Package Leaflet: Information for the User

Alendronic Acid Weekly STADA 70 mg 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Alendronic Acid Weekly STADA is and what it is used for

2. What you need to know before you start taking Alendronic Acid Weekly STADA

3. How to take Alendronic Acid Weekly STADA

4. Possible side effects

5. Storage of Alendronic Acid Weekly STADA

6. Contents of the pack and additional information

Alendronatebelongs to a group of medicines called bisphosphonates. Alendronate stops bone loss and reduces the risk of vertebral and hip fractures.

Alendronic Acid Weekly STADA is used:

• to treatosteoporosis. Alendronic Acid Weekly STADA has demonstrated a reduction in the risk of vertebral and hip fractures inwomen.

Alendronic Acid Weekly STADA is a weekly treatment.

Osteoporosis is a thinning and weakening of the bones. Initially, osteoporosis usually does not have symptoms, however, if left untreated, it can result in bone fractures. Although these are usually painful, vertebral fractures can go unnoticed until a loss of height occurs. Fractures can occur during daily activities, such as standing up, or from minor injuries that would not damage a normal bone. Fractures typically occur in the hip, spine, or wrist and can cause not only pain but also significant problems such as a hunched posture (“widow's hump”) and loss of mobility.

As well as treatment with Alendronic Acid Weekly STADA, your doctor may suggest changes to your lifestyle (e.g., exercise and dietary recommendations, quitting smoking) to help manage your condition. Consult with your doctor for more information on lifestyle changes.

Do not take Alendronate Sodium STADA Weeklyif you

• areallergicto alendronate, other bisphosphonates, or any of the other components of this medication (listed in section 6)
• havecertain esophageal abnormalities, such as narrowing or difficulty swallowing (a condition called achalasia)
• cannotremain upright or standing for at least 30 minutes
• havelow calcium levels in your blood

If you think any of these cases apply to you, do not take the tablets. Consult your doctor and follow their advice. (See also section 3 “How to take Alendronate Sodium STADA Weekly”)

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Alendronate Sodium STADA:

• if you havekidney problems
• if you have any allergies
• if you have anyswallowing difficultiesordigestive problems, such as inflammation of the stomach or duodenal wall, or if you have had severe stomach or intestinal disease, such as ulcers, bleeding, or surgery in the stomach or esophagus in the past year.
• if your doctor has told you that you haveBarrett's esophagus(a condition associated with changes in the cells lining the lower esophagus)
• if you have problems with calcium absorption or other issues that may causelow calcium levels in your blood, such as low vitamin D levels or a condition called hypoparathyroidism. Your doctor may prescribe a calcium or vitamin D supplement to prevent low calcium levels in your blood.
• if you havecancer
• if you are takingcorticosteroids(medications used to treat inflammation)

• if you are receivingchemotherapy or radiation therapy
• if you are being treated withangiogenesis inhibitors(such as bevacizumab or thalidomide),
• ifyou smoke
• if you have poor dental hygiene, gum disease, or a planned tooth extraction

You may be advised to have a dental check-up before starting treatment with Alendronate Sodium STADA.

It is essential to maintain good oral hygiene while taking Alendronate Sodium STADA. 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.

If you arebeing treated by a dentistor if you are planning to undergodental surgery or tooth extraction, inform your dentist that you are taking Alendronate Sodium STADA.

There may be irritation, inflammation, or ulceration of theesophaguswith symptoms of chest pain, burning, difficulty, or pain swallowing, especially if you do not follow the correct dosing instructions or your doctor's instructions (see also section 3 "How to take Alendronate Sodium STADA"). If you experience any of these symptomsstop takingAlendronate Sodium STADA andconsult your doctor immediately. See also section 4 "Possible side effects". If you ignore these symptoms and continue taking the tablets, it is likely that these throat reactions will worsen.

This medication may affect your blood calcium and phosphate levels. It is essential to inform your doctor that you are taking Alendronate Sodium STADA if you need to undergo ablood test.

Children and Adolescents

Alendronate Sodium STADA should not be administered to children or adolescents.

