Fosamax Weekly 70 mg tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package Leaflet: Information for the Patient
FOSAMAX Weekly 70 mg Tablets
Alendronic acid
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.
- It is particularly important that you understand the information in section 3 before taking this medicine.
Contents of this leaflet
- What FOSAMAX Weekly is and what it is used for
- What you need to know before taking FOSAMAX Weekly
- How to take FOSAMAX Weekly
- Possible side effects
- How to store FOSAMAX Weekly
- Contents of the pack and other information
1. What FOSAMAX Weekly is and what it is used for
What is FOSAMAX Weekly?
FOSAMAX Weekly is a tablet containing the active substance alendronic acid (commonly known as alendronate) and belongs to a group of non-hormonal medicines called bisphosphonates. FOSAMAX Weekly prevents bone loss that occurs in women after menopause and helps rebuild bone. FOSAMAX Weekly reduces the risk of spine and hip fractures.
What is FOSAMAX Weekly used for?
Your doctor has prescribed FOSAMAX Weekly to treat your osteoporosis. It reduces the risk of spine and hip fractures.
FOSAMAX Weekly is a weekly treatment.
What is osteoporosis?
Osteoporosis is thinning and weakening of the bones. It is common in women after menopause. During menopause, the ovaries stop producing the female hormone estrogen, which helps maintain a woman's skeleton in good health. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches menopause, the greater her risk of developing osteoporosis.
Long before, osteoporosis usually has no symptoms. However, if left untreated, it can lead to broken bones. Although these are usually painful, fractures of the spinal bones may go unnoticed until they cause loss of height. Bones may break during normal everyday activities, such as getting up from a chair, or due to minor injuries that would not normally break a healthy bone. Bone fractures typically occur in the hip, spine, or wrist and may cause not only pain but also significant problems such as stooped posture ("dowager's hump") and loss of mobility.
How can osteoporosis be treated?
In addition to your treatment with FOSAMAX Weekly, your doctor may suggest that you make lifestyle changes to help manage your condition, such as:
Stop smoking Smoking appears to increase the rate at which you lose bone and therefore may increase your risk of broken bones.
Exercise Like muscles, bones need exercise to stay strong and healthy. Consult your doctor before starting any exercise program.
Eat a balanced diet Your doctor may advise you about your diet or whether you should take any dietary supplements (especially calcium and vitamin D).
2. What you need to know before taking FOSAMAX Weekly
Do not take FOSAMAX Weekly
- if you are allergic to alendronic acid or to any of the other ingredients of this medicine (listed in section 6)
- if you have certain throat problems (esophagus – the tube connecting your mouth to your stomach), such as narrowing or difficulty swallowing
- if you cannot remain upright (sitting or standing) for at least 30 minutes
- if your doctor has told you that you have low blood calcium levels
If you think any of these apply to you, do not take the tablets. Speak to your doctor first and follow their advice.
Warnings and precautions
Talk to your doctor or pharmacist before starting FOSAMAX Weekly if:
- you have kidney problems,
- you have or have recently had digestive problems or difficulty swallowing,
- your doctor has told you that you have Barrett’s esophagus (a condition associated with changes in the cells lining the lower part of the esophagus),
- you have been told you have problems absorbing minerals in your stomach or intestines (malabsorption syndrome),
- you have been told you have low blood calcium levels,
- you have poor dental hygiene, gum disease, an upcoming dental extraction, or do not receive regular dental care,
- you have cancer,
- you are receiving chemotherapy or radiotherapy,
- you are receiving treatment with angiogenesis inhibitors (such as bevacizumab or thalidomide) used in cancer treatment,
- you are taking corticosteroids (such as prednisone or dexamethasone) used to treat conditions like asthma, rheumatoid arthritis, and severe allergies,
- you are or have been a smoker (as this may increase the risk of dental problems).
You may be advised to have a dental examination before starting treatment with FOSAMAX Weekly.
It is important to maintain good oral hygiene while taking FOSAMAX Weekly. You should have regular dental check-ups during treatment and contact your doctor or dentist if you experience any problems in your mouth or teeth, such as tooth loss, pain, or swelling.
Irritation, inflammation, or ulceration of the throat (esophagus – the tube connecting your mouth to your stomach) may occur, often with symptoms such as chest pain, heartburn, or difficulty or pain when swallowing, especially if patients do not drink a full glass of water and/or lie down within 30 minutes after taking FOSAMAX Weekly. These adverse effects may worsen if patients continue taking FOSAMAX Weekly after developing these symptoms.
Children and adolescents
FOSAMAX Weekly must not be given to children or adolescents under 18 years of age.
Other medicines and FOSAMAX Weekly
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Calcium supplements, antacids, and other oral medications may interfere with the absorption of FOSAMAX Weekly if taken at the same time. Therefore, it is important to follow the advice given in section 3.
Certain medicines used for rheumatic conditions or long-term pain relief called NSAIDs (e.g. acetylsalicylic acid or ibuprofen) may cause gastrointestinal problems. Therefore, caution should be taken if these medicines are taken at the same time as FOSAMAX Weekly.
Taking FOSAMAX Weekly with food and drinks
Food and drinks (including mineral water) may make FOSAMAX Weekly less effective if taken at the same time. Therefore, it is important to follow the advice given in section 3.
Pregnancy and breastfeeding
FOSAMAX Weekly is intended for use only in postmenopausal women. Do not take FOSAMAX Weekly if you are pregnant, think you may be pregnant, or are breastfeeding.
Driving and using machines
Adverse effects have been reported with FOSAMAX Weekly (e.g. blurred vision, dizziness, and severe bone, muscle, or joint pain) that may affect your ability to drive or operate machinery (see section 4).
FOSAMAX Weekly contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
FOSAMAX Weekly contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; essentially “sodium-free”.
3. How to take FOSAMAX Weekly
Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Take one FOSAMAX Weekly tablet once a week.
Follow these instructions carefully.
- Choose the day of the week that best fits your routine. Each week, take one FOSAMAX Weekly tablet on the day you have chosen.
It is very important that you follow instructions 2, 3, 4, and 5 to ensure the FOSAMAX Weekly tablet reaches the stomach quickly and to help reduce the possibility of irritation of the oesophagus (the tube connecting the mouth to the stomach).
- After getting up in the morning and before taking your first meal, drink, or other medication, swallow the FOSAMAX Weekly tablet whole with a full glass of water (not mineral water) (no less than 200 ml), so that FOSAMAX Weekly is properly absorbed.
- Do not take it with mineral water (still or sparkling).
- Do not take it with coffee or tea.
- Do not take it with juices or milk.
Do not crush or chew the tablet, nor allow it to dissolve in your mouth, due to the risk of developing mouth ulcers.
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Do not lie down—remain upright (sitting, standing, or walking)—for at least 30 minutes after swallowing the tablet. Do not lie down until after your first meal of the day.
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Do not take FOSAMAX Weekly at bedtime or before getting up in the morning.
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If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking FOSAMAX Weekly and inform your doctor.
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After swallowing a FOSAMAX Weekly tablet, wait at least 30 minutes before taking your first meal, drink, or other medication of the day, including antacids, calcium supplements, and vitamins. FOSAMAX Weekly is only effective if taken on an empty stomach.
If you take more FOSAMAX Weekly than you should
If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately. Do not induce vomiting and do not lie down.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone (91) 562 04 20, indicating the medication and the amount ingested.
If you forget to take FOSAMAX Weekly
If you miss a dose, wait until the following morning to take FOSAMAX Weekly. Do not take two tablets on the same day. Then resume taking one tablet once a week on your originally chosen day.
If you stop taking FOSAMAX Weekly
It is important that you take FOSAMAX Weekly for as long as your doctor prescribes it. Since it is not known how long FOSAMAX Weekly should be taken, you should periodically discuss with your doctor the need to continue treatment to determine whether FOSAMAX Weekly is still appropriate for you.
An Instruction Card is included in the FOSAMAX Weekly package. It contains important information to help you remember how to take FOSAMAX Weekly correctly.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Contact your doctor immediately if you notice any of the following adverse effects, which may be serious and for which you may require urgent medical treatment:
Common (may affect up to 1 in 10 people):
- burning sensation; difficulty swallowing; pain when swallowing; ulceration in the throat (esophagus – the tube connecting your mouth to your stomach) which may cause chest pain, burning, or difficulty or pain when swallowing.
Rare (may affect up to 1 in 1,000 people):
- allergic reactions such as hives; swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing; severe skin reactions,
- pain in the mouth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or tooth loss. These may be signs of jaw bone damage (osteonecrosis), usually associated with delayed healing and infection, often following dental extraction. Inform your doctor and dentist if you experience these symptoms,
- atypical femur fractures (thigh bone) which may occur rarely, particularly in patients on long-term treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as these may be early symptoms indicating a possible femur fracture,
- severe bone, muscle, and/or joint pain.
Frequency not known (cannot be estimated from available data):
- atypical fractures in sites other than the femur (thigh bone).
Other adverse effects include
Very common (may affect more than 1 in 10 people):
- bone, muscle, and/or joint pain, sometimes severe.
Common (may affect up to 1 in 10 people):
- joint swelling,
- abdominal pain; stomach discomfort or belching after eating; constipation; sensation of fullness or bloating in the stomach; diarrhea; flatulence,
- hair loss; itching,
- headache; dizziness,
- fatigue; swelling of the hands or legs.
Uncommon (may affect up to 1 in 100 people):
- nausea; vomiting,
- irritation or inflammation of the throat (esophagus – the tube connecting your mouth to your stomach) or stomach,
- black or tar-like stools,
- blurred vision; eye pain or redness,
- skin rash; redness of the skin,
- transient flu-like symptoms such as muscle pain, general malaise, and sometimes fever, which usually occur at the beginning of treatment,
- altered taste.
Rare (may affect up to 1 in 1,000 people):
- symptoms of low blood calcium levels, including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth,
- stomach ulcers or peptic ulcers (sometimes severe or with bleeding),
- narrowing of the throat (esophagus – the tube connecting your mouth to your stomach),
- skin rash that worsens with sunlight,
- mouth ulcers.
Very rare (may affect up to 1 in 10,000 people):
- consult your doctor if you have ear pain, discharge from the ear, or an ear infection. These could be symptoms of damage to the ear bones.
Reporting of adverse effects: If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of FOSAMAX Weekly
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 expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of FOSAMAX Weekly
The active substance is alendronic acid. Each tablet contains 70 mg of alendronic acid (as the trihydrate sodium salt).
The other components are microcrystalline cellulose (E-460), anhydrous lactose (see section 2), sodium croscarmellose, and magnesium stearate (E-572).
Appearance of the product and contents of the pack
FOSAMAX Weekly is presented as oval, white tablets, marked with an outline of a bone image on one side and "31" on the other.
The tablets are supplied in aluminum blisters in cartons with the following pack sizes: 2, 4, 8, 12 or 40 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Organon Salud, S.L.
Paseo de la Castellana, 77
28046 Madrid
Spain
Tel.: 915911279
Manufacturer
Merck Sharp & Dohme BV
Waarderweg 39
2031 BN, Haarlem, The Netherlands
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
This medicinal product is authorized in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names:
Austria Fosamax einmal wöchentlich 70 mg Tabletten
Belgium Fosamax 70 mg Hebdomadaire, comprimés
Denmark Fosamax
France Fosamax 70 mg, comprimé
Germany FOSAMAX einmal wöchentlich 70 mg Tabletten
Greece FOSAMAX 70 mg Μια φορ? την εβδομ?δα
Iceland Fosamax vikutafla
Ireland Fosamax Once Weekly 70 mg Tablets
Italy FOSAMAX 70 mg compresse
Luxembourg Fosamax 70 mg Hebdomadaire, comprimés
The Netherlands Fosamax 70 mg één tablet per week
Norway Fosamax
Portugal Fosamax 70 mg
Spain FOSAMAX Semanal 70 mg comprimidos
United Kingdom (Northern Ireland) FOSAMAX Once Weekly 70 mg Tablets
Date of the latest revision of this leaflet: 11/2023.
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)