MEPRAL 10 mg Enteric-Coated Hard Capsule

Зміст інструкції

1. Mepral 10 mg hard gastro-resistant capsules, 20 mg hard gastro-resistant capsules
   1. What is Mepral and what is it used for
   2. What you need to know before taking Mepral
   3. HOW TO TAKE MEPRAL
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE MEPRAL
   6. Contents of the pack and other information

Mepral 10 mg hard gastro-resistant capsules, 20 mg hard gastro-resistant capsules

Omeprazole

Read this leaflet carefully before 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 they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Mepral and what is it used for

Mepral contains the active ingredient omeprazole. It belongs to a group of medicines called
‘proton pump inhibitors’, which work by reducing the amount of acid produced by the stomach.
Mepral is used for the treatment of the following conditions:
In adults:

• ‘Gastro-oesophageal reflux disease’ (GERD). This disease occurs when acid leaks from the stomach into the oesophagus (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or the stomach (gastric ulcer).
• Ulcers infected by a 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.
• Ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Mepral can also be used to prevent ulcers from forming if you are taking NSAIDs.
• Excess acid in the stomach caused by an increase in tissue in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and weighing 10 kg or more

• ‘Gastro-oesophageal reflux disease’ (GERD). This disease occurs when acid leaks from the stomach into the oesophagus (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn. In children, the symptoms of this disease also include the return of stomach contents into the mouth (regurgitation), discomfort (vomiting) and poor weight gain.

Children over 4 years of age and adolescents
Ulcers infected by a bacterium called ‘ Helicobacter pylori’. If the child suffers from this condition,
the doctor may also prescribe antibiotics to treat the infection and allow the
ulcer to heal.

2. What you need to know before taking Mepral

Do not take Mepral

• If you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6),
• If you are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If you are taking a medicine containing nelfinavir (used for HIV infections).

Do not take Mepral if you fall into any of the above categories. If you have any doubts, ask your doctor or pharmacist before taking Mepral.

Warnings and precautions
Talk to your doctor or pharmacist before taking Mepral.
Severe skin reactions that include Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported in association with treatment with Mepral.
Stop taking Mepral and consult your doctor immediately if you notice any symptoms relating to these severe skin reactions described in section 4.
Mepral can mask the symptoms of other diseases. Therefore, if you should experience the symptoms described below before taking Mepral or while you are taking it, contact your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting of food or blood.
• Darkening of the stools (presence of blood in the stools).
• Severe or persistent diarrhoea, because omeprazole has been associated with a slight increase in infectious diarrhoea.
• Serious liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to Mepral that reduces stomach acid.
• If you are to undergo 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 it may be necessary to stop therapy with Mepral. Remember to report any other undesirable effects such as joint pain.
If you take Mepral for a long time (more than 1 year) your doctor will prescribe regular check-ups.
Tell your doctor if you notice the appearance of new and particular symptoms.
If you are taking a proton pump inhibitor such as Mepral, 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.
During treatment with omeprazole, inflammation of your kidneys may occur. Signs and symptoms may include a reduced urine volume or the presence of blood in the urine and/or hypersensitivity reactions such as fever, skin rashes and joint stiffness. Report these signs to your doctor.
This medicine can affect the way your body absorbs vitamin B12, especially if you need to take it for a long period. Contact your doctor if you notice any of the following symptoms, which may indicate low levels of vitamin B12:

• Extreme fatigue or lack of energy
• Tingling (paresthesia)
• Sore or red tongue, mouth ulcers
• Muscle weakness
• Blurred vision
• Memory problems, confusion, depression

Children
Some children with chronic illnesses may require long-term treatment, even though it is not recommended.
Do not give this medicine to children under 1 year of age or weighing less than 10 kg.

Other medicines and Mepral
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription. This is important because Mepral can affect the way some medicines work and in turn some medicines can have effects on the action of Mepral.
Do not take Mepral if you are taking a medicine containing nelfinavir(used for the treatment of HIV infections).

• Ketoconazole, itraconazole, posaconazole or voriconazole (used to treat fungal infections).
• Digoxin (used for the treatment of heart problems).
• Diazepam (used for the treatment of anxiety, to relax muscles or for epilepsy).
• Phenytoin (used for epilepsy). If you are taking phenytoin, your doctor will monitor you at the beginning and end of treatment with Mepral.
• Medicines used to thin the blood, such as warfarin or other vitamin K antagonists. Your doctor will monitor you at the beginning and end of treatment with Mepral.
• Rifampicin (used for the treatment of tuberculosis).
• Atazanavir (used for the treatment of HIV infection).
• Tacrolimus (used in organ transplantation).
• St John's Wort (Hypericum perforatum) (used for the treatment of mild depression).
• Cilostazol (used for the treatment of intermittent claudication).
• Saquinavir (used for the treatment of HIV infection).
• Clopidogrel (used to prevent blood clots (thrombi)).
• Erlotinib (used for the treatment of cancer).
• Methotrexate (a chemotherapeutic medicine used in high doses for the treatment of cancer) - if you are taking methotrexate in high doses, your doctor may temporarily interrupt treatment with Mepral.

