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OMEPRAZOLE OLAINFARM CPS 20MG 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 2020-Oct-01
OMEPRAZOLE-drug/medicine -capsules -tablets aproximate price on "OMEPRAZOLE OLAINFARM CPS 20MG N14" in Riga city, Latvia is:

  • 3.09€  3.59$  2.82£  279Rub  32.8SEK  14PLN  12.52₪ 


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine -capsules -tablets  OMEPRAZOLE OLAINFARM CPS 20MG N14     Recheck

ATC codeA02BC01 

Active substances: Omeprazolum

 

Latvijas zāles medikaments Made in Latvia. 
Vendor, principal: Olainfarm
No prescription needed/Patient care products, dressings, gloves, medical devices,...

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OMEP UNO, 20 mg, skrandyje neirios kietosios kapsulės, N14 paveikslėlis

 .

OMEPRAZOLE OLAINFARM 20MG N14

Package leaflet: information for the user

Omeprazole Olainfarm 20 mg gastro-resistant hard capsules

Omeprazole

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

Always take this medicine exactly in the way that is described in this leaflet or was explained to you by your doctor or pharmacist.
-   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. See section 4.
-   You must talk to a doctor if you do not feel better or of you feel worse after 14 days.

Contents of this leaflet

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

1. What Omeprazole Olainfarm is and what it is used for

Omeprazole Olainfarm contains omeprazole as the active ingredient. It is part of a group of medications called proton pump inhibitors. These medications reduce the amount of acid produced in the stomach.
Omeprazole Olainfarm is used for short term symptomatic treatment of reflux disease (heartburn, gastric acid reflow) in adults.
Reflux is the reflowing of gastric acid from the stomach back to the oesophagus, causing pain and inflammation. It can cause the following symptoms: a burning sensation in the chest and the throat (heartburn) and an acidic taste in the mouth (from the acid reflux).
The capsules may need to be taken for 2-3 consecutive days for the symptoms to improve.
You must consult your doctor if you do not feel better or if you feel worse after 14 days.

2. What you need to know before taking Omeprazole Olainfarm Do not take Omeprazole Olainfarm

-   If you are allergic to omeprazole or any of the ingredients of this medicine (listed in section 6);
-   If you are allergic to any other medications which contain proton pump inhibitors (e.g. pantoprazole, lanzoprazole, rabeprazole, esomperazole);
-   If you are undergoing treatment with nelfinavir (used to treat HIV).
Consult your doctor or pharmacist before using Omeprazole Olainfarm if you are unsure of anything.

Warnings and precautions

Omeprazole Olainfarm may mask the symptoms of other diseases, so you should talk to your doctor immediately if you notice any of the following before or during treatment with Omeprazole Olainfarm:
-   you experience unexplained weight loss and have difficulty swallowing;
-   you have abdominal pain or indigestion;
-   you are vomiting food or blood;
-   your stool turns black (bloody faeces);
-   you get severe or persistent diarrhoea, as omeprazole has been linked to increased susceptibility to infectious diarrhoea;
-   you have previously had gastric ulcers or undergone gastric surgery;
-   you have persistently been using symptomatic treatment because of indigestion or heartburn (for over 4 weeks)
-   you have persistently been suffering from heartburn or indigestion for the last four weeks;
-   you are jaundiced or have severe liver disease
-   you are over 55 years of age and the symptoms are new or have recently changed;
-   you have ever experienced cutaneous reactions after treatment with gastric acid reducing medications similar to Omeprazole Olainfarm.
Consult your doctor as soon as possible if you notice a rash, especially on areas of the skin that are exposed to sunlight, as you may have to discontinue treatment with Omeprazole Olainfarm. Make sure to mention any other side effects like joint pain.
If you are planning to get a specific blood test (chromogranin A) done, let your doctor know at once before you start taking the medicine.
Treatment with omeprazole may affect the results of blood tests. Let your doctor know that you are taking Omeprazole Olainfarm if you need to have any kind of blood test done.
Omepraozole must not be used for the prevention of symptoms.

Children and adolescents

This medicine must not be used by children and adolescents under the age of 18.

Other medicines and Omeprazole Olainfarm

Let your doctor or pharmacist know if you are taking, have recently taken or are planning to take any other medications. This is necessary because Omeprazole Olainfarm can affect the way some medicines work, and other medicines have an effect on Omeprazole Olainfarm.
Do not use Omeprazole Olainfarm if you are undergoing treatment with nelfinavir (used to treat HIV).
Please inform your doctor if you are taking any of the following medications:
-   pozaconazole, ketoconazole, itraconazole or voriconazole (used to treat fungal infections);
-   digoxin (used to treat cardiac disease);
-   diazepam (used to treat anxiety, as a muscle relaxant and an anti-seizure medicine);
-   phenytoin (anti-seizure medicine). Your doctor must observe you while starting and discontinuing treatment with Omeprazole Olainfarm if you are taking phenytoin;
-   blood thinners, such as warfarin and other vitamin K antagonists. Your doctor may need to observe you while starting and discontinuing treatment with Omeprazole Olainfarm;
-   rifampicin (used to treat tuberculosis);
-   atazanavir (used to treat HIV);
-   tacrolimus (used in organ transplantation);
-   products containing St. John’s Wort (Hypericumperforatum) (used to treat mild depression);
-   cilostazol (used to treat intermittent claudication);
-   saquinavir (used to treat HIV);
-   clopidogrel (used to prevent blood clots (thrombosis));
-   erlotinib (anti-cancer drug);
-   methotrexate (used as an anti-cancer    drug in high doses). If you are taking high dose
methotrexate, your doctor may temporarily discontinue treatment with Omeprazole Olainfarm.

Omeprazole Olainfarm with food, drink and alcohol

You may take the capsules with food or on an empty stomach.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Your doctor will decide if you can take Omeprazole Olainfarm at the time.

Driving and operating machinery

Omeprazole Olainfarm is unlikely to affect the ability to drive and operate machinery. Possible side effects may include dizziness and visual disorders (see section 4). You must not drive or operate machinery if you experience either of these.

Omeprazole Olainfarm contains sucrose

Omeprazole Olainfarm contains sucrose. 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 Omeprazole Olainfarm

Always use this medication exactly as is described in this leaflet or was explained to you by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Dosage for adults

The recommended dose is 20 mg (1 capsule) once a day for 14 days. Contact to your doctor if your symptoms persist after that period.
You may need to take the capsules for 2-3 days before the symptoms begin to recede.

Elderly patients (over 65 years of age)

No changes to the dosage are necessary.

Patients with liver damage

Please consult your doctor before using the medicine.

Patients with kidney damage

No changes to the dosage are necessary.

Children and adolescents

This medicine must not be used by children and adolescents under the age of 18.

Using the medication

-   It is recommended that you take the capsules in the morning.
-   You can take Omeprazole Olainfarm with food or on an empty stomach.
-   Swallow the capsules whole with half a glass of water. The capsules must not be chewed or crushed. This is because the capsules contain pellets with a gastric acid proof coating, which stops the medicine from being dissolved by gastric acid. It is important not to damage the pellets.

If you have difficulties swallowing the capsules

-   If you have difficulties swallowing the capsules:
•   Open the capsules and swallow the contents immediately with half a glass of water or mix the contents of the capsule with a bit of yogurt, acidic juice (e.g. apple, orange or pineapple juice) or apple puree.
•   Always stir the mixture just before drinking it (the mixture is cloudy). Then drink the mixture at once or within 30 minutes.
•   To ensure that you have consumed all of the active ingredient, rinse the glass with half a glass of fluid and drink that too. The solid particles contain the active ingredient, they must not be chewed or crushed.

If you take more Omeprazole Olainfarm than you should

Consult your doctor or pharmacist at once if you have taken more Omeprazole Olainfarm than you should have.

If you forget to take Omeprazole Olainfarm

If you forgot to take a dose, take it as soon as you remember. Do not take the forgotten dose if it is almost time for the next dose. 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.

Discontinue the use of Omeprazole Olainfarm and seek immediate medical attention if you

experience any of the rare but severe side effects listed below:
-   sudden onset wheezing, swelling of the lips, tongue, throat, or body; rashes, fainting or difficulty swallowing (severe allergic reaction);
-   reddened skin with blisters or peeling. Severe blisters and bleeding can also occur on the lips, around the eyes, mouth, nose, and genitals. This may be Stevens-Johnsons syndrome or toxic epidermal necrolysis;
-   jaundiced skin, dark-coloured urine, and fatigue, which may be the symptoms of liver function disorder.
The side effects may occur with certain frequency, which has been defined as follows:
Very common:
May occur in more than 1 user out of 10
Common:
May occur in less than 1 user out of 10
Uncommon:
May occur in less than 1 user out of 100
Rare:
May occur in less than1 user out of 1000
Very rare:
May occur in less than 1 user out of 10000
Unknown:
The frequency cannot be determined based on available data
Other side effects may include:
Common side effects
-   headache;
-   gastrointestinal problems: diarrhoea, abdominal pain, constipation, flatulence;
-   nausea or vomiting;
-   benign stomach polyps.

Uncommon side effects

-   swelling of the feet and ankles;
-   sleep disorders (insomnia);
-   temporary confusion, skin sensitivity disorders like a prickling sensation on the skin, drowsiness;
-   dizziness;
-   altered hepatic function markers in the blood;
-   rash, urticaria, pruritus;
-   general malaise and lack of energy.

Rare side effects

-   blood disorders, such as decreased leucocyte and thrombocyte counts in the blood. This may cause weakness, bruising, or increase the susceptibility to infectious diseases;
-   allergic reactions, sometimes severe ones, including swelling of the lips, tongue, and throat, fever, wheezing in the chest;
-   low blood potassium. This may cause weakness, vomiting and cramps;
-   irritability, aggressiveness, depression;
-   taste disorders;
-   eye damage, such    as    blurred vision;
-   acute wheezing in the chest or shortness of breath (bronchospasm);
-   dry mouth;
-   inflammation of the    oral mucosa;
-   a certain type of colonic inflammation (microscopic colitis);
-   candidiasis, a fungal infection that may affect the intestine;
-   liver function disorders, including icterus, which causes jaundice, dark urine, and fatigue;
-   hair loss (alopecia);
-   skin photosensitivity;
-   joint pain (arthralgia) and muscle pain (myalgia);
-   severe renal function disorders (interstitial nephritis);
-   increased perspiration;
-   colonic inflammation (microscopic colitis).

Very rare side effects

-   changes in blood cell counts, including agranulocytosis (lack of white blood cells);
-   aggressiveness;
-   seeing, feeling, or hearing things that are not there (hallucinations);
-   severe liver function disorders which cause liver insufficiency and encephalitis;
-   severe rash, blisters, or skin peeling. This may be in connection with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
-   muscle weakness;
-   enlarged mammary glands in men.
In very rare cases, Omeprazole Olainfarm may have an immunosuppressive effect on white blood cells. If you have developed skin disease in conjunction with symptoms like fever with severely reduced state of health or a fever with localised signs of infectious disease such as neck pain, sore throat or mouth or difficulties urinating, you must seek an appointment with your doctor at once to rule out the lack of white blood cells (agranulocytosis). It is also important that you let your doctor know about your medication at that time.

Side effects with unknown frequency

-   skin rash, possibly with joint pain (subacute cutaneous lupus erythematosus).
Do not be frightened by the list of possible side effects. You may not get any of them.

Reporting side effects

Consult your doctor or pharmacist if you experience any side effects. These may include some not included in this leaflet. You can also report side effects yourself via www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Omeprazole Olainfarm

Store this medication away from the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

OPA/aluminium/PVC/aluminium/PET (peelable) and OPA/aluminium/PVC/PVdC/PVC/alumiinium (non peelable) blister

Store below 30 °C.
Store in the original pack, protected from humidity.

HDPE bottle

Store below 30 °C.
Keep the bottle tightly closed, protected from humidity.
The capsules must be used within 3 months after the bottle is first opened.
Do not throw the medicines away with waste water or household waste. Ask your pharmacist how to dispose of medications you are no longer using. These measures will help to protect the environment.

6. Contents of the package and other information

What Omeprazole Olainfarm contains

-   The active ingredient is omeprazole:
One capsule contains 20 mg of omeprazole.
-   The other ingredients are:
•   Contents of the capsule: sugar spheres (corn starch and sucrose), sodium lauryl sulphate, anhydrous disodium hydrogen phosphate, mannitol (E421), hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide (E171), methacrylic acid-ethyl acrylate copolymer (1:1) dispersion.
•   Capsule shell: gelatine, colourants quinoline yellow (E104) and titanium dioxide (E171).

What Omeprazole Olainfarm looks like and contents of the package

Gelatine hard capsule, size 2, with an opaque yellow cap and an opaque yellow body, containing white to cream-coloured spherical microgranules.
Packs
OPA/aluminium/PVC/PVC/aluminium/PET (peelable) blister:
14 capsules.
OPA/alumiinium/PVC/PVdC/PVC/aluminium (non peelable) blister:
14 capsules.
HDPE bottle:
14 capsules.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer AS “OLAINFARM”

Rūpnīcu iela 5 Olaine, LV-2114 Latvia
Phone: +371 67013701 Fax: +371 67013777 e-mail: olainfarm@olainfarm.lv

This leaflet was last revised in April 2017.






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





• Medicaments images are for illustrative purposes only and may differ from the actual product.


[*1]

DDD. Information source: WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health - [Nov-2015]


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