Source: Marketing Authorisation Holder Revision Year: 2022 Publisher: Novagen Pharma (Pty) Ltd., Office 2, 100 Sovereign Drive, Route 21 Corporate Park, Nellmapius Drive, Irene-Pretoria, South Africa, (t) +27 12 345 3175
If you are hypersensitive (allergic) to alendronate, or any of the other ingredients of DENSATE 70 mg.
If you have severe kidney problems.
If you have disorders of the oesophagus e.g. narrowing or achalasia (a condition causing difficulty in swallowing, regurgitation and sometimes chest pain).
If you have low blood calcium levels.
If you have a vitamin D deficiency.
If you cannot stand or sit upright for 30 minutes after taking DENSATE 70 mg.
If you are pregnant.
If you are breastfeeding.
In children. The safety of DENSATE 70 mg in children has not been determined.
If you have stomach or intestine problems such as inflammation of the small intestine, difficulty in swallowing, inflammation of the stomach, ulcers or a disease of the oesophagus.
A dental examination should be considered before you start treatment with DENSATE 70 mg if you have cancer, are undergoing chemotherapy, are taking corticosteroids or have poor oral hygiene. If you have any of these conditions and are taking DENSATE 70 mg, certain dental procedures should be avoided if possible. If you develop bone destruction in the jaw (called osteonecrosis of the jaw) while taking DENSATE 70 mg, having dental surgery may make this condition worse. Consult your dentist for more details.
Before starting therapy with DENSATE 70 mg, low blood calcium levels and vitamin D deficiency should be corrected.
Tell your doctor if you have stomach or intestine problems such as inflammation of the small intestine, difficulty in swallowing, inflammation of the stomach, ulcers or a disease of the oesophagus.
DENSATE 70 mg may cause problems in your oesophagus (the tube that connects the mouth and stomach). These problems include inflammation, or ulcers of the oesophagus, which may sometimes bleed and cause narrowing of the oesophagus.
This may occur especially if you do not drink a full glass of water with DENSATE 70 mg or if you lie down in less than 30 minutes after taking DENSATE 70 mg, or before your first food of the day.
Stop taking DENSATE 70 mg and call your doctor right away if you get any of these signs of possible serious problems of the oesophagus: Chest pain, new or worsening heartburn, trouble or pain when swallowing.
Mouth sores (ulcers) may occur if the DENSATE 70 mg tablet is chewed or sucked.
Do not take DENSATE 70 mg at bedtime or before getting up for the day. Small decreases in blood levels of calcium and phosphate may occur, especially in patients taking glucocorticoid medicines. Make sure that you are taking in adequate calcium and vitamin D, especially if you are receiving glucocorticoid medicines.
DENSATE 70 mg tablets are sugar free.
Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines)
After swallowing your DENSATE 70 mg tablet, wait at least 30 minutes before you take other oral medicines, including antacids and calcium supplements. Calcium supplements, antacids and other oral medicines will interfere with the absorption of DENSATE 70 mg if taken at the same time. Concomitant administration of nonsteroidal anti-inflammatory medicines (NSAIDs) such as indomethacin and ibuprofen with DENSATE 70 mg may cause digestive problems.
Low blood calcium levels occur with concurrent administration of DENSATE 70 mg and aminoglycoside antibiotics, such as amikacin, gentamicin, netilmicin, streptomycin and tobramycin.
Take DENSATE 70 mg after you get up for the day and at least 30 minutes before taking your first food, drink, or other medicine. Swallow your DENSATE 70 mg tablet with a full glass of plain water only.
Do not take DENSATE 70 mg with mineral water or other beverages.
The safe use of DENSATE 70 mg during pregnancy and breastfeeding has not been determined.
DENSATE 70 mg is only intended for use in postmenopausal women.
Do not take DENSATE 70 mg if you are pregnant or if you are breastfeeding.
If you are pregnant or breastfeeding your baby please consult your doctor, pharmacist or other healthcare professional for advice before taking DENSATE 70 mg.
There is no information to show that DENSATE 70 mg affects the ability to drive a car or operate machinery.
DENSATE 70 mg can have side effects.
If any of the following happens, stop taking DENSATE 70 mg and tell your doctor immediately or go to the casualty department at your nearest hospital: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
These are all very serious side effects. If you have them, you may have had a serious allergic reaction to DENSATE 70 mg. 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:
chest pain
new or worsening heartburn
trouble or pain when swallowing.
black or tar-like stools, vomiting blood
severe joint, bone or muscle pain
jaw pain, numbness or swelling
severe skin reactions
These are all serious side effects. You may need urgent medical attention.
Other side effects include: symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth; headache; blurred vision, pain or redness in the eye; abdominal (stomach area) pain; heartburn; abdominal swelling; ulcers of the oesophagus; irritation or inflammation of the oesophagus; narrowing of the oesophagus; mouth sores (ulcers); stomach ulcers; ulcers in the duodenum (first part of the small intestine); inflammation of the stomach; excess amount of air/gas in the stomach; nausea; vomiting; constipation; diarrhoea; rash; redness of the skin; itching; transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment; decreases in blood levels of calcium and phosphate.
Tell your doctor if any of the above side effects are severe, bothersome, do not go away or about any concerns you have while taking DENSATE 70 mg.
Not all side effects reported for DENSATE 70 mg are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DENSATE 70 mg, please consult your doctor, pharmacist or other healthcare professional for advice.
If you notice any side effects not mentioned in this leaflet, please inform your doctor of pharmacist.
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