Mopralpro Omeprazole 20 mg capsules

NOTICE

ANSM - Updated on: 24/03/2016

Name of the medicinal product

MOPRALPRO 20 mg, gastro-resistant tablet

Omeprazole magnesium

framed

Please read this entire manual carefully as it contains important information for you.

This medication is available without a prescription. However, you should use MOPRALPRO 20 mg carefully to get the best results.

· Keep this leaflet, you may need to read it again.

· Consult your pharmacist if you need further advice or advice.

· If symptoms worsen or persist after 14 days, consult a physician.

· You should not take Mopralpro 20 mg for more than 14 days without consulting your doctor.

· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Review summary

In this notice :

1. WHAT IS MOPRALPRO 20 mg, gastro-resistant tablet AND WHAT IT IS USED FOR?

2. BEFORE YOU TAKE MOPRALPRO 20 mg, Gastro-resistant tablet?

3. HOW TO TAKE MOPRALPRO 20 mg, Gastro-resistant tablet?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE MOPRALPRO 20 mg gastro-resistant tablet?

6. ADDITIONAL INFORMATION

1. WHAT IS MOPRALPRO 20 mg, gastro-resistant tablet AND WHAT IT IS USED FOR?

Pharmacotherapeutic group

The tablets contain an active substance, omeprazole, which is a substance called "proton pump inhibitor". Omeprazole is a potent inhibitor of acid secretion in your stomach.

Therapeutic indications

This medication is indicated for the short-term treatment of symptoms of gastroesophageal reflux (eg heartburn, acid regurgitation) in adults (from 18 years of age).

Gastroesophageal reflux is the rise of acid from the stomach into the esophagus which can become inflammatory and painful. This can cause symptoms such as burning in the chest going up to the throat (heartburn) and sour taste in the mouth (acid regurgitation).

Acid reflux and heartburn may disappear after one day of treatment with MOPRALPRO 20 mg. However this medication is not intended to provide immediate relief. It may be necessary to continue treatment for 2 or 3 consecutive days for symptom improvement.

2. BEFORE YOU TAKE MOPRALPRO 20 mg, Gastro-resistant tablet?

List of information needed before taking the medication

If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.

Cons-indications

Do not take MOPRALPRO 20 mg:

· if you are under 18 years of age

· if you are allergic (hypersensitive) to omeprazole or any of the other ingredients of MOPRALPRO 20 mg ( see section 6. "What Mopralpro 20 mg contains" )

· if you are taking a medication containing nelfinavir (used in the treatment of HIV infection)

If in doubt, ask your pharmacist or doctor for advice.

Precautions for use; special warnings

Take special care with MOPRALPRO 20 mg: MOPRALPRO 20 mg can mask the symptoms of other diseases; consult your doctor before taking MOPRALPRO 20 mg if:

· your symptoms are accompanied by unintentional weight loss (not related to a diet or exercise program),

· you suffer from disorders of swallowing,

· you are suffering from persistent stomach pain or digestion problems,

· you are vomiting food or blood,

· your stools are black,

· you have significant or persistent diarrhea,

· you suffer for the first time from stomach pains or that these pains have experienced a recent aggravation,

· you have already suffered from a gastric ulcer or if you have undergone a stomach surgery,

· you have liver problems or jaundice (jaundice, yellowing of the skin and eyes)

· you are under continuous symptomatic treatment for indigestion or stomach burns for 4 weeks or more,

· you are over 55 years old and you take a daily medication for indigestion dispensed without a prescription,

· you are more than 55 years old and have symptoms appearing for the first time or have recently changed,

· if you have ever developed a skin reaction after treatment with a drug similar to MOPRALPRO reducing gastric acid.

If you develop a rash, especially in areas exposed to the sun, consult your doctor as soon as possible, as you may need to stop your MOPRALPRO treatment. Do not forget to mention any other adverse effects, such as pain in your joints

MOPRALPRO 20 mg should not be used as a preventive treatment.

If symptoms recur after treatment with MOPRALPRO 20 mg, consult your doctor, as he alone can judge whether additional tests are necessary.

The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).

If in doubt, ask your doctor for advice.

Interaction with other medicines

Taking other medicines

If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist as MOPRALPRO 20 mg may interact with other medicines.

Do not take MOPRALPRO 20 mg if you are taking a medication containing nelfinavir (used in the treatment of HIV infection).

