CANDESARTAN 8 mg /12.5 Mg Tabletki

Treść ulotki

1. Candesartan and Hydrochlorothiazide Sandoz 8 mg/12.5 mg tablets
   1. What is Candesartan and Hydrochlorothiazide Sandoz and what is it used for
   2. What you need to know before taking Candesartan and Hydrochlorothiazide Sandoz
   3. How to take Candesartan and Hydrochlorothiazide Sandoz
   4. Possible side effects
   5. How to store Candesartan and Hydrochlorothiazide Sandoz
   6. Contents of the pack and other information
2. Candesartan and Hydrochlorothiazide Sandoz 16 mg/12.5 mg tablets
   1. What is Candesartan and Hydrochlorothiazide Sandoz and what is it used for
   2. What you need to know before taking Candesartan and Hydrochlorothiazide Sandoz
   3. How to take Candesartan and Idroclorotiazide Sandoz
   4. Possible side effects
   5. How to store Candesartan and Hydrochlorothiazide Sandoz
   6. Package contents and other information
3. Candesartan and Hydrochlorothiazide Sandoz 32 mg/12.5 mg tablets
   1. What is Candesartan and Hydrochlorothiazide Sandoz and what it is used for
   2. What you need to know before taking Candesartan and Hydrochlorothiazide Sandoz
   3. How to take Candesartan and Hydrochlorothiazide Sandoz
   4. Possible side effects
   5. How to store Candesartan and Hydrochlorothiazide Sandoz
   6. Contents of the pack and other information

Candesartan and Hydrochlorothiazide Sandoz 8 mg/12.5 mg tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

The name of the medicine is Candesartan and Hydrochlorothiazide Sandoz. It is used to treat high blood pressure (hypertension) in adult patients. It contains two active ingredients: candesartan cilexetil and hydrochlorothiazide.
These work together to lower blood pressure.

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It causes relaxation and dilation of blood vessels. This helps to reduce blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics (which help you to urinate). This helps the body to eliminate water and salts such as sodium in the urine. This contributes to reducing blood pressure.

The doctor may prescribe Candesartan and Hydrochlorothiazide Sandoz if your blood pressure has not been
adequately controlled by candesartan cilexetil or hydrochlorothiazide alone.

2. What you need to know before taking Candesartan and Hydrochlorothiazide Sandoz

DO NOT take Candesartan and Hydrochlorothiazide Sandoz if:

• you are allergicto candesartan cilexetil, to hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6)
• you are allergic to sulfonamide medicines. If you are not sure whether this condition may concern you, consult your doctor
• you have a severe liver diseaseor obstruction of the bile ducts(a problem with the drainage of bile from the gallbladder).
• you suffer from severe kidney disorders
• you are pregnant for more than 3 months(it is also better to avoid Candesartan and Hydrochlorothiazide Sandoz at the beginning of pregnancy - see section “Pregnancy”)
• you have ever had gout.
• you have persistently low levels of potassiumin your blood.
• you have persistently high levels of calciumin your blood.
• you suffer from diabetesor your kidney function is impairedand are being treated with a medicinethat lowers blood pressure containing aliskiren.

If you are not sure whether any of these conditions apply to you, consult your doctor or pharmacist before taking
Candesartan and Hydrochlorothiazide Sandoz.

Warnings and precautions
Talk to your doctor or pharmacist before taking Candesartan and Hydrochlorothiazide Sandoz if:

• you have problems with your heart, liver or kidneys.
• you have recently undergone a kidney transplant.
• you vomit, have recently had severe vomitingor diarrhoea.
• you have a disease of the adrenal gland, known as Conn's syndrome (also called primary hyperaldosteronism).
• you have diabetes
• you have had a disease called systemic lupus erythematosus(SLE).
• you have low blood pressure.
• you have ever had a stroke.
• you have had allergiesor asthma.
• 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 suffer from kidney problems related to diabetes
• aliskiren
• if you have had skin cancerin the past or if you are developing an unexpected skin lesionduring treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, can increase the risk of some types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Candesartan and Hydrochlorothiazide Sandoz.
• If you have a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and can occur within a period ranging from a few hours to weeks after taking Candesartan and Hydrochlorothiazide Sandoz. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at greater risk of developing this.
• inform your doctor if you think you may be pregnant (or if there is a possibility of starting a pregnancy). Candesartan and Hydrochlorothiazide Sandoz is not recommended at the beginning of pregnancy, and should not be taken if you are pregnant for more than 3 months, as it can cause serious harm to the baby if taken during this period (see section Pregnancy).

