10 mg tablets of
alendronic acid
1. What Alendronate STADA is and what it is used for
Alendronate belongs to a group of medicines called bisphosphonates. Alendronate Stada prevents loss of bone mass and reduces the risk of spine and hip fractures (bone fractures).
Alendronate Stada is used
- to treat osteoporosis ( osteoporosis ). It is also used to prevent osteoporosis in patients treated with cortisone preparations (medicines that can be used to treat inflammation ). Alendronate Stada may reduce the risk of vertebral and hip fractures in women and spinal fractures in men.
Osteoporosis means thinning and weakening of the skeleton. Early osteoporosis usually has no symptoms, but if left untreated, osteoporosis can lead to bone fractures. Although fractures usually cause pain, fractures of the vertebrae can go unnoticed until they cause a decrease in length. Fractures can occur during everyday activities, such as lift, or from minor injuries that would not normally damage a healthy skeleton. These fractures are most common in the hips, vertebrae, and wrists, which can not only cause pain but also other ailments, e.g. cow safety and reduced mobility.
In addition to your treatment with Alendronate Stada, your doctor may suggest that you change your lifestyle (exercise and diet, smoking cessation) to improve your condition. Your doctor can give you more information about lifestyle changes.
Alendronate contained in Alendronate Stada 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.
2. What you need to know before using Alendronate STADA
Do not use Alendronate STADA
- if you are allergic to alendronic acid, other bisphosphonates, or any of the other ingredients of this medicine (listed in section 6).
- if you suffer from certain problems in the esophagus such as narrowing or difficulty swallowing (a condition called achalasia)
- if you can not sit or stand upright for 30 minutes
- if you have a low calcium level in your blood.
If any of the above applies to you, do not take the tablets without first discussing them with your doctor. See also section 3 “How to take Alendronate Stada”
Warnings and cautions
Talk to your doctor or pharmacist before taking Alendronate Stada
- if you have any kidney disease
- if you have any allergies you
- if you have difficulty swallowing or digestive problems such as inflammation of the stomach or duodenum (the upper part of the small intestine), or if you have had serious stomach disease such as stomach ulcers, bleeding from the stomach or intestines, or undergone surgery in the stomach or esophagus during the past year.
- if your doctor has told you that you have Barrett’s esophagus (a condition with changes in the cells of the lower esophagus).
- if the body has problems absorbing calcium, or if you have other diseases that can lead to low calcium levels in the blood e.g. low levels of vitamin D or a disease called hypoparathyroidism (when the parathyroid glands do not function normally). Your doctor may prescribe calcium or vitamin D to prevent low levels of calcium in your blood.
- if you have cancer
- if you take corticosteroid s (drugs that can be used to treat inflammation )
- if you are undergoing chemotherapy or radiation therapy
- if you smoke
- if you have poor dental health, gum problems, have a planned tooth extraction.
Your doctor may ask you to have a dental examination before starting treatment with Alendronate Stada.
It is important to maintain good oral hygiene when you are treated with Alendronate Stada. 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.
If you are being treated by a dentist or if you are going to undergo a dental surgery or have a tooth extracted, it is important that you tell them that you are taking Alendronate Stada for your dentist.
Irritation, inflammation or sores in the esophagus, often accompanied by symptoms such as chest pain, heartburn or difficulty or pain in swallowing may occur, especially if you have not followed the dosing instructions or your doctor’s instructions correctly (see section 3. “How to tar Alendronate Stada ”). You should stop taking alendronate Stada and contact your doctor immediately if you get any of these symptoms. (See section 4. “Possible side effects”.) If you ignore these symptoms and continue taking your tablet, it is likely that these swallowing problems will get worse.
Your levels of calcium and phosphate in your blood may be affected by Alendronate Stada. If you are going to take a blood sample, it is therefore important that you tell your doctor that you are taking these tablets.
Children and young people
Alendronate Stada should not be given to children and adolescents.
