DENSATE Tablet Ref.[50335] Active ingredients: Alendronic acid

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

4.1. Therapeutic indications

DENSATE 70 mg belongs to a class of medicines called bisphosphonates. DENSATE 70 mg works by preventing bone breakdown and increasing bone density.

The treatment of osteoporosis (thinning of bone) in women after menopause. It reduces the chance of having a hip or spinal fracture (break). The treatment of osteoporosis in men. It reduces the chance of having a spinal fracture (break).

4.2. Posology and method of administration

Dosage

For the treatment of osteoporosis (thinning of bone) in women after menopause, the usual dose is one 70 mg tablet once weekly. For the treatment of osteoporosis in men, the usual dose is one 70 mg tablet once weekly.

How to take DENSATE 70 mg

Do not share medicines prescribed for you with any other person.

Always take DENSATE 70 mg exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of DENSATE 70 mg is too strong or too weak, talk to your doctor or pharmacist.

It is important to take DENSATE 70 mg only as directed by your doctor.

It is very important that you follow the following steps to help DENSATE 70 mg reach your stomach quickly and help reduce possible irritation of your oesophagus (the tube that connects your mouth with your stomach):

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.

Do not crush, chew or suck the tablet. Swallow the tablet whole.

Do not lie down, stay fully upright (sitting, standing or walking) for at least 30 minutes after swallowing DENSATE 70 mg. Do not lie down until after your first food of the day.

Do not take DENSATE 70 mg at bedtime or before getting up for the day.

After swallowing DENSATE 70 mg, wait at least 30 minutes before taking calcium and vitamin D supplements. Calcium and vitamin D supplements should be taken if your diet is inadequate.

If you forget to take DENSATE 70 mg

If you miss a dose, take only one DENSATE 70 mg on the morning after you remember. Do not take two tablets on the same day. Continue your usual schedule of one DENSATE 70 mg tablet once a week on your chosen day.

4.9. Overdose

If you take more DENSATE 70 mg than you should

Do not make yourself vomit and do not lie down.

Taking milk and antacids is recommended.

Overdose symptoms may include low levels of calcium in the blood, low levels of phosphate in the blood, upset stomach, heartburn, inflammation of the oesophagus, inflammation of the stomach or ulcer.

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

6.4. Special precautions for storage

Store in a dry place at or below 25°C (room temperature).

Do not remove blisters from carton until required for use.

Keep original containers well closed.

Store all medicines out of reach of children.

6.5. Nature and contents of container

DENSATE 70 mg: Tablets are packed in printed aluminium foil with heat seal lacquer and clear PVC laminated with aclar.

Each blister contains 4 tablets.

Pack size: 4’s – Each carton contains 1 blister of 4 tablets each.

6.6. Special precautions for disposal and other handling

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets toilets).

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