Mepral

Package leaflet: Information for the user

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

Omeprazole
Please read all of 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 or pharmacist.
• 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.
• If you experience any side effects, including 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 taking 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 Mepral is and what it is used for

Mepral contains the active substance 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 to treat the following conditions:

In adults:

• 'Gastro-oesophageal reflux disease' (GERD). This condition occurs when acid leaks out of the stomach and passes into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or in the stomach (gastric ulcer).
• Ulcers infected with a bacterium called 'Helicobacter pylori'. If you have 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.
• Excessive acid production caused by overgrowth of tissue in the pancreas (Zollinger-Ellison syndrome).

In children:
Children aged over 1 year and with body weight greater than or equal to 10 kg

• 'Gastro-oesophageal reflux disease' (GERD). This condition occurs when acid leaks out of the stomach and passes into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of this condition may also include regurgitation (bringing up of stomach contents into the mouth), vomiting, and poor weight gain.

Children aged over 4 years and adolescents
Ulcers infected with a bacterium called 'Helicobacter pylori'. If your child has 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 to any of the excipients 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 any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Mepral.

Warnings and precautions

Talk to your doctor or pharmacist before taking Mepral.

Serious skin adverse reactions including 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 Mepral treatment.

Stop taking Mepral and contact your doctor immediately if you notice any symptoms related to these serious skin adverse reactions described in section 4.

Mepral may mask symptoms of other diseases. Therefore, if you experience any of the following symptoms before or while taking Mepral, contact your doctor immediately:

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Dark-coloured stools (indicating presence of blood in the stool).
• Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
• Severe liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to Mepral that reduces gastric acidity.
• If you are due to have a specific blood test (Chromogranin A).

If you develop a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as treatment with Mepral may need to be discontinued. Remember to also report any other side effects such as joint pain.

If you have been taking Mepral for a long time (more than 1 year), your doctor will prescribe regular check-ups.

Inform your doctor if you notice the appearance of new or unusual symptoms.

If you take a proton pump inhibitor such as Mepral, particularly for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.

During treatment with omeprazole, inflammation of the kidneys may occur. Signs and symptoms may include reduced urine volume or presence of blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. Report such signs to your doctor.

This medicine may affect the way your body absorbs vitamin B₁₂, especially if you need to take it for a long time. Contact your doctor if you notice any of the following symptoms, which could indicate low vitamin B₁₂ levels:

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

Children

Some children with chronic conditions may require long-term treatment, although this 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 without a prescription. This is important because Mepral can affect how some medicines work, and some medicines can affect how Mepral works.

Do not take Mepral if you are taking a medicine containing nelfinavir (used to treat HIV infections).

Inform your doctor or pharmacist if you are taking any of the following medicines:

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

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

Mepral with food and drink

See section 3.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether you can take Mepral during this time.

Omeprazole is excreted in breast milk, but it is unlikely to affect the infant when used at therapeutic doses. Your doctor will decide whether you can take Mepral while breastfeeding.

Driving and using machines

It is unlikely that Mepral will affect your ability to drive or operate machinery. However, adverse drug reactions such as dizziness and visual disturbances may occur (see section 4). If you experience these, do not drive or operate machinery.

Mepral capsules contain lactose and sodium

Mepral capsules contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Mepral capsules contain 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 directed by your doctor or pharmacist. If you have
any doubts, consult 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 symptoms of GERD, such as heartburn and acid regurgitation:

• If your doctor has informed you that your esophagus is slightly damaged, the recommended dose is 20 mg once daily for 4–8 weeks. Your doctor may increase the dose to 40 mg for an additional 8 weeks if the esophagus has not yet fully healed.
• Once the esophagus has healed, the recommended dose is 10 mg once daily.
• If the esophagus is not damaged, the usual dose is 10 mg once daily.

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

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

For the treatment of stomach ulcers (gastric ulcer):

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

For preventing the recurrence of duodenal and gastric ulcers:

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

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

• The recommended dose is 20 mg once daily for 4–8 weeks.

For preventing the formation of duodenal and gastric ulcers if you are taking NSAIDs:

• The usual dose is 20 mg once daily.

For the treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

• The recommended dose is 20 mg of Mepral twice daily for one week.
• Your doctor will also instruct you to take two antibiotics, selected from amoxicillin, clarithromycin, and metronidazole.

