INIPEPSIA 20MG TABLETS 14 PANTOPRAZOLE

INIPEPSIA 20MG TABLETS 14 PANTOPRAZOLE View larger

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INIPEPSIA 20MG TABLETS 14 PANTOPRAZOLE indicated in the short-term treatment of gastroesophageal reflux disease (eg heartburn, acid regurgitation) in ladulte.

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INIPEPSIA 20MG TABLETS 14 PANTOPRAZOLE

 

For warnings, the precautions and cons-indications, please see the instructions.

 

Description INIPEPSIA 20MG TABLETS 14 PANTOPRAZOLE

 

INIPEPSIA indicated in the short term treatment of gastroesophageal reflux disease (e.g. pyrosis, acid regurgitation) in ladulte.

 

Application advice and opinions on INIPEPSIA 20MG TABLETS 14

 

The recommended dose is 20 mg of pantoprazole (one tablet) daily.

Taking tablets for 2 or 3 consecutive days may be necessary for obtaining an improvement in symptoms. Once the missing symptoms, treatment should be stopped.

The duration of treatment should not exceed 4 weeks without medical advice.

If symptoms persist after 2 weeks of continuous treatment, the patient should consult a doctor.

 

Composition INIPEPSIA 20MG TABLETS 14

 

Pantoprazole.................................................................................................................................. 20.00 mg

Form of pantoprazole sodium sesquihydrate ............................................ ............................... 22.56 mg

 

Precaution for use with INIPEPSIA 20MG TABLETS 14

 

Should not be administered with latazanavir

 

Introducing INIPEPSIA 20MG TABLETS 14

 

Box of 14 tablets

 

Warnings on drugs


Warning, the drug is not a product like any other. Read the package leaflet before ordering. Do not leave medicines out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Attention to incompatibilities on products in your.

Tell your pharmacist online treatments underway to identify possible incompatibilities. The checkout form contains a custom message field provided for this purpose.

Click here to find record of the drug at the site of the National Security Agency of Medicines and Health Products.

Pharmacovigilance : Report or a related adverse event (s) (s) (s) the use of a drug

VIDAL OF THE FAMILY

INIPEPSIA

Gastric antisecretory

pantoprazole

. Presentations . Composition . Indications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

INIPEPSIA: compressed enteric (yellow); box of 7.
-

INIPEPSIAL: compressed enteric (yellow); box of 14.
-

Laboratory Mayoly-Spindler

COMPOSITION (summary)
p cp
pantoprazole 20 mg

INDICATIONS (summary)
This drug belongs to the family of proton pump inhibitors (PPIs). It reduces the secretion of gastric acids and thus makes it possible to combat the pains due to the reflux of the acid content of the stomach in the esophagus. It acts prolonged but delayed: the decline in the acidity of the stomach requires a delay of a few days.
It is used in the treatment of short-term symptoms of gastroesophageal reflux (heartburn, regurgitation ...).
WARNING (Contents)
The effect of proton pump inhibitors is not immediate. 2 or 3 days of treatment may be required to observe a decrease in pain. This medication may not be appropriate if heartburn is too much (less than twice a week). Consult your pharmacist.
It is best to consult a doctor in the following situations:
  • digestive disorders appearing for the first time, or if disorders have changed recently;
  • disorders associated with weight loss;
  • difficulty swallowing or persistent abdominal discomfort.
Precautions are necessary in patients with hepatic impairment .
People with gastroesophageal reflux should avoid using drugs containing aspirin or NSAIDs that increase stomach acid. Paracetamol, on the other hand, is safe to treat pain or fever.
Driver: This medicine may cause dizziness and difficulty in seeing.
DRUG INTERACTIONS (summary)
This medicinal product must not be combined with medicinal products containing atazanavir ( REYATAZ ).
PREGNANCY AND BREAST-FEEDING (summary)
Pregnancy :
No adverse effects to the unborn child have been established with this medication. Nevertheless, as a precaution, its use during pregnancy is reserved for situations for which there is no therapeutic alternative.

