Domperidone Tablets 10mg Taj Pharma
- Name of the medicinal product
Domperidone 10mg Tablets
- Qualitative and quantitative composition
Each tablet contains Domperidone maleate equivalent to 10mg domperidone base.
For a full list of excipients see section 6.1.
- Pharmaceutical form
Domperidone 10mg Tablet is presented as a white round biconvex tablet with “Dm 10” inscription on one side.
- Clinical particulars
4.1 Therapeutic indications
Domepridone is indicated for the relief of the symptoms of nausea and vomiting.
4.2 Posology and method of administration
Domeperidone should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting.
Domperidone 10mg Tablets are for oral administration.
It is recommended to take oral domperidone tablets before meals. If taken after meals, absorption of the drug is somewhat delayed.
Patients should try to take each dose at scheduled time. If a scheduled dose is missed, the missed dose should be omitted and the usual dosing schedule resumed. The dose should not be doubled to make up for a missed dose.
Usually, the maximum treatment duration should not exceed one week.
Adults and adolescents (12 years of age and older and weighing 35 kg or more)
One 10mg tablet up to three times per day with maximum dose of 30 mg per day.
The efficacy of Domperidone in children less than 12 years of age has not been established (see section 5.1).
The efficacy of Domperidone in adolescents 12 years of age and older and weighing less than 35 kg has not been established.
Domperidone is contraindicated in moderate or severe hepatic impairment (see section 4.3). Dose modification in mild hepatic impairment is however not needed (see section 5.2).
Since the elimination half-life of domperidone is prolonged in severe renal impairment, on repeated administration, the dosing frequency of Domperidone tablets should be reduced to once or twice daily depending on the severity of the impairment, and the dose may need to be reduced. Such patients on prolonged therapy should be reviewed regularly (see sections 4.4 and 5.2)
Domperidone is contraindicated in the following situations:
- In patients with moderate or severe hepatic impairment (see section 5.2).
- In patients who have known existing prolongation of cardiac conduction intervals, particularly QTc, patients with significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure (see section 4.4)
- Co-administration with QT-prolonging drugs, at the exception of apomorphine (see section 4.4 and 4.5).
- Co-administration with potent CY3A4 inhibitors (regardless of their QT prolonging effects) (see section 4.5)
- Known hypersensitivity to domperidone or any of the excipients.
- Prolactin-releasing pituitary tumour (prolactinoma.)
- Renal impairment
Domperidone should not be used when stimulation of gastric motility could be harmful: gastro-intestinal haemorrhage, mechanical obstruction or perforation.
4.4 Special warnings and precautions for use
Precautions for use
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Use in infants
Neurological side effects are rare (see “Undesirable effects” section). Since metabolic functions and the blood-brain barrier are not fully developed in the first months of life the risk of neurological side effects is higher in young children.
Overdosing may cause extrapyramidal symptoms in children, but other causes should be taken into consideration.
The elimination half-life of domperidone is prolonged in severe renal impairment. For repeated administration, the dosing frequency of domperidone should be reduced to once or twice daily depending on the severity of the impairment. The dose may also need to be reduced.
Domperidone has been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been very rare cases of QT prolongation and torsades de pointes in patients taking domperidone. These reports included patients with confounding risk factors, electrolyte abnormalities and concomitant treatment which may have been contributing factors (see section 4.8).
Epidemiological studies showed that domperidone was associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death (see section 4.8). A higher risk was observed in patients older than 60 years, patients taking daily doses greater than 30 mg, and patients concurrently taking QT-prolonging drugs or CYP3A4 inhibitors.
Domperidone should be used at the lowest effective dose in adults and children.
Domperidone is contraindicated in patients with known existing prolongation of cardiac conduction intervals, particularly QTc, in patients with significant electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia), or bradycardia, or in patient with underlying cardiac diseases such as congestive heart failure due to increased risk of ventricular arrhythmia (see section 4.3). Electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia) or bradycardia are known to be conditions increasing the proarrythmic risk.
