Leaflet: information for the user

Alendronic acid/Calcitriol WeeklyStada70mg/2.800UI tablets EFG

Read 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.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• It is especially important that you understand the information included in section 3. How to take Alendronic acid/alcitriol Weekly, before taking this medicine.

What is Alendronate/Colecalciferol Weekly?

This medication is a tablet that contains two active ingredients, alendronate (commonly known as alendronate) and colecalciferol, also known as vitamin D3.

What is Alendronate?

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

What is Vitamin D?

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

Why is this medication used?

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

What is Osteoporosis?

Osteoporosis causes wear and fragility of the bones. It is common in women after menopause. In 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 her risk of osteoporosis.

Initially, osteoporosis does not present symptoms. However, if left untreated, it can cause bone fractures. Although these are usually painful, spinal fractures can go unnoticed until they cause loss of height. Weakened bones can break during normal daily activities, such as standing up or 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 back (widow's hump) and loss of mobility.

How can Osteoporosis be treated?

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

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

ExerciseAs muscles and 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.

Do not take Alendronate/Colecalciferol Weekly

?if you are allergic to alendronate sodium trihydrate, colecalciferol, or any of the other components of this medication (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 remain standing or sitting 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 cases 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 medication 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 cover 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 tooth extraction, or do not receive regular dental care,

?you have cancer,

?you are undergoing chemotherapy or radiation therapy,

• youarebeing treated 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 medication.

It is essential to maintain good oral hygiene while taking this medication. 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 esophageal ulceration (esophagus - 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 this medication. These adverse effects may worsen if patients continue taking this medication after developing these symptoms.

Girls and Adolescents

This medication should not be administered to girls and adolescents under 18 years of age.

Taking Alendronate/Colecalciferol Weekly with Other Medications

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

It is likely that calcium supplements, antacids, and some oral medications will interfere with the absorption of this medication if taken at the same time. Therefore, it is essential to follow the instructions given in the section 3. How to Take Alendronate/Colecalciferol Weekly and wait at least 30 minutes before taking any other medication or supplement.

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 Alendronate/Colecalciferol Weekly.

It is likely that certain medications or food additives will prevent the absorption of the vitamin D in this medication, including artificial fat substitutes, mineral oils, weight loss medication, orlistat, and cholesterol-lowering medications, cholestyramine, and colestipol. Medications for epilepsy (seizures) (such as phenytoin or phenobarbital) may reduce the effectiveness of vitamin D. Individually, it may be considered necessary to take additional vitamin D supplements.

Taking Alendronate/Colecalciferol Weekly with Food and Drinks

It is likely that food and drinks (including mineral water) will reduce the effectiveness of this medication if taken at the same time. Therefore, it is essential to follow the advice given in the section 3. How to Take Alendronate/Colecalciferol Weekly. You should wait at least 30 minutes before taking any food and drinks except water.

Pregnancy and Breastfeeding

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

Driving and Operating Machines

Adverse effects associated with this medication (such as blurred vision, dizziness, and intense bone, muscle, or joint pain) may affect your ability to drive or operate machines. (See Possible Adverse Effects). If you experience any of these adverse effects, do not drive until you feel better.

This Medication Contains Lactose and Sucrose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This Medication Contains Sodium

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

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 this medicationonce a week.

Follow these instructions carefully.

1)Choose the day of the week that best fits your routine. Every week, take one tablet of this medication on the day you have chosen.

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

2)After getting up in the morning and before taking any food, drink, or other medication, swallow the entire Ácido alendrónico/colecalciferol Weekly tablet only with a full glass of water (not mineral water) (not less than 200 ml), so that this medication 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 mouth ulcers appearing.

3)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.

4)Do not take this medication at bedtime or before getting up in the morning.

5)If you have difficulty or pain swallowing, chest pain, or new or worsening heartburn, stop taking this medication and inform your doctor.

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

If you take more Ácido alendrónico/colecalciferol Weekly 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Ácido alendrónico/colecalciferol Weekly

If you forget a dose, take one tablet the next morning after remembering. Do not take two tablets on the same day.Then, take one tablet once a week, on the originally chosen day.

If you interrupt treatment with Ácido alendrónico/colecalciferol Weekly

It is essential to take Ácido alendrónico/colecalciferol Weekly while your doctor prescribes the medication. Since it is unknown for how long you should take this medication, you must periodically discuss with your doctor the need to continue treatment with this medication to determine if Ácido alendrónico/colecalciferol Weekly is still suitable for you.

In the box of this medication, there is a Instructions Card. It contains important information to remind you how to take this medication correctly.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience 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:

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 pain, 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. Contact 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

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 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 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 those of 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 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),

?esophageal stricture (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, the ear is discharging, or you have an ear infection. These may be signs of damage to the ear bones.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if they seem like possible side effects that do not appear in this prospectus. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and the blister pack

after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash.Deposit containers and unused medicines at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of containers and unused medicines. By doing so, you will help protect the environment.

C Composition of Alendronic Acid/Colecalciferol Weekly Stada

The active principles are alendronic acid and colecalciferol (vitamin D 3 ). Each tablet contains 70 mg of alendronic acid (as sodium trihydrate salt) and 70 micrograms (2.800 UI) of colecalciferol (vitamin D 3 ).

The other components are microcrystalline cellulose, lactose, sodium croscarmellose, magnesium stearate, refined sunflower oil, butylhydroxytoluene (BHT)-E-321, gelatin, sucrose, cornstarch and aluminium and magnesium silicate.

Appearance of the product and contents of the packaging

Alendronic Acid/Colecalciferol Weekly Stada 70 mg/2.800 UI tablets are white to off-white, oblong, biconvex, speckled, marked with “2800” on one face, 12.3 ± 0.2 mm in length and 6.5 ± 0.2 mm in width.

This medication is available in Aluminium/Aluminium (PA/Al/PVC-Al) blisters, in packs containing 4 or 12 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for Manufacturing

Pharmathen International S.A

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

69300 Rodopi,

Greece

or

Pharmathen S.A.

6, Dervenakion street

Pallini 15351

Athens

Greece

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

Last review date of this leaflet: August 2020

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