Varibona 35 mg, filmomhulde tablet

Varibona 35 mg 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.

Varibona 35 mg 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.

Do not take Varibona 35 mg

• If you are allergic to risedronate sodium or any of the other ingredients of Varibona 35 mg (see section 6, “What Varibona 35 mg contains”)
• 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.

Take special care and talk to your doctor before you start taking Varibona 35 mg

• 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 oesophagus (the tube that connects your mouth with your stomach). For instance you may have had pain or difficulty in swallowing food.
• 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 Varibona 35 mg.

Your doctor will advise you on what to do when taking Varibona 35 mg if you have any of the above.

Taking other medicines

Medicines containing one of the following lessen the effect of Varibona 35 mg if taken at the same time:

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

Take these medicines at least 30 minutes after your Varibona 35 mg tablet.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Children

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

Taking Varibona 35 mg with food and drink

It is very important that you do not take your Varibona 35 mg 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, “Taking other medicines”).

Take food and drinks (other than plain water) at least 30 minutes after your Varibona 35 mg tablet.

Pregnancy and breast-feeding

Do not take Varibona 35 mg if you may be pregnant, are pregnant or planning to become pregnant (see section 2, “Do not take Varibona 35 mg”). The potential risk associated with the use of risedronate sodium in pregnant women is unknown.

Do not take Varibona 35 mg if you are breast-feeding. (see section 2, “Do not take Varibona 35 mg”).

Varibona 35 mg should only be used to treat postmenopausal women and men.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Varibona 35 mg is not known to affect your ability to drive and use machines.

Important information about some of the ingredients of Varibona 35 mg

Varibona 35 mg contains a small amount of lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Varibona 35 mg.

Dosage

Always take Varibona 35 mg exactly as your doctor has told you. You should check with your doctor if you are not sure.

Usual dose:

Take one Varibona 35 mg tablet once a week.

Choose one day of the week that best fits your schedule. Every week, take the Varibona 35 mg tablet on your chosen day.

When to take the Varibona 35 mg

Take your Varibona 35 mg tablet at least 30 minutes before the first food, drink (other than plain water) or other medicine of the day.

How to take the Varibona 35 mg

• 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 Varibona 35 mg than you should

If you or somebody else has accidentally taken more Varibona 35 mg tablets than prescribed, drink one full glass of milk and seek medical attention.

If you forget to take Varibona 35 mg

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 two tablets in one day to make up for the tablet you missed.

If you stop taking Varibona 35 mg

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

Like all medicines, Varibona 35 mg can cause side effects, although not everybody gets them.

Stop taking Varibona 35 mg and contact a doctor immediately if you experience any of the following:

• Symptoms characteristics of severe tissue swelling (angioedema reaction)
  • Swelling of face, tongue or throat
  • Difficulties in swallowing
  • Hives and difficulties in breathing
• Severe skin reactions involving blisters under the skin.

Tell your doctor as soon as possible 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, “Take special care and talk to your doctor before you start taking Varibona 35 mg”).
• Symptoms from oesophagus such as pain when you swallow, difficulties in swallowing, chest pain or new or worsened heartburn.

Other side effects are:

Common side effects (affects 1 to 10 users in 100)

• 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 (affects 1 to 10 users in 1000)

• 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, “Take special care and talk to your doctor before you start taking Varibona 35 mg”), 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 (affects 1 to 10 users in 10000)

• 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.

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.

During postmarketing experience the following have been reported (unknown frequency)

• Eye inflammation.
• Osteonecrosis (death of bone tissue) in the jaw.
• Hair loss.
• Allergic reactions such as urticaria (skin rash), swelling of the face, lips, tongue and/or neck, difficulty in swallowing or breathing.
• Severe skin reactions including vesiculation (blistering) under the skin.
• Liver disorders, some cases were severe.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage condition.

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 to protect the environment.

What Varibona 35 mg 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, crospovidone, magnesium stearate and microcrystalline cellulose.

Film coating: iron oxide yellow E172, iron oxide red E172, hypromellose, macrogol, hydroxypropyl cellulose, colloidal anhydrous silica, titanium dioxide E171.

What Varibona 35 mg looks like and contents of the pack

Varibona 35 mg film-coated tablets are light-orange coloured, round, tablets of 9.1 mm diameter, debossed with the letter “J” on one side and “35” on the other.

The tablets are supplied in blister packs of 4 or 12 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Terix Labs Ltd.

6 Agias Elenis str, Agias Elenis Building, office 43

1060 Nicosia Cyprus

Manufacturer:

PSI supply nv Axxes Business Park

Guldensporenpark 22 – Block C 9820 Merelbeke

Belgium

Or

Rafarm SA

8 Kapadistriou & 12 Korinthou str

15451 Neo Phisico Athens

Greece

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

The Netherlands: Varibona Cyprus: Varibona

Greece: Varibona

This leaflet was last approved in