Vomidon 10 mg Tablets

VOMIDON TABLETS is used in adults and adolescents over 12 years of age and weighing over 35 kg for:

• Short term relief not exceeding 7 days for stomach discomfort due to food moving slowly through the stomach and intestines, where you may feel symptoms such as:
• fullness during or shortly after a meal
• a “heavy stomach”
• bloated feeling
• excessive belching
• passing wind (flatulence)
• nausea
• vomiting
• a burning feeling and/or pain in the stomach area
• Short term use not exceeding 7 days for discomfort due to backflow of stomach acid, where you may experience belching and/or heartburn
• Short term use not exceeding 7 days except when used for nausea and vomiting due to various causes including chemotherapy, radiotherapy or other medicines where use should not exceed 4 weeks.

VOMIDON TABLETS are unsuitable for use in children at or less than 12 years of age. VOMIDON TABLETS are unsuitable for use in adolescents weighing less or 35 kg body weight.

Do not take VOMIDON TABLETS:

• if you are hypersensitive (allergic) to domperidone or any of the other ingredients in VOMIDON TABLETS (listed in section 6).
• if you suffer from a disease of the pituitary gland called prolactinoma.
• if you have severe stomach cramps or persistent black stools.
• if you have a liver disease.
• If you are taking certain medicines that slow down the breakdown (metabolism) of other medicines in the body and can affect your heart rhythm, such as:
• itraconazole, ketoconazole, posaconazole or voriconazole, which are used to treat fungal infections
• erythromycin, clarithromycin or telithromycin or quinolones which are antibiotics
• amiodarone, a heart medicine
• ritonavir or saquinvair which are medicines for HIV/AIDS
• if you have or had heart problems including heart failure, a previous heart attack, angina (chest pains), or heart rhythm disorders including a rapid or slow or irregular heart beat.

If you are not sure about any of these please consult your doctor. Stop taking VOMIDON TABLETS and contact your doctor immediately if you experience an abnormal heart beat.

Warnings and precautions

Take special care with VOMIDON TABLETS:

• if you are elderly caution should be taken with VOMIDON TABLETS since you are at greater risk to serious cardiac effects with doses greater than 30 mg per day.
• if you are taking antacids or anti-secretary medicines simultaneously with VOMIDON TABLETS as this reduces the effects of VOMIDON TABLETS. Therefore VOMIDON TABLETS should be taken before meals and antacids or anti-secretary medicines taken after meals.
• if you have kidney impairment you may require a lower dose which will be calculated by the prescriber.

Stop taking VOMIDON TABLETS and contact your doctor immediately if you experience an abnormal heart beat.

Do not share medicines prescribed for you with any other person. Always take VOMIDON TABLETS exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how long your treatment with VOMIDON TABLETS will last. Do not stop early because your symptoms may reappear. If you have the impression that the effect of VOMIDON TABLETS is too strong or too weak, tell your doctor or pharmacist.

It is recommended to take oral VOMIDON TABLETS 15 – 30 minutes before meals. If taken after meals, absorption of the medicine is somewhat delayed. Take VOMIDON TABLETS with some liquid.

You should always take the lowest amount of VOMIDON TABLETS that works for you and you should not take it for longer than seven days. Although the amount of VOMIDON TABLETS you should usually take is described below, your doctor may adjust your dose to your personal needs.

When a doctor has prescribed VOMIDON TABLETS for you, the following information applies: If VOMIDON TABLETS are for nausea and vomiting, you should not usually need to take it for more than one week. Talk to your doctor if your nausea and vomiting lasts or more than one week. If VOMIDON TABLETS are for stomach discomfort, stomach acid backflow or nausea and vomiting due to chemotherapy, radiotherapy or other medicines, do not take VOMIDON TABLETS for longer than 4 weeks without talking to your doctor.

A dults and adolescents ≥ 35 kg: Take 1 of the 10 mg tablets three times per day with water. Do not take more than 3 tablets per day. The maximum dose per day is 30 mg.

Formulation (domperidone per unit) Dosage Maximum dose per day Uncoated tablet (10 mg/tablet) 1 tablet three to four times a day 30 mg (3 x 10 mg tablet

Using VOMIDON TABLETS in infants and children: Do not give VOMIDON TABLETS to infants and children who are under 12 years of age and weigh less than 35 kg.

Duration of treatment: Must not exceed one week for treatment of nausea and vomiting. Up to four weeks for other indications. If treatment exceeds four weeks, the need for continued treatment to be reassessed.

If you have the impression that the effect of VOMIDON TABLETS is too strong or too weak, tell your doctor or pharmacist.

If you take more VOMIDON TABLETS than you should: Signs and Symptoms If you have taken too much VOMIDON TABLETS you may experience agitation, altered state of awareness or trance, seizure, sleepiness, confusion, uncontrolled movements, such as irregular eye movements, or abnormal posture, such as twisted neck. See your doctor, especially if a child has taken the medicine.

It is important not take more VOMIDON TABLETS than you should. In the event of overdosage, patients should consult a doctor or pharmacist. If neither is available, they contact the nearest hospital or poison centre. Take along any tablets that are left, the container and the label so that the hospital staff can easily tell what medicine you have taken.

If you forget to take VOMIDON TABLETS: It is important to take your VOMIDON TABLETS regularly at the same time each day. If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for forgotten individual doses.

If you stop taking VOMIDON TABLETS: Take VOMIDON TABLETS for as long as your doctor recommends. Don’t stop unless your doctor advises you to.

VOMIDON TABLETS can have side effects. Not all side effects reported for VOMIDON TABLETS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VOMIDON TABLETS, please consult your health care provider for advice.

If any of the following happens, stop taking VOMIDON TABLETS and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Allergic reaction (urticarial) including:
• pruritus (severe itching of the skin).
• rash.
• sudden cardiac death, serious abnormal heart beats, sudden life-threatening severe allergic reaction, rapid swelling of the skin or mucosal tissues, convulsions in children

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to VOMIDON TABLETS. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Frequency unknown Convulsions, Urinary retention, Continuous muscle spasms or contractions involving irregular jerky movements in children

These are all serious side effects. You may need urgent medical attention.

Tell your doctor immediately if you notice any of the following:

• depression
• anxiety
• loss of interest in sex or diminished interest in sex
• headache
• somnolence
• restlessness
• diarrhoea
• rash
• itchiness
• enlarged or swollen breasts
• painful or tender breasts
• milk discharge from breasts or difficulty breast feeding
• irregular or stopped menstrual periods
• a general feeling of weakness
• dry mouth
• feeling dizzy

Less frequent side effects:

• movements that you cannot control, such as muscle tremors, spasms or stiffness, feeling restless or difficulty sitting still, slow movement
• severe allergic reaction that may include:
• a swollen face, lips, mouth, tongue or throat
• difficulty swallowing or breathing
• itchy rash (hives)
• palpitations
• seizures (fits)
• unexpected death resulting from an abrupt loss of heart function in a person who may or may not have known heart disease.

Other less frequent side effects include:

• hypersensitivity
• hives
• unusual discharge from breasts
• feeling agitated
• nervousness
• inability to urinate
• changes in certain laboratory test results

Inadvertent ingestion in children resulted in:

• movements that you cannot control, such as muscle tremors, spasms or stiffness, feeling restless or difficulty sitting still, slow movement.
• seizures
• feeling agitated

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of VOMIDON TABLETS.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from light. Store in the original package. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).