OLMEDIE 10 мг Фильм-coated таблетки

Содержание инструкции

1. Olmedie 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets
   1. What is Olmedie and what it is used for
   2. What you need to know before taking Olmedie
   3. How to take Olmedie
   4. Possible side effects
   5. How to store Olmedie
   6. Package contents and other information

Olmedie 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

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

1. What is Olmedie and what it is used for

Olmedie belongs to a group of medicines called angiotensin II receptor antagonists.
It lowers blood pressure by relaxing the blood vessels.
Olmedie is used for the treatment of high blood pressure (also called “hypertension”)
in adults and in children and adolescents from 6 to less than 18 years of age. High blood
pressure can damage the blood vessels in organs such as the heart, kidneys, brain and eyes. In some
cases this can lead to a heart attack, heart or kidney failure, stroke or blindness. Usually high
blood pressure has no symptoms. It is important to have your blood pressure controlled to prevent
damage from occurring.
High blood pressure can be controlled with medicines such as Olmedie tablets.
Your doctor has probably recommended that you make some changes to your lifestyle to
help reduce your blood pressure (e.g. losing weight, stopping smoking, reducing the
amount of alcohol you drink and reducing the amount of salt in your diet). Your doctor may also
advise you to take regular exercise, such as walking or swimming. It is important to follow this
advice from your doctor.

2. What you need to know before taking Olmedie

Do not take Olmedie

• 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 Olmedie even at the beginning of pregnancy - see section Pregnancy.)
• if you suffer from yellowing of the skin and eyes (jaundice) or have problems with bile drainage 1/6

from the gallbladder (obstruction of the bile duct e.g. by gallstones).

• if you have diabetes or impaired kidney function and are being treated with a medicine that lowers blood pressure containing aliskiren.

Warnings and precautions
Talk to your doctor or pharmacist before taking Olmedie.

Tell 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 diabetes related to kidney problems.
• aliskiren.

Your doctor may check your kidney function, blood pressure and the amount of electrolytes
(e.g. potassium) in your blood at regular intervals.
See also the information provided under “Do not take Olmedie”.

Tellyour doctor if you have any of the following health problems:

• kidney problems
• liver disease
• heart failure or problems with the heart or heart muscle
• severe vomiting, diarrhea, treatment with high doses of water tablets (diuretics) or if you are following a low-salt diet
• increased level of potassium in the blood
• problems with the adrenal glands

Tell your doctor if you experience severe, persistent diarrhea that causes substantial weight loss.
Your doctor may assess your symptoms and decide how to continue with treatment for high blood
pressure.
As with any other medicine that lowers blood pressure, an excessive drop in blood
pressure in patients with disorders of blood circulation in the heart or brain could
lead to a heart attack or stroke. Your doctor will therefore carefully monitor your blood
pressure.
You must tell your doctor if you think you are (or might become) pregnant. Olmedie is not
recommended at the beginning of 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 during this period (see section
Pregnancy).

Children and adolescents
Olmedie has been studied in children and adolescents. For more information, talk to your
doctor. Olmedie 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 because no experience is available.

Other medicines and Olmedie
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 about any of the following:

• other medicines for lowering blood pressure, as the effect of Olmedie may be increased. Your doctor may need to change the dose and/or take other precautions:
• if you are taking an ACE inhibitor or aliskiren (see the information under “Do not take 2/6

Olmedie” and ”Warnings and precautions”)

• potassium supplements, salt substitutes containing potassium, water tablets (diuretics) or heparin (for blood thinning). Using these medicines at the same time as Olmedie may increase potassium levels in the blood.
• lithium (a medicine used to treat mood swings and some types of depression) which, when used in combination with Olmedie, may increase lithium toxicity. If you need to take lithium, your doctor will measure your lithium levels in the blood.
• non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis) which, when used in combination with Olmedie, may increase the risk of kidney failure and the effect of Olmedie may be reduced by NSAIDs.
• colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, which may decrease the effect of Olmedie. Your doctor may advise you to take Olmedie at least 4 hours before colesevelam hydrochloride
• some antacids (remedies for indigestion) may slightly reduce the effect of Olmedie.

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, you should regularly have your blood pressure checked by your doctor so that
you can be sure that your blood pressure does not become too low.

Black patients
As with other similar medicines, the blood pressure lowering effect of Olmedie is rather
lower in black patients.

Olmedie with food and drink
Olmedie can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you are pregnant or are planning to become
pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will usually
tell you to stop taking Olmedie before becoming pregnant or as soon as you find out
you are pregnant and will advise you to take another medicine instead of Olmedie.
Olmedie is not recommended at the beginning of pregnancy, and must not be taken after more than 3 months of
pregnancy, 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 are planning to start breastfeeding. Olmedie is not recommended
for mothers who are breastfeeding, the doctor may choose another treatment, if you wish to breastfeed,
especially if the baby is newly born or premature.

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.

Olmediecontains lactose
If you have been told that you have an intolerance to some sugars, contact your doctor before taking
this medicine.

3. How to take Olmedie

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Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

Adults
The recommended starting dose is one 10 mg tablet daily. However, if blood pressure is not
controlled, your doctor may decide to adjust the dose to 20 or 40 mg once daily, or prescribe
additional medicines.

Children and adolescents from 6 to less than 18 years of age
The recommended starting dose is 10 mg once daily. If blood pressure is not adequately
controlled, the doctor may decide to change the dose to 20 or 40 mg once daily. In children weighing
less than 35 kg, the dose should not exceed 20 mg once daily.
In patients with mild to moderate renal impairment, the dose should not exceed 20 mg once daily.
The tablets can be taken with or without food. Swallow the tablets with a sufficient amount of
water (e.g. a glass). If possible, take the daily dose at the same time each day, for example at
breakfast time.

If you take more Olmedie than you should
If you take more tablets than you should or if the child accidentally swallows some, go immediately to
your doctor or the nearest emergency room and take the package of the medicine with you.

If you forget to take Olmedie
If you forget to take a dose, take the normal dose the next day as usual.
Do not take a double dose to make up for a missed dose.

If you stop taking Olmedie
It is important to continue taking Olmedie until your doctor tells you to stop.
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.
If they do occur, they are often mild and do not require stopping treatment.
Even if many people do not experience them, the following side effects can be serious:
In rare cases (may affect 1 in 1,000 people) the following allergic reactions have been reported, which may involve the whole body:
Swelling of the face, mouth and/or larynx (altered voice) together with burning and rash that
may occur during treatment with Olmedie. If this happens, stop the
treatment with Olmedie and contact your doctor immediately.
Rarely (but significantly more often in elderly people) Olmedie may cause a
greater lowering of blood pressure in more sensitive individuals or as a result of an
allergic reaction. This may lead to severe dizziness or fainting. If this happens
stop the treatment with Olmedie, contact your doctor immediately and remain in a lying
position.
Frequency not known: if you experience yellowing of the whites of the eyes, dark urine, skin itching,
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even if you have started therapy with Olmedie a long time ago, contact your doctor immediatelywho
will assess the symptoms and decide how to proceed with therapy for the treatment of arterial hypertension.
These are other known side effects so far with Olmedie:
Common (may affect more than 1 in 10 people):
Dizziness, headache, nausea, indigestion, diarrhea, stomach pain, gastroenteritis, fatigue, sore throat, runny or blocked nose, bronchitis, flu-like symptoms, cough, pain, chest pain,
back, bone or joint pain, urinary tract infections, swelling of the ankles, feet, legs,
hands or arms, blood in the urine.
Some changes in blood test results have also been found and they are as follows:
increased levels of fat (hypertriglyceridemia), increased levels of uric acid (hyperuricemia),
increased urea in the blood, increased liver and muscle function tests.
Uncommon (may affect more than 1 in 100 people):
Rapid allergic reactions that can affect the whole body and can cause
breathing problems, as well as a rapid drop in blood pressure which can also lead to fainting
(anaphylactic reactions), dizziness, vomiting, weakness, malaise, muscle pain, skin rashes,
allergic skin rashes, itching, rash (skin eruption), skin nodules (hives), angina
(chest pain or discomfort).
In blood test results, a decrease in the number of a type of blood cells has been found,
known as platelets (thrombocytopenia).
Rare (may affect more than 1 in 1,000 people):
Loss of strength, muscle cramps, impaired kidney function, kidney failure.
Some variations in blood test results have been observed. This includes an increase
in potassium levels (hyperpotassemia) and an increase in levels related to
kidney function.

Children and adolescents
In children, side effects are similar to those reported in adults. However, dizziness and
headache have been observed more frequently in children, and nosebleeds are a common side effect
seen only in children.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
the national reporting system at www.agenziafarmaco.gov.it/content/come-
segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Olmedie

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

6. Package contents and other information

What Olmedie contains

• The active ingredient is olmesartan medoxomil. Each film-coated tablet of Olmedie 10 mg contains 10 mg of olmesartan medoxomil. Each film-coated tablet of Olmedie 20 mg contains 20 mg of olmesartan medoxomil. Each film-coated tablet of Olmedie 40 mg contains 40 mg of olmesartan medoxomil.
• The other ingredients are microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropylcellulose and magnesium stearate in the tablet core and titanium dioxide, talc, macrogol 3000 and polyvinyl alcohol in the tablet coating.

Description of the appearance of Olmedie and package contents
The 10 mg film-coated tablets are white, round, slightly biconvex, with the S1 mark imprinted
on one side of the tablet; tablet diameter: 6.5 mm; thickness: 2.4 mm – 3.4
mm.
The 20 mg film-coated tablets are white, round, slightly biconvex, with the S2 mark imprinted
on one side of the tablet; tablet diameter: 8 mm; thickness: 3.4 mm – 4.5
mm.
The 40 mg film-coated tablets are white, oval, biconvex, with the S3 mark imprinted on one side of the
tablet; tablet dimensions: 13x8 mm; thickness: 4.3 mm – 5.5 mm.
Olmedie 10 mg, 20 mg and 40 mg film-coated tablets are available in packs of 28 and 30
film-coated tablets in blisters.

Marketing Authorisation Holder
LABORATORIO FARMACEUTICO CT S.r.l. – Via Dante Alighieri, 71 - 18038 Sanremo (IM)
Italy

Manufacturer responsible for batch release
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz Lohmann Straße 5, 27472 Cuxhaven, Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
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