PROSPECTO: INFORMATION FOR THE USER

Weekly Alendronic AcidPharma Combix70 mg tablets EFG

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

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

3. How to take Weekly Alendronic Acid Pharma Combix

4. Possible adverse effects

5. Storage of Weekly Alendronic Acid Pharma Combix

6. Contents of the package and additional information

What is Alendronic Acid Weekly Pharma Combix?

Alendronic Acid Weekly Pharma Combix 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 Weekly Pharma Combix reduces the risk of fractures of the spine and hip.

What is Alendronic Acid Weekly Pharma Combix used for?

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

Alendronic Acid Weekly Pharma Combix 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 bones become weaker. The earlier a woman reaches menopause, the greater her risk of osteoporosis.

Usually, osteoporosis does not have symptoms before menopause. However, if left untreated, it can result in broken bones. Although these usually hurt, vertebral bone fractures may go unnoticed until they cause loss of height. Bones can break during normal daily activities, such as standing up or 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 back (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 Pharma Combix not only prevents bone loss but also helps to rebuild the bone that may have been lost and reduces the risk of fractures of bones in the spine and hip.

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

Stopping smoking: It appears that smoking increases the rate at which you lose bone and, therefore, may increase your risk of broken bones.

Exercise: As 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 (especially calcium and vitamin D).

Do not take AcidAlendrónico Semanal Pharma Combix

• If you are allergic to the active ingredient or any of the other components ofthis medication (listed in section 6).
• If you have certain throat (esophagus - the tube that connects the mouth to the stomach) abnormalities such as narrowing or difficulty swallowing.
• If you cannot stand or sit 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 Semanal Pharma Combix if:

• You have kidney problems,
• You have, or have recently had, digestive problems or difficulty swallowing,
• 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 mineral absorption problems in your stomach or intestines (malabsorption syndrome),
• You have been told that you have low blood calcium,
• 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 being treated with angiogenesis inhibitors (such as bevacizumab or thalidomide) used in cancer treatment,
• You are taking corticosteroids (such as prednisone or dexamethasone) used in the treatment of diseases 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 Acid Alendrónico Semanal Pharma Combix.

It is essential to maintain good oral hygiene while taking Alendrónico Semanal Pharma Combix. 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 esophagus ulceration (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 Acid Alendrónico Semanal Pharma Combix. These adverse effects may worsen if patients continue taking Acid Alendrónico Semanal Pharma Combix after developing these symptoms.

Children and adolescents:

Acid Alendrónico Semanal Pharma Combix should not be administered to children or adolescents under 18 years of age.

Other medications and Acid Alendrónico Semanal Pharma Combix

Inform your doctor or pharmacist if you are using, 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 Semanal Pharma Combix if taken at the same time. Therefore, it is essential to follow the advice given in section 3.

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 Semanal Pharma Combix.

Taking Acid Alendrónico Semanal Pharma Combix with food and drinks

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

Pregnancy and breastfeeding

Acid Alendrónico Semanal Pharma Combix is only intended for use in postmenopausal women. Do not take Acid Alendrónico Semanal Pharma Combix if you are pregnant or think you may be pregnant, or during breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Adverse effects have been reported with Acid Alendrónico Semanal Pharma Combix (such as blurred vision, dizziness, and intense bone, muscle, or joint pain) that may affect your ability to drive or operate machinery (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 Pharma Combix 70 mgonce a week.

1. Choose the day of the week that best suits your routine. Take one tablet of Alendronate Weekly Pharma Combix every week on the day you have chosen.

It is very important to follow instructions 2, 3, 4 and 5 to help the Alendronate Weekly Pharma Combix tablet reach your stomach quickly and help 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, or other medication, swallow the entire Alendronate Weekly Pharma Combix tablet with a full glass of water (not mineral water) (not less than 200 ml) to allow Alendronate Weekly Pharma Combix to be 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 juices or milk.

Do not crush or chew the tablet, or allow it to dissolve in your mouth, as there is a possibility of mouth ulcers appearing.

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 the first meal of the day.

1. Do not take Alendronate Weekly Pharma Combix at bedtime or before getting up in the morning.

1. If you have difficulty or pain swallowing, chest pain, or new or worsening heartburn, stop taking Alendronate Weekly Pharma Combix and inform your doctor.

1. After swallowing a tablet of Alendronate Weekly Pharma Combix, 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 Pharma Combix is only effective if taken on an empty stomach.

If you take more Alendronate Weekly Pharma Combix 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, immediately consult your doctor or pharmacist or call the Toxicological Information Service. Phone: (91) 562-0420, indicating the medication and amount ingested.

If you forget to take Alendronate Weekly Pharma Combix

If you forget a dose, wait until the next morning to take Alendronate Weekly Pharma Combix.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 with Alendronate Weekly Pharma Combix

It is essential to take Alendronate Weekly Pharma Combix for as long as your doctor prescribes the medication.

Since it is unknown how long you should take Alendronate Weekly Pharma Combix, discuss periodically with your doctor the need to continue treatment with this medication to determine if Alendronate Weekly Pharma Combix is still suitable for you.

Like all medicines, this medicine 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 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. 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 possible femur fractures,
• intense bone, muscle, and/or joint pain.

Other side effects include

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

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

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

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

Infrequent (may affect up to 1 in 100 patients):

• 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 patients):

• 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 affectup 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 signs of damage to the bones in 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. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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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 indicated 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 packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Alendronic Acid Weekly Pharma Combix

The active ingredient is alendronic acid. Each tablet contains 70 mg of alendronic acid as alendronate sodium trihydrate.

The other components (excipients) are:microcrystalline cellulose, crospovidone, and magnesium stearate.

Appearance of the product and content of the packaging:

Alendronic Acid Weekly Pharma Combix is presented in the form of tablets. The tablets are white, oval, and flat.

Each package contains 4 tablets.

Holder of the marketing authorization:

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing:

Teva Pharma, S.L.U.Polígono Malpica c/ C nº 4

50016 Zaragoza

or

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70. Polígono Industrial URTINSA II

28923 (Alcorcón) Madrid

Spain

Revision date of this prospectus:August 2019

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