FRILANS 15 mg Enteric-Coated Hard Capsules

Зміст інструкції

1. FRILANS 15 mg hard gastro-resistant capsules, 30 mg hard gastro-resistant capsules
   1. WHAT FRILANS IS AND WHAT IT IS USED FOR
   2. BEFORE TAKING FRILANS
   3. HOW TO TAKE FRILANS
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE FRILANS
   6. OTHER INFORMATION

FRILANS 15 mg hard gastro-resistant capsules, 30 mg hard gastro-resistant capsules

Lansoprazole
Generic medicine

Read this leaflet carefully before 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, pharmacist or nurse.
• This medicine has been prescribed only for you. Do not give it to other people, even if they have the same symptoms as you, because it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. (See section 4).

Contents of this leaflet:

• 1. What FRILANS is and what it is used for
• 2. Before taking FRILANS
• 3. How to take FRILANS
• 4. Possible side effects
• 5. How to store FRILANS
• 6. Further information

1. WHAT FRILANS IS AND WHAT IT IS USED FOR

The active ingredient of FRILANS is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid that your stomach produces.
Your doctor may prescribe FRILANS for the following indications in adults:

• Treatment of duodenal and stomach ulcers
• Treatment of inflammation of the esophagus (reflux esophagitis)
• Prevention of reflux esophagitis
• Treatment of heartburn and acid regurgitation
• Treatment of infections caused by the bacterium Helicobacter pylori in combination with antibiotic therapy
• Treatment or prevention of duodenal or stomach ulcers in patients who require continuous treatment with NSAIDs (NSAIDs are used against pain or inflammation)
• Treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed FRILANS for another indication or with a different dosage than that
reported in this leaflet. Follow your doctor's instructions for taking your
medicine.
Contact your doctor if you do not feel better or if you feel worse after 14 days of treatment.

2. BEFORE TAKING FRILANS

Do not take FRILANS

• if you are allergic to lansoprazole or to any of the excipients of this medicine (listed in section 6)

Warnings and precautions
Talk to your doctor or pharmacist before taking FRILANS
Tell your doctor if you have a serious liver disease. Your doctor may need to adjust the dosage
Talk to your doctor before taking FRILANS if you have ever had a skin reaction after a
treatment with a medicine similar to FRILANS that reduces stomach acid.
If you notice the appearance of a rash on the skin, especially in areas exposed to sunlight, contact
your doctor as soon as possible, as you may need to stop therapy with FRILANS.
Also remember to report any other undesirable effects such as joint pain.
Your doctor may have performed or will perform an additional examination called endoscopy in order to
diagnose your condition and/or exclude a malignant disease.
If you experience diarrhea during treatment with FRILANS, contact your doctor immediately, as
FRILANS has been associated with a small increase in infectious diarrhea.
If your doctor has prescribed FRILANS in addition to other medicines for the treatment
of Helicobacter pyloriinfection (antibiotics) or together with anti-inflammatory medicines for the
treatment of pain or rheumatic disease: please read the package leaflets
of these medicines carefully.
If you take FRILANS for a long time (for more than one year) your doctor will probably keep you under
regular observation. You should tell him/her whenever you see him/her about any symptom or circumstance that
is new and exceptional.
If you are taking a proton pump inhibitor such as FRILANS, especially for a period longer than
one year, there may be a slight increase in the risk of fractures of the hip, wrist or
spine. If you suffer from osteoporosis or are taking corticosteroids (which can increase the
risk of osteoporosis) consult your doctor.
Tell your doctor before taking this medicine if you are to undergo a specific blood test (Chromogranin A).

Other medicines and FRILANS
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, tell your doctor or pharmacist if you are taking medicines containing any of the
following active ingredients, as FRILANS may affect their mechanism of action:

• HIV protease inhibitors such as atazanavir and nelfinavir (for the treatment of HIV)
• methotrexate (for the treatment of autoimmune diseases and cancer)
• ketoconazole, itraconazole, rifampicin (used for the treatment of infections)
• digoxin (used to treat heart problems)
• warfarin (for the treatment of blood clots)
• theophylline (used to treat asthma)
• tacrolimus (used to prevent transplant rejection)
• fluvoxamine (used to treat depression and other psychiatric illnesses)
• antacids (used to treat heartburn and acid reflux)
• sucralfate (used to heal ulcers)
• St. John's wort (Hypericum perforatum)(used to treat mild depression)

Taking FRILANS with food and drink and alcohol
To get the best results, you should take FRILANS at least 30 minutes before eating food.

Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
Undesirable effects such as dizziness, vertigo, fatigue and visual disturbances sometimes occur
in patients taking FRILANS. If you experience undesirable effects such as these, you should
be careful because your reaction ability may be reduced.
You alone are responsible for deciding whether you are fit to drive a motor vehicle or
perform tasks that require high concentration. The use of medicines is one of the factors that can reduce the ability to perform these actions safely, due to their effects or
side effects.
You can find descriptions of these effects in other sections.
Read all the information contained in this leaflet as a guide.
If you are not sure about something, discuss it with your doctor, nurse or pharmacist.

FRILANS contains sucrose
If your doctor has diagnosed you with intolerance to certain sugars, contact him/her before taking
this medicine.

3. HOW TO TAKE FRILANS

Always take this medicine exactly as your doctor or pharmacist has told you. If you
have any doubts, ask your doctor or pharmacist.
Swallow the capsule whole with a glass of water. If you find it difficult to swallow the capsules, your doctor
may advise alternative methods for taking the medicine. Do not crush or chew these capsules
or the contents of an emptied capsule, as the medicine would not work properly.
If you take FRILANS once a day, try to take it at the same time each day. You may get the
best results if you take FRILANS first thing in the morning.
If you take FRILANS twice a day, you must take the first dose in the morning and the second in the
evening.
The dose of FRILANS depends on your condition. The usual doses of FRILANS for adults
are given below. Your doctor may sometimes prescribe a different dose and tell you how long
the treatment should last.

Treatment of heartburn and acid reflux:one 15 mg or
30 mg capsule for 4 weeks. If your symptoms persist, you should tell your doctor. If your symptoms do not improve
within 4 weeks, consult your doctor.

Treatment of duodenal ulcer:one 30 mg capsule every day for 2 weeks

Treatment of gastric ulcer:one 30 mg capsule every day for 4 weeks

Treatment of esophageal inflammation (reflux esophagitis):one 30 mg capsule every
day for 4 weeks

Long-term prevention of reflux esophagitis:one 15 mg capsule every day, the
doctor may adjust the dose up to one 30 mg capsule every day.

Treatment ofHelicobacter pyloriinfection:the usual dose is one 30 mg capsule in
combination with two different antibiotics in the morning and one 30 mg capsule in combination with
two different antibiotics in the evening. The treatment will generally be every day for 7 days.
The recommended antibiotic combinations are:

• FRILANS 30 mg together with clarithromycin 250-500 mg and amoxicillin 1000 mg
• FRILANS 30 mg together with clarithromycin 250 mg and metronidazole 400-500 mg If you are being treated for an infection in the presence of an ulcer, the ulcer is unlikely to return if the infection is treated successfully. To allow the medicine to work optimally, take it at the scheduled time and never miss a dose.

Treatment of duodenal or stomach ulcer in patients who require continued treatment
with NSAIDs:one 30 mg capsule every day for 4 weeks.

Prevention of duodenal or stomach ulcer in patients who require continued treatment
with NSAIDs:one 15 mg capsule every day, the doctor may adjust the dose up to
one 30 mg capsule every day.

Zollinger-Ellison syndrome:the usual initial dose is two 30 mg capsules every day, then
based on your response to FRILANS, the doctor will decide the most appropriate dose for you

Use in children
FRILANS should not be given to children.

If you take more FRILANS than you should
If you take more FRILANS than you have been told, contact your doctor immediately

If you forget to take FRILANS
If you forget to take a dose, take it as soon as you remember, unless it is almost time to
take the next dose. If this happens, do not take the forgotten dose and take the rest of the
capsules as normal. Do not take a double dose to make up for a missed capsule.

