ALENDRONIC ACID/CHOLECALCIFEROL WEEKLY HEMONY 70 mg/2800 IU TABLETS

Introduction

Package Leaflet: Information for the User

Alendronic Acid/Cholecalciferol Weekly Hemony 70 mg/2,800 IU Tablets EFG

Alendronic Acid/Cholecalciferol

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

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

• Keep this leaflet, as 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.
• It is especially important that you understand the information in section 3, How to take Alendronic Acid/Cholecalciferol Weekly Hemony, before you take this medicine.

Contents of the pack

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

1. What is Alendronic Acid/Cholecalciferol Weekly Hemony and what is it used for

What is Alendronic Acid/Cholecalciferol Weekly Hemony?

This medicine is a tablet that contains two active ingredients, alendronic acid (commonly called alendronate) and cholecalciferol, also known as vitamin D3.

What is alendronate?

Alendronate belongs to a group of non-hormonal medicines called bisphosphonates. Alendronate prevents bone loss that occurs in women after they have entered menopause, and helps to rebuild bone. It reduces the risk of vertebral and hip fractures.

What is vitamin D?

Vitamin D is an essential nutrient, necessary for calcium absorption and to keep bones healthy. The body can only absorb calcium properly from food if it contains sufficient vitamin D, which occurs in very few foods. The main source of vitamin D is production in the skin, through exposure to sunlight. As we age, our skin produces less vitamin D. Vitamin D deficiency can lead to bone loss and osteoporosis, and in severe cases can cause muscle weakness that can result in falls and increase the risk of fractures.

What is this medicine used for?

Your doctor has prescribed this medicine to treat your osteoporosis and because you are at risk of having a vitamin D deficiency. This medicine reduces the risk of vertebral and hip fractures in women after menopause.

What is osteoporosis?

Osteoporosis causes wear and tear and fragility of the bones. It is common in women after menopause. During menopause, the ovaries stop producing a type of female hormone, estrogen, which helps to keep the skeleton healthy. As a result, bone loss occurs and the bones become more fragile. The earlier a woman reaches menopause, the greater the risk of osteoporosis.

Initially, osteoporosis does not present symptoms. However, if left untreated, it can cause bone fractures. Although these are usually painful, vertebral fractures can go unnoticed until they cause loss of height. Weakened bones can break during normal daily activity, such as getting up or from minor injuries that would not normally break a normal 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?

In addition to your treatment with this medicine, your doctor may suggest that you make changes to your lifestyle to help slow down your disease, such as:

Stopping smokingSmoking seems to increase the rate of bone loss and, therefore, may increase your risk of bone fractures.

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 on whether you should take any dietary supplements.

2. What you need to know before you take Alendronic Acid/Cholecalciferol Weekly Hemony

Do not take Alendronic Acid/Cholecalciferol Weekly Hemony

? if you are allergic to alendronate sodium trihydrate, cholecalciferol, or any of the other ingredients of this medicine (listed in section 6),

? if you have certain problems in your throat (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 calcium levels in your blood.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine if:

? you have kidney problems,

? you have, or have recently had, swallowing or digestive problems,

? your doctor has told you that you have Barrett's esophagus (a disease 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 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 thalidomide),

? you are taking corticosteroids (such as prednisone or dexamethasone),

? 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 this medicine.

It is important to maintain good oral hygiene when taking this medicine. 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 inflammation.

Irritation, inflammation, or ulcers of the throat (esophagus - the tube that connects your mouth to your stomach) may occur, often with symptoms of chest pain, heartburn, difficulty or pain swallowing, especially if patients do not drink a full glass of water and/or if they lie down before 30 minutes after taking this medicine. These side effects may worsen if patients continue to take this medicine after developing these symptoms.

Girls and adolescents

This medicine must not be given to girls and adolescents under 18 years of age.

Taking Alendronic Acid/Cholecalciferol Weekly Hemony 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 some oral medicines may interfere with the absorption of this medicine if taken at the same time. Therefore, it is important that you follow the instructions given in section 3, How to take Alendronic Acid/Cholecalciferol Weekly Hemony, and wait at least 30 minutes before taking any other medicine or supplement.

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

Certain medicines or food additives may prevent the absorption of vitamin D from this medicine, including artificial fat substitutes, mineral oils, weight loss medicine, orlistat, and cholesterol-lowering medicines, cholestyramine, and colestipol. Medicines for epilepsy (seizures) (such as phenytoin or phenobarbital) may decrease the effectiveness of vitamin D. Individual consideration may be given to the need for additional vitamin D supplements.

Taking Alendronic Acid/Cholecalciferol Weekly Hemony with food and drinks

Food and drinks (including mineral water) may reduce the effectiveness of this medicine if taken at the same time. Therefore, it is important that you follow the advice given in section 3, How to take Alendronic Acid/Cholecalciferol Weekly Hemony. You should wait at least 30 minutes before taking any food and drinks except water.

Pregnancy and breastfeeding

This medicine is only intended for use in postmenopausal women. You should not take this medicine if you are pregnant or think you may be pregnant, or if you are breastfeeding.

Driving and using machines

Side effects with this medicine (such as blurred vision, dizziness, and severe bone, muscle, or joint pain) may affect your ability to drive or use machines. (See Possible side effects). If you experience any of these side effects, do not drive until you feel better.

This medicine contains lactose and sucrose.

This medicine contains lactose and sucrose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Alendronic Acid/Cholecalciferol Weekly Hemony

Follow the instructions for administration of this medicine exactly as prescribed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Take one tablet of this medicine once a week.

Follow these instructions carefully.

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

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

1. After getting up in the morning and before taking any food, drink, or other medicine, swallow the Alendronic Acid/Cholecalciferol Weekly Hemony tablet whole with a full glass of water (not less than 200 ml), so that this medicine is 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 juice or milk.

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

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 the first meal of the day.

1. Do not take this medicine 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 this medicine and inform your doctor.

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

If you take more Alendronic Acid/Cholecalciferol Weekly Hemony than you should

If you take too many tablets by mistake, drink a full glass of milk and consult 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, 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Alendronic Acid/Cholecalciferol Weekly Hemony

If you forget a dose, take a single tablet the next morning. Do not take two tablets on the same day.Then, take one tablet once a week, on the original day you chose.

If you stop taking Alendronic Acid/Cholecalciferol Weekly Hemony

It is important that you take Alendronic Acid/Cholecalciferol Weekly Hemony while your doctor prescribes it for you. As it is not known how long you should take this medicine, you should discuss with your doctor periodically the need to continue treatment with this medicine to determine if Alendronic Acid/Cholecalciferol Weekly Hemony is still suitable for you.

A Instructions Card is included in the box of this medicine. It contains important information to remind you how to take this medicine correctly.

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.

Consult your doctor immediatelyif you experience any of the following side effects, which may be serious and require urgent medical treatment:

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

? heartburn; difficulty swallowing; pain swallowing; ulcers in the throat (esophagus - the tube that connects your mouth to your stomach) that may cause chest pain, heartburn, or difficulty or pain 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,

? 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 may be signs of damage to the bone in the jaw (osteonecrosis) usually associated with delayed healing and infection, often after a dental extraction. Contact your doctor and dentist if you experience these symptoms,

? atypical fractures of the thigh bone (femur) that may 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 may be early symptoms of a possible fracture of the femur,

? severe pain in bones, muscles, and/or joints.

Other side effects include

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

? pain, sometimes severe, in bones, muscles, and/or joints.

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 bloated stomach or swollen stomach; 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 throat (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,

? transient symptoms, similar to those of 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 sensation in the fingers or around the mouth,

? stomach or duodenal ulcers (sometimes severe or with bleeding),

? narrowing of the throat (esophagus - the tube that connects your mouth to your stomach),

? skin rash that worsens with sunlight,

? ulcers in the mouth.

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, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alendronic Acid/Cholecalciferol Weekly Hemony

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

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

Store in the original blister to protect from moisture and light.

Do not store above 30°C.

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 to protect the environment.

6. Packaging Contents and Additional Information

Composition of Alendronic Acid/Cholecalciferol Weekly Hemony

The active ingredients are alendronic acid and cholecalciferol (vitamin D3). Each tablet

contains 70 mg of alendronic acid (as sodium trihydrate salt) and 70 micrograms (2,800 IU) of cholecalciferol (vitamin D3).

The other ingredients are microcrystalline cellulose (E-460), anhydrous lactose, medium-chain triglycerides, gelatin, sodium croscarmellose, sucrose, anhydrous colloidal silica, magnesium stearate (E-572), butylhydroxytoluene (E-321), and modified cornstarch.

Appearance of the Product and Packaging Contents

The Alendronic Acid/Cholecalciferol Weekly Hemony 70 mg/2,800 IU tablets are white, capsule-shaped, and marked with "28" on one side and smooth on the other.

The tablets are supplied in aluminum blisters, in cardboard boxes, in the following package sizes:

• 4 tablets (1 blister containing 4 tablets)

Marketing Authorization Holder

Hemony Pharmaceutical Germany GmbH

Plan 5

20095 Hamburg

Germany

Manufacturer

GE PHARMACEUTICALS LTD.

Industrial Zone Chekanitza South Area

Botevgrad

2140 Bulgaria

Date of the Last Revision of this Leaflet:March 2017

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/