Package leaflet: information for the patient

Alendropol Veckotablett 70 mg tablets

sodium alendronate

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 signs of illness are the same as yours.

What is in this leaflet

1. What Alendropol Veckotablett is and what it is used for

2. What you need to know before you take Alendropol Veckotablett

3. How to take Alendropol Veckotablett

4. Possible side effects

5. How to store Alendropol Veckotablett

6. Contents of the pack and other information

Alendropol Veckotablett belong to a group of medicines called bisphosphonates. They do not contain hormones. Alendropol Veckotablett help to rebuild bone and prevent reduction of bone mass that occurs in women in relation to menopause. Alendropol Veckotablett reduces the risk for spinal and hip fractures.

Your doctor has prescribed Alendropol Veckotablett to treat your osteoporosis. Alendropol Veckotablett reduce the risk for spinal and hip fractures.

What is osteoporosis?

Osteoporosis leads to thinner and weaker bones. It is usual in women after the menopause. With menopause the ovaries stop producing the female hormone oestrogen which helps keep a woman’s bones healthy. Consequently bone mass is lost and bones become weaker. The earlier a woman reaches menopause, the greater the risk for osteoporosis.

At an early stage, osteoporosis usually has no symptoms. Without treatment however, osteoporosis can lead to fractures. Although fractures usually cause pain, spinal fractures can go unnoticed until they lead to a reduction in height. Fractures can occur during daily activities, such as lifting, or following minor injuries which usually do not lead to fractures. Fractures usually occur in the hip, bones of the spine or wrists and in addition to being painful can lead to severe problems such as bent body posture (curved spine) and reduced mobility.

How can osteoporosis be treated?

Osteoporosis can be treated and it is never too late to start treatment. Alendropol Veckotablett prevent not only loss of bone mass but also actually help to rebuild lost bone mass and reduce the risk for spinal and hip fractures.

In addition to your treatment with Alendropol Veckotablett, your doctor can recommend lifestyle changes to improve your condition, such as:

Do not take Alendropol Veckotablett

• If you have certain problems with your oesophagus, (the passage leading from throat to the stomach), such as scarring (stricture) or difficulties in swallowing

• If you cannot stand or sit upright for at least 30 minutes

• If you are allergic to alendronate, or any of the other ingredients of this medicine (listed in section 6).

• If your doctor has said that you have low levels of calcium in your blood.

If you think that some of the above is true in your case, do not take the tablets. Talk to your doctor first and then follow his/her advice.

Warnings and precautions

Talk to your doctor or pharmacist before takingAlendropol Veckotablett

• If you have problems with your kidneys

• If you have any swallowing or digestion problems

• If your doctor has told you that you have Barrett's oesophagus (a condition associated with changes in the cells that line the lower oesophagus)

• If your doctor has told you that you have low blood calcium

• If you have poor dental health, gum disease, a planned dental extraction or you don’t receive routine dental care

• If you have cancer

• If you are undergoing chemotherapy or radiotherapy

• If you are taking corticosteroids (such as prednisone or dexamethasone)

• If 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 Alendropol Veckotablett.

It is important to maintain good oral hygiene when being treated with Alendropol Veckotablett. 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 Alendropol Veckotablett and contact your doctor if you experience irritation, inflammation, or ulcers of the oesophagus, often with symptoms such as pain behind the breastbone, heartburn or pain or difficulty in swallowing. These side effects may get worse if you continue to take Alendropol Veckotablett after experiencing such problems. The risk of experiencing these side effects is increased if instructions in section, 3 How to take Alendropol Veckotablett, are not followed.

Children and adolescents
Alendronate should not be given to children and adolescents.

Other medicines and Alendropol Veckotablett

It is likely that the calcium supplement, antacid (which reduces gastric acid) and other medicines which are ingested orally can interfere with how Alendropol Veckotablett are absorbed in the body, if they are taken at the same time. It is therefore important that you follow the advice in section 3.How to take Alendropol Veckotablett.

Certain medicines for rheumatism or long-term pain called NSAIDs (e.g. aspirin or ibuprofen) might cause digestive problems. Therefore, the doctor should be consulted and caution used if these medicines are taken at the same time as Alendropol Veckotablett.

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

Alendropol Veckotablett with food and drink

It is likely that food and beverages (even mineral water) can make Alendropol Veckotablett less effective if taken at the same time. It is therefore important that you follow the advice in section 3. How to take Alendropol Veckotablett.

Pregnancy and breast-feeding

Alendropol Veckotablett are only for women after the menopause. Do not take Alendropol Veckotablett 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 withAlendropol Veckotablettthat may affect your ability to drive or operate machinery. Individual responses to Alendropol Veckotablett may vary (see section 4).

Alendropol Veckotablett contains lactose.

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

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

Take an Alendropol Veckotablettonce a week

Follow the instructions below carefully to be sure that you get the most of Alendropol Veckotablett

It is very important to follow sections 2 to 6 in the instructions so that Alendropol Veckotablett reaches your stomach fast and to reduce the risk of irritation of the oesophagus.

• Do not take the tablet with mineral water (either still or sparkling)

• Do not take the tablet with coffee or tea

• Do not take the tablet with juice or with milk

Do not crush or chew the tablet or let it dissolvein your mouth

It is important that you take Alendropol Veckotablett as long as your doctor has prescribed. Alendropol Veckotablett can only treat your osteoporosis if you continue taking the tablets.

If you take more Alendropol Veckotablett than you should

If you take too many tablets by mistake, drink a whole glass of milk and contact your doctor immediately. Do not try to induce vomiting and do not lie down. If you have taken too many tablets or if, for example, a child has ingested the medicine by mistake, tell your doctor or nearest hospital casualty department so that they can assess the risk and give you advice.

If you forget to takeAlendropol Veckotablett

If you forget to take a dose, just take a tablet the morning after you remember. Do not take two tablets on the same day. Then go back to taking one tablet per week, on the week day you had previously chosen.

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 everybodygets them.

Stop taking Alendropol Veckotablett and contact a doctor immediately if you get any of the following, rare, symptoms:

Serious allergic reactions (angioedema):

• Swelling of the face, tongue or throat

• Difficulty swallowing

• Hives and difficulty breathing

Rash made worse by sunlight; severe skin reactions sometimes with redness and blister formation (including Stevens-Johnson syndrome and toxic epidermal necrolysis).

Very common(may affect more than 1 in 10 people):

Common(may affect up to 1 in 10 people)

• heartburn; difficulty swallowing; ulceration of the gullet

• 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; inflammation of the stomach lining

• black or tar-like stools,

• inflammation of the eye with symptoms such as 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 of 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,

• ulceration of the mouth and throat,

• stomach or peptic ulcers (sometimes severe or with bleeding),

• narrowing of the gullet

• 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. 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.

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

Reporting of side effects

If you get any side effects, talk to your doctor orpharmacist.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 Alendropol Veckotablett

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and immediate packaging.

The expiry date refers to the last day of that month.

There are no special storage requirements.

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 Alendropol Veckotablett contains

The active substance is alendronate. Each tablet contains 70 mg alendronate in the form of alendronate sodium trihydrate.

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

What Alendropol Veckotablett looks like and contents of the pack

Alendropol Veckotablett are white, oblong, biconvex tablets.

Pack sizes of 2, 4, 8, 12 or 40 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This leaflet was last revised in

2016-06-03