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OMEPRAZOLE GRINDEX CPS 20MG N28

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-28
OMEPRAZOLE-GRINDEX-drug/medicine -capsules -tablets aproximate price on "OMEPRAZOLE GRINDEX CPS 20MG N28" in Riga city, Latvia is:
  • 3.55€  3.84$  3.04£  410Rub  40.8SEK  15PLN  14.05₪ 


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine -capsules -tablets  OMEPRAZOLE GRINDEX CPS 20MG N28     Recheck

ATC codeA02BC01 

Active substances: Omeprazolum

 

Latvijas zāles medikaments Made in Latvia. 
Vendor, principal: Grindex

 Prescription drug (℞) 

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 .

OMEPRAZOLE-RATIOPHARM 20MG N15

Package leaflet: information for the user

Omeprazole-ratiopharm, 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.

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

1.   What Omeprazole-ratiopharm is and what it is used for

Omeprazole is an intestinal medicine for lowering gastric acid production, which belongs in the group of proton pump inhibitors.
Omeprazole is used for the following indications:
Adults
-   Treatment of duodenal ulcers and prevention of their recurrence.
-   Treatment of gastric ulcers and prevention of their recurrence.
-   Treatment of peptic ulcers related to a Helicobacter pylori (H. pylori) infection in combination
with suitable antibiotics.
-   Treatment of gastric and duodenal ulcers caused by nonsteroidal anti-inflammatory drugs
(NSAIDs).
-   Prevention of gastric and duodenal ulcers caused by NSAIDs in at-risk patients.
-   Treatment of reflux oesophagitis.
-   Prevention of recurrence in the case of treated reflux oesophagitis.
-   Symptomatic treatment of gastroesophageal reflux disease.
-   Treatment of Zollinger-Ellison syndrome.
Children
Children older than 1 year whose weight is > 10 kg
-   - Treatment of reflux oesophagitis.
-   - Treatment of heartburn related to gastroesophageal reflux disease and symptoms of gastric
acid reflux.
Children and adolescents over 4 years of age
-   Treatment of duodenal ulcers related to H. pylori infection in combination with antibiotics.

2.   What you need to know before you take Omeprazole-ratiopharm Do not take Omeprazole-ratiopharm

-   If you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6).
-   Omeprazole must not be used at the same time with nelfinavir (HIV medicine).

Warnings and precautions

Talk to your doctor or pharmacist before using Omeprazole-ratiopharm.
-   If the medicine is used in children.
-   If the medicine is used in elderly patients.
-   In the case of kidney or liver disease.
-   In the case of any other chronic disease or condition (e.g. osteoporosis, anaemia, immune deficiency).
-   If you have ever had skin reactions after treatment with a medicine similar to Omeprazole-ratiopharm, which reduces stomach acidity.
-   If 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 Omeprazole-ratiopharm. Be sure to mention any other side effects, such as joint pain.
A precise diagnosis must be made before starting treatment. This will be done by your doctor. Long-term treatment must be carried out under a doctor’s supervision. Tell your doctor about any new symptoms that have occurred during treatment (e.g. weight loss, repeated vomiting, difficulty swallowing, haematemesis, melena, fatigue, shortness of breath, cramps in limbs, dizziness, arrhythmias, generally feeling unwell, etc.). Your doctor will perform the necessary examinations.
Omeprazole-ratiopharm may be used for long-term treatment of reflux oesophagitis only in patients who constantly experience repeated episodes or recurrence and complications and whose condition cannot be controlled with interval therapy.
Before treatment, the possible malignancy of the ulcers should be considered. Talk to your doctor about this, as the treatment may conceal the symptoms and delay timely diagnosis.
In the case of severe hepatic impairment, the levels of liver enzymes must be checked regularly during treatment with omeprazole.
Prolonged use (> 1 year) of proton pump inhibitors and use in large doses may slightly increase the risk of hip, wrist or spine fractures, mainly in the elderly and people with other risk factors. Based on data from monitoring studies, the use of proton pump inhibitors may increase general risk of bone fracture by 10...40%. This may partly be due to other risk factors. Treatment of patients at risk for osteoporosis must conform to current treatment guidelines and they must get sufficient vitamin D and calcium.
Hypomagnesemia
There are reports of severe hypomagnesemia in patients who received treatment with PPIs (e.g. omeprazole) for at least three months, although in most cases for at least one year. Severe symptoms of hypomagnesemia, such as tiredness, tetany, delirium, convulsions, vertigo and ventricular arrhythmia, which can at first be concealed and neglected, may occur. In most patients, hypomagnesemia subsided after stopping treatment with PPIs and receiving magnesium replacement therapy.
In the case of patients who will presumably receive prolonged treatment or take PPIs with digoxin or other medicines that may cause hypomagnesemia (e.g. diuretics), measuring magnesium levels before and regularly during treatment with proton pump inhibitors must be considered.
Treatment with proton pump inhibitors may slightly increase the risk of gastrointestinal infections, such as Salmonella and Campylobacter.
Your doctor will monitor you regularly if you need long-term treatment with Omeprazole-ratiopharm, especially the treatment lasts longer than 1 year.

