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Actonel once a week 35 mg film coated tablets, Risedronic acid
Actonel once a week 35 mg film coated tablets
Risedronic acid
Each film coated tablet contains 32,5 mg risedronic acid (INN) (35
mg risedronate sodium). Excipients: Lactose monohydrate,
microcrystalline cellulose, crospovidone, magnesium stearate. Film
coating: Dri-Klear (hypromellose, macrogol 400, hydroxypropyl
cellulose, macrogol 8000 and silicon dioxide), Chroma-Tone White
DDB-7536W (titanium dioxide E171, hypromellose), ferric oxide yellow
(E172), ferric oxide red (E172).
WHAT IS ACTONEL
Actonel once a week 35 mg are supplied in packs of 4 tablets.
Actonel once a week belongs to a group of non-hormonal medicines
called bisphosphonates, which are used to treat certain bone
diseases. Actonel works by slowing down the process of old bone
being removed, allowing the bone-forming cells time to rebuild
normal bone, making them stronger and therefore less likely to
fracture. This medication is indicated for the treatment of
postmenopausal osteoporosis, to reduce the risk of vertebral
fractures and the treatment of established postmenopausal
osteoporosis, to reduce the risk of hip fractures.
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BEFORE TAKING ACTONEL
Do not take Actonel:
o if you are allergic to risedronate sodium or to any of its
excipients.
o if you have a low blood calcium level (hypocalcaemia) or you have
severe renal impairment.
o if you are pregnant or breast feeding.
Take special care with Actonel once a week
Medications that belong to the same group as Actonel once a week (bisphosphonates)
may cause oesophagitis and oesophageal ulcerations. Therefore
patients should pay attention to the dosing instructions (see
section 3. How to take Actonel once a week). Patients who have a
history of oesophageal disorders or who are unable to stay in the
upright position for at least 30 minutes after taking the tablet
should use this medication with special caution. Consult your doctor
before taking Actonel once a week if you have a low blood calcium
level (hypocalcaemia) or disturbances of bone or mineral metabolism
(for example, vitamin D deficiency or parathyroid hormone
abnormalities). The evidence to support efficacy of this medication
in patients over 80 years of age is limited therefore consult your
doctor before taking Actonel.
Taking Actonel once a week with food and drink
Patients should not take Actonel once a week with food or drinks
other than plain water (not mineral water).
Pregnancy
Consult your doctor or pharmacist before taking any medication.
Actonel once a week must not be used during pregnancy.
Lactation
Consult your doctor or pharmacist before taking any medication.
Actonel once a week must not be used during lactation.
Driving and using machines:
Actonel once a week is unlikely to affect your ability to drive or
to use machines.
Taking other medicines
As a general rule, always tell your doctor or pharmacist if you are
taking or have recently taken any other medicines, even those that
do not require a prescription. You should not take Actonel once a
week at the same time as medications containing calcium, magnesium,
iron or aluminium as they may interfere with the absorption of
Actonel once a week and lessen its effect. Therefore Actonel once a
week should be taken at least 30 minutes before the first meal,
other medicinal product or drink (other than water) of the day. If
you regularly (3 or more days per week) take medications that
contain acetyl salicylic acid or anti-inflammatories called
non-steroidal anti-inflammatory drugs you may experience upper
gastrointestinal adverse events. If considered appropriate Actonel
once a week may be used concomitantly with oestrogen
supplementation.
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HOW TO TAKE ACTONEL
Follow these instructions unless indicated otherwise by your doctor.
The recommended dose in adults is one Actonel once a week 35 mg
tablet orally once a week. The tablet should be taken on the same
day each week.
The absorption of Actonel once a week is affected by food, thus to
ensure adequate absorption patients should take Actonel at least 30
minutes before the first meal, other medicinal product or drink
other than plain water (not mineral water) of the day.
The tablet must be swallowed whole and not chewed or broken. To aid
delivery of the tablet to the stomach Actonel is to be taken while
in an upright position (you may sit or stand) with a glass of plain
water (not mineral water). Patients should not lie down for at least
30 minutes after taking the tablet.
Your doctor will consider supplemental calcium and vitamin D if the
dietary intake is inadequate.
Your doctor will indicate the duration of your treatment with
Actonel. Please consult your doctor before you stop treatment.
If you take more Actonel than you should:
Decreases in serum calcium following overdose may be expected.
Therefore milk or antacids containing magnesium, calcium or
aluminium should be given as soon as possible to reduce absorption
of the medication. In cases of substantial overdose, gastric lavage
may be considered.
If you have taken more Actonel than you should, consult your doctor
or pharmacist immediately.
"In case of overdose or accidental ingestion, immediately consult
your local poison centre (Servicio de Información Toxicológica),
Telephone 91 562 04 20".
If you forget to take Actonel:
Patients should be instructed that if a dose is missed, one Actonel
once a week tablet should be taken on the day that the tablet is
remembered. Patients should then return to taking one tablet once a
week on the day the tablet is normally taken. Do not take two
tablets in one day to make up for the tablet you missed. Remember to
take you medication.
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POSSIBLE SIDE EFFECTS
Like all medicines, Actonel once a week can have side effects.
The most common side effects (1% to 10% patients) are:
abdominal pain, nausea, constipation, diarrhoea, gas, stomach ache
and dyspepsia.
pain in bones, muscles and joints
headache.
The following uncommon side effects (0.1% to 1% patients) have been
reported: inflammation of the stomach and the small intestine,
mastication difficulty and difficulty in swallowing, oesophageal
ulcer, oesophageal stricture, inflammation of the tongue and
inflammation of the iris. Mild decreases in serum phosphate and
calcium levels have been observed in the blood tests of some
patients. In rare instances (0,01% to 0,1% patients) abnormal liver
tests have been reported. Very rarely, skin and subcutaneous tissue
disorders, which may be allergic type reactions, have been reported.
These include generalised urticaria accompanied by swelling of the
feet, hands, throat, lips and respiratory tract (angioedema), skin
rash, blistering of the skin (bullous skin reactions), some severe.
If you notice any other side effects not mentioned in this leaflet,
please consult your doctor or pharmacist immediately.
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STORAGE OF ACTONEL
No special precautions for storage.
Expiry
Do not use Actonel once a week after the expiry date marked on the
pack.
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