“Your bones are for life. Look after them and they will carry you far.”- Susan Hampshire
SCHEDULING STATUS S4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
ACTAMAX 35 mg (film coated tablet)
Please read this patient information leaflet carefully before using ACTAMAX
- Keep this infromation. You may need to read it again.
- If you have any further questions, please ask your doctor or your pharmacist.
- ACTAMAX 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 ACTAMAX CONTAINS
ACTAMAX 35 mg: Each film coated tablet contains 35 mg risedronate sodium hemipentahydrate.
The other ingredients are:
- magnesium stearate
- microcrystalline cellulose
- Opadry white II OY-LS-28908
- Pregelatinised starch (Starch 1500)
WHAT ACTAMAX IS USED FOR
ACTAMAX is prescribed by medical practitioners to treat osteoporosis (thinning of the bone) in woman after menopause in combination with calcium 500 – 1 000 mg per day. 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 ACTAMAX
Do not take ACTAMAX:
- If you are hypersensitive (allergic) to the active substance or any of the ingredients.
- If you are pregnant.
- While you are breastfeeding.
- When you are using other prescription or non-prescription medicines in particular calcium, magnesium containing products (consult your doctor).
- If you are suffering from any medical problems especially a history of oesophageal or gastrointestinal disorders, or severe kidney disease (consult your doctor).
Take special care with ACTAMAX:
- Immediately stop taking ACTAMAX tablets if you develop symptoms of oesophageal disease (such as difficulty or pain upon swallowing, retrosternal pain or new or worsening heartburn) and consult your doctor.
Taking ACTAMAX with food or drink:
ACTAMAX tablets must always be taken at least 30 minutes before the first food, drink or any other medicine of the day, other than water, or at least two hours away from food or drink at any other time of the day.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding your baby while taking ACTAMAX, please consult your doctor, pharmacist or other healthcare professional for advice.
DO NOT use ACTAMAX if you are pregnant, suspecting you are pregnant or planning to become pregnant.
DO NOT use ACTAMAX if you are breastfeeding.
Driving and using machinery:
ACTAMAX 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 ACTAMAX.
Taking other medicines with ACTAMAX:
If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of ACTAMAX with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional for advice.
Medications contacting calcium, magnesium, iron and aluminium may interfere with the absorption of ACTAMAX and should not be taken at the same time.
HOW TO TAKE ACTAMAX
Always take ACTAMAX exactly as your doctor has instructed you. The dosage and dosage interval will be determined by your condition. You should check with your doctor or pharmacist if you are unsure.
The usual dosage is:
If you are prescribed ACTAMAX 35 mg: one tablet once a week on the same day of the week.
ACTAMAX tablets must always be taken at least 30 minutes before the first food, drink or any other medicine of the day, other than water, or at least two hours away from food or drink at any other time of the day and at least 30 minutes before going to bed. The tablets must be swallowed whole and not sucked or chewed. Food, drinks and medications containing calcium, magnesium, iron and aluminium may interfere with the absorption of ACTAMAX and should not be taken at the same time.
You should take ACTAMAX while in an upright position with a glass of plain water (≥ 120 ml) to aid delivery to the stomach. You should not lie down for 30 minutes after taking the tablet.
Take ACTAMAX tablets preferably on arising in the morning.
Two tablets should not be taken on the same day.
If you take more ACTAMAX than you should:
In the event of an overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison centre.
If you forget to take ACTAMAX:
One ACTAMAX tablet should be taken on the day that the tablet is remembered if a dose is missed. Patients should then return to taking one tablet once a week on the day the tablet is normally taken.
Do not take a double dose to make up for forgotten individual doses.
If you have trouble remembering when to use your medicine, ask your pharmacist for information.
POSSIBLE SIDE EFFECTS
ACTAMAX may have side effects.
Not all side effects reported for ACTAMAX are included in this leaflet.
Should your general health worsen while taking ACTAMAX, please consult your doctor, pharmacist or other health care professional for advice.
Some of the side effects that may occur and may need medical attention are:
- If you develop a condition called angioedema
This condition has the following symptoms and immediate medical attention is required:
- Sudden appearance of red welts, especially near the eyes and lips, but also on the hands, feet and inside of the throat.
- Burning, painful, swollen areas; sometimes itchy patches or rash on the hands, feet or face.
- Hoarseness, tight or swollen throat, breathing trouble.
- Dyspepsia, nausea, abdominal pain, constipation, diarrhoea, gastrointestinal disorders.
- Difficulty or pain upon swallowing, retrosternal pain, severe, persistent or worsening heartburn.
- Musculoskeletal pain, bone pain.
- Hypersensitivity, generalised rash and skin reactions.
- Decreases in serum calcium and phosphate levels.
If any of these side effects persists or worsens please inform your medical practitioner as soon as possible.
STORING AND DISPOSING OF ACTAMAX
- Store at or below 25 °C
- KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.
- Do not use the tablets after the expiry date printed on the carton.
- Do not remove a tablet from the outer carton until you are ready to use the dose.
- Return all unused medicine to your pharmacist.
- Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).
PRESENTATION OF ACTAMAX
Tablets are packed in white opaque PVC/PE/PVDC and silver aluminium blister strips of 1 x 4 tablets each inside an outer cardboard box
IDENTIFICATION OF ACTAMAX
White, round, biconvex film-coated tablets, embossed with “35” on one side, 11.2 ± 0.1 mm in diameter and 5.0 mm ± 0.2 mm in thickness.
ACTAMAX 35 mg: 42/3.2/0455
NAME AND ADDRESS OF REGISTRATION HOLDER
Pharma Dynamics (Pty) Ltd
1st Floor Grapevine House, Steenberg Office Park
Cape Town, South Africa
DATE OF PUBLICATION