Coabesart

Package leaflet: Information for the user

COABESART 150 mg/12.5 mg film-coated tablets, 300 mg/12.5 mg film-coated tablets, 300 mg/25 mg film-coated tablets

Irbesartan and Hydrochlorothiazide
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, because it may be harmful. If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
What COABESART is and what it is used for
What you need to know before taking COABESART
How to take COABESART
Possible side effects
How to store COABESART
Contents of the pack and other information

1. What COABESART is and what it is used for

COABESART is a combination of two active substances: irbesartan and hydrochlorothiazide.
Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to its receptors located in the blood vessels, causing them to narrow. This leads to an increase in blood pressure. Irbesartan prevents angiotensin-II from binding to these receptors, resulting in relaxation of the blood vessels and a reduction in blood pressure.
Hydrochlorothiazide belongs to a group of medicines (so-called thiazide diuretics) that increase urine production, thereby lowering blood pressure.
The two active ingredients in COABESART work together to reduce blood pressure to a greater extent than either medicine alone.
COABESART is used to treat high blood pressure (essential hypertension) when treatment with either irbesartan or hydrochlorothiazide alone has not adequately controlled your blood pressure.

2. What you need to know before taking COABESART

Do not take COABESART:

• if you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to hydrochlorothiazide or to medicines chemically related to sulfonamides
• if you are more than 3 months pregnant (it is better to avoid taking COABESART even in the early stages of pregnancy – see section “Pregnancy”)
• if you have severe liver or kidney problems
• if you have difficulty urinating
• if you have a condition associated with persistently high calcium levels or low potassium levels in the blood
• 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 COABESART if you are in any of the following situations:

• if you have previously had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking COABESART
• excessive vomiting or diarrhoea
• if you have kidney disorders, including kidney transplant
• if you have heart disorders
• if you have liver disorders
• if you have diabetes
• if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, tremor, headache, flushing or paleness, numbness, rapid and pounding heartbeat), especially if you are being treated for diabetes
• if you have systemic lupus erythematosus (also known as lupus or SLE)
• if you have primary hyperaldosteronism (a condition associated with excessive production of the hormone aldosterone, causing sodium retention and subsequently increased blood pressure)
• 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 kidney problems related to diabetes, or aliskiren.
• if you have previously experienced breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking COABESART, consult a doctor immediately. Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals. See also the section "Do not take COABESART". You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). COABESART 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 child if taken during this period (see section “Pregnancy”).

Additionally, inform your doctor:

• if you are on a low-salt diet
• if you experience symptoms such as excessive thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an excessively rapid heartbeat, which may indicate an excessive effect of hydrochlorothiazide (contained in COABESART)
• if you have noticed an increased, abnormally rapid sensitivity of the skin to sunlight, with symptoms of sunburn (such as redness, itching, swelling, rash)
• if you are due to undergo surgery or receive anaesthetics
• if you experience a decrease in vision or pain in one or both eyes while taking COABESART. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye (glaucoma), and may occur from a few hours to a week after taking COABESART. This could lead to permanent vision loss if not treated. If you previously had an allergic reaction to penicillin or sulfonamides, you may be at higher risk of developing this condition. You should stop taking COABESART and consult your doctor promptly.
  Caution for athletes: The active substance contained in this preparation is included in the list of prohibited substances for doping. Hydrochlorothiazide, contained in this medicine, may lead to positive results in anti-doping tests.

Children and adolescents
COABESART must not be given to children and adolescents (under 18 years of age).
Other medicines and COABESART
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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 the sections: "Do not take COABESART" and “Warnings and precautions”).
• Diuretic medicines such as hydrochlorothiazide contained in COABESART may interact with other medicines.
• Preparations containing lithium must not be taken together with COABESART, unless under strict medical supervision.

You may need regular blood tests if you are using:

• potassium supplements
• salt substitutes containing potassium
• potassium-sparing agents or other diuretics
• certain laxatives
• medicines for the treatment of gout
• vitamin D supplements
• medicines to control heart rhythm
• medicines for diabetes (oral medications such as repaglinide or insulin)
• carbamazepine (a medicine used to treat epilepsy).

It is also important to inform your doctor if you are taking other medicines to lower blood pressure, steroids, cancer treatments, painkillers or medicines for arthritis, or colestyramine and colestipol to lower blood cholesterol.
COABESART with food and drink
COABESART can be taken with or without food.
Due to the hydrochlorothiazide contained in COABESART, if you drink alcohol while taking this medicine, you may feel more dizzy when standing up, especially when moving from a sitting to a standing position.
Pregnancy, breastfeeding and fertility
Pregnancy
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 COABESART before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of COABESART.
COABESART 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 child if taken after the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breastfeeding or planning to breastfeed.
COABESART is not recommended for women who are breastfeeding. Your doctor may choose an alternative treatment for you if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
It is unlikely that COABESART will affect your ability to drive or use machines. However, dizziness or tiredness may occasionally occur during treatment for high blood pressure. If this happens, talk to your doctor before driving or operating machinery.
COABESART contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars (e.g. lactose), contact him before taking this medicine.
COABESART contains sodium. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take COABESART

