Pariet Pharmacy 10mg Gastro-Resistant Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER PARIET Pharmacy 10 mg gastro-resistant tablets
Rabeprazole sodium
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
• You must talk to your doctor if you do not feel better or if you feel worse after 14 days.
What is in this leaflet:
1 What Pariet Pharmacy is and what it is used for
2 What you need to know before you take Pariet Pharmacy
3 How to take Pariet Pharmacy
4 Possible side effects
5 How to store Pariet Pharmacy
6 Contents of the pack and other information
1. WHAT PARIET PHARMACY IS AND WHAT IT IS USED FOR
Pariet Pharmacy tablets contain the active ingredient rabeprazole sodium. This belongs to a group of medicines called 'Proton Pump Inhibitors' (PPIs). They work by lowering the amount of acid that your stomach produces.
Pariet Pharmacy tablets give relief of heartburn and acid reflux (when acid and food from your stomach escapes into your food pipe).
You must talk to a doctor if you do not feel better or if you feel worse after 14 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARIET PHARMACY
Do not take Pariet Pharmacy:
• 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 think that you are pregnant.
• if you are breast-feeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Pariet Pharmacy:
• if you have lost weight without trying to, have been told you are anaemic, have had bleeding from your stomach or have black stools
• if you have difficulty swallowing or it is painful to swallow
• if you are being sick a lot or there is blood in your sick
• if you have noticed a lump in your stomach
• if you have had stomach ulcers in the past or surgery for ulcers
• if you have yellowing of the skin (jaundice) or any other serious illness
• if you are 55 years or older with symptoms that are new or recently changed
• if you have been taking medicines for heartburn or indigestion on a daily basis for 4 weeks or more
• if you are allergic to other proton pump inhibitor medicines
• if you have ever had liver problems
• if you are due to have an endoscopy
• if you have reduced body stores or risk factors for reduced vitamin B12 and receive long term treatment with rabeprazole sodium. As with all acid reducing agents, rabeprazole sodium may lead to a 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 get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Pariet. Remember to also mention any other ill-effects like pain in your joints.
If you are not sure if any of the above applies to you, talk to your pharmacist before using Pariet Pharmacy.
Children
Do not give this medicine to children or teenagers under the age of 18 years as there is no experience of its use in this age group.
Other medicines and Pariet Pharmacy
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• Ketoconazole or itraconazole - used to treat infections caused by a fungus. Pariet Pharmacy may lower the amount of this type of medicine in your blood. Your doctor may need to adjust your dose.
• Atazanavir - for HIV infection. Pariet Pharmacy may lower this type of medication in your blood and they should not be used together.
Do not take other medicines to control stomach acid (e.g. other PPIs or tablets called H2 blockers) at the same time as this medicine.
Methotrexate (a chemotherapy medicine used in high doses to treat cancer) - if you are taking a high dose of methotrexate, your doctor may temporarily stop your Pariet treatment
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Pariet Pharmacy.
Avoid using Pariet Pharmacy if you are going to have a urea breath test.
Pregnancy and breast-feeding
• Do not use if you are pregnant or think you may be pregnant
• Do not use if you are breast-feeding or planning to breast feed
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or while breast-feeding.
Pariet Pharmacy with food and drink
Having your tablets with or after food does not affect how Pariet Pharmacy works.
Driving and using machines
It is unlikely that Pariet Pharmacy would affect your ability to drive and use machines. However, occasionally Pariet Pharmacy can cause drowsiness. If this happens, do not drive or use any tools or machines.
3. HOW TO TAKE PARIET PHARMACY
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet once a day for up to 2 weeks until your symptoms are completely gone. If you still have symptoms after taking Pariet Pharmacy every day for 4 weeks you should talk to your doctor.
• Only remove a tablet from the blister strip when it is time to take your medicine.
• Swallow your tablets whole with a drink of water. Do not chew or crush the tablets.
• You may not get immediate relief of your symptoms with the first dose of Pariet Pharmacy.
If you take more Pariet Pharmacy than you should
If you take more Pariet Pharmacy than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you forget to take Pariet Pharmacy
Do not take a double dose to make up for a forgotten dose. 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 have any further questions on 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.
The side effects are usually mild and improve without you having to stop taking this medicine.
Stop taking Pariet Pharmacy and see a doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:
• Allergic reactions - the signs may include: sudden swelling of your face, difficulty breathing or low blood pressure which may cause fainting or collapse
• Frequent infections, such as a sore throat or high temperature (fever), or ulcers in your mouth or throat
• Bruising or bleeding easily.
These side effects are rare (may affect up to 1 in 1,000 people).
Other possible side effects:
Common: may affect up to 1 in 10 people
• Infections
• Difficulty sleeping
• Headache or feeling dizzy
• Cough, runny nose or sore throat (pharyngitis)
• Effects on your stomach or gut such as stomach pain, diarrhoea, wind (flatulence), feeling sick (nausea), being sick (vomiting) or constipation
• Non-specific pain or back pain
• Weakness or flu-like symptoms.
Uncommon: may affect up to 1 in 100 people
• Feeling nervous or drowsy
• Chest infection (bronchitis)
• Painful and blocked sinuses (sinusitis)
• Dry mouth
• Indigestion or belching
• Skin rash or redness
• Muscle, leg or joint pain
• Bladder infection (urinary tract infection)
• Chest pain
• Chills or fever
• Changes in how your liver is working (shown in blood tests)
Rare: may affect up to 1 in 1,000 people
• Anorexia
• Depression
• Hypersensitivity
• Visual disturbance
• Sore mouth (stomatitis) or taste disturbance
• Upset stomach
• Liver problems including yellowing of your skin and whites of your eyes (jaundice)
• Itchy rash or blistering skin
• Sweating
• Kidney problems
• Weight gain
• Changes in white blood cells (shown in blood tests)
• Reduction in platelets.
Very rare: may affect up to 1 in 10,000 people
• Severe skin blistering, or soreness or ulcers in your mouth and throat.
Not known: frequency cannot be estimated from the available data
• Breast swelling
• Fluid retention
• Changes in sodium levels(measured in blood tests)
• Confusion
• Rash, possibly with pain in the joints
If you are on Pariet for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE PARIET PHARMACY
Keep this medicine out of the sight and reach of children.
Do not store this medicine above 25 °C.
Do not refrigerate.
Do not use this medicine after the expiry date which is stated on the carton and blister foil. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Pariet Pharmacy contains
The active substance is rabeprazole sodium. Each tablet contains 10 mg of the active substance rabeprazole sodium.
The other ingredients are:
mannitol, magnesium oxide, low-substituted hyprolose, hyprolose, magnesium stearate, ethylcellulose, hypromellose phthalate, diacetylated monoglycerides, talc, titanium dioxide (E171), red iron oxide (E172), Carnauba wax and ink (white shellac, black iron oxide (E172)), dehydrated ethyl alcohol, 1-butanol.
What Pariet Pharmacy looks like and contents of the pack
Pariet Pharmacy 10 mg gastro-resistant tablets are pink, film coated biconvex tablets with ‘E241’ printed on one side.
The tablets are packed in blister strips and come in pack sizes that contain: 14 tablets.
Marketing Authorisation Holder
Eisai Ltd., European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom
Manufacturer:
Eisai Manufacturing Ltd., European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom
Pariet Pharmacy bulk tablets are manufactured for Eisai Ltd. by:
Bushu Pharmaceuticals Ltd., Misato factory, 950, Hiroki, Ohaza, Misato-machi, Kodama-gun, Saitama-ken, Japan