70 mg tablets of
sodium alendronate
1. What Alendronate Orifarm Weekly Tablet is and what it is used for
Alendronate Orifarm Weekly Tablets belong to a class of non-hormonal preparations, called bisphosphonates.
Alendronate Orifarm Weekly Tablet is used to:
- Treat a disease called osteoporosis (osteoporosis) that is common in postmenopausal women.
- reduce the risk of hip and vertebral fractures.
Alendronate Orifarm Weekly tablet slows down the loss of bone mass that occurs in connection with menopause. Alendronate Orifarm Weekly Tablet also builds new bone mass and therefore reduces the risk of bone fractures ( fractures ) in the hip bones and vertebrae.
Osteoporosis leads to a thinning and weakening of the skeleton. After menopause, the ovaries stop producing the female sex hormone, estrogen. Then the bone mass decreases and the skeleton becomes weaker. The earlier a woman reaches menopause, the greater the risk of her getting osteoporosis.
Osteoporosis is an insidious disease, which usually has no symptoms. Without treatment, osteoporosis can lead to fractures (fractures) usually in the hip, vertebrae, and wrists. Although fractures usually cause pain, fractures of the vertebrae can go unnoticed until they cause a decrease in length. Fractures can easily occur during everyday activities, such as heavier lifting. Even events that do not usually lead to injuries, such as falls, can cause fractures in patients with osteoporosis.
Alendronate contained in Alendronate Orifarm 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 you take Alendronate Orifarm Weekly Tablet
Do not take Alendronate Orifarm Weekly Tablet
- if you are allergic to sodium alendronate or any of the other ingredients of this medicine (listed in section 6)
- if you have pathological changes, such as narrowing of the esophagus
- if you can not sit or stand upright for 30 minutes
- if you have a low calcium level in your blood
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Alendronate Orifarm Weekly Tablet:
- if you have kidney disease
- if you have had or have pain or swelling in the gums and/or jaw, numb jaw, if the jaw feels heavy, or if you have lost a tooth
- If you are undergoing dental treatment or undergoing dental surgery, tell your dentist that you are being treated with Alendronate Orifarm Weekly Tablet.
- if your doctor has told you that you have Barrett’s esophagus (a condition with changes in the cells of the lower esophagus)
- you have been told that you have problems absorbing minerals in your stomach or intestines (malabsorption syndrome)
- if you are taking certain other medicines- glucocorticoid s (e.g. prednisolone or dexamethasone) used for treating conditions such as asthma, rheumatoid arthritis, and severe allergy angiogenesis inhibitors (eg bevacizumab or thalidomide) used to treat cancer
- if you have cancer
- if you are being treated with chemotherapy or radiation therapy
- if you are a smoker.
Before using the Alendronate Orifarm Weekly Tablet, you should also tell your doctor if you:
- have difficulty and/or pain in swallowing or have pain located behind the sternum
- have to stomach ulcer-like problems or if within the past year you have had gastrointestinal diseases such as stomach ulcers (including bleeding) or have had surgery on the gastrointestinal tract.
- has an insufficient function in the parathyroid glands (parathyroid gland), too low in the blood of calcium (calcium) or vitamin D ( vitamin D deficiency).
While taking Alendronate Orifarm Weekly Tablet:
- You are encouraged to maintain good oral hygiene, have regular check-ups at the dentist, and report any oral symptoms such as loose teeth, pain, or swelling to your doctor.
- You are encouraged to report any pain in the thigh, hip, or groin to your doctor, as this may be a symptom of a crack in the hip bone.
- you must contact a doctor if you experience symptoms of esophageal irritation, e.g. difficulty swallowing, pain or swelling, retrosternal pain (pain behind the sternum when swallowing), or new-onset or worsening heartburn
Children and young people
Alendronate should not be given to children and adolescents.
Other medicines and Alendronate Orifarm Weekly tablet:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Alendronate Orifarm Weekly Tablets should not be taken at the same time as food, calcium tablets, gastric acid neutralizing agents, vitamins, and/or other medicines, as these may affect the absorption of Alendronate Orifarm Weekly Tablets in the body.
Wait at least 30 minutes after taking Alendronate Orifarm Weekly Tablet before taking any other medicine or eating.
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 at the same time as Alendronate Orifarm Weekly Tablet.
Alendronate Orifarm Weekly tablet with food and drink
It is important to take Alendronate Orifarm Weekly Tablet only with regular tap water. Other drinks reduce the uptake and thus the effect of the Alendronate Orifarm Weekly Tablet.
The effect of the treatment can be reduced if Alendronat Orifarm Weekly Tablet is taken at the same time as other medicines, foods, or drinks (other than regular water).
Wait at least 30 minutes after taking Alendronate Orifarm Weekly Tablet before taking any other medicine or eating.
Pregnancy and breastfeeding
Alendronate Orifarm Weekly Tablet is only for postmenopausal women. Do not take Alendronate Orifarm Weekly Tablet if you are or think you may be pregnant or breast-feeding.
Pregnancy:
Do not use Alendronate Orifarm Weekly Tablet if you are pregnant.
Breast-feeding:
Unknown if Alendronate Orifarm Weekly Tablet passes into breast milk. Do not use Alendronate Orifarm Weekly Tablet if you are breast-feeding.
Driving and using machines
Side effects (such as blurred vision, dizziness, and severe leg, muscle or joint pain) have been reported with Alendronate Orifarm Weekly Tablet which may affect your ability to drive and use machines (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.
How to take Alendronate Orifarm Weekly Tablet
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
One tablet Alendronate Orifarm Weekly tablet is taken once a week. To make sure that Alendronat Orifarm Weekly Tablet is useful and to avoid irritation in the esophagus, it is important that you take the medicine as prescribed below. This reduces the risk of the tablet getting stuck in the esophagus.
| Choose the day of the week that suits you best. Then take one tablet of Alendronate Orifarm Weekly Tablet on the selected day each week.Take Alendronat Orifarm Weekly Tablet once a week when ascending with a full glass of plain tap water on an empty stomach. Wait at least 30 minutes after taking Alendronat Orifarm Weekly Tablet before taking the first meal of the day, food, drink or other medicine. The tablet should be swallowed whole. Do not crush, chew or suck on the tablet due to the risk of mouth sores .Do not lie down after taking Alendronate Orifarm Weekly Tablet. Remain in an upright position (sitting, standing or walking) for at least 30 minutes after taking the tablet. Do not lie down until you have eaten the first meal of the day.If you find it difficult and / or painful to swallow, feel pain located behind the sternum or new onset or worsening heartburn, stop taking Alendronat Orifarm Weekly Tablet and contact your doctor immediately. |
If you forget to take Alendronate Orifarm Weekly Tablet
If you forget to take a tablet, take one tablet of Alendronate Orifarm Weekly Tablet in the morning the day after you remember. Do not take a double dose to make up for a forgotten dose. Then return to taking one tablet per week on the day you originally decided.
If you stop taking Alendronate Orifarm Weekly Tablet
Take Alendronate Orifarm Weekly Tablet once a week as directed. It is important that you continue to take Alendronate Orifarm Weekly Tablets for as long as your doctor recommends.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Alendronate OrifarmVecko tablet and contact a doctor immediately or see the nearest emergency department if you experience the following symptoms:
Common side effects (may affect up to 1 in 10 people):
- difficulty and/or pain when swallowing, irritation, or sore throat.
Uncommon side effects (may affect up to 1 in 100 people):
- pain localized behind the sternum or newcomer or worsening heartburn.
Rare side effects (may affect up to 1 in 1,000 people):
- swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing.
- severe widespread skin damage (skin peeling of the epidermis and superficial mucous membranes)
- an extremely severe allergic reaction with skin rash, usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as genitals.
- 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.
Other side effects are
Very common side effects (may affect more than 1 user in 10):
- muscle, joint, and leg pain that can sometimes be severe
Common side effects (may affect up to 1 in 10 people):
- headache, dizziness, vertigo
- stomach pain feeling uncomfortable in the stomach, also acid regurgitation, constipation, diarrhea, abdominal tension, flatulence
- hair loss, itching
- swelling of the joints
- weakness, peripheral edema (swollen tissues)
Uncommon side effects (may affect up to 1 in 100 people):
- nausea, vomiting, bloody stools
- skin rash and redness
- taste disorders
- inflammation in the eye or in the iris
- short-term transient flu-like symptoms (muscle aches, general malaise, and, in rare cases, fever) usually at the start of treatment
Rare side effects (may affect up to 1 in 1,000 people):
- low levels of calcium in the blood
- skin rash that worsens with sun exposure
- degradation of the jawbone ( osteonecrosis )
- gastric ulcer-like problems sometimes of a more severe nature with bleeding have occurred, but it is unclear whether a causal relationship with alendronate exists
- sores in the mouth
Very rare side effects (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.
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 Alendronat Orifarm 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.
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 70 mg per tablet.
- The other ingredients are magnesium stearate, mannitol (E 421), and microcrystalline cellulose.
What the medicine looks like and the contents of the pack
Oval, white, biconvex tablets, APO labeled on one side and ALE 70 on the other.
Pack sizes:
Blister: 1, 4, 12, 24 tablets
Jar: 100 tablets
Not all pack sizes may be marketed
Marketing Authorization Holder and Manufacturer
Orifarm Generics A / S
Energizer 15
5260 Odense S
Denmark
Local representative:
Orifarm Generics AB
Box 56048
102 17 Stockholm
info@orifarm.com
This medicinal product is authorized under the European Economic Area under the names:
Denmark: Alendronate Orifarm