Label: Information for the User

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

Alendronic Acid/Colecalciferol (Vitamin D3)

Read this label carefully before taking this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.
• It is especially important that you understand the information included in section 3. How to take Alendronic Acid/Colecalciferol Weekly Bluefish, before taking this medicine.

What is Alendronate/Colecalciferol Weekly Bluefish?

Alendronate/Colecalciferol Weekly Bluefish is a tablet that contains two active ingredients, alendronate (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 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 occurs in very few 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 Alendronate/Colecalciferol Weekly Bluefish used for?

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

What is osteoporosis?

Osteoporosis is a condition characterized by the weakening 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 her risk of osteoporosis.

Initially, osteoporosis does not present any symptoms. However, if left untreated, it can cause bone fractures. Although these are usually painful, spinal fractures can go unnoticed until they cause a loss of height. Weakened bones can break during normal daily activities, such as standing up or minor injuries that would not normally break a healthy 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?

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

Quitting 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 Alendronate/Colecalciferol Weekly Bluefish

• if you are allergic to alendronate sodium trihydrate, colecalciferol, or any of the other components of this medication (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 remain standing or sitting upright for at least 30 minutes,
• if your doctor has told you that you have low levels of calcium 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 Alendronate/Colecalciferol 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 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), which are used in cancer treatment,
• 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 Alendronate/Colecalciferol Weekly Bluefish.

It is essential to maintain good oral hygiene while taking Alendronate/Colecalciferol Weekly Bluefish. 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.

There may be irritation, inflammation, or esophageal ulcers (esophagus - the tube that connects your mouth to your stomach), 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 of taking Alendronate/Colecalciferol Weekly Bluefish. These adverse effects may worsen if patients continue taking Alendronate/Colecalciferol Weekly Bluefish after developing these symptoms.

Girls and Adolescents

Alendronate/Colecalciferol Weekly Bluefish should not be administered to girls and adolescents under 18 years of age.

Use of Alendronate/Colecalciferol Weekly Bluefish with other Medications

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 Alendronate/Colecalciferol Weekly Bluefish if taken at the same time. Therefore, it is essential to follow the instructions given in section 3 (How to take Alendronate/Colecalciferol Weekly Bluefish) and wait at least 30 minutes before taking any other medication or supplement.

Certain medications for rheumatism or long-term pain called NSAIDs (e.g., aspirin or ibuprofen) may cause digestive problems. Therefore, caution should be exercised if taken at the same time as Alendronate/Colecalciferol Weekly Bluefish.

It is likely that certain medications or food additives will prevent the absorption of vitamin D from Alendronate/Colecalciferol Weekly Bluefish, including artificial fat substitutes, mineral oils, weight loss medication, orlistat, and cholesterol-lowering medications, colestiramine, and colestipol. Medications for epilepsy (seizures) (such as phenytoin or phenobarbital) may reduce the effectiveness of vitamin D.

Individually, it may be considered necessary to take additional vitamin D supplements.

Taking Alendronate/Colecalciferol Weekly Bluefish with Food and Drinks

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

Pregnancy and Breastfeeding

Alendronate/Colecalciferol Weekly Bluefish is only intended for use in postmenopausal women.

You should not take Alendronate/Colecalciferol Weekly Bluefish if you are or think you may be pregnant, or if you are breastfeeding.

Driving and Operating Machines

Adverse effects have been reported with Alendronate/Colecalciferol Weekly Bluefish (e.g., blurred vision, dizziness, and intense pain in bones, muscles, or joints) that may affect your ability to drive or operate machines. (See Possible Adverse Effects). If you experience any of these adverse effects, do not drive until you feel better.

Alendronate/Colecalciferol Weekly Bluefish contains Lactose and Sucrose

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

This medication may cause tooth decay.

Alendronate/Colecalciferol Weekly Bluefish 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 Bluefish Weekly Alendronate/Colecalciferol tabletonce a week.

Follow these instructions carefully.

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

It is very important to follow instructions 2), 3), 4) and 5) to help the Bluefish Weekly Alendronate/Colecalciferol 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 Bluefish Weekly Alendronate/Colecalciferol tablet with a full glass of water (not mineral water) (not less than 200 mL), so that Bluefish Weekly Alendronate/Colecalciferol 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 30 minutes after swallowing the tablet. Do not lie down until after the first meal of the day.

4) Do not take Bluefish Weekly Alendronate/Colecalciferol 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 Bluefish Weekly Alendronate/Colecalciferol and inform your doctor.

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

If you take more Bluefish Weekly Alendronate/Colecalciferol than 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, 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Bluefish Weekly Alendronate/Colecalciferol

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

If you interrupt treatment with Bluefish Weekly Alendronate/Colecalciferol

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

In the Bluefish Weekly Alendronate/Colecalciferol box, there is an Instruction Card. It contains important information to remind you how to take Bluefish Weekly Alendronate/Colecalciferol 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 immediately if 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 10 people):

• 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 1,000 people):

• 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. 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 symptoms and indicative of a possible femur fracture,
• intense bone, muscle, and/or joint pain.

Other side effects include

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

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

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

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

Rare (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 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 1,000 people):

• 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),
• narrowing of the esophagus (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 have ear pain, your ear is discharging, or you have an ear infection. These may be signs of damage to the bones of the ear.

Reporting 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/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 blister pack and the box 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.

Do not dispose of medications through drains or trash. Deposit empty containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Alendronate/Colecalciferol WeeklyBluefish

• The active ingredients are alendronate and colecalciferol (vitamin D3).

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

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

Appearance of the product and contents of the package

Alendronate/Colecalciferol Weekly Bluefish 70 mg/5,600 IU tablets are rectangular, white to off-white, biconvex, speckled, and engraved with 5,600 on one side, measuring 11.4 ± 0.2 mm in length and 7.2 ± 0.2 mm in width.

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

Only some package sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Bluefish Pharmaceuticals AB,

P.O. Box 49013,

100 28 Stockholm,

Sweden

Responsible Manufacturer

Pharmathen International S.A

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

Rodopi 69300,

Greece

and/or

Pharmathen S.A.

6, Dervenakionstreet

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 medication by contacting the local representative of the marketing authorization holder:

Bluefish Pharma S.L.U.,

AP 36007

2832094 Madrid, Sucursal 36

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:August 2022

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