Patient Information Leaflet

FOSAMAX Weekly 70 mg Tablets

alendronic acid

Read this leaflet carefully before you start taking this medicine. It contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you are unsure about anything, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they 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.

1.What is FOSAMAX Weekly and what is it used for

2.What you need to know before you start taking FOSAMAX Weekly

3.How to take FOSAMAX Weekly

4.Possible side effects

5.Storage of FOSAMAX Weekly

6.Contents of the pack and additional information

What is FOSAMAX Weekly?

FOSAMAX Weekly is a tablet that contains the active ingredient alendronic acid (commonly known as alendronate) and belongs to a group of non-hormonal medications called bisphosphonates. FOSAMAX Weekly prevents bone loss that occurs in women after menopause and helps to rebuild bone. FOSAMAX Weekly reduces the risk of fractures of the spine and hip.

What is FOSAMAX Weekly used for?

Your doctor has prescribed FOSAMAX Weekly to treat your osteoporosis. It reduces the risk of fractures of the spine and hip.

FOSAMAX Weekly is a weekly treatment.

What is osteoporosis?

Osteoporosis is a 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 to maintain a woman's healthy skeleton. As a result, bone loss occurs and the bones become weaker. The earlier a woman reaches menopause, the greater her risk of osteoporosis.

Usually, osteoporosis does not have symptoms for a long time. However, if left untreated, it can result in broken bones. Although these usually hurt, fractures of the bones of the spine can go unnoticed until they cause loss of height. Bones can break during normal daily activities, such as getting up or from minor injuries that would not normally break a normal bone. Fractures of bones usually occur in the hip, spine, or wrist and can cause not only pain but also significant problems such as a hunched posture (widow'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 your condition, such as:

Stopping smokingIt appears that smoking increases the rate at which you lose bone and, therefore, may increase your risk of broken bones.

ExerciseAs muscles, bones need exercise to stay strong and healthy. Consult your doctor before starting any exercise program.

Eating a balanced dietYour doctor may advise you on your diet or whether you should take any dietary supplements (especially calcium and vitamin D).

Do not take FOSAMAX Weekly

• if you are allergic to alendronic acid or any of the other ingredients in this medication (listed in section 6)
• if you have certain throat problems (esophagus - the tube that connects your mouth to your stomach), such as narrowing or difficulty swallowing
• if you cannot stay upright or seated for at least 30 minutes
• • if your doctor has told you that you have low blood calcium

If you think any of these cases apply to you, do not take the tablets. Talk to your doctor first and follow their advice.

Warnings and precautions

Consult your doctor or pharmacist before starting to take FOSAMAX Weekly if:

• you have, or have recently had, digestive problems or difficulty swallowing,
• your doctor has told you that you have Barrett's esophagus (a disease associated with changes in the cells that cover the lower part of the esophagus),
• you have been told that you have problems absorbing minerals in your stomach or intestines (malabsorption syndrome),
• you have been told that you have low blood calcium,
• you have poor dental hygiene, gum disease, a planned tooth extraction, or do not receive regular dental care,

• you have cancer,
• you are undergoing chemotherapy or radiation therapy,
• you are taking angiogenesis inhibitors (such as bevacizumab or thalidomide) used in cancer treatment,
• you are taking corticosteroids (such as prednisone or dexamethasone) used in the treatment of diseases such as 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 check-up before starting treatment with FOSAMAX Weekly.

It is essential to maintain good oral hygiene while taking FOSAMAX Weekly. You should have regular dental check-ups during your treatment and contact your doctor or dentist if you experience any problems in your mouth or teeth, such as tooth loss, pain, or inflammation.

Irritation, inflammation, or esophageal ulceration (esophagus - the tube that connects your mouth to your stomach) may occur, often with symptoms of chest pain, burning, difficulty, or pain swallowing, especially if patients do not drink a full glass of water and/or if they 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 should not be administered to children or adolescents under 18 years of age.

Other medications and FOSAMAX Weekly Weekly

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

It is likely that calcium supplements, antacids, and other oral medications will interfere with the absorption of FOSAMAX Weekly if taken at the same time. Therefore, it is essential to follow the advice given in section 3.

Certain medications for rheumatism or long-term pain called NSAIDs (such as aspirin or ibuprofen) may cause digestive problems. Therefore, caution should be exercised if these medications are taken at the same time as FOSAMAX Weekly.

Taking FOSAMAX Weekly with food and drinks

It is likely that food and drinks (including mineral water) will make FOSAMAX Weekly less effective if taken at the same time. Therefore, it is essential to follow the advice given in section 3.

Pregnancy and breastfeeding

FOSAMAX Weekly is only intended for use in postmenopausal women. Do not take FOSAMAX Weekly if you are pregnant or think you may be pregnant, or during breastfeeding.

Driving and operating machinery

Adverse effects with FOSAMAX Weekly (such as blurred vision, dizziness, and intense bone, muscle, or joint pain) may affect your ability to drive or operate machinery (see section 4).

FOSAMAX Weekly contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

FOSAMAX Weekly contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free."

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Take one FOSAMAX Weekly tabletonce a week.

Follow these instructions carefully.

1)Choose the day of the week that best suits your routine. Every week, take one FOSAMAX Weekly tablet on the day you have chosen.

It is very important to follow instructions 2, 3, 4, and 5 to help the FOSAMAX Weekly tablet reach the stomach quickly and reduce the possible irritation of the esophagus (the tube that connects the mouth with the stomach).

2)After getting up in the morning and before taking the first meal, drink, or other medication, swallow the entire FOSAMAX Weekly tablet with a full glass of water (not mineral water)(not less than 200ml), so that FOSAMAX Weekly is absorbed properly.

• do not take it with mineral water (with or without gas).
• do not take it with coffee or tea.
• do not take it with juices or milk.

Do not crush or chew the tablet or allow it to dissolve in your mouth, due to the possibility of the appearance of ulcers in the mouth.

3)Do not lie down - remain upright (sitting, standing, or walking) - for at least 30minutes after swallowing the tablet. Do not lie down until after the first meal of the day.

4)Do not take FOSAMAX Weekly at bedtime or before getting up in the morning.

5)If you have difficulty or pain swallowing, chest pain, or new or worsening heartburn, stop taking FOSAMAX Weekly and inform your doctor.

6)After swallowing a FOSAMAX Weekly tablet, wait at least 30minutes before consuming the 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 moreFOSAMAX Weeklythan you should

If you accidentally take too many tablets, drink a full glass of milk and go to your doctor immediately. Do not induce vomiting and do not lie down.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone (91)5620420, indicating the medication and the amount ingested.

If you forgot to takeFOSAMAX Weekly

If you forget a dose, wait until the next morning to take FOSAMAX Weekly.Do not take two tablets on the same day.Then, take one tablet once a week, on the originally chosen day.

If you interrupt the treatment with FOSAMAX Weekly

It is essential to take FOSAMAX Weekly for as long as your doctor prescribes the medication. Since it is unknown how long you should take FOSAMAX Weekly, you should discuss periodically with your doctor the need to continue treatment with this medication to determine if FOSAMAX Weekly is still suitable for you.

The FOSAMAX Weekly box includes a Instructions Card. It contains important information to remind you how to take FOSAMAX Weekly correctly.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Seek medical attention immediatelyif you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment:

Frequent (may affect up to 1 in 10people):

• burning sensation; difficulty swallowing; pain when swallowing; esophageal ulcer (the tube that connects your mouth to your stomach) that may cause chest pain, burning, or difficulty or pain when swallowing.

Rare (may affect up to 1 in 1,000people):

• allergic reactions such as urticaria; swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing; severe skin reactions,
• mouth and/or jaw pain, 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 after a dental extraction. Inform your doctor and dentist if you experience these symptoms,
• atypical femur fractures that may occur in rare cases, especially in patients undergoing prolonged treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as they may be early signs and indicative of a possible femur fracture,
• intense bone, muscle, and/or joint pain.

Frequency not known (cannot be estimated from available data):

• atypical fractures in locations other than the femur (thigh bone).

Other side effects include

Very frequent(may affect more than 1 in 10people):

• intense pain in bones, muscles, and/or joints.

Frequent(may affect up to 1 in 10people):

• swelling of the joints,
• abdominal pain; uncomfortable sensation in the stomach or belching after eating; constipation; feeling of fullness or bloating in the stomach; diarrhea; flatulence,
• hair loss; itching,
• headache; dizziness,
• fatigue; swelling of the hands or legs.

Infrequent(may affect up to 1 in 100people):

• nausea; vomiting,
• irritation or inflammation of the throat (esophagus - the tube that connects your mouth to your stomach) or stomach,
• black stools or similar to tar,
• blurred vision; eye pain or redness,
• skin rash; skin redness,
• transient symptoms similar to the flu, such as muscle pain, general feeling of discomfort, and, sometimes, fever that, in general, appear at the beginning of treatment,
• alteration of taste.

Rare(may affect up to 1 in 1,000people):

• symptoms of low calcium levels in the blood, including muscle cramps or spasms and/or tingling in the fingers or around the mouth,
• stomach ulcers or peptic ulcers (sometimes severe or with bleeding),
• esophageal stricture (the tube that connects your mouth to your stomach),
• skin rash that worsens with sunlight,
• mouth ulcers.

Very rare (may affect up to 1 in 10,000people):

• see your doctor if you have ear pain, the ear is draining, or you have an ear infection. These may be signs of damage to the bones in the ear.

Reporting of side effects:
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the blister after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of FOSAMAXWeekly

The active ingredient is alendronic acid. Each tablet contains 70mg of alendronic acid (as sodium trihydrate salt).

The other components are microcrystalline cellulose (E-460), anhydrous lactose (see section2), sodium croscarmellose and magnesium stearate (E-572).

Appearance of the product and contents of the package

FOSAMAX Weekly is presented in the form of oval-shaped tablets, white, marked with a bone outline on one side and “31” on the other.

The tablets are supplied in aluminum blisters in boxes in the following package sizes: 2, 4, 8, 12 or 40tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Organon Health, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Phone: 915911279

Responsible manufacturer

Merck Sharp & Dohme BV

Waarderweg 39

2031 BN, Haarlem, Netherlands

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

This medicine is authorized in the member states of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

AustriaFosamax einmal wöchentlich 70mg Tabletten

BelgiumFosamax 70mg Hebdomadaire, comprimés

DenmarkFosamax

FranceFosamax 70mg, comprimé

GermanyFOSAMAX einmal wöchentlich 70mg Tabletten

GreeceFOSAMAX 70mgΜιαφορ?τηνεβδομ?δα

IcelandFosamax vikutafla

IrelandFosamax Once Weekly 70mg Tablets

ItalyFOSAMAX70mgcompresse

LuxembourgFosamax 70mg Hebdomadaire, comprimés

NetherlandsFosamax 70mg één tablet per week

NorwayFosamax

PortugalFosamax 70mg

SpainFOSAMAX Semanal 70mgcomprimidos

United Kingdom(Northern Ireland)FOSAMAX Once Weekly 70mg Tablets

Last review date of this leaflet:11/2023.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)