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Alendronat Arrow

Document: Alendronat Arrow 10 mg tablet ENG PL change

Package leaflet and information for the user


Alendronat Arrow 10mg 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:

What Alendronat Arrow 10mg Tablets are and what they are used for

What you need to know before you take Alendronat Arrow 10mg Tablets

How to take Alendronat Arrow 10mg Tablets

Possible side effects

How to store Alendronat Arrow 10mg Tablets

Contents of the pack and other information


1. What Alendronat Arrow 10mg Tablets are and what they are used for


Alendronic acid belongs to a group of non-hormonal medicines known as bisphosphonates, which prevent bone loss from the body.


Alendronic acid is used to treat a condition called osteoporosis (brittle bones). This condition is common in women after the menopause. The earlier a woman reaches the menopause, the greater the risk of her developing osteoporosis.


Without treatment, osteoporosis can cause thinning and weakening of the bones in the skeleton which can then lead to fractures, usually of the hip, backbone and wrists. Fractures can occur easily in people suffering from osteoporosis including during normal everyday activities such as heavy lifting or from a minor injury or fall.


Alendronic acid helps to prevent bone loss and to build up bone which may have been lost due to osteoporosis. It can therefore reduce the risk of back and hip fractures.


2. What you need to know before you take Alendronat Arrow 10mg Tablets


Do not take Alendronat Arrow 10mg Tablets:



Warnings and precautions


Talk to your doctor or pharmacist before taking these tablets:



It is important to maintain good oral hygiene when being treated with Alendronat Arrow10mg 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.


Other medicines and Alendronat Arrow 10mg Tablets


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


Do not take any other medicines orally (by mouth) at the same time as taking Alendronat Arrow 10mg Tablets. You should leave at least 30 minutes between your dose of Alendronat Arrow 10mg Tablets and any other oral medicines. It is important that you follow all of the advice given in section 3 - ‘How to take Alendronat Arrow 10mg Tablets.’


You should speak to your Doctor before you take Alendronat Arrow10mg if you are currently taking a non-steroidal anti-inflammatory drug (NSAID).


Alendronat Arrow 10mg Tablets with food and drink

These tablets must be taken on an empty stomach as food and drink can greatly reduce the effectiveness of the medicine. You must take the tablets with a full glass of plain water at least 30 minutesbefore any other food or drink. It is important that you follow all of the advice given in section 3 - ‘How to take Alendronat Arrow 10mg Tablets.’


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.


Do not take Alendronat Arrow 10mg Tablets if you are pregnant, think you may be pregnant or are breast-feeding.


Driving and using machines

Alendronat Arrow 10mg Tabletsare not expected to have any effects on your ability to drive and use machines. However in rare cases patients taking Alendronat Arrow 10mg Tablets can suffer from side effects including dizziness, severe muscle joint and bone pain and eye pain or inflammation. If you are affected in this way, you should contact your doctor before driving or using machinery.


Alendronat Arrow 10mg Tablets contain lactose

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



3. How to take Alendronat Arrow 10mg Tablets


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


The recommended dose is one tablet per day.


The following instructions are particularly important to ensure that your medicine is effective and to reduce the likelihood of the medicine irritating your oesophagus (gullet):


  • Immediately after getting up for the day, take the Alendronat Arrow 10mg Tablet on an empty stomach. It should only be taken with a full glass of plain water (not less than 200ml) and should be taken at least 30 minutes before any other food, drink or medicine. Do not take your tablet with tea, coffee, mineral water or juice.

  • The tablet must be swallowed whole. You must not chew or crush the tablet or allow it to dissolve in your mouth.

  • Wait at least 30 minutes after taking the tablet before you drink or eat the first meal of the day or take any other medicine (this includes calcium supplements, vitamins and antacids (which are used to treat indigestion)).

  • Do not lie down after taking Alendronat Arrow 10mg Tablets. You must stay upright (sitting, standing or walking) for at least 30 minutes after you have swallowed the tablet. It is also important that you do not lie down before you have eaten the first meal of the day.

  • Do not take your tablet at bedtime or before you get out of bed in the morning.

  • If you find it difficult and/or painful to swallow, or you feel pain behind the breast-bone or new or worsened heartburn, stop taking the tablets and contact your doctor.


