Norifaz

Patient Information Leaflet

Norifaz, 75 mg, film-coated tablets
Sodium risedronate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not share it with others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Norifaz is and what it is used for
2. What you need to know before taking Norifaz
3. How to take Norifaz
4. Possible side effects
5. How to store Norifaz
6. Contents of the pack and other information

1. What Norifaz is and what it is used for

What Norifaz is
Norifaz belongs to a group of non-hormonal medicines called bisphosphonates, which are used in the treatment of bone diseases. The medicine acts directly on the bones, strengthening them and thereby reducing the risk of fractures.
Bone is living tissue. Old bone tissue is constantly removed from the skeleton and replaced with new bone tissue.
Postmenopausal osteoporosis is a condition affecting women after menopause, in which bones become weaker, more fragile and more prone to fractures following a fall or minor strain.
The spine, hip and wrist are most commonly affected, but any bone may fracture. Spinal fractures due to osteoporosis may also cause back pain, loss of height and spinal deformity. Many patients have no symptoms of osteoporosis and may not even know they have the condition.
What Norifaz is used for
Treatment of osteoporosis in postmenopausal women.

2. Important information before using Norifaz

When not to use Norifaz

• If the patient is allergic to sodium risedronate or any of the other ingredients of this medicine (listed in section 6)
• If the patient has been diagnosed with hypocalcaemia (low calcium levels in the blood)
• If the patient may be pregnant, is pregnant, or plans to become pregnant
• In breastfeeding women
• If the patient has severe kidney disease

Warnings and precautions
Before starting Norifaz, discuss the following with your doctor or pharmacist:

• If the patient is unable to sit or stand upright for at least 30 minutes
• If the patient has disorders of bone metabolism or mineralization (e.g. vitamin D deficiency, parathyroid hormone disorders, which may lead to low blood calcium levels)
• If the patient currently has or has previously had oesophageal disorders (the tube connecting the mouth to the stomach). For example, if the patient currently has or has previously experienced pain or difficulty swallowing food, or if the patient has been diagnosed with Barrett’s oesophagus (a condition involving changes in the cells lining the lower part of the oesophagus)
• If the patient currently has or has previously had pain, swelling, numbness, or a feeling of heaviness in the jaw, or following tooth loss
• If the patient is undergoing dental treatment or has planned dental surgery, the dentist should be informed about taking Norifaz. The doctor will advise the patient on how to proceed while taking Norifaz if any of the above conditions occur

Children and adolescents
Sodium risedronate is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.

Norifaz with other medicines
Medicines containing any of the following elements, when taken at the same time as Norifaz, reduce its effectiveness:

• calcium
• magnesium
• aluminium (e.g. some medicines used for indigestion)
• iron

These medicines should be taken at least 30 minutes after taking Norifaz.

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Norifaz with food and drink
It is very important NOT to take Norifaz with food or drink (other than plain water) so that the medicine can work properly. It is especially important not to take this medicine at the same time as dairy products (such as milk), as they contain calcium (see section 2, "Norifaz with other medicines").

Meals and drinks (other than plain water) should be consumed at least 30 minutes after taking Norifaz.

Pregnancy and breastfeeding
Norifaz MUST NOT be taken if the patient may be pregnant, is pregnant, or plans to become pregnant (see section 2, "When not to use Norifaz"). The potential risk associated with taking sodium risedronate (the active substance in Norifaz) during pregnancy is unknown.

Norifaz MUST NOT be taken during breastfeeding (see section 2, "When not to use Norifaz").

Norifaz should only be used in the treatment of postmenopausal women.

Driving and operating machinery
It is unknown whether Norifaz affects the ability to drive or operate machinery.

Norifaz contains lactose
Norifaz contains 286.24 mg of lactose (143.12 mg glucose and 143.12 mg galactose) per dose. This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Norifaz contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Norifaz

This medicine should always be taken exactly as recommended by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.

Recommended dose:
Norifaz should be taken on the SAME two consecutive days each month, for example, on the 1st and 2nd day of the month or on the 15th and 16th day of the month.
You should choose TWO consecutive days that best fit your schedule for taking Norifaz. Take ONE Norifaz tablet in the morning on the first chosen day. Take the SECOND tablet in the morning of the following day.
The medicine should be taken on the same two consecutive days every month. You may mark the calendar with a pen or a sticker to indicate the dates of taking the medicine, which will help you remember.

WHEN to take the Norifaz tablet
Norifaz should be taken at least 30 minutes before the first meal, drink (except plain water), or any other medicine of the day.

HOW to take the Norifaz tablet

• The tablet should be taken in an upright position (sitting or standing). This helps prevent heartburn.
• The tablet should be swallowed with at least one glass (120 ml) of plain water. Do not take the tablet with mineral water or any other drink except plain water.
• The tablet should be swallowed whole. Do not suck or chew the tablet.
• After taking the tablet, do not lie down for 30 minutes.

