Drug Ingredient Information
LEVOSULPIRIDE-75MG+ESOMEPRAZOLE-40MG
LEVOSULPIRIDE
| Information for
patients
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| Drug Information |
Abdominal distention, upper abdominal distress, heartburn, belching and vomiting |
| Drug Alert |
| Alert |
Should be use with caution in patients receiving antihypertensive, hypnotic and analgesic drugs, because concurrent use may increase the effects of these drugs. |
| Before Consuming
the Medicine
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| Avoid Drug |
Phaeochromocytoma, epilepsy, manic states, hyperprolactinaemia, mammary dysplasia, malignant mastopathies, cardiac impairment. GI bleeding, mechanical obstruction or perforation. |
| Drug Special Care |
Hypersensitivity to sulpiride
Pre-existing breast cancer or other prolactin-dependent tumors
Phaeochromocytoma
Intoxication with other centrally active drugs
Concomitant use of levodopa
Pre-existing Parkinson's Disease
Patients below 18 years of age (insufficient clinical data)
Pre-existing severe heart disease/bradycardia, or hypokalemia (predisposing to long QT syndrome and severe arrhythmias)
Patients with pre-existing epilepsy. Anticonvulsant therapy should be maintained. |
| Drug Drug Interactions |
Reduced bioavailability with sucralfate, aluminium- and magnesium-containing antacids. Effect on GI motility may be antagonised by anticholinergic agents, narcotics and analgesics. Avoid alcohol. |
| Drug Pregnancy Interaction |
Pregnancy: Animal studies did not reveal any embryotoxicity or fetotoxicity, nor did limited human experience. Due to insufficient human data, pregnant women should be treated with sulpiride only if strictly indicated. Additionally, the newborns of treated women should be monitored, because isolated cases of extrapyramidal side effects have been reported. |
| Drug Breast feeding Interaction |
Lactation: Sulpiride is found in the milk of lactating women. Since the consequences are unclear, women should not breastfeed during treatment. |
| Drug Machinery Interaction |
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| Drug More Information |
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| How to take the
Medicine
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| Consumption Info |
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| Drug quanitty |
Schizophrenia 200-300 mg/day. Dyspeptic syndrome; Functional dyspepsia; GERD; Irritable bowel syndrome; Cytotoxic-induced nausea and vomiting; Vasomotor headache; Vertigo 25 mg 3 times/day. IV Cytotoxic-induced nausea and vomiting 25-50 mg 30 min prior, during and 30 mins after end of chemotherapy. IV/IM Dyspeptic syndrome; Functional dyspepsia; Nausea and vomiting due to motility disorders; Vasomotor headache; Vertigo 25 mg 2-3 times/day |
| Drug Dose |
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| Excess Drug Consumption |
Sulpiride has a relatively low order of acute toxicity. Substantial amounts may cause severe but reversible dystonic crises with torticollis, protrusion of the tongue, and/or trismus. In some cases all the classical symptoms typical of severe Parkinson's Disease may be noted; in others, over-sedation/coma may occur. The treatment is largely symptomatic. Some or all extrapyramidal reactions may respond to the application of anticholinergic drugs such as biperiden or benztropine. All patients should be closely monitored for signs of long-QT syndrome and severe arrhythmias. |
| Forgot Drug Consumption |
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| Stop Drug Consumption |
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| Possible Side
Effects
|
| General Information |
Amenorrhoea, gynaecomastia, galactorrhoea, changes in libido.
Potentially Fatal: Neuroleptic malignant syndrome. |
| Common Drug Side Effects |
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| Rare Drug Side Effects |
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| Very Rare Drug Side Effects |
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| Drug Side Effects Symptoms |
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| How to Store the
Medicine
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| How to Store the Medicine |
Store at 15-30°C (59-86°F). |
ESOMEPRAZOLE
| Information for
patients
|
| Drug Information |
It contains a medicine called esomeprazole. This belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.
Esomeprazole is used to treat the following conditions:
Adults and young people aged 12 years and above
•‘Gastro-oesophageal reflux disease’ (GORD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.
