• Keep this leaflet. You may need read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
• It is particularly important to understand the information in Section 3, "How to take Alendronic Acid/Colecalciferol", before taking this medicine.

1. What Alendronic Acid/Colecalciferol is and what it is used for
2. What you need to know before you take Alendronic Acid/Colecalciferol
3. How to take Alendronic Acid/Colecalciferol
4. Possible side effects
5. How to store Alendronic Acid/Colecalciferol
6. Contents of the pack and other information

Alendronic Acid/Colecalciferol is a tablet containing the two active substances, alendronic acid (commonly called alendronate) and colecalciferol known as vitamin D3.

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.

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.

Your doctor has prescribed Alendronic Acid/Colecalciferol to treat your osteoporosis and because you are at risk of vitamin D insufficiency. Alendronic Acid/Colecalciferol reduces the risk of spine and hip fractures in women after menopause.

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.

As well as your treatment with Alendronic Acid/Colecalciferol, 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 program.

Eating a balanced diet

Your doctor can advise you about your diet or whether you should take any dietary supplements.

• 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.

Talk to your doctor or pharmacist before taking Alendronic Acid/Colecalciferol if:

• you suffer from kidney problems
• you have, or have recently had, 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 trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
• 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 angiogenesis inhibitors (such as bevacizumab, or thalidomide)
• 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)

You may be advised to have a dental check-up before starting treatment with Alendronic Acid/ Colecalciferol.

It is important to maintain good oral hygiene when being treated with Alendronic Acid/Colecalciferol. 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.

Irritation, inflammation or ulceration of the gullet (oesophagus — the tube that connects your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking Alendronic Acid/Colecalciferol. These side effects may worsen if patients continue to take Alendronic Acid/Colecalciferol after developing these symptoms.

Alendronic Acid/Colecalciferol should not be given to children and adolescents less than 18 years of age.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of Alendronic Acid/Colecalciferol if taken at the same time. Therefore, it is important that you follow the advice given in Section 3, “How to take Alendronic Acid/Colecalciferol’; and wait at least 30 minutes before taking any other oral medicines or supplements.

Certain medicines for rheumatism or long-term pain called NSAlDs (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 Alendronic Acid/Colecalciferol.

It is likely that certain medicines or food additives may prevent the vitamin D in Alendronic Acid/Colecalciferol from getting into your body, including artificial fat substitutes, mineral oils, the weight loss medicine, orlistat, and the cholesterol-lowering medicines, cholestyramine and colestipol. Medicines for fits (seizures) (like phenytoin or phenobarbital) may decrease the effectiveness of vitamin D. Additional vitamin D supplements may be considered on an individual basis.

It is likely that food and beverages (including mineral water) will make Alendronic Acid/ Colecalciferol less effective if taken at the same time. Therefore, it is important that you follow the advice given in Section 3, “How to take Alendronic Acid/Colecalciferol”. You must wait at least 30 minutes before taking any food and beverages except water.

Alendronic Acid/Colecalciferol is only intended for use in postmenopausal women. You should not take Alendronic Acid/Colecalciferol if you are or think you may be pregnant, or if you are breast-feeding.

There have been side effects (for example blurred vision, dizziness and severe bone, muscle or joint pain) reported with Alendronic Acid/Colecalciferol that may affect your ability to drive or operate machinery (see “Possible side effects”). If you experience any of these side effects you should not drive until you feel better.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Follow these instructions carefully.

1) Choose the day of the week that best fits your schedule, Every week, take one Alendronic Acid/Colecalciferol tablet on your chosen day.

It is very important to follow instructions 2), 3), 4) and 5) to help the Alendronic Acid/Colecalciferol 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/Colecalciferol tablet whole with a full glass of water only (not mineral water and not less than 200 ml), so that Alendronic Acid/Colecalciferol 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/Colecalciferol 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/Colecalciferol and contact your doctor.

6) After swallowing your Alendronic Acid/ Colecalciferol 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/Colecalciferol is effective only if taken when your stomach is empty.

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 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.

It is important that you continue taking Alendronic Acid/Colecalciferol for as long as your doctor prescribes the medicine. Since it is not known for how long you should take Alendronic Acid/Colecalciferol, you should discuss the need to stay on this medicine with your doctor periodically to determine if Alendronic Acid/Colecalciferol is still right for you.

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
• abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence
• hair loss; itching
• headache; dizziness
• tiredness; swelling in the hands or legs

Uncommon (may affect up to 1 in 100 people):

• nausea; vomiting
• irritation or inflammation of the gullet (oesophagus — the tube that connects your mouth with your stomach) or stomach
• black or tar-like stools
• blurred vision; pain or redness in the eye
• rash; redness of the skin
• transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment
• taste disturbance

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
• stomach or peptic ulcers (sometimes severe or with bleeding)
• narrowing of the gullet (oesophagus - the tube that connects your mouth with your stomach)
• rash made worse by sunlight
• mouth ulcers

Very rare (may affect up to 1 in 10,000 people):

• talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear

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 MHRA Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substances are alendronic acid and colecalciferol (vitamin D3). Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2800 lU) colecalciferol (vitamin D3).

The other ingredients are: microcrystalline cellulose (E460), lactose anhydrous, medium chain triglycerides, gelatin, croscarmellose sodium, sucrose, silica, colloidal anhydrous, magnesium stearate (E572), butyl hydroxytoluene (E321), pregelatinized starch (maize).

Alendronic Acid/Colecalciferol 70 mg/2800 IU tablets are available as white caplet shaped tablets debossed ”28” on one side and plain on the other side.

The tablets are supplied in aluminium blisters in cartons in the following pack sizes

• 2 tablets (1 blister containing 2 tablets)
• 4 tablets (1 blister containing 4 tablets)
• 6 tablets (3 blisters each containing 2 tablets)
• 12 tablets (3 blisters each containing 4 tablets).

Not all pack sizes may be marketed.

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