ALENDRONIC ACID WEEKLY PENSA 70 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Alendronic Acid Weekly pensa 70 mg Film-Coated 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.
• 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 particularly important that you understand the information in section 3. How to take Alendronic Acid Weekly pensa, before you take this medicine.

Contents of the pack

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

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

What is alendronic acid?

Alendronic acid belongs to a group of non-hormonal medicines called bisphosphonates.

Alendronic acid prevents bone loss in women after the menopause and helps to rebuild bone. Alendronic acid reduces the risk of spinal and hip fractures.

What is Alendronic Acid Weekly pensa used for?

Your doctor has prescribed alendronic acid for the treatment of your osteoporosis. Alendronic acid reduces the risk of spinal and hip fractures.

Alendronic Acid Weekly pensa is a weekly treatment.

What is osteoporosis?

Osteoporosis is a thinning and weakening of the bones. It is common in women after the menopause. At the menopause, the ovaries stop producing the female hormone, oestrogen, which helps to keep a woman's skeleton healthy.

As a result, bone loss occurs and the bones become weaker. The earlier a woman reaches the menopause, the greater her risk of osteoporosis.

For a long time, osteoporosis usually has no symptoms. However, if left untreated, it can result in broken bones. Although these usually hurt, spinal fractures can go unnoticed until they cause loss of height. Bones can break during normal everyday activity, such as lifting or minor injuries that would not normally break a bone. Fractures usually occur in the hip, spine or wrist and can not only be painful but also cause considerable problems such as a curved back (dowager's hump) and loss of mobility.

Osteoporosis can be treated and it is never too late to start treatment. Alendronic acid not only prevents further bone loss but actually helps to rebuild bone that you may have lost and reduces the risk of bone fractures in the spine and hip.

As well as your treatment with alendronic acid, your doctor may suggest that you make changes to your lifestyle to help your condition, such as:

Stopping smoking.Smoking appears to increase the rate at which you lose bone and may therefore increase your risk of broken bones.

Exercise.Like muscles, bones need exercise to stay strong and healthy. Consult your doctor before starting any exercise programme.

Eating a balanced diet.Your doctor may advise you about your diet or whether you should take any dietary supplements (especially calcium and vitamin D).

2. What you need to know before you take Alendronic Acid Weekly pensa

Do not takeAlendronic Acid Weekly pensa

• If you are allergic to alendronate sodium trihydrate or any of the other ingredients of this medicine (listed in section 6).
• If you have certain problems with your gullet (oesophagus - the tube that connects your mouth with 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 blood calcium levels

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

Warnings and precautions

Consult your doctor before taking Alendronic Acid Weekly pensa.

It is important that you tell your doctor before taking Alendronic Acid Weekly pensa if:

• you have kidney problems,
• you have digestive problems or problems swallowing,
• your doctor has told you that you have Barrett's oesophagus (a condition associated with changes in the cells that line the lower part of the oesophagus),
• your doctor has told you that you have low blood calcium levels,
• you have poor dental health, gum disease, a planned dental extraction or do not receive regular dental check-ups,
• you have cancer,
• you are undergoing chemotherapy or radiotherapy,
• you are taking corticosteroids (such as prednisone or dexamethasone),
• you are being treated with angiogenesis inhibitors (such as bevacizumab or thalidomide),
• 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 alendronic acid.

It is important to maintain good oral hygiene when you are taking alendronic acid. You should have regular dental check-ups throughout your treatment and should contact your doctor or dentist if you experience any problems with your mouth or teeth, such as loose teeth, pain or swelling.

Irritation, inflammation or ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) may occur, often with symptoms of chest pain, burning or difficulty swallowing, especially if patients do not drink a full glass of water and/or if they lie down after taking alendronic acid. These side effects may get worse if patients continue taking alendronic acid after developing these symptoms.

Children and adolescents

Alendronic Acid Weekly pensa should not be given to children or adolescents.

Other medicines andAlendronic Acid Weekly pensa

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

Calcium supplements, antacids and other oral medicines may interfere with the absorption of alendronic acid, if taken at the same time. Therefore, it is important that you follow the advice given in section 3.

Certain medicines for rheumatism or long-term pain, called NSAIDs (e.g. aspirin or ibuprofen), may cause digestive problems. Therefore, caution is advised if these medicines are taken at the same time as alendronic acid.

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

TakingAlendronic Acid Weekly pensawith food, drinks and alcohol

Food and drinks (including mineral water) may reduce the effectiveness of alendronic acid, if taken at the same time. Therefore, it is important that you follow the advice given in section 3. “How to take Alendronic Acid Weekly pensa”.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Alendronic acid is only intended for use in postmenopausal women. Do not take alendronic acid if you are pregnant or think you may be pregnant, or if you are breast-feeding.

Driving and using machines

Alendronic acid has been associated with adverse effects (including blurred vision, dizziness and severe bone, muscle or joint pain) that may affect your ability to drive or use machines. Individual responses to alendronic acid may vary. (See Possible side effects).

