Bone Health

“Your bones are for life. Look after them and they will carry you far.”

- Susan Hampshire

Osteoporosis

Bisphosphonates

Osteonate-RGB

SCHEDULING STATUS S3

PROPRIETARY NAME AND DOSAGE FORM
OSTEONATE
70 mg tablets

Please read this patient information carefully before taking OSTEONATE 70 mg tablets.

  • Keep this information. You may need to read it again.
  • If you have further questions, please ask your doctor or your pharmacist.
  • OSTEONATE  has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.

WHAT OSTEONATE 70 mg CONTAINS

The active ingredient is alendronate monosodium salt trihydrate.
The inactive ingredients are microcrystalline cellulose, crospovidone, magnesium stearate.

WHAT OSTEONATE 70 mg IS USED FOR

OSTEONATE 70 mg is prescribed to treat osteoporosis (thinning of the bone) after menopause. The dosage and duration of the treatment are unique to your situation and you should not deviate from the doctor’s instructions.

BEFORE YOU TAKE OSTEONATE 70 mg

Do not take OSTEONATE 70 mg:

  • If you are hypersensitive (allergic) to the active substance or any of the ingredients (see WHAT OSTEONATE 70 mg CONTAINS).
  • If you are pregnant.
  • While you are breastfeeding.
  • When you are using other prescription or non prescription medicines (consult you doctor).
  • If you are suffering from any medical problems especially a history of oesophageal and gastrointestinal disorders, and severe kidney problems.
  • If you are not able to stay in an upright position for at least 30 minutes after taking OSTEONATE 70 mg.

Take special care with OSTEONATE 70 mg
Stop taking OSTEONATE 70 mg tablets immediately and consult you doctor if you develop the following symptoms of oesophageal disease:

  • difficulty or pain upon swallowing;
  • chest pain or new or worsening heartburn.
  • Your doctor may require you to visit your dentist before starting treatment, especially if you have other medical conditions such as cancer.
  • You should avoid dental procedures or surgery while taking OSTEONATE 70 mg.
  • Do not suck or chew the tablet as it may cause burning in the mouth and throat.
  • Using other medicines with OSTEONATE 70 mg:

Consult with your doctor or pharmacist for advice if you need to take any other medicines.

If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of OSTEONATE 70 mg with these medicines may cause undesirable interactions. Consult your doctor or pharmacist before taking such medicines.

Do not take any milk, antacid or aluminium-, magnesium-, iron- or calcium products with OSTEONATE 70 mg as it will decrease the absorption of the OSTEONATE 70 mg in the stomach. Make sure that your daily multivitamin supplement does not contain calcium, aluminium, magnesium or iron.

Pregnancy and breastfeeding:
DO not use OSTEONATE 70 mg in pregnancy.
DO not use OSTEONATE 70 mg during breastfeeding as it enters breast milk.

Driving and using machinery:
OSTEONATE 70 mg will most likely not make you drowsy or impair your ability to drive and use machinery but take care if you feel dizzy, tired or drowsy while using OSTEONATE 70 mg.

HOW TO TAKE OSTEONATE 70 mg

Take the OSTEONATE 70 mg exactly as prescribed by your doctor.

The dosage and dosage interval will be determined by your condition.
Consult your pharmacist if you are not sure how often and how much to use of this medication.

  • Take the OSTEONATE 70 mg tablet with a full glass of plain water on an empty stomach, in the morning as soon as you get out of bed and at least 30 minutes before any food, beverage, or any other medication.
  • Do not take any milk, antacid or aluminium-, magnesium-, iron- or calcium products with OSTEONATE 70 mg as it will decrease the absorption of the OSTEONATE 70 mg in the stomach.
  • Do not lie down for at least 30 minutes after you have taken OSTEONATE 70 mg tablets If you have trouble remembering when to use your medicine, ask your pharmacist for information.

If you take more OSTEONATE 70 mg than you should:
In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.

If you forget to take OSTEONATE 70 mg:
If you forget to take OSTEONATE 70 mg, take your recommended  dose as soon as you remember. However, if it is time for your next scheduled dose, do not take the missing dose but instead resume your usual dosing schedule that has been established. Do not take a ‘double dose’ to make up for missed doses.

If you have trouble remembering when to use your medicine, ask your pharmacist for some hints.

POSSIBLE SIDE EFFECTS

OSTEONATE 70 mg may have side effects.

Not all side effects reported for this medicine are included in this leaflet.

Should your health worsen while taking this medicine, please consult your doctor or pharmacist for advice.

Some of the side effects that occur frequently and might need medical attention are:

Abdominal pain, difficulty with swallowing, heartburn, irritation of pain of the oesophagus, muscle pain, skin rash, constipation, diarrhoea, full feeling, gas, headache, nausea

If any of these side effects persists or worsens please inform your doctor as soon as possible.

STORING AND DISPOSAL OF OSTEONATE 70 mg

  • Store below 25 °c.
  • Protect from light and moisture.
  • Keep blisters in outer carton until required for use.
  • KEEP ALL MEDICINES OUT OF REACH OF CHILDREN
  • Do not use the tablets after the expiry date printed on the carton. Return all unused medicine to your pharmacist.
  • Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets)

PRESENTATION OF OSTEONATE 70 mg

OSTEONATE 70 mg tablets are packed as 4 in a PVC I PVDC aluminium blister strip in an outer carton.

IDENTIFICATION OF OSTEONATE 70 mg

OSTEONATE 70 mg tablets are white oval, smooth, flat and marked in one face with “70”

REGISTRATION NUMBER

Osteonate 70 mg
RSA S3 42/3.2/0235
NAM NS2 11/3.2/0046

NAME AND ADDRESS OF REGISTRATION HOLDER

Pharma Dynamics (Pty) Ltd.
F02
Grapevine House
Steenberg
Office Park
WESTLAKE
7945

DATE OF PUBLICATION

May 2010
Version: PD9044A

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