Alendronic acid/colecalciferol Semanal Bluefish 70 mg/2,800 IU tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alendronic acid/colecalciferol Weekly Bluefish 70 mg/2,800 IU tablets EFG

alendronic acid / colecalciferol (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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• It is especially important that you understand the information contained in section 3, How to take Alendronic acid/colecalciferol Weekly Bluefish, before taking this medicine.

Contents of this leaflet

1. What Alendronic acid/colecalciferol Weekly Bluefish is and what it is used for
2. What you need to know before you take Alendronic acid/colecalciferol Weekly Bluefish
3. How to take Alendronic acid/colecalciferol Weekly Bluefish
4. Possible side effects
5. How to store Alendronic acid/colecalciferol 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 is Alendronic Acid/Cholecalciferol Weekly Bluefish?

Alendronic Acid/Cholecalciferol Weekly Bluefish is a tablet containing two active substances, alendronic acid (commonly known as alendronate) and cholecalciferol, also 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 menopause and helps rebuild bone. It reduces the risk of spinal and hip fractures.

What is vitamin D?

Vitamin D is an essential nutrient required for calcium absorption and for maintaining healthy bones. The body can only properly absorb calcium from food if sufficient vitamin D is present, which is found in very few foods. The main source of vitamin D is its 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 may cause muscle weakness, increasing the risk of falls and 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 vitamin D insufficiency. Alendronic Acid/Cholecalciferol Weekly Bluefish reduces the risk of spinal and hip fractures in postmenopausal women.

What is osteoporosis?

Osteoporosis is a condition characterized by weakening and thinning of the bones. It is common in women after menopause. During menopause, the ovaries stop producing certain female hormones, called estrogens, which help 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 developing osteoporosis.

Initially, osteoporosis does not present symptoms. However, if left untreated, it can lead to bone fractures. Although these are usually painful, spinal fractures may go unnoticed until they cause loss of height. Weakened bones may break during normal daily activities, such as standing up, or from 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 stooped posture (commonly known as "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 lifestyle changes to help slow the progression of your disease, such as:

Smoking cessation Smoking appears to increase the rate of bone loss and therefore may increase your risk of bone fractures.

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

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

2. What you need to know before starting to take Alendronic acid/colecalciferol Bluefish Weekly

Do not take Alendronic acid/colecalciferol Weekly Bluefish

• if you are allergic to sodium alendronate trihydrate, colecalciferol, or any of the other ingredients of this medicine (listed in section 6),
• if you have certain problems in your throat (esophagus – the tube connecting 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 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 Alendronic acid/colecalciferol Weekly Bluefish if:

• you have kidney problems,
• you have, or have recently had, problems with swallowing or digestive issues,
• your doctor has told you that you have Barrett's oesophagus (a condition associated with changes in the cells lining the lower part of the oesophagus),
• you have been told that you have difficulty absorbing minerals in your stomach or intestines (malabsorption syndrome),
• you have poor dental hygiene, gum disease, an upcoming dental extraction, or do not receive regular dental care,
• you have cancer,
• you are receiving chemotherapy or radiotherapy,
• you are being treated with 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 examination before starting treatment with Alendronic acid/colecalciferol Weekly Bluefish.

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

Irritation, inflammation, or ulceration of the throat (oesophagus – the tube connecting your mouth to your stomach) may occur, often with symptoms such as chest pain, heartburn, difficulty or pain when swallowing, especially if patients do not drink a full glass of water and/or lie down within 30 minutes after taking Alendronic acid/colecalciferol Weekly Bluefish. These adverse effects may worsen if patients continue taking Alendronic acid/colecalciferol Weekly Bluefish after developing these symptoms.

Girls and adolescents

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

Use of Alendronic Acid/Cholecalciferol SemanalBluefish with other medicines

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

Calcium supplements, antacids, and certain oral medications may interfere with the absorption of Alendronic Acid/Cholecalciferol SemanalBluefish if taken at the same time. Therefore, it is important that you follow the instructions provided in section 3 (How to take Alendronic Acid/Cholecalciferol SemanalBluefish) and wait at least 30 minutes before taking any other medicine or supplement.

Certain medicines used for rheumatism or long-term pain, called NSAIDs (for example, acetylsalicylic acid or ibuprofen), may cause gastrointestinal problems. Therefore, caution should be taken if these medicines are taken at the same time as Alendronic Acid/Cholecalciferol SemanalBluefish.

Certain medicines or food additives may impair the absorption of vitamin D from Alendronic Acid/Cholecalciferol SemanalBluefish, including artificial fat substitutes, mineral oils, the weight-loss medicine orlistat, and cholesterol-lowering medicines such as cholestyramine and colestipol. Medicines for epileptic seizures (convulsions) (such as phenytoin or phenobarbital) may reduce the effectiveness of vitamin D.

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

Taking Alendronic Acid/Cholecalciferol Semanal Bluefish with food and drinks

Food and drinks (including mineral water) are likely to reduce the effectiveness of Alendronic Acid/Cholecalciferol Semanal 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 Semanal Bluefish). You must wait at least 30 minutes before taking any food and drinks, except water.