The doctor may check your kidney function, blood pressure and the amount of electrolytes (such as
potassium) in your blood at regular intervals.
See also what is reported under “Do not take Candesartan and Hydrochlorothiazide Sandoz”.
The doctor may need to visit you more often and do some tests if you experience any of these conditions.
If you are about to undergo surgery, inform your doctor or dentist that you are taking Candesartan and
Hydrochlorothiazide Sandoz. This is because Candesartan and Hydrochlorothiazide Sandoz, when combined with some
anaesthetics, can cause an excessive drop in blood pressure.
Candesartan and Hydrochlorothiazide Sandoz can increase the sensitivity of your skin to the sun.

Children and adolescents
There is no experience with the use of Candesartan and Hydrochlorothiazide Sandoz in children and adolescents (under
18 years of age). Therefore Candesartan and Hydrochlorothiazide Sandoz should not be administered to
children and adolescents.
Consult your doctor if you are an athlete who is about to undergo a doping test, because Candesartan and
Hydrochlorothiazide Sandoz contains an active ingredient that can cause positive doping test results.
For those who play sports: the use of the drug without therapeutic necessity constitutes doping and may
still result in positive doping tests.

Other medicines and Candesartan and Hydrochlorothiazide Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. Candesartan and Hydrochlorothiazide Sandoz can affect the mechanism of action of other
medicines, and some medicines can have an effect on Candesartan and Hydrochlorothiazide Sandoz. If you are
taking certain medicines, your doctor may need to do blood tests from time to time.
In particular, tell your doctor if you are taking any of the following medicines as your doctor may
need to adjust the dose and/or take other precautions:

• an ACE inhibitor or aliskiren (see also what is reported under “Do not take Candesartan and Hydrochlorothiazide Sandoz” and “Warnings and precautions”).
• Other medicines that help lower blood pressure, including beta-blockers, medicines containing aliskiren, diazoxide and ACE inhibitors such as enalapril, captopril, lisinopril or ramipril.
• Medicines to control the heartbeat (antiarrhythmic agents) such as digoxin and beta-blockers.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines for relieving pain and inflammation).
• Acetylsalicylic acid (if you are taking more than 3 g per day) (medicine for relieving pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines that increase the level of potassium in the blood).
• Heparin (a medicine for thinning the blood).
• Medicines that help you urinate (diuretics).
• Lithium (a medicine for mental health problems).
• Medicines whose action may be affected by blood potassium levels, such as some antipsychotic drugs.
• Medicines to lower cholesterol, such as colestipol or colestyramine (a resin-type medicine to reduce lipids).
• Calcium or vitamin D supplements.
• Anticholinergic agents such as atropine and biperidene.
• Amantadine (for the treatment of Parkinson's disease or for severe infections caused by viruses).
• Barbiturates (a type of sedative also used to treat epilepsy).
• Medicines to treat cancer.
• Steroids, such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines for diabetes (oral tablets or insulin).
• Laxatives.
• Amphotericin (for the treatment of fungal infections).
• Carbenoxolone (for the treatment of esophageal disease or oral ulcers).
• Penicillin or co-trimoxazole also known as trimethoprim/sulfamethoxazole (antibiotics).
• Cyclosporine, a medicine used in organ transplantation to prevent rejection.
• Other medicines that can enhance the antihypertensive effect, such as baclofen (a medicine to relieve spasticity), amifostine (used for cancer treatment) and some antipsychotic medicines.

Candesartan and Hydrochlorothiazide Sandoz with food, drinks and alcohol

• you can take Candesartan and Hydrochlorothiazide Sandoz with or without food
• when you are prescribed Candesartan and Hydrochlorothiazide Sandoz, talk to your doctor before drinking alcohol. Alcohol can make you feel weak or dizzy.

Pregnancy and breastfeeding
Pregnancy

You must inform your doctor if you think you may be pregnant (or if there is a possibility of starting a pregnancy). As a rule, your doctor will advise you to stop taking Candesartan and
Hydrochlorothiazide Sandoz before starting pregnancy or as soon as you find out you are
pregnant and will advise you to take another medicine instead of Candesartan and Hydrochlorothiazide
Sandoz. Candesartan and Hydrochlorothiazide Sandoz is not recommended at the beginning of pregnancy, and should not
be taken if you are pregnant for more than 3 months, as it can cause serious harm to the
baby if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or are about to start breastfeeding. Candesartan and Hydrochlorothiazide Sandoz
is not recommended for women who are breastfeeding and your doctor may choose another treatment
for you if you wish to breastfeed, especially if the baby is newborn or premature.

Driving and operating machinery
Some people may feel tired or dizzy when taking Candesartan and Hydrochlorothiazide Sandoz.
If this happens to you, do not drive or use tools or machinery.

Candesartan and Hydrochlorothiazide Sandoz contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking this
medicine.

Candesartan and Hydrochlorothiazide Sandoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially ‘sodium-free’.

3. How to take Candesartan and Hydrochlorothiazide Sandoz

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist. It is important to continue taking Candesartan and Hydrochlorothiazide Sandoz every
day.
The recommended dose of Candesartan and Hydrochlorothiazide Sandoz is one tablet once a day.
Swallow the tablet with a sip of water.
Try to take the tablet at the same time each day. This will help you to remember to take it.

