70 mg film-coated tablets
alendronic acid
1. What Alendronate Sandoz Weekly Tablet is and what it is used for
What is Alendronate Sandoz Weekly Tablet?
Alendronate Sandoz Weekly Tablet is a film-coated tablet containing the active substance sodium alendronate trihydrate.
What is alendronate?
Alendronate belongs to a group of non-hormonal medicines called bisphosphonates. Alendronate prevents the loss of bone mass, which can occur in postmenopausal women, and helps build new bone mass. It reduces the risk of vertebral and hip fractures.
What is Alendronate Sandoz Weekly Tablet used for?
Your doctor has prescribed an Alendronate Sandoz Weekly Tablet for the treatment of osteoporosis (osteoporosis). Alendronate Sandoz Weekly Tablet reduces the risk of vertebral and hip fractures.
Alendronate Sandoz Weekly tablet is taken once a week.
What is osteoporosis?
Osteoporosis is a thinning and weakening of the bone mass. It is common in postmenopausal women. During menopause, the ovaries stop producing the female sex hormone estrogen, which helps keep a woman’s skeleton healthy. As a result, the bone mass decreases, and the skeleton becomes weakened. The earlier a woman reaches menopause, the greater the risk of osteoporosis.
At an early stage, osteoporosis usually produces no symptoms. If left untreated, however, the result can be a broken bone. Although bone fractures generally hurt, fractures of the vertebrae may remain unnoticed until they cause a decrease in length. Bone fractures can occur during a normal everyday activity such as lifting or after a minor injury that would not normally break a normal bone. Bone fractures most often occur in the hip, spine, or wrist and can not only lead to pain but also to significant problems such as ankle insecurity and impairment of mobility.
How can osteoporosis be treated?
Osteoporosis can be treated and it is never too late to start treatment. Alendronate Sandoz Weekly Tablet not only prevents bone mass loss but actually helps to rebuild lost bone mass and reduces the risk of bone fractures in the vertebrae and hips.
In addition to treatment with Alendronate Sandoz Weekly Tablets, your doctor may suggest that you make lifestyle changes that help your condition, such as:
Stop smoking
Smoking seems to increase the rate of bone mass loss and can therefore increase the risk of bone fractures.
Exercise
Like the muscles, the bone mass needs exercise to stay strong and healthy. Ask your doctor for advice before starting any exercise program.
Balanced diet Your doctor can give you advice on your diet or if you should take any supplements (especially calcium and vitamin D).
Alendronic acid contained in Alendronate Sandoz Weekly Tablet may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Alendronate Sandoz Weekly Tablet
Do not take Alendronate Sandoz Weekly Tablet
- if you are allergic to alendronic acid or any of the other ingredients of this medicine (listed in section 6)
- if you have certain problems with the esophagus (esophagus – the tube that connects the mouth to the stomach) such as the narrow passage or difficulty swallowing
- if you can not stand or sit up for at least 30 minutes
- if your doctor has told you that you have low blood calcium 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.
Warnings and cautions
Talk to your doctor before taking Alendronate Sandoz Weekly Tablet
- if you have any kidney problems
- if you have any problems swallowing or with digestion
- if you have low calcium in your blood
- 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 gum problems, a planned tooth extraction, poor dental health, or do not receive regular dental care
- if you have cancer
- whether you are receiving chemotherapy or radiation therapy
- if you are taking angiogenesis inhibitors (eg bevacizumab or thalidomide)
- if you are taking corticosteroids (eg prednisolone or dexamethasone)
- if you are or have been a smoker (as this may increase the risk of dental problems).
You may be advised to undergo a dental check-up before starting treatment with Alendronate Sandoz Weekly Tablet. It is important to maintain good oral hygiene during treatment with Alendronate Sandoz Weekly Tablet. You should undergo regular dental checkups throughout your treatment. You should contact your doctor or dentist if you experience problems with your mouth or teeth such as loose teeth, pain, or swelling.
Irritation, inflammation, or ulcer in the esophagus (esophagus – the tube that connects the mouth to the stomach), often with symptoms such as chest pain, heartburn or difficulty swallowing or pain associated with swallowing, especially if the patient does not drink a large glass of water and/or lies down within 30 minutes of taking Alendronate Sandoz Weekly Tablet. These side effects may worsen if the patient continues to take Alendronate Sandoz Weekly Tablets after these symptoms have developed.
Children and young people
Alendronate Sandoz Weekly tablet should not be given to children and adolescents.
Other medicines and Alendronate Sandoz Weekly tablet
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is likely that calcium supplements, antacids (stomach acid-neutralizing medicines), and certain medicines are taken by mouth may affect the absorption of Alendronate Sandoz Weekly Tablets if taken at the same time. Therefore, it is important that you follow the advice given in section 3, “How to take Alendronate Sandoz Weekly Tablet”.
Some medicines for rheumatism or long-term pain, called NSAIDs (eg acetylsalicylic acid or ibuprofen ), can cause indigestion. Therefore, caution should be exercised when taking these medicines while taking Alendronate Sandoz Weekly Tablet.
Alendronate Sandoz Weekly tablet with food and drink
It is likely that food and drink (including mineral water) will reduce the effect of the Alendronate Sandoz Weekly Tablet if taken at the same time. Therefore, it is important that you follow the advice given in section 3, “How to take Alendronate Sandoz Weekly Tablet”.
Pregnancy and breastfeeding
Alendronate Sandoz Weekly Tablet is only for use by menopausal women.
You should not take Alendronate Sandoz Weekly Tablet if you are or think you may be pregnant.
You should not take Alendronate Sandoz Weekly Tablet if you are breast-feeding.
Driving and using machines
Alendronate Sandoz Weekly Tablet may affect your ability to drive and use machines. Patients taking Alendronate Sandoz Weekly Tablets may experience side effects such as dizziness, severe pain in muscles, joints, and bones, and eye pain or inflammation. If you get these side effects, talk to your doctor before driving or using machines. The reaction to Alendronate Sandoz may vary from person to person. (See section 4).
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.
Alendronate Sandoz Weekly tablet contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘sodium-free’.
How to take Alendronate Sandoz Weekly Tablet
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Take one 70 mg film-coated tablet once a week.
Follow these instructions carefully to be sure to get the best effect from Alendronate Sandoz Weekly Tablet
1) Choose the day of the week that suits you best. Every week you should take an Alendronate Sandoz Weekly Tablet 70 mg film-coated tablet on the selected day of the week.
It is very important that the instructions in 2), 3), 4) and 5) are followed so that Alendronate Sandoz Weekly Tablet reaches the stomach quickly and the risk of irritation in the esophagus (the esophagus – the tube that connects the mouth to the stomach) is reduced.
2) After getting up for the day and before taking anything to eat, drink or any other medicine, swallow your Alendronate 70 mg film-coated tablet, only with a large glass of water (not mineral water) (at least 200 ml).
- Do not swallow the tablet with mineral water (with or without bubbles).
- Do not swallow the tablet with coffee or tea.
- Do not swallow the tablet with juice or milk.
3) Do not chew the tablet and do not let it melt in your mouth.
4) Do not lie down – be completely upright (sitting, standing, or walking) for at least 30 minutes after swallowing the tablet. Do not lie down until after eating the first food of the day.
5) Do not take Alendronate Sandoz Weekly Tablet at bedtime or before getting up for the day.
6) If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking Alendronate Sandoz Weekly Tablet and consult a doctor.
7) After swallowing Alendronate Sandoz Weekly Tablets, wait at least 30 minutes before eating, drinking, or taking any other medicines for the day, including antacids, calcium supplements, and vitamins. Alendronate Sandoz Weekly Tablet is only effective when your stomach is empty.
