70 mg tablets
alendronic acid
What Alendronate Teva Weekly Tablet is and what it is used for
- Alendronate Teva Weekly Tablets belong to a group of medicines called bisphosphonates that counteract the loss of bone mass in the body.
- It is used to treat osteoporosis (osteoporosis) in postmenopausal women. It reduces the risk of bone fractures ( fractures ) in the hip bones and vertebrae.
Alendronic acid contained in Alendronate Teva Weekly Tablets 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 Teva Weekly Tablet
Do not take Alendronate Teva weekly tablet
- if you are allergic to alendronic acid or any of the other ingredients of this medicine (listed in section 6).
- if you suffer from certain disorders of the esophagus (also called the esophagus, and connects the oral cavity with the stomach)
- if you can not sit or stand upright for at least 30 minutes
- if your doctor has told you that you have low blood calcium
Warnings and cautions
Talk to your doctor or pharmacist before taking Alendronate Teva Weekly Tablet
- if you have difficulty 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 inflammation of the gastric mucosa or duodenum (upper part of the small intestine)
- if you have had surgery on your stomach or esophagus (except for pyloroplasty, which means that the outlet from the stomach widens) during the past year
- if you have stomach ulcers or other digestive problems
- if you have kidney problems
It is important that you tell your doctor before taking Alendronate Teva Weekly Tablet:
- if you have cancer
- whether you are receiving chemotherapy or radiation therapy
- if you are using steroids (eg cortisone or sex hormones)
- if you do not receive regular dental care
- if you have gum disease
- if you are a smoker
During the treatment period, the dentist’s recommendation for appropriate preventive dental care should be followed.
Children and Adolescents
Alendronate Teva Weekly tablet should not be given to children and adolescents.
Other medicines and Alendronate Teva Weekly tablet
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Talk to your doctor before taking non-steroidal anti-inflammatory drugs ( NSAIDs ) while you are taking Alendronate Teva Weekly Tablet.
Do not take any other medicines at the same time as this medicine. If you are taking other medicines to be taken by mouth – allow at least 30 minutes between this medicine and your other medicine.
Alendronate Teva with food and drink
These tablets should be taken on an empty stomach as food and drink can greatly reduce the effect of the drug. Take the tablets at least 30 minutes before the first meal of the day.
Pregnancy and breastfeeding
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. You should not use Alendronate Teva Weekly Tablet if you are pregnant or breast-feeding.
Driving and using machines
In some people, this medicine may cause side effects that may affect their ability to drive or use machines (such as vision problems). Do not drive or handle machines if you are affected.
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 Teva Weekly Tablet contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
How to take Alendronate Teva
once a week
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by the doctor who adjusts it individually for you.
The following instructions are especially important to ensure that your medicine is useful and to reduce the risk of irritation to your esophagus:
- Choose the day of the week that suits you best. Then every week, take one tablet of Alendronate Teva Weekly Tablet on the selected day.
- Take the tablet on an empty stomach immediately upon rising in the morning. Take it with a full glass of plain tap water (not tea, coffee, mineral water, or juice) 30 minutes before food, drink, or other medicine.
- The tablet should be swallowed whole. Do not chew or suck on the tablet.
- Do not lie down after taking the tablet. You must remain in an upright position (sitting, standing or walking) until you have eaten the first meal of the day, which is taken no earlier than 30 minutes after taking the Alendronate Teva Weekly Tablet.
- Do not take the tablet at bedtime or before getting out of bed.
- If you experience difficulty and/or pain in swallowing, chest pain, or new-onset or worsening heartburn, stop taking this medicine and contact your doctor.
Common dosing instructions are given below:
Adults (including the elderly): One 70 mg tablet once a week.
Drink a whole glass of milk and do not lie down. Overdose can cause painful muscle cramps, fatigue, weakness, fatigue, and spasms. It can also cause upset stomach, indigestion, and painful inflammation of the upper gastrointestinal tract.
If you forget to take Alendronate Teva Weekly Tablet:
If you forget to take a tablet, take one in the morning the next day. Never take two tablets on the same day. Then return to taking one tablet per week on the day you originally decided.
Do not take a double dose to make up for a forgotten 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.
A few people may develop an allergic reaction, which can also happen with other drugs.
Serious side effects are
If any of the following occur, contact your doctor immediately or go to the emergency department of the nearest hospital:
Uncommon (may affect up to 1 in 100 people):
- Eye inflammation (often painful)
- Rare: (may affect up to 1 in 1,000 people): Allergic reactions including hives and rapid swelling of the skin and mucous membranes ( hives and angioedema ), difficulty breathing, swelling of the lips, face, and throat
- Severe whore reaction with extensive blistering and flaking, which leads to the skin looking scalded ( toxic epidermal necrolysis )
- Severe reaction with small blisters on red-purple, flat, and thickened skin spots, also around or in the mouth and/or eyes and/or abdomen ( Stevens-Johnson syndrome)
- Rash on exposure to sunlight
- Jaw problems (generally after tooth extraction and/or local infection )
- Abnormal 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.
If you find it difficult and/or painful to swallow, feel pain located behind the sternum (in the middle of the chest area), or new or worsening heartburn, stop taking the tablets and contact your doctor.
Other side effects are
The following side effects have been reported (frequencies reported are approximate):
Very common (may affect more than 1 user in 10):
- Pain in bones, muscles, and joints can sometimes be severe.
Common (may affect up to 1 in 10 people):
- Stomach pain, indigestion or heartburn, constipation, diarrhea, gas
- Sores in the esophagus (esophagus), difficulty swallowing, satiety or flatulence, acid regurgitation
- Headache, dizziness
- Joint swelling, swelling of hands, or legs ( edema ).
- Hair loss, itching
- Fatigue
Uncommon (may affect up to 1 in 100 people):
- Rash and redness of the skin
- Nausea, vomiting, inflammation of the esophagus or stomach, superficial damage to the esophagus that can cause pain and difficulty swallowing, black tarry stools.
- Taste changes.
- Transient symptoms (aching muscles, general malaise, and sometimes fever) at the beginning of treatment
Rare (may affect up to 1 in 1,000 people):
- Low blood calcium levels
- Narrowing of the esophagus, cold sores, stomach ulcers, and other ulcers in the gastrointestinal tract
Calcium and phosphate levels in the blood may be affected by Alendronate Teva Weekly Tablets, but you may not feel any discomfort from this.
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 thigh, hip, or groin as this may be an early sign of a possible femoral fracture.
Osteonecrosis (bone tissue death ) in the jaw (jaw problems, more common after having a tooth extracted and/or having an infection in the mouth) has been reported in patients treated with bisphosphonates, including alendronic acid. Osteonecrosis of the jaw has usually occurred in patients being treated for cancer but some cases have occurred in patients being treated for osteoporosis.
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 Teva Weekly Tablet
Keep this medicine out of the sight and reach of children
This medicine does not require any special storage instructions. Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiration date is the last day of the specified 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.
6. Contents of the packaging and other information
Content declaration
- The active substance is alendronic acid. Each tablet contains 70 mg of alendronic acid (as alendronate sodium monohydrate).
- The other ingredients are microcrystalline cellulose, croscarmellose sodium, and magnesium stearate.
What it looks like and contents of the pack:
The name of your medicine is Alendronate Teva Weekly Tablet 70 mg tablets.
- The drug is available in packs of 2, 4, 8, and 40 tablets and 50 tablets in single-dose packs for hospital use.
Not all pack sizes may be marketed.