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

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

If you stop taking Candesartan and Hydrochlorothiazide Sandoz
If you stop taking Candesartan and Hydrochlorothiazide Sandoz, your blood pressure may
increase again. Therefore, do not stop taking Candesartan and Hydrochlorothiazide Sandoz without
first talking to your doctor.
If you have any further questions on 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 everyone gets them.
It is important that you are aware of what these side effects may be. Some
of the side effects of Candesartan and Idroclorotiazide Sandoz are caused by candesartan cilexetil and
some are caused by hydrochlorothiazide.

Stop taking Candesartan and Idroclorotiazide 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 can cause difficulty swallowing.
• severe itching of the skin (with raised blisters).

Candesartan and Idroclorotiazide Sandoz can cause a decrease 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
happens, contact your doctor. Your doctor may occasionally perform blood tests to check if
Candesartan and Idroclorotiazide Sandoz has had any effects on your blood (agranulocytosis).
Other possible side effects include:

Common (may affect up to 1 in 10 people)

• Changes in blood test results:
• A reduced amount of sodium in the blood. If this reduction is severe, you may notice weakness, lack of energy or muscle cramps.
• An increased or decreased amount of potassium in the blood, especially if you already have kidney problems or heart failure. If this increase or decrease is severe, you may notice fatigue, weakness, an irregular heartbeat or tingling.
• An increased amount of cholesterol, sugar or uric acid in the blood.
• Sugar in the urine
• Feeling dizzy/lightheaded or weak
• Headache.
• Respiratory infection.

Uncommon (may affect up to 1 in 100 people)

• Low blood pressure. This can make you feel weak or dizzy.
• Loss of appetite, diarrhea, constipation, stomach irritation.
• Skin rash, rash with swelling (urticaria), rash caused by sensitivity to sunlight.

Rare (may affect up to 1 in 1,000 people)

• Jaundice (yellowing of the skin or the white of the eye). If this happens, contact your doctor immediately.
• Effects on the function of your kidneys, especially if you already have kidney problems or heart failure.
• Difficulty sleeping, depression, feeling restless.
• Tingling or prickling in the arms or legs.
• Blurred vision for a short period.
• Abnormal heartbeat.
• Difficulty breathing (including inflammation of the lungs and fluid in the lungs).
• High temperature (fever).
• Inflammation of the pancreas. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels causing the appearance of red or purple spots on the skin.
• A reduction in red blood cells, white blood cells or platelets. You may notice fatigue, infection, fever, easy bruising.
• Severe skin rash that develops rapidly, with blistering and peeling of the skin and sometimes in the mouth.

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

• Swelling of the face, lips, tongue and/or throat.
• 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 the white of the eye and flu-like symptoms.
• Cough.
• Nausea.

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

• Sudden myopia
• Decreased 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)
• Systemic and cutaneous lupus erythematosus (an allergic condition that causes fever, joint pain, rash that may include redness, blisters, peeling and swelling)
• Skin and lip cancer (non-melanoma skin cancer).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 Candesartan and Hydrochlorothiazide 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 package and bottle/blister, after
“Exp.”. The expiry date refers to the last day of the month.
Do not store at a temperature above 25°C. Keep the medicine in its original packaging to
protect it from moisture.
Shelf life after first opening of the bottle: use within 3 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Candesartan and Hydrochlorothiazide Sandoz contains
The active ingredientsare candesartan cilexetil and hydrochlorothiazide.
Each tablet contains 8 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.

Other ingredientsare: lactose monohydrate, starch (corn), povidone K-30, carrageenan (E407),
croscarmellose sodium and magnesium stearate

Description of the appearance of Candesartan and Hydrochlorothiazide Sandoz and contents of the pack
8 mg/12.5 mg tablets:
White, oval, biconvex, with a fracture line on both sides.
The notch is to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.
The fracture line is only to break the tablet to facilitate swallowing and not to divide the tablets into two equal parts.
Al/Al blisters with desiccant: 7, 10, 14, 20, 21, 28, 30, 50, 56, 60, 84, 90, 98 or 100 tablets
Al/Al perforated unit-dose blisters with desiccant: 50 x 1 tablets
HDPE bottle with PP cap and desiccant: 7, 14, 21, 28, 56, 84, 98, 100 or 250 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA)

Manufacturers responsible for batch release
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
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 Stryków, Poland
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

Candesartan and Hydrochlorothiazide Sandoz 16 mg/12.5 mg tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

The name of the medicine is Candesartan and Hydrochlorothiazide Sandoz. It is used to treat high blood pressure (hypertension) in adult patients. It contains two active ingredients: candesartan cilexetil and hydrochlorothiazide. These work together to lower blood pressure.