Breastfeeding:
The data currently available do not indicate whether this drug passes into breast milk: it is not recommended for use during breast-feeding.
DIRECTIONS FOR USE AND DOSAGE (summary)
This medication is taken before a meal, preferably at the same time each day. It should be swallowed with a glass of water, without being crushed or crushed.

Usual dosage:

  • Adult over 18 years: 1 tablet per day.
Treatment should not exceed 4 weeks without medical advice. If symptoms persist after 2 weeks of treatment or recurrence at discontinuation of treatment, testing may be required.

TIPS (summary)
Drug therapy for gastroesophageal reflux can only be conceived when the following simple measures have not been able to eliminate the symptoms:
  • do not lie down within two hours after a meal;
  • do not lean forward (bend knees to pick up objects);
  • do not wear clothes that compress the abdomen (sheath ...);
  • raise the head of the bed 5 to 10 cm by placing wedges under the feet or a thick pillow under the mattress;
  • avoid soft drinks, prefer easy-to-digest foods.
These tips are intended to prevent the acid content of the stomach from flowing back into the esophagus during digestion.
If you are a smoker, continuing smoking is an important barrier to treatment; nicotine increases gastric acidity and reduces the effectiveness of the muscle that closes the junction between the esophagus and the stomach.
POSSIBLE ADVERSE EFFECTS (summary)
Frequently: headache, diarrhea or constipation, abdominal discomfort.
Rarely: nausea, vomiting, joint pain, dizziness , blurred vision, depression, hallucinations, confusion of ideas, itching, rash .
Very rarely: dry mouth, allergic reaction , gynecomastia , increased transaminases or triglycerides , muscle pain, edema, drops in white blood cells or platelets in the blood, hepatitis .


GLOSSARY (summary)


NSAIDs
Abbreviation for non-steroidal anti-inflammatory drug. Family of anti-inflammatory drugs that are not derived from cortisone (steroids), and the best known of which is aspirin.


diarrhea
The strict medical sense of diarrhea is "emission of stools too frequent and too abundant". In fact, common sense equates diarrhea with the notion of fluid and frequent stools. Normally the stools are pasty, but the emission of stool fluid or barely formed, without pain or particular associated disorder, is not pathological. Diarrhea may occur when liquid stool emissions are repeated throughout the day and the needs are overwhelming or painful.
Many medicines can accelerate intestinal transit and make the stools more liquid, without this undesirable effect being of real concern.
Antibiotics can alter the digestive flora, essential for digestion, and cause more or less troublesome but benign diarrhea. The effect appears immediately or after a few days of treatment. A severe and exceptional form of diarrhea, pseudomembranous colitis, can be observed after antibiotic treatment; this condition results in the emission of mucus and false membranes (resembling skin flaps) associated with abdominal pain; constipation may replace the initial diarrhea. Pseudomembranous colitis can occur several days after discontinuation of antibiotic treatment and requires urgent medical advice.


skin rash
Appearance of pimples or plaques on the skin. These lesions can be due to a food, a drug, and translate an allergy or a toxic effect. Many viruses can also cause pimple eruptions: rubella, roseola and measles are the most common.


enteric
Qualifies certain tablets or capsules in which the active substance is protected from the acidity of the stomach.


white blood cells
Cell present in the blood. There are several types: neutrophils, which increase during infections; the eosinophilic polynuclear cells, which are high in allergic persons or in cases of parasitosis; basophilic polynuclear cells; lymphocytes and monocytes, the number of which increases in the event of viral infection or of bone marrow disease.


gynecomastia
Increased breast volume in humans, congenital or due to disease, tumor or certain medications.


hepatitis
Inflammation of the liver. It may be due to a drug, a virus, alcohol or some other cause.
Viral hepatitis usually heals without treatment. Unlike hepatitis A and E almost always benign, hepatitis B and C can become chronic: the virus persists in the patient's body which remains contagious but does not necessarily suffer from liver problems. Chronic hepatitis is said to be active when the virus continues to destroy liver cells, resulting in increased transaminases in the blood.


Hepatic insufficiency
Inability of the liver to perform its function, which is essentially the elimination of some waste, but also the synthesis of many biological substances essential to the body: albumin, cholesterol and coagulation factors (vitamin K, etc.).


platelets
Small cells in the blood: they participate in the formation of clots.


allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


gastroesophageal reflux
Raising the gastric juice in the esophagus and in the back of the throat, favored by the extended position after meals, by leaning forward, by wearing clothes that compress the abdomen. This reflux is sometimes due to a hiatal hernia.


symptoms
Trouble felt by a person with an illness. The same symptom can translate different diseases and the same disease does not necessarily give the same symptoms in all the patients.


transaminases
Enzymes dosed in the blood, which rate rises during some hepatitis. They are included in blood tests as SGOT and SGPT or ASAT and ALAT.


triglycerides
Fats circulating in the blood. They come mainly from the assimilation of fatty substances, sugars and alcohol.


dizziness
Symptom that can mean an impression of loss of balance (common sense) or, more strictly, a sense of rotation on oneself or the environment (medical sense).

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Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Last updated: 30/04/2013

Name of the medicinal product

INIPEPSIA 20 mg gastro-resistant tablet

Pantoprazole sodium sesquihydrate

framed

Read all of this leaflet carefully before you start taking this medicine. It contains important information for your treatment.

If you have any further questions, ask your doctor or pharmacist.

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

· If you need more information and advice, ask your pharmacist.

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

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

Review summary

In this notice :

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

2. BEFORE YOU TAKE INIPEPSIA 20 mg gastro-resistant tablet?

3. HOW TO TAKE INIPEPSIA 20 mg gastro-resistant tablet?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

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

6. ADDITIONAL INFORMATION.

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

Pharmacotherapeutic group

INIPEPSIA contains an active substance, pantoprazole, which reduces the amount of acid produced in the stomach by blocking the "proton pump" .

Therapeutic indications

INIPEPSIA is used for the short-term treatment of symptoms of gastroesophageal reflux (eg heartburn, acid regurgitation) in adults.

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 a day of treatment with INIPEPSIA. 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 INIPEPSIA 20 mg gastro-resistant tablet?

List of information needed before taking the medication

Not applicable.

Cons-indications

Never take INIPEPSIA 20 mg, gastro-resistant tablet

- If you are allergic (hypersensitive) to pantoprazole or any other ingredient of INIPEPSIA (see section 6 "What INIPEPSIA contains")

- if you are taking a medication containing atazanavir (for the treatment of HIV infection)

- if you are under 18 years of age

- if you are pregnant or breastfeeding.

Precautions for use; special warnings

Take special care with INIPEPSIA 20 mg, gastro-resistant tablet

Consult your doctor if:

- you have taken continuously a treatment for heartburn or indigestion for 4 weeks or more;

- you are over 55 years old and take a daily medication for indigestion delivered without a prescription;

- you are over 55 years old and have symptoms that appear for the first time or have recently changed;

- you have a history of gastric ulcer or stomach surgery;

- you have liver problems or jaundice (jaundice, yellowing of the skin or eyes);

- you regularly consult your doctor because of serious disorder or illness;

- you must do an endoscopy or a urea breath test .

Consult your doctor immediately before or after taking INIPEPSIA if you notice any of the following symptoms, which could be a sign of another more serious illness:

- unintentional weight loss (not related to diet or exercise program)

- vomiting, especially if repeated

- vomiting blood, appearing under the aspect of dark coffee beans

- blood in the stool, which may be black or tarry

- difficulty or pain in swallowing

- pallor and weakness (anemia)

- pain in the chest

- stomach ache

- severe and / or persistent diarrhea, as INIPEPSIA has been associated with a slight increase in infectious diarrhea.

Your doctor may decide that you need to undergo additional tests.

In the event of a blood test, tell your doctor that you are taking INIPEPSIA.

Acid uproar and heartburn may disappear after one day of treatment with INIPEPSIA. However this medication is not intended to provide immediate relief.

You should not take it as a preventive measure.

If you suffer from heartburn or repeated and persistent indigestion, regular medical follow-up is recommended.

Interaction with other medicines

Taking or using other medicines

INIPEPSIA may affect the effectiveness of other medicines. Consult your doctor or pharmacist if you are taking a medication containing any of the following active ingredients:

- ketoconazole (used in the treatment of mycoses);

- warfarin and phenprocoumone (used to reduce blood clotting and prevent clotting). Additional blood tests may be required;

- atazanavir (used in the treatment of HIV infection). You should not take INIPEPSIA if you are taking Atazanavir.

