NORIFAZ 75 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Norifaz, 75 mg, Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Norifaz and what is it used for
   1. What is Norifaz
   2. What is Norifaz used for
4. Important information before taking Norifaz
   1. When not to take Norifaz
   2. Warnings and precautions
   3. Children and adolescents
   4. Norifaz and other medicines
   5. Norifaz with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Norifaz contains lactose
   9. Norifaz contains sodium
5. How to take Norifaz
   1. When to take the Norifaz tablet
   2. How to take the Norifaz tablet
   3. Taking more Norifaz than prescribed
   4. Missing a dose of Norifaz
   5. In the next month, return to the normal schedule of taking the tablets.
   6. Stopping Norifaz treatment
6. Possible side effects
   1. Very rare
   2. Reporting side effects
7. How to store Norifaz
8. Contents of the pack and other information
   1. What Norifaz contains
   2. What Norifaz looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. This medicinal product is authorized in the countries of the European Economic Area under the following names:

Package Leaflet: Information for the Patient

Norifaz, 75 mg, Coated Tablets

Sodium Risedronate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Norifaz and what is it used for
• 2. Important information 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 is Norifaz and what is it used for

What is Norifaz

Norifaz belongs to a group of non-hormonal medicines called bisphosphonates, which are used to treat bone diseases. The medicine works directly on the bones, strengthening them and thus reducing the risk of fractures.
Bone is a living tissue. Old bone tissue is constantly being removed from the skeleton and replaced with new bone tissue.
Postmenopausal osteoporosis is a condition that occurs in women after menopause, in which the bones become weaker, more brittle, and more prone to fractures in the event of a fall or strain.
The most common fractures occur in the spine, hip, and wrist, but any bone in the body can fracture. Osteoporotic fractures can also cause back pain, loss of height, and curvature of the spine. In many patients, no symptoms of osteoporosis are present, and the patient may not even know they have the disease.

What is Norifaz used for

Treatment of osteoporosis in postmenopausal women.

2. Important information before taking Norifaz

When not to take Norifaz

• If you are allergic to sodium risedronate or any of the other ingredients of this medicine (listed in section 6)
• If you have been diagnosed with a condition called hypocalcemia (low calcium levels in the blood)
• If you may be pregnant, are pregnant, or are planning to become pregnant
• In breastfeeding women
• If you have severe kidney disease.

Warnings and precautions

Before starting to take Norifaz, discuss it with your doctor or pharmacist:

• If you are unable to sit or stand upright for at least 30 minutes.
• If you have bone metabolism or mineralization disorders (e.g., vitamin D deficiency, hormonal disorders of the parathyroid gland, which can lead to decreased calcium levels in the blood).
• If you have or have had esophageal diseases (the tube that connects the mouth to the stomach). For example, if you have or have had pain or difficulty swallowing food, or if you have been diagnosed with Barrett's esophagus (a condition that occurs with changes in the cells lining the lower part of the esophagus).
• If you have or have had pain, swelling, numbness, or a feeling of heaviness in the jaw or after tooth loss.
• If you are undergoing dental treatment or are planning to have dental surgery, inform your dentist that you are taking Norifaz. The dentist will advise you on how to proceed while taking Norifaz if you experience any of the above conditions.

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 and other medicines

Medicines containing any of the following elements taken at the same time as Norifaz reduce its effectiveness:

• calcium
• magnesium
• aluminum (e.g., some antacids)
• iron. These medicines should be taken at least 30 minutes after taking Norifaz.

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan 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 it can work properly. It is especially important not to take this medicine with dairy products (such as milk), as they contain calcium (see section 2, "Norifaz and other medicines").
Meals and liquids (other than plain water) should be consumed at least 30 minutes after taking Norifaz.

Pregnancy and breastfeeding

Norifaz should not be taken if you may be pregnant, are pregnant, or are planning to become pregnant (see section 2, "When not to take Norifaz"). The potential risk associated with taking sodium risedronate (the active substance of Norifaz) in pregnant women is not known.
Norifaz should not be taken during breastfeeding (see section 2, "When not to take Norifaz").
Norifaz should only be used to treat postmenopausal women.

Driving and using machines

It is not known whether Norifaz affects the ability to drive and use machines.

Norifaz contains lactose

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

Norifaz contains sodium

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

3. How to take Norifaz

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
Recommended dose:
Norifaz should be taken on two consecutive days of each month, e.g., the 1st and 2nd day of the month or the 15th and 16th day of the month.
Choose two consecutive days that suit your schedule, during which you will take Norifaz. Take one tablet of Norifaz on the first chosen day in the morning, and the second tablet on the next morning.
Take the medicine on the same two consecutive days each month. You can mark the dates of taking the medicine in your calendar with a pen or sticker, which will help you remember to take the medicine.

When to take the Norifaz tablet

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

How to take the Norifaz tablet

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

Your doctor may recommend taking additional calcium or vitamin supplements. This may be necessary if your daily intake of these components in your diet is insufficient.

Taking more Norifaz than prescribed

If you or someone else has taken too many Norifaz tablets, drink a full glass of milk and contact your doctor.

Missing a dose of Norifaz

If you miss a dose, follow these instructions:
How to proceed?
If there are more than 7 days until the next scheduled dose:
Take the first tablet the next morning, and the second tablet the following morning.
If there are less than 7 days until the next scheduled dose:
Do not take the missed tablets.

• 1. and 2. tablet

Do not take the missed tablets
If there are more than 7 days until the next scheduled dose:
Take the second tablet the next morning.
Only 2.
tablet
Do not take the missed tablet
If there are less than 7 days until the next scheduled dose:

In the next month, return to the normal schedule of taking the tablets.

In any case:

• If you miss a dose of Norifaz in the morning, do not take it later that day.
• Do not take three tablets in the same week.

Stopping Norifaz treatment

Stopping treatment may cause the bone loss process to resume. Consult your doctor before making a decision to stop treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Norifaz can cause side effects, although not everybody gets them.
Stop taking Norifaz and contact your doctor immediatelyif you experience any of the following symptoms:

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

If you experience any of the following side effects, contact your doctor immediately:

• eye inflammation, usually with pain, redness, and sensitivity to light.
• bone necrosis (death of bone tissue) of the jaw associated with delayed healing and infections, often following tooth extraction (see section 2, "Warnings and precautions").
• esophageal symptoms, such as pain when swallowing, difficulty swallowing, chest pain, or worsening of heartburn. In rare cases, atypical fractures of the thigh bone may occur, especially in patients who have been treated for osteoporosis for a long time. Contact your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin area, as this may indicate a possible fracture of the thigh bone.

In clinical trials, other observed side effects were usually mild and did not cause patients to stop taking the tablets.
Common side effect(may affect up to 1 in 10 people)

• indigestion, nausea, vomiting, stomach pain, stomach cramps, or discomfort in the stomach, constipation, feeling of fullness, bloating, diarrhea.
• bone, muscle, or joint pain.
• headache.

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

• esophageal inflammation or ulceration (the tube that connects the mouth to the stomach) causing difficulty and pain when swallowing (see also section 2, "Warnings and precautions"), stomach and duodenal inflammation.
• inflammation of the colored part of the eye (iris) (redness and pain in the eye with possible vision disturbances).
• fever and/or flu-like symptoms.

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

• tongue inflammation (redness, swelling, and sometimes pain), narrowing of the esophagus (the tube that connects the mouth to the stomach).
• abnormal liver function test results. These can only be detected by blood tests.

After the medicine was placed on the market, the following additional side effects were reported (frequency not known):

• hair loss
• liver disorders, in some cases severe.

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

Very rare

• If you experience ear pain, ear discharge, and/or ear infection, tell your doctor. These may be symptoms of bone tissue damage in the ear.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Norifaz

Keep the medicine out of the 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 that month.
Store in the original package 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. This will help protect the environment.

6. Contents of the pack and other information

What Norifaz contains

• The active substance of Norifaz is sodium risedronate. Each coated tablet contains 75 mg of sodium risedronate (which corresponds to 69.6 mg of risedronic acid).
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, crospovidone (Type A), magnesium stearate. AquaPolish pink 044.53coating: hypromellose 4,8-7,2 mPas, hydroxypropylcellulose, macrogol 400, macrogol 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 pink, biconvex, round tablets with a diameter of 11.5 mm, with the number "75" embossed on one side.
The pack contains 2 or 6 coated tablets in PVC/PVDC/Aluminum blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized in the countries of the European Economic Area under the following names:

Greece
Norifaz
Hungary
Optirize 75 mg filmtabletta
Date of last revision of the leaflet:03.2021