Alendronic Acid 70 Mg Tablets
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Pharma code 493
Alendronic Acid is used to treat osteoporosis (thinning of the bones) in post-menopausal women. Alendronic Acid will reduce your risk of back and hip fractures.
ALENDRONIC ACID 70 mg TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you
start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Alendronic Acid is and what it is used for
2. Before you take Alendronic Acid
3. How to take Alendronic Acid
4. Possible side effects
5. How to store Alendronic Acid
6. Further information
OWHAT ALENDRONIC ACID IS AND WHAT IT IS USED FOR
Alendronic Acid belongs to a group of drugs called bisphosphonates, which prevent bone loss from the body.
Do NOT take Alendronic Acid if you:
• are allergic (hypersensitive) to alendronic acid or any of the other ingredients of this medicine
• suffer from certain disorders of the oesophagus (also called the gullet, 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
• have been told by your doctor that you have low blood calcium or other mineral levels.
If you think any of these apply to you, do not take the tablets. Talk to your doctor first and follow the advice given.
Take special care with Alendronic Acid
It is important to tell your doctor before taking Alendronic acid
• 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).
Talk to your doctor before you start to take this medicine if you:
• have difficulty swallowing
• have inflammation of the stomach lining or the duodenum (first section of the small intestine)
• have a stomach ulcer or other digestive problems
• have kidney problems
• have cancer (see 'taking other medicines' below)
• have poor dental hygiene
• are due to have dental surgery
• have had surgery on your stomach or gullet (not including pyloroplasty where the outlet from the stomach is widened) in the last year
• have had a stomach ulcer or stomach bleeding in the last year.
A dental examination should be considered before you start treatment with Alendronic acid if you have any of the conditions below.
• You have cancer
• You are undergoing chemotherapy or radiotherapy
• You are taking steroids
• You don't receive routine dental care
• You have gum disease
• You smoke.
Appropriate preventative dental care, as recommended by the dentist, should be followed during treatment.
Taking other medicines
Talk to your doctor if you are receiving any of the following:
• Chemotherapy or radiotherapy.
Do NOT take any other oral medication (including NSAIDs (Non Steroidal Anti-inflammatory Drugs)/pain killers such as paracetamol and ibuprofen; calcium supplements and antacids) at exactly the same time as taking your Alendronic Acid Tablets. If you are taking any other medicines, you should take your dose of Alendronic Acid at least 30 minutes before your other medication.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Alendronic Acid with food and drink
These tablets should be taken on an empty stomach, as food and drink (including mineral water) can greatly reduce the effectiveness of the medicine. Take the tablets at least 30 minutes before your first meal of the day.
Pregnancy and breast-feeding
Alendronic Acid is only intended for post-menopausal women. Do NOT take Alendronic Acid if you are pregnant, planning to become pregnant or are breast-feeding.
Driving and using machines
Alendronic Acid may cause side effects including blurred vision, dizziness and severe bone, muscle or joint pain. Do NOT drive or operate machinery if you are affected. Individual responses to Alendronic Acid may vary (See Possible side effects).
HOW TO TAKE ALENDRONIC ACID
Always take Alendronic Acid 70 mg Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
You should follow the instructions below carefully to make sure your medicine is effective and to reduce the risk of your medicine irritating your gullet.
• Choose the day of the week when you will take your tablet that best fits your schedule. Every week, take one Alendronic Acid 70 mg Tablet on your chosen day
• Alendronic Acid should be taken on an empty stomach first thing when you get up in the morning. It should be taken with a full glass of plain water (not tea, coffee, mineral water or juice) half an hour before any food, drink or other medication
• The tablets should be swallowed whole, not chewed or sucked
• Do NOT lie down after taking your tablet. You must stay upright (sitting, standing or walking) until you have taken your first meal of the day, which must be at least half an hour after your dose of Alendronic Acid
• Do NOT take your tablets at bedtime or before getting out of bed
• 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/pain upon swallowing may occur, especially, if you do not drink a full glass of water and/or if you lie down less than
30 minutes after taking Alendronic acid
• If you develop pain from the symptoms described above, stop taking Alendronic Acid 70 mg Tablets and contact your doctor.
