Magnesium Side Effects

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Explain possible side effects and interaction/safety considerations for magnesium without overstating causality or efficacy.

Part of vitamins & minerals side effects.

What is magnesium?

Magnesium contains the active ingredient Omeprazole magnesium.

• Active ingredient — Omeprazole magnesium
• Registration number — 32/11.4.3/0222; 32/11.4.3/0223; 32/11.4.3/0224
• Registration holder — Equity Pharmaceuticals (Pty) Ltd

It is approved for:

• ulcers in the upper part of the intestine (duodenal ulcer)
• stomach ulcers (gastric ulcer)
• stomach ulcers or duodenal ulcers caused by medicines for pain and joint inflammation (NSAID associated gastric and duodenal ulcers or erosions)
• ulcers, which are infected with bacteria, called Helicobacter pylori
• inflammation of the gullet caused by a return flow of fluid from the stomach (reflux oesophagitis)
• disease with symptoms caused by a return flow of fluid from the stomach (symptomatic gastro- oesophageal reflux disease)
• acid-related upper abdominal pain or discomfort (acid related dyspepsia)
• hormone-producing tumours in the pancreas causing excess acid in the stomach (Zollinger-Ellison syndrome). Children:
• For the short term (up to 3 months) treatment of severe ulcerative oesophagitis, which has not responded to previous medical treatment. Severe ulcerative reflux oesophagitis is an inflammation of the oesophagus (gullet), including the development of ulcers on the lining of the gullet, caused by stomach acid flowing back into the gullet

Possible side effects of magnesium

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.

Reported side effects

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing (severe allergic reaction)
• Rash or itching (sever skin reactions)
• Fainting, decreased consciousness
• These are all very serious side effects. If you have them, you may have had a serious allergic reaction to LOSEC MUPS. 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:
• Discomfort/tightness in the chest
• Signs of recurrent infections such as fever or sore throat
• A decrease in the amount of urine, blood in the urine, tiredness, nausea and lack of appetite which can be symptoms of kidney problems. Sometimes fever, rash, joint pains may be present
• Yellowing of the skin and eyes, dark urine, and tiredness which may be symptoms of liver problems
• These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following: Common / Frequent side effects:
• headache
• diarrhoea
• constipation
• stomach ache
• nausea/vomiting
• wind
• masses of cells on the lining inside your stomach, known as fundic gland polyps. Uncommon / Less frequent side effects:
• skin rash
• dermatitis
• itchy skin
• sensation of burning/ prickling/ numbness
• dizziness, light-headedness
• difficulty sleeping
• feeling sleepy
• sensation of movement of oneself or of one’s surroundings
• feeling ill
• inflammation in the gut (leading to diarrhoea)
• sore joints and muscles
• muscular weakness
• hair loss
• dry mouth
• inflammation in the mouth
• gastrointestinal fungal infection
• disorientation, aggression, confusion
• blood disorders
• development of breasts in males
• taste disorders
• low blood sodium and low blood magnesium (which may result in low blood calcium and/or blood potassium)
• if you are very ill, you may feel confused, nervous, depressed or hallucinate
• sensitivity to sunlight
• increased sweating
• blurred vision
• fracture of hip, wrist or spine

Interactions and medicines to check

The approved leaflet names these interactions.

• if you are taking any of the following medicines used to prevent or treat:
• fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole)
• anxiety (diazepam)
• epilepsy (phenytoin)
• blood clotting (warfarin or other vitamin K blockers or clopidogrel)
• intermittent claudication (cilostazol)
• transplant rejection (tacrolimus)
• HIV (atazanavir, nelfinavir or saquinavir)
• heart problems (digoxin)
• tuberculosis (rifampicin)
• depression (St John’s Wort / Hypericum perforatum)
• if you are using a certain type of anti-cancer medicine (such as erlotinib or another anti-cancer medicine from the same class)
• if you are taking LOSEC MUPS at the same time as some medicines for HIV, such as atazanavir and nelfinavir, as it is not recommended
• if you are taking a high dose of methotrexate, LOSEC MUPS may need to be temporarily withdrawn

Who should use extra caution?