If you stop taking FRILANS
Do not stop treatment prematurely if your symptoms have improved. Your condition
may not be completely healed and may recur if you do not complete your course of
treatment.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines FRILANS can cause side effects, although not everybody gets them.
The following side effects are common (may affect more than 1 in 100 people):

• headache, dizziness
• feeling unwell or malaise, diarrhoea, stomach pain, constipation, flatulence, dry or inflamed mouth or throat, benign polyps of the stomach
• changes in liver function tests
• skin rash, itching
• fatigue

The following side effects are uncommon (may affect up to 1 in 100 people):

• changes in red blood cell count
• depression
• joint or muscle pain, hip, wrist or spine fracture
• fluid retention or swelling The following side effects are rare (may affect up to 1 in 1,000 people):
• anaemia (paleness)
• insomnia, hallucinations, confusion
• restlessness, vertigo, tingling sensation on the skin (paresthesia), drowsiness, tremor
• vision disorders
• inflammation of the tongue (glossitis), candidiasis (fungal infection, can affect the skin or mucous membranes), pancreatitis, altered sense of taste
• liver inflammation (can manifest with yellowing of the skin or eyes)
• skin reactions such as a burning or stinging sensation under the skin, bruising, redness, hair loss
• sensitivity to light
• kidney problems
• breast enlargement in men
• fever, excessive sweating, angioedema, loss of appetite, impotence. You should immediately see a doctor if you experience symptoms of angioedema such as swelling of the face, tongue or throat, difficulty swallowing, hives and difficulty breathing.

The following side effects are very rare (may affect up to 1 in 10,000 people):

• very rarely FRILANS can cause a reduction in the number of white blood cells, resulting in decreased resistance to infections. An infection manifests with symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of local infection, inflammation of the throat/pharyngitis/mouth or urinary problems, see a doctor immediately. A blood test will be performed to assess a possible reduction in white blood cells (agranulocytosis)
• colitis (inflammation of the colon), inflammation of the mouth (stomatitis)
• very severe skin reactions such as redness, blisters, severe inflammation and skin loss.
• severe hypersensitivity reactions including shock. Symptoms of a hypersensitivity reaction may include fever, rash, swelling and sometimes a drop in blood pressure.
• changes in laboratory values such as sodium, cholesterol and triglyceride levels

The frequency of the following side effects is not known (cannot be estimated from available data):

• if you take FRILANS for more than three months, it is possible that blood magnesium levels may decrease. Low magnesium levels can manifest with fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low magnesium levels can also lead to a decrease in blood potassium or calcium levels. The doctor should decide whether to periodically check magnesium levels in the blood.

• visual hallucinations
• erythema, possible joint pain.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE FRILANS

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the blister and the carton. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C. Store in the original packaging.
Keep the container (the bottle) tightly closed to protect the medicine from humidity.
Use the contents within 3 months of opening the container.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What FRILANS contains

• The active ingredient is lansoprazole. Each capsule contains 15 mg or 30 mg of lansoprazole.
• The capsules also contain sugar granules (sucrose, corn starch), povidone, dibasic sodium phosphate dihydrate, sodium lauryl sulfate, ethyl acrylate-methacrylic acid copolymer (1:1) dispersion 30%, talc, macrogol, titanium dioxide (E 171), polysorbate 80. Capsule shell: gelatin, titanium dioxide (E171). The 15 mg capsule also contains red iron oxide (E172).

Description of the appearance of FRILANS and contents of the pack
15 mg capsules: gelatin capsule of white/reddish-brown color containing enteric-coated granules of
color from white to light brown or slightly pink.
30 mg capsules: gelatin capsule of white color containing enteric-coated granules of
color from white to light brown or slightly pink.
Pack sizes
A plastic container with 14, 28, 56 and 98 capsules. The containers for 14, 28 or 56 capsules
contain a desiccant. The container for 98 capsules contains two desiccants.
Boxes of 7, 14, 28, 49, 56 and 98 capsules in blister packs.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Laboratorio Farmaceutico C.T. S.r.l. - Strada Solaro n. 75/77 – Sanremo (IM)

Manufacturer
Krka d.d., Novo Mesto, Smarjeska cesta 6, 8501 Novo Mesto, Slovenia

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