OLMESARTAN 10 mg Фильм-Coated Таблетки

Содержание инструкции

1. Olmesartan medoxomil Pensa 10 mg, 20 mg, 40 mg film-coated tablets
   1. What Olmesartan medoxomil Pensa is and what it is used for
   2. What you need to know before taking Olmesartan medoxomil Pensa
   3. How to take Olmesartan medoxomil Pensa
   4. Possible side effects
   5. How to store Olmesartan medoxomil Pensa
   6. Package Contents and Other Information

Olmesartan medoxomil Pensa 10 mg, 20 mg, 40 mg film-coated tablets

Generic medicine

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Olmesartan medoxomil Pensa is and what it is used for
• 2. What you need to know before you take Olmesartan medoxomil Pensa
• 3. How to take Olmesartan medoxomil Pensa
• 4. Possible side effects
• 5. How to store Olmesartan medoxomil Pensa
• 6. Contents of the pack and other information

1. What Olmesartan medoxomil Pensa is and what it is used for

Olmesartan medoxomil Pensa belongs to a group of medicines called angiotensin II receptor antagonists. They lower blood pressure by relaxing blood vessels.
Olmesartan medoxomil Pensa is used to treat high blood pressure (also called “arterial hypertension”) in adults, children and adolescents aged between 6 and 18 years. High blood pressure can damage blood vessels in organs such as the heart, kidneys, brain and eyes. In some cases, this can lead to heart attacks, heart or kidney failure, stroke or blindness. Usually, high blood pressure does not present with symptoms. It is important to check your blood pressure to prevent the onset of damage.
High blood pressure can be controlled with medicines such as Olmesartan medoxomil Pensa tablets. Your doctor has probably also recommended that you make some changes to your lifestyle to help reduce your blood pressure (for example, lose weight, stop smoking, reduce alcohol intake and reduce salt intake in your diet). Your doctor may also have advised you to exercise regularly, such as walking or swimming. It is important that you follow this advice from your doctor.

2. What you need to know before taking Olmesartan medoxomil Pensa

Do not take Olmesartan medoxomil Pensa

• if you are allergic to olmesartan medoxomil or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant for more than three months (it is best to avoid Olmesartan medoxomil Pensa even in the early stages of pregnancy - see section “Pregnancy”).

 if you suffer from yellowing of the skin and eyes (jaundice) or from impaired bile flow from the gallbladder (biliary obstruction, for example gallstones).
if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure containing aliskiren.

Warnings and precautions
Talk to your doctor before taking Olmesartan medoxomil Pensa.

Consult your doctorif you are taking any of the following medicines used to treat high blood pressure:

• an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren

The doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
Also read the information in section “Do not take Olmesartan medoxomil Pensa”.

Consult your doctorif you also have any of the following health problems:

• Kidney problems.
• Liver disease.
• Heart failure or problems with the heart valves or heart muscle.
• Severe vomiting or diarrhea, if you are being treated with high doses of water tablets (diuretics) or if you are on a low-salt diet.
• Increased levels of potassium in your blood.
• Problems with the adrenal glands.

Tell your doctor if you experience severe and prolonged diarrhea with significant weight loss. The doctor will assess your symptoms and decide whether to continue this antihypertensive treatment.
As with any medicine that lowers blood pressure, an excessive reduction in blood pressure in patients with circulatory disorders of the heart or brain could lead to a heart attack or stroke. The doctor will therefore carefully monitor your blood pressure.
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Olmesartan medoxomil Pensa is not recommended in early pregnancy and must not be taken if you are pregnant for more than three months, as it can cause serious harm to the baby (see section “Pregnancy”).

Patients of Black ethnicity
As with other similar drugs, the blood pressure-lowering effect of Olmesartan medoxomil Pensa is somewhat reduced in patients of Black ethnicity.

Elderly patients
If you are over 65 years of age and your doctor decides to increase your dose of olmesartan medoxomil to 40 mg per day, your blood pressure should be regularly monitored by your doctor to avoid it dropping too low.

Children and adolescents
Olmesartan medoxomil Pensa has been studied in children and adolescents. Consult your doctor for further information.
Olmesartan medoxomil Pensa is not recommended in children from 1 to 6 years of age and should not be used in children under 1 year of age.

Other medicines and Olmesartan medoxomil Pensa
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:
In particular, tell your doctor or pharmacist if you are taking:

• Other medicines that lower blood pressure can increase the effect of Olmesartan medoxomil Pensa. Your doctor may need to adjust your dose and/or take other precautions. If you are taking an ACE inhibitor or aliskiren (see also “Do not take Olmesartan medoxomil Pensa” and “Warnings and precautions”).
• Potassium supplements, salt substitutes containing potassium, diuretics or heparin (to thin the blood). Taking these medicines together with Olmesartan medoxomil Pensa may increase the levels of potassium in your blood.
• Lithium (a medicine used to treat mood swings and some types of depression) together with Olmesartan medoxomil Pensa may increase lithium toxicity. If you need to take lithium, your doctor will measure your lithium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to reduce pain, swelling and other symptoms of inflammation, including arthritis) taken together with Olmesartan medoxomil Pensa may increase the risk of kidney failure and the effectiveness of Olmesartan medoxomil Pensa may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, which may decrease the effect of Olmesartan medoxomil Pensa. Your doctor may advise you to take Olmesartan medoxomil Pensa at least 4 hours before colesevelam hydrochloride.
• Some antacids (used for indigestion) may slightly reduce the effectiveness of Olmesartan medoxomil Pensa.

Olmesartan medoxomil Pensa with food and drink
Olmesartan medoxomil Pensa can be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
You should tell your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Usually your doctor will advise you to stop taking Olmesartan medoxomil Pensa before becoming pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Olmesartan medoxomil Pensa. Olmesartan medoxomil Pensa is not recommended in early pregnancy and must not be taken if you are pregnant for more than 3 months as it can cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or planning to start breastfeeding. Olmesartan medoxomil Pensa is not recommended for women who are breastfeeding and your doctor may choose another treatment for you if you wish to breastfeed, especially if the baby is newly born or premature.
If you are pregnant or breastfeeding, 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
You may feel drowsy or dizzy during treatment for high blood pressure. If this happens, do not drive or use machines until the symptoms have disappeared. Ask your doctor for advice.

Olmesartan medoxomil Pensa contains lactose.
This medicine contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Olmesartan medoxomil Pensa

Always take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
The recommended initial dose is one 10 mg tablet once a day. However, if blood pressure is not controlled, your doctor may decide to increase the dose to 20 mg or 40 mg once a day, or may prescribe other medicines.
In patients with mild to moderate renal impairment, the dose should not exceed 20 mg once a day.
The tablets can be taken with or without food. The tablets must be swallowed with a sufficient amount of water (for example, a glass). If possible, take your daily dose every day at the same time, for example with breakfast.
Children and adolescents from 6 to 18 years of age:
The recommended initial dose is 10 mg once a day. If the patient's blood pressure is not adequately controlled, the doctor may decide to adjust the dose up to 20 mg or 40 mg once a day. In children weighing less than 35 kg, the dose will not exceed 20 mg once a day.

If you take more Olmesartan medoxomil Pensa than you should
If you take more tablets than you should or if a child accidentally ingests some, go immediately to your doctor or to the emergency room of the nearest hospital and bring the medicine package with you.

If you forget to take Olmesartan medoxomil Pensa
If you forget to take a dose, take the normal dose the next day as usual.

Do nottake a double dose to make up for a missed dose.

If you stop taking Olmesartan medoxomil Pensa
It is important that you continue to take Olmesartan medoxomil Pensa until your doctor tells you to stop.
If you have any doubts about 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. If they occur, they are often mild and do not require stopping the
treatment.
Although they do not occur in many people, the following side effects can be serious:
On very rare occasions (which may affect up to 1 in 1000 people), the following allergic reactions have been reported, which can affect the whole body:
swelling of the face, mouth and/or larynx (vocal cords) together with itching and skin rash may occur during treatment with Olmesartan medoxomil Pensa. If this
happens, stop taking Olmesartan medoxomil Pensa and contact
your doctor immediately.
Rarely (but slightly more often in elderly patients), Olmesartan medoxomil Pensa may
cause an excessive reduction in blood pressure in sensitive individuals or as
a result of an allergic reaction. This could cause severe dizziness or fainting. If this
happens, stop taking Olmesartan medoxomil Pensa, contact
your doctor immediately and lie down.
Frequency not known: if you experience yellowing of the whites of your eyes, dark urine, itching of the
skin, even if you have been taking Olmesartan medoxomil Pensa for a long time, contact
your doctor immediatelywho will assess the symptoms and decide how to proceed with therapy for
the treatment of high blood pressure.
These are the other side effects known so far with Olmesartan medoxomil Pensa:

Common (may affect up to 1 in 10 people)
Dizziness, headache, nausea, indigestion, diarrhea, stomach pain, gastroenteritis, fatigue,
sore throat, runny or stuffy nose, bronchitis, flu-like symptoms, cough, pain,
chest pain, back pain, bone or joint pain, urinary tract infection, swelling
of the ankles, feet, legs, hands or arms, blood in the urine.
Some changes in laboratory tests have also been observed, including the
following:
increased fats in the blood (hypertriglyceridemia), increased uric acid in the blood
(hyperuricemia), increased urea in the blood, increased liver and
muscle function tests.

Uncommon side effects (may affect up to 1 in 100 people):
Rapid allergic reactions that can affect the whole body and can cause
breathing problems or a rapid drop in blood pressure, which can also cause
fainting (anaphylactic reactions), swelling of the face, dizziness, vomiting, weakness, feeling
unwell, muscle pain, skin rash, allergic skin rash, itching, rash
(skin eruption), skin blisters (urticaria), angina (chest pain or discomfort).
A decrease in the number of a type of blood cell, known as platelets (thrombocytopenia) has been observed in blood tests.

Rare side effects (may affect up to 1 in 1,000 people):
Lack of energy, muscle cramps, impaired kidney function, kidney failure.
Some changes in laboratory tests have also been observed. These include
increased potassium levels (hyperpotassemia) and increased levels of substances related to
kidney function.

Additional side effects in children and adolescents:
In children, side effects are similar to those reported for adults. However, dizziness
and headache have been observed more often in children, and nosebleeds are a
common side effect only in children.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Olmesartan medoxomil Pensa

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 pack after EXP. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Olmesartan medoxomil Pensa contains

• The active ingredient is olmesartan medoxomil. Each film-coated tablet contains 10 mg, 20 mg or 40 mg of olmesartan medoxomil
• The other ingredients are microcrystalline cellulose, lactose monohydrate, povidone, hydroxypropylcellulose, magnesium stearate, opadry Y-1-7000 (hypromellose, titanium dioxide, macrogol)

Description of the appearance of Olmesartan medoxomil Pensa and package contents
Olmesartan medoxomil Pensa 10 mg film-coated tablet white, cylindrical, biconvex,
with a breaking line on one side and imprinted OL1 on the other side.
Olmesartan medoxomil Pensa 20 mg film-coated tablet white, cylindrical, biconvex,
with a breaking line on one side and imprinted OL2 on the other side.
Olmesartan medoxomil Pensa 40 mg film-coated tablet white, oblong, biconvex,
with a breaking line on one side and imprinted OL4 on the other side.
Olmesartan medoxomil Pensa film-coated tablets are available in packs of 28
tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini 12
20124 Milan

Manufacturer
LABORATORIOS CINFA, S.A.
Ctra. Olaz Chipi, 10
Pol. Ind. Areta de Huarte
31620 Navarre, Spain

This medicinal product is authorised in the Member States of the European Economic Area with the
following names:
Italy – Olmesartan medoxomil Pensa