Product Information for the User

FOSAVANCE 70mg/2.800UI tablets

FOSAVANCE 70mg/5.600UI tablets

alendronate acid/colecalciferol

Read this entire product information carefully before starting to take this medication, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section4.
• It is especially important that you understand the information included in section3 before taking this medication.

1.What is FOSAVANCE and for what it is used

2.What you need to know before starting to take FOSAVANCE

3.How to take FOSAVANCE

4.Possible adverse effects

5.Storage of FOSAVANCE

6.Contents of the package and additional information

What is FOSAVANCE?

FOSAVANCE is a tablet that contains two active ingredients, alendronic acid (commonly known as alendronate) and colecalciferol, also known as vitamin D3.

What is alendronate?

Alendronate belongs to a group of non-hormonal medications called bisphosphonates. Alendronate prevents bone loss that occurs in women after they enter menopause, and helps to rebuild bone. It reduces the risk of fractures of the spine and hip.

What is vitamin D?

Vitamin D is an essential nutrient, necessary for the absorption of calcium and to maintain healthy bones. The body can only absorb calcium correctly from food if it contains sufficient vitamin D, which is rare in many foods. The main source of vitamin D is the production in the skin, through exposure to sunlight. As we age, our skin produces less vitamin D. A deficiency in vitamin D can lead to bone loss and osteoporosis, and in severe cases can cause muscle weakness that can result in falls and increase the risk of fractures.

What is FOSAVANCE used for?

Your doctor has prescribed FOSAVANCE to treat your osteoporosis and because you are at risk of having a vitamin D deficiency. It reduces the risk of fractures of the spine and hip in women after menopause.

What is osteoporosis?

Osteoporosis causes wear and tear and fragility of the bones. It is common in women after menopause. In menopause, the ovaries stop producing a type of female hormone, estrogen, which helps to maintain a healthy skeleton. As a result, bone loss occurs and the bones become more fragile. The earlier a woman reaches menopause, the greater the risk of osteoporosis.

Initially, osteoporosis does not present symptoms. However, if left untreated, it can cause bone fractures. Although these are usually painful, spinal fractures can go unnoticed until they cause loss of height. Weakened bones can break during normal daily activity, such as standing up or minor injuries that would not normally break a normal bone. Bone fractures typically occur in the hip, spine, or wrist, and can cause not only pain but also significant problems such as a hunched back (widow's hump) and loss of mobility.

How can osteoporosis be treated?

Along with your treatment with FOSAVANCE, your doctor may suggest that you make lifestyle changes to help slow down your disease, such as:

Stopping smokingSmoking appears to increase the rate of bone loss and, therefore, may increase your risk of bone fractures.

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 dietary supplements.

Do not take FOSAVANCE

• if you are allergic to alendronate acid, colecalciferol, or any of the other components of this medication (listed in section6),
• if you have certain problems in your throat (esophagus - the tube that connects your mouth to your stomach), such as narrowing or difficulty swallowing,
• if you cannot remain standing or sitting upright for at least 30minutes,
• if your doctor has told you that you have low calcium levels in your blood.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take FOSAVANCE if:

• you have kidney problems,
• you have, or have recently had, swallowing or digestive problems,
• 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 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 FOSAVANCE.

It is essential to maintain good oral hygiene while taking FOSAVANCE. 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 ulcer (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 30minutes of taking FOSAVANCE. These adverse effects may worsen if patients continue taking FOSAVANCE after developing these symptoms.

Girls and adolescents

FOSAVANCE should not be administered to girls and adolescents under 18years of age.

Other medications and FOSAVANCE

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

It is likely that calcium supplements, antacids, and some oral medications will interfere with the absorption of FOSAVANCE if taken at the same time. Therefore, it is essential to follow the instructions given in section3 and wait at least 30minutes before taking any other medication or supplement.

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 taken at the same time as FOSAVANCE.

It is likely that certain medications or food additives will prevent the absorption of vitamin D from FOSAVANCE, including artificial fat substitutes, mineral oils, weight loss medication, orlistat, and cholesterol-lowering medications, colestiramine, and colestipol. Epilepsy medications (such as phenytoin or phenobarbital) may reduce the effectiveness of vitamin D. Individually, the need for additional vitamin D supplements may be considered.

Taking FOSAVANCE with food and drinks

It is likely that food and drinks (including mineral water) will reduce the effectiveness ofFOSAVANCE if taken at the same time. Therefore, it is essential to follow the advice given in section3. You should wait at least 30minutes before taking any food and drinks except water.

Pregnancy and breastfeeding

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

Driving and operating machinery

Adverse effects with FOSAVANCE (such as blurred vision, dizziness, and intense bone, muscle, or joint pain) may affect your ability to drive or operate machinery (see section4). If you experience any of these adverse effects, do not drive until you feel better.

FOSAVANCE contains lactose and sucrose.

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

FOSAVANCE contains sodium.

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

Follow exactly the administration instructions for FOSAVANCE indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Take one FOSAVANCE tabletonce a week.

Follow these instructions carefully.

1)Choose the day of the week that best fits your routine. Take one FOSAVANCE tablet every week on the day you have chosen.

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

2)After getting up in the morning and before taking any food, drink or other medication, swallow the entire FOSAVANCE tablet with a full glass of water (not mineral water) (not less than 200ml), so that FOSAVANCE 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 juice or milk.

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

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 FOSAVANCE 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 FOSAVANCE and inform your doctor.

6)After swallowing a FOSAVANCE tablet, wait at least 30minutes before taking the first meal, drink or other medication of the day, including antacids, calcium supplements and vitamins. FOSAVANCE is only effective if taken on an empty stomach.

If you take more FOSAVANCE than you should

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

If you forget to take FOSAVANCE

If you forget a dose, take a single tablet the next morning after remembering. Do not take two tablets on the same day.Then, take a tablet once a week, on the originally chosen day.

If you interrupt treatment with FOSAVANCE

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

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

Consult your doctor immediatelyif you experience 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 pain, 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. Contact 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 unknown (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 stools resembling 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):

• consult your doctor if you have ear pain, the ear is discharging, 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 thenational reporting system included in theAppendix V. 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.

Store in the original blister to protect it from moisture and light.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need.This will help protect the environment.

Composition of FOSAVANCE

The active principles are alendronic acid and colecalciferol (vitamin D3).Each FOSAVANCE 70mg/2.800UI tablet contains 70mg of alendronic acid (as sodium trihydrate salt) and 70micrograms (2.800UI) of colecalciferol (vitamin D3).Each FOSAVANCE 70mg/5.600UI tablet contains 70mg of alendronic acid (as sodium trihydrate salt) and 140micrograms (5.600UI) of colecalciferol (vitamin D3).

The other components are microcrystalline cellulose (E-460), anhydrous lactose (see section2), medium-chain triglycerides, gelatin, sodium croscarmellose, sucrose (see section2),colloidal silicon dioxide, magnesium stearate(E-572), butylhydroxytoluene(E-321), modified maize starch and aluminium sodium silicate(E-554).

Appearance of the product and contents of the pack

FOSAVANCE 70mg/2.800UI tablets have a white to off-white colour, modified capsule shape, and are marked with a silhouette of a bone on one side and “710” on the other.FOSAVANCE 70mg/2.800UI tablets are available in packs containing 2, 4, 6 or 12tablets.

FOSAVANCE 70mg/5.600UI tablets have a white to off-white colour, modified rectangular shape, and are marked with a silhouette of a bone on one side and “270” on the other.FOSAVANCE 70mg/5.600UI tablets are available in packs containing 2, 4 or 12tablets.

Only some pack sizes may be marketed.

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

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Further information is available on the website of the European Medicines Agency:https://www.ema.europa.eu.