Alendronic Acid Weekly pensa contains sodium

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

3. How to take Alendronic Acid Weekly pensa

Take onealendronic acid tablet once a week.

Follow exactly the instructions for administration given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Follow these instructions carefully to ensure you benefit from alendronic acid.

1. Choose the day of the week that best fits your schedule. Every week, take one alendronic acid tablet on the day you have chosen.

It is very important that you follow the instructions 2, 3, 4 and 5 to help the alendronic acid tablet reach your stomach quickly and to help reduce the chance of irritation to your gullet (oesophagus - the tube that connects your mouth with your stomach).

1. After getting up for the day and before taking any food, drink or other medicine, swallow your alendronic acid tablet whole with a full glass of water (not less than 200 ml) (do not take with mineral water).
   • do not take with mineral water (fizzy or still).
   • do not take with coffee or tea.
   • do not take with juice or milk.

Do not crush or chew the tablet or let it dissolve in your 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 food of the day.

1. Do not take alendronic acid at bedtime or before getting up for the day.

1. If you have difficulty or pain upon swallowing, chest pain or new or worsening heartburn, stop taking alendronic acid and tell your doctor.

1. After swallowing your alendronic acid tablet, wait at least 30 minutes before taking any food, drink or other medicine, including antacids, calcium supplements and vitamins. Alendronic acid is only effective if taken on an empty stomach.

If you take more Alendronic Acid Weekly pensa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or contact the national poison control centre, phone: 91 562 04 20, quoting the medicine and the amount taken.

If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately. Do not try to vomit and do not lie down.

If you forget to take Alendronic Acid Weekly pensa

If you miss a dose, wait until the next morning to take your alendronic acid tablet. Do not take two tablets in one day. After that, go back to taking one tablet once a week, on the day you originally chose.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Alendronic Acid Weekly pensa

It is important that you continue taking alendronic acid for as long as your doctor prescribes it. Alendronic acid can only treat your osteoporosis if you continue taking the tablets.

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.

The following terms are used to describe how often side effects may occur:

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):

• heartburn; difficulty swallowing; pain upon swallowing; ulcers in the gullet (oesophagus - the tube that connects your mouth with your stomach) which may cause chest pain, heartburn or difficulty swallowing,
• swelling of the joints,
• abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; feeling of having a bloated stomach or feeling full; diarrhoea; wind,
• 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 gullet (oesophagus - the tube that connects your mouth with your stomach) or stomach,
• black or tar-like stools,
• blurred vision; eye pain or redness,
• skin rash; redness of the skin,
• flu-like symptoms such as muscle pain, general feeling of being unwell and, some times, fever, which usually occur at the start of treatment,
• change in taste.

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,
• symptoms of low blood calcium levels, 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 gullet (oesophagus - the tube that connects your mouth with your stomach),
• skin rash made worse by sunlight; severe skin reactions,
• mouth or jaw pain, and/or swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loss of a tooth. These could be signs of bone damage in the jaw (osteonecrosis) often associated with delayed healing and infection, usually after a tooth extraction. Contact your doctor and dentist if you experience these symptoms,
• atypical fractures of the thigh bone (femur) which may occur very rarely, especially in patients on long-term treatment for osteoporosis. Tell your doctor if you experience pain, weakness or discomfort in the thigh, hip or groin, as these may be early signs of a possible fracture of the thigh bone,
• mouth ulcers when the tablets have been chewed or sucked.

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

• Tell your doctor if you have ear pain, discharge from the ear or an ear infection. These could be signs of bone damage in the ear.

Laboratory findings:

Very common: mild and transient decreases in blood calcium and phosphate levels, usually within the normal range.

Paediatric population:

Alendronate sodium has been studied in a small number of patients under 18 years of age with osteogenesis imperfecta. The results are insufficient to support the use of alendronate sodium in paediatric patients with osteogenesis imperfecta.

Tell your doctor or pharmacist about these or any other symptoms.

It will help if you keep a note of when they happen, how long they last and anything that may have triggered them.

Reporting of side effects:

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System of Medicines for Human Use http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alendronic Acid Weekly pensa

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 refers to the last day of that month.

This medicine does not require any special storage conditions. Do not remove the tablets from the blister pack until you are ready to take them.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

What is in Alendronic Acid Weekly pensa

• The active substance is alendronate sodium trihydrate.

Each tablet contains 70 mg of alendronic acid as alendronate sodium trihydrate.

• The other ingredients are microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, sodium stearyl fumarate.

The coating contains Opadry composed of talc and hypromellose.

Appearance and packaging

Alendronic Acid Weekly pensa is available as white or almost white, round, biconvex film-coated tablets, approximately 9.7 mm in diameter.

The tablets are packaged in cartons containing PVC-PVdC/aluminium blisters of 4 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios Alter S.A

C/ Mateo Inurria, 30

28036 Madrid-Spain

Date of last revision of this leaflet:May 2022

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/