Candesartan Sandoz

Package leaflet: Information for the user

Candesartan Sandoz 4 mg, 8 mg, 16 mg, 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, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:
1 What Candesartan Sandoz is and what it is used for
2 What you need to know before taking Candesartan Sandoz
3 How to take Candesartan Sandoz
4 Possible side effects
5 How to store Candesartan Sandoz
6 Contents of the pack and other information

1. What Candesartan Sandoz is and what it is used for

The name of this medicine is Candesartan Sandoz. The active substance is candesartan cilexetil. It belongs to a group of medicines called angiotensin II receptor antagonists. It works by causing relaxation and dilation of blood vessels. This helps to reduce blood pressure. It also allows the heart to pump blood more easily throughout the body.
This medicine is used for:

• treating high blood pressure (hypertension) in adults and in children and adolescents aged between 6 and 18 years.
• Candesartan Sandoz may be used to treat heart failure in adult patients 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 need to know before taking Candesartan Sandoz

Do not take Candesartan Sandoz:

• 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 three months pregnant (it is better to avoid Candesartan Sandoz even in the early stages of pregnancy – see section Pregnancy);
• if you have severe liver disease or biliary obstruction (a problem with bile drainage from the gallbladder);
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient is a child under 1 year of age.

If you are unsure whether any of these conditions apply to you, consult your doctor or pharmacist before taking Candesartan Sandoz.

Warnings and precautions

Talk to your doctor or pharmacist before taking Candesartan Sandoz:

• if you have heart, liver or kidney problems or are on dialysis;
• if you have recently had a kidney transplant;
• if you are vomiting, have recently had severe vomiting, or have diarrhoea;
• if you have a disease of the adrenal gland known as Conn's syndrome (also called primary hyperaldosteronism);
• if you have low blood pressure;
• if you have ever had a stroke;
• 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 section "Other medicines and Candesartan Sandoz").

Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Candesartan Sandoz is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken during this period (see section Pregnancy).

Your doctor may check 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 Candesartan Sandoz".

If you have any of these conditions, your doctor may decide to see you more frequently and carry out certain tests.

If you are about to undergo surgery, tell your doctor or dentist that you are taking Candesartan Sandoz. This is because Candesartan Sandoz, when combined with certain anaesthetics, may cause a drop in blood pressure.

Children and adolescents

Candesartan cilexetil has been studied in children. For further information, consult your doctor.

Candesartan Sandoz must not be given to children under 1 year of age due to the potential risk to developing kidneys.

Other medicines and Candesartan Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Candesartan Sandoz may affect how other medicines work, and some medicines may affect Candesartan Sandoz. If you are taking certain medicines, your doctor may need to carry out blood tests from time to time.

In particular, inform your doctor if you are taking any of the following medicines, as your doctor may need to adjust your dose and/or take other precautions:

• other medicines that help lower your blood pressure, including beta-blockers, diazoxide, and ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril;
• 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 are taking more than 3 g per day) (a medicine used to relieve pain and inflammation);
• potassium supplements or potassium-containing salt substitutes (medicines that increase potassium levels in the blood);
• heparin (a medicine used to thin the blood);
• tablets that help you pass urine (diuretics);
• lithium (a medicine used to treat mental health conditions);
• if you are taking an ACE inhibitor or aliskiren (see also sections: "Do not take Candesartan Sandoz" and "Warnings and precautions");
• if you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Candesartan Sandoz with food and drink (especially alcohol)

• You may take Candesartan Sandoz with or without food.
• When you are prescribed Candesartan Sandoz, talk to your doctor before drinking alcohol. Alcohol may make you feel weak or cause dizziness.

Pregnancy and breast-feeding

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 normally advise you to stop taking Candesartan Sandoz before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Candesartan Sandoz is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken beyond the third month of pregnancy.

Breast-feeding

Inform your doctor if you are breast-feeding or planning to breast-feed. Candesartan Sandoz is not recommended for women who are breast-feeding, and your doctor may choose an alternative treatment if you wish to breast-feed, especially if your baby is a newborn or was born prematurely.

Driving and using machines

Some people may feel tired or experience dizziness while taking Candesartan Sandoz. If this happens to you, do not drive or operate tools or machinery.

Candesartan Sandoz contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Candesartan Sandoz

Always take Candesartan Sandoz exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist. It is important to continue taking Candesartan Sandoz every day.
Candesartan Sandoz may be taken with or without food.
Swallow the tablet with a glass of water.
Try to take the tablet at the same time each day. This will help you remember to take it.

High blood pressure:

• The usual dose of Candesartan Sandoz is 8 mg once daily. Your doctor may increase this dose to 16 mg once daily and further up to 32 mg once daily, depending on your blood pressure response.
• In some patients, such as those with liver problems, kidney problems, or who have recently lost fluids (e.g., due to vomiting, diarrhoea, or taking tablets that help increase urine output), your doctor may prescribe a lower initial dose.
• Some black patients may have a reduced response to this medicine when used as monotherapy and may require a higher dose.

Use in children and adolescents with high blood pressure:
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 then to 16 mg once daily.

Heart failure:

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

If you take more Candesartan Sandoz than you should
If you take more Candesartan Sandoz than prescribed by your doctor, contact a doctor or pharmacist immediately for advice.

If you forget to take Candesartan Sandoz
Do not take a double dose to make up for the missed tablet. Take only the next dose as usual.

If you stop taking Candesartan Sandoz
If you stop treatment with Candesartan Sandoz, your blood pressure may rise again. Therefore, do not stop treatment with Candesartan Sandoz without first talking to your doctor.

If you have any questions about the use of 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 what these possible side effects may be.
Stop taking Candesartan Sandoz and seek immediate medical help if you experience 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, blister-like rashes)

Candesartan Sandoz may cause a reduction in the number of white blood cells in the blood. Your resistance to infections may decrease, and you may notice fatigue, infection, or fever. If this occurs, contact your doctor. Your doctor may occasionally perform blood tests to monitor whether Candesartan Sandoz has affected your blood (agranulocytosis).

Possible side effects include:
Common (may affect from 1 to 10 users out of 100)

• Dizziness/feeling of spinning
• Headache
• Respiratory infection
• Low blood pressure. This may make you feel weak or cause dizziness.
• Changes in blood test results:
• Increased levels of potassium in the blood, especially if you already have kidney problems or heart failure. If this is severe, you may also notice fatigue, 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 less than 1 user out of 10,000)

• Swelling of the face, lips, tongue and/or throat
• Reduction in red or white blood cells. You may notice fatigue, infection, or fever
• Rash, skin rash with swelling (urticaria)
• Itching
• Back pain, joint and muscle pain
• Changes in liver function, including inflammation of the liver (hepatitis). You may notice fatigue, yellowing of the skin and whites of the eyes, and flu-like symptoms
• Nausea
• Changes in blood test results:
• Reduced levels of sodium in the blood. If this is severe, you may also notice weakness, lack of energy, or muscle cramps
• Cough

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 not reported in adults, and 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
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Candesartan Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and on the blister after EXP. The expiry date refers to the last day of that month.
HDPE bottle: use within 3 months after first opening.
Store the medicine in the original packaging to protect it from moisture.
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 Candesartan Sandoz 4 mg contains
The active substance is candesartan cilexetil.
Each tablet contains 4 mg of candesartan cilexetil.
The excipients are:
monohydrate lactose
maize starch
povidone 30
carrageenan
sodium croscarmellose
magnesium stearate

What Candesartan Sandoz 8 mg contains
The active substance is candesartan cilexetil.
Each tablet contains 8 mg of candesartan cilexetil.
The excipients are:
monohydrate lactose
maize starch
povidone 30
carrageenan
sodium croscarmellose
magnesium stearate
red iron oxide (E172) (only in 8, 16 and 32 mg tablets)
titanium dioxide (E171) (only in 8, 16 and 32 mg tablets)

What Candesartan Sandoz 16 mg contains
The active substance is candesartan cilexetil.
Each tablet contains 16 mg of candesartan cilexetil.
The excipients are:
monohydrate lactose
maize starch
povidone 30
carrageenan
sodium croscarmellose
magnesium stearate
red iron oxide (E172)
titanium dioxide (E171)

What Candesartan Sandoz 32 mg contains
The active substance is candesartan cilexetil.
Each tablet contains 32 mg of candesartan cilexetil.
The excipients are:
monohydrate lactose
maize starch
povidone 30
carrageenan
sodium croscarmellose
magnesium stearate
red iron oxide (E172)
titanium dioxide (E171)

Description of the appearance of Candesartan Sandoz and contents of the pack
Tablet.
Candesartan Sandoz 4 mg tablets: white, round, biconvex tablets, marked with the inscription "4" on one side and a break line on the other.
Candesartan Sandoz 8 mg tablets: pink, mottled, round, biconvex tablets, marked with the inscription "8" on one side and a break line on the other.
Candesartan Sandoz 16 mg tablets: pink, mottled, round, biconvex tablets, marked with the inscription "16" on one side and a break line on the other.
Candesartan Sandoz 32 mg tablets: pink, mottled, round, biconvex tablets, marked with the inscription "32" on one side and a break line on the other.
The tablet can be divided into two equal parts.

Candesartan Sandoz 4 mg, 8 mg and 16 mg tablets
Al/Al blister packs: 7, 14, 20, 28, 30, 50, 56, 58, 60, 84, 90, 91, 98, 100, 250, 300 tablets
Perforated Al/Al unit dose blisters: 50 x 1 tablet
Al/Al blister packs with silica gel desiccant: 7, 14, 20, 28, 30, 50, 56, 58, 60, 84, 90, 91, 98, 100, 250, 300 tablets
Perforated Al/Al unit dose blisters with silica gel desiccant: 50 x 1 tablet
HDPE bottles with PP cap and silica gel desiccant: 30, 100, 500 tablets

Candesartan Sandoz 32 mg tablets
Al/Al blister packs: 7, 14, 20, 28, 30, 50, 56, 58, 60, 84, 90, 91, 98, 100, 250, 300 tablets
Al/Al blister packs with silica gel desiccant: 7, 14, 20, 28, 30, 50, 56, 58, 60, 84, 90, 91, 98, 100, 250, 300 tablets
HDPE bottles with PP cap and silica gel desiccant: 30, 100, 500 tablets

Warning! The HDPE bottle contains a desiccant. Do not ingest.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz SpA, L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturers responsible for batch release
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia
LEK S.A., ul. Domaniewska 50 C, 02-672 Warszawa, Poland
LEK S.A., ul. Podlipie 16, 95-010 Strykow, Poland
Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen, Germany
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia