HELIDES caps. 20 mg
HELIDES caps. 20 mg
HELIDES WHAT IS AND WHAT IT IS USED
HELIDES is a medicinal product containing esomeprazole, which belongs to a group of drugs called proton pump inhibitors. They work by reducing the amount of acid that your stomach produces.
HELIDES used to treat the following conditions:
Gastro-oesophageal reflux disease (GORD), where acid from the stomach comes back up into the esophagus (the tube that connects your throat to your stomach), causing pain, inflammation and burning.
Ulcers in the stomach or upper abdomen, the result of an infection caused by bacteria called "Helicobacter pylori". If you have these symptoms, your doctor may prescribe antibiotics to treat the infection, resulting in ulcer healing.
Stomach ulcers caused by medicines called NSAIDs (nonsteroidal anti-inflammatory drugs). HELIDES can be used to prevent stomach ulcers when taking NSAIDs.
Treatment of the syndrome of Zollinger - Ellison, because of its growth in the pancreas is formed too much stomach acid.
After intravenous treatment with esomeprazole: to prevent re-bleeding ulcer.
BEFORE YOU USE HELIDES
Do not take HELIDES:
if you are allergic (hypersensitive) to esomeprazole or other HELIDES ingredients (listed in Section 6: Further information);
if you are allergic to other medications, proton pump inhibitors;
if you are taking medicine containing nelfinavir (used to treat HIV). Do not take HELIDES if any of these apply to you. If you are unsure, check with your doctor or pharmacist before taking HELIDES.
Take special care with HELIDES
Consult your doctor or pharmacist before taking HELIDES:
if you have severe liver problems;
if you have severe kidney problems.
HELIDES can obfuscated symptoms of other diseases. Therefore, if you experience any of these symptoms before taking HELIDES or while taking it, tell your doctor immediately:
lose significant weight without cause or have difficulty swallowing;
You have stomach pain or indigestion;
vomit food or blood;
have black stools (or mixed with blood) or have diarrhea.
If you are prescribed HELIDES "on demand", you should contact your doctor if your symptoms continue or change in character.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is due to the possibility HELIDES affect or be affected by the action of certain drugs.
HELIDES Do not take if you are taking a medicine containing nelfinavir (used to treat HIV).
Please tell your doctor or pharmacist if you are taking any of these medicines:
Atazanavir (used to treat HIV).
Ketoconazole, itraconazole or voriconazole (used to treat infections caused by fungus).
Citalopram, imipramine or clomipramine (used to treat depression).
Diazepam (used to treat anxiety, muscle relaxation, or epilepsy);
Phenytoin (used in epilepsy). If you are taking phenytoin, need to be monitored by your doctor when you start or stop taking Helides.
Medicines used to thin the blood, such as warfarin. You may have your doctor monitor when starting or stopping HELIDES.
cisapride (used to treat indigestion and burning).
If your doctor has prescribed antibiotics amoxicillin and clarithromycin, and HELIDES to treat ulcers caused by infection due to Helicobacter pylori, it is important to tell your doctor about all other medicines you are taking.
Pregnancy and lactation
Consult your doctor or pharmacist before taking any medicine. Before you take HELIDES tell your doctor that you are pregnant or planning
pregnancy. Your doctor will decide whether you can take HELIDES during this time.
It is not known whether HELIDES passes into breast milk. Therefore, you should not take HELIDES if you are breastfeeding.
Taking HELIDES with food and drink
You can take your capsules with food or on an empty stomach.
Driving and operating machinery
HELIDES unlikely to affect your ability to drive or operate machinery.
Important information about some of the ingredients of HELIDES
HELIDES contains sucrose, a sugar, propyl p-hydroxybenzoate (E216) and methyl p-hydroxybenzoate (E218):
If you have an intolerance to some sugars, contact your doctor before taking this medicine
Para-hydroxybenzoates may cause allergic reactions (possibly delayed).
HOW TO TAKE HELIDES
Always HELIDES exactly as prescribed by your doctor. Ask your doctor or pharmacist if you are unsure.
HELIDES not recommended for children under 12 years.
If you are taking this medicine for a long time, you should be monitored by your doctor (especially if taken for more than one year).
If your doctor has prescribed this medication, if necessary, advise you of any change in your symptoms.
Taking this medicine
You can take the capsules at any time of day.
You can take the capsules with food or on an empty stomach.
Swallow the capsules whole with a glass of water. Do not crush or chew the capsules or their contents. This is due to the fact that the capsules contain coated pellets, which prevents it be disturbed by the acid in your stomach. It is important that the granules are not damaged.
What to do if you have trouble swallowing capsules
If you have difficulty swallowing:
Carefully open the capsule over a glass of plain water and empty the contents of the capsule (pellets) in glass. Do not use other liquids.
Stir, then drink the mixture immediately or within 30 minutes. Always stir the mixture just before drinking.
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. The solids contain medication - do not chew or crush.
If you do not swallow the contents of the drug can be mixed with water and placed in a syringe. Then you can take it through a tube directly into the stomach ("stomach tube").
How much medicine to take
Your doctor will tell you how many capsules how long to take them. This will depend on your condition and how well your liver is working.
The usual doses are given below.
For the treatment of burning caused by gastroesophageal reflux disease (GERD):
Adults and children over 12 years:
If your doctor has determined that your esophagus is slightly damaged, the usual dose is one 40 mg capsule HELIDES once daily for 4 weeks. For medical advice you should continue to take the same dose 4 weeks if your esophagus is healed.
The usual dose after healing of the esophagus is one capsule HELIDES 20 mg once daily.
If your esophagus is damaged, the usual dose is one capsule HELIDES 20 mg once daily. After mastering the condition, your doctor may advise you to take the medicine if needed, up to one capsule a day each day.
If you have severe liver problems, your doctor may prescribe a lower dose.
To treat ulcers caused by Helicobacter pylori infection and relapse prevention:
Adults 18 years and older:
The usual dose is one 20 mg capsule HELIDES twice daily for one week.
Your doctor may also prescribe antibiotics called amoxicillin and clarithromycin.
To treat stomach ulcers caused by NSAIDs (nonsteroidal anti-inflammatory drugs):
Adults 18 years and older:
The usual dose is one 20 mg capsule HELIDES once daily for 4 to 8 weeks.
For the prevention of stomach ulcers if you take NSAIDs (nonsteroidal anti-inflammatory drugs):
Adults 18 years and older:
The usual dose is one 20 mg capsule HELIDES once daily.
For the treatment of very large volume of acid formed due to growth in the pancreas (syndrome Zollinger - Ellison):
Adults 18 years and older:
The usual dose is one 40 mg capsule HELIDES twice daily.
Your doctor will adjust the dosage according to your needs and decide how long you should take your medicine.
The maximum dose is 80 mg twice daily. After prolonged treatment with intravenous esomeprazole prevention of re-bleeding ulcer.
The usual dose is one capsule HELIDES 40 mg once daily for 4 weeks.
If you take more than the dose HELIDES
Tell your doctor or pharmacist.
If you forget to take HELIDES:
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missing.
Do not take a double dose (two doses at the same time) to make up.
POSSIBLE SIDE EFFECTS
Like all medicines, HELIDES may cause side effects, although not everybody gets them.
If you notice any of the following serious side effects, stop taking HELIDES and contact your doctor immediately:
Sudden wheezing, swelling of the lips, tongue, throat or body, rash, nausea, or difficulty in swallowing (severe allergic reaction).
Redness of the skin with blisters or peeling. Can be blistering and bleeding of the lips, eyes, mouth, nose and genitals. This could be a syndrome of Stevens - Johnson or 'toxic epidermal necrolysis'.
Yellow skin, dark urine and fatigue, which may be signs of liver problems. These effects are rare and affects 1 to 10 users in 10,000 patients.
Other side effects include:
Common (affects 1 to 10 users in 100)
effects on the stomach or gut: diarrhea, abdominal pain, constipation, flatulence (flatulence);
nausea or vomiting.
Uncommon (affects 1 to 10 users in 1,000):
swelling of feet and ankles;
inability to sleep (insomnia);
confusion, tingling, drowsiness;
changes in blood tests for control of liver function;
skin rash, hives (urticaria) or itching.
Rare (affects 1 to 10 users in 10,000)
Blood problems such as low white cells or platelets. This can cause weakness, bruising or higher risk of infection.
Low levels of sodium in the blood. This can cause weakness, vomiting and cramps.
Feelings of anxiety, confusion, or depression;
Change in taste;
Eye problems such as blurred vision;
Sudden feeling of wheezing or shortness of breath (bronchospasm);
Inflammation of the mouth;
An infection called "thrush" which affects the stomach and is caused by fungus.
Liver problems, including jaundice, in which symptoms are yellowing of the skin, dark urine and fatigue;
Loss of hair (alopecia);
Skin rash when exposed to sunlight;
Joint pain (arthralgia) or muscle aches (myalgia);
Feeling of general fatigue and loss of energy;
Very rare (affects less than 1 in 10,000 patients)
changes in blood counts, including agranulocytosis (lack of white blood cells);
feeling, hearing and seeing things that are not there (hallucinations);
Severe liver problems leading to liver failure and inflammation of the brain;
sudden severe rash or blistering or peeling. This may be associated with fever and joint pains (Erythema multiforme syndrome, Stevens Johnson, toxic epidermal necrolysis).
severe kidney problems;
breast enlargement in men.
In very rare cases HELIDES can affect the white blood cells, leading to immune deficiency. If you have an infection with symptoms such as fever with very poor general condition, or fever with local infection symptoms such as pain in the neck, throat, or mouth, or difficulty in urinating, you should consult with your doctor as soon as possible. In this case, the lack of white blood cells (agranulocytosis) can be detected by a blood test. It is important for you to give information about your medications on time.
Do not be afraid of these side effects. May not manifest any of them.
If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
HOW TO STORE HELIDES
Keep out of reach of children.
Do not store above 25 ° C.
Store in the original package (blister) or store container (bottle) tightly closed to protect from moisture.
Do not use HELIDES after the expiry date stated on the carton or bottle or blister foil. The expiry date refers to the last day of that month.
After opening the bottle, the capsules should be taken within three months.
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.
The active substance is esomeprazole.
HELIDES capsules in two dosage forms containing 20 mg or 40 mg esomeprazole (as magnesium dihydrate).
The other ingredients are:
Sugar spheres (sucrose and maize starch), hypromellose, dimethicone emulsion 35% (containing
dkmetikon, propyl p-hydroxybenzoate (E216), methyl p-hydroxybenzoate (E218), sorbic acid, sodium benzoate, polyethylene glycol sorbitan monolaurate, oktilfenoksi-polietoksi-ethanol and propylene glycol), polysorbate 80, mannitol, diacetylated monoglycerides, talc , copolymer of methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30% containing copolymers of methacrylic acid and ethyl acrylate copolymer, sodium lauryl sulfate and polysorbate 80, triethyl citrate and makrogolglitserolovi stearates.
Blalk iron oxide (E172), gelatin, yellow iron oxide (E172) and titanium dioxide (E 171)
HELIDES looks like and contents of pack
HELIDES capsules 20 mg yellow opaque cap and white opaque body, printed with black imprint "20 mg" on the cap and body.
HELIDES capsules 40 mg yellow opaque cap and white opaque body, printed with black imprint "40 mg" on the cap and body