ALENDRONIC ACID/CHOLECALCIFEROL WEEKLY AUROVITAS 70 mg/5600 IU TABLETS

Introduction

Package Leaflet: Information for the User

Alendronic Acid/Cholecalciferol Weekly Aurovitas 70 mg/5600 UI Tablets EFG

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.

• 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 before taking this medicine.

Contents of the pack

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

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

What is Alendronic Acid/Cholecalciferol Weekly?

This medicine is a tablet that contains two active substances, alendronic acid (commonly called alendronate) and cholecalciferol, 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 maintain healthy bones. The body can only absorb calcium properly from food if it contains sufficient vitamin D, which occurs with 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 maintain a healthy skeleton. 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 stooped 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 lifestyle changes 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 Aurovitas

Do not take Alendronic Acid/Cholecalciferol Weekly

• if you are allergic to alendronic acid, 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 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), which are used in the treatment of cancer,
• you are taking corticosteroids (such as prednisone or dexamethasone), which are 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 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 ulceration 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 when swallowing, especially if patients do not drink a full glass of water and/or if they lie down within 30 minutes of taking this medicine. These adverse 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 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, and that you 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.

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. The need for additional vitamin D supplements may be considered on an individual basis.

Taking Alendronic Acid/Cholecalciferol Weekly with food, drinks, and alcohol

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 instructions given in section 3. You should wait at least 30 minutes before taking any food and drinks, except water.

Pregnancy, breastfeeding, and fertility

This medicine is only intended for use in postmenopausal women. You must not take this medicine if you are pregnant or 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 before taking this medicine.

Driving and using machines

Some side effects of this medicine, such as blurred vision, dizziness, and severe bone, muscle, or joint pain, may affect your ability to drive or use machines (see section 4). If you experience any of these side effects, do not drive until you feel better.

This medicine containslactose and sucrose

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Alendronic Acid/Cholecalciferol Weekly Aurovitascontains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., it is essentially "sodium-free".

3. How to take Alendronic Acid/Cholecalciferol Weekly Aurovitas

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

Take one tablet of this medicineonce a week.

Follow these instructions carefully.

1. Choose the day of the week that best fits 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 tablet whole with a full glass of water (at least 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 your 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 when 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 your 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 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

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

If you stop taking Alendronic Acid/Cholecalciferol Weekly

It is important that you take Alendronic Acid/Cholecalciferol Weekly 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 is still suitable for you.

A Patient Instruction 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 for which you may need urgent medical treatment:

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

? heartburn; difficulty swallowing; pain when swallowing; ulcer in the throat (esophagus - the tube that connects your mouth to your stomach) that may 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 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 bone, muscle, and/or joint pain.

Frequency not known(cannot be estimated from the available data)

• Atypical fracture in places other than the thigh bone (femur).

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):

? joint swelling,

? 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 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 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 not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alendronic Acid/Colecalciferol Weekly Aurovitas

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 indicated.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofAlendronic Acid/Colecalciferol Weekly Aurovitas

• The active ingredients are: alendronic acid and colecalciferol (vitamin D3).

Each tablet contains 70 mg of alendronic acid (as alendronate sodium trihydrate) and 140 micrograms of colecalciferol (equivalent to 5,600 IU of vitamin D3).

Each tablet contains up to 64 mg of lactose and 27.5 mg of sucrose.

• The other ingredients are: lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, refined sunflower oil, butylhydroxytoluene (E-321), gelatin (gelling grade), sucrose, corn starch, and magnesium aluminum silicate.

Appearance of the Product and Package Contents

White to off-white tablets, modified rectangle shape, speckled, marked with 5600 on one side, 11.4±0.2 mm in length and 7.2±0.2 mm in width.

Alendronic Acid/Colecalciferol Weekly Aurovitas is available in blister packs.

Package Sizes: 4 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Pharmathen S.A.

6, Dervenakion Str.

15351 Pallini, Attiki

Greece

Or

Pharmathen International S.A.

Industrial Park Sapes, Rodopi Prefecture, Block No 5

69300 Rodopi

Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Alendronic Acid/Colecalciferol Weekly Aurovitas 70 mg/5,600 IU tablets EFG

Italy: Acido Alendronico e Colecalciferolo Aurobindo

Portugal: Alendronic Acid + Colecalciferol Generis

Date of the Last Revision of this Leaflet:July 2024

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