Do not take INIPEPSIA with other drugs that limit the level of acidity produced by the stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or anti-H2 (eg ranitidine, famotidine ).

You may, however, take INIPEPSIA with an antacid (eg magaldrate, alginic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate or a combination of these substances) if necessary.

If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist. This also concerns herbalist preparations and homeopathic medicines.

Interactions with food and beverages

Food and drinks

The tablet should be swallowed whole with a little water before a meal.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and breast feeding

Do not take INIPEPSIA if you are pregnant or think you may be pregnant or if you are breast-feeding.

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

Sport

Not applicable.

Effects on ability to drive or use machines

Driving and using machines

If you experience any side effects such as dizziness or blurred vision, you should not drive or use machines.

List of excipients with known effect

Not applicable.

3. HOW TO TAKE INIPEPSIA 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

Always take INIPEPSIA exactly as described in this leaflet. If in doubt, consult your doctor or pharmacist.

Take one tablet per day. Do not exceed this recommended dose of 20 mg pantoprazole per day.

You should take this medication for at least 2 or 3 consecutive days. Stop taking INIPEPSIA when you no longer experience any symptoms. Acid uproar and heartburn may disappear after a single day of treatment with INIPEPSIA. However this medication is not intended to provide immediate relief.

If your symptoms persist after 2 weeks of continuous treatment, see your doctor.

Do not exceed 4 weeks of treatment without medical advice.

Take the tablet before a meal at the same time each day. Swallow the whole tablet with a glass of water. Do not crush or crush the tablet.

Children and Youth

INIPEPSIA should not be taken by a child or a person under 18 years of age.

Symptoms and Instructions for Overdose

If you take more than INIPEPSIA 20 mg, gastro-resistant tablet that you should:

Consult your doctor or pharmacist immediately. If possible, show your medication and this leaflet. There are no known symptoms of overdose.

Instructions for omission of one or more doses

If you forget to take INIPEPSIA 20 mg, gastro-resistant tablet :

Do not take a double dose to make up for the missed dose. Take one tablet the next day at the usual time.

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

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

As all INIPEPSIA medicines can cause side effects, although not everyone is subject to them.

Tell your doctor immediately or contact the nearest hospital emergency department if you experience any of the following serious side effects . Stop immediately taking INIPEPSIA, but take this leaflet and / or tablets with you.

- Serious allergic reactions (rare): Hypersensitivity reactions, called anaphylaxis, anaphylactic shock and angioedema. Typical symptoms are swelling of the face, lips, mouth, tongue and / or throat, which may cause difficulty in breathing or swallowing, hives, severe dizziness with accelerated heartbeat, and abundant perspiration.

- Serious skin reactions (indeterminate frequency): rash with swelling, skin peeling or blisters, lesions or bleeding around the eyes, nose, mouth or genitals and rapidly deteriorating your general condition or rash following exposure to the sun.

- Other serious reactions (indeterminate frequency): yellowing of the skin and eyes (due to severe hepatic impairment) or kidney problems, eg pain in urination and lower back pain with fever.

The frequency of adverse reactions that may occur is as follows:

· Very common: affect more than one user in 10

· Frequent: affect 1 to 10 users out of 100

· Uncommon: affect 1 to 10 users in 1000

· Rare: affect 1 to 10 users out of 10,000

· Very rare: affect less than one user in 10,000

· Indeterminate: The available information does not allow to evaluate the frequency.

- Uncommon side effects:

Headache, dizziness, diarrhea, nausea, feeling sick, vomiting, bloating and flatulence (gas), constipation, dry mouth, stomach pain and abdominal discomfort, rash or urticaria, itching, feeling weak, feeling exhausted or feeling general discomfort, sleep disorders, increased liver enzymes in the blood.

- Rare side effects:

Disorders of vision, such as blurred vision, joint pain, muscle pain, weight change, increased body temperature, swelling of the extremities, allergic reactions, depression, increased bilirubin and substance levels fat in the blood (ascertained by a blood test) increased chest in man, high fever and significant decrease in granulocytes (ascertained by a blood test).

