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GASEC GASTROCAPS 40MG N14

Attention: Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for treating a health problem or disease, or prescribing any medication. iDrugs24.com is not responsible for any damage to your health as the result of self treatment.

# On 2024-Mar-29
GASEC-drug/medicine -capsules -tablets aproximate price on "GASEC GASTROCAPS 40MG N14" in Riga city, Latvia is:
  • 6.04€  6.53$  5.16£  698Rub  69.6SEK  26PLN  24.04₪ 


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine -capsules -tablets  GASEC GASTROCAPS 40MG N14     Recheck

ATC codeA02BC01 

Active substances: Omeprazolum

 


Vendor, principal: Mepha Ltd.

 Prescription drug (℞) 

* This table was compiled fully automatically, independently from any advertisers, transparently and without any modification relaying the open offers available on the mentioned dates.Only the distribution of over-the-counter remedies through the website is permitted in Latvia in accordance with national laws and regulations.
 .

GASEC GASTROCAPS 40MG N14

Package leaflet: information for the user

Gasec Gastrocaps 40 mg gastro-resistant hard capsules

Omeprazole

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.
-   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 for you only. Do not pass it on to others. It may harm them, even if their symptoms are similar to yours.
-   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.

What is in this leaflet

1.   What Gasec Gastrocaps is and what it is used for
2.   What you need to know before you take Gasec Gastrocaps
3.   How to take Gasec Gastrocaps
4.   Possible side effects
5.   How to store Gasec Gastrocaps
6.   Contents of the pack and other information

1. What Gasec Gastrocaps is and what it is used for

Gasec Gastrocaps contains the active substance omeprazole. It belongs in the group of medicines
called proton pump inhibitors. They work by reducing the amount of acid produced in your stomach.
Gasec Gastrocaps is used to treat the following conditions:
Adults
-   Gastroesophageal reflux disease (GERD). This is where acid from the stomach escapes into the oesophagus (connects your throat to your stomach) causing pain, inflammation and heartburn.
-   Ulcers in the upper part of the intestine (duodenal ulcers) or stomach (gastric ulcers).
-   Ulcers that are infected with bacteria called Helicobacter pylori. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
-   Ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Gasec Gastrocaps can also be used to stop ulcers from forming if you are taking NSAIDs.
-   Excessive production of acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).
Children
Children older than 1 year whose weight is > 10 kg
-   Gastroesophageal reflux disease (GERD). This is where acid from the stomach escapes into the oesophagus (connects your throat to your stomach) causing pain, inflammation and heartburn.
In children, the symptoms of the condition can include the return of stomach contents into the mouth (regurgitation), vomiting and poor weight gain.
Children and adolescents over 4 years of age
-   Ulcers that are infected with bacteria called Helicobacter pylori. If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before you use Gasec Gastrocaps Do not take Gasec Gastrocaps:

-   If you are allergic to omeprazole or any of the other ingredients of this medicine (listed in
section 6)
-   If you are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
-   If you are using a medicine which contains nelfinavir (used for the treatment of HIV).
If you are not sure about any aspects of taking this medicine, talk to your doctor or pharmacist before taking Gasec Gastrocaps.

Warnings and precautions

Gasec Gastrocaps may conceal the symptoms of other diseases. Therefore, if you get any of the following symptoms before you start taking or while you are taking Gasec Gastrocaps, talk to your doctor immediately:
-   You lose a lot of weight for no reason and have problems swallowing.
-   You get stomach pain or indigestion.
-   Y ou 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 the frequency of infectious diarrhoea.
-   You have severe liver problems.
-   If you have ever had skin reactions after treatment with a medicine similar to Gasec Gastrocaps, which reduces stomach acidity.
-   You are about to undergo a specific blood test (Chromogranin A).
If you get a rash, especially in an area not protected from the sun, tell your doctor about it as soon as possible, as you may have to discontinue treatment with Gasec Gastrocaps. Be sure to mention any other side effects, such as joint pain.
If you take Gasec Gastrocaps on a long-term basis (longer than 1 year), your doctor will monitor you regularly. Report any new and unusual symptoms and circumstances whenever you see your doctor.
Prolonged use (> 1 year) of a medicine of this type (proton pump inhibitor) may slightly increase your risk of wrist, hip or spine fracture. The risk is higher for the elderly and people who have other risk factors.
Long-term treatment with omeprazole may cause hypomagnesemia (magnesium deficiency in the blood). Symptoms of hypomagnesemia exhibit a slow onset and they are easy to miss at the beginning. Severe symptoms may follow, such as fatigue, muscle rigidity, delirium, cramps, dizziness and ventricular arrhythmia. The symptoms will subside after stopping treatment and undergoing magnesium replacement therapy.
If you are taking this medicine on a long-term basis or in combination with medicines that flush magnesium from the body (e.g. digoxin and diuretics or “water tablets”), your doctor may run a blood test on you to determine the magnesium levels before starting treatment and regularly during treatment.

