Alendronate Stada 70 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alendronic acid weekly STADA 70 mg tablets EFG

Read the entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Alendronic acid weekly STADA is and what it is used for
2. What you need to know before taking Alendronic acid weekly STADA
3. How to take Alendronic acid weekly STADA
4. Possible side effects
5. How to store Alendronic acid weekly STADA
6. Contents of the pack and other information

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

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

Alendronic Acid Weekly STADA is used:

• to treat osteoporosis. Alendronic Acid Weekly STADA has been shown to reduce the risk of vertebral and hip fractures in women.

Alendronic Acid Weekly STADA is a weekly treatment.

Osteoporosis is thinning and weakening of the bones. In the early stages, osteoporosis usually has no symptoms; however, if left untreated, it can result in bone fractures. Although fractures are usually painful, spinal fractures may go unnoticed until a loss of height occurs. Fractures may occur during everyday activities, such as standing up, or from minor injuries that would not harm a normal bone. Fractures typically occur in the hip, spine, or wrist, and may cause not only pain but also significant problems such as stooped posture ("dowager's hump") and loss of mobility.

Along with your treatment with Alendronic Acid Weekly STADA, your doctor may recommend that you make lifestyle changes (e.g., exercise and dietary advice, quitting smoking) to help manage your condition. Please consult your doctor for further information on lifestyle changes.

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

DO NOT take Alendronic Acid Weekly STADA if you

• are allergic to alendronate, other bisphosphonates, or any of the other ingredients of this medicine (listed in section 6)
• have certain disorders of your oesophagus (the tube connecting your mouth to your stomach), such as narrowing or if your oesophagus does not function properly, causing difficulty swallowing (a condition called achalasia)
• cannot remain upright or standing for at least 30 minutes
• have low levels of calcium in your blood

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Alendronic Acid Weekly STADA if:

• you have kidney problems
• you have any allergies
• you have difficulty swallowing or digestive problems, such as inflammation of the stomach or duodenal wall (the first part of the small intestine), or if you have had serious stomach or intestinal conditions such as ulcers, gastrointestinal bleeding, or stomach or oesophageal surgery within the past year
• your doctor has told you that you have Barrett’s oesophagus (a condition associated with changes in the cells lining the lower oesophagus)
• you have problems absorbing calcium or other conditions that may cause low blood calcium levels, such as low vitamin D levels or underactive parathyroid glands (a condition called hypoparathyroidism). Your doctor may prescribe calcium or vitamin D supplements to prevent low blood calcium levels
• you have cancer
• you are taking corticosteroids (medicines used to treat inflammation)
• you are receiving chemotherapy or radiotherapy
• you are being treated with angiogenesis inhibitors (such as bevacizumab or thalidomide)
• you smoke
• you have poor dental hygiene, gum disease, or have an upcoming dental extraction

You may be advised to have a dental check-up before starting treatment with Alendronic Acid Weekly STADA.

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

If you are being treated by a dentist or are scheduled for dental surgery or tooth extraction, inform your dentist that you are taking Alendronic Acid Weekly STADA.

Irritation, inflammation, or ulceration of the oesophagus may occur, often with symptoms such as chest pain, heartburn, or difficulty or pain when swallowing, especially if you do not follow the dosing instructions or your doctor’s advice correctly (see also section 3 “How to take Alendronic Acid Weekly STADA”). If you experience any of these symptoms, stop taking Alendronic Acid Weekly STADA and contact your doctor immediately. See also section 4 “Possible side effects”. If you ignore these symptoms and continue taking the tablets, these throat reactions may worsen.

This medicine may affect blood levels of calcium and phosphate. It is important to inform your doctor that you are taking Alendronic Acid Weekly STADA if you need to have a blood test.

Children and adolescents

Alendronic Acid Weekly STADA must not be given to children or adolescents.

Other medicines and Alendronic Acid Weekly STADA

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

Inform your doctor if you are taking corticosteroids (medicines used to treat inflammation). You may need certain tests before starting treatment with Alendronic Acid Weekly STADA (e.g., a dental examination).

You may experience stomach irritation if you take painkillers (e.g., acetylsalicylic acid, ibuprofen) together with Alendronic Acid Weekly STADA.

The following medicines may interfere with the absorption of Alendronic Acid Weekly STADA if taken at the same time:

• calcium supplements
• antacids (medicines used to relieve heartburn)
• some oral medicines

Therefore, you should wait at least 30 minutes after taking Alendronic Acid Weekly STADA before taking any other medicine (see also section 3 “How to take Alendronic Acid Weekly STADA”).

Taking Alendronic Acid Weekly STADA with food and drink

Food and drinks (including mineral water) may make Alendronic Acid Weekly STADA less effective if taken at the same time. Therefore, it is important to follow the advice given in section 3 “How to take Alendronic Acid Weekly STADA”.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You must not take Alendronic Acid Weekly STADA if you are pregnant or think you may be pregnant.

Breastfeeding

You must not take Alendronic Acid Weekly STADA while breastfeeding.

Driving and using machines

Alendronic Acid Weekly STADA may cause side effects (including blurred vision, dizziness, and severe bone, muscle, or joint pain) that could affect your ability to drive or operate machinery. Individual responses to Alendronic Acid Weekly STADA may vary (see section 4 “Possible side effects”).

Alendronic Acid Weekly STADA contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

Alendronic Acid Weekly STADA contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet: essentially “sodium-free”.

