Plaunac

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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

1. What PLAUNAC is and what it is used for

Plaunac belongs to a group of medicines called angiotensin II receptor antagonists. These medicines lower blood pressure by relaxing blood vessels.
Plaunac is used to treat high blood pressure (also known as "hypertension"). 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 help prevent such complications.
High blood pressure can be controlled with medicines such as Plaunac tablets. Your doctor has likely also advised you to 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 encouraged 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 PLAUNAC

Do not take Plaunac

• 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 Plaunac tablets during early pregnancy); see section "Pregnancy and breastfeeding";
• 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 Plaunac.
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), especially 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.
See also information under the heading "Do not take Plaunac".
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, diarrhoea, treatment with high doses of diuretics, or if you are on a low-salt diet.
• Increased levels of potassium in the blood.
• Adrenal gland disorders.

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). Plaunac 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 child if taken during this period (see section "Pregnancy and breastfeeding").

Children and adolescents
Plaunac is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Plaunac
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 each of the following:

• Other medicines that lower blood pressure may increase the effect of Plaunac. Your doctor may need to adjust the dose and/or take other precautions. If you are taking an ACE inhibitor or aliskiren (see also information under "Do not take Plaunac" and "Warnings and precautions").
• Potassium supplements, potassium-containing salt substitutes, diuretics, or heparin (used to thin the blood). Taking these medicines together with Plaunac may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood swings and certain types of depression) taken together with Plaunac 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 Plaunac may increase the risk of kidney failure, and the effectiveness of Plaunac may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, which may reduce the effect of Plaunac. Your doctor may advise you to take Plaunac at least 4 hours before colesevelam hydrochloride.
• Some antacids (used for indigestion) may slightly reduce the effectiveness of Plaunac.

Elderly
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 must be regularly monitored by your doctor to prevent excessive lowering.

Patients of black ethnicity
As with other similar medicines, the blood pressure-lowering effect of Plaunac is somewhat reduced in patients of black ethnicity.

Plaunac with food and drink
Plaunac 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). Normally, your doctor will advise you to stop taking Plaunac before becoming pregnant or as soon as you find out you are pregnant, and will recommend another medicine instead of Plaunac. Plaunac 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 child if taken after the third month of pregnancy.

Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed.
Plaunac is not recommended for women who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn or premature.

If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breast-feeding, 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.

Plaunac contains lactose
This medicine contains lactose (a type of sugar). 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 use PLAUNAC

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 your blood pressure
is not controlled, your doctor may decide to increase the dose to 20 or 40 mg once daily, or may
prescribe other 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. Swallow the tablets with a sufficient amount of
water (for example, a glass). If possible, take your daily dose at the same time each day, for
example with breakfast.
If you take more Plaunac 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 department, taking the medicine pack with you.
If you forget to take Plaunac
If you forget to take a dose, take your normal dose the next day. Do not take a double dose to
make up for the forgotten tablet.
If you stop taking Plaunac
It is important to continue taking Plaunac unless your doctor tells you to stop.
If you have any questions about how to use Plaunac, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. If they do occur, they are mostly mild and do not require discontinuation of treatment.
Although they do not occur in everyone, the following two side effects can be serious:
In rare cases (affecting up to 1 in 1,000 people), the following allergic reactions affecting the entire body have been reported:
During treatment with Plaunac, swelling of the face, mouth and/or larynx (site of the vocal cords), associated with itching and skin rash, may occur. If this happens, stop taking Plaunac and contact your doctor immediately.
Rarely (but slightly more frequently in elderly patients), Plaunac 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 Plaunac, contact your doctor immediately, and remain lying down.

The following are the other side effects known so far with Plaunac:

Common side effects (may affect up to 1 in 10 people):
Dizziness, headache, nausea, indigestion, diarrhoea, stomach pain, gastroenteritis, fatigue, sore throat, nasal secretion, bronchitis, influenza-like symptoms, cough, pain, chest, back, bone or joint pain, urinary tract infection, swelling of ankles, feet, legs, hands or arms, blood in urine.

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

Uncommon side effects (may affect up to 1 in 100 people):
Rapid allergic reactions affecting the whole body, which may cause breathing difficulties or a rapid drop in blood pressure that may 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 particle normally present in the blood, called platelets (thrombocytopenia), has been observed.

Rare side effects (may affect up to 1 in 1,000 people):
Lack of energy, muscle cramps, reduced 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:
http://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 PLAUNAC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the blister (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 Plaunac 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, monohydrate lactose, hydroxypropylcellulose,
low-substituted hydroxypropylcellulose, magnesium stearate, titanium dioxide (E171), talc and
hypromellose (see section 2 “Plaunac contains lactose”).

Description of the appearance of Plaunac and the contents of the pack
Plaunac 10 mg film-coated tablets, round, white in colour, with the code C13 engraved on one side;
Plaunac 20 mg film-coated tablets, round, white in colour, with the code C14 engraved on one side;
Plaunac 40 mg film-coated tablets, oval, white in colour, with the code C15 engraved on one side.
Plaunac is available in packs of 14, 28, 30, 56, 84, 90, 98 and 10x28 film-coated tablets, and in packs of 10, 50 and 500 film-coated tablets with pre-scored blisters for single doses.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Menarini International Operations Luxembourg S.A. - 1, Avenue de la Gare, L-1611 Luxembourg.
Under licence from Daiichi Sankyo Europe GmbH

Sales concessionaire: Laboratori Guidotti S.p.A., Via Livornese 897, La Vettola - Pisa

Manufacturers
Daiichi Sankyo Europe GmbH
Luitpoldstrasse 1
85276 Pfaffenhofen (Germany)
Berlin Chemie AG
Glienicker Weg, 125
12489 Berlin (Germany)
Laboratorios Menarini, S.A.
Alfons XII, 587 - E 08918 Badalona Barcelona (Spain)

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Olmes
Italy: Plaunac
Spain: Openvas