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It causes relaxation and widening of the blood vessels. This helps to reduce blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics (which help to urinate). This helps the body to eliminate water and salts such as sodium in the urine. This contributes to reducing blood pressure.

Your doctor may prescribe Candesartan and Hydrochlorothiazide Sandoz if your blood pressure has not been adequately controlled by candesartan cilexetil or hydrochlorothiazide alone.

2. What you need to know before taking Candesartan and Hydrochlorothiazide Sandoz

DO NOT take Candesartan and Hydrochlorothiazide Sandoz if:

• you are allergicto candesartan cilexetil, to hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6)
• you are allergic to sulfonamide medicines. If you are not sure whether this condition may concern you, consult your doctor
• you have a severe liver diseaseor obstruction of the bile ducts(a problem with drainage

of bile from the gallbladder).

• you suffer from severe kidney disorders
• you are pregnant for more than 3 months(it is also better to avoid Candesartan and Hydrochlorothiazide Sandoz at the beginning of pregnancy - see the section “Pregnancy”)
• you have ever had gout.
• you have persistently low levels of potassiumin the blood.
• you have persistently high levels of calciumin the blood.
• you suffer from diabetesor your kidney function is impairedand are being treated with amedicine that lowers blood pressure containing aliskiren

If you are not sure whether any of these conditions apply to you, consult your doctor or pharmacist before
taking Candesartan and Hydrochlorothiazide Sandoz.

Warnings and precautions
Talk to your doctor or pharmacist before taking Candesartan and Hydrochlorothiazide Sandoz if:

• you have problems with the heart, liver or kidneys.
• you have recently undergone a kidney transplant.
• you vomit, have recently had severe vomitingor diarrhea.
• you have a disease of the adrenal gland, known as Conn's Syndrome (also called primary hyperaldosteronism).
• you have diabetes
• you have had a disease called systemic lupus erythematosus(SLE).
• you have low blood pressure.
• you have ever had a stroke.
• you have had allergiesor asthma.
• 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 suffer from kidney problems related to diabetes
• aliskiren
• if you have had skin cancerin the past or if you are developing an unexpected skin lesionduring treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of some types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Candesartan and Hydrochlorothiazide Sandoz.
• If you have a decrease in visionor eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and can occur within hours to weeks of taking Candesartan and Hydrochlorothiazide Sandoz. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing this.
• think you may be pregnant (or if there is a possibility of becomingpregnant). Candesartan and Hydrochlorothiazide Sandoz is not recommended at the beginning of pregnancy, and should not be taken if you are pregnant for more than 3 months, as it can cause serious harm to the baby if taken during this period (see the section Pregnancy).

The doctor may check your kidney function, blood pressure and the amount of
electrolytes (e.g. potassium) in the blood at regular intervals.
See also what is reported under “Do not take Candesartan and Hydrochlorothiazide Sandoz”.
The doctor may need to visit you more often and do some tests if you experience any of these
conditions.
If you are going to have surgery, tell your doctor or dentist that you are taking Candesartan and
Hydrochlorothiazide Sandoz. This is because Candesartan and Hydrochlorothiazide Sandoz, when combined
with some anesthetics, can cause an excessive drop in blood pressure.
Candesartan and Hydrochlorothiazide Sandoz may increase the sensitivity of the skin to the sun.

Children and adolescents
There is no experience with the use of Candesartan and Hydrochlorothiazide Sandoz in children and adolescents
(under 18 years of age). Therefore Candesartan and Hydrochlorothiazide Sandoz should not be
administered to children and adolescents.
Consult your doctor if you are an athlete who is about to undergo a doping test, because
Candesartan and Hydrochlorothiazide Sandoz contains an active ingredient that may cause positive
doping test results.
For those who play sports: the use of the drug without therapeutic need constitutes doping and
may still result in positive doping tests.

Other medicines and Candesartan and Hydrochlorothiazide Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. Candesartan and Hydrochlorothiazide Sandoz can affect the mechanism of
action of other medicines, and some medicines can have an effect on Candesartan and
Hydrochlorothiazide Sandoz. If you are taking certain medicines, your doctor may need to
have blood tests done from time to time.
In particular, tell your doctor if you are taking any of the following medicines as your doctor
may need to adjust the dose and/or take other precautions:

• an ACE inhibitor or aliskiren (see also what is reported under “Do not take Candesartan and Hydrochlorothiazide Sandoz” and “Warnings and precautions”).
• Other medicines that help lower blood pressure, including beta-blockers, medicines containing aliskiren, diazoxide and ACE inhibitors such as enalapril, captopril, lisinopril or ramipril.
• Medicines to control the heartbeat (antiarrhythmic agents) such as digoxin and beta-blockers.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines to relieve pain and inflammation).
• Acetylsalicylic acid (if you are taking more than 3 g per day) (medicine to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines that increase the level of potassium in the blood).
• Heparin (a medicine to thin the blood).
• Medicines that help you urinate (diuretics).
• Lithium (a medicine for mental health problems).
• Medicines whose action may be affected by blood potassium levels, such as some antipsychotic drugs.
• Medicines to lower cholesterol, such as colestipol or colestyramine.
• Calcium or vitamin D supplements.
• Anticholinergic agents such as atropine and biperidene.
• Amantadine (for the treatment of Parkinson's disease or for severe infections caused by viruses).
• Barbiturates (a type of sedative also used to treat epilepsy).
• Medicines to treat cancer.
• Steroids, such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines for diabetes (oral tablets or insulin).
• Laxatives.
• Amphotericin (for the treatment of fungal infections).
• Carbenoxolone (for the treatment of esophageal disease or oral ulcers).
• Penicillin or co-trimoxazole also known as trimethoprim/sulfamethoxazole (antibiotics).
• Cyclosporine, a medicine used in organ transplantation to prevent rejection.
• Other medicines that can enhance the antihypertensive effect, such as baclofen (a medicine to relieve spasticity), amifostine (used for cancer treatment) and some antipsychotic drugs.

Candesartan and Hydrochlorothiazide Sandoz with food, drinks and alcohol

• you can take Candesartan and Hydrochlorothiazide Sandoz with or without food
• when you are prescribed Candesartan and Hydrochlorothiazide Sandoz, talk to your doctor before drinking alcohol. Alcohol can make you feel weak or dizzy.

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). As a rule, your doctor will advise you to stop taking
Candesartan and Hydrochlorothiazide Sandoz before starting pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of
Candesartan and Hydrochlorothiazide Sandoz. Candesartan and Hydrochlorothiazide Sandoz is not
recommended at the beginning of pregnancy, and should not be taken if you are pregnant for
more than 3 months, as it can cause serious harm to the baby if taken after the third month of
pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or planning to start breastfeeding. Candesartan and
Hydrochlorothiazide Sandoz is not recommended for women who are breastfeeding and your doctor may
choose another treatment for you if you wish to breastfeed, especially if the baby is newborn or
premature.

Driving and operating machinery
Some people may feel tired or dizzy when taking Candesartan and Hydrochlorothiazide
Sandoz. If this happens to you, do not drive or use tools or machinery.

Candesartan and Hydrochlorothiazide Sandoz contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking
this medicine.

Candesartan and Hydrochlorothiazide Sandoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially
‘sodium-free’.

3. How to take Candesartan and Idroclorotiazide Sandoz

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist. It is important to continue taking Candesartan and
Idroclorotiazide Sandoz every day.
The recommended dose of Candesartan and Idroclorotiazide Sandoz is one tablet once a
day.
Swallow the tablet with a sip of water.
Try to take the tablet at the same time each day. This will help you to remember to
take it.

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

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

If you stop taking Candesartan and Idroclorotiazide Sandoz
If you stop taking Candesartan and Idroclorotiazide Sandoz, your blood pressure
may increase again. Therefore, do not stop treatment with Candesartan and Idroclorotiazide
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 everyone will experience them.
It is important that you are aware of what these side effects may be. Some of the side effects of
Candesartan and Idroclorotiazide Sandoz are caused by candesartan cilexetil and some are caused by
hydrochlorothiazide.

Stop taking Candesartan and Idroclorotiazide 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 can cause difficulty swallowing.
• severe itching of the skin (with raised blisters).

Candesartan and Idroclorotiazide Sandoz can cause a decrease 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 happens, contact your doctor. The doctor may occasionally perform blood tests to
check if Candesartan and Idroclorotiazide Sandoz has had any effects on your blood
(agranulocytosis).
Other possible side effects include:

Common (may affect up to 1 in 10 people)

• Changes in blood test results:
• A reduced amount of sodium in the blood. If this reduction is severe, you may notice

weakness, lack of energy or muscle cramps.

• An increased or decreased amount of potassium in the blood, especially if you already have
  kidney problems or heart failure. If this increase or decrease is severe, you may notice fatigue,
  weakness, an irregular heartbeat or tingling.
• An increased amount of cholesterol, sugar or uric acid in the blood.
• Sugar in the urine
• Feeling dizzy/lightheaded or weak
• Headache.
• Respiratory infection.

Uncommon (may affect up to 1 in 100 people)

• Low blood pressure. This can make you feel weak or dizzy.
• Loss of appetite, diarrhea, constipation, stomach irritation.
• Skin rash, rash with swelling (urticaria), rash caused by sensitivity to sunlight.