Other medicines and Omeprazole-ratiopharm

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Excreation time of diazepam (medicine used for states of fear and tension), R-warfarin (anticoagulant) and phenytoin (medicine used for epilepsy) is extended by Omeprazole-ratiopharm. This is why you should be careful when also taking anticoagulants and in the case of epilepsy. Tell your doctor if you have any of the conditions stated above.
Using omeprazole and clarithromycin (antibiotic for bacterial infections) and probably other macrolide antibiotics at the same time will increase the concentration of both medications in the blood. When using omeprazole and clarithromycin at the same time, taking other medicines should be done with caution, especially in the case of severe liver and kidney function disorders.
Omeprazole may increase or decrease the absorption of medicines whose bioavailability is dependent on gastric acidity. The absorption of ketoconazole (antifungal medicine) may decrease and absorption of erythromycin (antibiotic) may increase.
Omeprazole must not be used in combination with atazanavir/ritonavir due to the decrease in the concentration of the latter.
Similarly to other medicines blocking the production of gastric acid, omeprazole may decrease the absorption of vitamin B12 (cyanocobalamin) due to hypochlorhydria or achlorhydria. This must be taken into account in the case of long-term treatment in patients whose vitamin B12 stores are low or who have risk factors for vitamin B12 absorption disorder.
Interactions have been reported between clopidogrel and ompeprazole. The clinical significance of the reported interaction has not been established. As a precaution, taking omeprazole and clopidogrel at the same time should be avoided.

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

Omeprazole has no effect on the ability to drive or use machines. Side effects, such as dizziness and impaired vision, may occur. Do not drive or use machines if you develop these symptoms.

NB! These may also occur in the case of short-term usage!

Omeprazole-ratiopharm contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before using this medicine.

3. How to take Omeprazole-ratiopharm

Always use this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Unless your doctor has determined otherwise, the recommended doses are as follows:
Duodenal ulcer
The recommended dose is 20 mg once a day. The duration of the treatment is 2...4 weeks.
Gastric ulcer or reflux oesophagitis
The recommended dose is 20 mg once a day. The duration of the treatment is 4...8 weeks.
Notes:
In the case of duodenal ulcers, benign gastric ulcers and reflux oesophagitis, your doctor may in isolated cases increase the dose of omeprazole to 40 mg once a day.
In patients with gastric or duodenal ulcers, monotherapy with omeprazole is used only when there are contraindications for combined therapy with antibiotics.
Treatment of gastric and duodenal ulcers caused by nonsteroidal anti-inflammatory drugs
The recommended dose is 20 mg a day. The duration of the treatment is 4...8 weeks.
Prevention of gastric and duodenal ulcers caused by nonsteroidal anti-inflammatory drugs in at-risk
patients
The recommended dose is 20 mg a day.
Prevention of recurrence in the case of treated reflux oesophagitis
The recommended dose is 10...20 mg a day. The treatment is carried out as advised by the doctor. Omeprazole-ratiopharm 20 mg gastro-resistant hard capsules are not suitable for taking a 10 mg dose. Your doctor will prescribe another medicine for taking this dose.
Symptomatic treatment of gastroesophageal reflux disease
The recommended dose is 10...20 mg a day. The treatment is carried out as advised by the doctor. The duration of the treatment is 2...4 weeks. Omeprazole-ratiopharm 20 mg gastro-resistant hard capsules are not suitable for taking a 10 mg dose. Your doctor will prescribe another medicine for taking this dose.
If your symptoms have not improved at all after 2 weeks of treatment, your doctor will perform additional examinations.
Zollinger-Ellison syndrome
The treatment is carried out as advised by the doctor. The starting dose is 60 mg once a day. If the daily dose exceeds 80 mg, it must be divided into two and taken twice a day (every 12 hours). Zollinger-Ellison syndrome may require long-term treatment.
Elderly:
No dosage adjustment is necessary in elderly patients.

Use in children and adolescents

Children older than 1 year whose weight is ≥ 10 kg
Treatment of reflux oesophagitis
Treatment of heartburn related to gastroesophageal reflux disease and symptoms of gastric acid reflux The recommended dosage regimen is as follows:
Age
Body weight
Dosage
≥ 1 year
10...20 kg
10 mg once a day. The dose may be increased to 20 mg once a day, if necessary.
≥ 2 years
> 20 kg
20 mg once a day. The dose may be increased to 40 mg once a day, if necessary.
Reflux oesophagitis: the duration of the treatment is 4...8 weeks.
Treatment of heartburn related to gastroesophageal reflux disease and symptoms of gastric acid reflux: the duration of the treatment is 2...4 weeks. If the symptoms have not improved after 2...4 weeks of treatment, your doctor will perform additional examinations on your child.
Children and adolescents over 4 years of age
Treatment of duodenal ulcers caused by H. pylori
Your doctor will determine a suitable combination therapy based on national, regional and local guidelines concerning the use of antibiotics for bacterial resistance, the duration of treatment (usually 7 days, but can be up to 14 days) and correct use of antibacterial preparations.
The treatment is carried out as advised by the doctor.
The recommended dosage regimen is as follows:
Body weight
Dosage
15...30 kg
Combination with two antibiotics: 10 mg of omeprazole, 25 mg of amoxicillin per kg of body weight and 7.5 mg of clarithromycin per kg of body weight are administered together twice a day over the course of one week.
31...40 kg
Combination with two antibiotics: 20 mg of omeprazole, 750 mg of amoxicillin and 7.5 mg of clarithromycin per kg of body weight are administered together twice a day over the course of one week.
> 40 kg
Combination with two antibiotics: 20 mg of omeprazole, 1 g of amoxicillin and 500 mg of clarithromycin are administered together twice a day over the course of one week.
Impaired kidney function
The dosage does not need to be adjusted in the case of impaired kidney function.
Impaired liver function
The dose of omeprazole may be lowered in the case of impaired liver function.
Method of administration
The capsules are swallowed whole with sufficient water (e.g. 1 glass), preferably in the morning before a meal (breakfast) (also see sections 4.5 and 5.2).

If you take more Omeprazole-ratiopharm than you should

In the case of suspected overdose, talk to a doctor. Symptoms of overdose include nausea, vomiting, dizziness, abdominal pain, diarrhoea, headache and changes in mental state. The symptoms will subside over time. If necessary, your doctor will assign treatment for them.

If you forget to take Omeprazole-ratiopharm

Do not use a double dose to make up for a forgotten dose.

If you stop taking Omeprazole-ratiopharm

If you stop taking this medicine or stop prematurely, e.g. before the mucous membrane has healed completely, you must take into account that the complaints may return. This is why you should carefully follow the instructions of your doctor concerning the duration of the treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been proven or suspected in clinical trials or postmarketing surveillance of omeprazole. None of them is dose-dependent. The following side effects are listed in order of incidence and categorised by the organ system affected,
The side effects are defined according to the following categories: very common (> 1/10); common (> 1/100 to < 1/10); uncommon (> 1/1,000 to < 1/100); rare (> 1/10,000 to < 1/1,000); very rare (< 1/10,000); unknown (incidence cannot be estimated from available data).
Blood and lymphatic system disorders
In rare cases changes in the blood panel, temporary thrombocytopenia and leukopaenia have been reported.
In very rare cases pancytopenia (decrease in the levels of platelets, white blood cells or red and white blood cells) and agranulocytosis (decrease in the formation of white blood cells) have been reported.
Immune system disorders
Rare: Allergic reactions such as fever, angioedema and anaphylactic reaction/shock.
Metabolic and nutritional disorders
Rare: Hyponatremia (deficiency of sodium in the blood).
Unknown: Hypomagnesemia (deficiency of magnesium in the blood). Sever hypomagnesemia may lead to hypocalcaemia (deficiency of calcium in the blood).
Psychiatric disorders Uncommon: Insomnia.
Rare: Agitation, confusion or depression.
Very rare: Aggressive behaviour, hallucinations.
Nervous system disorders
Common: Headache.
Uncommon: Tiredness, insomnia, dizziness. These complaints generally subsided during treatment. Rare: Taste disorders.
In rare cases and usually in patients suffering from a severe disease or in elderly patients, states of confusion and hallucinations have been reported, and in very rare cases, depressive or aggressive reactions.
Eye disorders.
Rare: Blurred vision.
Ear and labyrinth disorders Uncommon: Vertigo.
Respiratory, chest, and mediastinal disorders Rare: Bronchospasm.
Gastrointestinal disorders
Common: Abdominal pain, constipation, diarrhoea, abdominal bloating, nausea/vomiting, benign gastric polyps.
Rare: Dry mouth, inflammation of the mucous membrane of the mouth (stomatitis), fungal infections of the digestive tract (candidiasis).
Hepatic and biliary duct disorders Uncommon: Increase in liver enzyme activity.
Rare: Hepatitis with or without jaundice.
Very rare: Liver failure, encephalopathy in patients with prior liver disease.
Skin and subcutaneous tissue disorders
Uncommon: Inflammation of the skin (dermatitis), itching, rash, hives.
Rare: Hair loss (alopecia), light sensitivity of the skin (photosensitivity), also increased sweating.
Very rare: severe skin reactions: erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN).
Unknown: rash, which may be accompanied with joint pain.
Musculoskeletal and connective tissue disorders Uncommon: Hip, wrist or spine fracture.
Rare: Join pain (arthralgia), muscle pain (myalgia).
Very rare: Muscle weakness.
Renal and urinary disorders Rare: Interstitial nephritis.
Reproductive system and breast disorders
Rare: enlargement of the mammary glands in men (gynecomastia).
General disorders and application site reactions
Uncommon side effects include oedema in the legs (peripheral swelling).
Rare: Increased sweating.
If the following symptoms occur, contact your doctor immediately:
Noticeable unintentional weight loss, constant vomiting, difficulty swallowing, blood in stool or dark stools.

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 Omeprazole-ratiopharm

Keep this medicine out of the sight and reach of children.
Do not store above 30 °C.
HDPE jar: Keep the capsules in the original container, tightly sealed and protected from moisture. Once opened, use the medicine within 56 days.
Alu/alu blister: Store in the original package in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
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 Omeprazole-ratiopharm contains

-   The active substance is omeprazole.
-   The other ingredients are:
Contents of the capsule:
Sugar spheres (sucrose, corn starch).
Povidone (K-30).
Hypromellose (viscosity 3 mPas).
Methacrylic acid / ethyl acrylate copolymer (1:1). Sodium lauryl sulfate.
Sodium starch glycolate (type A).
Trisodium phosphate.
Sodium hydroxide.
Talc.
Triethyl citrate.
Titanium dioxide (E171).
Capsule body:
Quinoline yellow (E104).
Erythrosine (E127).
Gelatine.
Titanium dioxide (E171).
Purified water.
Capsule cap:
Erythrosine (E127).
Indigo carmine (E132).
Titanium dioxide.
Distilled water.
Gelatine.
White ink: shellac, anhydrous ethanol, isopropyl alcohol, propylene glycol, n-butyl alcohol,
polyvinylpyrrolidone, sodium hydroxide, titanium dioxide (E171).

What Omeprazole-ratiopharm looks like and contents of the pack

One gastro-resistant hard capsule contains 20 mg of omeprazole.
Contents of the capsule:
White to beige micropellets.
Capsule:
Cap: opaque blue with a marking “O”.
Body: opaque orange with a marking “20”.

Package

The carton contains an HDPE jar with a polypropylene cap containing a polyethylene drying agent. The jar contains 15, 30, 60 or 100 gastro-resistant hard capsules.
Alu/alu blisters:
15, 30, 56 or 60 gastro-resistant hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:

ratiopharm GmbH,
Graf-Arco-Str. 3,
89079 Ulm,
Germany

Manufacturers:

Merckle GmbH,
Ludwig-Merckle-Str. 3,
89143 Blaubeuren,
Germany
TEVA Pharma S.L.U Poligono Industrial Malpica Calle C.No 4 Zaragoza, 50016 Spain
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
UAB Sicor Biotech Estonian branch Hallivanamehe 4 11 317 Tallinn Phone: +372 661 0801

This leaflet was last revised in April 2017






  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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