PORONAL <70 mg Фильм-coated таблетки

Содержание инструкции

1. PORONAL 70 mg film-coated tablets
   1. WHAT IS PORONAL AND WHAT IS IT FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING PORONAL
   3. HOW TO TAKE PORONAL
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE PORONAL
   6. PACKAGE CONTENTS AND OTHER INFORMATION

PORONAL 70 mg film-coated tablets

Alendronic acid
Generic Medicine

Read 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, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• It is particularly important to understand the information contained in section
• 3. HOW TO TAKE PORONAL, before you take this medicine.

Contents of this leaflet:

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

1. WHAT IS PORONAL AND WHAT IS IT FOR

What is PORONAL?
PORONAL belongs to a group of non-hormonal drugs called bisphosphonates.
PORONAL prevents the loss of bone tissue that occurs in women after
menopause and promotes bone reconstruction. It reduces the risk of vertebral and
hip fractures.

What is PORONAL for?
Your doctor has prescribed PORONAL for the treatment of osteoporosis. PORONAL reduces
the risk of vertebral and hip fractures.

PORONAL is a treatment that must be taken once a week.
What is osteoporosis?
Osteoporosis is a thinning and weakening of the bones. It is common in women
after menopause. During menopause, the ovaries stop producing female hormones,
estrogens, which help to keep a woman's skeleton healthy. Consequently, bone tissue is lost and the bone becomes weaker. The risk of
osteoporosis is greater the earlier a woman reaches
menopause.
In the early stages, osteoporosis usually has no symptoms. However, if left untreated,
fractures can occur. Even though fractures are usually painful, fractures of the bones of the spine may not be felt
until they result in a decrease in height. Fractures can
occur during normal daily activities such as lifting weights, or with minor trauma
that would not be able to cause fractures in normal bone. Fractures usually occur in the hip, spine or wrist and can be
not only painful but can lead to significant deformities and disability, such as
curvature of the spine (hunchback) and limitations in movement.

How can osteoporosis be treated?
Along with treatment with PORONAL, your doctor may suggest changing your lifestyle to improve the condition of the disease, such as:

Stop smokingsmoking appears to increase the rate at which bone tissue is lost
and, therefore, may increase the risk of fractures.

Exerciselike muscles, bones need exercise to
stay strong and healthy. Consult your doctor before starting
any exercise program.

Balanced dietyour doctor can provide information on diet or the possible
need to take food supplements (especially
calcium and vitamin D).

2. WHAT YOU NEED TO KNOW BEFORE TAKING PORONAL

Do not take PORONAL:

• 1. If you are allergic (hypersensitive) to alendronic acid trihydrate or to any of the other ingredients of this medicine (listed in section 6).
• 2. If you have certain diseases of the esophagus (the channel that connects the mouth to the stomach), such as narrowing or difficulty swallowing.
• 3. If you are unable to stand or sit upright for at least 30 minutes.
• 4. If your doctor has told you that you have low levels of calcium in your blood.

If you think any of these apply to you, do not take the tablets. Consult your doctor and
follow the given instructions.

Warnings and precautions
Talk to your doctor or pharmacist before taking PORONAL if:

• you have Barrett's esophagus (a condition associated with changes in the cells lining the lower part of the esophagus)
• you suffer from kidney problems
• you suffer from allergies
• you have difficulty swallowing or have problems with the digestive system
• you have low levels of calcium in your blood
• you have been told you have a problem with the absorption of minerals in the stomach or intestine (malabsorption syndrome)
• you have poor dental health, gum problems, are planning to have a tooth extracted or do not have regular dental check-ups
• you are or have been a smoker (as this may increase the risk of dental problems)
• you have cancer
• you are taking angiogenesis inhibitors (such as bevacizumab, or thalidomide) which are used in the treatment of cancer
• you are undergoing chemotherapy or radiotherapy
• you are taking corticosteroids (such as prednisone or dexamethasone) which are used in the treatment of conditions such as asthma, rheumatoid arthritis and severe allergies

You may be required to have a dental check-up before starting
treatment with PORONAL, especially if one of the conditions mentioned above applies to
you.
During treatment with PORONAL, appropriate preventive dental procedures should be
followed, as recommended by your dentist.
It is important to maintain good oral hygiene during treatment with
PORONAL. You should have regular dental check-ups during treatment
and contact your doctor or dentist if you experience any problems with your mouth or
teeth such as tooth loss, pain or swelling.

Irritation, inflammation or ulceration of the esophagus (the channel that
connects the mouth to the stomach) may occur, often with symptoms of chest pain, burning
in the upper stomach, difficulty or pain swallowing, especially if patients do not drink
a full glass of water and/or lie down during the first 30 minutes after taking
PORONAL. These side effects may worsen if patients continue to
take PORONAL after experiencing these symptoms.

Children and adolescents
PORONAL should not be given to children and adolescents under 18
years of age.

Other medicines and PORONAL
Tell your doctor or pharmacist if you are taking, have recently taken, or may
take any other medicines, including those available without a prescription.
Calcium supplements, antacids, and some oral medicines
are likely to interfere with the absorption of PORONAL if taken at the same time.
It is therefore important to follow the instructions given in section 3.
Some medicines for rheumatism or long-term pain called NSAIDs (e.g.
acetylsalicylic acid or ibuprofen) may cause digestive problems. Therefore, caution should be
exercised when these medicines are taken at the same time as
PORONAL.

PORONAL with food and drink
Foods and beverages (including mineral water) are likely to decrease the effectiveness of
PORONAL if taken at the same time. It is therefore important to follow the instructions given
in section 3.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine .
PORONAL is only indicated for women after menopause. Do not take PORONAL if you are
pregnant or suspect you may be pregnant or if you are breastfeeding.

Driving and operating machinery
Side effects (such as blurred vision, dizziness and severe bone, muscle or joint pain) have been
reported with PORONAL that may affect your ability to drive or operate machinery (see section 4).

PORONAL contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is
essentially “sodium-free”.

3. HOW TO TAKE PORONAL

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Take one PORONAL tablet once a week.
Follow the instructions below carefully:

• 1) Choose a day of the week that best suits your activities. Take one PORONAL tablet once a week on the chosen day.

It is very important that you follow instructions 2), 3), 4), and 5) to facilitate entry

of the PORONAL tablet into the stomach quickly and help reduce the possibility

of irritating the esophagus (the channel that connects the mouth to the stomach).

• 2) After getting up from bed to start the day, and before taking any food, drink or other medicine of the day, swallow the PORONAL tablet whole with a glass filled only with tap water (not mineral water) (no less than 200 ml), so that PORONAL is adequately
  absorbed.

• Do not take it with mineral water (still or sparkling)
• Do not take it with coffee or tea
• Do not take it with juices or milk

Do not chew or crush the tablet and do not let it dissolve in your mouth due to the
possible formation of ulcers in the oral cavity.

• 3) Do not lie down – keep your torso in an upright position (while sitting, while standing, while walking) – for at least 30 minutes after swallowing the tablet. Do not lie down until you have eaten something.
• 4) Do not take PORONAL at bedtime or before getting out of bed in the morning.
• 5) If difficulty or pain occurs when swallowing, chest pain occurs, or heartburn in the upper part of the stomach appears or worsens, stop taking PORONAL and contact your doctor.
• 6) After swallowing the PORONAL tablet, wait at least 30 minutes before eating, drinking or taking other medicines of the day, including antacids, calcium supplements and vitamins. PORONAL is only effective when taken on an empty stomach.

If you take more PORONAL than you should:
If you accidentally take too many tablets, drink a glass of milk and contact
your doctor immediately. Do not induce vomiting and do not lie down.

If you forget to take PORONAL:
If you forget to take the tablet, it is sufficient to take one PORONAL
tablet the next morning. DO NOT take two tablets on the same day.
Subsequently, resume taking the tablet on the chosen day of the week.

