Patient leaflet - Alendronic Acid/cholecalciferol tablet 70 mg/2800 IU
1. What Alendronic acid/Cholecalciferol is and what it is used for
What is Alendronic acid/Cholecalciferol?
Alendronic acid/Cholecalciferol is a tablet containing the two active substances, alendronic acid (commonly called alendronate) and colecalciferol known as vitamin D3.
What is alendronate?
Alendronate belongs to a group of non-hormonal medicines called bisphosphonates. Alendronate prevents the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone. It reduces the risk of spine and hip fractures.
What is vitamin D?
Vitamin D is an essential nutrient, required for calcium absorption and healthy bones. The body can only absorb calcium properly from our food if it has enough vitamin D. Very few foods contain vitamin D. The main source is through exposure to summer sunlight, which makes vitamin D in our skin. As we get older our skin makes less vitamin D. Too little vitamin D may lead to bone loss and osteoporosis. Severe vitamin D deficiency may cause muscle weakness which can lead to falls and a greater risk of fractures.
What is Alendronic acid/Cholecalciferol used for?
Your doctor has prescribed Alendronic acid/Cholecalciferol to treat your osteoporosis and because you are at risk of vitamin D insufficiency. It reduces the risk of spine and hip fractures in women after menopause.
What is osteoporosis?
Osteoporosis is a thinning and weakening of the bones. It is common in women after the menopause. At the menopause, the ovaries stop producing the female hormone, oestrogen, which helps to keep a woman’s skeleton healthy. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches the menopause, the greater the risk of osteoporosis.
Early on, osteoporosis usually has no symptoms. If left untreated, however, it can result in broken bones. Although these usually hurt, breaks in the bones of the spine may go unnoticed until they cause height loss. Broken bones can happen during normal, everyday activity, such as lifting, or from minor injury that would not generally break normal bone. Broken bones usually occur at the hip, spine, or wrist and can lead not only to pain but also to considerable problems like stooped posture (‘dowager’s hump’) and loss of mobility.
How can osteoporosis be treated?
As well as your treatment with Alendronic acid/Cholecalciferol, your doctor may suggest you make changes to your lifestyle to help your condition, such as:
Stopping smoking Smoking appears to increase the rate at which you lose bone and, therefore, may increase your risk of broken bones.
Exercise Like muscles, bones need exercise to stay strong and healthy. Consult your doctor before you begin any exercise programme.
Eating a balanced diet Your doctor can advise you about your diet or whether you should take any dietary supplements.
2. What you need to know before you take Alendronic acid/Cholecalciferol
Do not take Alendronic acid/Cholecalciferol
- if you are allergic to alendronate sodium trihydrate, colecalciferol or any of the other ingredients of this medicine (listed in section 6)
- if you have certain problems with your gullet (oesophagus - the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing
- if you cannot stand or sit upright for at least 30 minutes
- if your doctor has told you that you have low blood calcium.
If you think any of these apply to you, do not take the tablets. Talk to your doctor first and follow the advice given.
Warnings and precautions
Talk to your doctor or pharmacist before taking Alendronic acid/Cholecalciferol if:
- you suffer from kidney problems
- you have, or have recently had, any swallowing or digestive problems such as inflammation of the stomach or gut, ulcers, bleeding or had surgery on your throat, gullet or stomach,
- 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 trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
- you have poor dental health, gum disease, a planned dental extraction, poorly fitted dentures or you don’t receive routine dental care
- you have cancer
- you are undergoing chemotherapy or radiotherapy
- you are taking angiogenesis inhibitors (such as bevacizumab, or thalidomide), which are used in the treatment of cancer
- you are taking corticosteroids (such as prednisone or dexamethasone), which are used in the treatment of asthma, rheumatoid arthritis and severe allergies
- you are or have been a smoker (as this may increase the risk of dental problems)
- you have, or have recently had, an ear infection or problems with your ear,
- you have low levels of vitamin D or parathyroid hormone in your blood. These need to be treated before you start taking this medicine.
You may be advised to have a dental check-up before starting treatment with Alendronic acid/Cholecalciferol.
During treatment
It is important to maintain good oral hygiene when being treated with Alendronic acid/Cholecalciferol. 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.
Stop taking Alendronic acid/Cholecalciferol and contact your doctor immediately if you experience irritation, inflammation or ulceration of the gullet (oesophagus – the tube that connects your mouth with your stomach), which you may notice as chest pain, heartburn, or difficulty or pain upon swallowing. This is more likely to happen if you do not drink a full glass of water and/or if you lie down less than 30 minutes after taking Alendronic acid/Cholecalciferol. It is important that you carefully follow the instruction on how to take this medicine.
Contact your doctor immediately if you notice ear pain, discharge from the ear or have an ear infection while taking this medicine.
Contact your doctor immediately if you notice any thigh, hip or groin pain while taking this medicine. This may be an early indication of a possible fracture of the thigh bone.
Your doctor may give you additional vitamin D supplements if you do not receive enough from your diet or other supplements.
Children and adolescents
Alendronic acid/Cholecalciferol should not be given to children and adolescents less than 18 years of age.
Other medicines and Alendronic acid/Cholecalciferol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescription, or any of the following:
- calcium supplements
- antacids for indigestion
- corticosteroid medicines such as prednisolone or dexamethasone, used to reduce inflammation; as it is important that you have a good dietary intake of calcium and vitamin D
- certain medicines for rheumatism or long-term pain called NSAIDs (e.g. acetylsalicylic acid or ibuprofen) might cause digestive problems. Therefore, caution should be used when these drugs are taken at the same time as this medicine
- artificial fat substitutes
- mineral oils
- orlistat, a medicine used to lose weight
- medicines used to lower cholesterol such as cholestyramine or colestipol
- cimetidine (a medicine that reduces the amount of acid in your stomach)
- medicines used to treat fits (seizures) such as phenytoin or phenobarbital
- thiazide medicines used to lower blood pressure such as hydrochlorothiazide.
It is important that you follow the advice given in section 3, ‘How to take Alendronic acid/Cholecalciferol’ and wait at least 30 minutes after taking this medicine before taking any other medicines.
Alendronic acid/Cholecalciferol with food and drink
It is likely that food and beverages (including mineral water) will make Alendronic acid/Cholecalciferol less effective if taken at the same time. Therefore, it is important that you follow the advice given in section 3. You must wait at least 30 minutes before taking any food and beverages except water.
Pregnancy and breast-feeding
Alendronic acid/Cholecalciferol is only intended for use in postmenopausal women. You should not take Alendronic acid/Cholecalciferol if you are or think you may be pregnant, or if you are breast-feeding.
Driving and using machines
There have been side effects (for example blurred vision, dizziness and severe bone, muscle or joint pain) reported with alendronate/colecalciferol that may affect your ability to drive or operate machinery (see section 4). If you experience any of these side effects you should not drive until you feel better.
Alendronic acid/Cholecalciferol contains lactose and sucrose
If you have been told by your doctor that you have an intolerance to some sugars such as lactose or sucrose, contact your doctor before taking this medicine.
3. How to take Alendronic acid/Cholecalciferol
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Take one Alendronic acid/Cholecalciferol tablet once a week.
Follow these instructions carefully.
- 1)
Choose the day of the week that best fits your schedule. Every week, take one Alendronic acid/Cholecalciferol tablet on your chosen day.
It is very important to follow instructions 2), 3), 4) and 5) to help the Alendronic acid/Cholecalciferol tablet reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagus - the tube that connects your mouth with your stomach).
- 2)
After getting up for the day and before taking any food, drink, or other medicine, swallow your Alendronic acid/Cholecalciferol tablet whole with a full glass of water only (not mineral water) (not less than 200 ml), so that Alendronic acid/Cholecalciferol is adequately absorbed.
- • Do not take with mineral water (still or sparkling).
- • Do not take with coffee or tea.
- • Do not take with juice or milk.
Do not crush or chew the tablet or allow it to dissolve in your mouth because of the possibility of mouth ulceration.
- 3) Do not lie down — stay fully upright (sitting, standing or walking) — for at least 30 minutes after swallowing the tablet. Do not lie down until after your first food of the day.
- 4) Do not take Alendronic acid/Cholecalciferol at bedtime or before getting up for the day.
- 5) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking Alendronic acid/Cholecalciferol and contact your doctor.
- 6)
After swallowing your Alendronic acid/Cholecalciferol tablet, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins.
Alendronic acid/Cholecalciferol is effective only if taken when your stomach is empty.
If you take more Alendronic acid/Cholecalciferol than you should
If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately. Do not make yourself vomit, and do not lie down.
If you forget to take Alendronic acid/Cholecalciferol
If you miss a dose, just take one tablet on the morning after you remember. Do not take two tablets on the same day. Return to taking one tablet once a week, as originally scheduled on your chosen day.
If you stop taking Alendronic acid/Cholecalciferol
It is important that you continue taking Alendronic acid/Cholecalciferol for as long as your doctor prescribes the medicine. Since it is not known how long you should take Alendronic acid/Cholecalciferol, you should discuss the need to stay on this medicine with your doctor periodically to determine if Alendronic acid/Cholecalciferol is still right for you.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
See your doctor immediately if you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment:
Common (may affect up to 1 in 10 people):
- new or worsening heartburn, acid reflux, difficulty, discomfort or pain upon swallowing (these are signs of ulceration of the oesophagus).
Uncommon (may affect up to 1 in 100 people):
- blurred vision, watery eyes, pain or redness in the eye, increased sensitivity to light, floaters (shadows passing across your sight) or gritty eyes
- dark-black or tar-like stools
- inflammation, irritation, or erosion of the lining of the stomach or gullet.
Rare (may affect up to 1 in 1,000 people):
- allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing; severe skin reactions
- a skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome) or severe skin reactions which starts with painful red areas, then large blisters and ends with peeling of layers of skin. This is accompanied by fever and chills, aching muscles and generally feeling unwell (toxic epidermal necrolysis)
- pain in the mouth, and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be signs of bone damage in the jaw (osteonecrosis) generally associated with delayed healing and infection, often following tooth extraction. Contact your doctor and dentist if you experience such symptoms
- unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone
- bone, muscle and/or joint pain which is severe
- mouth ulcers, pain in the mouth, throat, chest or stomach which may be associated with eating. You may feel bloated, sick or be sick, have a loss of appetite or have a loss of weight. You may also notice particles that look like coffee grounds (upper gastrointestinal bleeding) on stools. These may be signs of inflammation, ulceration or bleeding in the digestive tract.
Very rare (may affect up to 1 in 10,000 people):
- ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear.
Other side effects include
Very common (may affect more than 1 in 10 people):
- bone, muscle and/or joint pain which is sometimes severe.
Common (may affect up to 1 in 10 people):
- joint swelling
- stomach pain, uncomfortable feeling in the stomach or belching after eating, constipation, full or bloated feeling in the stomach, diarrhoea, wind
- hair loss, itching skin
- headache, dizziness
- swelling in the hands or legs
- spinning sensation when standing still (vertigo)
- unusual weakness.
Uncommon (may affect up to 1 in 100 people):
- feeling sick (nausea), being sick (vomiting)
- rash, redness of the skin
- temporary flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment
- bad taste in the mouth.
Rare (may affect up to 1 in 1,000 people):
- symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth
- narrowing of the gullet (oesophagus – the tube that connects your mouth with your stomach)
- rash made worse by sunlight.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Alendronic acid/Cholecalciferol
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.
Store in the original blister in order to protect from moisture and light.
Do not store above 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Alendronic acid/Cholecalciferol contains
The active substances are alendronic acid and colecalciferol (vitamin D3).
- Each 70 mg/2800 IU tablet contains 70 mg of alendronic acid (as sodium trihydrate) and 70 micrograms (2800 IU) of colecalciferol (vitamin D3).
- Each 70 mg/5600 IU tablet contains 70 mg of alendronic acid (as sodium trihydrate) and 140 micrograms (5600 IU) of colecalciferol (vitamin D3).
The other ingredients are microcrystalline cellulose (E460), lactose, sucrose (see section 2, ‘Alendronic acid/Cholecalciferol contains lactose and sucrose’), medium chain triglycerides, gelatin, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate (E572), butylhydroxytoluene (E321), pregelatinised maize starch.
What Alendronic acid/Cholecalciferol looks like and contents of the pack
Alendronic acid/Cholecalciferol 70 mg/2,800 IU tablets are white caplet shaped, marked “28” on one side and plain on the other side.
Alendronic acid/Cholecalciferol 70 mg/5,600 IU tablets are white, modified rectangle shaped, marked “56” on one side and plain on the other side.
The tablets are available in aluminium blisters containing 4 tablets.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Manufacturer
GE Pharmaceuticals Ltd, Industrial zone, ‘Chekanitza-South’ area, Botevgrad, 2140, Bulgaria.