- Very rare side effects:

Reduction in the number of blood platelets that may lead to bleeding or bruising, reduction in the number of white blood cells that may lead to more frequent infections, abnormal decreases in red blood cells and white blood cells, and platelets ( ascertained by a blood test).

- Frequency not known:

Hallucinations, confusion (especially in patients with a history of these disorders), decreased sodium levels in the blood, decreased magnesium levels in the blood.

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.

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

Keep out of sight and reach of children.

Expiration date

Do not use INIPEPSIA after the expiry date which is stated on the label, box or bottle after EXP. The expiry date refers to the last day of the month.

Storage conditions

No special storage conditions.

If necessary, warnings against visible signs of deterioration

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 INIPEPSIA 20 mg, Gastro-resistant tablet contains ?

The active substance is:

Pantoprazole ................................................. .................................................. ............................... 20.00 mg

In the form of pantoprazole sodium sesquihydrate ............................................ 22.56 mg

For a gastro-resistant tablet.

The other components are:

Core : mannitol, sodium carboxymethyl starch, anhydrous sodium carbonate, copolymer of methacrylic acid and methyl methacrylate, calcium stearate.

Intermediate coating : hypromellose, titanium dioxide (E171), talc, macrogol, sodium laurilsulfate, purified water.

Gastro-resistant coating : methacrylic acid / ethyl acrylate copolymer 30% dispersion, propylene glycol, yellow iron oxide (E172), titanium dioxide (E171), talc, purified water.

Pharmaceutical form and content

What is INIPEPSIA 20 mg gastro-resistant tablets and contents of the pack?

This medication is in the form of a picon yellow, elliptical, biconvex, coated tablet.

Boxes of 7 or 14 tablets.

Bottle of 7 or 14 tablets.

Not all pack sizes may be marketed.

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

MAYOLY SPINDLER LABORATORIES

6 AVENUE OF EUROPE

BP 51

78401 chatou CEDEX

exploiting

MAYOLY SPINDLER LABORATORIES

6 AVENUE OF EUROPE

BP 51

78401 chatou CEDEX

Maker

actavis hf

reykjavikurvegur 76-78

220 hafnarfjordur

Iceland

OR

ACTAVIS LTD

BLB 016 BULEBEL INDUSTRIAL ESTATE

ZEJTUN ZTN 3000

MALTA

or

balkanpharma dupnitsa ad

3 samokovsko shosse str.

dupnitsa 2600

Bulgaria

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

In accordance with the regulations.

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) www.ansm.sante.fr .

Information for health professionals only

Not applicable.

Other

SANITARY EDUCATION COUNCILS

The following lifestyle and diet recommendations may also help relieve heartburn or other symptoms due to acid ascents.

· Avoid hearty meals

· Eating slowly

· Stop smoking

· Reduce alcohol or caffeine consumption

· Lose Weight (in case of overweight)

· Avoid tight clothing or a tight belt

· Avoid eating less than 3 hours before bedtime

· Raising the head of the bed (in case of nocturnal disturbances)

· Reduce the consumption of foods that cause heartburn, including chocolate, peppermint, spearmint, greasy and fried foods, acidic foods, spicy foods, citrus fruits and juices, tomatoes.

Medicines for heartburn Pharmacy Online: Order your medication to treat your heartburn against acid reflux

 

There are various treatments for heartburn that aim to relieve quickly, accelerate healing and prevent the development of complications and recurrences.

- Gastric dressings are as plaster covering the walls of the stomach to protect the acidity. (They replace or complement the role of mucus when it is insufficient). They are clay-based compounds, for example.

 

- Different classes of antacids fight against excessive stomach acid:

• "inhibitors of the proton pump" and antihistamines which decrease secretion of acidity;

• drugs that "absorb" the acidity already present.

 

- Synthetic Prostaglandins play a protective role at all levels.

 

- Treatment with two antibiotics for suppressing the presence of the bacterium Helicobacter pylori prevents relapses and allows better healing of the mucosa.

 

For more Information of Interest, ask your pharmacist for advice

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