OLMESARTAN 10 mg Фильм-Coated Таблетки

Содержание инструкции

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

Olmesartan Medoxomil Accord 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Generic medicine
Read this leaflet carefully before taking this medicine because 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 any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse (see section 4). Contents of this leaflet:
• 1. What Olmesartan Medoxomil Accord is and what it is used for.
• 2. What you need to know before you take Olmesartan Medoxomil Accord.
• 3. How to take Olmesartan Medoxomil Accord.
• 4. Possible side effects.
• 5. How to store Olmesartan Medoxomil Accord.
• 6. Contents of the pack and other information.

1. What is Olmesartan Medoxomil Accord and what it is used for

Olmesartan Medoxomil Accord belongs to a group of medicines called angiotensin II receptor antagonists. They lower blood pressure by relaxing blood vessels.
Olmesartan Medoxomil Accord is used to treat high blood pressure (also called “arterial hypertension”)
in adults, children and adolescents from 6 to less than 18 years of age. 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 has no symptoms. It is
important to check your blood pressure to prevent damage.
High blood pressure can be controlled with medicines such as Olmesartan Medoxomil Accord. Your doctor
has probably also recommended that you make some changes to your lifestyle to help
lower your blood pressure (for example, lose weight, quit 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 these recommendations from your doctor.

2. What you need to know before taking Olmesartan Medoxomil Accord

Do not take Olmesartan Medoxomil Accord

• if you are allergic (hypersensitive) 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 Accord even in the early stages of pregnancy - see section “Pregnancy”).
• if you have jaundice (yellowing of the skin and eyes) or impaired bile flow from the gallbladder (bile duct 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 precautionsTalk to your doctor before using Olmesartan Medoxomil Accord.

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 (such as potassium) in your blood at regular intervals.
See also what is stated in the section "Do not take Olmesartan Medoxomil Accord”

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, diarrhea, treatment with high doses of diuretics, or if you are following a low-salt diet.
• Increased levels of potassium in the blood.
• Problems with the adrenal glands.

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

Children and adolescents
Olmesartan Medoxomil Accord has been studied in children and adolescents. For more information, consult
your doctor. Olmesartan Medoxomil Accord is not recommended for children from 1 year to less than 6 years of age
and should not be used in children under 1 year of age as there is no evidence available.

Other medicines and Olmesartan Medoxomil Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
In particular, inform your doctor or pharmacist about the use of any of the following medicines:

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

Elderly people
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
decreasing too much.

Black patients
As with other similar medicines, the blood pressure-lowering effect of Olmesartan Medoxomil
Accord tablets is somewhat reduced in black patients.

Olmesartan Medoxomil Accord with food and drink
Olmesartan Medoxomil Accord can be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). As a rule, your doctor will advise you to stop taking Olmesartan Medoxomil Accord
tablets 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 Accord tablets.
Olmesartan Medoxomil Accord tablets are not recommended in early pregnancy and should not be
taken if you are pregnant for more than three months, as it can cause serious harm to the baby if
taken after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or are planning to start breastfeeding. Olmesartan Medoxomil Accord
tablets are not recommended for women who are breastfeeding; your doctor may choose another
treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
You may feel drowsy or dizzy while being treated 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 Accord contains lactose
This medicine contains lactose (a type of sugar). If your doctor has told you that you have an intolerance
to certain sugars, contact him before taking this medicine.

3. How to take Olmesartan Medoxomil Accord

Take this medicine following exactly the instructions of your doctor, pharmacist or
nurse. If you have any doubts, ask your doctor, pharmacist or nurse.
The recommended initial dose is one 10 mg tablet once a day. However, if your blood
pressure is not controlled, your doctor may decide to increase the dose to 20 or 40 mg once a day,
or they 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. Swallow the tablets 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 less than 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 increase the dose to 20 or 40 mg once a day.
In children weighing less than 35 kg, the dose should not be higher than 20 mg once a day.

If you take more Olmesartan Medoxomil Accord than you should
If you take more tablets than you should or if a child accidentally swallows any, go
immediately to your doctor or the nearest emergency room, bringing the medicine packaging with you.

If you forget to take Olmesartan Medoxomil Accord
If you forget to take a dose, take your usual dose the next day. Do not take a double
dose to make up for the missed tablet.

If you stop taking Olmesartan Medoxomil Accord
It is important to continue taking Olmesartan Medoxomil Accord unless your doctor tells you to
stop.
If you have any questions about the use of Olmesartan Medoxomil Accord, 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 do occur, they are mostly mild and do not require stopping treatment.
Although they do not appear in all people, the following side effects can be serious:
In rare cases (which can affect up to one in 1000 people), the following allergic reactions have been reported which can affect the whole body:
During treatment with Olmesartan Medoxomil Accord, swelling of the face, mouth and/or
larynx (the area where the vocal cords are located) may occur, associated with itching and rash. If this happens, stop
taking Olmesartan Medoxomil Accord and contact your doctor immediately.
Rarely (but slightly more often in elderly people) Olmesartan Medoxomil Accord can cause
excessive reductions 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 Accord, contact your doctor immediately and lie down.
These are the other side effects known so far with Olmesartan Medoxomil Accord:

Common side effects (may affect up to 1 in 10 people):
Dizziness, headache, nausea, indigestion, diarrhoea, stomach pain, gastroenteritis, fatigue, irritation of the
throat, increased nasal secretion, bronchitis, flu-like symptoms, cough, pain, chest pain, back pain,
bone or joint pain, urinary tract infection, swelling of ankles, feet, legs, hands or arms,
blood in urine.
Some changes in laboratory tests have also been observed, including the following: increased
blood fats (hypertriglyceridaemia), increased uric acid in the blood (hyperuricaemia), 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, rash,
allergic skin rash, itching, rash (skin eruption), skin blisters (urticaria), angina (chest pain or
discomfort).
A reduction in the number of a type of particles normally present in the blood, called
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, reduced kidney function, kidney failure.
Some changes in laboratory tests have also been observed. These include increased levels
of potassium (hyperkalaemia) and increased levels of substances related to kidney function.
Intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain,
nausea, vomiting and diarrhoea

Not known: frequency cannot be estimated from the available data:
if you experience yellowing of the whites of your eyes, dark urine, skin itching, even if you have been taking
Olmesartan Medoxomil Accord 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.

Additional side effects in children and adolescents:
Side effects in children are similar to those reported in adults. However, dizziness and headache
occur more frequently in children and nosebleeds are a common side effect found
only in children.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through
Website: 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 Accord

• 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 and on the blister 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 Accord Contains
The active ingredient is olmesartan medoxomil.
Each film-coated tablet contains 10 mg.
Each film-coated tablet contains 20 mg
Each film-coated tablet contains 40 mg
The other ingredients are:
microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, low substitution
hydroxypropylcellulose, magnesium stearate, titanium dioxide (E171), talc and hypromellose.

Description of the Appearance of Olmesartan Medoxomil Accord and Package Contents
Olmesartan Medoxomil Accord 10 mg are film-coated tablets, round, white in color,
biconvex, with “IO2” imprinted on one side and smooth on the other;
Olmesartan Medoxomil Accord 20 mg are film-coated tablets, round, white in color,
biconvex, with “IO3” imprinted on one side and smooth on the other;
Olmesartan Medoxomil Accord 40 mg are film-coated tablets, oval, white in color, biconvex,
with “IO4” imprinted on one side and smooth on the other;
Olmesartan Medoxomil Accord is available in packs of 14, 28, 30, 56, 84, 90, 98 and 280 film-coated
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta
08039-Barcelona,
Spain.

Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000
Malta
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice,
Poland

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom
(Northern Ireland) under the following denominations: