Zanprol 10 Mg Tablets
148mm
3mm
orange or pineapple) or apple sauce.
1 Always stir the mixture just before drinking (the mixture will not be clear). Then drink the mixture straight away or within 3G minutes.
1 To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it. Do not use milk or fizzy water. The solid pieces contain the medicine - do
Adults aged 18 years and •
prescription, but you still need to use Zanprol Tablets
carefully to get the best results from them.
• Keep this leaflet you may need to read it again.
• If you have any questions, or if there is anything you do not understand, ask your pharmacist.
• You must contact your doctor if your symptoms worsen or do not improve after 14 days.
• If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Zanprol Tablets are and what they are used for
2. Before you take Zanprol Tablets
3. How to take Zanprol Tablets
4. Possible side effects
5. How to store Zanprol Tablets
6. Further information
Zanprol Tablets are used to give long lasting relief of acid reflux and heartburn.
Zanprol Tablets contain the active substance omeprazole. It belongs to a group of medicines called 'proton pump inhibitors'. They work by reducing the amount of acid that your stomach produces.
Zanprol is used in adults for the short-term treatment of reflux symptoms (for example, heartburn, acid egurgitation).
Reflux is the backflow of acid from the stomach into the gullet "foodpipe", which may become inflamed and painful. This may cause you symptoms such as a painful burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms.
containing nelfinavir (used to treat HIV infection).
You should specifically tell your doctor or pharmacist if you are taking dopidogrel (used to prevent blood clots (thrombi)).
Tell your doctor or pharmacist if you are taking any c the following medicines:
• Ketoconazole, itraconazole or voriconazole (used t treat infections caused by a fungus).
• Digoxin (used to treat heart problems).
• Diazepam (used to treat anxiety, relax muscles or ir epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Zanprol.
• Medicines that are used to thin your blood, such as warfarin or other vitamin K blockers. Your doctor may need to monitor you when you start or stop taking Zanprol.
• Rifampicin (used to treat tuberculosis).
• Atazanavir (used to treat HIV infection).
• Tacrolimus (in cases of organ transplantation).
• St. John's wort (Hypericum perforatum)
(used to treat mild depression).
• Cilostazol (used to treat intermittent claudication).
• Saquinavir (Used to treat HIV infection).
Taking Zanprol with food and drir
You can take your tablets with food' stomach.
Pregnancy i
: feeding
Before taking Zanprol, tell your doctor or pharmacist if you are pregnant or trying to get pregnant. Your doctor will decide whether you can take Zanprol if you are breastfeeding.
Before you take Zanprol Tablets
Do not take Zanprol Tablets:
• if you are allergic (hypersensitive) to omeprazole or any of the other ingredients (listed in Section 6).
• if you are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medicine containing nelfinavir (for HIV infection).
If you are not sure, talk to your doctor or pharmacist before taking Zanprol.
' Do not take Zanprol for more than 14 days without ' consulting a doctor. If you do not experience relief, / if you experience a worsening of symptoms, consult ' your doctor.
/ Zanprol may hide the symptoms of other diseases.
' Therefore, if any of the following happen to you / before you start taking Zanprol or while you are ' taking it, talk to your doctor straight away:
' • You lose a lot of weight for no reason and have / problems swallowing.
'• You get stomach pain or indigestion.
/ • You begin to vomit food or blood.
' • You pass black stools (blood-stained faeces).
' • You experience severe or persistent diarrhoea, as / omeprazole has been associated with a small ' increase in infectious diarrhoea.
/ • You have had previous gastric ulcer or gastrointestinal surgery.
' • You are on continuous symptomatic treatment of , indigestion or heartburn for 4 or more weeks.
' • You continuously suffer from indigestion or / heartburn for 4 or more weeks.
' • You have jaundice or severe liver disease.
- • You are aged over 55 years with new or recently ^ changed symptoms.
Driving and using machines
Zanprol is not likely to affect your ability to drive or use any tools or machines. Side effects such as dizziness and visual disturbances may occur (see section 4). If affected, you should not drive or operate machinery.
Important information about: ingredients of Zanprol
Zanprol Tablets contain lactose monohydrate, if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Zanprol Tablets
Always take Zanprol exactly as described in this leafli You should check with your doctor or pharmacist if
The usual dose is two 10 mg tablets i days, Contact your doctor if you are symptoms after this period.
It might be necessary to take the tablets for 2-3 ,
consecutive days to achieve improvement of symptoms'
e a day for 14 : free from
It is recommended that you take your tablets in morning.
1 You can take your tablets with food or on an err stomach.
Swallow your tablets whole with half a glass of water. Do not chew or crush the tablets.
HWhat to do if you have trouble swallowing the tablets
f you have trouble swallowing the tablets:
Break the tablet and disperse it in a spoonful of water (non-fizzy), any acidic juice (e.g. apple.
Initially swallow 2 tablets once daily with plenty of water.
If your symptoms improve, reduce the dose to 1 tablet daily. If your symptoms come back, swallow 2 tablets once daily.
If you take more Zanprol than you should
1 you take more Zanprol than recommended, talk to our doctor or pharmacist straight away.
If you forget to take a dose, take it as soon as you remember it. however, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
z Like all medicines, Zanprol car ' although not everybody gels •
' If you notice any of the following rare but serious side effects, stop taking Zanprol and consult a doctor ^immediately:
'• Sudden wheezing, swelling of your lips, tongue and / throat or body, rash, fainting or difficulties in ' swallowing (severe allergic reaction).
/ • Reddening of the skin with blisters or peeling. There ' may also be severe blisters and bleeding in the lips, eyes, ' mouth, nose and genitals. This could be ‘Stevens-Johnson / syndrome1 or ‘toxic epidermal necrolysis'.
' • Yellow skin, dark urine and tiredness which can be / symptoms of liver problems.
have side effects.
Very rare side effects
• changes in blood count including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling or hearing things that are not there (hallucinations).
• Severe liver problems leading to liver failure and inflammation of the brain.
• Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Enlarged breast in men.
• Hypomagnesaemia.
Zanprol may in very rare cases affect the white blood cells leading to immune deficiency. If you have any infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important for you to give information about your medicine at this time.
Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effecrts not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Zanprol
Tablets
• Keep out of the reach and sight of children.
• Do not use this medicine after the ‘EXP1 date shown on the pack.
• Do not store above 30°C.
• Store in the original package to protect from moisture
• Medicines 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.
ISide effects may occur with certain frequencies, which are defined as follows:
Very common: affects more than 1 user in 10 Common: affects 1 to 10 users in 100 Uncommon: affects 1 to 10 users in 1,000 dRare: affects 1 to 10 users in 10,000 / Very rare: affects less than 1 user in 10,000 ' Not known: frequency cannot be estimated from the /available data Other side effects include:
/ Common side effects ,• Headache.
' • Effects on your stomach or gut: diarrhoea, stomach / pain, constipation, wind (flatulence).
' • Feeling sick (nausea) or being sick (vomiting).
- Uncommon side effects , • Swelling of the feet and ankles.
' • Disturbed sleep (insomnia).
/• Dizziness, tingling feelings such as "pins and ' needles", feeling sleepy.
/ • Spinning feeling (vertigo).
/• Changes in blood tests that check how the liver is working. '• Skin rash, lumpy rash (hives) and itchy skin.
/• Generally feeling unwell and lacking energy.
' Rare side effects
- • Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make ' infections more likely.
/ • Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing. / • Low levels of sodium in the blood. This may cause ' weakness, being sick (vomiting) and cramps.
' • Feeling agitated, confused or depressed.
/ • Taste changes.
• Eyesight problems such as blurred vision.
/ • Suddenly feeling wheezy or short of breath (bronchospasm). • Dry mouth.
' • An inflammation of the inside of the mouth.
/ • An infection called "thrush" which can affect the gut ' and is caused by a fungus.
/ • Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
' • Hair loss (alopecia).
/•Skin rash on exposure to sunshine.
' • Joint pains (arthralgia) or muscle pains (myalgia).
/ • Severe kidney problems (interstitial nephritis).
^ • Increased sweating.
6. Further information
Active ingredient Each gastro-resistant tablet contains Omeprazole 10 mg.
Other ingredients Lactose monohydrate, sodium starch glycollate, sodium stearate, sodium stearyl fumarate, hydroxypropyl methylcellulose (HPMC) acetate succinate, sepisperse AP-3527 (containing propylene glycol, titanium dioxide (E 171), red iron oxide (E 172), hydroxypropyl methylcellulose, yellow iron oxide (E 172)), talc, triethyl citrate, monoethanolamine, sodium laurilsulfate, carnauba wax.
Packs of Zanprol Tablets contain 7,14 or 28 tablets (not all packs may be marketed).
The markc
Ltd., 32 Va
SW1V 2SA,
The manufacturer is Dexcel-Pharma Ltd,
7 Sopwith Way, Drayton Fields Industrial Estate, Daventry, Northamptonshire, NN11 8PB, U.K.
2012.
ZAN0138081 2v1
12mm
12mm