Patient Information Leaflet

Lansoprazole Almus 15 mg hard capsules, 30 mg hard capsules

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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What LANSOPRAZOLE ALMUS is and what it is used for
What you need to know before taking LANSOPRAZOLE ALMUS
How to take LANSOPRAZOLE ALMUS
Possible side effects
How to store LANSOPRAZOLE ALMUS
Contents of the pack and other information

1. What LANSOPRAZOLO ALMUS is and what it is used for

The active substance of LANSOPRAZOLO ALMUS is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced in your stomach.
Your doctor may prescribe LANSOPRAZOLO ALMUS 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 when given in combination with antibiotic therapy
Treatment or prevention of duodenal or gastric ulcers in patients requiring continuous treatment with pain or anti-inflammatory medicines (non-steroidal anti-inflammatory drugs - NSAIDs)
Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed LANSOPRAZOLO ALMUS for another indication or at a different dosage than that stated in this leaflet. Follow your doctor's instructions for taking the medicine.
Contact your doctor if you do not feel better or if you feel worse after 14 days.

2. What you need to know before taking LANSOPRAZOLE ALMUS

Do not take LANSOPRAZOLE ALMUS:

if you are allergic to lansoprazole or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
While taking lansoprazole, inflammation of the kidneys may occur. Signs and symptoms may include reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You must report these signs to your doctor.
Tell your doctor if you have severe liver disease. Your doctor may need to adjust your dose.
Your doctor may perform or may have already performed an additional examination called endoscopy to diagnose your condition and/or rule out malignant disease.
If you develop diarrhoea during treatment with LANSOPRAZOLE ALMUS, contact your doctor immediately, as LANSOPRAZOLE ALMUS has been associated with a small increased risk of infectious diarrhoea.
If your doctor has prescribed LANSOPRAZOLE ALMUS in combination with other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines for pain or rheumatic diseases: please read the package leaflet of these medicines carefully as well.
If you take a proton pump inhibitor such as LANSOPRAZOLE ALMUS, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis (reduced bone density) or if your doctor tells you that you are at risk of osteoporosis (e.g., if you are taking steroids).
If you take LANSOPRAZOLE ALMUS long-term (for more than 1 year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances at every visit to your doctor.
Talk to your doctor before taking lansoprazole:

If you have low levels of vitamin B12 or have risk factors for low vitamin B12 levels and are receiving long-term treatment with lansoprazole. As with all agents that reduce acid, lansoprazole may lead to reduced absorption of vitamin B12.
If you are scheduled for a specific blood test (Chromogranin A).
If you have ever had a skin reaction after treatment with a medicine similar to lansoprazole that reduces gastric acidity.

If you notice the appearance of a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with lansoprazole. Remember to also report any other adverse effects such as joint pain.
Other medicines and LANSOPRAZOLE ALMUS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
In particular, tell your doctor or pharmacist if you are taking medicines containing any of the following active substances, as LANSOPRAZOLE ALMUS may affect their mechanism of action:

HIV protease inhibitors such as atazanavir and nelfinavir (used to treat HIV)
methotrexate (used to treat autoimmune diseases and cancer)
ketoconazole, itraconazole, rifampicin (used to treat infections)
digoxin (used to treat heart problems)
warfarin (used to treat 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 or acid reflux)
sucralfate (used to heal ulcers)
St. John’s wort (Hypericum perforatum) (used to treat mild depression)

LANSOPRAZOLE ALMUS with food and drink
To achieve the best results, take LANSOPRAZOLE ALMUS at least 30 minutes before eating.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, 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 LANSOPRAZOLE ALMUS.
If you experience adverse effects like these, you should exercise caution, as your attention capacity may be reduced.
You are solely responsible for deciding whether you are fit to drive a motor vehicle or perform other tasks requiring increased concentration. The use of medicines is one of the factors that may impair 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 as a guide.
If you are unsure about anything, discuss it with your doctor or pharmacist.
LANSOPRAZOLE ALMUS contains sucrose and sodium
This medicine contains sucrose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take LANSOPRAZOLE ALMUS

Take this medicine exactly as your doctor has told you. If you are unsure,
consult your doctor or pharmacist.
Swallow the capsule whole with a glass of water. If you have difficulty swallowing hard capsules,
your doctor may recommend an alternative way of taking the medicine. Do not crush or chew
these hard capsules or the contents of emptied hard capsules, as the medicine will not work properly.
If you take LANSOPRAZOLE ALMUS once daily, try to take it at the same time each day.
You may achieve better results if you take LANSOPRAZOLE ALMUS first thing in the morning.
If you take LANSOPRAZOLE ALMUS twice daily, you should take the first dose in the morning and the
second dose in the evening.
The dose of LANSOPRAZOLE ALMUS depends on your condition. The usual doses of LANSOPRAZOLE
ALMUS for adults are listed below. Sometimes your doctor may prescribe a different dose and will
tell 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
have not improved within 4 weeks, contact 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. The treatment lasts for 7 days.
The recommended antibiotic combinations are:
30 mg of LANSOPRAZOLE ALMUS together with 250–500 mg of clarithromycin and 1,000 mg of
amoxicillin
30 mg of LANSOPRAZOLE ALMUS together with 250 mg of clarithromycin and 400–500 mg of
metronidazole
If you are being treated for this infection because you have an ulcer, the ulcer is unlikely to recur if
the infection is successfully treated. To achieve the best results from this therapy, take the medicine
at the prescribed times and do not miss any dose.
Treatment of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs:
one 30 mg capsule daily for 4 weeks.
Prevention of duodenal or gastric ulcer in patients requiring continuous 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 hard capsules daily; thereafter, based
on your response to LANSOPRAZOLE ALMUS, your doctor will decide the most appropriate dose for you.
Use in children
LANSOPRAZOLE ALMUS must not be given to children.
If you take more LANSOPRAZOLE ALMUS than you should
If you take more LANSOPRAZOLE ALMUS than prescribed, seek immediate advice from your doctor.
If you forget to take LANSOPRAZOLE ALMUS
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 capsules as usual. Do not take a
double dose to make up for a forgotten capsule.
If you stop taking LANSOPRAZOLE ALMUS
Do not stop treatment prematurely even if your symptoms have improved. Your condition may not
be completely healed and symptoms may return if you do not complete the full course of treatment.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people)

headache, dizziness
diarrhoea, constipation, stomach pain, feeling unwell, intestinal gas (flatulence), dry or inflamed mouth or throat
rash, itching
changes in liver function tests
fatigue
benign stomach polyps

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

depression
joint and muscle pain
fluid retention or swelling
changes in red blood cell count

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

fever
restlessness, drowsiness, confusion, hallucinations, insomnia, vision disturbances, dizziness
altered taste sensation, loss of appetite, inflammation of the tongue (glossitis)
skin reactions such as burning or prickling sensation under the skin, bruising, redness and excessive sweating
light sensitivity
hair loss
tingling sensation on the skin (paraesthesia), tremor
anaemia (pallor)
kidney problems
pancreatitis
liver inflammation (may present with yellowing of the skin or eyes)
breast swelling in men, impotence
candidiasis (fungal infection, may affect the skin or mucous membranes)
angioedema; you must see a doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue or pharynx, difficulty swallowing, hives, or breathing difficulties

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

severe hypersensitivity reactions including shock. Symptoms of hypersensitivity reactions may include fever, rash, swelling and sometimes a drop in blood pressure
inflammation of the mouth (stomatitis)
inflammation of the colon (colitis)
changes in laboratory values such as sodium, cholesterol and triglyceride levels
very severe skin reactions with redness, blistering, severe inflammation and skin loss
very rarely, LANSOPRAZOLO ALMUS may cause a reduction in the number of white blood cells, and resistance to infections may therefore decrease. If you develop an infection with symptoms such as fever and severe worsening of your general condition, or fever with signs of local infection such as inflamed throat/pharynx/mouth or urinary problems, you must see a doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis)

Frequency not known (cannot be estimated from the available data)

if you take LANSOPRAZOLO ALMUS for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present with fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium. Your doctor should decide whether to monitor your blood magnesium levels regularly
low sodium levels in the blood. Common symptoms include nausea and vomiting, headache, drowsiness and fatigue, confusion, muscle weakness or spasms, irritability, seizures, coma
erythema, possibly associated with joint pain
visual hallucinations

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 LANSOPRAZOLE ALMUS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via 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 LANSOPRAZOLO ALMUS contains
LANSOPRAZOLO ALMUS 15 mg hard capsules

The active substance is lansoprazole. Each hard capsule contains 15 mg of lansoprazole.
The other components are sucrose spheres and maize starch, heavy magnesium carbonate, hypromellose, polysorbate 80, polyethylene glycol 6000, triethyl citrate, talc, titanium dioxide (E171), methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion (Eudragit L30 D-55), sodium hydroxide.
Capsule components: gelatin, titanium dioxide (E171), erythrosine (E127), iron oxide red (E172).

LANSOPRAZOLO ALMUS 30 mg hard capsules

The active substance is lansoprazole. Each hard capsule contains 30 mg of lansoprazole.
The other components are sucrose spheres and maize starch, heavy magnesium carbonate, hypromellose, polysorbate 80, polyethylene glycol 6000, triethyl citrate, talc, titanium dioxide (E171), methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion (Eudragit L30 D-55), sodium hydroxide.
Capsule components: gelatin, titanium dioxide (E171), erythrosine (E127), iron oxide red (E172).

Description of the appearance of LANSOPRAZOLO ALMUS and pack contents
Blister packs of 14 and 28 hard capsules.
Marketing Authorization Holder
Almus S.r.l. – Via Cesarea, 11/10 – 16121 Genoa – Italy
Manufacturer
Laboratorios Salvat, S.A. – C/Gall 30-36 Esplugues del Llobregat, Barcelona – Spain