ALENDRONIC ACID/CHOLECALCIFEROL WEEKLY BLUEFISH 70 mg/5,600 IU TABLETS

Introduction

Package Leaflet: Information for the User

Alendronic Acid/Cholecalciferol Weekly Bluefish 70 mg/5,600 IU Tablets EFG

Alendronic acid / cholecalciferol (vitamin D3)

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. How to take Alendronic Acid/Cholecalciferol Weekly Bluefish, before you take this medicine.

Contents of the pack

1. What is Alendronic Acid/Cholecalciferol Weekly Bluefish and what is it used for
2. What you need to know before you take Alendronic Acid/Cholecalciferol Weekly Bluefish
3. How to take Alendronic Acid/Cholecalciferol Weekly Bluefish
4. Possible side effects
5. Storing Alendronic Acid/Cholecalciferol Weekly Bluefish
6. Contents of the pack and other information

1. What is Alendronic Acid/Cholecalciferol Weekly Bluefish and what is it used for

What isAlendronic Acid/Cholecalciferol Weekly Bluefish?

Alendronic Acid/Cholecalciferol Weekly Bluefish is a tablet that contains two active substances, alendronic acid (commonly called alendronate) and cholecalciferol, known as vitamin D3.

What is alendronate?

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

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 properly from food if it contains sufficient vitamin D, which occurs with very few foods. The main source of vitamin D is production in the skin, through exposure to sunlight. As we age, our skin produces less vitamin D. Vitamin D deficiency 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 Alendronic Acid/Cholecalciferol Weekly Bluefish used for?

Your doctor has prescribed Alendronic Acid/Cholecalciferol Weekly Bluefish to treat your osteoporosis and because you are at risk of having a vitamin D deficiency. Alendronic Acid/Cholecalciferol Weekly Bluefish reduces the risk of vertebral and hip fractures in women, after menopause.

What is osteoporosis?

Osteoporosis is a wasting and fragility of bones. It is common in women after menopause. During 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 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, vertebral fractures can go unnoticed until they cause loss of height. Weakened bones can break during normal daily activity, such as when getting up or from minor injuries that would not normally break a normal bone. Bone fractures usually occur in the hip, spine, or wrist, and can cause not only pain but also significant problems such as a hunched posture (dowager's hump) and loss of mobility.

How can osteoporosis be treated?

In addition to your treatment with Alendronic Acid/Cholecalciferol Weekly Bluefish, your doctor may suggest that you make lifestyle changes to help slow down your disease, such as:

Quit smokingSmoking seems 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.

Eat a balanced dietYour doctor may advise you on your diet or whether you should take any dietary supplements.

2. What you need to know before you take Alendronic Acid/Cholecalciferol Weekly Bluefish

Do not take Alendronic Acid/Cholecalciferol Weekly Bluefish

• if you are allergic to alendronate sodium trihydrate, cholecalciferol, or any of the other ingredients of this medicine (listed in section 6),
• 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 stand or sit upright for at least 30 minutes,
• 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 before taking this medicine and follow their advice.

Warnings and precautions

Consult your doctor or pharmacist before taking Alendronic Acid/Cholecalciferol Weekly Bluefish 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 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 poor dental hygiene, gum disease, a planned dental extraction, or do not receive regular dental care,
• you have cancer,
• you are undergoing chemotherapy or radiotherapy,
• you are undergoing treatment with angiogenesis inhibitors (such as bevacizumab or talidomide), which are used in the treatment of cancer,
• you are taking corticosteroids (such as prednisone or dexamethasone), which are used to treat conditions 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 Alendronic Acid/Cholecalciferol Weekly Bluefish.

It is important to maintain good oral hygiene when taking Alendronic Acid/Cholecalciferol Weekly Bluefish. You should have regular dental check-ups during your treatment and should 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 ulcers of the throat (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 before 30 minutes after taking Alendronic Acid/Cholecalciferol Weekly Bluefish. These adverse effects may worsen if patients continue taking Alendronic Acid/Cholecalciferol Weekly Bluefish after developing these symptoms.

Girls and adolescents

Alendronic Acid/Cholecalciferol Weekly Bluefish should not be given to girls and adolescents under 18 years of age.

Using Alendronic Acid/Cholecalciferol Weekly Bluefish with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of Alendronic Acid/Cholecalciferol Weekly Bluefish if taken at the same time. Therefore, it is important that you follow the instructions given in section 3 (How to take Alendronic Acid/Cholecalciferol Weekly Bluefish) and wait at least 30 minutes before taking any other medicine or supplement.

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

It is likely that certain medicines or food additives will prevent the absorption of vitamin D from Alendronic Acid/Cholecalciferol Weekly Bluefish, including artificial fat substitutes, mineral oils, weight loss medication, orlistat, and cholesterol-lowering medicines, cholestyramine, and colestipol. Medicines for epilepsy (seizures) (such as phenytoin or phenobarbital) may decrease the effectiveness of vitamin D.

Individually, the need for additional vitamin D supplements may be considered.

Taking Alendronic Acid/Cholecalciferol Weekly Bluefish with food and drinks

It is likely that food and drinks (including mineral water) will reduce the effectiveness of Alendronic Acid/Cholecalciferol Weekly Bluefish if taken at the same time. Therefore, it is important that you follow the advice given in section 3 (How to take Alendronic Acid/Cholecalciferol Weekly Bluefish). You should wait at least 30 minutes before taking any food and drinks except water.

Pregnancy and breastfeeding

Alendronic Acid/Cholecalciferol Weekly Bluefish is only intended for use in postmenopausal women.

Do not take Alendronic Acid/Cholecalciferol Weekly Bluefish if you are or think you may be pregnant, or if you are breastfeeding.

Driving and using machines

Adverse effects have been reported with Alendronic Acid/Cholecalciferol Weekly Bluefish (such as blurred vision, dizziness, and severe bone, muscle, or joint pain) that may affect your ability to drive or use machines. (See Possible side effects). If you experience any of these adverse effects, do not drive until you feel better.

Alendronic Acid/Cholecalciferol Weekly Bluefish

This medicine contains lactose and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

It may cause cavities.

Alendronic Acid/Cholecalciferol Weekly Bluefish contains sodium

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

3. How to take Alendronic Acid/Cholecalciferol Weekly Bluefish

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

Take one Alendronic Acid/Cholecalciferol Weekly Bluefish tablet once a week.

Follow these instructions carefully.

1. Choose the day of the week that best suits your routine. Each week, take one Alendronic Acid/Cholecalciferol Weekly Bluefish tablet on the day you have chosen.

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

1. After getting up in the morning and before taking any food, drink, or other medicine, swallow the Alendronic Acid/Cholecalciferol Weekly Bluefish tablet whole with a full glass of water (not mineral water) (at least 200 mL), so that Alendronic Acid/Cholecalciferol Weekly Bluefish 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 ulcers in the mouth.

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 the first meal of the day.

1. Do not take Alendronic Acid/Cholecalciferol Weekly Bluefish 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 Alendronic Acid/Cholecalciferol Weekly Bluefish and inform your doctor.

1. After swallowing an Alendronic Acid/Cholecalciferol Weekly Bluefish tablet, wait at least 30 minutes before taking the first food, drink, or other medicine of the day, including antacids, calcium supplements, and vitamins. Alendronic Acid/Cholecalciferol Weekly Bluefish is only effective if taken on an empty stomach.

If you take more Alendronic Acid/Cholecalciferol Weekly Bluefish than you should

If you take too many tablets by mistake, drink a glass of milk and go to the 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 Toxicology Information Service, 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Alendronic Acid/Cholecalciferol Weekly Bluefish

If you forget a dose, take a single tablet the next morning you remember. Do not take two tablets on the same day. Then, take one tablet once a week, on the original day you chose.

If you stop taking Alendronic Acid/Cholecalciferol Weekly Bluefish

It is important that you take Alendronic Acid/Cholecalciferol Weekly Bluefish while your doctor prescribes the medicine. As it is not known how long you should take Alendronic Acid/Cholecalciferol Weekly Bluefish, you should discuss with your doctor periodically the need to continue treatment with this medicine to determine if Alendronic Acid/Cholecalciferol Weekly Bluefish is still suitable for you.

A Instructions Card is included in the Alendronic Acid/Cholecalciferol Weekly Bluefish box. It contains important information to remind you how to take Alendronic Acid/Cholecalciferol Weekly Bluefish correctly.

If you have any other 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 all people suffer from them.

Consult your doctor immediately if you experience any of the following adverse effects, which may be serious, and for which you may need urgent medical treatment:

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

• burning; difficulty swallowing; pain when swallowing; ulcer in the throat (esophagus - the tube that connects your mouth to your stomach) that can 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 can 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 can be signs of damage to the bone in the jaw (osteonecrosis) usually associated with delayed healing and infection, often after a dental extraction. Contact your doctor and dentist if you experience these symptoms,
• atypical fractures of the femur (thigh bone) that can occur rarely, 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 these can be early and indicative symptoms of a possible femur fracture,
• severe bone, muscle, and/or joint pain.

Other adverse effects include

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

• bone, muscle, and/or joint pain, which may be severe.

Frequent (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; flatulence,
• 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 throat (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; skin redness,
• transient symptoms, similar to those of the flu, such as muscle pain, general feeling of discomfort, and sometimes fever, which usually appear at the beginning of treatment,
• taste disturbance.

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

• symptoms of low calcium levels in the blood, 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 that connects 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 experience ear pain, ear discharge, or ear infection. These could be symptoms of damage to the bones of the ear.

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 that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Alendronic Acid/Cholecalciferol Weekly Bluefish

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

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

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Alendronic Acid/Cholecalciferol Weekly Bluefish

• The active ingredients are alendronic acid and cholecalciferol (vitamin D3).

Each tablet contains 70 mg of alendronic acid as alendronate sodium trihydrate and 140 micrograms (5,600 IU) of cholecalciferol (vitamin D3).

• The other ingredients are microcrystalline cellulose, lactose, sodium croscarmellose, magnesium stearate, refined sunflower oil, butylhydroxytoluene (BHT)-E321, gelatin, sucrose, corn starch, and aluminum and magnesium silicate.

Appearance of the Product and Package Contents

The Alendronic Acid/Cholecalciferol Weekly Bluefish 70 mg/5,600 IU tablets are rectangular, white to off-white, biconvex, speckled, engraved with 5,600 on one side, 11.4 ± 0.2 mm long, and 7.2 ± 0.2 mm wide.

The tablets are supplied in aluminum/aluminum (PA/AL/PVC-Aluminum) blisters in a carton box in the following package sizes: 4 and 12 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bluefish Pharmaceuticals AB,

P.O. Box 49013,

100 28 Stockholm,

Sweden

Manufacturer

Pharmathen International S.A.

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

Rodopi 69300,

Greece

and/or

Pharmathen S.A.

6, Dervenakion street

Pallini 15351

Attiki,

Greece

and/or

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

Sachsen-Anhalt

39179 Barleben

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Bluefish Pharma S.L.U.,

AP 36007

2832094 Madrid, Branch 36

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet:August 2022

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