Other medicines and Gasec Gastrocaps

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Gasec Gastrocaps can affect the way other medicines work and some medicines can also have an effect on Gasec Gastrocaps.
Do not take Gasec Gastrocaps if you are taking a medicine containing nelfinavir (used to treat HIV). Tell your doctor or pharmacist if you are taking any of the following medicines:
-   Ketoconazole, itraconazole or voriconazole (used to treat fungal infections).
-   Digoxin (used to treat heart problems).
-   Diazepam (used to treat anxiety, relax muscles or for epilepsy).
-   Phenytoin (used for epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Gasec Gastrocaps.
-   Medicines used to thin the blood, such as warfarin or other vitamin K blockers. Medical monitoring may be necessary when you start or stop taking Gasec Gastrocaps.
-   Rifampicin (used to treat tuberculosis).
-   Atazanavir (used to treat HIV).
-   Tacrolimus (in the case of organ transplantation).
-   St. John’s Wart (Hypericum perforatum) (used to treat mild depression).
-   Cilostazol (used to treat intermittent claudication).
-   Saquinavir (used to treat HIV).
-   Clopidogrel (used to prevent blood clots (thrombi)).
If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Gasec Gastrocaps to treat ulcers caused by a Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.

Gasec Gastrocaps with food and drink

It is recommended to take Gasec Gastrocaps capsules in the morning, preferably on an empty stomach. The capsules are swallowed whole with half a glass of water. Do not chew or crush the capsules.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Based on current studies, omeprazole does not endanger the health of the foetus/new-born.
Omeprazole may be used during pregnancy. Omeprazole is excreted into breast milk but it is not likely to influence the child at therapeutic doses.

Driving and using machines

Gasec Gastrocaps is not likely to affect your ability to drive or use any tools or machines. Potential side effects include dizziness and visual disturbances (see section 4). If affected, you should not drive or use machines.

Gasec Gastrocaps contains sucrose

Gasec Gastrocaps capsules contain sucrose. If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor or pharmacist before taking this medicine.

3. How to use Gasec Gastrocaps

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will tell you how many capsules to take, and how long to take them for. This will depend on your condition and age.
The recommended doses are given below.
Adults
To treat symptoms of GERD, such as heartburn and acid reflux (regurgitation):
-   If your doctor has determined that your oesophagus has been slightly damaged, the recommended dose is 20 mg once a day for 4...8 weeks. Your doctor may advise you to take a dose of 40 mg for a further 8 weeks if your oesophagus has not yet healed.
-   The recommended dose once the oesophagus has healed is 10 mg once a day.
-   If your oesophagus has not been damaged, the recommended dose is 10 mg once a day.

To treat ulcers in the upper part of the intestine (duodenal ulcers):

-   The recommended dose is 20 mg once a day for 2 weeks. Your doctor may advise you to take the same dose for a further 2 weeks if your ulcer has not yet healed.
-   If the ulcer does not fully heal, the dose can be increased to 40 mg once a day for 4 weeks.
To treat ulcers in the stomach (gastric ulcers):
-   The recommended dose is 20 mg once a day for 4 weeks. Your doctor may advise you to take the same dose for a further 4 weeks if your ulcer has not yet healed.
-   If the ulcer does not fully heal, the dose can be increased to 40 mg once a day for 8 weeks.

To prevent the duodenal and gastric ulcers from recurring:

-   The recommended dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40 mg once a day.

To treat duodenal and gastric ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

-   The recommended dose is 20 mg once a day for 4...8 weeks.

To prevent duodenal and gastric ulcers if you are taking NSAIDs:

-   The recommended dose is 20 mg once a day

To treat ulcers caused by a Helicobacter pylori infection and to prevent it from recurring:

-   The recommended dose is 20 mg twice a day for one week.
-   Your doctor will also advise you to take two antibiotics from the following: amoxicillin, clarithromycin and metronidazole.

To treat excessive production of acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome):

-   The recommended dose is 60 mg once a day.
-   Your doctor will adjust the dose depending on your needs and will also decide how long you need to take the medicine for.
Children
To treat symptoms of GERD, such as heartburn and acid regurgitation:
-   Children older than 1 year and with a weight of more than 10 kg may take Gasec Gastrocaps. The dose for children is based on the child’s weight and the correct dose will be determined by a doctor.

To treat ulcers caused by a Helicobacter pylori infection and to prevent it from recurring:

-   Children over 4 years of age may take Gasec Gastrocaps. The dose for children is based on the child’s weight and the correct dose will be determined by a doctor.
-   Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for your child.

Taking this medicine

-   It is advisable to take the capsules in the morning.
-   You can take your capsules with food or on an empty stomach.
-   Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules. This is necessary because the capsules contain coated pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.

What to do if you or your child have trouble swallowing the capsules?

If you or your child have trouble swallowing the capsules:
-   Open the capsules and swallow the contents directly with half a glass of water or put the contents into a glass of still (noncarbonated) water, any acidic fruit juice (e.g. apple, orange or pineapple) or apple sauce.
-   Always stir the mixture just before drinking it (the mixture will not be clear). Then drink the mixture straight away or within 30 minutes.
-   Make sure that you have drunk all of the medicine. For this, rinse the glass carefully with another half a glass of water and drink it. The solid pieces contain the medicine. Do not chew or crush them.

If you take more Gasec Gastrocaps than you should

If you take more Gasec Gastrocaps than prescribed by your doctor, talk to your doctor or pharmacist immediately. Symptoms of overdose include nausea, vomiting, dizziness, abdominal pain, diarrhoea, headache and changes in mental state. The symptoms will subside with time. If necessary, your doctor will assign treatment for them.

If you forget to take Gasec Gastrocaps

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 use a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following rare but severe side effects, stop taking Gasec Gastrocaps and
contact a doctor immediately.
-   Sudden wheezing, swelling of your lips, tongue and throat or rash on your body, fainting or difficulties in swallowing (severe allergic reaction).
-   Redness of the skin with blisters or peeling. There may also be severe blistering and bleeding on the lips, eyes, mouth, nose and genitals. This could be Stevens-Johnson Syndrome or toxic epidermal necrolysis.
-   Yellow skin, dark urine and tiredness which can be symptoms of liver problems.
Side effects may appear with different frequencies, classified as follows:
Very common:
affects more than 1 user in 10
Common:
affects 1...10 users in 100
Uncommon:
affects 1...10 users in 1,000
Rare:
affects 1...10 users in 10,000
Very rare:
affects less than 1 user in 10,000
Unknown:
cannot be estimated from available data
Other side effects

Common side effects

-   Benign polyps in the stomach.
-   Headache.
-   Disturbances of the digestive system: diarrhoea, abdominal pain, constipation, flatulence.
-   Nausea or vomiting.

Uncommon side effects

-   Swelling of the feet and ankles.
-   Sleep disorders (insomnia).
-   Dizziness, tingling sensation, drowsiness.
-   Dizziness (vertigo).
-   Changes in blood tests for liver function.
-   Skin rash, hives (urticaria) and itchy    skin.
-   Generally feeling unwell and lacking energy.
-   Swelling of the hands and feet.
-   Fractured hip, wrist or spine (see section 2).

Rare side effects

-   Blood problems, such as reduced levels of white blood 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, vomiting and cramps.
-   Feeling agitated, confused or depressed.
-   Changes in the sense of taste.
-   Visual disturbances, such as blurred vision.
-   Sudden fits of wheezing or shortness    of breath (bronchospasm).
-   Dry mouth.
-   Inflammation of the mucous membrane of the mouth.
-   An infection called “thrush” which can affect the intestine and is caused by a fungus.
-   A certain type of inflammation of the colon, the so-called microscopic colitis.
-   Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
-   Hair loss (alopecia).
-   Skin rash on exposure to sunshine.
-   Joint pain (arthralgia) or muscle pain (myalgia).
-   Severe kidney problems (interstitial    nephritis).
-   Increased perspiration.

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.
-   Severe rash with a sudden onset, blistering or peeling of the skin. This may be associated with a high fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
-   Muscle weakness.
-   Enlarged breasts in    men.

Side effects with unknown frequency

-   Lack of magnesium in the blood (hypomagnesemia, see section 2 “What you need to know before you use Gasec Gastrocaps”). Severe hypomagnesemia can lead to hypocalcaemia.
-   Rash which may be    accompanied with joint pain.
Gasec Gastrocaps can in very rare cases affect white blood cells, which may lead to immune deficiency. If you have an infection with symptoms such as fever and feeling very unwell or fever with signs of a local infection (pain in the neck, throat or mouth or difficulty urinating), you must see your doctor as soon as possible to rule out a severe lack of white blood cells (agranulocytosis). You must tell your doctor about the medicines you are taking.
Immediately talk to your doctor if any of the following symptoms occur: visible unintentional loss of weight, persistent vomiting, difficulties with swallowing, blood in excrement, or dark excrement.
Do not be discouraged by the list of possible side effects. You may not develop any of them.

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 www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gasec Gastrocaps

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after “EXP”. The expiry date refers to the last day of that month.
Do not store above 30 °C.
Keep the container tightly sealed and protected from moisture.
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 protect the environment.

6. Contents of the pack and other information

What Gasec Gastrocaps contains

-   The active ingredient is omeprazole.
Each capsule contains 40 mg of omeprazole.
-   The excipients are:_
Gastro-resistant micropellets
Sugar pellets
(sucrose + corn starch),
povidone (K-30),
sodium lauryl sulphate,
sodium starch glycolate (type A),
trisodium phosphate,
hypromellose,
triethyl citrate,
methacrylic acid / ethyl acrylate copolymer (1:1), sodium hydroxide, titanium dioxide E171, talc
Capsule body
Gelatin
Titanium dioxide E171 Red iron oxide E172 Yellow iron oxide E172 Erythrosine (E127)
Quinoline yellow (E104)
Capsule cap
Gelatin
Titanium dioxide E171 Indigotine
Yellow iron oxide E172 Black iron oxide E172 Erythrosine (E127) Indigo carmine (E132)

What Gasec Gastrocaps looks like and contents of the pack

Gelatine hard capsules with an orange capsule body bearing the marking “40” and a blue capsule cap bearing the marking “O”. A capsule contains white to beige enteric-coated micropellets.
The capsules are available in aluminium/aluminium blister packs or high-density polyethylene bottles (HDPE bottles) with a screw cap. The polypropylene caps are provided with a capsule of drying agent in order to protect the formulated medicine from moisture. A warning is printed in blue or red ink on the bottom of the capsule of drying agent, which instructs not to swallow it.
The pack contains 14 or 28 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Teva B.V.
Swensweg 5 2031 GA Haarlem Netherlands
Manufacturer
TEVA Pharma S.L.U
Poligono Industrial Malpica
Calle C.No 4
Zaragoza, 50016
Spain

For any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

UAB Sicor Biotech Estonian branch Hallivanamehe 4 11317 Tallinn Estonia
Phone: +372 6610801

This leaflet was last revised in September 2018.






  Instruction, annotation source for medicine: State Agency of Medicines, Estonia




[*1]

DDD. Information source: WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health


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