Use with apomorphine
Domperidone is contra-indicated with QT prolonging drugs including apomorphine, unless the benefit of the co-administration with apomorphine outweighs the risks, and only if the recommended precautions for co-administration mentioned in the apomorphine SmPC are strictly fulfilled. Please refer to the apomorphine SmPC
Treatment with domperidone should be stopped if signs or symptoms occur that may be associated with cardiac arrhythmia, and the patient should consult their physician.
Patient should be advised to promptly report any cardiac symptoms.
4.5 Interaction with other medicinal products and other forms of interaction
The main metabolic pathway of domperidone is through CYP3A4. In vitro data suggest that the concomitant use of drugs that significantly inhibit this enzyme may result in increased plasma levels of domperidone.
Increased risk of occurrence of QT-interval prolongation, due to pharmacodynamic and/or pharmacokinetic interactions.
Concomitant use of the following substances is contraindicated
QTc-prolonging medicinal products
- anti-arrhythmics class IA (e.g., disopyramide, hydroquinidine, quinidine)
- anti-arrhythmics class III (e.g., amiodarone, dofetilide, dronedarone, ibutilide, sotalol)
- certain antipsychotics (e.g., haloperidol, pimozide, sertindole)
- certain antidepressants (e.g., citalopram, escitalopram)
- certain antibiotics (e.g. , erythromycin, levofloxacin, moxifloxacin, spiramycin)
- certain antifungal agents (e.g., pentamidine)
- certain antimalarial agents (in particular halofantrine, lumefantrine)
- certain gastro-intestinal medicines (e.g., cisapride, dolasetron, prucalopride)
- certain antihistaminics (e.g., mequitazine, mizolastine)
- certain medicines used in cancer (e.g., toremifene, vandetanib, vincamine)
- certain other medicines (e.g., bepridil, diphemanil, methadone) (see section 4.3).
- apomorphine, unless the benefit of the co-administration outweighs the risks, and only if the recommended precautions for co-administration are strictly fulfilled. Please refer to the apomorphine SmPC.
Potent CYP3A4 inhibitors (regardless of their QT prolonging effects), i.e :
- protease inhibitors
- systemic azole antifungals
- some macrolides (erythromycin, clarithromycin and telithromycin) (see section 4.3).
Concomitant use of the following substances is not recommended
Moderate CYP3A4 inhibitors i.e. diltiazem, verapamil and some macrolides.
(see section 4.3)
Concomitant use of the following substances requires caution in use
Caution with bradycardia and hypokalaemia-inducing drugs, as well as with the following macrolides involved in QT-interval prolongation: azithromycin and roxithromycin (clarithromycin is contraindicated as it is a potent CYP3A4 inhibitor).
The above list of substances is representative and not exhaustive.
Separate in vivo pharmacokinetic/pharmacodynamic interaction studies with oral ketoconazole or oral erythromycin in healthy subjects confirmed a marked inhibition of domperidone’s CYP3A4 mediated first pass metabolism by these drugs.
With the combination of oral domperidone 10mg four times daily and ketoconazole 200mg twice daily, a mean QTc prolongation of 9.8 msec was seen over the observation period, with changes at individual time points ranging from 1.2 to 17.5 msec. With the combination of domperidone 10mg four times daily and oral erythromycin 500mg three times daily, mean QTc over the observation period was prolonged by 9.9 msec, with changes at individual time points ranging from 1.6 to 14.3 msec. Both the Cmax and AUC of domperidone at steady state were increased approximately three-fold in each of these interaction studies. In these studies domperidone monotherapy at 10mg given orally four times daily resulted in increases in mean QTc of 1.6 msec (ketoconazole study) and 2.5 msec (erythromycin study), while Ketoconazole monotherapy (200mg twice daily) led to increases in QTc of 3.8 and 4.9 msec, respectively, over the observation period.
4.6 Fertility, pregnancy and lactation
There are limited post-marketing data on the use of domperidone in pregnant women. A study in rats has shown reproductive toxicity at a high, maternally toxic dose. The potential risk for humans is unknown. Therefore, domperidone should only be used during pregnancy when justified by the anticipated therapeutic benefit.
Domperidone is excreted in human milk and breast-fed infants receive less than 0.1% of the maternal weight-adjusted dose. Occurrence of adverse effects, in particular cardiac effects cannot be excluded after exposure via breast milk. A decision should be made whether to discontinue breast-feeding or to discontinue/abstain from domperidone therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the women. Caution should be exercised in case of QTc prolongation risk factor in breast-fed infants.
4.7 Effects on ability to drive and use machines
Domperidone has no or negligible influence on the ability to drive or use machines.
4.8 Undesirable effects
Tabulated list of adverse reactions
The safety of domperidone was evaluated in clinical trials and in postmarketing experience. The clinical trials included 1275 patients with dyspepsia, gastro-oesophageal reflux disorder (GORD), Irritable Bowel Syndrome (IBS), nausea and vomiting or other related conditions in 31 double-blind, placebo-controlled studies. All patients were at least 15 years old and received at least one dose of domperidone (domperidone base). The median total daily dose was 30 mg (range 10 to 80 mg), and median duration of exposure was 28 days (range 1 to 28 days). Studies in diabetic gastroparesis or symptoms secondary to chemotherapy or parkinsonism were excluded.
The following frequencies are used for the description of the occurrence of adverse reactions:
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),
Where frequency cannot be estimated from clinical trials data, it is recorded as “Not known”.
|System Organ Class||Adverse Drug Reaction|
|Immune system disorder||Anaphylactic reaction (including anaphylactic shock)|
|Psychiatric disorders||Loss of libido|
|Nervous system disorders||Somnolence|
|Eye disorders||Oculogyric crisis|
|Cardiac disorders (see section 4.4)||Ventricular arrhythmias|
Sudden cardia death
Torsade de Pointes
|Gastrointestinal disorders||Dry mouth||Diarrhoea|
|Skin and subcutaneous tissue disorder||Rash|
|Renal and urinary disorders||Urinary retention|
|Reproductive system and breast disorders||Galactorrhoea|
|General disorders and administration site conditions||Asthenia|
|investigations||Liver function test abnormal|
Blood prolactin increased
In 45 studies where domperidone was used at higher dosages, for longer duration and for additional indications including diabetic gastroparesis, the frequency of adverse events (apart from dry mouth) was considerably higher. This was particularly evident for pharmacologically predictable events related to increased prolactin. In addition to the reactions listed above, akathisia, breast discharge, breast enlargement, breast swelling, depression, hypersensitivity, lactation disorder, and irregular menstruation were also noted.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Overdose has been reported primarily in infants and children. Symptoms of overdosage may include agitation, altered consciousness, convulsions, disorientation, somnolence and extrapyramidal reactions.
There is no specific antidote to domperidone, but in the event of overdose, standard symptomatic treatment should be given immediately. Gastric lavage as well as the administration of activated charcoal, may be useful. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. Close medical supervision and supportive therapy is recommended.
Anticholinergic, anti-parkinson drugs may be helpful in controlling the extrapyramidal reactions.
- Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Propulsives, ATC code: A03F A03
Domperidone is a dopamine antagonist with anti-emetic properties domperidone does not readily cross the bloodbrain barrier. In domperidone users, especially in adults, extrapyramidal side effects are very rare, but domperidone promotes the release of prolactin from the pituitary. Its anti-emetic effect may be due to a combination of peripheral (gastrokinetic) effects and antagonism of dopamine receptors in the chemoreceptor trigger zone, which lies outside the blood-brain barrier in the area postrema. Animal studies, together with the low concentrations found in the brain, indicate a predominantly peripheral effect of domperidone on dopamine receptors. Studies in man have shown oral domperidone to increase lower oesophageal pressure, improve antroduodenal motility and accelerate gastric emptying. There is no effect on gastric secretion.
In accordance with ICH-E14 guidelines, a thorough QT study was performed. This study included a placebo, an active comparator and a positive control and was conducted in healthy subjects with up to 80 mg per day 10 or 20 mg administered 4 times a day of domperidone. This study found a maximal difference of QTc between domperidone and placebo in LS-means in the change from baseline_of 3.4 msec for 20 mg domperidone administered 4 times a day on Day 4. The 2-sided 90% CI (1.0 to 5.9 msec) did not exceed 10 msec. No clinically relevant QTc effect were observed in this study when domperidone was administered at up to 80 mg/day (i.e., more than twice the maximum recommended dosing).
However, two previous drug-drug interaction studies showed some evidence of QTc prolongation when domperidone was administered as monotherapy (10 mg 4 times a day). The largest time-matched mean difference of QTcF between domperidone and placebo was 5.4 msec (95 % CI: -1.7 to 12.4) and 7.5msec (95 % CI: 0.6 to 14.4), respectively.
Clinical study in infants and children 12 years of age and younger
A multicentre, double-blind, randomised, placebo-controlled, parallel-group, prospective study was conducted to evaluate the safety and efficacy of domperidone in 292 children with acute gastroenteritis aged 6 months to 12 years (median age 7 years). In addition to oral rehydration treatment (ORT), randomised subjects received domperidone oral suspension at 0.25 mg/kg (up to a maximum of 30 mg domperidone/day), or placebo, 3 times a day, for up to 7 days. This study did not achieve the primary objective, which was to demonstrate that domperidone suspension plus ORT is more effective than placebo plus ORT at reducing vomiting episodes during the first 48 hours after the first treatment administration (see section 4.2).
5.2 Pharmacokinetic properties
Domperidone is rapidly absorbed after oral administration with peak plasma concentrations occurring at approximately 1 hr after dosing.. The Cmax and AUC values of domperidone increased proportionally with dose in the 10 mg to 20 mg dose range. A 2- to 3-fold accumulation of domperidone AUC was observed with repeated four times daily (every 5 hr) dosing of domperidone for 4 days.
The low absolute bioavailability of oral domperidone (approximately 15%) is due to an extensive first-pass metabolism in the gut wall and liver. Although domperidone’s bioavailability is enhanced in normal subjects when taken after a meal, patients with gastrointestinal complaints should take domperidone 15-30 minutes before a meal. Reduced gastric acidity impairs the absorption of domperidone. Oral bioavailability is decreased by prior concomitant administration of cimetidine and sodium bicarbonate. The time of peak absorption is slightly delayed and the AUC somewhat increased when the oral drug is taken after a meal.
Oral domperidone does not appear to accumulate or induce its own metabolism; a peak plasma level after 90 minutes of 21ng/ml after two weeks oral administration of 30 mg per day was almost the same as that of 18 ng/ml after the first dose. Domperidone is 91-93% bound to plasma proteins. Distribution studies with radiolabelled drug in animals have shown wide tissue distribution, but low brain concentration. Small amounts of drug cross the placenta in rats.
Domperidone undergoes rapid and extensive hepatic metabolism by hydroxylation and N-dealkylation. In vitro metabolism experiments with diagnostic inhibitors revealed that CYP3A4 is a major form of cytochrome P-450 involved in the N-dealkylation of domperidone, whereas CYP3A4, CYP1A2 and CYP2E1 are involved in domperidone aromatic hydroxylation.
Urinary and faecal excretions amount to 31 and 66% of the oral dose respectively, The proportion of the drug excreted unchanged is small (10% of faecal excretion and approximately 1% of urinary excretion). The plasma half life after a single oral dose is 7-9 hours in healthy subjects but is prolonged in patients with severe renal insufficiency.
In subjects with moderate hepatic impairment (Pugh score 7 to 9, Child-Pugh rating B), the AUC and Cmax of domperidone is 2.9- and 1.5- fold higher, respectively, than in healthy subjects.
The unbound fraction is increased by 25%, and the terminal elimination half-life is prolonged from 15 to 23 hours. Subjects with mild hepatic impairment have a somewhat lower systemic exposure than healthy subjects based on Cmax and AUC, with no change in protein binding or terminal half-life. Subjects with severe hepatic impairment were not studied. Domperidone is contraindicated in patients with moderate or severe hepatic impairment (see section 4.3).
In subjects with renal insufficiency (creatinine clearance<30 ml/min/1.73m2) the elimination half-life of domperidone was increased from 7.4 to 20.8 hours, but plasma drug levels were lower than in healthy volunteers.
Since very little unchanged drug (approximately 1%) is excreted via the kidneys, it is unlikely that the dose of a single administration needs to be adjusted in patients with renal insufficiency.
However, on repeated administration, the dosing frequency should be reduced to once or twice daily depending on severity of the impairment, and the dose may need to be reduced.
No pharmacokinetic data are available in the Pharmacokinetic properties.
5.3 Preclinical safety data
Electrophysiological in vitro and in vivo studies indicate an overall moderate risk of domperidone to prolong the QT interval in humans. In in vitro experiments on isolated cells transfected with hERG and on isolated guinea pig myocytes exposure ratios ranged between 26 – 47-fold, based on IC50 values inhibiting currents through IKr ion channels in comparison to the free plasma concentrations in humans after administration of the maximum daily dose of 10 mg administered 3 times a day. safety margins for prolongation of action potential duration in in vitro experiments on isolated cardiac tissues exceeded the free plasma concentrations in humans at maximum daily dose (10 mg administered 3 times a day) by 45-fold.
Safety margins in in vitro proarrhythmic models (isolated Langendorff perfused heart) exceeded the free plasma concentrations in humans at maximum daily dose (10 mg administered 3 times a day) by 9– up to 45-fold. In in vivo models the no effect levels for QTc prolongation in dogs and induction of arrhythmias in a rabbit model sensitized for torsade de pointes exceeded the free plasma concentrations in humans at maximum daily dose (10 mg administered 3 times a day) by more than 22-fold and 435-fold, respectively. In the anesthetized guinea pig model following slow intravenous infusions, there were no effects on QTc at total plasma concentrations of 45.4ng/ml, which are 3-fold higher than the total plasma levels in humans at maximum daily dose (10 mg administered 3 times a day). The relevance of the latter study for humans following exposure to rally administered domperidone is uncertain.
In the presence of inhibition of the metabolism via CYP3A4 free plasma concentrations of domperidone can rise up to 3- fold.
At a high, maternally toxic dose (more than 40 times the recommended human dose), teratogenic effects were seen in the rat. No teratogenicity was observed in mice and rabbits.
- Pharmaceutical particulars
6.1 List of excipients
Microcrystalline cellulose, Lactose monohydrate, Maize starch
Povidone K30, Sodium lauryl sulphate, Silica colloidal, anhydrous
6.3 Shelf life
6.4 Special precautions for storage
Do not store above 25°C. Store in the original package.
6.5 Nature and contents of container
The tablets are packed in blisters constituted from a PVC and aluminium foil in packs of 30 and 100.
6.6 Special precautions for disposal and other handling
- Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
Domperidone Tablets 10mg Taj Pharma
Domperidone 10 mg FILM-COATED TABLETS
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- 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.
- Your doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect
In this leaflet:
- What Domperidone is and what it is used for
2. What you need to know before you take Domperidone
3. How to take Domperidone
4. Possible side effects
5. How to store Domperidone
6. Contents of the pack and other information
- WHAT Domperidone IS AND WHAT IT IS USED FOR
The name of your medicine is Domperidone 10mg Film-Coated Tablets (called Domperidone in this leaflet). Domperidone contains a medicine called domperidone. This belongs to a group of medicines called ‘dopamine antagonists’.
This medicine is used in adults and in adolescents 12 years of age and older and a body weight of 35kg or more to treat nausea (feeling sick) and vomiting (being sick).
- WHAT YOU NEED TO KNOW BEFORE YOU TAKE Domperidone
Do not take Domperidone tablets if:
- You are allergic (hypersensitive) to domperidone or any of the other ingredients of Domperidone 10mg Film-Coated Tablets (listed in section 6: Contents of the pack and other information). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
- You have a tumour of the pituitary gland (prolactinoma)
- You have a blockage or tear in your intestines
- You have black, tarry bowel motions (stools) or notice blood in your bowel motions. This could be a sign of bleeding in the stomach or intestines.
- You have a moderate or severe liver disease.
- Your ECG (electrocardiogram) shows a heart problem called “prolonged QT corrected interval”.
- You have or had a problem where your heart cannot pump the blood round your body as well as it should (condition called heart failure).
- You have a problem that gives you a low level of potassium or magnesium, or a high level of potassium in your blood.
