Olmesartan medoxomil PensA

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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 others, even if their symptoms are the same as yours, because it could 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 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. 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. These medicines lower blood pressure by relaxing blood vessels. Olmesartan medoxomil Pensa is used to treat high blood pressure (also known as "hypertension") in adults, children, and adolescents aged 6 to 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 attacks, heart or kidney failure, stroke, or blindness. High blood pressure usually does not cause symptoms. It is important to monitor your blood pressure regularly to prevent such complications.

High blood pressure can be controlled with medicines such as Olmesartan medoxomil Pensa tablets. Your doctor has likely also recommended that you make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol intake, and reducing dietary salt). Your doctor may also have advised you to exercise regularly, such as walking or swimming. It is important that you follow your doctor's advice.

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 to any of the excipients of this medicine (listed in section 6).
• if you are more than three months pregnant (it is better to avoid Olmesartan medoxomil Pensa even in the early stages of pregnancy – see section “Pregnancy”).

 if you have yellowing of the skin and eyes (jaundice) or disorders affecting bile flow from the gallbladder (biliary obstruction, for example 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 before taking Olmesartan medoxomil Pensa.

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

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

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

Consult your doctor if you also have any of the following health conditions:

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

Inform your doctor if you develop severe and prolonged diarrhoea with significant weight loss. Your doctor will evaluate your symptoms and decide whether to continue this antihypertensive treatment.
As with any medicine that lowers blood pressure, excessive reduction of blood pressure in patients with circulatory disorders of the heart or brain may 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 Pensa is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby when taken during this period (see section “Pregnancy”).

Patients of black ethnic origin
As with other similar medicines, the blood pressure-lowering effect of Olmesartan medoxomil Pensa is somewhat reduced in patients of black ethnic origin.

Elderly patients
If you are over 65 years of age and your doctor decides to increase your dose of olmesartan medoxomil to 40 mg daily, your blood pressure should be regularly monitored by your doctor to prevent it from 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 for children aged 1 to 6 years and must 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, inform your doctor or pharmacist if:

• Other medicines that lower blood pressure may increase the effect of Olmesartan medoxomil Pensa. Your doctor may need to adjust the dose and/or take other precautions. If you are taking an ACE inhibitor or aliskiren (see also the sections: “Do not take Olmesartan medoxomil Pensa” and “Warnings and precautions”).
• Potassium supplements, potassium-containing salt substitutes, diuretics, or heparin (used to thin the blood). Taking these medicines together with Olmesartan medoxomil Pensa may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood swings and certain types of depression) taken together with Olmesartan medoxomil Pensa 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) 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 reduce 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 must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Olmesartan medoxomil Pensa before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Olmesartan medoxomil Pensa. Olmesartan medoxomil Pensa is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.

Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Olmesartan medoxomil Pensa is not recommended for women who are breast-feeding, and your doctor may choose a different treatment if you wish to breast-feed, especially if the baby is newborn or was born prematurely.

If you are pregnant or breast-feeding, 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 experience drowsiness or dizziness during treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms resolve. Consult your doctor.

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

3. How to take Olmesartan medoxomil Pensa

Always take this medicine exactly as instructed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
The recommended starting dose is one 10 mg tablet once daily. However, if
blood pressure is not controlled, your doctor may decide to increase the dose to 20 mg or 40 mg
once daily, or may prescribe additional medicines.
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. The tablets should be swallowed with
an adequate amount of water (for example, a glass). If possible, take your daily dose at the same
time each day, for example with breakfast.
Children and adolescents aged 6 to 18 years:
The recommended starting dose is 10 mg once daily. 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 daily. In children weighing less than 35 kg, the dose will not exceed 20 mg once daily.
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 the nearest hospital emergency department and take the
medicine pack with you.
If you forget to take Olmesartan medoxomil Pensa
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 Olmesartan medoxomil Pensa
It is important that you continue taking Olmesartan medoxomil Pensa until your doctor
tells you otherwise.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. If they do occur, they are often mild and do not require discontinuation of treatment.

Although they do not occur in many people, the following side effects can be serious:

Very rarely (affecting up to 1 in 1,000 people), the following allergic reactions involving the whole body have been reported:

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 frequently in elderly patients), Olmesartan medoxomil Pensa may cause excessive lowering of 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 remain lying down.

Frequency not known: if you notice yellowing of the whites of the eyes, dark urine, or skin itching, even if you have been taking Olmesartan medoxomil Pensa for a long time, contact your doctor immediately. The doctor will assess your symptoms and decide how to proceed with treatment for high blood pressure.

The following 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, diarrhoea, stomach ache, gastroenteritis, fatigue, sore throat, runny or blocked nose, bronchitis, flu-like symptoms, cough, pain, chest, back, bone or joint pain, urinary tract infection, swelling of the ankles, feet, legs, hands or arms, blood in the urine.

Some laboratory test abnormalities have also been observed, including the following:
increase in blood fats (hypertriglyceridaemia), increase in uric acid in the blood (hyperuricaemia), increase in blood urea, increase in liver and muscle function tests.

Uncommon side effects (may affect up to 1 in 100 people):
Rapid allergic reactions that may affect the whole body and may cause breathing difficulties or a rapid drop in blood pressure, which may also lead to fainting (anaphylactic reactions), facial swelling, dizziness, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, exanthema (skin rash), skin blisters (wheals), angina (pain or discomfort in the chest).

In blood tests, a reduction in the number of a type of blood cell, known as platelets (thrombocytopenia), has been observed.

Rare side effects (may affect up to 1 in 1,000 people):
Lack of energy, muscle cramps, impaired kidney function, kidney failure.

Some laboratory test abnormalities have also been observed. These include increased potassium levels (hyperkalaemia) 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 in adults. However, dizziness and headache have been observed more frequently in children, and nosebleeds are a common side effect only in children.

Reporting of side effects
If you experience any side effect, 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 the following 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 Pensa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via 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 substance is olmesartan medoxomil. Each film-coated tablet contains 10 mg, 20 mg or 40 mg of olmesartan medoxomil.
• The other components 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 is white, cylindrical, biconvex, with a score line on one side and "OL1" imprinted on the other side.
Olmesartan medoxomil Pensa 20 mg film-coated tablet is white, cylindrical, biconvex, with a score line on one side and "OL2" imprinted on the other side.
Olmesartan medoxomil Pensa 40 mg film-coated tablet is white, oblong, biconvex, with a score line on one side and "OL4" imprinted on the other side.
Olmesartan medoxomil Pensa film-coated tablets are available in packs containing 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini 12
20124 Milano, Italy

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

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