Rare (may affect up to 1 in 1,000 people)

• Jaundice (yellowing of the skin or the white of the eye). If this happens, contact your doctor
  immediately.
• Effects on the functioning of your kidneys, especially if you already have kidney problems or
  heart failure.
• Difficulty sleeping, depression, feeling restless.
• Tingling or prickling in the arms or legs.
• Blurred vision for a short period.
• Abnormal heartbeat.
• Difficulty breathing (including inflammation of the lungs and fluid in the lungs).
• High temperature (fever).
• Inflammation of the pancreas. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels causing the appearance of red or purple spots on the skin.
• A reduction in red blood cells, white blood cells or platelets. You may notice fatigue, infection,
  fever, easy bruising.
• Severe skin rash that develops rapidly, with blistering and peeling of the skin and sometimes in
  the mouth.

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

• Swelling of the face, lips, tongue and/or throat.
• 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 the white of the eye and flu-like symptoms.
• Cough.
• Nausea.

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

• Sudden myopia
• Decreased 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)
• Systemic and cutaneous lupus erythematosus (allergic condition that causes fever, joint pain,
  rash that may include redness, blisters, peeling and swelling)
• Skin and lip cancer (non-melanoma skin cancer)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through 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 Candesartan and Hydrochlorothiazide 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 package and on the
bottle/blister, after “Exp.”. The expiry date refers to the last day of the month.
Do not store at a temperature above 25°C. Store the medicine in its original packaging
to protect it from moisture.
Shelf life after first opening of the bottle: use within 3 months.
Do not dispose of any medicine in 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 and Hydrochlorothiazide Sandoz contains
The active ingredientsare candesartan cilexetil and hydrochlorothiazide.
Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
The other ingredientsare: lactose monohydrate, starch (corn), povidone K30, carrageenan (E407),
sodium croscarmellose, magnesium stearate, red iron oxide (E172) and yellow iron oxide
(E172)

Description of the appearance of Candesartan and Hydrochlorothiazide Sandoz and package contents
16 mg/12.5 mg tablets:
Apricot-colored, mottled, oval, biconvex, with a fracture line on both sides.
The notch is to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.
Al/Al blisters with desiccant: 7, 10, 14, 20, 28, 30, 56 or 98 tablets
Al/Al perforated single-dose blisters with desiccant: 50 x 1 tablets
HDPE bottle with PP cap and desiccant: 7, 14, 21, 28, 56, 84, 98, 100 or 250 tablets
Not all pack sizes may be marketed.

Marketing authorisation holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA)

Manufacturers responsible for batch release
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
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 Stryków, Poland
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

Candesartan and Hydrochlorothiazide Sandoz 32 mg/12.5 mg tablets

Candesartan and Hydrochlorothiazide Sandoz 32 mg/25 mg tablets
Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

The name of the medicine is Candesartan and Hydrochlorothiazide Sandoz and it is used to treat high blood pressure (hypertension) in adult patients. It contains two active ingredients: candesartan cilexetil and hydrochlorothiazide. These work together to lower blood pressure.

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It causes relaxation and dilation of blood vessels. This helps to reduce blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics (tablets that help to urinate) and helps the body to eliminate water and salts such as sodium in the urine. This contributes to reducing blood pressure.

Your doctor may prescribe you Candesartan and Hydrochlorothiazide Sandoz if your blood pressure has not been adequately controlled by candesartan cilexetil or hydrochlorothiazide alone.

2. What you need to know before taking Candesartan and Hydrochlorothiazide Sandoz

Do not take Candesartan and Hydrochlorothiazide Sandoz if:

• you are allergicto candesartan cilexetil or hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6).
• you are allergic to sulfonamide medicines. If you are not sure whether this condition applies to you, consult your doctor.
• you have a serious liver diseaseor obstruction of the bile ducts(a problem with the drainage of bile from the gallbladder).
• you suffer from severe kidney disorders.
• you are pregnant for more than 3 months(it is also better to avoid Candesartan and Hydrochlorothiazide Sandoz at the beginning of pregnancy - see the section “Pregnancy”).
• you have ever had gout.
• you have persistently lowlevels of potassiumin your blood.
• you have persistently highlevels of calciumin your blood.
• you suffer from diabetesor your kidney function is impairedand are being treated with amedicine that lowers blood pressure containing aliskiren

If you are not sure whether any of these conditions apply to you, consult your doctor or pharmacist
before taking Candesartan and Hydrochlorothiazide Sandoz.

Warnings and precautions
Talk to your doctor or pharmacist before taking Candesartan and Hydrochlorothiazide Sandoz if:

• you have problems with the heart, liver or kidneys.
• you have recently had a kidney transplant.
• you vomit, have recently had severe vomitingor have diarrhoea.
• you have a disease of the adrenal gland, known as Conn's syndrome (also called primary hyperaldosteronism).
• you have diabetes
• you have ever had a disease called systemic lupus erythematosus(SLE).
• you have low blood pressure.
• you have ever had a heart attack.
• you have ever had allergies or asthma.
• 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 suffer from kidney problems related to diabetes
• aliskiren
• if you have had skin cancerin the past or if you are developing an unexpected skin lesionduring treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of some types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Candesartan and Hydrochlorothiazide Sandoz.
• If you have a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and can occur from a few hours to weeks after taking Candesartan and Hydrochlorothiazide Sandoz. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at greater risk of developing this.
• think you may be pregnant (or if there is a possibility of becomingpregnant). Candesartan and Hydrochlorothiazide Sandoz is not recommended at the beginning of pregnancy, and should not be taken if you are pregnant for more than 3 months, as it can cause serious harm to the baby if taken during this period (see the section Pregnancy).

