10 mg tablet of
aledronic acid
1. What Alendronate Arrow is and what it is used for
Alendronic acid belongs to a group of non-hormonal drugs called bisphosphonates, which prevent the loss of bone mass from the skeleton.
Alendronic acid is used to treat a condition called osteoporosis (osteoporosis). This condition is common in postmenopausal women. The earlier a woman enters menopause, the greater the risk that she will develop osteoporosis.
Without treatment, osteoporosis can lead to thinner and weaker skeletal bones, which can lead to bone fractures ( fractures ), usually in the hip bones, vertebrae, and wrists. In people with osteoporosis, a fracture can easily occur during normal daily activities, such as heavy lifting, or in connection with minor injuries or falls.
Alendronic acid helps to prevent the loss of bone mass and to build up bone mass that may have already been lost due to osteoporosis. In this way, it can reduce the risk of fractures in your back and hips.
Alendronic acid contained in Alendronate Arrow may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. Before you take Alendronate Arrow
Do not take Alendronate Arrow
- If you are allergic to alendronic acid or any of the other ingredients of this medicine (listed in section 6).
- If you have certain conditions in the esophagus (ie the esophagus, which goes from the mouth to the stomach), such as narrowing of the esophagus or difficulty swallowing.
- If your doctor has told you that you have low calcium in your blood.
- If you can not stand or sit upright for at least 30 minutes straight.
Warnings and cautions
Talk to your doctor or pharmacist before taking Alendronate Arrow
- If you have difficulty swallowing or if it hurts when you swallow.
- If you have inflammation of the lining of the stomach or of the duodenum (the first part of the small intestine).
- If you have stomach ulcers or other indigestion, including bleeding in the stomach.
- If you have had surgery on your stomach or esophagus in the past year (apart from fluoroscopy, which is an operation on the site where the outlet from the stomach dilates).
- If your doctor has told you that you have Barrett’s esophagus (a condition with changes in the cells of the lower esophagus).
- If you have or have ever had kidney problems.
- If you have or have ever had low vitamin D levels. In that case, your doctor may want to check your vitamin D levels during treatment with alendronic acid.
- If you have or have had a condition called hypoparathyroidism (a condition that causes the parathyroid gland to not function properly).
- If you have or have had pain, swelling, or numbness in the jaw, tooth loss, or a “feeling of heaviness” in the jaw.
- If you are undergoing dental treatment or you are going to undergo a dental operation.
- If you have cancer, are undergoing chemotherapy or radiation therapy, are taking steroids, do not go to the dentist regularly, have an infection in your mouth, or smoke. In such cases, your doctor may want a dentist to check your teeth before starting treatment.
It is important to maintain good oral hygiene when treating with Alendronate Arrow. You should undergo regular dental checkups throughout your treatment. You should contact your doctor or dentist if you experience any problems with your mouth or teeth such as loose teeth, pain, or swelling.
Taking other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take any other medicines orally (orally) while you are taking Alendronate Arrow. You should allow at least 30 minutes between the dose of Alendronate Arrow and other oral medicines. It is important that you follow all the instructions given in section 3 – “How to take Alendronate Arrow”.
You should talk to your doctor before taking Alendronate Arrow 10 mg if you are currently taking a medicine that belongs to the group of non-steroidal anti-inflammatory drugs ( NSAIDs ).
Alendronate Arrow with food, drink, and alcohol
These tablets must be taken on an empty stomach as food and drink may significantly impair the effect of the medicine. You must take the tablets with a full glass of plain water for at least 30 minutes before eating or drinking anything. It is important that you follow all the instructions given in section 3 – “How to take Alendronate Arrow”.
Pregnancy, breastfeeding, and fertility
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 Alendronate Arrow if you are pregnant, think you may be pregnant, or are breast-feeding.
Driving and using machines
Alendronate Arrow is not expected to affect your ability to drive or use machines. However, in rare cases, patients taking Alendronate Arrow may experience side effects, including dizziness, severe muscle, joint and leg pain, and pain or inflammation in the eyes. If you are affected in this way, consult a doctor before driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Important information about some of the ingredients of Alendronate Arrow
These 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 use Alendronate Arrow
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is one tablet per day.
The following instructions are especially important to ensure that the medicine is effective and to reduce the likelihood of the medicine irritating your esophagus.
- Take Alendronate Arrow on an empty stomach immediately after getting up in the morning. The tablet must be taken with a full glass of plain water (not less than 200 ml) and it must be taken at least 30 minutes before eating or drinking anything or taking any other medicine. Do not take the tablet with tea, coffee, mineral water, or juice.
- The tablet must be swallowed whole. Do not chew or crush the tablet or allow it to dissolve in your mouth.
- Wait at least 30 minutes after taking the tablet before drinking or eating your first meal of the day or taking any other medicine (this includes calcium supplements, vitamins, and antacids (used for indigestion).
- Do not lie down after taking Alendronate Arrow You must stay upright (sit, stand or walk) for at least 30 minutes after swallowing the tablet. It is also important that you do not lie down before eating your first meal of the day.
- Do not take the tablet at bedtime or before getting up in the morning.
- If you find it difficult and/or it hurts to swallow, or if it hurts behind the sternum, or if you get heartburn or your heartburn worsens, you should stop taking the tablets and contact a doctor.
Your doctor may also advise you to take vitamin D or calcium supplements while you are taking Alendronate Arrow. In this case, follow the doctor’s advice carefully.
It is important that you continue to take Alendronate Arrow for as long as your doctor prescribes it. You must continue to take the tablets for Alendronate Arrow to be an effective treatment for your osteoporosis.
Use for children and adolescents
Alendronate Arrow should not be given to children and adolescents.
If you forget to take Alendronate Arrow
Take one tablet when you get up the next morning and then return to taking one tablet a 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 product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although severe allergic reactions are very rare. You should stop taking Alendronate Arrow and contact your doctor immediately if you get any of the following symptoms:
- sudden wheezing, difficulty breathing, swollen eyelids, swollen face or swollen lips, rash or itching (especially if you get itchy all over your body). This is called “angioedema”.
- skin rash, blisters, or other symptoms on the skin, eyes, mouth, or genitals, itching or fever (symptoms of severe skin reactions are called Stevens-Johnson syndrome or toxic epidermal necrolysis ).
If you find it difficult and/or it hurts to swallow, or if it hurts behind the sternum, or if you get heartburn or your heartburn worsens, you should stop taking the tablets and contact a doctor. If you ignore such symptoms and continue to take the tablets, there is a high risk that they will worsen.
The following side effects have been reported:
The very common side effect is (can occur in more than 1 in 10)
• Muscle, joint or skeletal pain, which is sometimes severe
Common side effects are (may affect up to 1 in 10 people)
- Magnet
- Gas formation
- Dizziness
- Indigestion
- Inflated or bloated stomach
- Ulceration of the esophagus (esophagus)
- Constipation
- Reflux of acid from the stomach (reflux)
- Pain or difficulty swallowing
- Diarrhea
- Headache
- Dizziness
- Hair loss
- Itching ( pruritus )
- Joint swelling
- Weakness or lack of energy
- Excess fluid (swelling), usually in the legs (peripheral edema )
Less common side effects are (may affect up to 1 in 100 people)
- Nausea and vomiting
- Inflammation of the stomach
- Inflammation and/or burns ( erosion ) in the esophagus
- Rash
- Black, tarry stools
- Reddening of the skin
- Taste changes
- Eye inflammation
- Transient flu-like symptoms (muscle aches, general malaise, and, in rare cases, fever) usually at the beginning of treatment
Rare side effects are (may affect up to 1 in 1000 people)
- Narrowing of the esophagus
- Allergic reactions ( hypersensitivity reactions ) with skin swelling and rash
- Ulcers in the stomach or elsewhere in the gastrointestinal tract (although it has not been established that such ulcers are caused by alendronic acid)
- Sores in the mouth and/or throat
- Skin rash with photosensitivity
- Unusual femoral fractures, especially in patients receiving long-term treatment for osteoporosis, may occur in rare cases. Contact your doctor if you experience pain, weakness, or discomfort in the thighs, hips, or groin as this may be an early sign of a possible femoral fracture.
- Severe skin reactions ( Stevens-Johnson syndrome and toxic epidermal necrolysis )
- Low calcium levels, which can cause muscle cramps or spasms and tingle in the fingers or around the mouth
- Pain and/or inflammation in the jaws (this is more common in people who have had a tooth extracted and/or have an infection in the mouth)
Very rare (may affect up to 1 in 10,000 people)
- Talk to a doctor if you have ear pain, discharge from the ear, and/or an ear infection. This may be a sign of a bone injury in the ear.
Reporting of side effects ar
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly via the Medical Products Agency, Box 26, SE-751 03 Uppsala. Website: www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Alendronate Arrow
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 expiration date is the last day of the specified month.
Do not store above 25 ° C. Store in the original package.
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.
6. FURTHER INFORMATION
Content declaration:
- The active substance is alendronic acid. Each tablet contains 10 mg of alendronic acid as sodium alendronate trihydrate.
- The other ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate.
What the medicine looks like and the contents of the pack
Alendronate Arrow 10 mg are white to off-white capsule-shaped tablets debossed with “AN 10” on one side and “>” on the other.
The tablets are packaged in blister packs of 14, 28, (50 x 1), 98, and 112 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, UK
Manufacturer:
Arrow Pharm (Malta) Limited, HF 62, Hal Far Industrial Estate, Hal Far, BBG 3000, Malta
or
Quality (Burnley) Limited, Talbot Street, Briercliffe, Burnley, BB10 2JY, United Kingdom
or
Medicament, as, Fibichova 143, 566 17 Vysoké Mýto, Czech Republic
or
Sun Pharmaceutical Industries (Europe) BV, Polarisavenue 87, HOOFDDORP, 2132JH, The Netherlands
Elle
Actavis Ltd. BLB 016, Bulebel Industrial Estate, Zejtun, ZTN 3000, Malta
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
Actavis AB
11289 Stockholm
This medicinal product is authorized under the European Economic Area under the names:
| France | Alendronic Acid Arrow 10 mg, compressed |
| Germany | ALENDRONIC ACID BASICS 10 mg tablets |
| Italy | Alendronato Arrow 10 mg compress |
| Norway | Alendronate Arrow 10 mg tablet |
| UK | United Kingdom Alendronic Acid 10mg Tablets |