Package leaflet: Information for the user

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

Equivalent medicine
Please read all of this leaflet carefully before you start 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What CARDOL is and what it is used for
What you need to know before taking CARDOL
How to take CARDOL
Possible side effects
How to store CARDOL
Contents of the pack and other information

1. What CARDOL is and what it is used for

CARDOL belongs to a group of medicines called angiotensin II receptor antagonists.
They lower blood pressure by relaxing blood vessels.
CARDOL is used to treat high blood pressure (also known as “arterial hypertension”) in adults and 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. Usually, high blood pressure does not cause symptoms. It is important to monitor your blood pressure to prevent the development of such complications.
High blood pressure can be controlled with medicines such as CARDOL 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 encouraged you to exercise regularly, such as walking or swimming. It is important that you follow your doctor’s advice.

2. What you should know before taking CARDOL

Do not take CARDOL:

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 CARDOL during early pregnancy – see the section on pregnancy).
if you have yellowing of the skin and eyes (jaundice) or impaired 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 or pharmacist before taking CARDOL.
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.
See also the section “Do not take CARDOL”.
Consult your doctor if you 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 problems. Inform your doctor if you develop severe and prolonged diarrhoea accompanied by 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 lowering 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). CARDOL 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
CARDOL has been studied in children and adolescents.
For further information, consult your doctor. CARDOL is not recommended for children aged 1 to 6 years and must not be used in children under 1 year of age, as there is no available experience in this age group.
Other medicines and CARDOL
Inform 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 you are taking any of the following medicines:

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

Elderly
If you are over 65 years of age and your doctor decides to increase your olmesartan dose to 40 mg daily, your blood pressure must be regularly monitored by your doctor to prevent it from dropping too low.
Patients of Black ethnicity
As with other similar medicines, the blood pressure-lowering effect of CARDOL is somewhat reduced in patients of Black ethnicity.
CARDOL with food and drinks
CARDOL 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 CARDOL before becoming pregnant or as soon as you find out you are pregnant, and will recommend another medicine instead of CARDOL. CARDOL 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.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. CARDOL is not recommended for women who are breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
You may experience drowsiness or dizziness during antihypertensive treatment.
If this occurs, do not drive or operate machinery until symptoms resolve.
Consult your doctor.
CARDOL contains lactose
This medicine contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take CARDOL

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 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. Swallow the tablets with a sufficient amount of water (for example, a glass of water). If possible, take your daily dose at the same time each day, for example with breakfast. The tablet must be swallowed whole and not chewed.

Use in 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 must not exceed 20 mg once daily.

If you take more CARDOL than you should
If you take more tablets than prescribed or if a child accidentally ingests any tablets, go immediately to your doctor or the nearest emergency department, taking the medicine pack with you.

If you forget to take CARDOL
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 CARDOL
It is important to continue taking CARDOL unless your doctor tells you otherwise.
If you have any doubts about how to use CARDOL, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, CARDOL may cause side effects, although not everyone experiences them.
If they do occur, they are mostly mild and do not require discontinuation of treatment.
However, although not occurring in all individuals, the following side effects can be serious:
Rarely (affecting up to 1 in 1,000 people), the following allergic reactions affecting the whole body have been reported:
During treatment with CARDOL, 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 CARDOL and contact your doctor immediately.
Rarely (but slightly more frequently in elderly people), CARDOL may cause excessive lowering of blood pressure in sensitive individuals or as a result of an allergic reaction.
This could lead to severe dizziness or fainting. If this happens, stop taking CARDOL, 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, contact your doctor immediately, even if you started treatment with CARDOL a long time ago. Your doctor will evaluate your symptoms and decide how to proceed with therapy for the treatment of arterial hypertension.

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

Common side effects (may affect up to 1 in 10 people):
Dizziness, headache, nausea, indigestion, diarrhoea, stomach pain, gastroenteritis, fatigue, throat irritation, runny or blocked nose, 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 levels of fats in the blood (hypertriglyceridaemia), increased uric acid in the 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 that may affect the whole body and may cause breathing difficulties or a rapid drop in blood pressure that may even lead to fainting (anaphylactic reactions), facial swelling, vertigo, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, rash (skin eruption), skin blisters (wheals), angina (pain or discomfort in the chest).

A reduction in the number of a type of blood 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, impaired kidney function, kidney failure.

Some laboratory test abnormalities have also been observed.
These include increased levels of potassium (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, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 CARDOL

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 each blister or
bottle 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 CARDOL contains

The active substance is olmesartan medoxomil. Each tablet contains 5 mg, 10 mg, 20 mg or 40 mg of olmesartan medoxomil.
The other components are:
Tablet core: microcrystalline cellulose, monohydrate lactose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose and magnesium stearate
Film coating: Opadry II White 33G28435 containing: titanium dioxide (E171), hypromellose 6cP, lactose monohydrate, macrogol 3350 and triacetin.

Description of the appearance of CARDOL and contents of the pack
CARDOL 10 mg, film-coated tablets are white, round, biconvex tablets with a diameter of 6.5 mm, marked with "OL 10" on one side.
CARDOL 20 mg, film-coated tablets are white, round, biconvex tablets with a diameter of 8.5 mm, marked with "OL 20" on one side.
CARDOL 40 mg, film-coated tablets are white, oval, biconvex tablets of 15x7 mm, marked with "OL 40" on one side.
CARDOL is available in packs of 28 film-coated tablets in aluminum blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
S.F. Group S.r.l.
Via Tiburtina, 1143
00156 Rome
Italy

Manufacturer
Actavis Ltd.,
BLB 015-016 Bulebel Industrial Estate,
Zejtun ZTN 3000,
Malta

This medicinal product is authorized in the European Economic Area countries with the following names:
Italy: CARDOL

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco).