PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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

Lansoprazole
Generic medicine
Please read all of 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful to them.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. (See section 4).

Contents of this leaflet:

What FRILANS is and what it is used for
Before you take FRILANS
How to take FRILANS
Possible side effects
How to store FRILANS
Further information

1. WHAT FRILANS IS AND WHAT IT IS USED FOR

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

Treatment of duodenal and gastric ulcers
Treatment of inflammation of the oesophagus (reflux oesophagitis)
Prevention of reflux oesophagitis
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 gastric ulcers in patients requiring long-term treatment with NSAIDs (NSAIDs are used to treat pain or inflammation)
Treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed FRILANS for another indication or at a different dosage than that stated in this leaflet. Follow your doctor's instructions for taking your medicine.
Contact your doctor if you do not feel better or 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.
Inform your doctor if you have severe liver disease. Your doctor may need to adjust the dose.
Talk to your doctor before taking FRILANS if you have ever had a skin reaction after treatment with a medicine similar to FRILANS that reduces stomach acidity.
If you notice the appearance of a rash on the skin, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with FRILANS.
Remember to also report any other adverse effects such as joint pain.
Your doctor may have performed or may perform an additional test called endoscopy to diagnose your condition and/or rule out malignant disease.
If you develop diarrhea during treatment with FRILANS, contact your doctor immediately, as FRILANS has been associated with a small increased risk of infectious diarrhea.
If your doctor has prescribed FRILANS in combination with other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines for pain or rheumatic disease, please read carefully the package leaflets of these medicines.
If you take FRILANS long-term (for more than one year), your doctor will likely monitor you regularly. You should report to your doctor any new or unusual symptoms or circumstances at each visit.
If you take a proton pump inhibitor such as FRILANS, especially for 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 may increase the risk of osteoporosis), consult your doctor.
Inform your doctor before taking this medicine if you are scheduled for a specific blood test (chromogranin A).

Other medicines and FRILANS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking medicines containing any of the following active substances, 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 to treat 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 disorders)
antacids (used to treat heartburn and acid regurgitation)
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 achieve the best results, 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, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Adverse effects such as dizziness, vertigo, fatigue, and visual disturbances may occasionally occur in patients taking FRILANS. If you experience such adverse effects, you should exercise caution, as your reaction ability may be reduced.
Only you are responsible for deciding whether you are fit to drive a motor vehicle or perform tasks requiring high concentration. The use of medicines is one of the factors that may reduce your ability to perform these activities safely, due to their effects or side effects.
Descriptions of these effects can be found in other sections.
Read all the information in this leaflet carefully.
If you are unsure about anything, discuss it with your doctor, nurse, or pharmacist.
FRILANS contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. HOW TO TAKE FRILANS

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Swallow the capsule whole with a glass of water. If you have difficulty swallowing the capsules, your
doctor may advise you on alternative methods for taking the medicine. Do not crush or chew these capsules
or the contents of an emptied capsule, as the medicine will not work properly.
If you take FRILANS once daily, try to take it at the same time every day. You may achieve the
best results if you take FRILANS first thing in the morning.
If you take FRILANS twice daily, you should 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 listed
below. Your doctor may sometimes prescribe a different dose and will inform you how long the treatment
should last.
Treatment of heartburn and acid regurgitation: one 15 mg or 30 mg capsule for 4 weeks. If symptoms
persist, inform your doctor. If symptoms do not improve within 4 weeks, consult your doctor.
Treatment of duodenal ulcer: one 30 mg capsule daily for 2 weeks
Treatment of gastric ulcer: one 30 mg capsule daily for 4 weeks
Treatment of inflammation of the oesophagus (reflux oesophagitis): one 30 mg capsule daily for 4 weeks
Long-term prevention of reflux oesophagitis: one 15 mg capsule daily; your doctor may adjust the dose up
to one 30 mg capsule daily.
Treatment of Helicobacter pylori infection: 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. Treatment is usually given daily 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 associated with an ulcer, it is unlikely that the ulcer will recur if the infection is successfully treated. To allow the medicine to work optimally, take it at the scheduled time and never skip a dose.

Treatment of duodenal or gastric ulcer in patients requiring continued treatment with NSAIDs: one 30 mg capsule daily for 4 weeks.
Prevention of duodenal or gastric ulcer in patients requiring continued treatment with NSAIDs: one 15 mg capsule daily; your doctor may adjust the dose up to one 30 mg capsule daily.
Zollinger-Ellison syndrome: the usual initial dose is two 30 mg capsules daily; thereafter, depending on your response to FRILANS, your doctor will decide the most appropriate dose for you.
Use in children
FRILANS must not be given to children.
If you take more FRILANS than you should
If you take more FRILANS than prescribed, 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 for your next
dose. In that case, do not take the missed dose and take the next dose at the usual time. Do not take a
double dose to make up for a forgotten dose.
If you stop taking FRILANS
Do not stop treatment prematurely, even if your symptoms have improved. Your condition may not be
fully healed and symptoms may return if you do not complete the full course of treatment.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, FRILANS may cause adverse reactions, although not everybody gets them.

The following adverse reactions are common (occur in more than 1 out of 100 patients):

headache, dizziness
feeling unwell or malaise, diarrhoea, stomach ache, constipation, intestinal gas, dry or inflamed mouth or throat, benign gastric polyps
changes in liver function tests
skin rash, itching
fatigue

The following adverse reactions are uncommon (occur in less than 1 out of 100 patients):

changes in red blood cell count
depression
joint or muscle pain, hip, wrist or spinal fracture
fluid retention or swelling

The following adverse reactions are rare (occur in less than 1 out of 1000 patients):

anaemia (pallor)
insomnia, hallucinations, confusion
restlessness, dizziness, tingling sensation on the skin (paresthesia), somnolence, tremor
visual disturbances
inflammation of the tongue (glossitis), candidiasis (fungal infection, may affect skin or mucous membranes), pancreatitis, altered sense of taste
liver inflammation (may present with yellowing of the skin or eyes)
skin reactions such as burning or itching sensation under the skin, bruising, redness, hair loss
photosensitivity
kidney problems
breast enlargement in men
fever, excessive sweating, angioedema, loss of appetite, impotence

You must immediately contact your doctor if you experience symptoms of angioedema such as swelling of the face, tongue or throat, difficulty swallowing, hives, or breathing difficulties.

The following adverse reactions are very rare (occur in less than 1 out of 10000 patients):

very rarely, FRILANS may cause a reduction in the number of white blood cells, leading to decreased resistance to infections. This may manifest as an infection with symptoms such as fever and severe deterioration in general condition, or fever accompanied by symptoms of local infection such as sore throat/pharyngitis/mouth inflammation or urinary problems. In such cases, consult your doctor immediately. A blood test will be performed to assess for 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, blistering, severe inflammation and skin loss
severe hypersensitivity reactions including shock. Symptoms of a hypersensitivity reaction may include fever, skin 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 adverse reactions is unknown (cannot be estimated from the available data):

if you take FRILANS for more than three months, blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium. Your doctor should decide whether periodic monitoring of blood magnesium levels is necessary.
visual hallucinations
erythema, possible joint pain

If any of the adverse reactions worsen, or if you notice any adverse reactions not listed in this leaflet, inform your doctor.

Reporting of adverse reactions

If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting adverse reactions, 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 carton. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original packaging.
Keep the container (the bottle) tightly closed to protect the medicine from moisture.
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 no longer required. This will help protect the environment.

6. OTHER INFORMATION

What FRILANS contains

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

Description of the appearance of FRILANS and contents of the pack
15 mg capsules: white/red-brown gelatin capsule containing enteric-coated granules of white to light brown or slightly pinkish color.
30 mg capsules: white gelatin capsule containing enteric-coated granules of white to light brown or slightly pinkish color.
Pack sizes
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 Authorization Holder
Laboratorio Farmaceutico C.T. S.r.l. - Strada Solaro No. 75/77 – Sanremo (IM)
Manufacturer
Krka d.d., Novo Mesto, Smarjeska cesta 6, 8501 Novo Mesto, Slovenia
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