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Dosage
The recommended dose of COABESART is one or two tablets daily.
COABESART will be prescribed by your doctor if your previous antihypertensive therapy has not provided adequate blood pressure reduction. Your doctor will advise you on how to switch from your previous treatment to COABESART.
Method of administration
COABESART is for oral use. Swallow the tablets with a sufficient amount of liquid (for example, a glass of water). You may take COABESART with or without food. Try to take the medicine at the same time every day. It is important to continue therapy unless otherwise instructed by your doctor.
Maximum blood pressure lowering effect will be achieved within 6–8 weeks after starting treatment.
If you take more COABESART than you should
If you accidentally take too many tablets, contact your doctor immediately.
Children must not take COABESART
COABESART must not be given to children and adolescents under 18 years of age. If a child swallows any tablets, contact your doctor immediately.
If you forget to take COABESART
If you forget to take a dose, simply continue with your next dose at the usual time. Do not take a double dose to make up for the forgotten dose.
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 everybody gets them.
Some of these side effects may be serious and may require medical attention.
As with similar medicines, rare cases of skin allergic reactions (rash, urticaria) as well as localized swelling of the face, lips and/or tongue have been reported in patients treated with irbesartan. If you experience any of these symptoms or have difficulty breathing, stop taking COABESART and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention:
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people

The side effects reported in clinical studies in patients treated with COABESART were:

Common (may affect up to 1 in 10 people)

• nausea/vomiting
• urinary disorders
• fatigue
• dizziness (also when moving from a sitting or lying position to a standing position)
• Blood tests may show increased levels of an enzyme that measures muscle and heart function (creatine kinase) or increased levels of substances that measure kidney function (blood urea nitrogen, creatinine). If any of these side effects cause you problems, discuss them with your doctor.

Uncommon (may affect up to 1 in 100 people)

• diarrhoea
• hypotension
• weakness
• rapid heartbeat
• hot flushes
• swelling
• sexual dysfunction (problems with sexual activity)
• blood tests may show decreased levels of potassium and sodium in the blood

If any of these side effects cause you problems, talk to your doctor.

Side effects reported after marketing of COABESART
The frequency of these side effects is not known.
These side effects include: headache, tinnitus, cough, taste disturbances, indigestion, joint and muscle pain, liver function abnormalities and renal dysfunction, elevated potassium levels in the blood, and allergic reactions (rash, urticaria, localized swelling of the face, lips, mouth, tongue or throat).
Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.
As with any combination of two active substances, side effects associated with each of the components cannot be excluded.

Side effects associated with taking IRBESARTAN alone
In addition to the side effects listed above, chest pain, severe allergic reactions (anaphylactic shock), reduced number of red blood cells (anaemia - symptoms may include tiredness, headache, shortness of breath during physical activity, dizziness and pale appearance), and reduced platelet count (blood cells essential for blood clotting) have been reported.

Side effects associated with taking IDROCHLOROTHIAZIDE alone

• loss of appetite
• stomach irritation
• stomach cramps
• constipation
• jaundice (yellowing of the skin and/or whites of the eyes)
• inflammation of the pancreas characterized by severe pain in the upper stomach, often with nausea and vomiting
• sleep disorders
• depression
• blurred vision
• sudden-onset reduced distance vision (acute myopia), reduced vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma) (frequency not known)
• absence of white blood cells, which may lead to frequent infections
• fever
• decreased platelet count (a component essential for blood clotting)
• reduced red blood cell count (anaemia) characterized by fatigue, headache, shortness of breath during exercise, dizziness and pale appearance
• kidney problems
• lung problems including pneumonia or fluid accumulation in the lungs
• increased sensitivity of the skin to sunlight
• inflammation of blood vessels, a skin disorder characterized by skin peeling over the entire body
• lupus erythematosus, identified by a rash that may appear on the face, neck and scalp
• allergic reactions
• muscle weakness and muscle spasms
• irregular heartbeat
• drop in blood pressure upon changing body position
• swelling of the salivary glands
• elevated blood sugar levels
• sugar in the urine
• increases in certain types of blood fats
• elevated levels of uric acid in the blood which may cause gout
• skin and lip cancer (non-melanoma skin cancer) (Frequency “not known”)
• acute respiratory distress (symptoms include severe shortness of breath, fever, weakness and confusion) (very rare)

It is known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.

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: 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 COABESART

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original packaging to protect from light.
Do not dispose of medicines 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 COABESART contains
COABESART 150 mg/12.5 mg: each tablet contains 150 mg of irbesartan and 12.5 mg of
hydrochlorothiazide, which are the active substances.
COABESART 300 mg/12.5 mg: each tablet contains 300 mg of irbesartan and 12.5 mg of
hydrochlorothiazide, which are the active substances.
COABESART 300 mg/25 mg: each tablet contains 300 mg of irbesartan and 25 mg of
hydrochlorothiazide, which are the active substances.

All strengths contain the following excipients: Monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, Poloxamer 188, pregelatinized starch, magnesium stearate.

Additionally, the film coating of COABESART 150 mg/12.5 mg tablets also contains Opadry pink 03A34089 (composed of hypromellose, stearic acid, titanium dioxide (E 171), microcrystalline cellulose, yellow iron oxide (E 172), and red iron oxide (E 172)).

The film coating of COABESART 300 mg/25 mg tablets also contains Opadry pink 03A36005 (composed of hypromellose, stearic acid, titanium dioxide (E 171), microcrystalline cellulose, black iron oxide (E 172), and red iron oxide (E 172)).

Description of the appearance of COABESART and package contents

• COABESART 150 mg/12.5 mg: light pink, oval, biconvex coated tablets, 14.1 x 8.1 mm.
• COABESART 300 mg/12.5 mg: light pink, oval, biconvex coated tablets, 17.5 x 9.4 mm.
• COABESART 300 mg/25 mg: brick-red, oval, biconvex coated tablets with a break line. This break line is intended solely to facilitate tablet splitting for easier ingestion and is NOT FOR DIVIDING THE TABLET INTO EQUAL DOSES. All strengths are supplied in blisters.

Pack contents:
28 coated tablets.

Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder
S.F. GROUP S.r.l.
Via Tiburtina, 1143
00156 - Roma (RM)
Italy

Manufacturer:
Genetic S.p.A. – Contrada Canfora – 84084 Fisciano (SA) - Italy

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Coabesart

This patient information leaflet was last updated on