- You are taking certain medicines (see “Other medicines and Domperidone”)
Do not take Domperidone if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Domperidone.
Warnings and precautions
Before taking this medicine contact your doctor if:
- You suffer from liver problems (liver function impairment or failure) (see “Do not take Domperidone tablets if”)
- You suffer from kidney problems (kidney function impairment or failure). It is advisable to ask your doctor for advice in case of prolonged treatment as you may need to take a lower dose or take this medicine less often, and your doctor may want to examine you regularly.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Domperidone. Do this even if they have applied in the past.
Domperidone may be associated with an increased risk of heart rhythm disorder and cardiac arrest. This risk may be more likely in those over 60 years old or taking doses higher than 30 mg per day. The risk also increases when Domperidone is given together with some drugs. Tell your doctor or pharmacist if you are taking drugs to treat infection (fungal infections or bacterial infection) and/or if you have heart problems or AIDS/HIV (see “Other medicines and Domperidone).
Domperidone should be used at the lowest effective dose in adults and adolescents 12 years of age and older and a body weight of 35kg or more.
While taking Domperidone, contact your doctor if you experience heart rhythm disorders such as palpitations, trouble breathing, loss of consciousness. Treatment with Domperidone should be stopped.
Other medicines and Domperidone
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you can buy without a prescription, including herbal medicines. This is because Domperidone can affect the way some other medicines work. Also, some medicines can affect the way Domperidone works.
Do not take Domperidone if you are taking medicine to treat:
- Fungal infections such as azole anti-fungals, specifically oral ketoconazole, fluconazole or voriconazole.
- Bacterial infections, specifically erythromycin, clarithromycin, telithromycin, moxifloxacin, pentamidine (these are antibiotics)
- Heart problems or high blood pressure (e.g., amiodarone, dronedarone, quinidine, disopyramide, dofetilide, sotalol, diltiazem, verapamil)
- Psychoses (e.g., haloperidol, pimozide, sertindole)
- Depression (e.g., citalopram, escitalopram)
- Gastro-intestinal disorders (e.g., cisapride, dolasetron, prucalopride)
- Allergy (e.g., mequitazine, mizolastine)
- Malaria (in particular halofantrine)
- AIDS/HIV (protease inhibitors)
- Cancer (e.g., toremifene, vandetanib, vincamine)
Tell your doctor or pharmacist if you are taking drugs to treat infection, heart problems or AIDS/HIV.
Domperidone and apomorphine
Before you use Domperidone and apomorphine, your doctor will ensure that you tolerate both medicines when used simultaneously. Ask your doctor or specialist for a personalised advice. Please refer to the apomorphine leaflet.
It is important to ask your doctor or pharmacist if Domperidone is safe for you when you are taking any other medicines, including medicines obtained without prescription.
Taking Domperidone with food and drink
It is recommended to take Domperidone before meals, as when taken after meals the absorption of the medicine is slightly delayed.
Pregnancy and breast-feeding
Talk to your doctor or pharmacist before taking Domperidone if:
- You are pregnant, might become pregnant or think you may be pregnant
- You are breast-feeding. It is best not to take Domperidone if you are breast-feeding.
Small amounts of Domperidone have been detected in breast-milk. Domperidone may cause unwanted side effects affecting the heart in a breast-fed baby. Domperidone should be used during breast feeding only if your physician considers this clearly necessary. Ask your doctor for advice before taking this medicine.
Driving and using machines:
Domperidone does not affect your ability to drive or use machines.
Important information about some of the ingredients of Domperidone tablets
This medicine contains lactose. If you have been told that you cannot digest or tolerate some sugars, talk to your doctor before taking Domperidone.
- HOW TO TAKE Domperidone
Follow these instructions closely unless your doctor has advised you otherwise. You should check with your doctor or pharmacist if you are not sure.
Duration of treatment
Your doctor will decide how long you will need to take this medicine.
Symptoms usually resolve with 3-4 days of taking this medicine. Do not take Domperidone for longer than 7 days without consulting your doctor.
Taking this medicine
- Swallow the tablets whole with a drink of water.
- Take the tablets 15 to 30 minutes before a meal.
- Do not crush or chew them.