Your doctor may recommend additional calcium or vitamin supplements. This may be necessary if your daily dietary intake of these nutrients is insufficient.

Accidentally taking more Norifaz than recommended
If you or someone else accidentally takes too many Norifaz tablets, drink a full glass of milk and contact your doctor immediately.

Missed dose of Norifaz

| Missed dose | When? | What to do? | |-------------|-------|-------------| | First and second tablet | If more than 7 days remain until the next scheduled dose | Take the first tablet the next morning, and the second tablet the following morning. | | | If less than 7 days remain until the next scheduled dose | Do not take the missed tablets. | | Second tablet only | If more than 7 days remain until the next scheduled dose | Take the second tablet the next morning. | | | If less than 7 days remain until the next scheduled dose | Do not take the missed tablet. |

In the following month, return to the regular dosing schedule.

Under no circumstances:

• If you miss the morning dose of Norifaz, do not take it later the same day.
• DO NOT take three tablets within the same week.

Stopping Norifaz treatment
Stopping treatment may lead to the resumption of bone loss. Consult your doctor before deciding to discontinue treatment.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop taking Norifaz immediately and contact your doctor if any of the following symptoms occur:

• Signs of a severe allergic reaction, such as: swelling of the face, tongue or throat, difficulty swallowing, hives, and breathing difficulties.
• Severe skin reactions, including skin blistering.

If any of the following adverse reactions occur, you must inform your doctor immediately:

• Eye inflammation, usually with pain, redness, and sensitivity to light.
• Osteonecrosis of the jaw (death of bone tissue in the jaw) associated with delayed healing and infections, often following tooth extraction (see section 2, "Warnings and precautions").
• Symptoms affecting the oesophagus, such as: pain when swallowing, difficulty swallowing, chest pain, or new or worsening heartburn. In rare cases, atypical femoral fractures may occur, particularly in patients receiving long-term treatment for osteoporosis. You should consult your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin area, as these may be early signs indicating a potential femoral fracture.

In clinical trials, other observed adverse reactions were generally mild and did not cause patients to discontinue treatment.

Common adverse reactions (may affect up to 1 in 10 people)

• Indigestion, nausea, vomiting, abdominal pain, stomach cramps or discomfort, constipation, feeling of fullness, bloating, diarrhoea.
• Bone, muscle or joint pain.
• Headache.

Uncommon adverse reactions (may affect up to 1 in 100 people)

• Inflammation or ulceration of the oesophagus (the tube connecting the mouth to the stomach), causing difficulty and pain when swallowing (see also section 2, "Warnings and precautions"), inflammation of the stomach and duodenum (the part of the intestine leaving the stomach).
• Inflammation of the coloured part of the eye (iris) (eye redness and pain, possibly with visual disturbances).
• Fever and (or) flu-like symptoms.

Rare adverse reactions (may affect up to 1 in 1000 people)

• Inflammation of the tongue (redness, swelling and sometimes pain), narrowing of the oesophagus (the tube connecting the mouth to the stomach).
• Abnormal liver function test results have been observed. These can only be detected by blood tests.

After the medicine was placed on the market, the following additional adverse reactions have been reported (frequency unknown):

• Hair loss
• Liver disorders, in some cases severe.

In rare cases, at the beginning of treatment, a decrease in blood calcium and phosphate levels may occur in patients. These changes are usually minor and do not cause any symptoms.

Very rare

• If a patient experiences ear pain, ear discharge, and (or) ear infection, this should be reported to the doctor. These may be symptoms of bone tissue damage in the ear.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 4921301, Fax: +48 22 4921309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Norifaz

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after:
"EXP:". The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Norifaz contains

• The active substance is risedronate sodium. Each coated tablet contains 75 mg of risedronate sodium (equivalent to 69.6 mg of risedronic acid).
• Other components are:
  Tablet core: microcrystalline cellulose, lactose monohydrate, crospovidone (Type A), magnesium stearate.
  Coating AquaPolish pink 044.53: hypromellose 4.8–7.2 mPas, hydroxypropyl cellulose, polyethylene glycol 400, polyethylene glycol 8000, titanium dioxide (E 171), colloidal anhydrous silica, iron oxide red (E 172).

What Norifaz looks like and contents of the pack
Norifaz 75 mg coated tablets are light pink, biconvex, round tablets with a diameter of 11.5 mm, imprinted with the number "75" on one side.
The pack contains 2 or 6 coated tablets in PVC/PVDC/Aluminium blisters, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Manufacturer:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

This medicinal product is authorised in the European Economic Area under the following names:
Greece: Norifaz
Hungary: Optirize 75 mg filmtabletta