For the treatment of excessive stomach acid caused by pancreatic tissue overgrowth (Zollinger-Ellison syndrome):

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

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

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

For the treatment and prevention of recurrence of ulcers caused by Helicobacter pylori infection:

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

How to take this medicine

• It is recommended to take the capsules in the morning.
• The capsules may be taken with food or on an empty stomach.
• Swallow the capsules whole with half a glass of water. The capsules must not be chewed or crushed, as they contain coated granules designed to prevent the medicine from being broken down by stomach acid. 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 capsule and take the contents directly with half a glass of water, or pour the contents into a glass of water (non-carbonated), into an acidic fruit juice (such as apple, orange, or pineapple juice), or into apple puree.
• Always shake the mixture before drinking (the mixture will not be clear), and drink it immediately or within 30 minutes.
• To ensure you have taken the entire dose, rinse the glass thoroughly with half a glass of water and drink the rinse water. The solid particles contain the medicine—do not chew or crush them.

If you take more Mepral than you should
If you take more Mepral than 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 for your next dose, skip the missed dose. Do not take a double dose to make up for the forgotten 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 how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If you notice any of the following rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious adverse reactions, stop taking Mepral and contact your doctor immediately:

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

Other adverse reactions include:
Common adverse reactions (may affect up to 1 in 10 people)

• Headache.
• Stomach or intestinal problems: diarrhoea, stomach ache, constipation, passing wind (flatulence).
• Feeling unwell (nausea) or unwellness (vomiting).
• Benign polyps in the stomach.

Uncommon adverse reactions (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling, drowsiness.
• Sensation of spinning (vertigo).
• Abnormalities in blood tests related to liver function.
• Skin rash, skin rash with swelling of the skin (urticaria) and itching of the skin.
• General feeling of unwellness and lack of energy.
• If you take a proton pump inhibitor such as Mepral, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist or spine. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.

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

• Changes in blood composition, such as reduced numbers of white blood cells or platelets. This may cause weakness and easy bruising, or may make infections more likely.
• Low levels of sodium in the blood. This may cause weakness, feeling unwell (vomiting) and cramps.
• Restlessness, confusion or depression.
• Taste disturbances.
• Vision problems, such as blurred vision.
• Sudden wheezing or breathlessness (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• A fungal infection called “candidiasis” which may affect the intestine.
• Hair loss (alopecia).
• Skin rash during exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

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

• Changes in blood cell counts, including agranulocytosis (lack of white blood cells).
• Aggressiveness.
• Seeing, feeling or hearing things that are not real (hallucinations).
• Severe liver problems up to liver failure and inflammation of the brain.
• Erythema multiforme.
• Muscle weakness.
• Breast enlargement in men.

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

• Inflammation of the intestine (resulting in diarrhoea).
• If you take Mepral for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as 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 levels of potassium or calcium in the blood. Your doctor should decide whether periodic monitoring of blood magnesium levels is necessary.
• Reduced calcium levels in the blood (hypocalcaemia). Reduced calcium levels in the blood may result from very low magnesium levels.
• Reduced potassium levels in the blood (hypokalaemia).
• Erythema, possible joint pain.

In very rare cases, Mepral may affect white blood cells, leading to immunodeficiency. If you develop an infection with symptoms such as fever with a severe deterioration in your general health, or fever with symptoms of local infection such as neck, throat or mouth pain or difficulty urinating, you must contact your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important that in this case you inform your doctor about the medicine you are taking.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report adverse reactions directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, 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 stated on the carton, bottle, or blister after Exp. The expiry date refers to the last day of the month.
• Do not store above 30°C.
• Store 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 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 Mepral contains

• The active substance is omeprazole. Mepral gastro-resistant hard capsules contain 10 mg or 20 mg of omeprazole.
• The excipients are disodium hydrogen 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 (containing shellac, ammonia, potassium hydroxide and black iron oxide E 172), colloidal anhydrous silica, liquid paraffin (see section 2, "Mepral capsules contain lactose and sodium").

Description of the appearance of Mepral and package contents

• Mepral 10 mg capsules have an opaque pink body printed with "10" and an opaque pink cap printed with "A/OS".
• Mepral 20 mg capsules have an opaque pink body printed with "20" and an opaque reddish-brown cap printed with "A/OM".

Pack sizes:
10 mg:

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

20 mg:

• HDPE bottles containing 5, 7, 10, 14, 15, 28, 30, 50, 60 or 100 capsules; hospital packs containing 140, 280 or 700 capsules.
• Blister packs containing 7, 14, 15, 28, 30, 50, 60 or 84 capsules.

Not all pack sizes may be marketed.
Marketing Authorization 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 authorized in the European Economic Area countries under the
following names:
Italy Mepral
Further information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (AIFA) https://www.aifa.gov.it/.