Other Medications and Alendronate Sodium STADA

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

Inform your doctor if you are takingcorticosteroids(medications used to treat inflammation). You may need to undergo some tests before starting treatment with Alendronate Sodium STADA (e.g., dental examination).

You may experience stomach irritation if you take analgesics (e.g., aspirin, ibuprofen) with Alendronate Sodium STADA.

The following medications may interfere with the absorption of Alendronate Sodium STADA if taken at the same time:

Therefore, you should waitat least 30 minutesafter taking Alendronate Sodium STADA before taking any other medication (see also section 3 "How to take Alendronate Sodium STADA").

Taking Alendronate Sodium STADA with Food and Beverages

It is likely that foods and beverages (including mineral water) will make Alendronate Sodium STADA less effective if taken at the same time. Therefore, it is essential to follow the advice given in section 3. "How to take Alendronate Sodium STADA".

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should not take Alendronate Sodium STADA if you are or think you may be pregnant.

Breastfeeding

You should not take Alendronate Sodium STADA if you are breastfeeding.

Driving and Operating Machinery

Alendronate Sodium STADA may cause side effects (including blurred vision, dizziness, and severe bone, muscle, or joint pain) that may affect your ability to drive or operate machinery. Individual responses to Alendronate Sodium STADA may vary (see section 4 "Possible side effects").

Alendronate Sodium STADA contains lactose

If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

Alendronate Sodium STADA contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet: that is, it is essentially “sodium-free”.

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

The recommended dose of Alendronate Sodium STADA isone tabletonce a week(always choose the same day of the week).

It is very important that you carefully follow the instructions below to get the maximum benefit from your medication and avoid problems in your esophagus.

1. After getting up in the morning and before taking any food, drink, or other medication, swallow the entire Alendronate Sodium STADA tabletwith a full glass of tap water(NOT mineral water; not less than 200 ml or 7 fl.oz).
   • 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.

1. Do not chew or crush the tablet or let it dissolve in your mouth.

1. Do not lie down -remain upright (sitting, standing, or walking) - for at least 30 minutesafter swallowing the tablet. Do not lie down until after the first meal of the day.

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

1. Do not take Alendronate Sodium STADA at bedtime or before getting up in the morning.

1. If you have difficulty or pain swallowing, chest pain, or the appearance or worsening of stomach acid, stop taking Alendronate Sodium STADA and contact your doctor.

1. It is essential that you continue taking Alendronate Sodium STADA for as long as your doctor prescribes the medication. Alendronate Sodium STADA can only treat your osteoporosis if you continue taking the tablets.

If you take more Alendronate Sodium STADA than you should

If you accidentally take too many tablets, drink a full glass of milk to prevent the tablets from taking effect and consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Do not induce vomiting and do not lie down.

The symptoms of an overdose of alendronate may include

If you forget to take Alendronate Sodium STADA

If you forget to take a dose, take a single tablet the next morning after remembering. Do not take a double dose to compensate for the missed doses. Do not take two tablets on the same day. After that, take a tablet once a week, on the original day chosen. If unsure, consult your doctor.

If you interrupt treatment with Alendronate Sodium STADA

Always consult your doctor, if you want to stop taking Alendronate Sodium STADA or if you want to change the prescribed dosing schedule. Do not interrupt or suspend treatment without consulting your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop takingAlendronate Sodium STADA andconsult your doctor immediatelyif you have any of the following symptoms:

• severe allergic reaction symptoms (angioedema, which occurs rarely[may affect up to 1 in 1,000 people]) such as
• • swelling of the face, tongue, or throat and/or
  • difficulty swallowing and difficulty breathing and/or
  • hives

• severe skin reactions (which occur very rarely [may affect up to 1 in 10,000 people]) such as hives, blisters, or other skin, eye, mouth, or genital effects, itching, or burning (symptoms of the skin reaction called Stevens-Johnson syndrome or toxic epidermal necrolysis)

• chest pain, new or worsening burning, difficulty or pain swallowing (this may indicate esophageal irritation, inflammation, or ulceration; occurs frequently [may affect up to 1 in 10 people]). If you ignore these symptoms and continue taking the tablets, these esophageal reactions may worsen.