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin together with Mepral for the treatment of ulcers caused by Helicobacter pyloriinfections, it is very important that you tell them if you are taking any other medicines.

Mepral with food and drink
See section 3

Pregnancy, breastfeeding and fertility
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. The doctor will decide whether you can take Mepral during this period.
Omeprazole is excreted in breast milk but it is unlikely that when used at therapeutic doses it will have an effect on the baby. The doctor will decide whether you can take Mepral during breastfeeding.

Driving and using machines
It is unlikely that Mepral will affect your ability to drive or operate tools or machinery. Adverse reactions such as dizziness and visual disturbances (see section 4) may occur. If you suffer from these, do not drive or use machinery.

Mepral capsules contains lactose and sodium
Mepral capsules contains lactose. If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this medicine.
Mepral capsules contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. HOW TO TAKE MEPRAL

Take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.
Your doctor will tell you how many capsules to take and for how long. This will depend on your
condition and age.
The recommended dose is:
Adults:
For the treatment of GERD symptoms, such as heartburn and acid reflux:

• If your doctor has told you that your esophagus is slightly damaged, the recommended dose is 20 mg once a day for 4-8 weeks. Your doctor may increase the dose to 40 mg for another 8 weeks if the esophagus is not yet fully healed.
• The recommended dose once the esophagus has healed is 10 mg once a day.
• If the esophagus is not damaged, the usual dose is 10 mg once a day.

For the treatment of ulcers in the upper part of the intestine(duodenal ulcer):

• The recommended dose is 20 mg once a day for 2 weeks. Your doctor may extend the intake of this dose for another 2 weeks if the ulcer has not yet healed.
• If the ulcer is not completely healed, the dose may be increased to 40 mg once a day for 4 weeks.

For the treatment of stomach ulcers(gastric ulcer):

• The recommended dose is 20 mg once a day for 4 weeks. Your doctor may extend the intake of this dose for another 4 weeks if the ulcer has not yet healed.
• If the ulcer is not completely healed, the dose may be increased to 40 mg once a day for 8 weeks.

To preventthe recurrence of duodenal and gastric ulcers:

• The recommended dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40 mg once a day.

For the treatment of duodenal and gastric ulcers caused by taking NSAIDs(Non-Steroidal
Anti-inflammatory Drugs):

• The recommended dose is 20 mg once a day for 4-8 weeks.

To prevent the formation of duodenal and gastric ulcersif you are using NSAIDs:

• The usual dose is 20 mg once a day.

For the treatment of ulcers caused by infection with Helicobacter pyloriand prevention of their
recurrence:

• The recommended dose is 20 mg of Mepral twice a day for one week.
• Your doctor will also tell you to take two antibiotics, such as amoxicillin, clarithromycin and metronidazole.

For the treatment of excessive acid in the stomach caused by an increase in
tissue in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 60 mg per day.
• Your doctor will adjust the dose according to your needs and also decide how long you should take the medicine.

Use in children and adolescents:
For the treatment of GERD symptoms, such as heartburn and acid reflux:

• Mepral can be taken by children over 1 year of age and weighing more than 10 kg. The dose for children is based on the child's weight and the exact dose will be decided by the doctor.

For the treatment and prevention of the recurrence of ulcers causedby infection with
Helicobacter pylori:

• Mepral can be taken by children over 4 years of age. The dose for children is based on the child's weight and the exact dose will be decided by the doctor.
• Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin to your child.

Taking this medicine

• It is recommended to take the capsules in the morning.
• The capsules can be taken with food or on an empty stomach.
• The capsules should be swallowed whole with half a glass of water. The capsules must not be chewed or crushed, as they contain granules coated in such a way as to prevent the medicine from being broken down by the acid in the stomach. It is important not to damage the granules.

What to do if you or the child has difficulty swallowing the capsules

• If you or the child has difficulty swallowing the capsules:
• Open the capsules and swallow the contents directly with half a glass of water or pour the contents into a glass of water (non-carbonated), acidic fruit juice (e.g. apple, orange or pineapple) or applesauce.
• Always shake the contents before drinking (the mixture will not be clear), then drink the preparation immediately or within 30 minutes.
• To be sure you have taken all the medicine, rinse the glass thoroughly with half a glass of water and drink the contents. The solid particles contain the medicine - do not chew or crush them.

If you take more Mepral than you should
If you take an amount of Mepral greater than that prescribed by your doctor, contact
your doctor or pharmacist immediately.

If you forget to take Mepral
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 to make up for
the missed dose.

