkinsonian medication may be necessary.
As with other neuroleptics, neuroleptic malignant syndrome, a potentially fatal complication, which is characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated CPK levels, has been reported. In such an event, or in the event of hyperthermia of undiagnosed origin, all antipsychotic drugs, including sulpiride, should be discontinued.
Elderly patients are more susceptible to postural hypotension, sedation and extrapyramidal effects.
In patients with aggressive behaviour or agitation with impulsiveness, sulpiride could be given with a sedative.
Acute withdrawal symptoms, including nausea, vomiting, sweating and insomnia have been described after abrupt cessation of antipsychotic drugs. Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) have been reported. Therefore, gradual withdrawal is advisable.
Increased Mortality in Elderly people with dementia:
Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated. There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known.
Sulpiride is not licenced for the treatment of dementia-related behavioural disturbances.
Venous thromboembolism:
Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Sulpiride and preventive measures undertaken.
Breast cancer:
Sulpiride may increase prolactin levels. Therefore, caution should be exercised and patients with a history or a family history of breast cancer should be closely monitored during sulpiride therapy.
Precautions:
In elderly patients, as with other neuroleptics, sulpiride should be used with particular caution (see section 4.2).
In children, efficacy and safety of sulpiride have not been thoroughly investigated. Therefore, caution should be exercised when prescribing to children (see section 4.2).
When neuroleptic treatment is absolutely necessary in a patient with Parkinson's disease, sulpiride can be used, although caution is in order.
Neuroleptics may lower the epileptogenic threshold. Cases of convulsions, sometimes in patients with no previous history, have been reported with sulpiride. Caution is advised in prescribing it for patients with unstable epilepsy, and patients with a history of epilepsy should be closely monitored during therapy with sulpiride.
In patients requiring sulpiride who are receiving anti-convulsant therapy, the dose of the anti-convulsant should not be changed.
Cases of convulsions, sometimes in patients with no previous history, have been reported.
Sulpiride should be used with caution in patients with a history of glaucoma, ileus, congenital digestive stenosis, urine retention or hyperplasia of the prostate. As with all drugs for which the kidney is the major elimination pathway, the dose should be reduced and titrated in small steps in cases of renal insufficiency.
Prolongation of the QT interval:
Sulpiride induces a prolongation of the QT interval (see section 4.8). This effect is known to potentiate the risk of serious ventricular arrhythmias such as torsade de pointes.
Before any administration, and if possible according to the patient's clinical status, it is recommended to monitor factors which could favour the occurrence of this rhythm disorder, for example:
- Bradycardia less than 55 bpm
- Electrolyte imbalance in particular hypokalaemia
- Congenital prolongation of the QT interval
- On-going treatment with a medication likely to produce pronounced bradycardia (< 55 bpm), hypokalaemia, decreased intracardiac conduction, or prolongation of the QTc interval (see section 4.5)
Sulpiride should be prescribed with caution in patients presenting with these factors and patients with cardiovascular disorders which may predispose to prolongation of the QT interval.
Avoid concomitant treatment with other neuroleptics (see section 4.5).
Stroke:
In randomised clinical trials versus placebo performed in a population of elderly patients with dementia and treated with certain atypical antipsychotic drugs, a 3-fold increase of the risk of cerebrovascular events has been observed. The mechanism of such risk increase is not known. An increase in the risk with other antipsychotic drugs or other populations of patients cannot be excluded. Sulpiride should be used with caution in patients with stroke risk factors.
Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics, including sulpiride. Unexplained infections or fever may be evidence of blood dyscrasia (see section 4.8) and requires immediate haematological investigation.
Sulpiride should be used with caution in hypertensive patients, especially in the elderly population, due to the risk of hypertensive crisis. Patients should be adequately monitored.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5. Interaction with other medicinal products and other forms of interaction
Associations contra-indicated
Levodopa, antiparkinsonian drugs (including ropinirole): reciprocal antagonism of effects between levodopa or antiparkinsonian drugs (including ropinirole) and neuroleptics.
Associations not recommended
Alcohol: Enhances the sedative effects of neuroleptics. Avoid the consumption of alcoholic beverages and drugs containing alcohol.
Combination with the following medications could induce torsades de pointes or prolong the QT interval (see section 4.4):
- Bradycardia-inducing medications such as beta-blockers, bradycardia-inducing calcium channel blockers such as diltiazem and verapamil, clonidine; digitalis
- Medications which induce electrolyte imbalance, in particular those causing hypokalaemia: hypokalaemic diuretics, stimulant laxatives, IV amphotericin B, glucocorticoids, tetracosactides.
Electrolyte imbalance should be corrected
- Class Ia antiarrhythmic agents such as quinidine, disopyramide.
- Class III antiarrhythmic agents such as amiodarone, sotalol.
- Other medications such as pimozide, haloperidol, methadone, imipramine antidepressants, lithium, cisapride, thioridazine, IV erythromycin, halofantrine, pentamidine.
Associations to be taken into account
Antihypertensive agents: antihypertensive effect and possibility of enhanced postural hypotension (additive effect).
CNS depressants including narcotics, analgesics, sedative H1 antihistamines, barbiturates, benzodiazepines and other anxiolytics, clonidine and derivatives.
Antacids or sucralfate: The absorption of sulpiride is decreased after co-administration. Therefore, sulpiride should be administered two hours before these drugs.
Lithium: Increased risk of extrapyramidal effects. Discontinuation of both drugs is recommended at first signs of neurotoxicity.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are only very limited data available from the use of sulpiride in pregnant women. The safety of sulpiride during human pregnancy has not been established.
Sulpiride crosses the placenta. Studies in animals are insufficient with respect to reproductive toxicity (see section 5.3).
The use of sulpiride is not recommended during pregnancy and in women of child bearing potential not using effective contraception, unless the benefits justify the potential risks.
Neonates exposed to antipsychotics (including Sulpiride 200mg Film-Coated Tablets) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.
Breast-feeding
Sulpiride is excreted into breastmilk in rather large amounts, far above the accepted value of 10% of the maternal weight-adjusted dosage in some cases, but blood concentrations in breastfed infants have not been evaluated. There is insufficient information on the effects of sulpiride in newborns/ infants.
A decision must be made whether to discontinue breast-feeding or to abstain from sulpiride therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility
A decrease in fertility linked to the pharmacological effects of the drug (prolactin mediated effect) was observed in treated animals.
4.7. Effects on ability to drive and use machines
Even used as recommended, sulpiride may cause sedation so that the ability to drive vehicles or operate machinery can be impaired (see section 4.8).
4.8. Undesirable effects
The following frequency rating is used, when applicable:
Very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Blood and lymphatic system disorders (see section 4.4):
Uncommon: Leukopenia.
Not known: Neutropenia, agranulocytosis
Immune system disorders:
Not known: Anaphylactic reactions including urticaria, dyspnoea, hypotension and anaphylactic shock.
Endocrine disorders:
Common: Hyperprolactinaemia
Psychiatric disorders:
Common: Insomnia.
Not known: Confusion
Nervous system disorders:
Common: Sedation or drowsiness, extrapyramidal disorder (these symptoms are generally reversible upon administration of antiparkinsonian medication), Parkinsonism, tremor, akathisia.
Uncommon: Hypertonia, dyskinesia, and dystonia.
Rare: Oculogyric crisis.
Not known: Neuroleptic malignant syndrome, hypokinesia, tardive dyskinesia (have been reported, as with all neuroleptics, after a neuroleptic administration of more than three months. Antiparkinsonian medication is ineffective or may induce aggravation of the symptoms), convulsion.
Metabolism and nutrition disorders:
Not known: hyponatraemia, syndrome of inappropriate antidiuretic hormone secretion (SIADH)
Cardiac disorders:
Rare: Ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia.
Not known: electrocardiogram QT prolonged, cardiac arrest, torsade de pointes, sudden death (see section 4.4).
Vascular disorders:
Uncommon: Orthostatic hypotension.
Not known: Venous embolism, pulmonary embolism, deep vein thrombosis (see section 4.4).
Respiratory, thoracic and mediastinal disorders:
Not known: pneumonia aspiration (mainly in association with other CNS depressants).
Gastrointestinal disorders:
Common: constipation
Uncommon: Salivary hypersecretion.
Hepatobiliary disorders:
Common: Hepatic enzyme increased
Skin and subcutaneous tissue disorders:
Common: Maculo-papular rash.
Musculoskeletal and connective tissue disorders:
Not known: Torticollis, trismus.
Pregnancy, puerperium and perinatal conditions:
Not known: Extrapyramidal symptoms, drug withdrawal syndrome neonatal (see section 4.6)
Reproductive system and breast disorders:
Common: Breast pain, galactorrhoea.
Uncommon: Breast enlargement, amenorrhoea, orgasm abnormal, erectile dysfunction.
Not known: Gynaecomastia.
General disorders and administration site conditions:
Common: Weight gain.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Experience with sulpiride in overdosage is limited.
The range of single toxic doses is 1 to 16g but no deaths have occurred even at a dose of 16g.
Fatal outcomes have been reported mainly in combination with other psychotropic agents.
Symptoms
The clinical manifestations of poisoning vary depending upon the size of the dose taken. After single doses of 1g to 3g restlessness and clouding of consciousness have been reported and (rarely) extrapyramidal symptoms. Doses of 3g to 7g may produce a degree of agitation, confusion and extrapyramidal symptoms; more than 7g can cause, in addition, coma and low blood pressure.
The duration of intoxication is generally short, the symptoms disappearing within a few hours. Comas which have occurred after large doses have lasted up to four days.
No haematological or hepatic toxicity has been reported.
Treatment
Sulpiride is partly removed by haemodialysis.
There is no specific antidote to sulpiride. Treatment is only symptomatic. Appropriate supportive measures should therefore be instituted, close supervision of vital functions and cardiac monitoring (risk of QT interval prolongation and subsequent ventricular arrhythmias) is recommended until the patient recovers.
If severe extrapyramidal symptoms occur anticholinergics should be administrated.
Overdose may be treated with alkaline osmotic diuresis and, if necessary, anti-parkinsonian drugs. Emetic drugs are unlikely to be effective. Coma needs appropriate nursing, and cardiac monitoring is recommended until the patient recovers. Emetic drugs are unlikely to be effective in sulpiride overdosage.
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