Olmédie

Package leaflet: Information for the patient

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

Olmesartan medoxomil
Equivalent medicine
Please 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 taking 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 Olmedie is and what it is used for

Olmedie belongs to a group of medicines called angiotensin II receptor antagonists.
It lowers blood pressure by relaxing blood vessels.
Olmedie is used to treat high blood pressure (also known as "hypertension") in adults and in children and adolescents aged 6 to less than 18 years. High blood pressure can damage blood vessels in organs such as the heart, kidneys, brain and eyes. In some cases, this may lead to heart attack, heart or kidney failure, stroke or blindness. High blood pressure usually has no symptoms. It is important to keep your blood pressure under control to prevent damage from occurring.
High blood pressure can be controlled with medicines such as Olmedie tablets.
Your doctor has likely recommended that you make certain lifestyle changes to help reduce your blood pressure (e.g. losing weight, quitting smoking, reducing the amount of alcohol you drink, and reducing the amount of salt in your diet). Your doctor may also encourage you to exercise regularly, such as walking or swimming. It is important to follow your doctor's advice.

2. What you need to know before taking Olmedie

Do not take Olmedie

• if you are allergic to olmesartan medoxomil or to any of the other ingredients of this medicine (listed in section 6)

• if you are more than three months pregnant. (It is also advisable to avoid Olmedie during early pregnancy – see section Pregnancy.)

• if you have yellowing of the skin and eyes (jaundice) or have problems with bile drainage from the gallbladder (biliary obstruction, e.g. gallstones).

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Olmedie.
Tell your doctor if you are taking any of the following medicines used to treat high blood pressure:

• an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have diabetes related to kidney problems.
• aliskiren.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.
See also the information provided under "Do not take Olmedie".
Tell your doctor if you have any of the following health conditions:

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

Inform your doctor if you develop severe, persistent diarrhoea causing significant weight loss.
Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.
As with any other medicine that lowers blood pressure, a marked drop in blood pressure in patients with circulatory disorders affecting the heart or brain may lead to a heart attack or stroke. Your doctor will therefore monitor your blood pressure carefully.
You must inform your doctor if you think you are (or might become) pregnant. Olmedie is not recommended during early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see section Pregnancy).

Children and adolescents
Olmedie has been studied in children and adolescents. For further information, speak with your doctor. Olmedie is not recommended for children aged 1 year to less than 6 years, and must not be used in children under 1 year of age due to lack of available experience.

Other medicines and Olmedie
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 any of the following:

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

Olmedie” and “Warnings and precautions”)

• potassium supplements, salt substitutes containing potassium, water-eliminating tablets (diuretics), or heparin (for blood thinning). Taking these medicines together with Olmedie may increase potassium levels in the blood.
• lithium (a medicine used to treat mood swings and certain types of depression), which when taken together with Olmedie may increase lithium toxicity. If you need to take lithium, your doctor will monitor your lithium blood levels.
• non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), which when taken together 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 reduce the effect of Olmedie. Your doctor may advise you to take Olmedie at least 4 hours before colesevelam hydrochloride.
• certain antacids (remedies for indigestion), which may slightly reduce the effect of Olmedie.

Elderly people
If you are over 65 years old and your doctor decides to increase your dose of olmesartan medoxomil to 40 mg daily, you should have your blood pressure regularly checked by your doctor to ensure that your blood pressure does not become too low.

Black patients
As with other similar medicines, the blood pressure-lowering effect of Olmedie is somewhat 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, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy
You must inform your doctor if you think you are (or might become) pregnant. Your doctor will usually advise you to stop treatment with Olmedie before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine.
Olmedie is not recommended during early pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken beyond the first trimester.

Breast-feeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Olmedie is not recommended for breastfeeding mothers. Your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is newborn or was born prematurely.

Driving and using machines
You may experience drowsiness or dizziness during treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

Olmedie contains lactose
If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Olmedie

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Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Adults
The recommended starting dose is one 10 mg tablet per day. However, if your blood
pressure is not controlled, your doctor may decide to adjust the dose up to 20 or 40 mg once
daily, or prescribe additional medicines.
Children and adolescents aged 6 to less than 18 years
The recommended initial dose is 10 mg once daily. If blood pressure is not adequately controlled, your doctor may decide to change the dose up 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 must 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 with breakfast.
If you take more Olmedie than you should
If you take more tablets than prescribed or if a child accidentally swallows any, go immediately to a doctor or the nearest emergency department and bring the medicine pack with you.
If you forget to take Olmedie
If you forget to take a dose, take your usual dose the next day as normal.
Do not take a double dose to make up for the forgotten dose.
If you stop taking Olmedie
It is important to continue taking Olmedie until your doctor tells you to stop.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If side effects occur, they are often mild and do not require discontinuation of treatment.
Although many people do not experience them, the following side effects can be serious:
Rarely (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 sensation and rash, which
may occur during treatment with Olmedie. If this happens, stop treatment with Olmedie and contact your
doctor immediately.
Rarely (but significantly more often in elderly people), Olmedie may cause a greater drop in 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 taking Olmedie, contact your doctor immediately, and remain
lying down.
Frequency not known: if you experience yellowing of the whites of the eyes, dark urine, or skin itching,
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even if you have been taking Olmedie for a long time, contact your doctor immediately. Your doctor will
evaluate your symptoms and decide how to proceed with therapy for the treatment of arterial
hypertension.
Other side effects known so far with Olmedie include:
Common (may affect more than 1 in 10 people):
Dizziness, headache, nausea, indigestion, diarrhoea, stomach ache, gastroenteritis, fatigue, sore
throat, runny or blocked nose, bronchitis, influenza-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 observed, including: increased levels of fat
(hypertriglyceridaemia), increased levels of uric acid (hyperuricaemia), increased blood urea, increased
liver and muscle function tests.
Uncommon (may affect more than 1 in 100 people):
Rapid allergic reactions that may affect the whole body and may cause breathing difficulties, as well as
a rapid drop in blood pressure that may lead to fainting (anaphylactic reactions), dizziness, vomiting,
weakness, malaise, muscle pain, skin rashes, allergic skin rashes, itching, rash (skin eruption), skin
nodules (hives), angina (pain or discomfort in the chest).
In blood test results, a decrease in the number of a type of blood cell, known as platelets
(thrombocytopenia), has been observed.
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
(hyperkalaemia) and increased levels of compounds 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 experience any side effects, including those not listed in this leaflet, talk to your doctor or
pharmacist. You can also report side effects directly via 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 special storage conditions.
Do not dispose of any medicine via wastewater 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 substance 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, monohydrate lactose, 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 contents of the pack
The 10 mg film-coated tablets are white, round, slightly biconvex, with the mark S1 engraved 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 mark S2 engraved 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 mark S3 engraved 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 Authorization 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 authorized in the Member States of the European Economic Area under the following names:

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