Gasec. Intended for adults for short-term treatment of reflux symptoms (heartburn and acid reflux) treatment.
Gasec 20 mg gastro-resistant hard capsules
Omeprazole
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 directed by your doctor or pharmacist.
- Keep this leaflet You may need to read it.
- If you want more information or advice, ask your pharmacist.
- If you get side effects (even if it is not listed), ask your doctor or pharmacist. See. Chapter 4.
- If within 14 days of your being improved or even worse, see your doctor.
What is in this leaflet?
- What is Gasec is and what it is used for
- Before you Gasec
- How Gasec
- Possible side effects
- How to store Gasec
- Contents of the pack and other information
1. What is Gasec is and what it is used for
Gasec capsules veikioji substance is omeprazole, which family of medicines called proton pump inhibitors. These drugs reduce the amount of acid in your stomach.
Gasec intended for adults for short-term treatment of reflux symptoms (heartburn and acid reflux) treatment.
Reflux is acid regurgitation from the stomach into the esophagus, a nutritional tube, which may become an inflammatory and painful. This can cause symptoms such as a painful burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid atrūgimas).
You may need to use the capsules for 2-3 days in a row before falling symptoms.
If within 14 days of your being improved or even worse, see your doctor.
2. Before you Gasec
Gasec Do not
- If you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6).
- If you are allergic to other medicines that belong to the proton pump inhibitors (eg., Pantoprazole, lansoprazole, rabeprazole, esomeprazole).
- If you are taking a medicine containing nelfinavir (for HIV infection).
If in doubt, prior to taking Gasec, talk to your doctor or pharmacist.
Warnings and Precautions
Gasec can mask the symptoms of other diseases, and immediately consult a doctor if Gasec before taking or using this medication you have any of the following:
- For no apparent reason, a significant decrease in body weight or disturbance in swallowing;
- Indigestion or stomach pain;
- Begin to vomit food or blood;
- Excrement becomes black or soiled with blood;
- Severe or persistent diarrhea (using omeprazole, a slightly increased risk of infectious diarrhea);
- Before you have a history of stomach ulcers or you are an experienced gastrointestinal operations;
- If 4 or more weeks you continue symptomatic upset stomach or heartburn treatment;
- If you suffer from upset stomach or heartburn for 4 or more weeks;
- If you have jaundice or severe liver disease;
- If you feel pressure or pain in the chest area, which spreads to the shoulder, arm, neck, or jaw, and into a cold sweat;
- If you are older than 55 years of age and you experience new symptoms or they have recently changed.
Patients should not take omeprazole prophylactically.
Taking Gasec such as proton pump inhibitors, especially if they are used for more than one year may slightly increase the hip, wrist or spine fracture risk. If you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis), tell your doctor.
Other medicines and Gasec
If you are taking or have recently taken any other medicines, or because you are not sure, talk to your doctor or pharmacist. This is important because Gasec can affect the way some medicines work and some medicines can change Gasec performance.
Gasec not be taken with medicines containing nelfinavir (used to treat HIV infection).
Tell your doctor or pharmacist if you are taking any of these medicines:
- Ketoconazole, itraconazole or voriconazole (used to treat fungal infections);
- Digoxin (used to treat heart problems);
- Diazepam (used to relieve anxiety, relax muscles and treat epilepsy);
- Phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor will monitor you when you start or stop the use of Gasec;
- Medicines to thin the blood, for example., Warfarin or other vitamin K-depressant effects. Your doctor may need to monitor you when you start or stop the use of Gasec;
- Rifampicin (used to treat tuberculosis);
- Atazanavir or saquinavir (given to treat HIV infection);
- Tacrolimus (used in cases of organ transplantation);
- St. John's Wort (Hypericum perforatum) (used to treat mild depression);
- Cilostazol (used to treat intermittent claudication);
- Clopidogrel (used to prevent blood clots (thrombi)).
Gasec with food and drink
The capsules can be taken with food or on an empty stomach.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, you think you may be pregnant, or are planning to become pregnant before taking this medicine, talk to your doctor or pharmacist.
In this case, your doctor will decide whether you can currently use Gasec. Your doctor will decide whether you can take Gasec lactation.
Driving and using machines
Your ability to drive or to work with the tools and techniques Gasec not act, however, may experience side effects such as dizziness and visual disturbances (see. Section 4). If any of these effects, do not drive or operate machines can not.
Gasec capsules contain sucrose. If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicine.
3. How Gasec
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose is one 20 mg capsule, or two capsules of 10 mg once a day for 14 days. If, after the 14-day period the symptoms persist, contact your doctor.
To reduce the symptoms, you may need to use the capsules for 2-3 days in a row.
Taking this medicine
- Recommended that the capsules in the morning.
- The capsules can be taken with or without food.
- Swallow the capsules whole with half a glass of water. The capsules should not be chewed or crushed, because the capsule is coated pellets, which prevents the medicine to disrupt his stomach acid. It is important to intact granules.
What to do if you have trouble swallowing the capsule
- If you have trouble swallowing the capsules:
- Simply open the capsule and swallow the contents with a drink half a glass of water, or add the contents into a glass of still water, by any acidic fruit juice (eg., Apple, orange or pineapple) or apple sauce;
- Always stir the mixture before taking your (the mixture will not be clear); drink the mixture immediately or within 30 minutes;
- Make sure that you take all the medicine, rinse the glass well with half a glass of water and drink it. Solid particles are medicine, so they can not be chewed or crushed.
If you take a large dose Gasec
If you take more than your doctor has told Gasec should, immediately contact your doctor or pharmacist.
If you forget to Gasec
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, then skip the missed. Do not take a double dose to make up for a missed dose.
4. Possible side effects
This medicine, like all others, can cause side effects, although not everybody gets them.
Gasec immediately discontinue use and consult a doctor if you notice any of these rare but serious side effects:
- Sudden wheezing, lips, tongue, larynx or total body swelling, rash, fainting or difficulty swallowing (severe allergic reaction);
- Skin redness, blistering or peeling. It may also lead to the lips, eyes, mouth, nose, genital blisters and bleeding. This can be Stevens - Johnson syndrome or toxic epidermal necrolysis;
- Yellowing of the skin, darkened urine and fatigue (these may be symptoms of liver dysfunction).
Other side effects are listed below:
Common side effects (affects less than 1 user in 10)
- Headache.
- Effects on the stomach and intestines, diarrhea, abdominal pain, constipation, flatulence (bloating).
- Nausea and vomiting.
Uncommon side effects (affects less than 1 user in 100)
- Foot and ankle swelling.
- Difficulty in sleeping (insomnia).
- Dizziness, tingling sensation (pins and needles), somnolence.
- Vertigo.
- Blood tests, liver function abnormalities.
- Skin rash, hives and itchy skin.
- The femur, wrist and spine fractures.
- Malaise and lack of energy.
Rare side effects (affects less than 1 user in 1000)
- Blood changes (decrease in white blood cells or platelets (blood platelets)), which may feel weakness, bruising, increased risk of infection.
- Allergic reactions, sometimes very severe (swelling in the lips, tongue and throat, fever begin, wheezing breath).
- Reduced sodium levels in the blood (which may feel weakness, vomiting and cramps).
- Agitation, confusion (confusion), and depression.
- Altered taste disturbances (eg. Blurred) vision.
- Sudden onset of shortness of breath or wheezing (bronchospasm).
- Dry mouth, mouth inflammation.
- Fungal infection called thrush, which can damage the intestines.
- Liver disorders (ie, jaundice yellowing of the skin, dark urine, fatigue).
- Hair loss (alopecia), increased sweating, skin rash after exposure to sunlight.
- Joint pain (arthralgia) or muscle pains (myalgia).
- Severe kidney problems (interstitial nephritis).
Very rare side effects (affects less than 1 user in 10, 000)
- Decreased blood cell count - Neutropenia (low white blood cell disappearance)
- Aggressive, seeing, feeling or hearing things that are not there (hallucinations).
- Severe hepatic disorders, seen in liver failure and inflammation of the brain.