Inform your doctor or pharmacist if you are taking any medicine containing any of these active ingredients:

· clopidogrel (used to prevent the formation of blood clots)

· ketoconazole, itraconazole or voriconazole (used in the treatment of mycoses)

· digoxin (used to treat heart disease)

· diazepam (used to treat anxiety, to relax muscles or for epilepsy)

· phenytoin (used to treat epilepsy). If you are taking a medication containing phenytoin, your doctor should monitor you when you start or stop MOPRALPRO 20 mg.

· warfarin or other anti-vitamins K (used to thin the blood). Your doctor should monitor you when you start or stop MOPRALPRO 20 mg.

· Rifampicin (used in the treatment of tuberculosis)

· Atazanavir (used in the treatment of HIV infection).

· Tacrolimus (used in case of organ transplant)

· St. John's Wort (used to treat mild to moderate depression)

· Cilostazol (used to treat intermittent claudication)

· Saquinavir (used in the treatment of HIV infection)

Interactions with food and beverages

Food and drinks

MOPRALPRO 20 mg does not interfere with food or beverages.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and breast feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Before taking MOPRALPRO 20 mg, tell your doctor or pharmacist that you are pregnant or planning to become pregnant. Your doctor will decide if you can take MOPRALPRO 20 mg during this period.

Your doctor will also decide if you can take MOPRALPRO 20 mg while breastfeeding.

Sport

Sport

Not applicable.

Effects on ability to drive or use machines

Driving and using machines

The use of MOPRALPRO 20 mg does not affect the driving and use of machines.

However, undesirable effects such as dizziness and / or vision problems may occur ( see section 4 ). Patients with this type of adverse event should not drive or operate machinery.

List of excipients with known effect

Important information about some of the ingredients of MOPRALPRO 20 mg

This medicine contains sucrose.

3. HOW TO TAKE MOPRALPRO 20 mg, Gastro-resistant tablet?

Instructions for proper use

Not applicable.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Dosage

Always take MOPRALPRO 20 mg exactly as directed in the package leaflet. If in doubt, consult your doctor or pharmacist.

Reserved for adults (18 years and over)

The usual dose is 1 tablet per day

It is recommended to take MOPRALPRO 20 mg before the meal:

· in the morning in case of predominant symptoms during the day

· in the event of predominant symptoms during the night

It may be necessary to take the treatment for 2 or 3 consecutive days for symptom improvement.

Administration mode

Swallow the whole tablet with a sufficient amount of liquid (eg a glass of non-carbonated water) before the morning or evening meal.

It is important not to chew the tablets because they contain microgranules whose coating prevents their degradation by the acid of the stomach. The integrity of microgranules is important for their effectiveness.

If necessary, you can also dissolve the tablet in a glass of water (non-gaseous) or fruit juice, preferably at room temperature, gently shaking to avoid degrading the microgranules. You get a cloudy solution, which you must swallow immediately after its preparation or within the next 30 minutes. To be sure to take all the tablet, recover any deposits at the bottom of the glass with a little liquid.

If desired, you can also dissolve the tablet in a (non-carbonated) spoon of water, preferably at room temperature, and mix with compote. This mixture should be absorbed immediately after preparation or within 30 minutes. Small fragments should not be chewed.

Do not dissolve the tablets in milk or sparkling water.

Frequency of Administration

One intake per day.

Duration of treatment

Treatment with MOPRALPRO 20 mg should not exceed 14 days. If after 14 days your pain persists or worsens, consult your doctor.

Symptoms and Instructions for Overdose

If you take more MOPRALPRO 20 mg than you should:

Consult your doctor or pharmacist.

Instructions for omission of one or more doses

If you forget to take MOPRALPRO 20 mg:

Do not take a double dose to make up for a missed dose.

Risk of withdrawal syndrome

Not applicable.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

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

Tell your doctor immediately if you experience any of the following rare but serious side effects:

· Serious allergic reactions, called anaphylactic. Typical symptoms are swelling of the face, lips, mouth, tongue and / or throat, which can cause difficulty breathing or swallowing, hives.

· Serious skin reactions: Sudden skin redness with skin peeling or blisters, lesions or bleeding around the eyes, nose, mouth or genitals. These symptoms may include Stevens-Johnson syndrome or acute toxic epidermolysis.

· Yellowing of the skin, dark urine and fatigue that can be symptoms of liver problems.

The frequency of adverse events is defined as follows:

Frequent:

· headache,

· diarrhea, constipation, bloating (gas), stomach upset,

· nausea, vomiting.

