10 mg, 20 mg enteric-tablet is
rabeprazole sodium
What Pariet is and what it is used for
The Pariet tablet contains the active substance rabeprazole sodium. The pariet belongs to a group of drugs called proton pump inhibitors. They work by reducing the amount of acid produced in the stomach.
Pariet tablets are used to treat the following conditions:
- Gastroesophageal reflux disease ( GERD ), may include heartburn. GERD occurs when acid and food from the stomach penetrate the esophagus (esophagus).
- Ulcers in the stomach or upper part of the intestines ( duodenum ). If these wounds are infected with the bacterium Helicobacter pylori (H. pylori), you will also be treated with antibiotics. With the combined use of Pariet tablets and antibiotics, infection is eliminated and the wound heals. This treatment also prevents one infection and the wound from coming back.
- Zollinger-Ellison syndrome when the stomach produces too much acid.
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 pregnant or suspect you may be pregnant.
- if you are breastfeeding.
Do not use Pariet if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Pariet.
Warnings and cautions
Consult your doctor or pharmacist before taking Pariet if:
- you are allergic to other proton pump inhibitors or ‘substituted benzimidazoles’.
- blood and liver problems have been observed in some patients, but these often improve when treatment with Pariet is discontinued.
- you have a tumor in your stomach.
- you have had liver problems before.
- you are taking atazanavir for an HIV infection.
- you have a reduced ability to store vitamin B 12 in your body or risk factors for reduced vitamin B 12 and receive rabeprazole sodium as a long-term treatment. As with any acid-lowering drug, rabeprazole sodium may lead to reduced absorption of vitamin B 12.
- you have ever had a skin reaction after treatment with a drug like Pariet that reduces stomach acid.
- If you get a rash, especially in areas exposed to the sun, tell your doctor as soon as possible as you may need to stop treatment with Pariet. Also remember to mention any other side effects, such as joint pain.
- you should undergo a specific blood test (chromogranin A).
Talk to your doctor or pharmacist before using Pariet if you are not sure if any of the above apply to you.
Stop taking Pariet or see a doctor immediately, if you get severe (watery or bloody) diarrhea with symptoms such as fever, abdominal pain, or soreness.
Using proton pump inhibitors such as Pariet and especially if you use Pariet for more than a year, may increase the risk of having a hip, wrist, or vertebral fracture (bone fracture). Tell your doctor if you have osteoporosis or if you are taking medicines called corticosteroids as they may increase the risk of osteoporosis.
Children
The pariet should not be used for children.
Other drugs and Pariet
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This also includes over-the-counter medicines, including herbal medicines.
In particular, you must tell your doctor or pharmacist if you are taking any of the following medicines:
- Ketoconazole or itraconazole used to treat fungal infections. The parietal can reduce the amount of this type of drug in the blood. The doctor may need to adjust dose one.
- Atazanavir, is used to treat HIV infection. The pariet can reduce the amount of this type of drug in the blood and they should not be used together.
- Methotrexate (a chemotherapeutic drug used in high doses to treat cancer) – if you are taking high doses of methotrexate, your doctor may temporarily discontinue your treatment with Pariet.
Talk to your doctor or pharmacist before using Pariet if you are not sure if any of the above apply to you.
Pregnancy and breastfeeding and fertility
- Do not use Pariet if you are pregnant or suspect you may be pregnant
- Do not use Pariet if you are breast-feeding or planning to breast-feed
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You may feel sleepy while taking Pariet. Do not drive or use any tools or machines if this happens.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
The pariet contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per enteric tablet, ie it is essentially ‘sodium-free’.
How to take Pariet
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
How to take the medicine
- Do not take a tablet out of the blister strip until it is time to take the medicine.
- Swallow the tablets whole with water. Do not chew on the tablets or crush them.
- Your doctor will tell you how many tablets to take and how long to take them. This depends on your condition.
- If you are taking the medicine for a long time, your doctor will want you under supervision.
Adults and the elderly
For gastroesophageal reflux disease ( GERD )
Treatment of mild to severe symptoms ( symptomatic GERD )
- The usual dose is a Pariet 10 mg tablet once a day for up to four weeks
- Take the tablet in the morning before eating
- If the condition returns after four weeks of treatment, your doctor may prescribe you to take a 10 mg Pariet tablet if necessary.
Treatment of more severe symptoms ( erosive or ulcerative GERD )
- The usual dose is a Pariet 20 mg tablet once a day for 4-8 weeks
- Take the tablet in the morning before eating
Long-term treatment of symptoms (maintenance treatment of GERD )
- The usual dose is a Pariet tablet of 10 mg or 20 mg once a day for as long as your doctor prescribes it.
- Take the tablet in the morning before eating
- Your doctor will want to see you at regular intervals to check your symptoms and dose one
For ulcers in the stomach (peptic ulcer )
- The usual dose is a 20 mg Pariet tablet once a day for six weeks
- Take the tablet in the morning before eating
- Your doctor may prescribe you to take Pariet for another six weeks if your condition does not improve
For ulcers in the intestines (ulcers in the duodenum )
- The usual dose is a Pariet tablet of 20 mg once a day for four weeks
- Take the tablet in the morning before eating
- Your doctor may prescribe you to take Pariet for another four weeks if your condition does not improve
For wounds caused by H. pylori infection and to prevent the wounds from returning
- The usual dose is a 20 mg Pariet tablet twice a day for seven days
- Your doctor will also prescribe you antibiotics called amoxicillin and clarithromycin
For more information on the other medicines used for H. pylori treatment, see the package leaflet for each medicine.
Zollinger-Ellison syndrome when the stomach produces too much acid
- The usual dose is three Pariet tablets of 20 mg once a day initially
- Dose one can then be adjusted by the doctor depending on how you respond to the treatment
If you are undergoing long-term treatment, you need to see your doctor regularly for a review of dose one and your symptoms.
Patients with liver problems Consult your doctor. He will be extra careful when he or she starts treatment with Pariet and during the time you are being treated with Pariet.
If you use too much Pariet
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. Take the medicine pack with you.
If you forgot to take Pariet
- 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 and continue as usual
- If you forget to take your medicine for more than five days, consult your doctor before taking any more medicines
- Do not take a double dose (two doses at the same time) to make up for a forgotten tablet
If you stop taking Pariet
Relief of symptoms usually occurs before the wound has completely healed. You mustn’t stop taking the tablets before your doctor tells you to stop.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects are usually mild and get better without you having to stop taking the medicine.
Stop taking Pariet and see a doctor immediately if you notice any of the following side effects – you may need emergency care:
- Allergic reactions – signs may include: sudden swelling of the face, difficulty breathing, or low blood pressure, which may cause fainting or collapse
- Frequent infection, such as the sore throat or high fever, or sores in the mouth or throat
- Easy to get bruises or to start bleeding.
These side effects are rare (may affect up to 1 in 1,000 people).
- Severe blistering of the skin, or soreness or sores in the mouth and throat.
These side effects are very rare (may affect up to 1 in 10,000 people).
Other possible side effects:
Common (may affect up to 1 in 10 people)
- Infection is
- Difficulty sleeping
- Headache or dizziness
- Cough, runny nose, or sore throat ( pharyngitis )
- Effects on the stomach or intestines such as stomach pain, diarrhea, gas (flatulence), nausea (nausea), vomiting, or constipation
- Pain or back pain
- Weakness or flu-like symptoms
- Benign polyps are in the stomach.
Uncommon (may affect up to 1 in 100 people)
- Feeling anxious or drowsy
- Inflammation of the airways ( bronchitis )
- Painful and clogged sinuses (sinusitis)
- Dry mouth
- Digestive problems or regurgitation
- Skin rash or redness
- Muscle, leg, or joint pain
- Hip, wrist, or vertebral fractures (bone fractures)
- Bladder infection (urinary tract infection)
- Chest pain
- Chills or fever
- Changes in liver function (shown in blood tests)
Rare (may affect up to 1 in 1,000 people)
- Loss of appetite (anorexia)
- Depression
- Hypersensitivity (includes allergic reactions)
- Visual disturbances
- Soreness in the mouth ( stomatitis ) or taste disturbances
- Anxious stomach or stomach pain
- Liver problems including yellowing of the skin and whites of the eyes (jaundice)
- Itchy rash or blisters
- Sweating
- Kidney problems
- Weight gain
- Changes in white blood cells (shown in blood tests) that can lead to frequent infections
- Reducing the number of platelets in the blood leads to you bleeding or getting bruises more easily than normal.
Has been reported (occurs in an unknown number of users)
- Swollen breasts in men
- Fluid accumulates in the body
- Inflammation of the intestine (leading to diarrhea)
- Low levels of sodium in the blood can cause fatigue and confusion, muscle twitching, seizures, and coma
- Patients who have previously had liver problems can in very rare cases suffer from encephalopathy (a brain disease)
- Skin rash possibly with joint pain.
If you use Pariet for more than three months, your magnesium levels may drop. Low levels of magnesium can manifest as fatigue, involuntary muscle movements, confusion, cramps, dizziness, and rapid heartbeat. If you get any of these symptoms, contact your doctor immediately. Low levels of magnesium can also lead to decreased levels of potassium or calcium in the blood. Your doctor may measure the level of magnesium in your blood using regular blood tests.
Do not worry about this list of side effects. You may not be affected by any of them.
How the Pariet is to be kept
Keep out of sight and reach of children.
Do not store above 25 ° C.
Store in a cold place.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
Each 10 mg Pariet tablet contains 10 mg of the active substance rabeprazole sodium.
Other ingredients are:
mannitol, magnesium oxide, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, ethylcellulose, hypromellose phthalate, diacetylated monoglycerides, talc, titanium dioxide (E171), red iron oxide (E172), carnauba wax and ink (white shellac, E2 ) -butanol.
Each 20 mg Pariet tablet contains 20 mg of the active substance rabeprazole sodium.
Other ingredients are:
mannitol, magnesium oxide, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, ethylcellulose, hypromellose phthalate, diacetylated monoglycerides, talc, titanium dioxide (E171), yellow iron oxide ( E172 ), carnauba wax and ink (white shellac, red ) ethanol, 1-butanol.
What the medicine looks like and the contents of the pack
Pariet 10 mg entero-tablet is a pink, film-coated biconvex tablet with “E241” printed on one side.
Pariet 20 mg entero-tablet is a yellow, film-coated biconvex tablet with “E243” printed on one side.
The tablets are packaged in blister strips and are available in pack sizes of: 1, 5, 7, 14, 15, 25, 28, 30, 50, 56, 75, 98, 112 or 120 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Eisai AB, Svärdvägen 3A, 182 33 Danderyd
Manufacturer
Eisai GmbH, Edmund-Rumpler-Straße 3, 605 49 Frankfurt am Main, Germany