Alendronic Acid 70mg Tablets
Out of date information, search anotherPackage leaflet: Information for the patient Alendronic Acid 70 mg tablets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, pharmacist or nurse.
- 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Alendronic Acid is and what it is used for
2. What you need to know before you take Alendronic Acid
3. How to take Alendronic Acid
4. Possible side effects
5. How to store Alendronic Acid
6. Contents of the pack and other information
1. What Alendronic Acid is and what it is used for
Alendronic acid belongs to a group of medicines known as bisphosphonates.
Alendronic acid prevents loss of bone (osteoporosis) that occurs in women after they have been through the menopause. It has also been shown to help rebuild bone and reduce the risk of spine and hip fractures in women (after their menopause).
Your doctor has prescribed Alendronic Acid 70 mg tablets because you either have osteoporosis or you are at risk of developing this disease.
2. What you need to know before you take Alendronic Acid Do not take Alendronic Acid:
• if you are allergic to alendronic acid or any of the other bisphosphonate drugs, or to any of the other ingredients of this medicine (listed in section 6). Allergic reactions can include skin rash, problems breathing and swelling of the legs, arms, face, throat or tongue
• if you have certain problems with your gullet (oesophagus - the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing.
• if you are unable to stand or sit upright for at least 30 minutes
• if you have a low calcium level in your blood (hypocalcaemia)
If you think any of these apply to you, do not take the tablets. Talk to your doctor first and follow his advice.
Warning and precautions
Talk to your doctor, pharmacist or nurse before taking Alendronic Acid:
■ if you have difficulty and/or pain swallowing
■ if you have digestive problems such as stomach ulcers, inflammation of the stomach lining or the duodenum (first section of the small intestine)
■ if you have kidney problems
■ if you have any allergies
■ if you have vitamin D deficiency
■ if you have parathyroid gland problems (small paired glands located near the thyroid gland at the base of the neck)
■ if you have problems absorbing calcium.
■ if your doctor has told you that you have Barrett’s oesophagus (a condition associated with change in the cells that line the lower oesophagus)
■ if you have gum disease
■ if you have a planned dental extraction
Blood calcium and phosphate levels may be affected by these tablets. It is important that you tell your doctor that you are taking Alendronic acid if you have a blood test.
It is important that your diet contains the right levels of calcium and Vitamin D. Your doctor may want to supplement your diet.
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.
■ smoking
Appropriate preventive dental care, as recommended by the dentist, should be followed during treatment.
Talk to your doctor before you take Alendronic Acid if you have or have had pain or swelling of your gums and/or jaw, numbness of the jaw, if the jaw feels heavy or if you have lost a tooth. If you are being treated by a dentist or if you are going to have dental surgery, tell your dentist that you are taking Alendronic Acid.
During the course of your treatment with Alendronic Acid, stop taking the tablets and contact your doctor if you develop any of the following [irritation, inflammation or ulceration of the gullet]:
• difficulty or pain upon swallowing
• chest pain
• onset of heartburn or worsening of pre-existing heartburn
These symptoms may occur, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking Alendronic acid. These side effects may worsen if patients continue to take Alendronic acid after developing these symptoms.
Children and adolescents
Alendronic acid should not be given to children and adolescents.
Other medicines and Alendronic Acid
Do not take calcium tablets, antacids, vitamins and/or other oral medication at the same time as taking Alendronic acid tablets, as these can affect the absorption of this medicine. Wait at least 30 minutes after taking Alendronic acid before you take any other medicine.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
I
Alendronic Acid with food, drink and alcohol
It is likely that food and beverages (including mineral water) will make Alendronic acid less effective if taken at the same time. Therefore, it is important that you follow the advice given in section 3.
Pregnancy, breast-feeding and fertility
Alendronic acid is only intended for use in women after they have been through the menopause. You should not take Alendronic acid if you are or think you may be pregnant. Alendronic acid should not be taken during breast-feeding.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
There have been side effects (including blurred vision, dizziness and severe bone, muscle or joint pain) reported with Alendronic acid that may affect your ability to drive or operate machinery. Individual responses to Alendronic acid may vary (see Possible Side Effects).
