70 mg tablets
Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.
- Save 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 only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
- If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.
In this leaflet:
1. What Alendronate Mylan Weekly Tablet is and what it is used for
2. What you need to know before you use Alendronate Mylan Weekly Tablet
3. How to use Alendronate Mylan Weekly Tablet
4. Possible side effects
5. How to take Alendronate Mylan Weekly Tablet must be stored
6. Package contents and other information
What Alendronate Mylan Weekly Tablet is and what it is used for
Alendronate Mylan Weekly tablet contains the active substance alendronic acid, in the form of sodium alendronate.
Alendronate Mylan belongs to a group of medicines called bisphosphonates. Bisphosphonates are used in the treatment of bone diseases such as osteoporosis ( osteoporosis ). Osteoporosis leads to the skeleton becoming thinner and weaker.
Alendronate Mylan Weekly tablet is used in the treatment of osteoporosis in postmenopausal women. Alendronate Mylan Weekly Tablet may reduce the risk of fractures in the back and hips.
Alendronic acid contained in the Alendronate Mylan Weekly tablet 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. What you need to know before using Alendronate Mylan Weekly Tablet
Do not use Alendronate Mylan 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 a problem with the esophagus (the esophageal throat that connects the mouth to the stomach) and which makes it difficult to swallow or the food gets stuck.
- if you can not stand or sit upright for at least 30 minutes.
- if you have very low calcium levels in your blood (hypocalcemia).
Warnings and cautions
Talk to your doctor or pharmacist before taking Alendronate Mylan Weekly Tablet:
- if you have severe kidney problems
- if you have difficulty swallowing or digestive problems (irritation, inflammation, or ulcers in the esophagus (esophagus – the connection between the mouth and the stomach)
- if you have had a stomach ulcer, bleeding, or undergone surgery in the stomach, esophagus, or throat during the past year
- if you have pain when swallowing
- 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 low calcium levels in your blood, or if you suffer from vitamin D deficiency or hypoparathyroidism (which can affect your calcium levels). They need to be treated before you start taking Alendronate Mylan Weekly Tablet.
Irritation, inflammation, or sores in the esophagus often with symptoms such as chest pain, heartburn, difficulty, or pain that may occur when you swallow. Especially if the tablets are not taken with a full glass of water and/or if you lie down less than 30 minutes after taking the tablets. These side effects may worsen if you continue to take the tablets after you have developed these symptoms. See the instructions under “How to use Alendronate Mylan Weekly Tablet ” later in this leaflet to see how to take the tablets. If you have any further questions, ask your doctor or pharmacist.
Tooth and jaw problems
Alendronate Mylan Weekly tablet may cause damage in the form of bone tissue death or loss of bone tissue. The risk is increased:
- if you have poor dental health, gum problems, malfunctioning dentures, planned to extract teeth or if you do not visit the dentist regularly
- if you have cancer
- whether you are being treated with cytotoxic drugs or radiation
- if you are taking cortisone (such as prednisolone or dexamethasone)
- if you are taking angiogenesis inhibitors – medicines used to treat cancer to prevent the formation of new blood vessels (such as bevacizumab or thalidomide)
- if you are or have been a smoker
You can get advice on making a dental visit before starting treatment with Alendronate Mylan Weekly Tablet.
It is important that you have good oral hygiene when you are treated with Alendronate Mylan Weekly Tablet. You should regularly have your teeth checked by a dentist throughout the time you are being treated and you should contact your doctor or dentist if you experience any problems with loose teeth, swelling, or pain.
Other medicines and Alendronate Mylan Weekly tablet
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription or any of the following medicines:
- drugs containing calcium
- medicines for acid stomach (antacids)
- cortisone preparations (such as prednisolone or dexamethasone) that are used to reduce inflammation, as it is important that you have an adequate intake of calcium and vitamin D (a risk factor for dental problems – see “Dental and jaw problems”).
- Drugs for rheumatism or long-term pain, called NSAIDs (eg acetylsalicylic acid or ibuprofen ), can cause irritation of the gastrointestinal tract. Therefore, caution should be exercised when using such drugs concomitantly with Alendronic acid.
Wait at least 30 minutes after taking Alendronate Mylan Weekly Tablet before taking any other medicine.
Alendronate Mylan Weekly tablet with food and drink
Food and drink may reduce the absorption of the Alendronate Mylan Weekly tablet in the body. You should therefore take Alendronate Mylan Weekly Tablet with plain water at least half an hour before eating or drinking anything. (See section 3).
Pregnancy and breastfeeding
Alendronate Mylan Weekly tablet is only for menopausal women. Do not take Alendronate Mylan Weekly Tablet 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.
Driving and using machines
Side effects (including blurred vision, dizziness, and severe leg, muscle, or joint pain) have been reported with alendronate, which may affect your ability to drive and use machines. Avoid driving or using machines if you feel affected by the medicine.
You are responsible for assessing whether you can drive motor vehicles or perform work that requires sharpened attention. One of the factors that can affect this ability is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found under other headings in the package leaflet. Therefore, read all the information in this leaflet. If you are not sure, talk to your doctor or pharmacist.
Alendronate Mylan Weekly tablet contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Alendronate Mylan Weekly tablet contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.
3. How to use Alendronate Mylan Weekly Tablet
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Adults and the elderly
The recommended dose is 70 mg once a week.
Use in patients with kidney problems
Alendronate Mylan Weekly Tablet is not recommended for patients with severe kidney problems.
Use for children and adolescents
Alendronate Mylan Weekly tablet should not be given to children and adolescents younger than 18 years.
Method of administration
- Take the tablet on an empty stomach immediately when you get up in the morning, before eating or drinking anything.
- Swallow the tablet whole when you are upright (sitting, standing, or walking) with a full glass (at least 2 dl) of ordinary tap water.
- Do not take mineral water (still or bubbling)
- Do not take with coffee or tea
- Do not take with juice or milk
- Do not crush or chew the tablet or allow it to dissolve in your mouth.
- Do not take the tablet at bedtime.
- If you want to lie down after taking Alendronate Mylan Weekly Tablet, take something to eat first.
- You must wait at least 30 minutes after taking the tablet before eating, drinking, or taking any other medicine.
Stop taking this medicine and tell your doctor if you notice :
- tenderness, pain, and difficulty swallowing.
- pain located in the middle of the chest.
- heartburn, new-onset, or worse than normal.
- sores in the mouth or throat.
Do not induce vomiting and do not lie down. Overdose can cause upset stomach, heartburn, inflammation of the esophagus, stomach pain, nausea, vomiting, bloody vomiting, blood in the stool ( gastritis ), stomach ulcers. You may also have changes in your blood test results (such as low levels of calcium and phosphate in your blood).
If you forget to take Alendronate Mylan Weekly Tablet
If you forget to take a dose, take the tablet in the morning the day after you remember. Do not take two tablets on the same day. Then return to taking one tablet per week on the day you originally decided.
If you stop using Alendronate Mylan Weekly Tablet
Always consult your doctor before stopping the Alendronate Mylan Weekly Tablet.
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.
Stop using this medicine and tell your doctor immediately if you experience any of the following serious side effects:
Common (may affect up to 1 in 10 users):
- pain in the mouth, throat, chest, or stomach, which may be associated with eating. You may feel bloated, sick, or ill, have a decreased appetite, or have a weight loss. These may be signs of inflammation or ulcers in the gastrointestinal tract. If you are sick, you may also notice particles that look like coffee grounds or you may have black, tar-like stools.
- new or worsening heartburn or indigestion, pain in the middle of the chest, or pain when swallowing. Talk to your doctor as soon as possible if you get any of these symptoms
Uncommon (up to 1 in 100 users)
- tenderness or pain in one or both eyes. You may have redness, blurred vision, watery eyes, sensitivity to light or floaters (shadows that pass over your vision)
Rare side effects are (may affect more than 1 in 1000) :
- Allergic reactions such as hives: swelling of the face, lips, tongue, and/or throat which may cause difficulty in swallowing and breathing ( angioedema ).
- Skin condition with severe blisters and bleeding on the lips, eyes, mouth, nose, and genitals ( Stevens-Johnson syndrome) or severe skin reactions that begin with sore redness of the skin, followed by the formation of large blisters and end with skin detachment. This is accompanied by fever and chills, muscle aches, and general malaise ( toxic epidermal necrolysis ).
- Pain in the mouth and/or jaw, swelling or sores in the mouth, numbness or heaviness in the jaw or teeth that feel loose. This can be a sign of skeletal damage in the jaw ( osteonecrosis ) associated with delayed healing and infection, usually after tooth extraction. Contact your doctor and dentist if you experience such symptoms.
- An unusual type of fracture of the femur, especially in patients treated for a long time for 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 fracture of the femur.
Very rare (may affect up to 1 in 10 000 users):
- 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.
Contact your doctor if you experience such symptoms.
Other possible side effects:
Very common ( may affect more than 1 user in 10) :
- Pain in the skeleton, muscles, or joints that can sometimes be severe
Common (may affect up to 1 in 10 users):
- Swollen joints, swelling in hands or legs
- Abdominal pain, stomach discomfort, satiety or belching after a meal, constipation, feeling bloated, diarrhea, flatulence
- Hair loss, itching
- Headache, dizziness; loss of balance or that you experience a tingling sensation ( vertigo ), unusual fatigue
Uncommon (may affect up to 1 in 100 people):
- Nausea, vomiting
- Skin rash, reddening of the skin
- Transient flu-like symptoms such as aching muscles, general malaise, and sometimes fever. This usually happens at the beginning of treatment.
- taste changes
Rare (may affect up to 1 in 1000 people) :
- Symptoms of low calcium levels including muscle struggle or spasm and/or tingling sensation in fingers or around the mouth
- Narrowing of the esophagus (esophageal stricture; ulceration of the oral cavity/throat, perforation/ulceration/bleeding in the upper gastrointestinal tract).
- Skin rash aggravated by sunlight
Tell your doctor or pharmacist immediately if you experience these or other unusual symptoms. It makes it easier if you make a note of what you have experienced when it started and how long it lasted.
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 Mylan 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 after “EXP”.
The expiration date is the last day of the specified month.
This medicine does not have any 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
- The active substance is alendronic acid. Each tablet contains 70 mg of alendronic acid in the form of sodium alendronate.
- The other ingredients are lactose monohydrate, cellulose, microcrystalline, povidone, croscarmellose sodium, and magnesium stearate.
What the medicine looks like and the contents of the pack
Alendronate Mylan Weekly Tablet is white with curved sides marked with “AD70” on one side and “G” on the other.
Alendronate Mylan Weekly Tablet is available in blister packs of 4, 8, or 12 tablets. It is also available in cans of 4, 8, or 12 tablets and cans of 100 tablets (intended for dose dispensing).
The jars may contain a plastic separator on the top of the package.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
104 35 Stockholm
Tel: 08-555 227 50
Fax: 08-555 227 51
Further information on this medicine can be obtained from the Marketing Authorization Holder above.