FOSAMAX WEEKLY 70 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

FOSAMAX Weekly 70mg tablets

alendronic acid

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• It is especially important that you understand the information in section 3 before you take this medicine.

Contents of the pack

1. What FOSAMAX Weekly is and what it is used for
2. What you need to know before you take FOSAMAX Weekly
3. How to take FOSAMAX Weekly
4. Possible side effects
5. Storing FOSAMAX Weekly
6. 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 that contains the active substance alendronic acid (commonly called alendronate) and belongs to a group of non-hormonal medicines called bisphosphonates. FOSAMAX Weekly prevents bone loss in women after menopause and helps to 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 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 keep a woman's skeleton healthy. As a result, bone loss occurs and the bones become weaker. The earlier a woman reaches menopause, the greater her risk of osteoporosis.

For a long time, osteoporosis usually has no symptoms. However, if left untreated, it can result in broken bones. Although these usually hurt, spine fractures can go unnoticed until they cause a loss of height. Bones can break during normal daily activity, such as when getting up or from minor injuries that would not normally break a bone. Fractures usually occur in the hip, spine, or wrist and can cause not only pain but also serious problems such as a stooped back (dowager's hump) and loss of mobility.

How can osteoporosis be treated?

As well as your treatment with FOSAMAX Weekly, your doctor may suggest that you make changes to your lifestyle to help your condition, such as:

Stopping smokingSmoking appears to increase the rate at which you lose bone and may therefore increase your risk of broken bones.

ExerciseLike 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 food supplements (especially calcium and vitamin D).

2. What you need to know before you take FOSAMAX Weekly

Do not take FOSAMAX Weekly

• if you are allergic to alendronic acid or any of the other ingredients of this medicine (listed in section 6)
• if you have certain problems with your gullet (esophagus - the tube that connects your mouth to your stomach), such as narrowing or difficulty swallowing
• if you cannot stand or sit up 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. Talk to your doctor first and follow their advice.

Warnings and precautions

Talk to your doctor or pharmacist before taking FOSAMAX Weekly if:

• you have kidney problems

• you have, or have had, problems with your food pipe (esophagus) or stomach, such as ulcers

• your doctor has told you that you have a condition called Barrett's esophagus (a condition associated with changes in the cells that line 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 levels
• you have poor dental health, gum disease, a planned dental extraction, or do not receive regular dental care

• you have cancer
• you are undergoing chemotherapy or radiotherapy
• you are taking treatments that inhibit blood vessel formation (such as bevacizumab or thalidomide) used in the treatment of cancer
• you are taking corticosteroids (such as prednisone or dexamethasone) used to treat 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 important to maintain good oral hygiene when taking FOSAMAX Weekly. You should have regular dental check-ups throughout your treatment and should contact your doctor or dentist if you experience any problems with your mouth or teeth, such as loose teeth, pain, or swelling.

Irritation, inflammation, or ulceration of the gullet (esophagus - the tube that connects your mouth to your stomach) may occur, often with symptoms of chest pain, burning, difficulty or pain when swallowing, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking FOSAMAX Weekly. These side effects may worsen if patients continue taking FOSAMAX Weekly after developing these symptoms.

Children and adolescents

FOSAMAX Weekly should not be given to children and 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 take any other medicines.

Calcium supplements, antacids, and other oral medicines may interfere with the absorption of FOSAMAX Weekly if taken at the same time. Therefore, it is important that you follow the advice given in section 3.

Certain medicines for rheumatism or long-term pain, called NSAIDs (such as aspirin or ibuprofen), may cause stomach problems. Therefore, caution should be exercised 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 that you 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 if you are breastfeeding.

Driving and using machines

Side effects with FOSAMAX Weekly (such as blurred vision, dizziness, and severe bone, muscle, or joint pain) have been reported that may affect your ability to drive or use machines (see section 4).

FOSAMAX Weekly contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

FOSAMAX Weekly contains sodium

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

3. How to take FOSAMAX Weekly

Follow the instructions for administration of this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist again.

Take one FOSAMAX Weekly tablet once a week.

Follow these instructions carefully.

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

1. After getting up in the morning and before taking your first food, drink, or other medicine, swallow your FOSAMAX Weekly tablet whole with a full glass of water (not less than 200 ml), to help your body absorb the medicine.
   • do not take it with mineral water (fizzy or still)
   • do not take it with coffee or tea
   • do not take it with juice or milk

Do not chew or suck the tablet or allow it to dissolve in your mouth because of the risk of mouth ulcers.

1. Do not lie down - stay upright (sitting, standing, or walking) - for at least 30 minutes after swallowing the tablet. Do not lie down until after your first food of the day.

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

1. If you have difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking FOSAMAX Weekly and contact your doctor.

1. After swallowing a FOSAMAX Weekly tablet, wait at least 30 minutes before eating or drinking anything or taking any other medicine, 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 have taken too many tablets by mistake, drink a full glass of milk and contact your doctor immediately. Do not try to vomit or lie down.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone (91) 562 04 20, stating the medicine and the amount taken.

If you forget to take FOSAMAX Weekly

If you miss a dose, wait until the next morning to take FOSAMAX Weekly. Do not take two tablets on the same day.Then return to taking one tablet once a week on the 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 you should take FOSAMAX Weekly, you should discuss with your doctor whether you should continue treatment with this medicine to determine if FOSAMAX Weekly is still right for you.

A Patient Information Card is included in the pack with FOSAMAX Weekly. It contains important information to remind you how to take FOSAMAX Weekly correctly.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

See your doctor immediatelyif you notice any of the following serious side effects, for which you may need urgent medical treatment:

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

• heartburn; difficulty swallowing; pain when swallowing; ulcers in the gullet (esophagus - the tube that connects your mouth to your stomach) that can cause chest pain, heartburn, 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 loss of a tooth. These may be signs of damage to the bone in the jaw (osteonecrosis) usually associated with delayed healing and infection, often after a tooth extraction. Tell your doctor and dentist if you experience these symptoms
• atypical fractures of the thigh bone (femur) that can occur rarely, especially in patients on long-term treatment for osteoporosis. Tell your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin, as these may be early signs of a possible fracture of the thigh bone
• severe pain in bones, muscles, and/or joints

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

• atypical fracture in locations of the bone other than the thigh bone (femur)

Other side effects include

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

• pain in bones, muscles, and/or joints, sometimes severe

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

• swelling of the joints
• abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; feeling of fullness or bloating; diarrhea; gas
• hair loss; itching
• headache; dizziness
• fatigue; swelling of the hands or feet

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

• nausea; vomiting
• irritation or inflammation of the gullet (esophagus - the tube that connects your mouth to your stomach) or stomach
• black or tar-like stools
• blurred vision; eye pain or redness
• skin rash; redness of the skin
• symptoms similar to flu, such as muscle pain, general feeling of being unwell, and sometimes fever, which usually occur at the start of treatment
• change in 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 or duodenal ulcers (sometimes severe or with bleeding)
• narrowing of the gullet (esophagus - the tube that connects your mouth to your stomach)
• skin rash that gets worse when exposed to 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 bones of the ear.

Reporting of side effects:If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 is the last day of the month stated.

No special storage conditions are required.

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 protect the environment.

6. Container Content and Additional Information

FOSAMAX CompositionWeekly

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

The other ingredients are microcrystalline cellulose (E-460), anhydrous lactose (see section 2), sodium croscarmellose, and magnesium stearate (E-572).

Product Appearance and Container Content

FOSAMAX Weekly is presented in the form of oval, white tablets, marked with a bone image 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 40 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Organon Health, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer

Merck Sharp & Dohme BV

Waarderweg 39

2031 BN, Haarlem, Netherlands

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

This medicinal product is authorized in the Member States of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

Austria Fosamax einmal wöchentlich 70 mg Tablets

Belgium Fosamax 70 mg Hebdomadaire, comprimés

Denmark Fosamax

France Fosamax 70 mg, comprimé

Germany FOSAMAX einmal wöchentlich 70 mg Tablets

Greece FOSAMAX 70 mg Μια φορά την εβδομάδα

Iceland Fosamax vikutafla

Ireland Fosamax Once Weekly 70 mg Tablets

Italy FOSAMAX 70 mg compresse

Luxembourg Fosamax 70 mg Hebdomadaire, comprimés

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 last revision of this leaflet:11/2023.

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)