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.

• 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.

• 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.

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

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

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

• have certain problems with your gullet (oesophagus - the tube that connects your mouth with your stomach) such as narrowing or your gullet does not work properly and therefore you have difficulties in swallowing (a condition called achalasia)

• cannot stand or sit upright for at least 30 minutes

• have low calcium levels in your blood

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 kidney problems

• if you have any allergies

• if you have any swallowing problems or digestive problems such as inflammation of the stomach lining or the duodenum (first section of the small intestine), or if you have had severe disease of the stomach or bowel such as ulcers, bleeding from the stomach or the bowel or surgery on your stomach or gullet in the last year.

• 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 you have problems absorbing calcium or other disorders, which may lead to low calcium levels in your blood such as low vitamin D levels or the parathyroid gland does not work properly (a condition called hypoparathyroidism). Your doctor may prescribe you a calcium or vitamin D supplement to prevent low calcium levels in your blood.

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:

• calcium supplements

• antacids (medicines used to relieve heartburn)

• some oral medicines

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.

Pregnancy

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

Breast-feeding

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.

• Do NOT take with mineral water (still or sparkling).

• Do NOT take with coffee or tea.

• Do NOT take with juice or milk.

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

• low calcium level in the blood with symptoms such as skin sensations, e.g. numbness, burning, prickling, itching, or tingling (paraesthesia) or involuntary contraction of muscles

• low phosphate level in the blood with symptoms such as muscle dysfunction and weakness

• upset stomach and heartburn

• inflammation of the gullet or of the stomach lining and ulcers.

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:

• swollen face, tongue or throat and/or

• difficulties to swallow and difficulties to breath and/or

• hives

• severe skin reactions (occurs very rarely [may affect up to 1 in 10,000 people]) such as a rash, blistering or other effects on the skin, eyes, mouth or genitals, itching or high temperature (symptoms of skin reactions called Stevens-Johnson syndrome or toxic epidermal necrolysis)

• chest pain, new or worsened heartburn, or difficulty or pain upon swallowing (this may reflect an irritation, inflammation or ulceration of the gullet; occurs commonly [may affect up to 1 in 10 people]). If you ignore these symptoms and continue to take your tablets it is likely that these gullet reactions may get worse.

Other side effects include

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

Common (may affect up to 1 in 10 people):

• headache

• dizziness

• abdominal pain, uncomfortable feeling in the stomach or belching after eating, constipation, full or bloated feeling in the stomach, diarrhoea, flatulence

• hair loss (alopecia)

• itching

• joint swelling

• swelling in the hands or legs

• tiredness

• vertigo

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

• feeling sick, vomiting

• irritation or inflammation of the gullet or stomach, damage of the gullet lining (oesophageal erosions)

• black or tarlike stools

• rash, redness of the skin

• taste disturbance

• inflammation of the eye with blurred vision, pain or redness in the eye

• transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment

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

• narrowing of the gullet

• ulcers in the mouth or throat when the tablets have been chewed or sucked

• ulcers in the stomach or bowel (sometimes severe or with bleeding)

• rash made worse by sunlight

• symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth

• 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 in 10,000 people):

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>

Manufacturer

• Arrow Pharm (Malta) Limited, HF 62, Hal Far Industrial Estate, Birzebbugia BBG06, Malta

• STADA Arzneimittel AG, Stadastr. 2-18, 61118 Bad Vilbel, Germany

• STADApharm GmbH, Stadastr. 2-18, 61118 Bad Vilbel, Germany

• Lab.Medicamentos Internacionales (Medinsa), La Solana, 26, Torrejon de Ardoz (Madrid) Spain

• Sanico N.V., Veedijk 59, Industriezone IV, 2300 Turnhout, Belgium

• Centrafarm Services B.V., Nieuwe Donk 9, 4879 AC Etten-Leur, The Netherlands

• Clonmel Healthcare Ltd., Waterford Road, Clonmel , Co. Tipperary, Ireland

• Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Hertfordshire SG1 4SZ, United Kingdom

• Actavis Ltd., BLB 016, Bulebel Industrial Estate, Zejtun, ZTN 3000, Malta

• Qualiti (Burnley) Limited, talbot Street, Briercliffe, Burnley BB10 2JY, United Kingdom

• Juta Pharma GmbH, Gutenbergstrasse 13, 24941 Flensburg, Germany

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