RISEDRONATE SODIUM 75 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Patient leaflet - RISEDRONATE SODIUM 75 MG FILM-COATED TABLETS

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 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.

What is in this leaflet:

1. What Risedronate Sodium is and what it is used for

2. What you need to know before you take Risedronate Sodium

3. How to take Risedronate Sodium

4. Possible side effects

5. How to store Risedronate Sodium

6. Contents of the pack and other information.

1. what risedronate sodium is and what it is used forrisedronate sodium 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.

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 is used for

The treatment of osteoporosis in postmenopausal women.

2. what you need to know before you take risedronate sodium 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 breast-feeding.
if you have severe kidney problems.

Warnings and precautions

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 had problems in the past with your stomach, guts or oesophagus (the tube that connects your mouth with your stomach). For instance you may 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 had or have pain, swelling or numbness of the jaw or a “heavy jaw feeling” or loosening of a tooth.
if you have problems with your teeth or gums (such as tooth decay or a buildup of plaque (tartar))

Your doctor or pharmacist will advise you on what to do when taking Risedronate Sodium if you have any of the above.

Dental health

Medicines normally used to help treat swelling (inflammation) and pain, known as steroids (e.g. prednisolone) may increase the risk of bone death or decay (necrosis) of the jaw (osteonecrosis) (see section 4 for more information). Radiotherapy and chemotherapy, normally used in the treatment of Cancer, may also increase the risk.

If you are taking steroids, or receiving radiotherapy or chemotherapy talk to your doctor or pharmacist for advice before taking this medicine.

If you are undergoing dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Risedronate Sodium.

Children and adolescents

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

Other medicines and Risedronate Sodium

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

Medicines (which may also include vitamin/food supplements) containing one of the following lessen the effect of risedronate sodium 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 tablet.

Risedronate Sodiumwith food and drink

Take food and drinks (other than plain water) at least 30 minutes after your medicine.

It is very important that you do NOT take your medicine 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”).

Pregnancy and breast-feeding

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.

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

DO NOT take Risedronate Sodium if you are breast-feeding (see section 2, “Do not take Risedronate Sodium”). Risedronate sodium may be present in breast milk.

Risedronate Sodium should only be used to treat postmenopausal women.

Driving and using machines

Risedronate sodium is not known to affect your ability to drive and use machines.

Risedronate Sodium contains a source of glucose and sorbitol

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine product.

3. how to take risedronate sodiumalways take this medicine exactly as your doctor or pharmacist has told you. check with your doctor or pharmacist if you are not sure.

This medicinal product is for oral use.

The recommended dose is:

Risedronate sodium tablets should be taken on the SAME two consecutive days each month.

Choose two days of the month that will be easy to remember. You can choose either the same dates (such as the 1st and 2nd of the month or the 15th and 16th) or the same two days (such as the first Saturday and Sunday of each month). Choose TWO days in a row that best fit your schedule to take your Risedronate Sodium.

Take ONE Risedronate Sodium tablet in the morning of your first chosen day. Take the SECOND tablet in the morning of the following day.

Repeat every month keeping the same two consecutive days. To help you remember when to take your tablets next, you can mark a calendar ahead of time with a pen or stickers. You can also write down the dates in the space provided at the back of the box.

When to take the Risedronate Sodium tablet

Take your medicine at least 30 minutes before the first food, drink (other than plain water) or any other medicine of the day.

How to take the Risedronate Sodium tablet

Take the tablet whilst you are in an upright position (you may sit or stand) to avoid heartburn and/or other side effects such as problems in the oesophagus or stomach from occurring (see section 4 “Possible side effects” for more information).
Swallow it with at least one glass (120 ml) of plain water. Do not take your tablet with mineralwater or drinks other than plain water. Swallow it whole. Do not suck or chew your tablet.
Do not lie down for 30 minutes after taking your tablet.

Your doctor will tell you if you also need to take calcium and vitamin D supplements, if you are not getting enough from your diet. If needed, these should NOT be taken at the same time as risedronate sodium.

If you take more Risedronate Sodium than you should

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

If you forget to take Risedronate Sodium

You forgot 1st and 2nd tablets	When Next monthly dose is more than 7 days ahead	What to do Take 1st tablet the next morning and 2nd tablet the morning of the following day
	Next monthly dose is within 7 days	Do not take the tablets you have forgotten
2nd tablet only	Next monthly dose is more than 7 days ahead	Take 2nd tablet the next morning
	Next monthly dose is within 7 days	Do not take the tablet you have forgotten
The next month, take your tablets again as usual.

In any case:

If you miss your dose of Risedronate sodium tablet in the morning, do NOT take it later in the day.
Do NOT take three tablets within the same week.

If you stop taking Risedronate Sodium

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 the 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 and contact a doctor immediately if you experience any of the following:

Symptoms of a severe allergic reaction such as

o swelling of face, lips, tongue, throat and/or neck

o difficulties in breathing

o hives, skin rash

Severe skin reactions such as
■ blistering of the skin, mouth, eyes and other moist body surfaces (genitals) (Stevens Johnson syndrome).
■ inflammation of small blood vessels. You may notice palpable red spots on the skin (leukocytoclastic vasculitis)
■ red rash over many parts of the body and/or loss of the outer layer of skin (toxic epidermal necrolysis).

Liver problems (in most reported cases, this occurs when other medicines that may affect the liver are taken at the same time). You may notice

o yellowing of the skin or eyes, pale stools or dark urine, pain in the center of the stomach.

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

Eye inflammation, usually with pain, redness and light sensitivity.
Bone damage of the jaw (osteonecrosis) associated with delayed healing and infection, often following tooth extraction (see section 2, “Warnings and precautions”).
Symptoms from the oesophagus such as pain when you swallow, difficulties in swallowing, chest pain or new or worsened heartburn/indigestion.
Ulceration of the oesophagus (the tube that connects your mouth with your stomach)
Feelings of fullness, bloating, pain that is associated with eating, which may be severe, a loss of appetite or weight loss, sick with blood in it (your sick may look like it contains coffee granules) or poo (stools) with blood in it (your poo may be black, sticky or tarry). These may be signs of inflammation or ulcer of the stomach and duodenum (part of the bowel draining the stomach).

In clinical studies other side effects that were observed, that were usually mild to moderate, and did not cause the patient to stop taking their tablets:

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

Feeling sick, being sick, stomach ache or discomfort, constipation, diarrhoea.
Pain in your bones, muscles or joints or pain in your arms or legs.
Headache.

Uncommon side effects (may affect up to1 in 100 people)

Inflammation of the oesophagus (the tube that connects your mouth with your stomach) (see also section 2, “Warnings and precautions”).
Inflammation of the coloured part of the eye (iris) (red painful eyes with a possible change in vision).
Fever, and/or flu-like symptoms.

Rare side effects (may affect up to1 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.

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.
During post-marketing experience, the following have been reported (unknown frequency) Hair loss.

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.

In addition, 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.

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 Yellow Card Scheme at:. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store risedronate sodium

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

If your medicine is supplied in a bottle, it should be used within 100 days after the bottle is first opened. Therefore you must throw away the bottle 100 days after you first opened it, even if some tablets are left. To help you remember, write down the date that you opened it in the space on the bottle label.

This medicinal product 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 informationthe active substance is risedronate sodium. each film-coated tablet contains 75 mg risedronate sodium, equivalent to 69.6 mg risedronic acid.

The other ingredients are:

Tablet core : mannitol (E421), cellulose, microcrystalline, crosprovidone, silica, colloidal anhydrous and magnesium stearate.

Film-coating : titanium dioxide (E171), polydextrose (contains glucose and sorbitol [E420]), hypromellose triacetin, macrogol 8000 and iron oxide (E172).

What Risedronate Sodium looks like and contents of the pack

The film-coated tablets are pink, round, with two sides that curve out and a bevelled-edge. They are marked with “RR over 1 ” on one side and “M ” on the other side.

The tablets are available in blisters or bottles and come in pack sizes containing:

Blisters: 2, 4, 6, 8 and 12 tablets

Bottles: 28 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan

Potters Bar,

Hertfordshire, EN6 1TL

United Kingdom

Manufacturers

Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Ireland

Mylan Hungary Kft

Mylan utca 1.,

Komaron

2900

Hungary

This leaflet was last revised in 12/2020.

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