The doctor may check your kidney function, blood pressure and the amount of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is reported under “Do not take Candesartan and Hydrochlorothiazide Sandoz”.
The doctor may need to visit you more often and do tests if you experience any of these
conditions.
If you are about to have an operation, tell your doctor or dentist that you are taking Candesartan and
Hydrochlorothiazide Sandoz. This is because Candesartan and Hydrochlorothiazide Sandoz, when combined
with some anesthetics, can cause an excessive drop in blood pressure.
Candesartan and Hydrochlorothiazide Sandoz can increase the sensitivity of your skin to the sun.

Children and adolescents
There is no experience with the use of Candesartan and Hydrochlorothiazide Sandoz in children (under
18 years of age). Candesartan and Hydrochlorothiazide Sandoz should therefore not be given to
children and adolescents.
Consult your doctor if you are an athlete who is about to undergo a doping test, because
Candesartan and Hydrochlorothiazide Sandoz contains an active ingredient that can cause positive
doping test results.
For those who play sports: the use of the drug without a therapeutic need constitutes doping and
may still result in positive doping tests.

Other medicines and Candesartan and Hydrochlorothiazide Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Candesartan and Hydrochlorothiazide Sandoz can affect the mechanism of action of other medicines, and
some medicines can have an effect on Candesartan and Hydrochlorothiazide Sandoz. If you are
taking certain medicines, your doctor may need to do blood tests from time to time.
In particular, tell your doctor if you are taking any of the following medicines as your doctor
may need to adjust the dose and/or take other precautions:

• an ACE inhibitor or aliskiren (see also what is reported under “Do not take Candesartan and Hydrochlorothiazide Sandoz” and “Warnings and precautions”).
• Other medicines that help lower blood pressure, including beta-blockers, medicines containing aliskiren, diazoxide, and ACE inhibitors such as enalapril, captopril, lisinopril or ramipril.
• Medicines to control the heartbeat (antiarrhythmic agents) such as digoxin and beta-blockers.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines to relieve pain and inflammation).
• Acetylsalicylic acid (if you are taking more than 3 g per day) (a medicine to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in the blood).
• Heparin (a medicine to thin the blood).
• Medicines that help you urinate (diuretics).
• Lithium (a medicine for mental health problems).
• Medicines whose action may be affected by potassium levels in the blood, such as some antipsychotic drugs.
• Medicines to lower cholesterol, such as colestipol or colestyramine (cholesterol-lowering resin-based medicines).
• Calcium or vitamin D supplements.
• Anticholinergic agents such as atropine and biperidene.
• Amantadine (for the treatment of Parkinson's disease or severe infections caused by viruses).
• Barbiturates (a type of sedative also used to treat epilepsy).
• Medicines to treat cancer.
• Steroids, such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines for diabetes (tablets or insulin).
• Laxatives.
• Amphotericin (for the treatment of fungal infections).
• Carbenoxolone (for the treatment of esophageal disease or oral ulcers).
• Penicillin or co-trimoxazole also known as trimethoprim/sulfamethoxazole (antibiotics).
• Cyclosporine, a medicine used in organ transplantation to prevent rejection.
• Other medicines that can enhance the antihypertensive effect, such as baclofen (a medicine to relieve spasticity), amifostine (used for cancer treatment) and some antipsychotic medicines.

Candesartan and Hydrochlorothiazide Sandoz with food, drinks and alcohol

• you can take Candesartan and Hydrochlorothiazide Sandoz with or without food
• when you are prescribed Candesartan and Hydrochlorothiazide Sandoz, talk to your doctor before drinking alcohol. Alcohol can make you feel weak or dizzy.

Pregnancy and breastfeeding
Pregnancy

You must tell your doctor if you think you may be pregnant (or if there is a possibility of
becoming pregnant). As a rule, your doctor will advise you to stop taking
Candesartan and Hydrochlorothiazide Sandoz before starting pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Candesartan
and Hydrochlorothiazide Sandoz. Candesartan and Hydrochlorothiazide Sandoz is not recommended at the beginning
of pregnancy, and should not be taken if you are pregnant for more than 3 months, as it can cause serious harm to the baby if taken after the third month of pregnancy.
Breastfeeding

Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Candesartan and
Hydrochlorothiazide Sandoz is not recommended for women who are breastfeeding and your doctor may
choose another treatment for you if you wish to breastfeed, especially if the baby is newborn or
premature.