3. How to take Alendronic Acid
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is
Take one tablet once a week. Choose one day of the week that best fits your schedule. Every week, take the tablet on your chosen day. The following instructions are very important to ensure you get the most benefit from your medicine and to reduce side effects. It is important that you follow the instructions so that tablet reaches your stomach quickly and doesn’t irritate your oesophagus:
1. After getting up for the day and before taking any food, drink or other medication, swallow your tablet whole with a full glass of plain water, not less than 200 ml or 7 fl. oz. (not tea, coffee, mineral water (still or sparkling), milk or juice).
2. The tablet must be swallowed whole. Do not chew, or allow the tablet to dissolve in your mouth.
3. After taking the tablets, do not lie down for 30 minutes. You must stay upright (sitting, standing or walking) until you have had your first food of the day.
4. After swallowing your tablet, wait at least 30 minutes before taking your first food, drink, or any other medicines including antacids, calcium supplements and vitamins. Alendronic Acid is effective only if taken when your stomach is empty.
5. Do not take your tablets at bedtime or before getting out of bed in the morning.
If you take more Alendronic Acid than you should
If you take too many tablets, drink a full glass of milk and contact your doctor or the nearest hospital casualty department immediately. Do not make yourself vomit and do not lie down. An overdose can cause painful muscle spasms, tiredness, weakness, exhaustion and fits. It can also cause an upset stomach, indigestion and painful inflammation of the upper digestive system.
If you forget to take Alendronic Acid
If you forget to take a tablet one day, take it in the morning on the day you remember, then take the next one on your usual day.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Alendronic Acid
Do not stop taking your tablets without the advice of your doctor even if you feel better.
If you have any further questions on the use of this medicine, ask your doctor pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Common side effects (may affect up to 1 in 10 people):
■ heartburn; difficulty swallowing; pain upon swallowing; ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) which can cause chest pain, heartburn or difficulty or pain upon swallowing
■ bone, muscle and/or joint pain
■ abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence;
■ headache
Uncommon side effects (may affect up to 1 in 100 people):
■ nausea; vomiting
■ irritation or inflammation of the gullet (oesophagus - the tube that connects your mouth with your stomach) or stomach
■ black or tar-like stools
■ rash; itching; redness of the skin
Rare side effects (may affect up to 1 in 1,000 people):
■ allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing
■ symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth
■ stomach or peptic ulcers (sometimes severe or with bleeding)
■ narrowing of the gullet (oesophagus - the tube that connects your mouth with your stomach)
■ jaw problems associated with delayed healing and infection, often following tooth extraction
■ blurred vision, pain or redness in the eye
■ rash made worse by sunlight
■ severe bone, muscle and/or joint pain
■ mouth ulcers when the tablets have been chewed or sucked
■ transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of the treatment.
Very rare side effects (may affect up to 1 in 10,000 people):
■ severe skin reactions
During post-marketing experience the following side effects have been reported (frequency unknown):
• dizziness, changed sense of taste
• hair loss
• joint swelling,
• tiredness
• swelling in the hands or legs Laboratory test findings:
Very common: mild and transient decreases in blood calcium and phosphate levels, generally within the normal range.
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.
If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
5. How to store Alendronic Acid
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 carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage condition.
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 Alendronic Acid contains
- The active substance is alendronic acid. Each tablet contains 70 mg alendronic acid (equivalent to 91.363 mg sodium alendronate trihydrate).
- The other ingredients are: Microcrystalline cellulose, maize starch, sodium starch glycolate (Type A), povidone (Kollidon 30) and magnesium stearate
What Alendronic Acid looks like and contents of the pack
White to off-white, oval, biconvex, uncoated tablets debossed with ‘F’ on one side and ‘21’ on the other side.
They are supplied in blister packs of 2, 4, 8, 12, 20, 30, 40, 50 or 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder and Manufacturer
Amneal Pharma Europe Limited 70 Sir John Rogerson’s Quay Dublin 2 Ireland
Manufacturer
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000 Malta
This leaflet was last revised in 04/2014