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• if you are hypersensitive (allergic) to omeprazole, substituted benzimidazoles, or any of the other ingredients of LOSEC MUPS (listed in section 6)
• if you are allergic to other “proton pump inhibitors” or any of the other ingredients of LOSEC MUPS

Use with care, and tell your doctor, if

• If you are taking LOSEC MUPS at the same time as some medicines for HIV, such as atazanavir and nelfinavir, as it is not recommended
• If you notice any of the following:
• weight loss without trying to lose weight
• you begin to vomit blood or food
• pain or indigestion during treatment with LOSEC MUPS
• you pass black (blood-stained) stools. You should contact your doctor immediately
• If you have kidney problems. LOSEC MUPS can cause a kidney problem called acute interstitial nephritis (AIN) at any time during treatment. If you notice a decrease in the quantity of your urine, or you have blood in your urine, contact your doctor right away
• If you are using a certain type of anti-cancer medicine (such as erlotinib or another anti-cancer medicine from the same class)
• If you have severe liver problems. Your doctor may want to reduce the dosage
• If you are due to have a specific blood test (Chromogranin A)
• If you start suffering from stomach infections and runny tummy
• If you are feeling tired, confused, dizzy, have an irregular heartbeat and seizures/fits. This may be due to a lack of magnesium in your blood
• You may need to take a magnesium replacement and discontinue your LOSEC MUPS
• If you are taking a heart medicine called digoxin, or other medicines which may decrease your magnesium levels. Some population studies have indicated that the use of proton pump inhibitors (like LOSEC MUPS) may be associated with an increased risk of osteoporotic bone fractures (osteoporosis is a condition where certain bones become brittle). Please inform your doctor if you have been diagnosed with osteoporosis (brittle bone disease). Serious skin reactions have occurred in patients taking omeprazole, as in LOSEC MUPS. The rash can involve ulcers in the mouth throat, nose, genitals and conjunctivitis (swollen red eye). These serious skin reactions often occur after flu-like symptoms such as fever, headache and body ache. The rash may cover large parts of the body with blistering and peeling of the skin. If you develop a rash or any of these skin symptoms, even after several weeks, stop taking LOSEC MUPS and contact your doctor immediately If you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as you can, as you may need to stop your treatment with LOSEC MUPS. Remember to also mention any other ill effects like pain in your joints

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking this medicine

Dose, timing and other factors that can affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• if you are hypersensitive (allergic) to omeprazole, substituted benzimidazoles, or any of the other ingredients of LOSEC MUPS (listed in section 6)
• if you are allergic to other “proton pump inhibitors” or any of the other ingredients of LOSEC MUPS

Use with care, and tell your doctor, if

• If you are taking LOSEC MUPS at the same time as some medicines for HIV, such as atazanavir and nelfinavir, as it is not recommended
• If you notice any of the following:
• weight loss without trying to lose weight
• you begin to vomit blood or food
• pain or indigestion during treatment with LOSEC MUPS
• you pass black (blood-stained) stools. You should contact your doctor immediately
• If you have kidney problems. LOSEC MUPS can cause a kidney problem called acute interstitial nephritis (AIN) at any time during treatment. If you notice a decrease in the quantity of your urine, or you have blood in your urine, contact your doctor right away
• If you are using a certain type of anti-cancer medicine (such as erlotinib or another anti-cancer medicine from the same class)
• If you have severe liver problems. Your doctor may want to reduce the dosage
• If you are due to have a specific blood test (Chromogranin A)
• If you start suffering from stomach infections and runny tummy
• If you are feeling tired, confused, dizzy, have an irregular heartbeat and seizures/fits. This may be due to a lack of magnesium in your blood
• You may need to take a magnesium replacement and discontinue your LOSEC MUPS
• If you are taking a heart medicine called digoxin, or other medicines which may decrease your magnesium levels. Some population studies have indicated that the use of proton pump inhibitors (like LOSEC MUPS) may be associated with an increased risk of osteoporotic bone fractures (osteoporosis is a condition where certain bones become brittle). Please inform your doctor if you have been diagnosed with osteoporosis (brittle bone disease). Serious skin reactions have occurred in patients taking omeprazole, as in LOSEC MUPS. The rash can involve ulcers in the mouth throat, nose, genitals and conjunctivitis (swollen red eye). These serious skin reactions often occur after flu-like symptoms such as fever, headache and body ache. The rash may cover large parts of the body with blistering and peeling of the skin. If you develop a rash or any of these skin symptoms, even after several weeks, stop taking LOSEC MUPS and contact your doctor immediately If you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as you can, as you may need to stop your treatment with LOSEC MUPS. Remember to also mention any other ill effects like pain in your joints

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking this medicine

Serious symptoms 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

What to do if side effects occur

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.

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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