- Sudden onset of a severe rash or blistering and peeling, which can be associated with a high fever and joint pains (erythema multiforme (erythema), Stevens - Johnson (Stevens-Johnson) syndrome, toxic epidermal necrolysis).
- Muscle weakness, breast enlargement in men.
Not known
- Decreased magnesium levels in the blood. If you are taking Gasec more than 3 months, the potential levels of magnesium in the blood. Magnesium reduction affects fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, heart pounding. If you notice any of these symptoms, contact your doctor immediately. Due to the low levels of magnesium in the blood can reduce potassium and calcium. Your doctor may do regular blood tests to monitor levels of magnesium.
In very rare cases Gasec can damage white blood cells and weaken the immune system. If you get an infection with symptoms such as fever and a very deteriorated general condition, or fever with local infection symptoms, eg., Neck, throat or mouth pain or difficulty in urination, it is necessary as soon as possible to consult with your doctor, as it requires a blood test to make sure that disappeared the white blood cells (agranulocytosis or not). Do not forget to tell your doctor that you are taking this medicine.
This list of side effects do not worry, because you may not experience them.
Notification of side effects
If you experience side effects, including not listed, please tell your doctor or pharmacist. The side effects can also report directly by filling out the web site www.vvkt.lt the form by mail to the State Medicines Control Agency under the Lithuanian Ministry of Health, Žirmūnų g. 139A, LT 09120 Vilnius Tel: 8 800 73 568, fax 8 800 20131 or e-mail. Email NepageidaujamaR@vvkt.lt. When reporting side effects you can help us to get more information about the safety of the medicine.
5. How to store Gasec
Keep this medicine out of the sight and reach of children place.
On the carton, blister and bottle after EXP / EXP after the expiry date of this medicine. The expiry refers to the last day of the month.
Blisters: Do not store above 25 ° C.
Vial: Do not store above 30 o C.
Keep the bottle tightly closed in order to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. How to dispose of unwanted medication, ask your pharmacist. These measures will help to protect the environment.
6. Contents of the pack and other information
Gasec composition
- The active substance is omeprazole. Each hard gastro-resistant capsule contains 10 mg or 20 mg of omeprazole.
- Emergent material:
Capsule contents: sugar nuclei (containing sucrose and maize starch), sodium salt, sodium lauryl sulfate, povidone K30, trisodium phosphate dodecahydrate, methylcellulose, methacrylic acid and ethyl acrylate copolymer, triethyl citrate, titanium dioxide (E171), talc, sodium hydroxide. Capsule shell :, gelatin, coloring agents titanium dioxide (E171), erythrosine (E127), quinoline yellow (E104), red iron oxide (E172) (10 mg), indigo carmine (E132) (20 mg).
Printing ink: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E171).
Gasec appearance and contents of the pack
10 mg capsules: Capsules have an orange colored casing and red cap. The cap and white inscription "A" on the body "10".
20 mg capsules: Capsules have an orange colored casing and blue cap. The cap and white inscription "A" on the body "20".
Capsule content - white or off-white microbeads.
Pack sizes:
10 mg:
Alimini / aluminum blisters
Packs 5, 7, 14, 15, 20, 21, 25 or 28 Gastro-resistant hard capsules.
HDPE bottles
Packs 5, 7, 14, 15, 20, 21 or 28 Gastro-resistant hard capsules.
20 mg:
Alimini / aluminum blisters
Packaging of 5, 7 arba14 gastro-resistant hard capsules.
HDPE bottles
Packs of 5, 7 or 14 gastro-resistant hard capsules.
It may not be available in all packs.
Marketing Authorisation Holder and Manufacturer
MAH
Mepha Lda.
Lagoas Park
2740-298 Porto Salvo
Portugal
Manufacturers
TEVA Pharma, SLU
Polígono Industrial Malpica, calle C, No. 4, 50016 Zaragoza
Spain
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen
Hungary
TEVA UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG
United Kingdom
Pharmachemie BV
Swensweg 5, 2031 GA Haarlem
Netherlands