Rabeprazole Sodium 10 Mg Gastro-Resistant Tablets
Package leaflet: Information forthe user Rabeprazole Sodium 10 mg gastro-resistant tablets Rabeprazole Sodium 20 mg gastro-resistant tablets
Rabeprazole sodium
Read all ofthis leaflet carefully before you start taking this medicine because it contains important information foryou.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed foryou only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects notlisted in this leaflet. See section 4.
What is in this leaflet:
1. What Rabeprazole Sodium is and what it is used for
2. What you need to know before you take Rabeprazole Sodium
3. How to take Rabeprazole Sodium
4. Possible side effects
5. How to store Rabeprazole Sodium
6. Contents ofthe pack and other information
1. What Rabeprazole Sodium is and what it is used for
Rabeprazole Sodium tablet contains 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.
Rabeprazole Sodium tablets are used to treat the following conditions:
♦ ‘Gastro-oesophageal reflux disease' (GORD), which can include heartburn. GORD is caused when acid and food from your stomach escapes into your food pipe (oesophagus)
♦ Ulcers in your stomach or the upper part of your gut (intestine).
♦ Zollinger-Ellison Syndrome where your stomach produces too much acid.
2. What you need to know before you take Rabeprazole Sodium
Do not take Rabeprazole Sodium:
♦ You are allergic to rabeprazole sodium, or any of the other ingredients ofthis medicine (listed in Section 6 below).
♦ You are pregnant orthinkthat you are pregnant
♦ You are breast-feeding.
Do not use Rabeprazole Sodium if any ofthe above applies to you. Ifyou are not sure, talk to your doctor or pharmacist before using Rabeprazole Sodium.
Also see Pregnancy and breast-feeding section.
Children
Rabeprazole Sodium should not be used in children.
Warnings and precautions
Check with your doctor or pharmacist before taking Rabeprazole Sodium if:
♦ You are allergic to other proton pump inhibitor medicines or 'substituted benzimidazoles'
♦ Blood and liver problems have been seen in some patients but often get betterwhen Rabeprazole Sodium is stopped
♦ You have a stomach tumour
♦ You have ever had liver problems.
♦ If you are taking atazanavir- for HIV infection
♦ If you have ever had a skin reaction after treatment with a medicine similarto Rabeprazole Aurobindo 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 yourtreatmentwith Rabeprazole Aurobindo. Rememberto also mention any other ill-effects like pain in yourjoints.
Ifyou are not sure if any ofthe above appliesto you, talk to your doctor or pharmacist before using Rabeprazole Sodium.
If you experience severe (watery or bloody) diarrhoea with symptoms such as fever, abdominal pain or tenderness, stop taking Rabeprazole Sodium and see a doctor straight away.
Other medicines and Rabeprazole Sodium
Tell your doctor or pharmacist if you are taking, has recently taken any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of thefollowing medicines:
♦ Ketoconazole or itraconazole - used to treat infections caused byafungus. RabeprazoleSodium maylowertheamount of this type of medicine in your blood. Your doctor may need to adjust yourdose.
♦ Atazanavir- used to treat HIV-infection. Rabeprazole Sodium may lowerthe amount ofthis type of medicine in your blood and they should not be used together.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Rabeprazole Sodium.
Pregnancy and breast-feeding
♦ Do not use Rabeprazole Sodium ifyou are pregnant orthink you may be pregnant
♦ Do not use Rabeprazole Sodium ifyou are breast-feeding or planning to breast-feed
Ifyou are pregnant or breast-feeding, thinkyou 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 Rabeprazole Sodium. If this happens, do not drive or use any tools or machines.
3. How to take Rabeprazole Sodium
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist ifyou are not sure.
Taking this medicine
♦ 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
♦ Your doctor will tell you how many tablets to take and how long to take them for. This will depend on your condition
♦ If you are taking this medicine for a long time, your doctor will want to monitoryou.
Adults and the Elderly
For ‘gastro-oesophageal reflux disease’ (GORD)
Treatment of moderate to severe symptoms (symptomatic GORD)
♦ The usual dose is one Rabeprazole Sodium 10 mg tablet once a day for up to 4 weeks
♦ Take the tablet in the morning before eating
♦ If your condition returns after 4 weeks treatment, your doctor may tell you to take one Rabeprazole Sodium 10 mg tablet as and when you require it.
Treatment ofmore severe symptoms (erosive or ulcerative GORD)
♦ The usual dose is one Rabeprazole Sodium 20 mg tablet once a day for 4to8 weeks
♦ Take the tablet in the morning before eating.
Long-term treatment of symptoms (GORD maintenance)
♦ The usual dose is one Rabeprazole Sodium 10 mg or 20 mg tablet once a day for as long as your doctor has told you
♦ Take the tablet in the morning before eating
♦ Your doctor will want to see you at regular intervals to check your symptoms and dosage.
For ulcers ofthe stomach (peptic ulcers)
♦ The usual dose is one Rabeprazole Sodium 20 mg tablet once a day for 6 weeks
♦ Take the tablet in the morning before eating
♦ Your doctor may tell you to take Rabeprazole Sodium for another 6 weeks if your condition does not improve.
For ulcers ofthe intestine (duodenal ulcers)
♦ The usual dose is one Rabeprazole Sodium 20 mg tablet once a day for4weeks
♦ Take the tablet in the morning before eating
♦ Your doctor may tell you to take Rabeprazole Sodium for another 4 weeks if your condition does not improve.
Zollinger-Ellison Syndrome where excess acid is produced in the stomach
♦ The usual dose is three Rabeprazole Sodium 20 mg tablets once a day to start with
♦ The dose may then be adjusted by your doctor depending on how you respond to the treatment.
Ifyou are on long-term treatment you will need to see your doctor at regular intervalsfor review ofyourtablets and symptoms.
Children: The product should not to be used in children.
Patients with liver problems: You should consult your doctorwho will take special care when beginning treatment with Rabeprazole Sodium and while you continue to be treated with Rabeprazole Sodium.
If you take more Rabeprazole Sodium than you should
Ifyou take more Rabeprazole Sodium 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 Rabeprazole Sodium
♦ If you forget to take a dose, take it as soon as you remember it. However, if it is almost time foryour next dose, skip the missed dose and continue as usual
♦ If you forget to take your medicine for more than 5 days, talk to your doctor before taking any more medicine
♦ Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
■ Black
If you stop taking Rabeprazole Sodium
Relief of symptoms will normally occur before the ulcer has completely healed. It is important that you do not stop taking the tablets until told to do so by your doctor.
Ifyou have any further questions on the use ofthis product, 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 Rabeprazole Sodium and see a doctor straight away ifyou notice any ofthe following side effects - you may need urgent medical treatment:
♦ Allergic reactions - the signs may include: sudden swelling of yourface, difficulty breathing orlow blood pressure which may cause fainting or collapse
♦ Frequent infections, such as a sore throat orhigh temperature (fever), or ulcers in your mouth orthroat
♦ Bruising or bleeding easily.
These side effects are rare (affects 1to10 users in 10,000).
♦ Severe skin blistering, or soreness or ulcers in your mouth and throat.
These side effects are very rare (affects less than 1 user in
10,000).
Other possible side effects:
Common (affects 1to10 users in 1,000).
♦ Infections
♦ Difficulty sleeping
♦ Headache orfeeling 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
♦ Aches or back pain
♦ Weakness or flu-like symptoms.
Uncommon (affects 1 to 10 users in 1,000).
♦ Feeling nervous or drowsy
♦ Chest infection (bronchitis)
♦ Painful and blocked sinuses (sinusitis)
♦ Dry mouth
♦ Indigestion or belching
♦ Skin rash or redness
♦ Muscle, leg orjoint pain
♦ Bladder infection (urinary tract infection)
♦ Chest pain
♦ Chillsorfever
♦ Changes in how your liver is working (shown in blood tests)
♦ Taking a proton pump inhibitor like rabeprazole, especially over a period of more than one year, may slightly increase your risk offracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or ifyou are taking corticosteroids (which can increase the risk of osteoporosis).
Rare (affects 1 to 10 users in 10,000).
♦ Loss of appetite (Anorexia)
♦ Depression
♦ Hypersensitivity (includes allergic reactions)
♦ Visual disturbance
♦ Sore mouth (stomatitis) ortaste disturbance
♦ Upset stomach or stomach pain
♦ 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) which may result in frequent infection.
♦ Reduction in blood platelets resulting in bleeding or bruising moreeasilythan normal.
Other possible side effects (Not known - frequency cannot be estimated from the available data)
♦ breast swelling in men
♦ fluid retention
♦ Low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits and coma.
♦ Patients who have previously had liver problems may very rarely get encephalopathy (a brain disease)”.
♦ If you are on rabeprazole 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. Ifyou getany ofthesesymptoms, 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.
♦ Rash, possibly with pain in the joints
Do not be concerned by this list of side effects. You may not get
any ofthem.
Reporting of side effects
Ifyou get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety ofthis medicine.
5. How to store Rabeprazole Sodium
Keep this medicine out ofthe sight and reach of children.
Store below 25°C. Use within 3 months afterfirst opening the HDPE bottle. Do not swallow the desiccant. There may be more than one desiccant sachets present in the container.
Store in the original package in orderto protect from moisture.
Do not use this medicine afterthe expiry date which is stated on the carton and blister/ label ofthe bottle after EXP. The expiry date refers to the last day ofthe month.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Rabeprazole Sodium contains
- The active substance is rabeprazole sodium.
Each gastro-resistanttablet contains 10 mg rabeprazole sodium, equivalent to 9.42 mg rabeprazole.
Each gastro-resistanttablet contains 20 mg rabeprazole sodium, equivalent to 18.85 mg rabeprazole.
- The other ingredients are:
Tablet core: Mannitol, Magnesium oxide, hydroxy propylcellulose, crospovidone, low-substituted hydroxy propylcellulose, magnesium stearate.
Undercoating: Ethyl cellulose, magnesium oxide.
Entericcoating: Hypromellose phthalate, diacetylated monoglycerides, talc, titanium dioxide (E171), yellow iron oxide (E172) - 20mg only.
What Rabeprazole Sodium looks like and contents ofthe pack
Gastro-resistant tablet
Rabeprazole Sodium 10mg gastro-resistant tablet is round (diameter 5.72 mm), white, biconvex, enteric coated tablets.
Rabeprazole Sodium 20 mg gastro-resistant tablet is round (diameter 7.17 mm), yellow, biconvex, enteric coated tablets.
The Rabeprazole Sodium gastro-resistant tablets are available in Polyamide/Aluminium/ PVC/Aluminium foil blister pack and HDPE bottle with tamper proof polypropylene closure containing silica gel desiccant sachet(s).
Pack sizes:
Blister pack: 7, 10, 14, 20, 28, 30, 50, 56, 60, 98, 100 and 120 gastro-resistant tablets
HDPE bottle pack: 30 and 90 gastro-resistant tablets Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited Ares, Odyssey Business Park West End Road South Ruislip HA4 6QD United Kingdom
Manufacturer
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta
or
Milpharm Limited Ares, Odyssey Business Park West End Road South Ruislip HA4 6QD United Kingdom
This leaflet was last revised in 01/2016.
P15xxxxx