10 mg tablets of
Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.
- Save this information, 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 Teva is and what it is used for
2. What you need to know before taking Alendronate Teva
3. How to take Alendronate Teva
4. Possible side effects
5. How to store Alendronate Teva
6. Package contents and other information
What Alendronate Teva is and what it is used for
- Alendronate Teva belongs to a group of non-hormonal medicines called bisphosphonates, which are used in the treatment of skeletal diseases. Alendronate Teva acts directly on the skeleton by reducing the risk of fractures.
- Alendronate Teva is used to treat osteoporosis (a disease that weakens the skeleton and increases the risk of fractures ) in postmenopausal women. The drug reduces the risk of fractures in the vertebrae and hip bones.
Alendronic acid contained in Alendronate Teva 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
Do not take Alendronate Teva
- if you are allergic to alendronic acid or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to other medicines belonging to the same group of medicines as alendronic acid (bisphosphonates, eg risedronic acid, ethacrynic acid, or hadronic acid)
- if you have certain problems in the esophagus (also called the esophagus, which connects the oral cavity to the stomach)
- if your doctor has told you that you are suffering from hypocalcemia (low blood calcium)
- if you can not stand or sit upright for at least 30 minutes.
Warnings and cautions
Talk to your doctor or pharmacist before taking Alendronate Teva:
- 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 lining of the stomach or of the duodenum (first part of the small intestine)
- if you have had surgery on your stomach or esophagus (apart from pyloric resection, which means that the outlet from your stomach dilates) during the past year
- if you have stomach ulcers or other digestive problems
- if you have kidney problems
If any of these apply to you, talk to your doctor before starting treatment with Alendronate Teva.
Examination of your teeth should be considered before starting treatment with Alendronate Teva if any of the following apply to you:
- you have cancer
- you get chemotherapy or radiation therapy
- you take steroids you
- you do not get the regular dental care
- you have any gum disease
- you are a smoker
During the treatment period, the dentist’s recommendation for appropriate preventive dental care should be followed.
If it is difficult or painful to swallow if you feel pain behind the sternum (in the middle of the chest), or new or worsening heartburn, stop taking the tablets and contact your doctor.
Children and young people
Alendronate Teva should not be given to children and adolescents.
Other medicines and Alendronate Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take other medicines to be swallowed at the same time as you take Alendronate Teva. If you are taking other medicines to be swallowed, leave it on for at least 30 minutes after taking Alendronate Teva until you take your other medicine.
If you are taking Alendronate Teva, talk to your doctor before taking non-steroidal anti-inflammatory drugs ( NSAIDs ).
Alendronate Teva with food and drink
The tablets should be taken on an empty stomach as food and drink may significantly impair the effect of the medicine. 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 if you are pregnant or breast-feeding.
Driving and using machines
Some side effects that may affect your ability to drive and use machines have been reported with Alendronate Teva. Do not drive or use machines if you are affected by the medicine.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. 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 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
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 1 tablet daily.
The following instructions are especially important to ensure that your medicine is useful and to reduce the risk of irritation to your esophagus:
Take Alendronate Teva on an empty stomach immediately after getting up in the morning. The tablet must be taken with a full glass of plain water (not with tea, coffee, mineral water, or juice) at least 30 minutes before eating, drinking, or taking any other medicine.
The tablet should be swallowed whole. It must not be chewed or sucked on.
Do not lie down after taking the tablet. You need to stay upright (sit, stand, or walk) for the next half hour until you eat breakfast.
Do not take the tablets at bedtime or before getting up in the morning.
If it hurts when you swallow or you have difficulty swallowing, if you get chest pain or new-onset or worsening heartburn, then stop taking Alendronate Teva and contact your doctor.
Drink a full glass of milk and do not lie down. An overdose can cause painful muscle cramps, fatigue, weakness, fatigue, and cramps. It can also cause an upset stomach, digestive problems, and painful inflammation in the esophagus.
If you forget to take Alendronate Teva
If you forget to take a tablet, take one when you get up the next morning. 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.
As with all medicines, a few people may develop an allergic reaction.
If any of the following occur, contact your doctor immediately or go to the nearest emergency department:
- Difficulty breathing
- Swelling of the lips, face, and neck
The following adverse reactions have been reported with approximately the following frequency:
Very common (may affect more than 1 user in 10)
- Leg, muscle, or joint pain, sometimes severe.
Common (may affect up to 1 in 10 people)
- Stomach pain, indigestion or heartburn, constipation, diarrhea, gas in the stomach
- Ulceration of the esophagus (esophagus), difficulty swallowing, feeling full or tense in the stomach, acid regurgitation
- Joint swelling, swelling of hands or legs (so-called edema )
- Headache, dizziness, dizziness
- Itching, hair loss
- Fatigue, weakness, weakness ( asthenia ).
Uncommon (may affect up to 1 in 100 people)
- Rash, reddening of the skin
- Nausea, vomiting, inflammation of the esophagus, inflammation of the stomach, black stools.
- Taste changes
- Eye inflammation (often painful)
- Transient symptoms (muscle pain, malaise, and, in rare cases, fever) at the start of treatment.
Rare (may affect up to 1 in 1,000 people)
- Allergic reaction with hives and rapid swelling of the skin and mucous membranes ( angioedema )
- Rash with photosensitivity, other allergic (hypersensitivity) reactions (including Stevens-Johnson syndrome and so-called toxic epidermal necrolysis which can be life-threatening)
- Low calcium levels in the blood
- Gastric ulcer and other ulcers of the gastrointestinal tract, narrowing of the esophagus
- Sores in the mouth and esophagus if chewed or sucked on the tablet
- Jaw problems (usually after tooth extraction and/or local infection )
- Unusual fracture of the femur.
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.
Alendronate Teva can affect the levels of calcium and phosphate in your blood.
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 of the jaw (jaw problems, usually after tooth extraction and/or local infection ) 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
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 blister after “EXP”. The expiration date is the last day of the specified month.
This medicine does not require 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 (10 mg equivalent to 11.6 mg alendronate sodium monohydrate).
- The other ingredients are low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, colloidal aqueous silica, and sodium stearyl fumarate.
What the medicine looks like and the contents of the pack
- Alendronate Teva 10 mg tablets are white to off-white, round, biconvex tablets, engraved with “T” on one side and “10” on the other.
- Alendronate Teva 10 mg tablets are available in pack sizes of 14, 28, 30, 50, 56, 84, 90, 98, 112 and 140 tablets. Calendar pack of 28 tablets and single-pack of 50 x 1 tablets
Not all pack sizes may be marketed.