ALENDRONIC ACID 10 MG TABLETS - patient leaflet, side effects, dosage

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Package leaflet: Information for the user

Alendronic Acid 10 mg Tablets (Alendronic Acid)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to 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 sign and 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. See section 4.
• It is particularly important to understand the information in section 3 How to take Alendronic acid, before taking this medicine.

• 1. What Alendronic Acid Tablets are and what they are used for

• 2. What you need to know before you take Alendronic Acid Tablets

• 3. How to take Alendronic Acid Tablets

• 4. Possible side effects

• 5. How to store Alendronic Acid Tablets

• 6. Contents of the pack and other information

• 1. What Alendronic Acid Tablets are and what they are used for

What is Alendronic acid

Alendronic acid is a tablet containing the active substance alendronic acid (commonly called alendronate) and belongs to a group of medicines called bisphosphonates. Alendronic Acid prevents the loss of bone that occurs in women after they have been through the menopause. It can also prevent loss of bone in men or people taking steroids, such as prednisolone and methylpredniso­lone.. It also has been shown to help rebuild bone and makes bone and reduce the risk of spine and hip fractures (broken bones) in women (after their menopause) and in men who have thinning of their bones (osteoporosis).

What is Alendronic Acid Tablets are used for

Your doctor has prescribed alendronic acid because you either have osteoporosis or you are at risk of developing this disease.

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.

Osteoporosis can also occur in men due to a number of causes including ageing and/or a low level of the male hormone, testosterone. In all instances, bone is removed faster than it is formed, so bone loss occurs and bones become weaker.

Corticosteroids can also cause bone loss and osteoporosis in both men and women.

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 injuries that would not fracture normal bone. Broken bones usually occur at the hip, spine, or wrist and can lead not only to pain but also to considerable deformity problems like stooped posture (‘dowager’s hump’) and loss of mobility.

How can osteoporosis be treated/prevented?

As well as your treatment with alendronic acid, your doctor may recommend that you make some changes to your lifestyle, which may help your condition. These are:

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 (especially calcium and Vitamin D).

2. what you need to know before you take alendronic acid tablet

Do not take Alendronic Acid Tablets if you:

• are allergic to alendronic acid, the active ingredient, or any of the other ingredients of this medicine (listed in section6)
• have certain disorders of the oesophagus (sometimes called the gullet and is the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing
• cannot stand or sit upright for at least 30 minutes
• 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 tablets

It is important to tell your doctor before taking Alendronic Acid Tablets if

• you suffer from kidney problems
• 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 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.

It is important to maintain good oral hygiene when being treated with Alendronic acid tablets. 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 tablets. These side effects may worsen if patients continue to take alendronic acid tablets after developing these symptoms.

Children and adolescents

Alendronic acid tablets should not be given to children and adolescents less than 18 years of age.

Other medicines and Alendronic acid Tablets

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 tablets if taken at the same time. Therefore, it is important that you follow the advice given in section 3 How to take Alendronic acid Tablets.

Certain medicines for rheumatism or long-term pain called NSAIDs (e.g. acetylsalicyclic acid (aspirin) or ibuprofen) might cause digestive problems. Therefore, caution should be used when these medicines are taken at the same time as Alendronic acid Tablets.

Alendronic Acid Tablets with food and drink

It is likely that food and drinks (including mineral water) will make Alendronic acid Tablets 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 Tablets.

Pregnancy, breast-feeding and fertility

Alendronic acid tablet is only intended for use in postmenopausal women. You should not take alendronic acid tablets 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

Driving and using machines

There have been side effects (including blurred vision, dizziness and severe bone, muscle or joint pain) reported with alendronic acid tablets that may affect your ability to drive or operate machinery. Individual responses to alendronic acid tablets may vary (See section4.) Alendronic Acid Tablets contains lactose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine

3. How to take Alendronic Acid Tablets

Always take alendronic acid tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking your medicine

It is very important that you follow actions 1 to 5 help the tablet reach your stomach quickly and help reduce possible irritation of your oesophagus (the tube that connects your mouth with your stomach).

1. After getting up for the day, and before taking any food, drink or other medicines, swallow your alendronic acid tablets with a full glass of plain water only (not less than 200 ml).

• – 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.

• 2. 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.

• 3. Do not take alendronic acid tablets at bedtime or before getting up for the day.

• 4. If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking alendronic acid tablets and talk to your doctor immediately.

• 5. After swallowing your 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 Tablets will only work if your stomach is empty.

  		Artwork No.	–				Colours Used
  		Customer	Accord			■	Pantone Black
  		Description	Alendronic Acid 10 mg
  		Market	UK
  		Language	English
  		Size	170 × 550 mm (PIL)
  		Min. Font Size	9
  		Version No.	5 (Page 2 of 2) (IB020)
  		Date	06_10_16 (Alendronic Acid 10 mg (ACC-UK)IB020–			PIL)
  Prepared By Regulatory Affairs				Checked By Regulatory Affairs	Approved By Quality Assurance

  
  

  The recommended dose

  • for the treatment of osteoporosis in men or post-menopausal women the recommended dose is 10 mg once a day.
• for the treatment prevention of steroid induced osteoporosis in post-menopausal women not receiving hormone replacement therapy (HRT) with an oestrogen the recommended dose is 10 mg once a day.

If you take more Alendronic Acid Tablets 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 Tablets

If you forget to take your dose, skip the missed dose. Take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you stop taking Alendronic Acid Tablets

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

5. How to store Alendronic Acid Tablets

6. Contents of the pack and other information

4. Possible side effects