Patient Information Leaflet: Package Insert

Adelan Weekly 70 mg Tablets EFG

Alendronic Acid

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

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed for you only, and you must 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 leaflet. See section 4.

1. What Adelan Weekly is and for what it is used

2. What you need to know before taking Adelan Weekly

3. How to take Adelan Weekly

4. Possible side effects

5. Storage of Adelan Weekly 70 mg Tablets

6. Contents of the pack and additional information

Adelan Weekly is a tablet that contains the active ingredient alendronic acid (commonly known as alendronate) and belongs to a group of non-hormonal medications called bisphosphonates. Adelan Weekly prevents bone loss that occurs in women after menopause and helps to rebuild bone. Adelan Weekly reduces the risk of fractures of the spine and hip.

What is Adelan Weekly used for?

Your doctor has prescribed Adelan Weekly to treat your osteoporosis. Adelan Weekly reduces the risk of hip fractures.

What is osteoporosis?

Osteoporosis is a thinning and weakening of the bones. It is common in women after menopause. During menopause, the ovaries stop producing the female hormone estrogen, which helps to maintain a woman's healthy skeleton. As a result, bone loss occurs and the bones become weaker. The earlier a woman reaches menopause, the greater her risk of osteoporosis.

Long before menopause, osteoporosis usually has no symptoms. However, if left untreated, it can result in broken bones. Although these usually hurt, fractures of the spine bones can go unnoticed until they cause loss of height. Bones can break during normal daily activities, such as getting up or from minor injuries that would normally not break a normal bone. Fractures of bones usually occur in the hip, spine, or wrist and can cause not only pain but also significant problems such as a hunched posture (widow's hump) and loss of mobility.

How can osteoporosis be treated?

Osteoporosis can be treated and it is never too late to start treatment. Adelan Weekly not only prevents bone loss but also helps to rebuild the bone that may have been lost and reduces the risk of bone fractures in the spine and hip.

Along with your treatment with Adelan Weekly, your doctor may suggest that you make lifestyle changes to help your condition, such as:

Quitting smoking: it seems that smoking increases the rate at which you lose bone and, therefore, may increase your risk of broken bones.

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

Eating a balanced diet: su doctor may advise you on your diet or whether you should take any dietary supplements (especially calcium and vitamin D).

Do not take Adelan Weekly:

- if you are allergic to alendronate or any of the other components of this medication (listed in section 6).

- if you have certain throat (esophagus) conditions such as narrowing or difficulty swallowing.

- if you cannot stand or sit for at least 30 minutes,

- if your doctor has told you that your current blood calcium level is low.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Adelan Weekly.

It is important to inform your doctor before taking alendronate if:

- you have kidney problems,

- you have any allergies,

- you have, or have recently had, difficulty swallowing,

- you have low blood calcium levels,

- you have gum disease,

- you are planning to have a tooth extraction.

If you have any of the following diseases, a dental examination may be considered before starting treatment with alendronate.

- if you have cancer

- if you are undergoing chemotherapy or radiation therapy

- if you are taking corticosteroids (such as prednisone or dexamethasone)

- if you have poor dental hygiene

- if you have any gum disease

Appropriate dental preventive care should be followed during treatment, as recommended by your dentist.

Irritation, inflammation, or esophageal ulcer 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 30 minutes of taking alendronate. These adverse effects may worsen if patients continue taking alendronate after developing these symptoms.

Children and adolescents

Alendronate should not be administered to children or adolescents under 18 years of age.

Other medications and Adelan Weekly

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 other oral medications will interfere with the absorption of alendronate if used at the same time. Therefore, it is essential to follow the advice given in section 3.

Adelan Weekly with food, drinks, and alcohol

It is likely that food and drinks (including mineral water) will make alendronate less effective if used at the same time. Therefore, it is essential to follow the advice given in section 3.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Alendronate is only intended for use in postmenopausal women.

Driving and operating machinery:

Alendronate does not affect the ability to drive or operate machinery.

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

Remember to take your medication.

Take one alendronate tablet once a week.

Follow these instructions carefully.

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

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

1. After getting up in the morning and before taking the first meal, drink the tablet with a full glass of tap water (not less than 200 milliliters).

- Do not take it with mineral water.

- Do not take it with coffee or tea.

- Do not take it with juices or milk.

3.Do not chew the tablet or let it dissolve in the mouth.

4.Do not lie down after swallowing the tablet: remain upright (sitting, standing, or walking) for at least 30 minutes and do not lie down until after the first meal of the day.

5.Do not take this medication at bedtime or before getting up in the morning.

6.If you have difficulty or pain swallowing, chest pain, or new or worsening heartburn, stop taking this medication and inform your doctor.

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

If you estimate that the action of alendronate is too strong or too weak, inform your doctor or pharmacist.

If you take more Adelan Semanal than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested).

If you 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 forgot to take Adelan Semanal

Do not take a double dose to compensate for the missed doses.

If you forget a dose, wait until the next morning to take alendronate. 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 the treatment with Adelan Semanal

It is essential to continue taking alendronate for as long as your doctor prescribes the medication. Alendronate can only treat your osteoporosis if you continue taking the tablets.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Seek medical attention immediatelyif you notice 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, difficulty swallowing, pain when swallowing, esophageal ulcer (the tube that connects your mouth to your stomach), which may cause chest pain, burning, or difficulty 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,
• 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) generally associated with delayed healing and infection, often after a dental extraction. Inform 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 are:

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

• occasional 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, diarrhea, flatulence (gas), dysphagia (difficulty swallowing), feeling of a full or bloated stomach,
• 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 or tar-like stools,
• blurred vision, eye pain or redness,
• skin rash, redness of the skin,
• transient symptoms similar to the flu, such as muscle pain, general feeling of discomfort, and sometimes fever that usually 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, the ear is draining or you have an ear infection. These may be signs of damage to the bones of the ear.

Inform your doctor or pharmacist immediately about these or any other symptoms.

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 theSpanish System for Pharmacovigilance of Medicines for Human Use: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.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after EXP. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at your pharmacy.Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Adelan Weekly

• The active ingredient is alendronic acid. Each tablet contains 70 mg of alendronic acid as alendronate sodium trihydrate.
• The other components are: microcrystalline cellulose (E-460), mannitol (E-421) and magnesium stearate (E-572).

Appearance of the product and content of the packaging

Adelan Weekly 70 mg tablets are presented in the form of white, oval biconvex tablets with the letters APO engraved on one face and “ALE 70” on the other.

Each package contains 4 tablets.

Holder of marketing authorization and responsible for manufacturing

ESPECIALIDADES FARMACÉUTICAS CENTRUM, S.A.

C/ Sagitario, 14

03006 - Alicante (SPAIN)

Date of the last review of this leaflet:June 2020

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).