GASEC GASTROCAPS 20MG N14

ATC code: A02BC01 

Active substances: Omeprazolum

Vendor, principal: Mepha Ltd.. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

GASEC GASTROCAPS 20MG N14

Package leaflet: Information for the user

(Over-the-counter medicine*)

Gasec Gastrocaps 20 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.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
-   You must talk to a doctor if you do not feel better or if you feel worse after 14 days. See section
4.
What is in this leaflet
1.   What Gasec Gastrocaps 20 mg is and what it is used for
2.   What you need to know before you use Gasec Gastrocaps 20 mg
3.   How to use Gasec Gastrocaps 20 mg
4.   Possible side effects
5.   How to store Gasec Gastrocaps 20 mg
6.   Contents of the pack and other information

1. What Gasec Gastrocaps 20 mg is and what it is used for

Gasec Gastrocaps 20 mg contains the active ingredient omeprazole that reduces the production of gastric acid.
Gasec Gastrocaps 20 mg capsules are used in adults starting from 18 years of age for the short-term treatment of the symptoms of gastroesophageal reflux disease (e.g. heartburn, gastric reflux symptoms).
Your doctor can also prescribe Gasec Gastrocaps 20 mg hard capsules for other indications of omeprazole.
You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

2. What you need to know before you use Gasec Gastrocaps 20 mg

Do not use Gasec Gastrocaps 20 mg:

-   if you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6).
-   if you have had an unusual reaction to any other medicine, talk to your doctor or pharmacist;
-   if you are using a medicine which contains nelfinavir (used for the treatment of HIV).

Warnings and precautions

Talk to your doctor or pharmacist before using Gasec Gastrocaps 20 mg:
-   if you are pregnant, planning to have a baby, or breast-feeding (see “Pregnancy and breastfeeding”);
-   if there is a suspicion of a gastric ulcer, the possibility of a malignant tumour must be precluded before commencing treatment with omeprazole, as the treatment can disguise the symptoms of tumour growth and delay the diagnosis;
-   tell your doctor or pharmacist if you have other diseases, allergies or if you are taking other medicines (including over-the-counter medicines!);
-   if you have ever had skin reactions after treatment with a medicine similar to Gasec Gastrocaps, which reduces stomach acidity.
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 have had recurring indigestion or heartburn over an extended period of time, you must regularly see a doctor. If you are over 55 years old, it is very important that you tell your doctor if you are taking daily doses of an over-the-counter medicine against indigestion or heartburn.
Talk to your doctor:
-   if you have previously had a gastric ulcer or gastric or intestinal surgery;
-   if you have received continuous symptomatic treatment against indigestion or heartburn for a period of at least 4 weeks;
-   if your skin or the whites of your eyes have turned yellow (jaundice) or if you have a severe liver disease;
-   if you are over 55 years old and you have developed new symptoms or the nature of symptoms has changed.
Do not use omeprazole as a preventive medicine.

Other medicines and Gasec Gastrocaps 20 mg

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The activity of Gasec Gastrocaps 20 mg can be affected by other medicines, such as epilepsy drugs, certain tranquillisers, anti-fungal medicines or anticoagulants.

Gasec Gastrocaps 20 mg with food and drink

Taking the medicine with food does not change the effect of Gasec Gastrocaps 20 mg.

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.

Driving and using machines

The side effects of Gasec Gastrocaps 20 mg (headache and dizziness) can affect reaction speed, the ability to drive and operate machines or mechanisms.

Gasec Gastrocaps 20 mg contains sucrose

This medicine contains sucrose. If you have been told by your doctor that you have intolerance to some sugars, talk to your doctor or pharmacist before taking this medicine.

3. How to use Gasec Gastrocaps 20 mg

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults starting from 18 years of age
The standard dose is one 20 mg capsule once per day for 14 days. Talk to your doctor if the symptoms have not receded after this period. It may be necessary to take the capsules for 2-3 days before the symptoms start to recede.
Method and duration of administration
The capsules are taken in the morning, preferably on an empty stomach, without chewing and with half a glass of water.
Patients with swallowing difficulties can open the capsule and ingest the contents with half a glass of water or mix the contents of the capsule with non-carbonised water or mildly acidic liquid (e.g. juice or apple puree). The solution should be taken immediately (or within 30 minutes) after mixing. The solution should always be stirred immediately before drinking and the glass rinsed with another half a glass of water, which must also be ingested.
Alternatively, the patients can open the capsule, suck the contents, and swallow the pellets with half a glass of water. Do not mix the contents of the capsule with milk or carbonised water. Do not chew or crush the capsule.

If you use more Gasec Gastrocaps 20 mg than you should

Always talk to a doctor in case of an overdose!
Omeprazole overdose has caused nausea, vomiting, dizziness, stomach pain, diarrhoea and headache. Drowsiness, depression, and confusion have also been reported in isolated cases. All these symptoms of omeprazole overdose were transient.

If you forget to use Gasec Gastrocaps 20 mg

Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects can occur after taking Gasec Gastrocaps 20 mg:
Common (more than 1/100 but less than 1/10 patients) side effects can include benign polyps in the stomach, headache, constipation, bloating, stomach pain, nausea, vomiting. Other very rarely reported side effects include hives, dry mouth, blurred vision, enlarged breasts in men, swelling, redness of the skin, pruritus, joint pain. Hypomagnesemia has occurred with unknown incidence. Severe hypomagnesemia can lead to hypocalcemia.
Unknown (cannot be estimated from available data): rash that can be accompanied by joint pain.
Talk to your doctor if you get any symptoms that you feel may be connected with this medicine. 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.

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 20 mg

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. The expiry date refers to the last day of that month.
Do not store at a temperature higher than 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 20 mg contains

-   The active ingredient is omeprazole. Each capsule contains 20 mg of omeprazole.
-   The other ingredients are:_
Gastro-resistant micropellets
Sugar pellets
(sucrose + corn starch),
povidone (K-30),
sodium lauryl sulfate,
sodium starch glycolate (type A),
trisodium phosphate,
hypromellose,
triethyl citrate,
mehacrylic acid / ethyl acrylate copolymer (1:1), sodium hydroxide, titanium dioxide E171, talc
Capsule body
Gelatin
Titanium dioxide E171 Indigotine E132 Yellow iron oxide E172 Erythrosine (E127)
Quinoline yellow (E104)
Capsule cap
Gelatin
Titanium dioxide E171 Red iron oxide E172 Yellow iron oxide E172 Erythrosine (E127)
Indigo carmine (E132)

What Gasec Gastrocaps 20 mg looks like and contents of the pack

Gelatine hard capsules with an orange capsule body bearing the marking “20” and a blue capsule cap bearing the marking “O”. The capsule contains white to beige enterocoated 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.
The pack contains 7 or 14 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 information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
UAB Sicor Biotech Estonian branch
Hallivanamehe 4
11317 Tallinn
Republic of Estonia
Phone: +372 6610801

This leaflet was last revised in September 2018.

* Clarification - 7 or 14 tablets in a pack: over-the-counter medicine
28 or 56 tablets in a pack: prescription medicine