Other medicines and Alendronate STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor if you are taking corticosteroids (medicines that can be used to treat inflammation ). You may need to undergo certain tests before starting treatment with Alendronate Stada (eg dental examination).
You may get an upset stomach if you take painkillers (eg acetylsalicylic acid, ibuprofen ) with Alendronate Stada.
It is likely that the following medicines will affect the absorption of Alendronate Stada in the body if taken at the same time:
- calcium supplementation
- antacids (medicines for heartburn)
- some other oral medicines.
Therefore, you must wait at least 30 minutes after taking Alendronate Stada before taking any other medicines (see also section 3 “How to take Alendronate Stada”).
Alendronate STADA with food, drink, and alcohol
It is likely that food and drink (including mineral water) make Alendronate Stada less effective if taken at the same time. It is therefore important that you follow the instructions in section 3 “How to take Alendronate Stada”.
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.
Pregnancy
Do not use Alendronate Stada if you are pregnant or think you may be pregnant.
Breast-feeding
Do not use Alendronate Stada if you are breast-feeding.
Driving and using machines
Alendronate Stada can cause side effects (including blurred vision, dizziness, and severe skeletal, muscle, or joint pain) that may affect your ability to drive or use machines. Individual reactions to Alendronate Stada may vary (see section 4. “Possible side effects”).
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 STADA contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars (eg lactose ), contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Alendronate STADA
Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist. Dose one is determined by the doctor who adjusts it individually for you.
The recommended dose of Alendronate is 1 tablet daily.
It is very important that you follow the instructions below so that you get the most benefit from your medicine and that you avoid problems with the esophagus.
After getting up in the morning and before eating any food, drink, or other medicine, swallow Alendronate Stada whole with a full glass of plain water (not mineral water, not less than 200 ml).
- After getting up in the morning and before eating any food, drink, or other medicine, swallow Alendronate Stada whole with a full glass of plain water (not mineral water, not less than 200 ml).
- DO NOT take the tablet with mineral water (neither with nor without carbon dioxide).
- DO NOT take the tablet with coffee or tea.
- DO NOT take the tablet with juice or milk.
- Do not crush or chew the tablet or allow it to dissolve in your mouth.
- Do not lie down after taking Alendronate Stada. You should stay upright (sit, stand, or walk) for at least 30 minutes after swallowing the tablet. Do not lie down until you have eaten the first meal of the day.
- Wait at least 30 minutes after taking Alendronate Stada before eating your first meal of the day, drinking, or taking any other medicines, including heartburn, calcium supplements, or vitamins. Alendronate Stada is only effective if taken on an empty stomach
- Do not take Alendronate Stada at bedtime or before going to bed.
- If you have difficulty and/or it is painful to swallow, feel pain behind the sternum, or new-onset or worsening heartburn, stop taking Alendronate Stada and contact your doctor immediately.
- It is important that you continue to take Alendronate Stada for as long as your doctor recommends. Alendronate Stada can only treat your osteoporosis as long as you take the tablets.
Symptoms of overdose may include:
- low calcium levels in the blood with symptoms such as sensations in the skin, e.g. numbness, burning sensation, tingling, itching or ant crawling or involuntary muscle twitching.
- low phosphate levels in the blood with symptoms such as muscles not working properly and muscle weakness
- upset stomach and heartburn
- inflammation in the esophagus or in the stomach and stomach ulcers.
If you forget to use Alendronate STADA
If you forget to take a tablet, do not take any extra but follow the usual schedule with one tablet in the morning after the day you forgot to take the tablet. Do not take a double dose to make up for a forgotten tablet. Do not take two tablets on the same day. Return to taking one tablet daily. If you are not sure, ask your doctor.
If you stop using Alendronate STADA
Always consult your doctor if you want to stop taking Alendronate Stada, or if you want to change the prescribed dosing schedule. Do not stop treatment without first discussing it with your doctor.
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 taking Alendronate Stada immediately and seek medical attention immediately if you get any of the following symptoms:
- symptoms of a severe allergic reaction ( angioedema, rare [may affect up to 1 in 1,000 people]) such as
- Swelling of the face, tongue or throat and/or
- difficulty swallowing and difficulty breathing and/or
- rash
- severe skin changes (very rare [may affect up to 1 in 10,000 people]) e.g. rash and blistering, or other changes in the skin, eyes, mouth or genitals, itching or fever (these are symptoms of a skin condition called Steven-Johnson syndrome or toxic epidermal necrolysis ).
- chest pain, new-onset or worsening heartburn, or difficulty/pain in swallowing (this may be due to irritation, inflammation, or sore throat, common [may affect up to 1 in 10 people]). If you ignore these symptoms and continue taking your tablets, it is likely that these stomach side effects will get worse.
Other side effects include
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):
- headache
- dizziness
- stomach pain, stomach discomfort or belching after a meal, constipation, abdominal tension, diarrhea, flatulence
- hair loss (alopecia)
- itching
- joint swelling
- swelling of hands or legs
- fatigue
- vertigo ( vertigo )
Uncommon (may affect up to 1 in 100 people):
- Nausea, vomiting
- irritation or inflammation of the esophagus or stomach, ulcers of the esophagus (esophageal erosion)
- black or tar-like stools
- skin rash, reddening of the skin
- taste changes
- eye inflammation with blurred vision, pain, or redness in the eye
- transient flu-like symptoms such as aching muscles, general malaise, and sometimes fever usually at the beginning of treatment
Rare (may affect up to 1 in 1,000 people):
- constriction of the esophagus
- acid reflux when the tablet has been chewed or sucked on
- gastric ulcer (sometimes severe or bleeding)
- skin rash aggravated by sunlight
- symptoms of low calcium levels in the blood including muscle cramps, spasms, and/or a stinging sensation in the fingers or around the mouth
- 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 ( osteonecrosis ) 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 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.
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 ear infection. This may be a sign of a bone injury in the ear.
Talk to your doctor or pharmacist as soon as possible about these or other unusual symptoms.
It will be easier if you write a note about what you 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 STADA
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. The expiration date is the last day of the specified month.
Store below 25 ° C. Store in the original package. Moisture sensitive.
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 sodium alendronate trihydrate. 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 Stada 10 mg tablets are available as white to off-white, capsule-shaped tablets with the text “AN 10” on one side and the company logo on the other side.
The tablets are available in Triplex blister packs containing 14, 28, 30, 56, 98, 112, and 50×1 (single dose).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
STADA Arzneimittel AG, Stadastraße 2-18, 61118 Bad Vilbel, Germany
Other manufacturers
- Arrow Pharm (Malta) Limited, HF 62, Hal Far Industrial Estate, Birzebbugia BBG3000, Malta
- STADA Arzneimittel Ges. mbH, Muthgasse Strasse 36/2, 1190 Vienna, Austria
- STADApharm GmbH, Stadastr. 2-18, 61118 Bad Vilbel, Germany
- Lab. Medicamentos Internacionales (Medina), La Solana, 26, Torrejon de Ardoz (Madrid) Spain
- Sanico NV, Veedijk 59, Industrial Zone IV, 2300 Turnhout, Belgium
- Centrafarm Services BV, Nieuwe Donk 9, 4879 AC Etten-Leur, The Netherlands
- Clonmel Healthcare Ltd., Waterford Road, Clonmel, Co. Tipperary, Ireland
- Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Hertfordshire SG1 4SZ, UK
- Actavis Ltd, BLB 016, Bulebel Industrial Estate, Zejtun, ZTN 3000, Malta
- Quality (Burnley) Limited, talbot Street, Briercliffe, Burnley BB10 2JY, UK
- Juta Pharma GmbH, Gutenbergstrasse 13, 24941 Flensburg, Germany
- PharmaCoDane ApS, Marielundvej 46A, 2730 Herlev, Denmark
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark