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WHAT OLMESTA AND WHAT IT IS USED
Olmesta tablet contains olmesartan medoxomil, which belongs to a group of medicines called angiotensin II. Antagonists of angiotensin II act as the blood vessels expand, thanks to which lowers blood pressure.
Olmesta be used for treating patients of high blood pressure without a particular reason.
2. BEFORE YOU TAKE OLMESTA
Do not take Olmesta
if you are allergic (hypersensitive) to olmesartan medoxomil or any of the other ingredients of Olmesta;
if you are pregnant after the third month. (It is better not to take Olmesta during early pregnancy - see section Pregnancy and lactation);
if you have clogged stones, tumors or inflammation bile ducts that occurs with jaundice (yellowing of the skin).
Take special care with Olmesta
Prior to treatment with Olmesta tell your doctor if any of the following apply to you:
if you have severe vomiting, diarrhea or reduced volume of water and salt in the body;
If you have kidney or liver problems, and / or have undergone kidney transplant;
if you have heart disease, which affects the heart muscle or valves;
If you have high levels of potassium in the blood;
if you have a disease of the adrenal glands;
if you are under 18 years of age, as olmesartan medoxomil has not been studied in this age group;
if you think you are (or might become) pregnant. Olmesta not recommended in early pregnancy and must not be taken if you are pregnant after 3rd month, as it may cause serious harm to your baby if used at that stage (see. Section Pregnancy and lactation).
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines as they may interact with Olmesta:
lithium (used to treat mood swings and some types of depression). Lithium toxicity may be increased if used at the same time olmesartan medoxomil with. Therefore, your doctor may decide to measure the level of lithium in your blood;
potassium supplements, water pills (diuretics) or heparin (used to thin the blood) may increase potassium levels in the blood;
other medicines to treat high blood pressure, as the effect of olmesartan medoxomil can be enhanced;
nonsteroidal antiinflammatory drugs (NSAIDs) which are used for the treatment of pain, fever and inflammation may increase the risk of renal insufficiency and further weaken the effects of olmesartan medoxomil;
some medicines for indigestion (antacids) containing aluminum magnesium hydroxide as the effect of olmesartan medoxomil may be slightly weakened.
Taking Olmesta with food and drink
Olmesartan medoxomil can be taken with or without food. Your recommended daily dose of tablets should be swallowed with some water, preferably at the same time of day. Do not chew the tablets.
Pregnancy and lactation
You should tell your doctor if you are (or might become) pregnant. Your doctor will normally advise you to stop taking Olmesta before you become pregnant or as soon as possible after making sure that you are pregnant and will advise you to take another medicine instead Olmesta.
Olmesta use is not recommended in early pregnancy and must not be taken if you are pregnant after the third month, as it may seriously harm your baby.
Tell your doctor if you are breastfeeding or planning to breastfeed. Olmesta not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
Olmesta unlikely to affect your ability to drive or operate machinery. However, sometimes during the treatment may occur dizziness or fatigue. If you get these effects, talk to your doctor before you drive or operate machinery.
Important information about some of the ingredients of Olmesta
Olmesta contains lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, talk to him before you start taking this medicine.
3. HOW TO TAKE OLMESTA
Always take Olmesta just as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist.
Olmesta should be taken with some water once a day at approximately the same time of day with or without food, for example breakfast.
The recommended starting dose is 10 mg once daily.
If your blood pressure is not adequately controlled with this dose, your doctor may increase it to an optimal dose of 20 mg daily.
If necessary, further lowering of blood pressure, then your doctor may increase the dose to a maximum of Olmesta
Patients with impaired renal function
For patients who have mild or moderate renal impairment is recommended daily dose of 20 mg. If you have severe renal impairment should not take Olmesta.
Patients with impaired hepatic function
If you have mild hepatic impairment did not require dose adjustment.
If you have moderate or severe hepatic impairment, the recommended starting dose is 10 mg daily and should not exceed a dose of 20 mg daily. Your doctor will monitor your blood pressure and renal function if you are already taking medicine.
Do not use Olmesta if you have severely impaired liver function.
Children and adolescents (under 18 years)
Olmesta not recommended for use in children and adolescents under 18 years of age due to lack of data on safety and efficacy.
Patients of African descent
Like other such drugs, the blood pressure lowering effect of olmesartan medoxomil is somewhat less in black patients.
If you take more than the amount Olmesta
Immediately call your doctor or go to the nearest hospital where you will be placed under constant surveillance.
Please bring with you pack your medication.
The most likely effect of overdose is low blood pressure (hypotension).
If you forget to take Olmesta
If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue as usual. Do not take a double dose to make up the missed dose.
If you stop taking Olmesta
It is important to continue taking Olmesta unless your doctor has recommended you to stop.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Olmesta can cause side effects, although not everybody gets them. All medicines can cause allergic reactions, although serious allergic reactions are very rare.
You should stop taking Olmesta and immediately contact your doctor if you experience swelling of the face, mouth and / or larynx (vocal cords) together with itching and rash.
Rarely Olmesta can cause a sharp drop in blood pressure, which can lead to severe dizziness or fainting! If you get these symptoms, stop taking Olmesta, call your doctor and go to bed.
In clinical trials with olmesartan medoxomil have been reported following side effects:
Common: affects 1 to 10 users in 100:
Bronchitis, sore throat, cough, muscle pain, flu-like symptoms, runny or stuffy nose;
Disorders of the digestive system such as stomach pain, diarrhea, vomiting, indigestion (bloating and flatulence), inflammation of the stomach and nausea;
Inflammation of a joint or joints (arthritis), back pain, bone pain;
Blood in the urine, urinary tract infection;
Swelling of ankles, feet, legs, hands or arms;
Laboratory abnormalities including elevated liver enzymes, kidney function indicators such as creatinine, blood urea, blood fats (lipids).
Uncommon: affects 1 to 10 users in 1000:
Turning to the world (vertigo);
Pain or discomfort in the chest (angina pectoris, angina);
Likelihood of low blood pressure in the elderly.
Rare: affects 1 to 10 users in 10,000:
Low blood pressure;
Elevated potassium levels in the blood.
The following adverse reactions have been described since the drug on the market:
Very rare: affects less than 1 user in 10,000:
Reduced number of platelets in the blood;
Elevated potassium levels in the blood;
Stomach pain, nausea, vomiting;
Itchy skin, widely and symmetrically distributed skin rash, allergic reactions;
Muscle spasms, muscle pain, weakness, lack of energy, general discomfort and anxiety;
Kidney damage and loss of kidney function;
Loss of energy, fatigue, unwillingness to work, discomfort and inconvenience;
Elevated serum creatinine and blood urea nitrogen, elevated liver enzymes.
If any of the side effects gets serious, or if you notice any of this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE OLMESTA
Keep out of reach of children.
This medicinal product does not require any special storage conditions.
Do not use Olmesta after the expiry date stated on the blister and carton after "EXP" The expiry date refers to the last day of that month.
Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
The active substance is olmesartan medoxomil. Each tablet Olmesta contains 10 mg, 20 mg or 40 mg olmesartan medoxomil.
Other ingredients are:
Low-substituted hydroxypropyl cellulose;
Film-coating: Opadry II 85F18378 white [poly (vinyl alcohol) - partially hydrolyzed, titanium dioxide (E 171), macrogol 3350 (polyethylene glycol), talc].
Olmesta looks like and contents of the pack
Olmesta 10 mg film-coated tablets: White, round, convex tablets debossed with "O" on one side and "10" on the other.
Olmesta 20 mg film-coated tablets: White, round, convex tablets debossed with "O" on one side and "20" on the other.
Olmesta 40 mg film-coated tablets: White, oval film-coated tablets debossed with "O" on one side and "40" on the other.
Olmesta is available in blister packages of 14, 28, 30, 56, 90 and 98 tablets.
Not all pack sizes may be marketed.
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