Other side effects include

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

• bone, muscle, and/or joint pain, which is sometimes severe.

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

• headache
• dizziness
• abdominal pain, feeling of nausea in the stomach or belching after eating, constipation, feeling of fullness or bloating in the stomach, diarrhea, flatulence
• hair loss (alopecia)
• itching
• swelling of the joints
• fatigue
• swelling of the hands or legs
• dizziness

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

• feeling of dizziness, vomiting
• irritation or inflammation of the esophagus or stomach, damage to the esophageal mucosa (esophageal erosion)
• stool that is black or like tar
• skin rash, redness of the skin
• alteration of taste
• inflammation of the eye with blurred vision, pain, or redness of the eye
• transient symptoms similar to those of the flu, such as muscle pain, general feeling of malaise, and, sometimes, fever that usually appear at the beginning of treatment

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

• esophageal narrowing
• ulcers in the mouth or throat when the tablets have been chewed or sucked
• ulcers in the stomach or intestine (sometimes severe or with bleeding)
• eruption that worsens with sunlight
• symptoms of low calcium levels in the blood that include muscle cramps or spasms and/or tingling in the fingers or around the mouth
• pain in the mouth, and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness of 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 femoral fractures.Inform your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as they may be early signs and indicative of a possible femoral fracture.

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 symptoms of damage to the bones of the ear.

Reporting of 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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on 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 packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above25ºC. Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Alendronic Acid Weekly STADA

The active ingredient is alendronate sodium trihydrate. Each tablet contains 70 mg of alendronic acid as alendronate sodium trihydrate.

The other components are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, and magnesium stearate.

Appearance of the product and contents of the package

Alendronic Acid Weekly STADA tablets are presented in oval-shaped, white or almost white tablets.

The tablets are presented in triple-layer blisters, containing 2, 4, 8, 12, 14, 24, and 40 tablets, or in aluminum sachets, containing 2, 4, 8, 12, 14, 24, 40, and 100 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA S.L.

Frederic Mompou 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Responsible manufacturer

STADA Arzneimittel AG, Stadastr. 2-18, 61118 Bad Vilbel, Germany

or

STADA Arzneimittel Ges.m.b.H,Muthgasse 36/2, 1190 Vienna

or

Lab.Medicamentos Internacionales (Medinsa), La Solana, 26, Torrejon de Ardoz (Madrid) Spain

or

Sanico N.V., Veedijk 59, Industriezone IV, 2300 Turnhout, Belgium

or

Centrafarm Services B.V., Van deReijtstraat31-E, 4814 NE Breda, Netherlands

or

Clonmel Healthcare Ltd., Waterford Road, Clonmel, Co. Tipperary, Ireland

or

Qualiti (Burnley) Limited, talbot Street, Briercliffe, Burnley BB10 2JY, UK

or

Juta Pharma GmbH, Gutenbergstrasse13, 24941 Flensburg, Germany

or

STADA M&D SRL, Str.Trascaului, nr 10, Municipiul Turda, Judet Cluj 401135, Romania

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

GermanyAlendronsäure AL 70 mg Tablets

AustriaAlendronstad 70 mg once weekly - Tablets

BelgiumAlendronat EG 70 mg tablets

DenmarkAlendronate STADA

SpainAlendronic Acid Weekly STADA 70 mg EFG tablets

FranceAlendronate EG 70mg, tablet

NetherlandsAlendroninezuur CF 70 mg, tablets

IrelandOsteomel Once Weekly 70 mg tablets

ItalyAlendronato EG 70 mg compresse

LuxembourgAlendronat EG 70 mg comprimés

MaltaOsteomel Once Weekly 70 mg tablets

PortugalAlendronic Acid Cycle 70mg tablets

SwedenAlendronate STADA Weekly Tablet 70 mg tablets

Last review date of this leaflet:February 2022

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