PARIET 10 mg Enteric-Coated Tablet

Зміст інструкції

1. Pariet 10 mg gastro-resistant tablets, 20 mg gastro-resistant tablets
   1. What Pariet is and what it is used for
   2. What you need to know before taking Pariet
   3. How to take Pariet
   4. Possible side effects
   5. How to store Pariet
   6. Package Contents and Other Information

Pariet 10 mg gastro-resistant tablets, 20 mg gastro-resistant tablets

Rabeprazole sodium

Read this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If any of the side effects listed worsens, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Pariet is and what it is used for

Pariet tablets contain rabeprazole sodium as the active ingredient. This active ingredient
belongs to a class of medicines called Proton Pump Inhibitors (PPIs). They work
by reducing the amount of acid your stomach produces.
Pariet tablets are used for the treatment of the following diseases:

• “Gastroesophageal Reflux Disease” (GERD), which can include heartburn. Gastroesophageal reflux disease occurs when acid and food passes from the stomach into the esophagus.
• Stomach ulcer or ulcer of the upper part of the intestine. If these ulcers are infected by a bacterium called Helicobacter pylori(H. Pylori) you will also be prescribed antibiotics. The use of Pariet tablets together with antibiotics allows the elimination of the infection and the healing of the ulcer. Furthermore, the therapy prevents the infection and ensures that the ulcer does not recur.
• Zollinger-Ellison syndrome, when the stomach produces an extremely high amount of acid.

2. What you need to know before taking Pariet

Do not take Pariet

• If you are allergic (hypersensitive) to rabeprazole sodium or any of the other ingredients of this medicine (listed in section 6).
• If you are or think you might be pregnant.
• If you are breastfeeding.

Do not take Pariet if any of the above conditions apply to you. If you have any doubts, ask your
doctor or pharmacist before taking Pariet tablets.

Warnings and precautions
Talk to your doctor or pharmacist before taking Pariet

• if you are allergic to other proton pump inhibitors or “imidazole substitutes”
• if you have problems with your liver or blood; such problems have occurred in some patients and resolved with discontinuation of treatment with Pariet
• if you have been diagnosed with stomach cancer
• if you have had liver disease
• if you are taking atazanavir, for HIV infections
• if you have reduced body stores or risk factors that reduce the absorption of vitamin B12 and are receiving long-term treatment with rabeprazole sodium. Like all other acid-reducing agents, rabeprazole sodium can lead to reduced absorption of vitamin B12.
• if you have ever had a skin reaction after treatment with a medicine similar to Pariet that reduces stomach acid.
• 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 Pariet. Remember to report any other undesirable effects such as joint pain.
• if you are to undergo a specific blood test (Chromogranin A).

If you are unsure whether any of the above conditions may apply to you,
talk to your doctor or pharmacist before taking Pariet tablets.

Children
The use of Pariet is not recommended in children.
If you have severe diarrhea (watery or with blood) with symptoms such as fever, pain or abdominal tenderness,
stop taking Pariet and see your doctor.
If you take a proton pump inhibitor such as PARIET, 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.

Other medicines and Pariet
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription or herbal products.
In particular, tell your doctor or pharmacist if you are taking any of the following
medicines:

• Ketoconazole or itraconazole - used to treat fungal infections. Pariet may decrease the amount of these medicines in the blood. Your doctor may consider it appropriate to adjust the dosage.
• Atazanavir - used to treat HIV infections. Pariet may decrease the amount of this medicine in the blood and they should not be used together.
• Methotrexate (a chemotherapeutic medicine used at high doses to treat tumors) - if you are taking a high dose of methotrexate, your doctor may temporarily interrupt your treatment with Pariet.

If you are unsure whether any of the above conditions may apply to you, you
should talk to your doctor or pharmacist before taking Pariet tablets.

Pregnancy, breastfeeding and fertility

• Do not use Pariet if you are pregnant or think you might be.
• Do not use Pariet if you are breastfeeding or planning to breastfeed. If you are pregnant or breastfeeding, if you suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine

Driving and operating machinery
While taking Pariet you may feel drowsy. If this happens, do not drive and do not
use tools or machinery.

3. How to take Pariet

Always take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor or pharmacist.

Taking Pariet

• Remove the tablet from the blister pack just before taking it.
• Swallow the tablet whole with a glass of water. Do not chew or crush the tablets.
• Your doctor will tell you how many tablets to take and for how long. This will depend on your condition.
• If you are taking the medicine for a prolonged period of time, your doctor will need to monitor you.

Adults and the Elderly
“Gastroesophageal Reflux Disease” (GERD)
Treatment of moderate to severe symptoms (symptomatic GERD)

• The recommended dose is 1 Pariet 10 mg tablet once a day for four weeks.
• Take the tablet in the morning before breakfast.
• If symptoms recur after 4 weeks of treatment, your doctor may decide to continue treatment with 1 Pariet 10 mg tablet for as long as they deem necessary.

Treatment of more severe symptoms (erosive or ulcerative GERD)

• The recommended dose is 1 Pariet 20 mg tablet once a day for 4-8 weeks.
• Take the tablet in the morning before breakfast.

Long-term treatment of symptoms (GERD maintenance therapy)

• The recommended dose is 1 Pariet 10 mg or 20 mg tablet once a day for the time indicated by your doctor.
• Take the tablet in the morning before breakfast.
• Your doctor will want to review you at regular intervals to assess your symptoms and dosage.

Treatment of stomach ulcers (peptic ulcers)

• The recommended dose is 1 Pariet 20 mg tablet once a day for six weeks.
• Take the tablet in the morning before breakfast.
• Your doctor may prescribe you to continue treatment for another six weeks if your condition does not improve.

Treatment of duodenal ulcers

• The recommended dose is 1 Pariet 20 mg tablet once a day for four weeks.
• Take the tablet in the morning before breakfast.
• Your doctor may prescribe you to continue treatment for another four weeks if your condition does not improve.

Treatment and prevention of ulcers caused by H. pyloriinfections

• The recommended dose is 1 Pariet 20 mg tablet twice a day for seven days.
• Your doctor will prescribe you to also take antibiotics called amoxicillin and clarithromycin. For further information on the other medicines used in the treatment of Helicobacter pyloriinfection, please refer to their respective package leaflets.

Treatment of Zollinger-Ellison Syndrome, a condition in which the stomach produces a
very large amount of acid.

• It is recommended to start treatment with 3 Pariet 20 mg tablets once a day.
• The dose may subsequently be adjusted by your doctor based on your response to treatment. If you are on long-term treatment, you will need to see your doctor at regular intervals to check your symptoms and review the dose.

Patients with liver problems.
You should consult your doctor who will take particular care at the beginning of your treatment with
Pariet and throughout the therapy.

If you take more Pariet than you should
If you should take more tablets than you have been prescribed, consult your doctor or the
Emergency Room of the nearest hospital. Always bring the tablets or the packaging with you.

If you forget to take Pariet

• If you forget to take a dose, take it as soon as possible when you remember. However, if it is already time to take the next dose, skip the forgotten dose and continue as usual.
• If you forget to take the medicine for more than 5 days, call your doctor before taking the medicine again.
• Do not take a double dose (two doses at the same time) to make up for the missed tablet.

If you stop taking Pariet
Relief of symptoms usually occurs normally before the ulcer is completely
healed. It is important not to stop taking the tablets until your doctor tells you to.
If you have any 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.
Side effects are generally mild and resolve without stopping treatment
with the medicine.

Stop treatment with Pariet and consult your doctor immediately if you notice the
appearance of any of the side effects listed below – you may
need urgent medical attention:

• Allergic reactions - the signs may include: sudden swelling of the face, shortness of breath or low blood pressure, which may cause fainting or collapse.
• Frequent infections such as sore throat or fever or ulcers in the mouth or throat.
• Bruising or bleeding that occurs easily. These side effects are rare (occur in less than 1 in 1,000 people).
• Severe blistering of the skin or irritation or ulcers in the mouth and throat. These side effects are very rare (occur in less than 1 in 10,000 people).

Other possible side effects:
Common (occur in less than 1 in 10 people)

• Infections
• Difficulty sleeping
• Headache or dizziness
• Cough, cold, runny nose (“nasal congestion”), sore throat (pharyngitis)
• Effects on the stomach or intestines such as: abdominal pain, diarrhea, flatulence, nausea, vomiting or constipation
• Non-specific pain, back pain
• Weakness, flu-like syndrome.
• Benign polyps in the stomach.

Uncommon (occur in less than 1 in 100 people)

• Nervousness or drowsiness
• Lower airway infections (bronchitis)
• Stuffy and painful nose (sinusitis)
• Dry mouth
• Indigestion or belching
• Rash or redness of the skin
• Muscle, leg or joint pain
• Fractures of the hip, wrist and spine
• Bladder infections (urinary tract infections)
• Chest pain
• Chills or fever
• Liver disorders (highlighted by blood tests).

Rare (occur in less than 1 in 1,000 people)

• Loss of appetite (anorexia)
• Depression
• Hypersensitivity (including allergic reactions)
• Vision disorders
• Inflammation of the mouth (stomatitis) or taste disorders
• Stomach disorders or stomach pain
• Liver problems including yellowing of the skin and whites of the eyes (jaundice)
• Skin itching and blistering
• Sweating
• Kidney problems
• Weight gain
• Changes in white blood cells in the blood (highlighted by blood tests) that can lead to frequent infections
• Reduced platelets in the blood which can lead to bleeding or bruising more easily than normal.

Other possible side effects (frequency not known)

• Swelling of the breasts in men
• Fluid retention
• Low levels of sodium in the blood which can lead to fatigue, confusion, muscle spasms, seizures and coma
• Patients who have had previous liver problems may, very rarely, develop encephalopathy (brain disease)
• Erythema, possible joint pain
• Inflammation of the intestine (causing diarrhea)

If you take PARIET for more than three months, it is possible that your blood magnesium levels may decrease.
Low magnesium levels can manifest with fatigue, involuntary muscle contractions,
disorientation, seizures, dizziness, increased heart rate. If you have any of these
symptoms, consult your doctor immediately. Low magnesium levels can also lead to
a reduction in blood potassium or calcium levels. The doctor should decide whether to check
magnesium levels in the blood periodically.
Do not be alarmed by this list of side effects. You may not experience any of them.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell
your doctor or pharmacist. You can also report side effects directly through
the national reporting system at
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Pariet

Keep Pariet out of sight and reach of children.
Do not store at a temperature above 25°C.
Do not refrigerate.
Do not use Pariet after the expiry date which is stated on the packaging and blister. The expiry date refers to the last day of the month.
Medicines should not be disposed of 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 Pariet Contains
Each Pariet 10 mg tablet contains 10 mg of sodium rabeprazole as the active ingredient.
The excipients are:
mannitol, magnesium oxide, low substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate,
ethylcellulose, hydroxypropylmethylcellulose phthalate, acetylated monoglycerides, talc, titanium dioxide (E171), iron oxide
red (E 172), carnauba wax and ink (white shellac, iron oxide black (E172), anhydrous ethyl alcohol,
1-butanol).
Each Pariet 20 mg tablet contains 20 mg of sodium rabeprazole as the active ingredient.
The excipients are:
mannitol, magnesium oxide, low substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate,
ethylcellulose, hydroxypropylmethylcellulose phthalate, acetylated monoglycerides, talc, titanium dioxide (E171), iron oxide
yellow (E 172) carnauba wax and ink (white shellac, iron oxide red (E 172), glycerol
esterified with fatty acid, anhydrous ethyl alcohol, 1-butanol).

Description of Pariet and Package Contents
Pariet 10 mg gastro-resistant tablets are pink, biconvex tablets with the inscription “E241” on one
side.
Pariet 20 mg gastro-resistant tablets are yellow, biconvex tablets with the inscription “E243” on one
side.
The tablets are packaged in blisters of 1, 7, 14, 15, 25, 28, 30, 50, 56, 75 or 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Janssen-Cilag SpA
Via M.Buonarroti, 23
20093 Cologno Monzese (Milan)

Manufacturer
Janssen Pharmaceutica N.V.
Turnhoutseweg 30,
2340 Beerse, Belgium
and/or
Eisai Manufacturing Limited,
European Knowledge Centre,
Mosquito Way,
Hatfield, Hertfordshire,
AL10 9SN
United Kingdom

This medicinal product is authorised in the Member States of the European Union with the following brands:
Country NameMedicinal Product NameCountry NameMedicinal Product Name
Austria Pariet Italy Pariet
Belgium Alfence, Pariet Luxembourg Pariet
Denmark Pariet Netherlands Pariet
Finland Pariet Portugal Pariet
France Alfence, Pariet Spain Pariet
Germany Pariet Sweden Pariet
Greece Pariet Great Britain Pariet
Ireland Pariet