Your doctor may also ask you to take vitamin D or calcium supplements whilst you are taking Alendronat Arrow 10mg Tablets. If so, you should follow your doctor’s advice carefully.


It is important that you continue to take Alendronat Arrow 10mg Tablets for as long as your doctor recommends. Alendronat Arrow 10mg Tablets can only treat your osteoporosis effectively if you continue to take the tablets.


Use in children and adolescents

Alendronate should not be given to children and adolescents.


If you take more Alendronat Arrow 10mg Tablets than you should

You may suffer from a stomach upset, heartburn, inflammation of the gullet or stomach, muscle and stomach cramps, spasms, weakness and fits. You shoulddrink a full glass of milk and contact your nearest doctor or hospital casualty department immediately. Do not try and make yourself sick (vomit) and do not lie down.



If you forget to take Alendronat Arrow 10mg Tablets

Take one tablet on getting up the next morning after you remember and then return to taking one tablet per day as usual. Do not take two tablets on the same day. Do not take a double dose to make up for a forgotten dose.


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


Possible side effects


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


All medicines can cause allergic reactions, although serious allergic reactions are very rare. You should stop takingAlendronat Arrow 10mg Tablets and tell your doctor immediately if you get any of the following symptoms:



If you have difficulty and/or pain when swallowing, you feel pain behind the breast-bone or new or worsened heartburn, stop taking Alendronat Arrow 10mg Tablets and contact your doctor.If you ignore these symptoms and continue to take your tablets it is likely that these gullet reactions may get worse.


The following side effects have been reported:


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

Muscle, joint or bone pain, which is sometimes severe


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

Stomach pain

Wind

Vertigo

Indigestion

Full or bloated feeling in the stomach

Ulceration of the oesophagus (gullet)

Constipation

Regurgitation of acid from the stomach (reflux)

Pain or difficulty when swallowing

Diarrhoea

Headache

Dizziness

Hair loss

Itching (pruritus)

Joint swelling

Weakness or lack of energy

Excess fluid (swelling), usually in the legs (peripheral oedema)



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

Feeling and being sick (nausea and vomiting)

Inflammation of the stomach

Inflammation and/or thinning (erosion) of the gullet

Rash

Black tarry stools

Reddening of the skin

Changes in your sense of taste

Inflammation of the eye

Temporary flu-like symptoms (muscle pain, general feeling of illness and, in rare cases, fever) usually at the start of treatment.


Rare side effects (may affect up to 1 in 1000 people):

Narrowing of the gullet

Allergic (hypersensitivity) reactions including swelling and skin eruptions

Stomach or other peptic ulcers (although it is not clear whether these ulcers are caused by alendronic acid)

Mouth and/or throat ulcers

Skin rash with sensitivity to light

Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely. 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.

Severe skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis)

Low calcium levels which may cause muscle cramps or spasms and tingling sensation in the fingers or around the mouth.

Pain and/or inflammation of the jaw (this is more common in people who have had a tooth taken out and/or a mouth infection)


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 Alendronat Arrow 10mg Tablets


Keep out of the sight and reach of children.


Do not use this medicineafter the expiry date which is stated on 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.


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 Alendronat Arrow 10mg Tablets contain:


What Alendronat Arrow 10mg Tablets look like and contents of the pack


Alendronat Arrow 10mg Tablets are white to off-white capsule-shaped tablets stamped ’AN 10‘ on one side and ‘>’ on the other.


The tablets are available in blister packs of 14, 28, (50 x 1),56, 98 and 112 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, Hal Far, BBG 06, Malta


or


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


or


Juta Pharma GmbH, Gutenbergstrasse 13, 24941 Flensburg, Germany


or


Medicamenta, a.s., Fibichova 143, 566 17 Vysoké Mýto, Czech Republic

or


Basics GmbH, Hemmelrather Weg 201, 51377 Leverkusen, Germany


or


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


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


France Acide Alendronique Arrow10 mg, comprimé

Germany ALENDRONSÄURE BASICS 10 mg Tabletten

Norway Alendronat Arrow 10 mg tablett

Sweden Alendronat Arrow 10 mg tablett

United Kingdom Alendronic Acid 10mg Tablets


This leaflet was last revised in

28 October 2016