Package Insert: Information for the User

Alendronic Acid Weekly Cinfamed 70 mg Tablets EFG

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

What is Cinfamed Weekly Alendronic Acid?

Cinfamed Weekly Alendronic Acid 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. It prevents bone loss that occurs in women after menopause and helps to rebuild bone. Cinfamed Weekly Alendronic Acid reduces the risk of fractures of the spine and hip.

What is Cinfamed Weekly Alendronic Acid used for?

Your doctor has prescribed Cinfamed Weekly Alendronic Acid to treat your osteoporosis. It reduces the risk of fractures of the spine and hip.

Cinfamed Weekly Alendronic Acid 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, 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 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?

In addition to your treatment with Cinfamed Weekly Alendronic Acid, 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 Cinfamed weekly alendronate if:

• You are allergic to alendronate or any of the other ingredients of this medicine (listed in section 6).
• You have certain throat problems (esophagus - the tube that connects your mouth to your stomach), such as narrowing or difficulty swallowing.
• You cannot stand or sit for at least 30 minutes.
• 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 Cinfamed weekly alendronate if:

• You have kidney problems,
• You have, or have had recently, 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 Cinfamed weekly alendronate.

It is essential to maintain good oral hygiene while taking Cinfamed weekly alendronate. 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 ulcers (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 Cinfamed weekly alendronate. These adverse effects may worsen if patients continue taking Cinfamed weekly alendronate after developing these symptoms.

Children and adolescents

Cinfamed weekly alendronate should not be administered to children or adolescents under 18 years of age.

Taking Cinfamed weekly alendronate with other medicines

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

It is likely that calcium supplements, antacids, and other oral medicines will interfere with the absorption of Cinfamed weekly alendronate if taken at the same time. Therefore, it is essential to follow the advice given in section 3.

Certain medicines for rheumatism or long-term pain called NSAIDs (for example, acetylsalicylic acid or ibuprofen) may cause digestive problems. Therefore, caution should be exercised if taken at the same time as Cinfamed weekly alendronate.

Taking Cinfamed weekly alendronate with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist.

Cinfamed weekly alendronate is only intended for use in postmenopausal women. Do not take Cinfamed weekly alendronate if you are pregnant or think you may be, or during breastfeeding.

Driving and operating machines

Adverse effects with alendronate (such as blurred vision, dizziness, and intense bone, muscle, or joint pain) may affect your ability to drive or operate machines (see section 4).

Cinfamed weekly alendronate contains sodium

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

This medicine does not contain gluten.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.Consulte de nuevo a su médico o farmacéutico.

Take one weekly Alendronate Sodium cinfamed tabletonce a week.

Follow these instructions carefully.

1. Choose the day of the week that best suits your routine. Each week, take one Alendronate Sodium weekly tablet on the day you have chosen.

It is very important to follow instructions 2, 3, 4 and 5 to help the Alendronate Sodium weekly tablet reach the 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 Sodium weekly tablet only with a full glass of water(not mineral water)(not less than 200 ml),so that Alendronate Sodium is absorbed properly.

• 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 juices or milk.

Do not crush or chew the tablet, or allow it to dissolve in your mouth,due to the possibility of appearance of ulcers in the mouth.

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 Sodium 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 Sodium and inform your doctor.

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

If you take more Alendronate Sodium cinfamed than you should

If you accidentally take too many tablets, drink a full glass of milk and immediately see 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 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Alendronate Sodium cinfamed

If you forget a dose, wait until the next morning to take Alendronate Sodium.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 Sodium cinfamed

It is essential to continue taking Alendronate Sodium for as long as your doctor prescribes the medication. Since it is unknown how long you should take Alendronate Sodium, you should discuss periodically with your doctor the need to continue treatment with this medication to determine if Alendronate Sodium 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,this medicationcan 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, 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 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 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):

• 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; feeling of a full or bloated stomach; 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, which 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, your ear is discharging, or you have an ear infection. These may be symptoms 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 prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.esBy reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medicationafter 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 packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Alendronic Acid Weekly Cinfamed

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

Appearance of the product and contents of the packaging

Alendronic Acid Weekly Cinfamedis 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 and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Responsible for manufacturing

TEVA PHARMA, S.L.U.

Malpica Industrial Estate C/C, nº 4

50016-Zaragoza

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Last review date of this leaflet:April 2019

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/

You can access detailed and updated information on this medication by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/70911/P_70911.html

QR code to:https://cima.aemps.es/cima/dochtml/p/70911/P_70911.html