If you stop taking Mepral
Do not stop taking Mepral without first talking to your doctor or pharmacist.
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 everybody gets them.

If you notice any of the following rare side effects (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects, stop taking Mepral and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction) (rare).
• Redness of the skin with the appearance of blisters or peeling. A severe formation of blisters with bleeding of the lips, eyes, mouth, nose and genitals may also appear. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis” (very rare).
• Widespread skin rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) (rare)
• A widespread, red and scaly skin rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) (rare)
• Yellowing of the skin, dark colored urine and fatigue may be symptoms of liver problems (rare).

Other side effects include:

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

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, passing gas (flatulence),
• Feeling unwell (nausea) or feeling sick (vomiting).
• Benign polyps in the stomach.

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

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling, feeling sleepy.
• Feeling of spinning (vertigo).
• Changes in blood tests related to liver function.
• Skin rash, skin rash with swelling of the skin (urticaria) and itching on the skin.
• General feeling of being unwell and lack of energy.
• If you are taking a proton pump inhibitor like Mepral, 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.

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

• Changes in the composition of the blood, such as a reduction in the number of white blood cells or platelets. This can cause weakness and easy bruising, or may 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.
• Changes in taste.
• Problems with vision, such as blurred vision.
• Sudden wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• An infection called “candidiasis” that can affect the intestines and is caused by a fungus.
• Hair loss (alopecia).
• Skin rash during exposure to the sun.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Serious kidney problems (interstitial nephritis).
• Increased sweating.

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

• Changes in the blood cell count, including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling or hearing events that are not real (hallucinations).
• Serious liver problems up to liver failure and brain inflammation.
• Erythema multiforme.
• Muscle weakness.
• Enlargement of the breasts in men.

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

• Inflammation of the intestine (resulting in diarrhea).
• If you take Mepral for more than three months, it is possible that blood levels of magnesium may decrease. Low levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low levels of magnesium can also lead to a decrease in blood levels of potassium or calcium. The doctor should decide whether to check magnesium levels in the blood periodically.
• Reduced levels of calcium in the blood (hypocalcemia). The reduction in calcium levels in the blood may result from very low levels of magnesium.
• Reduced levels of potassium in the blood (hypokalaemia).
• Erythema, possible joint pain.

In very rare cases Mepral can affect white blood cells leading to an immuno-deficiency. If you should develop an infection with symptoms such as fever with a seriousdeterioration of general health or fever with symptoms of local infection such as sore throat, or difficulty urinating, you should consult a doctor as soon as possible, in order to rule out a lack of white blood cells (agranulocytosis) by performing a blood test. It is important in this case to inform the doctor about the medicine you are taking.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. 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 MEPRAL

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the package, bottle or blister after Exp. The expiry date refers to the last day of the month.
• Do not store at a temperature above 30°C.
• Keep this medicine in its original packaging (blister) or keep the bottle tightly closed to protect the medicine from moisture.

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. Contents of the pack and other information

What Mepral contains

• The active ingredient is omeprazole. Mepral gastro-resistant hard capsules contain 10 mg or 20 mg of omeprazole.
• The excipients are dibasic sodium phosphate dihydrate, low substituted hydroxypropylcellulose, hypromellose, anhydrous lactose, magnesium stearate, mannitol, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, microcrystalline cellulose, macrogol (polyethylene glycol 400), sodium lauryl sulfate, iron oxide E 172, titanium dioxide E 171, gelatin, printing ink (contains shellac, ammonia, potassium hydroxide and iron oxide black E 172), anhydrous colloidal silica, liquid paraffin (see section 2, “Mepral capsules contains lactose and sodium”).

Description of the appearance of Mepral and contents of the pack

• Mepral 10 mg capsules have an opaque pink body, with “10” printed on it, and an opaque pink cap with “A/OS” printed on it.
• Mepral 20 mg capsules have an opaque pink body, with “20” printed on it, and an opaque reddish-brown cap with “A/OM” printed on it.

Packs:
10 mg:

• HDPE bottles of 5, 7, 10, 14, 15, 28, 30, 50, 56, 60 or 100 capsules; hospital packs of 140, 280 or 700 capsules.
• Blisters: 7, 14, 15, 28, 30, 35, 50, 56 and 84 capsules 20 mg:
• HDPE bottles of 5, 7, 10, 14, 15, 28, 30, 50, 60 or 100 capsules; hospital packs of 140, 280, or 700 capsules.
• Blisters of 7, 14, 15, 28, 30, 50, 60 or 84 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24, 17489 Greifswald, Germany

Manufacturer
Saneca Pharmaceuticals a.s.
Nitrianska 100
Hlohovec, 920 27
Slovakia
or
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23 – 24
17489 Greifswald
Germany

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

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (AIFA) https://www.aifa.gov.it/.