Package leaflet: Information for the user

Alendrostad 10 mg tablets

Alendronic acid

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

What is in this leaflet

1. What Alendrostad is and what it is used for

2. What you need to know before you take Alendrostad

3. How to take Alendrostad

4. Possible side effects

5. How to store Alendrostad

6. Contents of the pack and other information

1. What Alendrostad is and what it is used for

Alendronate belongs to a group of medicines called bisphosphonates. Alendronate prevents the loss of bone, and reduces the risk of spine and hip fractures.

Alendrostad is used

to treat osteoporosis. It is also used to prevent osteoporosis in people who are taking medicines called glucocorticoids (medicines which may be used to treat inflammations). Alendrostad has been shown to reduce the risk of spine and hip fractures in women and spine fractures in men.

Osteoporosis is a thinning and weakening of the bones. Early on, osteoporosis usually has no symptoms, but if left untreated it can cause fractured bones. Although these usually hurt, fractures in the spine may go unnoticed until they cause height loss. Fractures can happen during normal, everyday activity, such as lifting, or from minor injury that would not damage healthy bone. Fractures 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 Alendrostad, your doctor may suggest you make changes to your lifestyle (e.g. exercise and diet recommendations, stop smoking) to help your condition. Consult your doctor for more information on lifestyle changes.

2. What you need to know before you take Alendrostad

DO NOT take Alendrostad if you

If you think any of these apply to you, do not take the tablets. Talk to your doctor first and follow the advice given. (See also section 3 “How to take Alendrostad”)

Warnings and precautions

Talk to your doctor or pharmacist before taking Alendrostad

  • if you have cancer.

  • if you are taking corticosteroids (medicines which may be used to treat inflammations).

  • if you are undergoing chemotherapy or radiotherapy.

  • if you smoke.

  • if you have poor dental health, gum disease, a planned dental extraction

You may be advised to have a dental check-up before starting treatment with Alendrostad.

It is important to maintain good oral hygiene when being treated with Alendrostad. 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 are being treated by a dentist or if you are going to have dental surgery or dental extraction, tell your dentist that you are taking Alendrostad.

Irritation, inflammation or ulceration of the gullet often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if you do not follow the dosage instructions or the instructions of your doctor correctly (see also section 3 “How to take Alendrostad”). You should stop taking Alendrostad and see your doctor immediately if you get any of these symptoms. Also see section 4. “Possible side effects”. If you ignore these symptoms and continue to take your tablet, it is likely that these gullet reactions may get worse.

Blood calcium and phosphate levels may be affected by these tablets. It is important that you tell your doctor that you are taking Alendrostad if you have a blood test.

Children and adolescents

Alendrostad should not be given to children and adolescents.

Other medicines and Alendrostad

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

Please inform your doctor if you are taking corticosteroids (medicines which may be used to treat inflammations). It is possible that you need some examinations before starting treatment with Alendrostad (e.g. dental examination).

You might get an irritated stomach if you are taking pain killers (e.g. acetylsalicylic acid, ibuprofen) together with Alendrostad.

It is likely that the following medicines will interfere with the absorption of Alendrostad if taken at the same time:

Therefore you must wait at least 30 minutes after taking Alendrostad before you take any other medicine (see also section 3 “How to take Alendrostad”).

Alendrostad with food and drink

It is likely that food and beverages (including mineral water) will make Alendrostad less effective if taken at the same time. Therefore, it is important that you follow the advice given in section 3. “How to take Alendrostad”.

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.


You should not take Alendrostad if you are or think you may be pregnant.


You should not take Alendrostad if you are breast-feeding.

Driving and using machines

Alendrostad can cause side effects (including blurred vision, dizziness and severe bone, muscle or joint pain) that may affect your ability to drive or operate machinery. Individual responses to Alendrostad may vary (See section 4 “Possible side effects.)

Alendrostad contains lactose

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

3. How to take Alendrostad

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose of Alendrostad 10 mg is one tablet once daily.

It is very important that you follow instructions given below carefully so that you get the most benefit from your medicine and avoid problems with your gullet.

After getting up for the day and before taking any food, drink, or other medicine, swallow your Alendrostad tablet whole with a full glass of plain water only (NOT mineral water; not less than 200 ml or 7 fl. oz.).

Do NOT chew or crush the tablet or allow it to dissolve in your mouth.

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.

After swallowing your Alendrostad, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins. Alendrostad is effective only if taken when your stomach is empty.

Do NOT take Alendrostad at bedtime or before getting up for the day.

If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking Alendrostad and contact your doctor.

It is important that you continue taking Alendrostad for as long as your doctor prescribes the medicine. Alendrostad can treat your osteoporosis only if you continue to take the tablets.

If you take more Alendrostad than you should

If you take too many tablets by mistake, drink a full glass of milk in order to make the tablets effectless and contact your doctor immediately. Do not make yourself vomit, and do not lie down.

Symptoms of an Alendronate overdose may include

If you forget to take Alendrostad

If you miss a dose, just take one tablet on the morning after you remember. Do not take a double dose to make up for a forgotten tablet. Do not take two tablets on the same day. Return to taking one tablet daily. If you are unsure, please ask your doctor.

If you stop taking Alendrostad

Always ask your doctor, if you want to stop taking Alendrostad or if you want to change the prescribed dosage schedule. Do not interrupt or discontinue the treatment without consulting your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Alendrostad and see your doctor immediately if you get any of the following symptoms:

symptoms of a severe allergic reaction (angioedema; occurs rarely [may affect up to 1 in 1,000 people]) such as

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):

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

Rare (may affect up to 1 in 1,000 people):

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.

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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alendrostad

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 blister and the carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25 °C. Store in the original package in order to protect from moisture.

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 Alendrostad contains

The active substance is sodium alendronate trihydrate. Each tablet contains 10 mg alendronic acid as sodium alendronate trihydrate.

The other ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate.

What Alendrostad looks like and contents of the pack

Alendrostad 10 mg tablets are available as white to off-white, capsule-shaped tablet, embossed "AN 10" on one side and "Arrow logo" on the other.

The tablets are supplied in triplex blister packs containing

14, 20, 28, 56, 98, 112, 120 and 50 x 1 (unit dose) tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

<To be completed nationally>


This medicinal product is authorised in the Member States of the EEA under the following names:

Germany Alendronsäure STADA10mg Tabletten

Sweden Alendrostad 10 mg tablett

This leaflet was last revised in.2016-04-14