Candesartan Teva Italia: detailed information

Package leaflet: Information for the user

Candesartan Teva Italia 8 mg tablets, 16 mg tablets, 32 mg tablets

Generic 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, because it may be harmful.
If you experience any side effect, tell your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Candesartan Teva Italia is and what it is used for

The name of this medicine is Candesartan Teva Italia. The active substance is Candesartan cilexetil.
This medicine belongs to a group of medicines known as angiotensin II receptor antagonists. It causes blood vessels to relax and widen, thereby helping to reduce blood pressure. In addition, it helps the heart pump blood to all parts of the body.

This medicine is used for:

treating high blood pressure (hypertension) in adults and in children and adolescents aged 6 to <18 years;
treating heart failure in adults with reduced heart muscle function, when angiotensin-converting enzyme (ACE) inhibitors cannot be used, or in addition to ACE inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRAs) cannot be used. (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. What you should know before taking Candesartan Teva Italia

Do not take Candesartan Teva Italia

if you are allergic to candesartan cilexetil or to any of the other ingredients of this medicine (listed in section 6);
if you are more than 3 months pregnant (it is nevertheless advisable to avoid Candesartan Teva Italia at the beginning of pregnancy - see section 2: Pregnancy and breastfeeding);
if you have severe liver disease or biliary obstruction (a problem with bile drainage from the gallbladder);
if the patient is a child under 1 year of age;
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are unsure whether any of these conditions apply to you, consult your doctor or pharmacist before
taking Candesartan Teva Italia.
Warnings and precautions
Talk to your doctor or pharmacist before taking Candesartan Teva Italia if:

you have heart, liver or kidney problems or are on dialysis;
you have recently undergone a kidney transplant;
you are experiencing vomiting, have vomited frequently recently, or have diarrhoea;
you have an adrenal gland disorder called Conn's syndrome (or primary hyperaldosteronism);
you have low blood pressure;
you have had a stroke;
inform your doctor if you think you may be (or may become) pregnant. Candesartan Teva Italia 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 when used at this stage (see section 2: Pregnancy and breastfeeding);
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
aliskiren
if you are taking an ACE inhibitor together with a medicine belonging to a class of medicines known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see "Other medicines and Candesartan Teva Italia"). Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals.

See also the information under the heading "Do not take Candesartan Teva Italia".
If you have any of these conditions, your doctor may ask you to have more frequent check-ups and
undergo certain tests.
If you are scheduled for surgery, inform your doctor or dentist that you are taking
Candesartan Teva Italia. This is necessary because, when combined with certain anaesthetics,
Candesartan Teva Italia may cause a drop in blood pressure.
Children and adolescents
Candesartan Teva Italia has been studied in children. For further information, consult your doctor.
Candesartan Teva Italia must not be administered to children under 1 year of age due to the potential risk to developing kidneys.
Other medicines and Candesartan Teva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Candesartan Teva Italia may affect how some other medicines work, and some medicines may affect Candesartan Teva Italia. If you are taking certain types of medicines, your doctor may need to perform periodic blood tests.
In particular, inform your doctor if you are taking any of the following medicines:

other medicines that help lower blood pressure, such as beta-blockers and diazoxide;
non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines used to relieve pain and inflammation);
acetylsalicylic acid (if you take more than 3 g per day) (a medicine used to reduce pain and inflammation);
potassium supplements or potassium-containing salt substitutes (medicines that increase potassium levels in the blood);
heparin (an anticoagulant);
diuretics;
lithium (a medicine used for mental health conditions).

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 Candesartan Teva Italia" and "Warnings and precautions").
If you are being treated with an ACE inhibitor together with other medicines used for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Candesartan Teva Italia with food, drinks and alcohol

You may take Candesartan Teva Italia with or without food.
If Candesartan Teva Italia is prescribed for you, consult your doctor before drinking alcohol. Alcohol may cause weakness or dizziness.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking/using this medicine.
Pregnancy
Inform your doctor if you think you may be (or may become) pregnant. Your doctor will usually advise you
to stop taking Candesartan Teva Italia before starting a pregnancy or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Candesartan Teva Italia.
Candesartan Teva Italia is not recommended during early pregnancy and must not be taken after the
3rd month of pregnancy, as it may cause serious harm to the unborn baby if used beyond the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Candesartan Teva Italia is not
recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you wish to breastfeed, especially if the infant is a newborn or premature.
Driving and using machines
Some people feel tired or dizzy when taking Candesartan Teva Italia. If you experience these symptoms, do not drive or operate tools or machinery.
Candesartan Teva Italia contains lactose, a type of sugar. If you know you are intolerant to certain sugars, please consult your doctor before taking this medicine.

3. How to take Candesartan Teva Italia

Take this medicine exactly as prescribed by your doctor or pharmacist.
Consult your doctor or pharmacist. It is important that you take Candesartan Teva Italia every day.
You may take Candesartan Teva Italia with or without food.
Swallow the tablet with water.
Try to take the tablet at the same time each day. This will help you remember to take your tablet.

High blood pressure:

The usual dose of Candesartan Teva Italia is 8 mg once daily. Your doctor may increase the dose to 16 mg once daily and subsequently up to 32 mg once daily, depending on your blood pressure response.
Your doctor may prescribe a lower starting dose for some patients, for example those with liver or kidney problems, or those who have recently lost body fluids due to vomiting, diarrhoea, or diuretic treatment.
Some patients of Black origin may have a reduced response to this type of medicine when taken alone. Therefore, these patients may require a higher dose.

Heart failure

The usual starting dose of Candesartan Teva Italia is 4 mg once daily. Your doctor may increase the dose by doubling it at intervals of at least 2 weeks, up to a maximum of 32 mg once daily. Candesartan Teva Italia may be taken together with other medicines for heart failure, and your doctor will decide which treatment is suitable for you.

Use in children and adolescents with hypertension:
Children aged 6 to <18 years:
The recommended starting dose is 4 mg once daily.
For patients weighing <50 kg: in some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose up to a maximum of 8 mg once daily.
For patients weighing ≥ 50 kg: in some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose to 8 mg once daily and 16 mg once daily.
The tablet may be divided into two equal doses.

If you take more Candesartan Teva Italia than you should
If you take more Candesartan Teva Italia than prescribed, contact your doctor or pharmacist immediately for advice.

If you forget to take Candesartan Teva Italia
Do not take a double dose to make up for the missed tablet. Simply take the next dose as usual.

If you stop taking Candesartan Teva Italia
If you stop taking Candesartan Teva Italia, your blood pressure may rise again. Therefore, do not stop taking Candesartan Teva Italia without first consulting your doctor.

If you have any doubts 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 everybody gets them.
It is important that you are aware of the side effects that could occur.
Stop taking Candesartan Teva Italia and contact your doctor immediately if you develop any of the following allergic reactions:

difficulty breathing, with or without swelling of the face, lips, tongue and/or throat;
swelling of the face, lips, tongue and/or throat, which may cause difficulty swallowing;
severe itching of the skin (with raised skin rashes).

Candesartan Teva Italia may cause a reduction in the number of white blood cells. Your resistance to infections may decrease, and you may feel tired or develop an infection or fever. In such cases, consult your doctor. Your doctor may occasionally carry out blood tests to check whether Candesartan Teva Italia has had any effect on your blood (agranulocytosis).

Other possible side effects:
Common (may affect up to 1 in 10 people)

Dizziness/feeling of vertigo.
Headache.
Respiratory tract infection.
Low blood pressure, which may cause dizziness or feeling weak.
Changes in blood test results:
increase in the amount of potassium in the blood, especially if you already have kidney problems or heart failure. If the increase in potassium is significant, you may experience tiredness, weakness, irregular heartbeat, or tingling.
Effects on kidney function, especially if you already have kidney problems or heart failure. In very rare cases, kidney failure may occur.

Very rare (may affect up to 1 in 10,000 people)

Swelling of the face, lips, tongue and/or throat.
Reduction in red or white blood cells. You may feel tired or develop an infection or fever.
Skin rash, hives.
Itching.
Cough.
Back pain, joint and muscle pain.
Changes in liver function, including inflammation of the liver (hepatitis). You may notice tiredness, yellowing of the skin and whites of the eyes, and flu-like symptoms.
Nausea.
Changes in blood test results:
reduction in the amount of sodium in the blood. If this reduction is significant, you may experience weakness, lack of energy, or muscle cramps.

Not known (frequency cannot be estimated from the available data)

Diarrhoea

Other side effects in children and adolescents
In children treated for high blood pressure, side effects appear to be similar to those observed in adults, but occur more frequently. Sore throat is a very common side effect in children, but is not reported in adults, while runny nose, fever, and increased heart rate are common in children but not reported in adults.

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.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
.

5. How to store Candesartan Teva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after the word {EXP}. The expiry date refers to the last day of the stated month.

Do not store above 30°C. Store in the original packaging to protect the medicine from moisture.

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 Candesartan Teva Italia contains

The active substance is Candesartan cilexetil. Each tablet of Candesartan Teva Italia 8 mg contains 8 mg of Candesartan cilexetil. Each tablet of Candesartan Teva Italia 16 mg contains 16 mg of Candesartan cilexetil. Each tablet of Candesartan Teva Italia 32 mg contains 32 mg of Candesartan cilexetil.
The other ingredients are pregelatinized maize starch, povidone K-30, carmellose calcium, microcrystalline cellulose (E460), lactose monohydrate, magnesium stearate, poloxamer 188, and red iron oxide (E172).

Description of the appearance of Candesartan Teva Italia and package contents

Candesartan Teva Italia 8 mg tablets are pink, capsule-shaped tablets, 7.7 mm in length and 3.5 mm in width, with a score line on both sides. On one side of the tablet is imprinted "C|8" and on the other side "8|C". The tablet can be divided into two equal doses.
Candesartan Teva Italia 16 mg tablets are pink, capsule-shaped tablets, 9.7 mm in length and 4.3 mm in width, with a score line on one side. On one side of the tablet is imprinted the number "16". On the other side of the tablet is imprinted "C | C". The tablet can be divided into two equal doses.
Candesartan Teva Italia 32 mg tablets are pink, capsule-shaped tablets, 12.2 mm in length and 5.4 mm in width, with a score line on one side. On one side of the tablet is imprinted the number "32". On the other side of the tablet is imprinted "C | C". The tablet can be divided into two equal doses.

Candesartan Teva Italia tablets are available in OPA/aluminum/PVC – PVC/PVAC/aluminum/OPA blisters in pack sizes of 7, 14, 15, 20, 28, 30, 50, 50 x 1 unit dose blister (hospital pack), 56, 60, 84, 90, 98, 100, 250 and 300 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy

Responsible person for batch release
TEVA Pharmaceutical Works Private Limited Company - Pallagi út 13, 4042 Debrecen, Hungary
TEVA Pharmaceutical Works Private Limited Company - H-2100 Gödöllő, Táncsics Mihály út 82, Hungary
TEVA UK Ltd - Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
Pharmachemie B.V. - Swensweg 5, 2031 GA Haarlem, The Netherlands
Teva Operations Poland Sp. z.o.o., ul. Mogilska 80, 31-546 Krakow, Poland
Merckle GmbH, Ludwing Merckle Strasse 3, 89143 Blaubeuren-Weiler, Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz baruna Filipovića 25, 10000 Zagreb, Croatia

This medicinal product is authorised in the European Economic Area Member States under the following names:
United Kingdom: Candesartan cilexetil 8 mg, 16 mg, 32 mg Tablets
Belgium: Candesartan Teva 8 mg, 16 mg, 32 mg tabletten
Germany: Candesartan-ratiopharm 8 mg, 16 mg, 32 mg Tabletten
Estonia: Cantar
Spain: Candesartan Teva 8 mg, 16 mg, 32 mg comprimidos EFG
France: Candesartan Teva 8 mg, 16 mg, 32 mg comprimé sécable
Republic of Ireland: Candesartan Teva 8 mg, 16 mg Tablets
Italy: Candesartan Teva Italia
Luxembourg: Candesartan-ratiopharm 8 mg, 16 mg, 32 mg Tabletten
Latvia: Cantar 16 mg tabletes
The Netherlands: Candesartan cilexetil Teva 8 mg, 16 mg, 32 mg tabletten
Portugal: Candesartan Teva
Sweden: Candesartan Teva 8 mg, 16 mg, 32 mg tabletter