Alendronat Orifarm Veckotablett

Document: Alendronat Orifarm Veckotablett tablet ENG PL change

Package leaflet: Information for the user

Alendronat Orifarm Veckotablett 70 mg tablets

alendronate sodium

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, pharmacist or nurse.
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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Alendronat Orifarm Veckotablett is and what it is used for

2. What you need to know before you take Alendronat Orifarm Veckotablett

3. How to take Alendronat Orifarm Veckotablett

4. Possible side effects

5. How to store Alendronat Orifarm Veckotablett

6. Contents of the pack and other information

1. What Alendronat Orifarm Veckotablett is and what it is used for

Alendronat Orifarm Veckotablett belongs to a group of non-hormonal medicines called bisphosphonates.

Alendronat Orifarm Veckotablett is used to:

treat a disease called osteoporosis (brittle bones) which is common in post-menopausal women.
reduce the risk of hip and spine fractures.

Alendronat Orifarm Veckotablett slows down the loss of bone that occurs in women after the menopause. At the same time, Alendronat Orifarm Veckotablett helps to rebuild bone and hence reduce the risk of broken bones (fractures) of the hip and spine.

Osteoporosis causes thinning and weakening of the bones. After the menopause, the ovaries stop producing the female sex hormone, oestrogen. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches the menopause, the greater the risk of osteoporosis.

Osteoporosis is an insidious disease that usually has no symptoms. If left untreated, osteoporosis can result in fractures (broken bones), usually of the hip, spine and wrists. Although these usually hurt, breaks in the bones of the spine may go unnoticed until they cause height loss. Fractures can easily arise during everyday activity, e.g. lifting heavy objects. Incidents that normally do not result in injury e.g. a fall, can also cause fractures in patients with osteoporosis.

2. What you need to know before you take Alendronat Orifarm Veckotablett

Do not take Alendronat Orifarm Veckotablett

if you are allergic to alendronate sodium or any of the other ingredients of this medicine (listed in section 6)
if you have problems/pathological changes e.g. narrowing of the oesophagus (the tube that connects your mouth with your stomach)
if you cannot stand or sit upright for 30 minutes
if you have a low blood calcium level

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Alendronat Orifarm Veckotablett:

if you have kidney disorders
if you have allergies
if you have or have had pain or swelling of the gums and/or the jaw, loss of feeling in the jaw, feeling of heavy jaw or if you have lost a tooth
if you are being treated at the dentist or if you will be undergoing teeth or jaw surgery, tell your dentist that you are being treated with Alendronat Orifarm Veckotablett
if your doctor has told you that you have Barrett’s oesophagus (a condition associated with changes in the cells that line the lower oesophagus)
if you are taking certain other medicines (glucocorticoids, cortisone products)
if you have cancer
if you are undergoing chemotherapy or radiotherapy
if you smoke

Before using Alendronat Orifarm Veckotablett you should also tell your doctor if you:

- have had difficulty and/or pain on swallowing or have had localised pain in the breastbone

have stomach ulcer-type problems or have in the recent year suffered from disorders of the digestive tract such as stomach ulcers (including bleeding ulcers) or had surgery of the digestive tract.
have inadequately functioning parathyroid glands, low calcium or vitamin D blood levels (Vitamin D deficiency).

While using Alendronat Orifarm Veckotablett you:

are encouraged to maintain good oral hygiene, receive routine dental check-ups, and report any oral symptoms such as dental mobility, pain, or swelling to your doctor.
are encouraged to report any thigh, hip or groin pain to your doctor as this could be symptoms of an incomplete femur fracture.
must contact your doctor, if you experience symptoms of oesophageal irritation such as difficulty swallowing, pain on swallowing, retrosternal pain (pain behind the sternum while swallowing) or new or worsening heartburn

Particular caution is required when taking Alendronat Orifarm Veckotablett with anti-inflammatory and analgesic medicines from the non-steroidal anti-inflammatory drug group (NSAIDs) as gastrointestinal side effects could occur more often.

Children and adolescents

Alendronat Orifarm Veckotablett should not be given to children and adolescents.

Other medicines and Alendronat Orifarm Veckotablett

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

Alendronat Orifarm Veckotablett should not be taken at the same time as food, calcium tablets, antacids, vitamins and/or other medicines, as this may affect the way Alendronat Orifarm Veckotablett are absorbed into the body.

Wait for at least 30 minutes after you have taken Alendronat Orifarm Veckotablett before taking any other medicine or food.

Alendronat Orifarm Veckotablett with food and drink

It is important that you take Alendronat Orifarm Veckotablett only with plain tap water. Other drinks reduce the absorption and hence the effect of Alendronat Orifarm Veckotablett.

The effect of treatment may be reduced if Alendronat Orifarm Veckotablett is taken at the same time as other medicines, food or drink (not including tap water).

