Domperidone Tablets 10mg Taj Pharma

1. NAME OF THE MEDICINAL PRODUCT

Domperidone Tablets 10mg Taj Pharma

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each uncoated tablet contains:
Domperidone maleate equivalent to
domperidone                                     10mg
Excipients                                             q.s.

3. PHARMACEUTICAL FORM
Tablets

4. 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.

Paediatric population

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.

Hepatic Impairment

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).

Renal Impairment

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)

4.3 Contraindications

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.

Renal Impairment

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.

Cardiovascular effects

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

Pregnancy-

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.

Breast-feeding

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 trial data, it is recorded as “Not known”.

System                     Organ Class          Adverse Drug Reaction  Frequency   Common  Uncommon        Not known
Immune
system
disorder
Anaphylactic reaction (including anaphylactic shock)
Psychiatric disorders                                                                     Loss of libido, Anxiety, Agitation, Nervousness

Nervous
system disorders                                                                         Somnolence, Headache, Convulsion

Extrapyramidal disorder
Eye
disorders                                                                                     Oculogyric crisis

Cardiac disorders
(see section 4.4)                                                                         Ventricular arrhythmias, Sudden cardiac death, QTc prolongation Torsade de Pointes

Gastrointestinal disorders                                                          Dry mouth, Diarrhoea
Skin and subcutaneous tissue disorder Rash                       Pruritus  Urticarial   angioedema

Renal and urinary disorders                                                     Urinary retention
Reproductive system
and
breast disorders                                                                Galactorrhoea, Breast pain, Breast tenderness, Gynaecomastia
Amenorrhoea
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.

4.9 Overdose

Symptoms
Overdose has been reported primarily in infants and children. Symptoms of overdosage may include agitation, altered consciousness, convulsions, disorientation, somnolence and extrapyramidal reactions.

Treatment
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.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Propulsives,

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

Absorption

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.

Distribution

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.

Metabolism

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.

Excretion

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.

Hepatic impairment

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).

Renal impairment

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.

Paediatric population

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.

6. PHARMACEUTICAL PARTICULARS

Each uncoated tablet contains:
Domperidone maleate  equivalent to
domperidone                                     10mg
Excipients                                             q.s.

6.1 List of excipients

Microcrystalline cellulose, Lactose monohydrate, Maize starch, Povidone K30, Sodium lauryl sulphate, Silica colloidal, anhydrous, Magnesium stearate

6.2 Incompatibilities

Not Applicable

6.3 Shelf life

24 months.

6.4 Special precautions for storage

Do not store above 25°C. Store in the original package.

6.5 Nature and contents of container

PVC/PVDC/Al blisters.

Pack sizes: Blisters: 7, 14, 28, 30, 50, 90, 100 and 500mg modified-release tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

None

7. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
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
E-mail: tajgroup@tajpharma.com

Domperidone Tablets 10mg

PACKAGE LEAFLET: INFORMATION FOR THE USER

Domperidone Maleate

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. Itmay harmthem, even if their symptoms are the same as yours.

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

IN THIS LEAFLET:

1.       What Domperidone Tablets are and what they are used for
2.       Before you take Domperidone Tablets
3.       How to take Domperidone Tablets
4.       Possible side effects
5.       How to store Domperidone Tablets
6.       Further information

1.    WHAT DOMPERIDONE TABLETS ARE AND WHAT THEY ARE USED FOR

Domperidone Tablets contain domperidone as the active ingredient, which belongs to a group of medicines called ‘dopamine antagonists’.
This medicine is used to treat nausea (feeling sick) and vomiting (being sick) in adults and adolescents (12 years of age and older and weighing 35 kg or more).

2.    BEFORE YOU TAKE DOMPERIDONE

Do Not take Domperidone Tablets if:

·         You are allergic (hypersensitive) to domperidone or any of the other ingredients in the tablets.

·         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 blockage or tear in your intestines

·         You have a tumour of the pituitary gland called a prolactinoma.

·         have a disorder known as phenylketonuria (a metabolic disorder) orodispersible tablets should not be used as they contain aspartamine

·         if you have a moderate or severe liver disease

·         if your ECG (electrocardiogram) shows a heart problem called “prolonged QT corrected interval”

·         If 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).

·         If you have a problem that gives you a low level of potassium or magnesium, or a high level of potassium in your blood.

·         if you are taking certain medicines (see “Taking other medicines”

Do not take domperidone tablets if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine. 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.

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 this medicinal product”)\

·         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.

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 30mg 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 section other medicines and Domperidone tablets).

Domperidone should be used at the lowest effective dose. 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.

Adolescents weighing less than 35 kg and childrenDomperidone should not be given to adolescents 12 years of age and older weighing less than 35 kg, or in any children less than 12 years of age, as it is not effective in these age groups.

Other medicines and Domperidone tablets

Do not take Domperidone tablet 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)

·         Hepatitis C (e.g., telaprevir)

·         cancer (e.g., toremifene, vandetanib, vincamine)

·         certain other medicines (e.g., bepridil, diphemanil, methadone)

Before you use Domperidone tablet 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 apomorphine leaflet

Tell your doctor or pharmacist if you are taking drugs to treat infection, heart problems or AIDS/HIV. It is important to ask your doctor or pharmacist if Domperidone tablet is safe for you when you are taking any other medicines, including medicines obtained without prescription.

Taking Domperidone Tablets with food and drink The tablets should be taken before meals.

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before taking Domperidone tablets if:

·         You are pregnant, might become pregnant or think you may be pregnant

·         You are breast-feeding. It is best not to take Domperidone tablets if you are breastfeeding. This is because small amount 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

You may feel sleepy, confused or have less control over your movements while taking Domperidone tablets. if this happens, do not drive or use any tools or machines.

Important information about some of the ingredients of Domperidone Tablets
The product contains lactose – if you know you have an intolerance to some sugars, tell your doctor before use.

Domperidone Tablets contain sodium This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially ‘sodium free’

3. HOW TO TAKE DOMPERIDONE TABLETS

Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
For oral use only.

The tablets must be swallowed with a glass of water.

Take the tablets 15 to 30 minutes before meals and, if needed, before you go to bed. Do not crush or chew them

Follow these instructions closely unless your doctor has advised you otherwise.

Duration of treatment:
Symptoms usually resolve with 3-4 days of taking this medicine. Do not take Domperidone tablets for longer than 7 days without consulting your doctor.

Adults and adolescents 12 years of age and older with a body weight of 35 kg 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 Tablets than you should
If you or someone else have used or taken too much Domperidone tablets, contact your doctor, pharmacist, nearest hospital casualty department or the poison centre immediately.

Always take any tablet left over with you, this leaflet and also the box, as this will allow easier identification of the tablets. In the events of overdose, symptomatic treatment could be implemented.

An ECG monitoring could be undertaken, because of the possibility of heart problem called prolonged QT interval.

Information for the doctor: close observation of the patient and general supportive measures are recommended.

Anticholinergic anti-Parkinson medication may help to counteract the extrapyramidal disorders.

If you forget to take Domperidone Tablets
If you miss a dose, take your medicine as soon as you remember. If it is almost time for your next dose, wait until that is due and continue as usual.

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Domperidone Tablets can have side effects, although not everybody gets them.

Uncommon (may affect up to 1 in 100 people):

·         Involuntary movements of the face or arms and legs, excessive trembling, excessive muscle stiffness or muscle spasm

Not known (frequency cannot be estimated from the available data):

·         Seizures

·         type of reaction that may occur soon after administration and is recognised by skin rash, itching, shortness of breath, and/or a swollen face

·         A severe hypersensitivity reaction that may occur soon after administration that is characterised by hives, itching, flushing, fainting, and difficulty breathing among other possible symptoms

·         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.

Stop treatment with Domperidone and contact your doctor immediately (in bold) if you experience any of the unwanted events described above.

Other unwanted effects that have been observed with Domperidone are listed below:

Common (may affect up to 1 in 10 people):

·         Dry mouth

Uncommon (may affect up to 1 in 100 people):

·       Anxiety

·       Agitation

·       Nervousness

·       Loss of interest in sex or diminished interest in sex

·       Headache

·       Sleepiness

·       Diarrhoea

·       Rash

·       Itchiness

·       Hives

·       Painful or tender breasts

·       Milk discharge from breasts

·       A general feeling of weakness

·       Feeling dizzy

Not known (frequency cannot be estimated from the available data):

·       Upward movement of the eyes

·       Stopped menstrual periods in women

·       Enlarged breasts in men

·       Inability to urinate

·       Changes in certain laboratory test results

·       Restless legs syndrome (uncomfortable feeling, with an irresistible urge to move your legs, and sometimes arms and other parts of your body)

Some patients who have used Domperidone for conditions and dosages requiring medical oversight have experienced the following unwanted effects:

Restlessness; swollen or enlarged breasts, unusual discharge from breasts, irregular menstrual periods in women, difficulty breastfeeding, depression, hypersensitivity.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

5. HOW TO STORE DOMPERIDONE

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package.

Do not use the tablets after the expiry date is stated on the label.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Domperidone Tablets contain The active substance is domperidone maleate, 10mg per tablet.
Each uncoated tablet contains: Domperidone maleate equivalent to
domperidone                                     10mg
Excipients                                             q.s.

What Domperidone Tablets looks like and contents of the pack

PVC/PVDC/Al blisters.

Pack sizes: Blisters: 7, 14, 28, 30, 50, 90, 100 and 500mg modified-release tablets.

Not all pack sizes may be marketed.

7. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
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
E-mail: tajgroup@tajpharma.com

Related Products

Taj Generics (Taj Pharma) provides a wide range of products to the Indian market, including an extensive range of generics and specialty products; Our products cover a vast array of therapeutic categories, and we offer an extensive range of dosage forms and delivery systems including oral solids, controlled-release, steriles, injectables, topicals, liquids, transdermals, semi-solids and high-potency products. Our Generics portfolio offers over 1500 products in the major therapeutic areas of gastro-intestinal, cardiovascular, pain management, oncology, anti-infectives, paediatrics and dermatology.