If you stop taking PORONAL
It is important to continue taking PORONAL until prescribed by your doctor.
PORONAL is effective for the treatment of osteoporosis only if you continue to take the
tablets.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Go to your doctor immediatelyif you notice any of the following side effects, which may be serious and may require urgent medical treatment:
Very common (may affect more than 1 in 10 people):

• bone, muscle and/or joint pain which is sometimes severe.

Common (may affect up to 1 in 10 people):

• heartburn; difficulty swallowing; pain when swallowing; ulcers of the esophagus (the tube connecting the mouth to the stomach) which can cause chest pain, heartburn or difficulty or pain when swallowing,
• joint swelling,
• abdominal pain; a feeling of discomfort in the stomach or belching after meals; constipation; a feeling of fullness or bloating in the stomach; diarrhea, intestinal gas,
• hair loss; itching,
• headache; dizziness,
• fatigue; swelling of the hands or legs.

Uncommon (may affect up to 1 in 100 people):

• nausea; vomiting,
• irritation or inflammation of the esophagus (the tube connecting the mouth to the stomach) or the stomach,
• black or dark stools,
• blurred vision; eye pain or redness,
• skin rash; skin redness,
• transient flu-like symptoms such as muscle aches, general feeling of unwellness and sometimes fever, usually at the beginning of treatment,
• taste disturbance.

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

• allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, which can cause difficulty breathing and swallowing,
• symptoms due to low levels of calcium in the blood including muscle cramps or spasms and/or tingling in the fingers or around the mouth,
• peptic or stomach ulcers (sometimes severe or with bleeding),
• narrowing of the esophagus (the tube connecting the mouth to the stomach),
• skin rash worsened by exposure to sunlight; severe skin reactions,
• pain in the mouth, and/or jaw, swelling or ulcers inside the mouth, numbness or a feeling of heaviness in the jaw, or tooth loss. These may be signs of damage to the jaw bone (osteonecrosis) generally associated with delayed healing and infection, often after tooth extraction. Contact your doctor and dentist if you experience these symptoms,
• rarely, an unusual fracture of the femur may occur, particularly in patients treated for a long time for osteoporosis. Contact your doctor if you experience pain, weakness or discomfort in the thigh, hip or groin as this could be an early indication of a possible femur fracture,
• for osteoporosis. Contact your doctor if you experience pain, weakness or discomfort in the thigh, hip or groin as this could be an early indication of a possible femur fracture,
• mouth ulcers,
• bone, muscle and/or joint pain that is severe.

Very rare (may affect up to 1 in 10,000 people):

• Consult your doctor if you experience ear pain, ear discharge and/or ear infection. These episodes may be signs of bone damage in the ear.

Not known (frequency cannot be estimated from the available data)

• unusual fracture in sites other than the femur.

Promptly inform your doctor or pharmacist if any of these symptoms occur or any other unusual symptoms.
It is helpful to make a note of any symptoms that occur, when they started and how long they lasted.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE PORONAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the label after
. The expiry date refers to the last day of that month.
Do not remove the tablets from the blister pack until it is time to take them.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What PORONAL contains
Active ingredient
The active ingredient is alendronic acid trihydrate sodium. Each tablet contains the equivalent
of 70 mg of alendronic acid, as alendronic acid trihydrate sodium.

Excipients
Core: microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, sodium
stearyl fumarate;
Coating: hypromellose, talc.

Description of the appearance of PORONAL and package contents
Film-coated tablets: pack of 4 tablets.

Marketing Authorisation Holder
Konpharma s.r.l,
Via Pietro Della Valle 1,
00193 Rome
Italy

Manufacturers
Special Product’s Line S.p.A.
Strada Paduni, 240 – 03012 Anagni (FR) Italy
LACHIFARMA S.P.A Laboratorio Chimico Farmaceutico Salentino
S.S. 16 Zona Industriale, 73010 Zollino (LE) – Italy