Wait for at least 30 minutes after you have taken Alendronat Orifarm Veckotablett before taking any other medicine or food.

Pregnancy and breast-feeding

Pregnancy:

Do not take Alendronat Orifarm Veckotablett if you are pregnant.

Breast-feeding:

It is not known whether Alendronat Orifarm Veckotablett pass into human breast milk. Do not take Alendronat Orifarm Veckotablett if you are breast-feeding.

Driving and using machines

Alendronat Orifarm Veckotablett should not affect your ability to drive or operate machinery. However, certain adverse reactions, such as dizziness and vertigo, that have been reported with alendronate may affect some patients’ ability to drive or operate machinery. Individual responses to alendronate may vary.

3. How to take Alendronate Orifarm Veckotablett

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Take one Alendronat Orifarm Veckotablett once a week. To ensure that you benefit from Alendronat Orifarm Veckotablett and to prevent irritation in the oesophagus, it is important that you take the medicine according to the instructions below. This will reduce the risk of the tablet becoming stuck in the oesophagus.

1. Choose the day of the week that best suits you. Every week take one Alendronat Orifarm Veckotablett on your chosen day.

2. Take one Alendronat Orifarm Veckotablettonce a week after getting up with a full glass of plain tap water on an empty stomach. Wait for at least 30 minutes after you have taken Alendronat Orifarm Veckotablettbefore taking any other medicine, drink or food. Swallow the tablet whole. Do not crush, chewor suck the tablet.

3. Do not lie downafter taking the Alendronat Orifarm Veckotablett. Stay in an upright position (sitting, standing or walking) for at least 30 minutes after taking the tablet. Do not lie down until after your first food of the day.

If you have difficulty and/or pain on swallowing, notice localised pain in the breast bone or new or worsening heartburn, stop taking your Alendronat Orifarm Veckotablett and contact your doctor immediately.

If you take more Alendronat Orifarm Veckotablett than you should

If you take too many tablets or a child takes the medication by mistake, you/they should drink a full glass of milk and contact the doctor or a hospital for an assessment of risk and advice. Do not make yourself vomit and do not lie down.

If you forget to take Alendronat Orifarm Veckotablett

If you forget to take a tablet, take just one Alendronat Orifarm Veckotablett on the morning after you remember.Do not take a double dose to make up for a forgotten dose. Return to taking one tablet once a week as originally scheduled on your chosen day.

If you stop taking Alendronat Orifarm Veckotablett

Take one Alendronat Orifarm Veckotablett once a week as prescribed. It is important that you continue to take your Alendronat Orifarm Veckotablett for as long as your doctor recommends it.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Alendronat Orifarm Veckotablettand contact a doctor or go to your nearest emergency department immediatelyif you experience any of the following symptoms:

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

difficulty and/or pain on swallowing, irritation or ulcers of the oesophagus

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

localised pain in the breastbone or new or worsening heartburn.

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

swelling of face, tongue or throat; difficulty swallowing; hives and breathing difficulties.
severe extensive skin damage (separation of the epidermis and superficial mucous membranes).
an extremely intense allergic reaction with skin rashes, commonly in the form of blisters or sores in the oral cavity and eyes, and other mucous membranes such as, for example, genitalia.
unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.

Other side effetcs

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

aching muscles, joints and bones which is sometimes severe

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

Headache, dizziness, vertigo
pain or discomfort in the stomach, acid reflux, constipation, diarrhoea, bloated feeling in the stomach, flatulens
loss of hair, itching
joint swelling
weakness, peripheral oedema (swelling of tissues)

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

nausea, vomiting, bloody stools
rash and redness of the skin
taste disorders
inflammation of the eye or iris of the eye
short-term, temporary flu-like symptoms (aching muscles, generally feeling unwell and on rare occasions fever) usually at the start of treatment

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

low levels of calcium in the blood
rash that gets worse upon exposure to sunlight
breakdown of the bone of the jaw (osteonecrosis)
stomach ulcer–type problems including those of a serious nature have occurred but it is not clear whether there is a link to alendronate
ulcers have occurred in the mouth/throat, sometimes as a result of chewing or sucking the tablet

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

Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alendronat Orifam Veckotablett

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 after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.These measures will help protect the environment.

6. Contents of the pack and other information

What Alendronat Orifarm Veckotablett contains

The active substance is alendronate sodium, 70 mg per tablet.
The other ingredients are magnesium stearate, mannitol (E 421) and microcrystalline cellulose.

What Alendronat Orifarm Veckotablett looks like and contents of the pack:

Oval, white, biconvex tablets, marked with APO on one side and ALE 70 on the other.

Pack sizes:

Blister: 1, 4, 12 and 24 tablets

Bottle: 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

Sweden: Alendronat Orifarm Veckotablett

Denmark: Alendronat Orifarm

This leaflet was last revised in 18 February 2016