Top of page cut-off to middle of registration mark: 44 mm.
The usual dosage is:
• Adults (including the elderly)
One 70 mg tablet once a week.
• Children and adolescents
Alendronic Acid should not be given to children and adolescents.
If you take more Alendronic Acid than you should
If you (or someone else) swallow a lot of the tablets all together or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Drink a full glass of milk and do not lie down.
An overdose is likely to cause upset stomach, indigestion, stomach ulcer and painful inflammation of the gullet and stomach.
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take Alendronic Acid
If you forget to take your tablet when you first get up on your chosen day, take one first thing when you get up the next morning. Never take two doses together or on the same day. Continue taking one tablet once a week on your chosen day.
If you stop taking Alendronic Acid
Do not stop taking your medicine without talking to your doctor first even if you feel better.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
^POSSIBLE SIDE EFFECTS
Like all medicines, Alendronic Acid can cause side effects, although not everybody gets them.
If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:
• An allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).
This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.
If the following happens, stop taking your tablets and tell your doctor immediately:
• Difficulty or pain when swallowing, pain behind the breastbone (centre of the chest), new or worsening heartburn.
If the following happens, tell your doctor immediately:
• Blistering of the skin, eyes, mouth and genitals.
Unusual fractures 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.
The following side effects have been reported at the approximate frequencies shown:
Very Common (may affect more than 1 in 10
people):
• Pain in the bones, muscles or joints which is sometimes severe.
Common (may affect up to 1 in 10 people)
• Abdominal pain, indigestion or heartburn, constipation, diarrhoea, wind
• Ulceration of the gullet which can cause chest pain, heart burn or difficulty/pain upon swallowing, difficulty swallowing, full or bloated feeling in the stomach, belching after eating, regurgitation of acid from the stomach
• Headache
• Dizziness
• Vertigo
• Hair loss (alopecia), itching (pruritus)
• Joint swelling
• Weakness and loss of strength (asthenia), swelling of tissues (peripheral oedema).
Uncommon (may affect up to 1 in 100 people)
• Rashes and reddening of the skin
• Feeling sick, being sick, inflammation of the stomach, inflammation and/or erosion of the gullet or stomach, black tarry stools
• Distortion of the sense of taste (dysgeusia)
• Eye inflammation (uveitis, scleritis, episcleritis)
• Transient flu-like symptoms, such as aching muscles, a general feeling of being unwell and sometimes fever (usually at the start of treatment).
Rare (may affect up to 1 in 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
• Jaw problems associated with delayed healing and infection, often following tooth extraction. This has mainly been reported in patients treated for cancer, but some cases have also been reported in patients treated for osteoporosis.
• Rash made worse by sunlight (sensitivity to light)
• Blurred vision, pain or redness in the eye
• Mouth ulcers when the tablets have been chewed or sucked
• Gullet narrowing, stomach and other peptic ulcers and bleeding (although it is not clear whether these are caused by alendronic acid)
• Severe skin reactions.
Blood calcium and phosphate levels may be affected by Alendronic Acid 70 mg Tablets.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
HOW TO STORE ALENDRONIC ACID
Keep out of the reach and sight of children.
Do not use Alendronic Acid after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
^ FURTHER INFORMATION
What Alendronic Acid tablets contain:
• The active ingredient is alendronic acid (as sodium monohydrate).
• The other ingredients are microcrystalline cellulose (E460), croscarmellose sodium and magnesium stearate.
What Alendronic Acid tablets look like and contents of the pack:
• The Alendronic Acid tablets are white to off-white, flat-faced, bevel-edged round tablets, debossed with 'T' on one side and plain on the other side.
• The product is available in pack sizes of 2, 4, 8, 12, 40, and 50 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: April 2013
PL 00289/0889
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TEVA UK LIMITED 160 x 323