3. How to take Alendronic Acid Weekly STADA

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose of Alendronic Acid Weekly STADA is one tablet once a week (always choose the same day of the week).

It is very important that you carefully follow the instructions below so that you obtain the maximum benefit from your medicine and avoid problems in your oesophagus.

1. After getting up in the morning and before taking any food, drink, or other medicine, swallow the Alendronic Acid Weekly STADA tablet whole with a full glass of tap water (NOT mineral water; no less than 200 ml or 7 fl.oz).

   • Do not take it with mineral water (still or sparkling).
   • Do not take it with coffee or tea.
   • Do not take it with juices or milk.

2. Do not chew, crush, or allow the tablet to dissolve in your mouth.

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 your first meal of the day.

4. After swallowing your Alendronic Acid Weekly STADA tablet, wait at least 30 minutes before taking any food, drink, or other medication of the day, including antacids, calcium supplements, and vitamins. Alendronic Acid Weekly STADA is effective only if taken on an empty stomach.

5. Do not take Alendronic Acid Weekly STADA at bedtime or before getting up in the morning.

6. If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking Alendronic Acid Weekly STADA and contact your doctor.

7. It is important that you continue taking Alendronic Acid Weekly STADA for as long as your doctor prescribes it. Alendronic Acid Weekly STADA can treat your osteoporosis only if you continue taking the tablets.

If you take more Alendronic Acid Weekly STADA than you should

If you take too many tablets by mistake, drink a full glass of milk to help prevent the tablets from having an effect, and immediately contact your doctor or pharmacist, or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount ingested. Do not induce vomiting and do not lie down.

Symptoms of an overdose of alendronic acid may include:

• Low calcium levels in the blood, with symptoms such as skin sensations, e.g., numbness, burning, stinging, itching, or tingling (paresthesia) or involuntary muscle contractions
• Low phosphate levels in the blood, with symptoms such as muscle dysfunction and weakness
• Stomach discomfort and heartburn
• Inflammation of the throat or stomach lining and ulcers.

If you forget to take Alendronic Acid Weekly STADA

If you forget to take a dose, take one tablet the morning after you remember. Do not take a double dose to make up for forgotten doses. Do not take two tablets on the same day. Then resume taking one tablet once a week on the originally chosen day. If you are unsure, consult your doctor.

If you stop taking Alendronic Acid Weekly STADA

Always consult your doctor if you wish to stop taking Alendronic Acid Weekly STADA or if you want to change the prescribed dosing schedule. Do not interrupt or stop treatment without consulting your doctor.

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

4. Possible adverse effects

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

Stop taking Alendronic acid STADA weekly and consult your doctor immediately if you experience any of the following symptoms:

• symptoms of a severe allergic reaction (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 (very rare [may affect up to 1 in 10,000 people]) such as rash, blisters or other skin effects, eyes, mouth or genitals, itching or burning (symptoms of skin reactions known as Stevens-Johnson syndrome or toxic epidermal necrolysis)

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

Other adverse effects include

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

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

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

• headache
• dizziness
• abdominal pain, stomach discomfort or burping after meals, constipation, feeling of fullness or bloating of the stomach, diarrhoea, flatulence
• hair loss (alopecia)
• itching
• joint swelling
• fatigue
• swelling of the hands or legs
• vertigo

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

• feeling of dizziness, vomiting
• irritation or inflammation of the oesophagus or stomach, damage to the oesophageal mucosa (oesophageal erosion)
• black or tar-like stools
• skin rash, redness of the skin
• altered taste
• eye inflammation with blurred vision, eye pain or redness
• transient flu-like symptoms such as muscle pain, general malaise and, sometimes, fever, which usually occur at the beginning of treatment

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

• narrowing of the oesophagus
• mouth or throat ulcers when the tablets have been chewed or sucked
• stomach or intestinal ulcers (sometimes severe or with bleeding)
• rash that worsens with sunlight
• symptoms of low calcium levels in the blood including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth
• 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 following a tooth 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 these may be early signs indicating a possible femoral fracture.

Very rare (may affect up to 1 in 10,000 people)

• consult your doctor if you have ear pain, ear discharge or an ear infection. These could be symptoms of damage to the ear bones.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alendronic Acid Weekly STADA

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Keep in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alendronic Acid Weekly STADA

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

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

Appearance of the medicine and contents of the pack

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

The tablets are supplied in triplex 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 certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA S.L.
Frederic Mompou 5
08960 Sant Just Desvern
(Barcelona)
[email protected]

Manufacturer

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

or

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

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 de Reijtstraat 31-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, United Kingdom

or

Juta Pharma GmbH, Gutenbergstrasse 13, 24941 Flensburg, Germany

or

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

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

Germany Alendronsäure AL 70 mg Tabletten
Austria Alendronstad 70 mg einmal wöchentlich - Tabletten
Belgium Alendronat EG 70 mg tabletten
Denmark Alendronat STADA
Spain Ácido Alendrónico Semanal STADA 70 mg comprimidos EFG
France Alendronate EG 70mg, comprimé
Netherlands Alendroninezuur CF 70 mg, tabletten
Ireland Osteomel Once Weekly 70 mg tablets
Italy Alendronato EG 70 mg compresse
Luxembourg Alendronat EG 70 mg comprimés
Malta Osteomel Once Weekly 70 mg tablets
Portugal Ácido Alendrónico Ciclum 70mg comprimidos
Sweden Alendronat STADA Veckotablett 70 mg tabletter

Date of the most recent revision of this leaflet: February 2022

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