•Ulcers in the stomach or upper part of the gut (intestine) that are infected with bacteria called ‘Helicobacter pylori’. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
Adults
•Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esomeprazole can also be used to stop stomach ulcers from forming if you are taking NSAIDs.
•Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).
•Prolonged treatment after prevention of rebleeding of ulcers with intravenous Esomeprazole . |
| Drug Alert |
| Alert |
•You are allergic (hypersensitive) to esomeprazole.
•You are allergic to other proton pump inhibitor medicines.
•You are taking a medicine containing nelfinavir (used to treat HIV).
Do not take Esomeprazole if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Esomeprazole . |
| Before Consuming
the Medicine
|
| Avoid Drug |
•You are allergic (hypersensitive) to esomeprazole.
•You are allergic to other proton pump inhibitor medicines.
•You are taking a medicine containing nelfinavir (used to treat HIV).
Do not take Esomeprazole if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Esomeprazole . |
| Drug Special Care |
Check with your doctor or pharmacist before taking Esomeprazole if:
•You have severe liver problems.
•You have severe kidney problems.
Esomeprazole may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Esomeprazole or while you are taking it, talk to your doctor straight away:
•You lose a lot of weight for no reason and have problems swallowing.
•You get stomach pain or indigestion.
•You begin to vomit food or blood.
•You pass black stools (blood-stained faeces).
If you have been prescribed Esomeprazole "on demand" you should contact your doctor if your symptoms continue or change in character. |
| Drug Drug Interactions |
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes medicines that you buy without a prescription. This is because Esomeprazole can affect the way some medicines work and some medicines can have an effect on Esomeprazole . Do not take Esomeprazole s if you are taking a medicine containing nelfinavir (used to treat HIV). Tell your doctor or pharmacist if you are taking any of the following medicines:
•Atazanavir (used to treat HIV).
•Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus).
•Citalopram, imipramine or clomipramine (used to treat depression).
•Diazepam (used to treat anxiety, relax muscles or in epilepsy).
•Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Esomeprazole .
•Medicines that are used to thin your blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazole .
•Cisapride (used for indigestion and heartburn).
If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Esomeprazole to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking. |
| Drug Pregnancy Interaction |
Before taking Esomeprazole , tell your doctor if you are pregnant or trying to get pregnant . Ask your doctor or pharmacist for advice before taking any medicine. |
| Drug Breast feeding Interaction |
Your doctor will decide whether you can take Esomeprazole during this time. It is not known if Esomeprazole passes into breast milk. Therefore, you should not take Esomeprazole if you are breastfeeding. |
| Drug Machinery Interaction |
Esomeprazole is not likely to affect you being able to drive or use any tools or machines. |
| Drug More Information |
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| How to take the
Medicine
|
| Consumption Info |
|
| Drug quanitty |
To treat heartburn caused by gastro-oesophageal reflux disease (GORD):
Adults and children aged 12 or above:
•If your doctor has found that your food pipe (gullet) has been slightly damaged, the usual dose is one Esomeprazole 40 mg gastro-resistant once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your gullet has not yet healed.
•The usual dose once the gullet has healed is one Esomeprazole 20 mg gastro-resistant once a day
•If your gullet has not been damaged, the usual dose is one Esomeprazole 20 mg gastro-resistant each day. Once the condition has been controlled, your doctor may tell you to take your medicine as and when you need it, up to a maximum of one Esomeprazole 20 mg gastroresistant each day.
•If you have severe liver problems, your doctor may give you a lower dose.
To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:
•Adults and young people aged 12 or above: the usual dose is one Esomeprazole 20 mg gastroresistant twice a day for one week.
•Your doctor will also tell you to take antibiotics for example amoxicillin and clarithromycin.
To treat stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):
•Adults aged 18 and above: the usual dose is one Esomeprazole 20 mg gastro-resistant once a day for 4 to 8 weeks.
To prevent stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):
•Adults aged 18 and above: the usual dose is one Esomeprazole 20 mg gastro-resistant once a day.
To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome):
•Adults aged 18 and above: the usual dose is Esomeprazole 40 mg twice a day.
•Your doctor will adjust the dose depending on your needs and will also decide how long you need to take the medicine for. The maximum dose is 80 mg twice a day.
To be used as prolonged treatment after prevention of rebleeding of ulcers with intravenous Esomeprazole :
•Adults aged 18 and above: the usual dose is one Esomeprazole 40 mg once a day for 4 weeks. |
| Drug Dose |
•Your doctor will tell you how many s to take and how long to take them for. This will depend on your condition, how old you are and how well your liver works.
•The usual doses are given below.
Always take Esomeprazole exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
•Esomeprazole gastro-resistant s are not recommended for children less than 12 years old.
•If you are taking this medicine for a long time, your doctor will want to monitor you (particularly if you are taking it for more than a year).
•If your doctor has told you to take this medicine as and when you need it, tell your doctor if your symptoms change.
Taking this medicine
•You can take your s at any time of the day.
•You can take your s with food or on an empty stomach.
•Swallow your s whole with a drink of water. Do not chew or crush the s. This is because the s contain coated pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.
What to do if you have trouble swallowing the s
•If you have trouble swallowing the s:
-Put them into a glass of still (non-fizzy) water. Do not use any other liquids.
-Stir until the s break up (the mixture will not be clear). Then drink the mixture straight away or within 30 minutes. Always stir the mixture just before drinking it.
-To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it. The solid pieces contain the medicine - do not chew or crush them.
•If you cannot swallow at all, the can be mixed with some water and put into a syringe. It can then be given to you through a tube directly into your stomach (‘gastric tube’). |
| Excess Drug Consumption |
If you take more Esomeprazole than prescribed by your doctor, talk to your doctor or pharmacist straight away. |
| Forgot Drug Consumption |
•If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose.
•Do not take a double dose (two doses at the same time) to make up for a forgotten dose. |
| Stop Drug Consumption |
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| Possible Side
Effects
|
| General Information |
•Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction).
•Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be ‘Stevens-Johnson syndrome’ or ‘toxic epidermal necrolysis’.
•Yellow skin, dark urine and tiredness which can be symptoms of liver problems. |
| Common Drug Side Effects |
•Headache.
•Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence).
•Feeling sick (nausea) or being sick (vomiting). |
| Rare Drug Side Effects |
•Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.
•Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.
•Feeling agitated, confused or depressed.
•Taste changes.
•Eyesight problems such as blurred vision.
•Suddenly feeling wheezy or short of breath (bronchospasm).
•An inflammation of the inside of the mouth.
•An infection called “thrush” which can affect the gut and is caused by a fungus.
•Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
•Hair loss (alopecia).
•Skin rash on exposure to sunshine.
•Joint pains (arthralgia) or muscle pains (myalgia).
•Generally feeling unwell and lacking energy.
•Increased sweating. |
| Very Rare Drug Side Effects |
•Changes in blood count including agranulocytosis (lack of white blood cells)
•Aggression.
•Seeing, feeling or hearing things that are not there (hallucinations).
•Severe liver problems leading to liver failure and inflammation of the brain.
•Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
•Muscle weakness.
•Severe kidney problems.
•Enlarged breasts in men.
•Low levels of magnesium in the blood. This may cause weakness, being sick (vomiting), cramps, tremor and arrhythmias (heart rhythm disturbances).
Esomeprazole may in very rare cases affect the white blood cells leading to immune deficiency. If you have an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important for you to give information about your medication at this time. Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. |
| Drug Side Effects Symptoms |
•Swelling of the feet and ankles.
•Disturbed sleep (insomnia).
•Dizziness, tingling feelings such as “pins and needles”, feeling sleepy.
•Spinning feeling (vertigo).
•Dry mouth.
•Changes in blood tests that check how the liver is working.
•Skin rash, lumpy rash (hives) and itchy skin. |
| How to Store the
Medicine
|
| How to Store the Medicine |
•Keep out of the reach and sight of children.
•Do not store above 30°C.
•Keep this medicine in the original container (blister) or keep the container tightly closed (bottle) in order to protect from moisture.
•Do not take your s after the expiry date (EXP) shown on the carton, wallet pack or blister foil. The expiry date refers to the last day of that month.
•Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment. |
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