The usual dose is:
- Adults and adolescents 12 years of age and older with a body weight of 35kg or more
The usual dose is one tablet taken up to three times per day, if possible before meals. Do not take more than three tablets per day.
People with kidney problems
Your doctor may tell you to take a lower dose or to take the medicine less often.
If you take more Domperidone than you should:
- If you have used or taken too many Domperidone tablets contact your doctor, pharmacist or the poisons centre at your nearest hospital casualty department immediately, in particular if a child has taken too much. Take the carton and any tablets left with you. This is so the doctors know what you have taken.
In the event of overdose, symptomatic treatment could be implemented. An ECG monitoring could be undertaken, because of the possibility of a heart problem called prolonged QT interval.
- The signs of taking more than you should include feeling sleepy, confused, uncontrolled movements (especially in children) which include unusual eye movements, unusual movements of the tongue or abnormal posture (such as a twisted neck).
If you forget to take Domperidone:
- If you forget to take Domperidone, take it as soon as you remember.
- However if it is almost time for the next dose, wait until that is due and then continue as normal.
- Do not take a double dose to make up for a forgotten dose.
- POSSIBLE SIDE EFFECTS
Like all medicines, Domperidone can have side effects, although not everybody gets them.
Stop taking Domperidone and see your doctor or go to a hospital straightaway if:
- You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). This may mean you are having an allergic reaction to Domperidone.
- You notice any uncontrolled movements. These include irregular eye movements, unusual movements of the tongue, and abnormal posture such as a twisted neck, trembling and muscle stiffness. This is more likely to happen in children. These symptoms should stop once you stop taking Domperidone.
- You have a very fast or unusual heartbeat. This could be a sign of a life-threatening heart problem.
- You have a fit (seizure).
Other side effects include:
Common (affects less than 1 in 10 people)
- Dry mouth
Uncommon (affects less than 1 in 100 people)
- Lowering of sexual drive (libido) in men
- Feeling anxious
- Feeling drowsy
- Itchy skin. You may also have a rash
- Unusual production of breast milk in men and women
- Painful or tender breasts
- A general feeling of weakness
Not known (Frequency cannot be estimated from the available data)
- Disorders of the cardiovascular system: heart rhythm disorders (rapid or irregular heart beat) have been reported; if this happens, you should stop the treatment immediately. Domperidone may be associated with an increased risk of heart rhythm disorder and cardiac arrest. This risk may be more likely in those over 60 years old or taking doses higher than 30 mg per day. Domperidone should be used at the lowest effective dose in adults and adolescents 12 years of age and older and a body weight of 35kg or more.
- Feeling agitated or irritable
- Feeling more nervous than usual
- Abnormal eye movements
- Inability to urinate
- Breast enlargement in men
- In women, menstrual periods may be irregular or stop
- A blood test shows changes in the way your liver is working.
Some patients who have used Domperidone for conditions and dosages requiring longer term medical supervision have experienced the following unwanted effects:
Restlessness; swollen or enlarged breasts, unusual discharge from breasts, irregular menstrual periods in women, difficulty breastfeeding, depression, hypersensitivity.
Side effects such as feeling drowsy, nervous, agitated or irritable or having a fit are more likely to happen in children.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.
- HOW TO STORE Domperidone
- Keep out of the sight and reach of children.
- Do not store above 25°C.
- Do not take Domperidone Tablets after the expiry date stated on the pack.
- Ask your pharmacist how to dispose of medicines you no longer need. Do not dispose of medicines by flushing down a toilet or sink, or by throwing them out with your normal household rubbish. This will help to protect the environment.
- CONTENTS OF THE PACK AND OTHER INFORMATION
What Domperidone 10mg Film-Coated Tablets contain
Each Domperidone Tablet contains 10mg of domperidone (the active ingredient). It also contains lactose, maize starch, microcrystalline cellulose, hypromellose, pregelatinised starch, povidone, propylene glycol, magnesium stearate, silica colloidal hydrated and polysorbate 20.
What Domperidone 10mg Film-Coated Tablets look like and contents of the pack
Each pack contains 30 or 100 white to cream coloured, film-coated tablets with Domperidone stamped on one side.
- Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST