Actonel once A week 35 mg film-coated tablets – patient leaflet, side effects, dosage

1. What Risedronate Sodium Accord Once a Week is and what it is used for

What Risedronate Sodium Accord Once a Week is

Risedronate Sodium Accord Once a

Week belongs to a group of

non-hormonal medicines called

bisphosphonates which are used to

treat bone diseases. It works directly on

your bones to make them stronger and

therefore less likely to break.

Bone is a living tissue. Old bone is constantly removed from your skeleton and replaced with new bone.

Postmenopausal osteoporosis is a condition occurring in women after the menopause where the bones become weaker, more fragile and more likely to break after a fall or strain.

Osteoporosis can also occur in men due to a number of causes including ageing and/or a low level of the male hormone, testosterone.

The spine, hip and wrist are the most likely bones to break, although this can happen to any bone in your body. Osteoporosis-related fractures can also cause back pain, height loss and a curved back. Many patients with osteoporosis have no symptoms and you may not even have known that you had it.

What Risedronate Sodium Accord Once a Week is used for

The treatment of osteoporosis in postmenopausal women, even if osteoporosis is severe. It reduces the risk of spinal and hip fractures in men.

2. What you need to know before you take Risedronate Sodium Accord Once a Week

Do not take Risedronate Sodium Accord Once a Week

• If you are allergic to risedronate sodium or any of the other ingredients of this medicine (listed in section 6).
• If your doctor has told you that you have a condition called hypocalcaemia (a low blood calcium level).
• If you may be pregnant, are pregnant or planning to become pregnant.
• If you are breastfeeding .

• If you have severe kidney problems.

  Warnings and precautions

Talk to your doctor or pharmacist before taking Risedronate Sodium Accord Once a Week:

• If you are unable to stay in an upright position (sitting or standing) for at least 30 minutes.
• If you have abnormal bone and mineral metabolism (for example lack of vitamin D, parathyroid hormone abnormalities, both leading to a low blood calcium level).
• If you have or have had problems in the past with your oesophagus (the tube that connects your mouth with your stomach). For instance you may have or have had pain or difficulty in swallowing food or you have previously been told that you have Barrett’s oesophagus (a condition associated with changes in the cells that line the lower oesophagus).
• If you have been told by your doctor that you have an intolerance to some sugars (such as lactose).
• If you have had or have pain, swelling or numbness of the jaw or a “heavy jaw feeling” or loosening of a tooth.
• If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Risedronate Sodium Accord Once a Week. Your doctor will advise you on what to do when taking Risedronate Sodium Accord Once a Week if you have any of the above.

Children and adolescents

Risedronate sodium is not recommended for use in children below 18 due to insufficient data on safety and efficacy.

Other medicines and Risedronate Sodium Accord Once a Week

Medicines containing one of the following lessen the effect of Risedronate Sodium Accord Once a Week if taken at the same time:

• calcium
• magnesium
• aluminium (for example some indigestion mixtures)
• iron.

Take these medicines at least 30 minutes after your Risedronate Sodium Accord Once a Week tablet.

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

Risedronate Sodium Accord Once a Week with food and drink

It is very important that you do NOT

take your Risedronate

Sodium Accord Once a Week tablet with

food or drinks (other than plain water)

so that it can work properly. In

particular do not take this medicine at the same time as dairy products (such as milk) as they contain calcium (see section 2, “Other medicines and Risedronate Sodium Accord Once a Week”).

Take food and drinks (other than plain water) at least 30 minutes after your Risedronate Sodium Accord Once a Week tablet.

Pregnancy and breast-feeding

Do NOT take Risedronate Sodium Accord Once a Week if you may be pregnant, are pregnant or planning to become pregnant (see section 2, “Do not take Risedronate Sodium Accord Once a Week”). The potential risk associated with the use of risedronate sodium (active substance in Risedronate Sodium Accord Once a Week) in pregnant women is unknown.

Do NOT take Risedronate Sodium Accord Once a Week if you are breast-feeding (see section 2, “Do not take Risedronate Sodium Accord Once a Week”). Risedronate Sodium Accord Once a Week should only be used to treat postmenopausal women and men.

Driving and using machines

Risedronate Sodium Accord Once a Week is not known to affect your ability to drive and use machines.

Risedronate Sodium Accord Once a Week contains lactose

If you have been told by your doctor that you may have an intolerance to some sugars, contact your doctor before taking this medicinal product (see section 2, “Warnings and precautions”).

Information on sodium content

This medicine contains less than 1mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.

3. How to take Risedronate Sodium Accord Once a Week

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

The recommended dose is ONE Risedronate Sodium Accord Once a Week tablet (35 mg of risedronate sodium) once a week.

Choose one day of the week that best fits your schedule. Every week, take the Risedronate Sodium Accord Once a Week tablet on your chosen day.

For your convenience, so that you take your tablet on the right day every week, there is a feature

included with the Risedronate Sodium Accord Once a Week pack:

There are boxes/spaces on the back of the

blister card. Please mark the day of the week you have chosen to take your Risedronate

Sodium Accord Once a Week tablet. Also, write in the dates you will take the tablet.

WHEN to take the Risedronate Sodium Accord Once a Week tablet

Take your Risedronate Sodium Accord Once a Week tablet at least 30 minutes before the first food, drink (other than plain water) or other medicine of the day.

HOW to take the Risedronate Sodium Accord Once a Week tablet

• Take the tablet whilst you are in an upright position (you may sit or stand) to avoid heartburn.

• Swallow it with at least one glass

  (120 ml) of plain water.

• Swallow it whole. Do not suck or chew it.

• Do not lie down for 30 minutes after

  taking your tablet.

Your doctor will tell you if you need calcium and vitamin supplements, if you are not taking enough from your diet.

If you take more Risedronate Sodium Accord Once a Week than you should

If you or somebody else has accidentally taken more Risedronate Sodium Accord Once a Week tablets than prescribed, drink one full glass of milk and seek medical attention.

If you forget to take Risedronate Sodium Accord Once a Week

If you have forgotten to take your tablet

on your chosen day, take it on the day

you remember.

Return to taking one tablet once a week

on the day the tablet is normally taken.

Do not take a double dose to make up

for a forgotten tablet.

If you stop taking Risedronate Sodium Accord Once a Week

If you stop treatment you may begin to lose bone mass. Please talk to your doctor before you consider stopping treatment.

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.

Stop taking Risedronate Sodium Accord Once a Week and contact a doctor immediately if you experience any of the following:

• Symptoms of a severe allergic reaction such as:

  • Swelling of the face, tongue or throat
  • Difficulties in swallowing
  • Hives and difficulties in breathing
• Allergic reactions of the skin such as urticaria (hives), skin rash, swelling of the face, lips, tongue and/or neck, difficulty in swallowing or breathing.

Front Side

Package leaflet: Information for the patient

Risedronate

Sodium Accord

risedronate sodium

Once a Week

film-coated tablets

(6032502) Date: 10.10.2024, 11.12.2024

• Severe skin reactions including vesiculation (blistering) under the skin; inflammation of small blood vessels, characterised by palpable red spots on the skin (leukocytoclastic vasculitis); a serious illness called Stevens-Johnson syndrome (SJS) with blistering of the skin, mouth, eyes and other moist body surfaces (genitals); a severe illness called toxic epidermal necrolysis (TEN) which causes a red rash over many parts of the body and/or loss of the outer layer of skin.

Tell your doctor promptly if you experience the following side effects:

• Eye inflammation, usually with pain, redness and light sensitivity.
• Bone necrosis of the jaw (osteonecrosis) associated with delayed healing and infection, often following tooth extraction (see section 2, “Warnings and precautions”).
• Symptoms from oesophagus such as pain when you swallow, difficulties in swallowing, chest pain or new or worsened heartburn.
• Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely. 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.

However in clinical studies the other side effects that were observed were usually mild and did not cause the patient to stop taking their tablets.

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

• Indigestion, feeling sick, stomach ache, stomach cramps or discomfort, constipation, feelings of fullness, bloating, diarrhoea.
• Pain in your bones, muscles or joints.
• Headache.

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

• Inflammation or ulcer of the oesophagus (the tube that connects your mouth with your stomach) causing difficulty and pain in swallowing (see also section 2, “Warnings and precautions”), inflammation of the stomach and duodenum (bowel draining the stomach).
• Inflammation of the coloured part of the eye (iris) (red painful eyes with a possible change in vision).

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

• Inflammation of the tongue (red swollen, possibly painful), narrowing of the oesophagus (the tube that connects your mouth with your stomach).
• Abnormal liver tests have been reported. These can only be diagnosed from a blood test.

During post-marketing experience, the following have been reported:

Very rare (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.

Not known (frequency cannot be estimated from the available data)

• Hair loss
• Serious liver disorders, mainly if you are treated with other medicinal products known to cause liver problems.

Rarely, at the beginning of treatment, a patient’s blood calcium

and phosphate levels may fall. These changes are usually small and cause no symptoms.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Risedronate Sodium Accord Once a Week

• 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 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 Risedronate Sodium Accord Once a Week contains

The active substance is risedronate sodium. Each tablet contains 35 mg risedronate sodium, equivalent to 32.5 mg risedronic acid.

The other ingredients are:

Tablet core: lactose monohydrate (see section 2), crospovidone A, magnesium stearate and cellulose microcrystalline.

Film coating: hypromellose, macrogol,

hydroxypropylcellulose, colloidal anhydrous silica, titanium dioxide [E171], iron oxide yellow [E172], iron oxide red [E172].

What Risedronate Sodium Accord Once a Week looks like and contents of the pack

Risedronate Sodium Accord Once a Week 35 mg film-coated tablets are light orange coloured, oval shaped, biconvex, film-coated tablets engraved with “RS1” on one side and plain on other side. The tablets are supplied in blister packs of 1, 2, 4, 10, 12 or 16 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Accord Healthcare Limited

Sage House

319 Pinner Road

North Harrow

Middlesex

HA1 4HF

United Kingdom

Manufacturer

Accord Healthcare B.V.,

Winthontlaan 200, 3526 KV Utrecht, The Netherlands or

Accord Healthcare Polska Sp. z o.o., Ul. Lutomierska 50,

95-200, Pabianice, Poland

Or

Accord Healthcare Ltd.,

Ground Floor, Sage House, 319 Pinner Road, Harrow,

HA1 4HF,

United Kingdom

This leaflet was last revised in December 2024

Back Side

INP113 10 4929 1 6032502

(6032502) Date: 10.10.2024, 11.12.2024