Do not take {TRADENAME}:
- if you are allergic to:
- calcium, vitamin D or any of the other ingredients of this medicine (listed in section 6),
- other biphosphonates (medicinal products from the same group as alendronic acid),
- soya or peanut. Calcium/Vitamin D3 contains soya oil.
(see “{TRADENAME} contains” and under section 6 “What {TRADENAME} contains”).
- if you have:
- certain problems with your gullet such as narrowing or your gullet does not work properly and you have difficulty swallowing (this is called ‘achalasia’),
- excessive amounts of calcium in your blood or in your urine,
- too low amounts of calcium in your blood.
- iIf you cannot stand or sit upright for at least 30 minutes.
- if you have severe kidney problems or kidney stones.
- if you have excessive amounts of vitamin D in the blood.
If you think any of these apply to you. Talk to your doctor and follow the advice given.
Warnings and precautions
- If you are on long-term treatment with Calcium/Vitamin D3 (extra checks may be needed),
- you suffer from kidney problems or you have a strong tendency to have kidney stones,
- if you have sarcoidosis (an immune system disorder which may cause increased levels of vitamin D in the body),
- if you have osteoporosis and have been unable to move around for a long time,
- if you take other products containing vitamin D or calcium. Additional doses of calcium and vitamin D should be taken under close medical supervision.
- you have any swallowing or digestive problems,
- your doctor has told you that you have Barrett's oesophagus (a condition associated with changes in the cells that line the lower oesophagus),
- you have been told you have low blood calcium,
- you have poor dental health, gum disease, a planned dental extraction or you don’t receive routine dental care,
- you have cancer,
- you are undergoing chemotherapy or radiotherapy,
- you are taking corticosteroids (such as prednisone or dexamethasone),
- you are or have been a smoker (as this may increase the risk of dental problems).
Talk to your doctor or pharmacist before taking {TRADENAME}.
You may be advised to have a dental check-up before starting treatment with {TRADENAME}.
It is important to maintain good oral hygiene when being treated with {TRADENAME}. You should have routine dental check-ups throughout your treatment and you should contact your doctor or dentist if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling.
If you don’t follow the dosing instructions or the instruction from your doctor (see section 3 ‘How to take {TRADENAME}) irritation, inflammation or ulceration of the gullet may often occur with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing. If you develop one of these symptoms, stop taking {TRADENAME} and contact your doctor immediately. See also section 4 “Possible side effects”.
If you ignore these symptoms the probability is high the effects on the gullet will worsen.
Rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals has been reported with use of Alendronic Acid.
Children and adolescents
{TRADENAME} cannot be given to children under 18 years of age.
Other medicines and {TRADENAME}
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The two medicinal products in the combination package {TRADENAME} can have an influence on the effect of other medicinal products and vice versa:
Alendronic acid 70 mg
Talk to you doctor if you use corticosteroids (medicinal products used for the treatment of inflammations). It is possible you have to have some medical examinations (e.g. dental examination) before you can start using Alendronic acid 70 mg and also {TRADENAME}.
It is possible you start suffering from stomach irritations if you take pain killers (e.g. acetylsaliylic acid, ibuprofen) together with Alendronic acid 70 mg.
Following medicinal products are likely to have an influence on the absorption of Alendronic acid 70 mg when taken together:
- calcium supplements (such as Calcium/Vitamin D3)
- medicinal products against heartburn (antacids)
- certain medicinal products taken by the month.
Therefore, it is important that you wait at least 30 minutes before taking any other oral medicines after Alendronic acid 70 mg. Never take an Alendronic acid 70 mg tablet and a Calcium/Vitamin D3 chewable
tablet on the same day.
Certain medicines for rheumatism or long-term pain called NSAIDs (e.g. aspirin or ibuprofen) might cause digestive problems. Therefore, caution should be used when these medicines are taken at the same time as Alendronic acid 70 mg
Calcium/Vitamin D3
If you also take tetracyclines (a type of antibiotics), you should take these at least 2 hours before or 4-6 hours after intake of Calcium/Vitamin D3. Calcium carbonate may interfere with the absorption of tetracycline preparations if taken at the same time.
Never take a tablet Alendronic acid 70 mg and a chewable tablet Calcium/Vitamin D3 on the same day in order to be sure that the calcium present in Calcium/Vitamin D3 has no influence on the effect of
Alendronic acid 70 mg. Follow strictly the instructions given under section 3 “How to take {TRADENAME}”).
Calcium can reduce the effect of levothyroxine (used to treat thyroid deficiency). For this reason, levothyroxine should be taken at least four hours before or four hours after Calcium/Vitamin D3.
The effect of quinolone antibiotics may be reduced if taken at the same time as calcium. Take quinolone antibiotics two hours before or six hours after taking Calcium/Vitamin D3.
Other medicines that may influence or be influenced by Calcium/Vitamin D3 are: tiazide diuretics (used in treatment of high blood pressure or oedema) and cardiac glycosides (used to treat heart disorders).
Important information on the combination package {TRADENAME}. As indicated under the section
“Alendronic acid 70 mg” the absorption of Alendronic acid is influenced by calcium. Therefore, never take a tablet Alendronic acid 70 mg and a chewable tablet Calcium/Vitamin D3 on the same day in order to be sure that the calcium present in Calcium/Vitamin D3 has no influence on the effect of Alendronic acid 70 mg. Follow strictly the instructions given under section 3 “How to take {TRADENAME}”).
{TRADENAME} with food and drink
Alendronic acid 70 mg
The Alendronic acid 70 mg tablet is taken with a full glass of plain water. When the tablet is taken with another type of beverage or with food this can have an influence on the way the product works. Therefore it is important to read the advice given in section 3 “How to take {TRADENAME}”.
Calcium/Vitamin D3 can be taken with or without food and drink.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
{TRADENAME} is only intended for use in postmenopausal women. You should not take {TRADENAME} if you are or think you may be pregnant, or if you are breast-feeding.
Driving and using machines
There have been no studies on the influence of {TRADENAME} on driving or using machines. However, Alendronic acid 70 mg can have side effects (for example blurred vision, dizziness and severe bone, muscle or joint pain) that may affect your ability to drive or operate machinery. (See section 4 “Possible side effects”.) These reactions can differ person by person.
{TRADENAME} contains soya oil, isomalt and sucrose
Calcium/Vitamin D3 contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product. Calcium/Vitamin D3 contains isomalt (E953) and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. May be harmful to the teeth.