If you forget to take Alendronate Sandoz Weekly Tablet
If you miss a dose, just take one tablet in the morning after you remember. Do not take two tablets on the same day. Return to taking one tablet per week, according to the original schedule on your chosen day of the week.
If you stop taking Alendronate Sandoz Weekly Tablet
It is important that you use Alendronate Sandoz Weekly Tablet for as long as your doctor prescribes it. As it is not known how long you will take Alendronate Sandoz Weekly Tablets, you should periodically discuss with your doctor the need to continue treatment with this medicine to determine if Alendronate Sandoz Weekly Tablets are still right for you.
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.
Contact a doctor immediately if you get any of the following side effects which may be serious and for which you may need urgent medical treatment:
Very common (may affect more than 1 user in 10):
- pain in the skeleton, muscles, and/or joints which can sometimes be severe
Common (may affect up to 1 in 10 people):
- heartburn, difficulty swallowing, pain when swallowing, ulcers in the esophagus (esophagus – the tube that connects the mouth to the stomach) which can cause chest pain, heartburn, or difficulty/pain when swallowing
Rare (may affect up to 1 in 1,000 people):
- allergic reactions such as hives, swelling of the face, lips, tongue, and/or throat, which may cause difficulty in swallowing and breathing
- severe skin reactions such as ring-shaped, red, and often blistering rash – common on hands and feet ( toxic epidermal necrolysis ), dermatitis in combination with high fever ( Stevens-Johnson syndrome )
- pain in the mouth and/or in the jaw, swelling or sores in the mouth, numbness or heaviness in the jaw, or tooth loss. This can be a sign of bone damage in the jaw usually associated with delayed healing and infection, often after tooth extraction. Contact your doctor or dentist if you experience such symptoms.
- unusual femoral fractures, especially in patients treated for long-term osteoporosis. Contact your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin as this may be an early sign of a possible femoral fracture.
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.
Other side effects that may occur:
Common (may affect up to 1 in 10 people)
- headache
- dizziness
- dizziness
- abdominal pain
- feeling uncomfortable in the stomach or belching after a meal
- constipation
- feeling full or bloated
- diarrhea
- weather voltage
- swollen joints
- hair loss
- itching
- fatigue
- swollen hands or legs
Uncommon (may affect up to 1 in 100 people)
- nausea
- vomiting
- irritation or inflammation of the esophagus
- black or tar-like stools
- rash
- reddening of the skin
- transient flu-like symptoms such as muscle aches, general malaise, and sometimes fever, usually at the beginning of treatment
- taste disorders
- blurred vision, pain in the eyes, or red eyes
Rare (may affect up to 1 in 1,000 people)
- narrowing of the esophagus, sores in the mouth if you have chewed or sucked on the tablets
- ulcers of the stomach or duodenum (sometimes severe or with bleeding)
- rash aggravated by sunlight
- symptoms of low calcium in the blood including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Alendronate Sandoz Weekly Tablet
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 and on the blister after EXP. or EXP. The expiration date is the last day of the specified month.
This medicine has no special storage instructions.
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. Contents of the packaging and other information
What Alendronate Sandoz Weekly Tablet contains
The active substance is alendronic acid.
One film-coated tablet contains 70 mg of alendronic acid (as sodium trihydrate).
The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, magnesium stearate, carrageenan, macrogol.
What the medicine looks like and the contents of the pack
White, round, biconvex film-coated tablet, marked with “ALN 70” on one side. The diameter of the tablet is about 10 mm.
The film-coated tablets are packaged in OPA-Aluminum-PVC / Aluminum-blister contained in a carton.
Pack sizes:
Blisters: 2, 4, 6, 8, 12, 14 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer:
Lek Pharmaceuticals dd, Verovśkova 57, 1526 Ljubljana, Slovenia
or
Lek Pharmaceuticals dd, Trimline 2D, 9220 Lendava, Slovenia
or
Lek SA, ul. Domanievska 50 C, 02-672 Warsaw, Poland
or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany