COLLEZOES 20 mg Enteric-Coated Tablet

Зміст інструкції

1. Collezoes 20 mg gastro-resistant tablets, 40 mg gastro-resistant tablets
   1. What Collezoes is and what it is used for
   2. What you need to know before taking Collezoes
   3. How to take Collezoes
   4. Possible side effects
   5. How to store Collezoes
   6. Package Contents and Other Information

Collezoes 20 mg gastro-resistant tablets, 40 mg gastro-resistant tablets

esomeprazole
Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 may be harmful.
• If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

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

1. What Collezoes is and what it is used for

Collezoes contains a medicine called esomeprazole. This belongs to a group of
medicines called ‘proton pump inhibitors’, which work by reducing the amount of acid
produced by your stomach.
Collezoes is used for the treatment of the following conditions:
Adults and young people starting from 12 years of age

• 'Gastro-oesophageal reflux disease' (GERD). This disease occurs when acid leaks from the stomach and passes into the oesophagus (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn.
• Ulcers in the stomach or in the upper part of the digestive tract (intestine), which are infected by the bacterium called 'Helicobacter pylori'. If you suffer from this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Adults

• Ulcers of the stomach caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Collezoes can also be used to prevent the formation of stomach ulcers if you are taking NSAIDs.
• Excess acid in the stomach caused by a growth in the pancreas (Zollinger Ellison syndrome).
• Prolonged treatment after prevention of bleeding ulcer relapses with esomeprazole intravenously.

2. What you need to know before taking Collezoes

Do not take Collezoes

• if you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other medicines that are proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• if you are taking a medicine containing nelfinavir (used for the treatment of HIV). Do not take Collezoes if any of these apply to you. If you are unsure, talk to your doctor or pharmacist before taking Collezoes.

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

• if you have severe liver problems.
• if you have severe kidney problems.
• if you have ever had a skin reaction after treatment with a medicine similar to Collezoes that reduces stomach acid.
• you are going to have a specific blood test (Chromogranin A)

If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your
doctor as soon as possible, as you may need to stop treatment with Collezoes. Remember to report
any other side effects such as joint pain.
Collezoes can mask the symptoms of other diseases. Therefore, if any of the
following events occur before you take Collezoes or while you are taking it, contact your
doctor immediately:

• you lose a lot of weight without reason and have difficulty swallowing.
• you have stomach pain or indigestion.
• you start vomiting food or blood.
• you pass black stools (stools stained with blood).

If Collezoes has been prescribed for you "on demand" you should contact your doctor if the symptoms persist or
change in character.
Taking a proton pump inhibitor such as Collezoes, especially for a period
longer than one year, may slightly increase the risk of fractures of the wrist, hip or
spine. Tell your doctor if you suffer from osteoporosis or are taking corticosteroids
(which can increase the risk of osteoporosis).

Other medicines and Collezoes
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This is important because Collezoes can affect the way
some medicines work and, in turn, some medicines can affect the action of
Collezoes.
Do not take Collezoes if you are taking a medicine containing nelfinavir(used for the treatment
of HIV).
Tell your doctor or pharmacist if you are taking any of the following medicines:

• Atazanavir (used for the treatment of HIV).
• Ketoconazole, itraconazole or voriconazole (used to treat fungal infections).
• Erlotinib (used for the treatment of cancer).
• Citalopram, imipramine or clomipramine (used for the treatment of depression).
• Diazepam (used for the treatment of anxiety, to relax muscles or in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you at the beginning and end of treatment with Collezoes.
• Medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you at the beginning and end of treatment with Collezoes.
• Cilostazol (used for the treatment of intermittent claudication - pain in the legs when walking, caused by insufficient blood supply).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapeutic medicine used at high doses for the treatment of cancer) - if you are taking a high dose of methotrexate, your doctor may decide to temporarily interrupt the treatment with Collezoes
• Rifampicin (used for the treatment of tuberculosis).
• St John's Wort ( Hypericum perforatum) (used for the treatment of depression). If your doctor has prescribed you amoxicillin and clarithromycin antibiotics together with Collezoes for the treatment of ulcers caused by Helicobacter pyloriinfection, it is very important that you tell your doctor if you are taking any other medicines.

Collezoes with food and drink
You can take the tablets with food or on an empty stomach.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will decide whether you can take Collezoes during this period.
It is not known whether Collezoes is excreted in breast milk. Therefore, you should not take Collezoes
while breastfeeding.

Driving and using machines
It is unlikely that Collezoes will affect your ability to drive or operate
tools or machinery.

Collezoes contains sucrose
Collezoes gastro-resistant tablets contain sucrose, which is a type of sugar. If your
doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this
medicine.

Collezoes contains Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say essentially
‘sodium-free’.

3. How to take Collezoes

Take this medicine always exactly as your doctor has instructed. If you have any doubts, ask your doctor or pharmacist.

• Collezoes gastro-resistant tablets are not recommended for children under 12 years of age.
• If you are taking the medicine for a long time, your doctor will want to monitor you (especially if you are taking it for more than one year).
• If your doctor has told you to take the medicine as and when you need it, tell your doctor if your symptoms change.

Taking this medicine

• You can take the tablets at any time of the day.
• You can take the tablets with food or on an empty stomach.
• Swallow the tablets whole with a glass of water. Do not chew or crush the tablets. This is because the tablets contain granules coated that prevent the medicine from being destroyed by stomach acids. It is important not to damage the granules.

What to do if you have difficulty swallowing the tablets

• If you have problems swallowing the tablets:
• Place them in a glass of still water (non-carbonated). Do not use other liquids.
• Mix until the tablets dissolve (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes. Always mix the mixture just before drinking it.
• To make sure you have drunk all the medicine, rinse the glass very well with half a glass of water and drink it. The solid parts contain the medicine - do not chew or crush them.
• If you are unable to swallow, the tablet can be mixed with water and the mixture poured into a syringe. It can then be administered to you directly into the stomach via a tube ('gastric tube').

How much to take

• Your doctor will tell you how many tablets to take and for how long to take them. This will depend on your condition, your age and your liver function.
• The usual doses are indicated below.

For the treatment of heartburn caused by gastro-oesophageal reflux disease (GERD):
Adults and children from 12 years of age:

• If the doctor has found that your digestive tract (oesophagus) has been slightly damaged, the usual dose is one Collezoes 40 mg tablet once a day for 4 weeks. The doctor may tell you to take the same dose for another 4 weeks if your oesophagus has not yet healed.
• Once your oesophagus has healed, the usual dose is one Collezoes 20 mg tablet once a day.
• If your oesophagus has not been damaged, the usual dose is one Collezoes 20 mg tablet daily. Once the condition has been controlled, your doctor may tell you to take the medicine as and when you need it, up to a maximum of one Collezoes 20 mg tablet daily.
• If you have severe liver problems, your doctor may prescribe you a lower dose.

For the treatment of ulcers caused by Helicobacter pyloriinfection and to prevent them
from returning:

• Adults and young people from 12 years of age: the usual dose is one Collezoes 20 mg tablet twice a day for one week.
• The doctor will also tell you to take antibiotics, for example, amoxicillin and clarithromycin.

For the treatment of stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory
Drugs):

• Adults from 18 years of age: the usual dose is one Collezoes 20 mg tablet once a day for 4 - 8 weeks.

To prevent stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory
Drugs):

• Adults from 18 years of age: the usual dose is one Collezoes 20 mg tablet once a day.

For the treatment of excess acid in the stomach caused by a growth in the pancreas (Zollinger Ellison syndrome):

• Adults from 18 years of age: the usual dose is one Collezoes 40 mg tablet twice a day.
• Your doctor will adjust the dose according to your needs and will also decide how long you should take the medicine. The maximum dose is 80 mg twice a day.

To be used as prolonged treatment after prevention of bleeding ulcer recurrences with esomeprazole via intravenous route:

• Adults from 18 years of age: the usual dose is one Collezoes 40 mg tablet once a day for 4 weeks.

If you take more Collezoes than you should
If you take Collezoes more than prescribed by your doctor, seek immediate medical
attention or contact your pharmacist.

If you forget to take Collezoes

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time to take the next dose, skip the missed dose.
• Do not take a double dose (two doses at the same time) to make up for the forgotten dose.

If you stop taking Collezoes
If you have further questions on 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 everybody gets them.

If you notice any of the following serious side effects, stop taking Collezoes
and contact your doctor immediately:

• Sudden shortness of breath, swelling of the lips, tongue and throat or body, rash, fainting or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blisters or peeling. There may also be blisters and bleeding on the lips, eyes, mouth, nose and genitals. This could be ‘Stevens-Johnson syndrome’ or ‘toxic epidermal necrolysis’.
• Yellowing of the skin, dark urine and fatigue, which can be symptoms of liver problems.

These effects are rare (may affect up to 1 in 1,000 people)
Other side effects include:
Common (may affect up to 1 in 10 people)

• Headache.
• Effects on the stomach or intestines: diarrhoea, stomach pain, constipation, gas (flatulence).
• Feeling unwell (nausea) or feeling sick (vomiting).
• Benign polyps in the stomach Uncommon (may affect up to 1 in 100 people)
• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling sensations like “pins and needles”, drowsiness.
• Feeling of spinning (vertigo).
• Dry mouth.
• Changes in blood values that are used to check liver function.
• Skin rash, hives (urticaria) and itching.
• Hip, wrist or spine fracture (if Collezoes is used at high doses and for a long duration).

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

• Blood problems, such as a decrease in the number of white blood cells or platelets. This can cause weakness, bruising or make you more likely to get infections.
• Low levels of sodium in the blood. This can cause weakness, feeling unwell (vomiting) and cramps.
• Feeling agitated, confused or depressed.
• Alteration of taste.
• Vision problems such as blurred vision.
• Sudden shortness of breath or wheezing (bronchospasm).
• Inflammation inside the mouth.
• An infection called “thrush” that can affect the esophagus and is caused by a fungus.
• Liver problems, including jaundice which can cause yellowing of the skin, dark urine and fatigue.
• Hair loss (alopecia).
• Skin redness following exposure to the sun.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Feeling generally unwell and lacking energy.
• Increased sweating.

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

• Changes in the number of blood cells including agranulocytosis (deficiency of white blood cells).
• Aggression.
• Seeing, hearing or feeling things that are not there (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Sudden onset of a severe rash or blisters or peeling of the skin. This may be associated with high fever and joint pain (erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Severe kidney problems.
• Breast enlargement in men. Not known (frequency cannot be estimated based on available data)
• Inflammation of the intestine (leading to diarrhoea).
• Erythema, possible joint pains.

If you have been treated with Collezoes for more than three months, a decrease in blood magnesium levels may occur. Low levels of magnesium can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, tell your doctor immediately. Low levels of magnesium can also lead to a decrease in potassium or calcium levels in the blood. Your doctor may decide to monitor magnesium levels in the blood through regular blood tests.
Collezoes can, in very rare cases, affect white blood cells causing immunodeficiency. If you have an infection with symptoms such as fever with a severelyreduced general condition or fever with symptoms of a local infection such as sore throat, sore throat or mouth or difficulty urinating, you should consult a doctor as soon as possible so that a deficiency of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important that you provide information about the medicine at this time.

If any side effect occurs, including those not listed in this leaflet, tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to 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 Collezoes

• Keep this medicine out of the sight and reach of children.
• Alu/Alu blisters:

Do not store above 25°C
Tristar Alu/PVDC blisters:
Do not store above 25°C

• Do not use this medicine after the expiry date that is stated on the package or blister after Exp. The expiry date refers to the last day of that month.
• 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 Collezoes Contains

• The active ingredient is esomeprazole magnesium dihydrate. One Collezoes 20 mg tablet contains 20 mg of esomeprazole (corresponding to 21.75 mg of esomeprazole magnesium dihydrate). One Collezoes 40 mg tablet contains 40 mg of esomeprazole (corresponding to 43.5 mg of esomeprazole magnesium dihydrate).
• The other ingredients are: Tablet contents Ethyl acrylate methyl methacrylate copolymer (1:1) dispersion 30%, talc, triethyl citrate, hypromellose, sugar spheres, magnesium stearate, hydroxypropyl cellulose, glycerol monostearate 40-55, polysorbate 80, microcrystalline cellulose, povidone, macrogol 6000, crospovidone, sodium stearyl fumarate.
• Tablet coating Hypromellose, titanium dioxide (E171), macrogol/PEG 400, red iron oxide (E172), yellow iron oxide (E172).

Description of the Appearance of Collezoes and Package Contents

• Collezoes 20 mg tablets are light pink, elliptical in shape, biconvex, film-coated, 6.55 x 13.6 mm.
• Collezoes 40 mg tablets are pink, elliptical in shape, biconvex, film-coated, 8.2 x 17 mm.
• The tablets will be available in packs of:

Packs:
Blister packs: 14 tablets.

• Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
S.F. Group S.r.l.
Via Tiburtina, 1143 – Rome - Italy

Manufacturers
Actavis hf.
Reykjavíkurvegur 76-78
IS -220 Hafnarfjörður
Iceland
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitza 2600
Bulgaria

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
IT: Collezoes