Progast Side Effects

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Answer the side-effect intent for progast without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Progast?

Progast contains the active ingredient Domperidone.

• Active ingredient — Domperidone
• Registration number — 42/5.7.2/0836
• Registration holder — Biotech Laboratories (Pty) Ltd

It is approved 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: S4 o fullness during or shortly after a meal, o a “heavy stomach”, o bloated feeling, o excessive belching, o passing wind (flatulence), o nausea and vomiting, o 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

Common side effects of Progast

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• feeling depressed
• anxiety
• lowering or loss of sexual drive (libido) in men
• headache
• feeling drowsy
• a feeling of muscle quivering, restlessness and inability to sit still
• diarrhoea
• dry mouth
• breast milk flowing from the nipple or swelling or the breast in male patients
• painful or tender breasts
• menstrual irregularities or stopped menstrual periods
• difficulty breastfeeding
• itching skin
• a general feeling of weakness

Less frequent side effects

• feeling irritable, thirst
• eye inflammation
• hot flushes
• change in appetite
• heartburn
• discharge from breasts or breast swelling
• hives, swollen tissue
• change in need to urinate, painful urination
• abdominal cramps
• constipation
• leg cramps
• painful swelling and sores inside the mouth
• lack of energy. Unknown frequency of side effect:
• feeling agitated
• feeling more nervous than usual
• feeling dizzy
• eye movement disorder
• uncommon tumour of the adrenal glands
• sudden swelling often caused by an allergic reaction
• condition where your bladder doesn’t completely empty each time you 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

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• you are hypersensitive (allergic) to domperidone or any of the other ingredients of BIO DOMPERIDONE 10 (listed in section 6)
• you have a tumour that releases prolactin (prolactinoma)
• your intestines are bleeding, have been perforated or you have an intestinal obstruction
• you are pregnant or breastfeeding
• if you have a problem that gives you a low level of potassium or magnesium, or a high level of potassium in your blood
• your heart beats excessively slow (bradycardia) or if you have a heart condition called heart-block
• you have a pre-existing heart disease
• you have a known heart condition of a congenital long QT interval or a family history thereof
• you are using one of the following medications: ketoconazole and itraconazole, fluconazole, voriconazole, posaconazole an anti-fungal treatment; antibiotics such as erythromycin, azithromycin, roxithromycin, clarithromycin, telithromycin, amiodarone, protease inhibitors used in the treatment of HIV such as amprenavir, atazanavir, fosamprenavir, indinavir, ritonavir, nelfinavir, saquinavir and quinolones
• if you have a moderate or severe liver disease

Use with care, and tell your doctor, if

• your liver function is impaired
• 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 regularly
• you are at risk of fluid retention (such as heart failure)
• you are an elderly person
• you are taking monoamine oxidase inhibitors such as selegiline used for the treatment of Parkinson’s disease or tranylcypromine and moclobemide used for the treatment of depression
• you are taking other medicines to treat infections (fungal infections or bacterial infections) and/or for heart problems or AIDS/HIV, While taking BIO DOMPERIDONE 10, contact your doctor if you experience heart rhythm disorders such as palpitations, trouble breathing, or loss of consciousness. Treatment with BIO DOMPERIDONE 10 should be stopped. Children and adolescents BIO DOMPERIDONE 10 tablets are unsuitable for use in children at or less than 12 years of age in adolescents weighing less or 35 kg body weight

Pregnancy and breastfeeding

• You should not take BIO DOMPERIDONE 10 if you are pregnant
• You should not take BIO DOMPERIDONE 10 if you are breastfeeding your baby
• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby please consult your doctor, pharmacist or other healthcare provider for advice before taking this medicine

Interactions and medicines to check

The approved leaflet names these interactions.

• Antibiotics such as erythromycin, azithromycin, clarithromycin, telithromycin or levofloxacin and moxifloxacin, spiramycin
• Medicines used for the treatment of fungal infections e.g., ketoconazole, itraconazole
• Medicines to treat heart problems or high blood pressure such as amiodarone, dronedarone, quinidine, disopyramide, dofetilide, sotalol, diltiazem, verapamil
• Medicines to treat psychoses; haloperidol, pimozide, sertindole
• Depression treatment e.g., citalopram, escitalopram, tranylcypromine and moclobemide
• Malaria treatment e.g., halofantrine
• Medicines to treat gastrointestinal disorders e.g., cisapride, dolasetron, prucalopride
• Allergy treatment e.g., mequitazine, mizolastine
• Cancer treatment e.g., toremifene, vandetanib, vincamine
• Medicine to treat angina pectoris e.g., bepridil
• Medicine to treat excessive sweating e.g., diphemanil
• Treatment of opioid dependence e.g., methadone
• MAO inhibitors (e.g., selegiline used for the treatment of Parkinson’s disease)
• Anti-cholinergic medicines (such as hyoscine butylbromide, mebeverine, ipratropium bromide, orphenadrine)
• Antacids, cimetidine used for heartburn and ulcers and sodium bicarbonate – These medicines can be taken if you are also taking BIO DOMPERIDONE tablets but they should not be taken at the same time. You should take oral BIO DOMPERIDONE tablets before meals and the stomach acid medicine after meals
• Dopaminergic agonists such as cabergoline. BIO DOMPERIDONE 10 with food and drink Take BIO DOMPERIDONE 10, 15 – 30 minutes before meals. If taken after meals, absorption of the medicine is somewhat delayed

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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