Casual:

· accumulation of water in the legs (edema),

· sleep disorders (insomnia),

· dizziness, tingling sensations, drowsiness,

· dizziness,

· increased levels of liver enzymes,

· itching, skin rash, skin irritation,

· general feeling of discomfort and lack of energy.

Rare:

· decrease in the number of blood cells (white blood cells, platelets),

· allergic reactions, sometimes very severe, which can cause swelling of the lips, tongue and throat, fever, whistling.

· decreased sodium levels in the blood,

· agitation, confusion, depression,

· alteration of taste,

· blurry vision,

· sudden whistling or difficulty breathing,

· dry mouth,

· inflammation of the mucous membrane of the mouth,

· infection in the mouth called "thrush" and caused by a fungus,

· liver problems that can lead to jaundice (yellowing of the skin), dark urine and fatigue,

· hair loss,

· rash of the skin in case of exposure to the sun,

· joint pain or muscle pain,

· kidney problems,

· increased sweating.

Very rare:

· change in the number of blood cells, lack of white blood cells,

· aggressiveness,

· hallucinations;

· severe liver problems leading to insufficient liver function and cerebral inflammation,

· Sudden reddening of the skin with skin peeling or blisters, which may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome or acute toxic epidermolysis),

· muscular weakness,

· swelling of the breasts in man,

· decrease in the level of magnesium in the blood.

Frequency not known:

· microscopic colitis,

· rash, potentially accompanied by joint pain.

Declaration of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly through the national reporting system : National Agency for the Safety of Medicines and Health Products (Ansm) and network of Regional Centers of Pharmacovigilance. Website: www.ansm.sante.fr . By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE MOPRALPRO 20 mg gastro-resistant tablets?

Keep out of the reach and sight of children.

Expiration date

Do not use MOPRALPRO 20 mg after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.

Storage conditions

Store at a temperature below 25 ° C.

Heat-sealed film: Store in original packaging to protect against moisture

If necessary, warnings against visible signs of deterioration

Do not use if you notice any visible signs of product degradation.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

Full list of active substances and excipients

What does MOPRALPRO 20 mg contain?

The active substance is:

Omeprazole magnesium

1 gastro-resistant tablet contains 20 mg omeprazole.

Other ingredients are: glycerol monostearate 40-55, hydroxypropylcellulose, hypromellose, red / brown iron oxide, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, paraffin, macrogol 6000, polysorbate 80, crospovidone, sodium hydroxide, sodium stearyl fumarate, sucrose spheres, talc, titanium dioxide, triethyl citrate.

Pharmaceutical form and content

What is MOPRALPRO 20 mg and contents of the pack?

MOPRALPRO 20 mg is available in blister pack of 7 or 14 gastro-resistant tablets. The gastro-resistant tablet is oval, pink, biconvex, labeled with "20 mg" on one side.

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Holder

BAYER HEALTHCARE SAS

220 AVENUE OF RESEARCH

59120 LOOS

exploiting

BAYER HEALTHCARE SAS

33 STREET OF INDUSTRY

74240 GAILLARD

Maker

CORDEN PHARMA GMBH

OTTO-HAHN-STRASSE

D-68723 PLANKSTADT

GERMANY

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

Date of approval of the notice

The last date on which this leaflet was approved is {date}.

AMM under exceptional circumstances

Not applicable.

Internet Information

Detailed information on this medicine is available on the Ansm website (France).

Information for health professionals only

Not applicable.

Other

Health Education Advice

This medication is intended to relieve heartburn and acid reflux. Heartburn and acid reflux may be due to changes in diet (acid or spicy foods, alcoholic beverages ...) or to certain medications (aspirin, anti-inflammatory drugs ...). Do not hesitate to talk to your doctor or pharmacist.

In order to limit the onset of symptoms, respect the following hygiene rules as much as possible:

· avoid abundant and high-fat meals,

· eat slowly,

· avoid certain foods such as chocolate, mint, spices, peppers, citrus juice, soft drinks, coffee,

· vary your diet,

· normalize your weight (in case of overweight) and exercise,

· avoid wearing too tight clothing or belt too tight,

· elevate the head of your bed in case of heartburn or nocturnal acid shifts,

· avoid the practice of an important effort just after the meal,

· do not smoke and limit alcohol consumption.

YOUR PHARMACIST, YOUR DOCTOR, KNOWS THE MEDICINES WELL.

DO NOT HESITATE TO REQUEST THEIR OPINIONS

NEVER LEAVE A MEDICINE FOR CHILDREN

VIDAL OF THE FAMILY

MOPRALPRO