ALENDRONIC ACID WEEKLY CINFAMED 70 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alendronic Acid Cinfamed 70 mg Tablets

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

• 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 Package Leaflet

1. What is Alendronic Acid Cinfamed and what is it used for
2. What you need to know before you take Alendronic Acid Cinfamed
3. How to take Alendronic Acid Cinfamed
4. Possible side effects
5. Storage of Alendronic Acid Cinfamed
6. Contents of the pack and other information

1. What is Alendronic Acid Cinfamed and what is it used for

What is Alendronic Acid Cinfamed?

Alendronic Acid Cinfamed is a tablet that contains the active substance alendronic acid (commonly called alendronate) and belongs to a group of non-hormonal medicines called bisphosphonates. It prevents bone loss in women after menopause and helps rebuild bone. Alendronic Acid Cinfamed reduces the risk of spine and hip fractures.

What is Alendronic Acid Cinfamed used for?

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

Alendronic Acid Cinfamed 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 keep a woman's skeleton healthy. As a result, bone loss occurs and the bones become weaker. The earlier a woman reaches menopause, the greater the 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, spine fractures can go unnoticed until they cause a loss of height. Bones can break during normal daily activity, such as when getting up or from minor injuries that would not normally break a bone. Bone fractures usually occur in the hip, spine, or wrist and can cause not only pain but also significant problems such as a hunched posture (dowager's hump) and loss of mobility.

How can osteoporosis be treated?

As well as your treatment with Alendronic Acid Cinfamed, your doctor may suggest that you make changes to your lifestyle to help your condition, such as:

Stopping smokingSmoking appears to increase the rate at which you lose bone and may therefore increase your risk of broken bones.

ExerciseLike 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 food supplements (especially calcium and vitamin D).

2. What you need to know before you take Alendronic Acid Cinfamed

Do not take Alendronic Acid Cinfamed:

• If you are allergic to alendronic acid or any of the other ingredients of this medicine (listed in section 6).
• If you have certain problems with your gullet (esophagus - the tube that connects your mouth to your stomach), such as narrowing or difficulty swallowing.
• If you cannot stand or sit upright for at least 30 minutes.
• If your doctor has told you that you have low blood calcium levels.

If you think any of these 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 Alendronic Acid Cinfamed if:

• you have kidney problems,
• you have, or have recently had, stomach or swallowing problems,
• your doctor has told you that you have Barrett's esophagus (a condition associated with changes in the cells that line the lower part of the esophagus),
• you have been told that you have problems absorbing minerals in your stomach or intestines (malabsorption syndrome),
• you have been told that you have low blood calcium levels,
• you have poor dental hygiene, gum disease, a planned dental extraction, or do not receive regular dental care,
• you have cancer,
• you are undergoing chemotherapy or radiotherapy,
• you are undergoing treatment with angiogenesis inhibitors (such as bevacizumab or talidomide) used in the treatment of cancer,
• 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 Alendronic Acid Cinfamed.

It is important to maintain good oral hygiene when taking Alendronic Acid Cinfamed. You should have regular dental check-ups during your treatment and should contact your doctor or dentist if you experience any problems in your mouth or teeth, such as tooth loss, pain, or swelling.

Irritation, inflammation, or ulcers of the gullet (esophagus - the tube that connects your mouth to your stomach) can occur, often with symptoms of chest pain, burning, difficulty or pain when swallowing, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking Alendronic Acid Cinfamed. These side effects can worsen if patients continue taking Alendronic Acid Cinfamed after developing these symptoms.

Children and adolescents

Alendronic Acid Cinfamed should not be given to children and adolescents under 18 years of age.

Taking Alendronic Acid Cinfamed with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Calcium supplements, antacids, and other oral medicines may interfere with the absorption of Alendronic Acid Cinfamed if taken at the same time. Therefore, it is important that you follow the advice given in section 3.

Certain medicines for rheumatism or long-term pain relief called NSAIDs (such as aspirin or ibuprofen) may cause stomach problems. Therefore, caution should be exercised if these medicines are taken at the same time as Alendronic Acid Cinfamed.

Taking Alendronic Acid Cinfamed with food and drinks

Food and drinks (including mineral water) may make Alendronic Acid Cinfamed less effective if taken at the same time. Therefore, it is important that you follow the advice given in section 3.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice.

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

Driving and using machines

Side effects such as blurred vision, dizziness, and severe bone, muscle, or joint pain have been reported with alendronic acid (see section 4) that may affect your ability to drive or use machines.

Alendronic Acid Cinfamed 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.

3. How to take Alendronic Acid Cinfamed

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

Take one Alendronic Acid Cinfamed tablet once a week.

Follow these instructions carefully.

1. Choose the day of the week that best fits your routine. Every week, take one Alendronic Acid Cinfamed tablet on the day you have chosen.

It is very important that you follow instructions 2, 3, 4, and 5 to help the Alendronic Acid Cinfamed tablet reach your stomach quickly and help reduce the possibility of esophagus irritation (the tube that connects your mouth to your stomach).

1. After getting up in the morning and before taking your first food, drink, or other medicine, swallow the Alendronic Acid Cinfamed tablet whole with a full glass of water (not less than 200 ml), so that alendronic acid is properly absorbed.

• 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, due to the possibility of mouth ulcers.

1. Do not lie down - stay upright (sitting, standing, or walking) - for at least 30 minutes after swallowing the tablet. Do not lie down until after your first food of the day.

1. Do not take Alendronic Acid Cinfamed at bedtime or before getting up in the morning.

1. If you have difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking Alendronic Acid Cinfamed and contact your doctor.

1. After swallowing an Alendronic Acid Cinfamed tablet, wait at least 30 minutes before consuming your first food, drink, or other medicine of the day, including antacids, calcium supplements, and vitamins. Alendronic Acid Cinfamed is only effective if taken on an empty stomach.

If you take more Alendronic Acid Cinfamed than you should

If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately. 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Alendronic Acid Cinfamed

If you miss a dose, wait until the next morning to take Alendronic Acid Cinfamed. Do not take two tablets on the same day.Afterward, take one tablet once a week, on the originally chosen day.

Do not take a double dose to make up for forgotten doses.

If you stop taking Alendronic Acid Cinfamed

It is important that you continue taking Alendronic Acid Cinfamed for as long as your doctor prescribes it. Since it is not known how long you should take Alendronic Acid Cinfamed, you should discuss with your doctor periodically the need to continue treatment with this medicine to determine if Alendronic Acid Cinfamed is still suitable for you.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

See your doctor immediatelyif you notice any of the following side effects, which can be serious, and for which you may need urgent medical treatment:

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

• heartburn, difficulty swallowing, pain when swallowing; ulcers in the gullet (esophagus - the tube that connects your mouth to your stomach), which can cause chest pain, heartburn, or difficulty or pain when 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 can cause difficulty breathing or swallowing; severe skin reactions,
• pain in the mouth and/or jaw, swelling or ulcers inside the mouth, numbness or a feeling of heaviness in the jaw, or tooth loss. These can be signs of jawbone damage (osteonecrosis) usually associated with delayed healing and infection, often after a tooth extraction. Inform your doctor and dentist if you experience these symptoms,
• atypical fractures of the thigh bone (femur) that can occur rarely, especially in patients on long-term treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as these can be early signs of a possible femur fracture,
• severe pain in bones, muscles, and/or joints.

Other side effects include

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

• pain in bones, muscles, and/or joints, which can be severe.

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

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

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

• nausea, vomiting,
• irritation or inflammation of the gullet (esophagus - the tube that connects your mouth to your stomach) or stomach,
• black or tarry stools,
• blurred vision; eye pain or redness,
• skin rash; redness of the skin,
• flu-like symptoms, such as muscle pain, general feeling of being unwell, and sometimes fever, which usually appear at the beginning of treatment,
• altered taste.

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

• symptoms of low blood calcium levels, including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth,
• stomach or duodenal ulcers, (sometimes severe or with bleeding),
• narrowing of the gullet (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, discharge from the ear, or an ear infection. These could be symptoms of damage to the bones of the ear.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) via their website: https://www.notificaram.es By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alendronic Acid Cinfamed

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alendronic Acid Cinfamed

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

Appearance of the product and pack contents

Alendronic Acid Cinfamed is presented in the form of tablets. The tablets are white, oval, and flat, marked on one side with "70".

Each pack contains 4 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

TEVA PHARMA, S.L.U.

Polígono Malpica C/C, nº 4

50016-Zaragoza

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of last revision of this leaflet:April 2019

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. 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