PATIENT INFORMATION LEAFLET

Actonel 30 mg film-coated tablets

(risedronate sodium)

Name of the Medicinal Product

Actonel 30 mg film-coated tablets.

What does Actonel 30 mg contain?

The active substance is called risedronate sodium. Each tablet contains 30 mg risedronate sodium.

The tablets also contain the following inactive ingredients:

Tablet core: lactose monohydrate, crospovidone, magnesium stearate and microcrystalline cellulose.

Film coat: hydroxypropylcellulose, hypromellose, macrogol 8000, macrogol 400, silicon dioxide, titanium dioxide (E171).

1. What is Actonel 30 mg and what is it used for?

Actonel belongs to a group of non hormonal medicines called bisphosphonates which are used to treat bone diseases. It is used to treat Paget's disease of the bone (osteitis deformans).

Bone is a living tissue. Old bone is constantly removed from your skeleton and replaced with new bone. Paget's disease occurs when this process, called remodeling, happens too quickly and in a disordered way. The new bone that is produced is weaker than normal and the affected bones may become enlarged, painful and may fracture. Actonel changes the bone remodeling process back to normal, returning the strength to the bone structure.

Actonel 30 mg tablets are oval white tablets with the letters RSN on one side and 30 mg on the other side. It is supplied in blister packs of 3, 14 and 28 tablets.

2. Information necessary before taking Actonel 30 mg

You must not take this medicine if

• you have had an allergic reaction in the past to Actonel or to any of the other ingredients listed under "What does Actonel 30 mg contain?"
• your doctor has told you that you have a condition called hypocalcaemia (a low blood calcium level)
• you may be pregnant or are (planning to become) pregnant
• you are breast feeding
• you have severe kidney problems.

 

3. When and how to take Actonel 30 mg

It is very important that you do NOT take your Actonel tablet with food or drinks (other than plain water) so that it can work properly.

Take ONE tablet once a day.

• IT IS BEST to take your tablet at least 30 minutes before the first food, drink (other than plain water) or other medicine of the day.

If you are unable to take your Actonel tablet at this time, you may take it on an empty stomach, at the same time every day, in one of the following ways:

• EITHER - Between meals: at least 2 hours after your last food, drink (other than plain water) or medicine. Do not eat or drink (other than plain water) for 2 hours after taking the tablet.

• OR - In the evening: at least 2 hours after the last food, drink (other than plain water) or medicine of the day. Actonel should be taken at least 30 minutes before going to bed.

The tablet must be swallowed whole and not sucked or chewed. It should be taken whilst you are in an upright position (you may sit or stand) and swallowed with at least a glass (120 ml) of plain water. You should not lie down for 30 minutes after taking your tablet and you should not take Actonel less than 30 minutes before going to bed.

The days of the week are printed on the blister foil to help you remember to take your medicine.

Your doctor will tell you how long your treatment with Actonel should last. Usually 2 months will be enough to treat your Paget's disease. However another course of treatment may be required. Please talk to your doctor before stopping your tablets in the middle of the course.

Don't forget to ask your doctor for another pack of Actonel before this one is finished.

Overdose: If you or somebody else has accidentally taken a large number of tablets, drink a full glass of milk and seek medical attention.

If you have forgotten to take your tablet, you can take it before breakfast, between meals, or in the evening, according to the instructions above. Do not take two tablets in one day to make up for the tablet you missed.

4. What side effects may occur when taking Actonel 30 mg?

Like all medicines, Actonel can have side effects. However in clinical tests the side effects that were observed were mild to moderate, and usually did not cause the patient to stop taking their tablets.

The most common side effects are diarrhoea, pain in your bones, muscles and joints, feeling sick, stomach ache and constipation. Other less common side effects are flu-like symptoms, unusual lumps or swellings, chest pain, cramps, weight loss, muscle weakness, dizziness, breathing difficulties, coughing, facial soreness, runny nose, rash, vision difficulties, dryness of the eye, ringing in the ears and a frequent need to pass water at night. Please tell your doctor if you experience any of these.

In a small number of patients, the following uncommon side effects have been reported: difficulty in swallowing and pain following swallowing, inflammation of the tongue and inflammation of the colored part of the eye. Please tell your doctor if you have problems which you think relate to any of these.

In addition abnormal liver tests have been reported rarely. These can only be diagnosed from a blood test.

Very rarely, allergic type reactions have been reported. These include skin rashes and swelling of the skin, particularly of the face, neck, fingers and toes. Tell your doctor if you experience any of these.

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

If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

How to store your Actonel 30 mg

Keep your tablets where children cannot reach or see them.

Do not take this medicine after the expiry date marked on the pack.