Pregnancy and breastfeeding

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

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

Driving and use of machines

Adverse reactions have been reported with Alendronic acid/colecalciferol Weekly Bluefish (e.g. blurred vision, dizziness, and severe bone, muscle or joint pain) which may affect your ability to drive or operate machinery. (See Possible adverse reactions). If you experience any of these adverse reactions, you should not drive until you feel better.

Alendronic acid/colecalciferol SemanalBluefish contains lactose and sucrose

This medicine contains lactose and sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

May cause dental caries.

Alendronic acid/colecalciferol Semanal Bluefish contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which means it is essentially "sodium-free".

3. How to take Alendronic Acid/Cholecalciferol Weekly Bluefish

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

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

Follow these instructions carefully.

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

It is very important that you follow steps 2), 3), 4), and 5) to help ensure that the tablet of Alendronic Acid/Cholecalciferol Weekly Bluefish reaches your stomach quickly and to help reduce the risk of irritation in the throat (oesophagus – the tube connecting 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 sparkling water) (no less than 200 mL), so that Alendronic Acid/Cholecalciferol Weekly Bluefish is properly absorbed.
   • 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, chew, or allow the tablet to dissolve in your mouth, as this may cause mouth ulcers.

1. 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 your first meal of the day.

2. Do not take Alendronic Acid/Cholecalciferol Weekly Bluefish at bedtime or before getting up in the morning.

3. If you have difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking Alendronic Acid/Cholecalciferol Weekly Bluefish and contact your doctor.

4. After swallowing a tablet of Alendronic Acid/Cholecalciferol Weekly Bluefish, wait at least 30 minutes before taking your first meal, 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 full glass of milk and contact your doctor immediately. Do not induce vomiting and do not lie down.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Alendronic Acid/Cholecalciferol Weekly Bluefish

If you miss a dose, take one tablet the morning after you remember. Do not take two tablets on the same day. Then resume taking one tablet once a week on your originally chosen day.

If you stop taking Alendronic Acid/Cholecalciferol Weekly Bluefish

It is important to continue taking Alendronic Acid/Cholecalciferol Weekly Bluefish for as long as your doctor prescribes it. Since it is not known how long Alendronic Acid/Cholecalciferol Weekly Bluefish should be taken, you should periodically discuss with your doctor whether continuing treatment with this medicine is still appropriate for you.

An Instruction Card is included in the Alendronic Acid/Cholecalciferol Weekly Bluefish pack. It contains important information to remind you how to take Alendronic Acid/Cholecalciferol Weekly Bluefish correctly.

If you have any further 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 everyone experiences them.

Contact 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:

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

• burning sensation; difficulty swallowing; pain when swallowing; ulcer in the throat (esophagus – the tube connecting your mouth to your stomach), which may cause chest pain, burning sensation, 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 tooth loss. These may be signs of bone damage in the jaw (osteonecrosis), usually associated with delayed healing and infection, often following a tooth extraction. Contact your doctor and dentist if you experience these symptoms,
• atypical femoral fractures (thigh bone), which may occur rarely, particularly in patients on long-term treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as these may be early symptoms indicating a possible femoral fracture,
• severe bone, muscle, and/or joint pain.

Other adverse effects include

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

• bone, muscle, and/or joint pain, sometimes severe.

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

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

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

• nausea; vomiting,
• irritation or inflammation of the throat (esophagus – the tube connecting your mouth to your stomach) or stomach,
• black or tar-like stools,
• blurred vision; eye pain or redness,
• skin rash; redness of the skin,
• transient flu-like symptoms such as muscle pain, general malaise, and sometimes fever, which usually occur at the beginning of treatment,
• altered 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 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 connecting 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, ear discharge, or an ear infection. These could be symptoms of bone damage in the ear.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alendronic Acid/Cholecalciferol Bluefish Weekly

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and any unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Alendronic Acid/Cholecalciferol SemicalBluefish

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

Each tablet contains 70 mg of alendronic acid as alendronate sodium trihydrate and 70 micrograms (2,800 IU) of cholecalciferol (vitamin D3).

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

Appearance of the Product and Contents of the Package

Alendronic acid/colecalciferol Weekly Bluefish 70 mg/2.800 IU tablets are oblong, white to off-white, biconvex, mottled tablets, engraved with "2.800" on one side, 12.3 ± 0.2 mm in length and 6.5 ± 0.2 mm in width.

The tablets are supplied in aluminum/aluminum (PA/AL/PVC-Aluminum) blisters, packed in cardboard boxes in the following pack sizes: 4 and 12 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer Responsible

Marketing Authorization Holder

Bluefish Pharmaceuticals AB,

P.O. Box 49013,

100 28 Stockholm,

Sweden

Manufacturer Responsible

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

Attica,

Greece

and/or

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

Saxony-Anhalt

39179 Barleben

Germany

Further information on this medicinal product can be requested from the local representative of the Marketing Authorization Holder:

Bluefish Pharma S.L.U.,

P.O. Box 36007

28320 Madrid, Office 36

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: August 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/