Prospect: information for the user

Alendronic Acid Weekly Qualigen 70 mg tablets EFG

Read this prospect carefully before starting to take this medicine because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they present the same symptoms of the disease, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect.
• It is particularly important that you understand the information in section 3. How to take Alendronic Acid Weekly Qualigen, before taking this medicine.

1. What is Alendronic Acid Weekly Qualigen and what it is used for

2. What you need to know before starting to take Alendronic Acid Weekly Qualigen

3. How to take Alendronic Acid Weekly Qualigen

4. Possible adverse effects

5. Storage of Alendronic Acid Weekly Qualigen

6. Contents of the package and additional informationl

Alendronic Acid belongs to a group of non-hormonal medications called bisphosphonates. It prevents bone loss that occurs in women after menopause and helps to rebuild bone. Alendronic Acid reduces the risk of fractures of the spine and hip.

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

Alendronic Acid Weekly Qualigen is a weekly treatment

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, vertebral fractures may go unnoticed until they cause loss of height. Bones can break during normal daily activity, such as standing up or from minor injuries that would not normally 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. Alendronic Acid Weekly Qualigen 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.

In addition to your treatment with Alendronic Acid Weekly Qualigen, your doctor may suggest that you make lifestyle changes to help your condition, such as:

Quitting smokingIt appears that smoking increases the rate at which you lose bone and may increase your risk of broken bones.

ExerciseAs 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 (especially calcium and vitamin D).

Do not take AcidAlendrónico Weekly Qualigen

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• If you have certain throat (esophagus - the tube that connects the mouth to the stomach) alterations such as narrowing or difficulty swallowing.
• If you cannot remain standing or sitting for at least 30 minutes.
• If your doctor has told you that you have low blood calcium.

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 Acid Alendrónico Weekly Qualigen.

It is essential to inform your doctor before taking Acid Alendrónico Weekly Qualigen:

• If you have kidney problems.
• If you have digestive problems or difficulty swallowing.
• If 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).
• If you have been told that you have low blood calcium.
• If you have poor dental hygiene, gum disease, a planned tooth extraction, or do not receive regular dental care.
• If you have cancer.
• If you are undergoing chemotherapy or radiation therapy.
• If you are being treated with angiogenesis inhibitors (such as bevacizumab or thalidomide),
• If you are taking corticosteroids (such as prednisone or dexamethasone)
• If 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 Acid Alendrónico Qualigen.

It is essential to maintain good oral hygiene while taking Acid Alendrónico. 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.

It may cause irritation, inflammation, or esophageal ulcer (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 after taking Acid Alendrónico Weekly Qualigen. These adverse effects may worsen if patients continue taking Acid Alendrónico Weekly Qualigen after developing these symptoms.

Children and adolescents

Acid Alendrónico Weekly Qualigen should not be administered to children or adolescents under 18 years of age.

Taking Acid Alendrónico Weekly Qualigen with other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.

It is likely that calcium supplements, antacids, and other oral medications will interfere with the absorption of Acid Alendrónico Weekly Qualigen, if taken at the same time. Therefore, it is essential to follow the advice given in section 3. How to take Acid Alendrónico Weekly Qualigen.

Certain medications for rheumatism or long-term pain called NSAIDs (such as aspirin or ibuprofen) may cause digestive problems. Therefore, caution should be exercised if taken at the same time as Acid Alendrónico Qualigen.

Inform your doctor or pharmacist if you are using or have used recently other medications, even those acquired without a prescription.

Taking Acid Alendrónico Weekly Qualigen with food and drink

It is likely that food and drinks (including mineral water) will make Acid Alendrónico Weekly Qualigen less effective, if taken at the same time. Therefore, it is essential to follow the advice given in section 3. How to take Acid Alendrónico Weekly Qualigen.

Pregnancy and breastfeeding

Acid Alendrónico Weekly Qualigen is only intended for use in postmenopausal women. If you are pregnant or breastfeeding, or think you may be pregnant and intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Adverse effects with Acid Alendrónico Weekly Qualigen (including blurred vision, dizziness, and intense bone, muscle, or joint pain) may affect your ability to drive or operate machinery. Individual responses to Acid Alendrónico may vary. (See section 4).

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

Take one tablet of Alendronate Weekly Qualigen 70 mgonce a week.

1. Choose the day of the week that best suits your routine. Every week, take one tablet of Alendronate Weekly Qualigen on the day you have chosen

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

2. After getting up in the morning and before taking the first meal, drink, or other medication, swallow the entire tablet of Alendronate Weekly Qualigen only with a full glass of water (not mineral water) (not less than 200ml).

• do not take it with mineral water (with gas 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 of alendronate or let it dissolve in your mouth.

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 Alendronate Weekly Qualigen 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 Alendronate Weekly Qualigen and inform your doctor.

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

If you take more Alendronate Weekly Qualigen than you should

If you accidentally take too many tablets, drink a full glass of milk and immediately consult your doctor. 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. Phone: (91) 56204 20, indicating the medication and the amount ingested.

If you forget to take Alendronate Weekly Qualigen

If you forget a dose, wait until the next morning to take Alendronate Weekly Qualigen.Do not take two tablets on the same day.Then, take one tablet once a week, on the originally chosen day.

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

If you interrupt treatment withAlendronate Weekly Qualigen

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

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

Like all medications, Alendronate Sodium Weekly Qualigen may cause side effects, although not everyone will experience them.

Seek medical attention immediatelyif you notice any of the following side effects, which may be severe, 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 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,

•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 jaw bone damage (osteonecrosis) usually 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 include

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

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

Frequent (may affect more than 1 in 10 people):

• Swelling of the joints,
• Abdominal pain; uncomfortable sensation in the stomach or belching after eating, constipation; feeling of a full stomach or bloating; diarrhea; flatulence,
• Hair loss; itching,
• Headache; dizziness,
• Fatigue; swelling of the hands or legs.

Infrequent (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 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, when the tablets have been chewed or sucked.

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

•Consult your doctor if you have ear pain, your ear is draining, or you have an ear infection. These may be symptoms of damage to the bones in the ear.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this prospectus.

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 prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Alendronic Acid Weekly Qualigen

• The active ingredient is alendronic acid. Each tablet contains 70 mg of alendronic acid as alendronate sodium trihydrate.trihidrato.
• The other components are:microcrystalline cellulose, crospovidone and magnesium stearate.

Appearance of the product and content of the packaging

Alendronic Acid WeeklyQualigen70 mg is presented in the form of tablets. The tablets are white, oval and flat, marked on one face with “70”.

Each package contains 4 tablets.

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing

Teva Pharma, S.L.U.

Polígono Malpica c/ C 4.

50016 - Zaragoza.

Spain

Last review date of this leaflet: February 2018

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