ALENDRONAT 70 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Alendronat Bluefish, 70 mg, tablets
   1. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
   2. Contents of the pack and other information
3. What Alendronat Bluefish is and what it is used for
4. Before you take Alendronat Bluefish
   1. When not to take Alendronat Bluefish
   2. Warnings and precautions
   3. Children and adolescents
   4. Alendronat Bluefish and other medicines
   5. Alendronat Bluefish with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Alendronat Bluefish contains sodium
5. How to take Alendronat Bluefish
   1. What to do if you take more Alendronat Bluefish than you should
   2. What to do if you forget to take Alendronat Bluefish
   3. What to do if you want to stop taking Alendronat Bluefish
6. Possible side effects
   1. Reporting of side effects
7. How to store Alendronat Bluefish
8. Contents of the pack and other information
   1. What Alendronat Bluefish contains
   2. What Alendronat Bluefish looks like and contents of the pack
   3. Marketing Authorisation Holder
   4. Manufacturer
   5. This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the User

Alendronat Bluefish, 70 mg, tablets

Alendronic acid

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

• You should 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.

Contents of the pack and other information

• 1. What Alendronat Bluefish is and what it is used for
• 2. Before you take Alendronat Bluefish
• 3. How to take Alendronat Bluefish
• 4. Possible side effects
• 5. How to store Alendronat Bluefish
• 6. Contents of the pack and other information

1. What Alendronat Bluefish is and what it is used for

The active substance, alendronate sodium trihydrate, belongs to a group of medicines called bisphosphonates. Alendronate prevents bone loss and allows bone mass to be rebuilt, reducing the risk of spine and hip fractures. Alendronat Bluefish is used to treat the following conditions:

• Postmenopausal osteoporosis.

Osteoporosis is a condition where bones become weak and brittle, often due to low estrogen levels in postmenopausal women. Early stages of osteoporosis may not show symptoms, but if left untreated, it can lead to bone fractures. Alendronat Bluefish not only prevents bone loss but also restores bone density and reduces the risk of fractures.

2. Before you take Alendronat Bluefish

Before taking Alendronat Bluefish, consult your doctor or pharmacist if you have any of the following conditions, as the medicine may not be suitable for you:

When not to take Alendronat Bluefish

• If you are allergic to alendronate sodium trihydrate or any other ingredients of this medicine.
• If you have problems with your esophagus, such as narrowing or difficulty swallowing.
• If you cannot stand or sit upright for at least 30 minutes.
• If you have low calcium levels in your blood.

If you think any of these conditions apply to you, do not take the medicine. Inform your doctor and follow their advice.

Warnings and precautions

Before taking Alendronat Bluefish, discuss with your doctor or pharmacist if you have:

• Kidney problems
• Any allergies
• Difficulty swallowing or digestive problems
• Low calcium levels in your blood
• Gum disease
• Planned dental extraction
• Barrett's esophagus (a condition related to changes in the cells lining the lower part of the esophagus)

If you have any of these conditions, consider a dental check-up before taking Alendronat Bluefish. Maintain good oral hygiene during treatment and report any dental problems or discomfort to your doctor or dentist.

Children and adolescents

Do not give Alendronat Bluefish to children and adolescents.

Alendronat Bluefish and other medicines

Tell your doctor or pharmacist about all medicines you are taking or plan to take, including supplements. Some medicines, such as calcium supplements, antacids, and certain oral medicines, may interfere with the absorption of Alendronat Bluefish.

• After taking Alendronat Bluefish, wait at least 30 minutes before taking any other medicine.

Alendronat Bluefish with food and drink

Food and drinks, including mineral water, may reduce the effectiveness of Alendronat Bluefish. After taking the medicine, wait at least 30 minutes before eating or drinking.

Pregnancy and breastfeeding

Do not take Alendronat Bluefish if you are pregnant or breastfeeding. If you are pregnant or think you may be pregnant, or if you plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Alendronat Bluefish may cause side effects such as blurred vision, dizziness, and severe bone, muscle, or joint pain, which may affect your ability to drive or use machines.

Alendronat Bluefish contains sodium

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

3. How to take Alendronat Bluefish

Always take Alendronat Bluefish exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

• 1. Choose a day of the week that best fits your schedule. Take Alendronat Bluefish once a week on the chosen day.
• 2. After getting up in the morning, take Alendronat Bluefish with a full glass of plain water (at least 200 ml or 7 ounces) before taking any food, drink, or other medicine. Do not chew or allow the tablet to dissolve in your mouth.
• 3. After taking Alendronat Bluefish, do not lie down - stay upright (sitting or standing) for at least 30 minutes and do not lie down until after you have eaten your first food of the day.
• 4. Do not take Alendronat Bluefish at bedtime or before getting up in the morning.
• 5. If you experience difficulty or pain when swallowing, chest pain, or difficulty or pain when swallowing, stop taking Alendronat Bluefish and contact your doctor.
• 6. After taking Alendronat Bluefish, wait at least 30 minutes before taking any other medicine, including antacids, calcium supplements, and vitamins.

What to do if you take more Alendronat Bluefish than you should

If you or someone else has taken more Alendronat Bluefish than prescribed, drink a full glass of milk and contact your doctor immediately. Do not induce vomiting or lie down.

What to do if you forget to take Alendronat Bluefish

If you forget to take a dose, take one tablet the next morning. Do not take a double dose to make up for a missed dose.

What to do if you want to stop taking Alendronat Bluefish

Before stopping treatment with Alendronat Bluefish, consult your doctor. Alendronat Bluefish is only effective in treating osteoporosis if you continue to take the tablets.

4. Possible side effects

Like all medicines, Alendronat Bluefish can cause side effects, although not everybody gets them.

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

• Bone, muscle, or joint pain, sometimes severe

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

• Heartburn, difficulty swallowing, pain when swallowing, esophagus inflammation (which may cause chest pain, heartburn, or difficulty or pain when swallowing)
• Joint swelling
• Abdominal pain, discomfort in the stomach, or bloating, constipation, feeling full or bloated, diarrhea, gas
• Hair loss, itching
• Headache, dizziness
• Fatigue, swelling of hands or feet

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

• Nausea, vomiting
• Esophagus or stomach inflammation
• Black or tarry stools
• Blurred vision, eye pain or redness
• Rash, skin redness
• Flu-like symptoms, such as muscle pain, general feeling of being unwell, sometimes with fever, usually at the start of treatment
• Taste disturbance

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

• Allergic reactions, such as hives, face, lip, tongue, or throat swelling, which may cause difficulty swallowing or breathing
• Low calcium levels in the blood, including muscle cramps, spasms, or tingling sensation in the fingers or around the mouth
• Ulcers in the stomach or duodenum (sometimes severe and bleeding)
• Esophagus narrowing
• Skin rash increased by sunlight; severe skin reactions
• Jaw pain, swelling, or numbness, loose teeth, or dental problems. These may be signs of jawbone damage, often associated with delayed healing and infection, usually after tooth extraction
• Unusual fractures of the thigh bone, especially in patients treated long-term for osteoporosis. If you experience pain, weakness, or discomfort in the thigh, hip, or groin, consult your doctor, as this may be an early sign of a fracture

Very rare (may affect up to 1 in 10,000 people):

• Ear pain, discharge from the ear, or ear infection. These may be signs of bone damage in the ear.

If you experience any of these side effects or any other unusual effects, tell your doctor or pharmacist. It will be helpful if you make a note of the effects, when they happened, and how long they lasted. If any of the side effects get worse or if you notice any not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the leaflet.

5. How to store Alendronat Bluefish

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

There are no special storage instructions.

Do not use this medicine after the expiry date which is stated on the packaging and blister pack after "EXP". The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Alendronat Bluefish contains

• The active substance is alendronic acid. Each tablet contains 70 mg of alendronic acid (equivalent to 91.35 mg of alendronate sodium trihydrate).
• The other ingredients are microcrystalline cellulose, crospovidone, magnesium stearate.

What Alendronat Bluefish looks like and contents of the pack

Each tablet is white, oval, and flat with "70" marked on one side. Alendronat Bluefish is available in aluminum/aluminum blister packs containing 4 or 12 tablets.

Marketing Authorisation Holder

Bluefish Pharmaceuticals AB, P.O. Box 49013, 10028, Stockholm, Sweden.

Manufacturer

Bluefish Pharmaceuticals AB, Gävlegatan 22, 113 30, Stockholm, Sweden.

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Date of revision of the leaflet:11.06.2020