Driving and operating machinery
Some people may feel tired or dizzy when taking Candesartan and Hydrochlorothiazide
Sandoz. If this happens to you, do not drive or use tools or machinery.

Candesartan and Hydrochlorothiazide Sandoz contains lactose.
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

Candesartan and Hydrochlorothiazide Sandoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially
‘sodium-free’.

3. How to take Candesartan and Hydrochlorothiazide Sandoz

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.
It is important to continue taking Candesartan and Hydrochlorothiazide Sandoz every day.
The recommended dose of Candesartan and Hydrochlorothiazide Sandoz is one tablet once a
day.
Swallow the tablet with a sip of water.
Try to take the tablet at the same time each day. This will help you to remember to
take it.

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

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

If you stop taking Candesartan and Hydrochlorothiazide Sandoz
If you stop taking Candesartan and Hydrochlorothiazide Sandoz, your blood pressure
may increase again. Therefore, do not stop treatment with Candesartan and Hydrochlorothiazide
Sandoz without first talking to your doctor.
If you have any further questions on 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 everyone will experience them.
It is important that you are aware of what these side effects may be. Some of the side effects of Candesartan and Idroclorotiazide Sandoz are caused by candesartan cilexetil and
some are caused by hydrochlorothiazide.

Stop taking Candesartan and Idroclorotiazide 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 can cause difficulty swallowing.
• severe skin itching (with raised blisters).

Candesartan and Idroclorotiazide Sandoz may cause a decrease 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 happens, contact your doctor. Your doctor may occasionally perform blood tests to check if Candesartan and Idroclorotiazide Sandoz has had any
effect on your blood (agranulocytosis).
Other possible side effects include:

Common (may affect up to 1 in 10 people)

• Changes in blood test results:
• A reduced amount of sodium in the blood. If this reduction is severe, you may experience weakness, lack of energy or muscle cramps.
• An increased or decreased amount of potassium in the blood, especially if you already have kidney problems or heart failure. If this is severe, you may experience fatigue, weakness, irregular heartbeat or tingling.
• An increased amount of cholesterol, sugar or uric acid in the blood.
• Sugar in the urine
• Feeling dizzy/lightheaded or weak
• Headache.
• Respiratory infection.

Uncommon (may affect up to 1 in 100 people)

• Low blood pressure. This can make you feel weak or dizzy.
• Loss of appetite, diarrhea, constipation, stomach irritation.
• Skin rash, rash with swelling (urticaria), rash caused by sensitivity to sunlight.

Rare (may affect up to 1 in 1,000 people)

• Jaundice (yellowing of the skin or the white of the eye). If this happens, contact your doctor immediately.
• Effects on the functioning of your kidneys, especially if you already have kidney problems or heart failure.
• Difficulty sleeping, depression, feeling restless.
• Tingling or prickling in the arms or legs.
• Blurred vision for a short period.
• Abnormal heartbeat.
• Difficulty breathing (including lung inflammation and fluid in the lungs).
• High temperature (fever).
• Inflammation of the pancreas. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels causing the appearance of red or purple spots on the skin.
• A reduction in red blood cells, white blood cells or platelets. You may notice fatigue, infection, fever or easy bruising.
• Severe skin rash that develops rapidly, with blistering or peeling of the skin and possible blistering in the mouth.

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

• Swelling of the face, lips, tongue and/or throat.
• Itching.
• Back pain, joint and muscle pain.
• Changes in liver function, including liver inflammation (hepatitis). You may notice fatigue, yellowing of the skin and the white of the eye and flu-like symptoms.
• Cough.
• Nausea.

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

• Sudden myopia
• Decreased 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)
• Systemic and cutaneous lupus erythematosus (an allergic condition that causes fever, joint pain, rash that may include redness, blisters, peeling, and swelling)
• Skin and lip cancer (non-melanoma skin cancer).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through 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 Candesartan and Hydrochlorothiazide 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 the bottle/blister
after “Exp.”. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture.
Shelf life after first opening of the bottle: 3 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Candesartan and Hydrochlorothiazide Sandoz contains
The active ingredientsare candesartan cilexetil and hydrochlorothiazide.
Each tablet contains 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
Each tablet contains 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide.
The other ingredientsare: lactose monohydrate, yellow iron oxide (E172), red iron oxide
(E172), black iron oxide (E172), corn starch, povidone K30, carrageenan (E407),
sodium croscarmellose and magnesium stearate
The other ingredientsare: lactose monohydrate, red iron oxide (E172), black iron oxide
(E172), corn starch, titanium dioxide (E171), povidone K30, carrageenan (E407),
sodium croscarmellose and magnesium stearate

Description of the appearance of Candesartan and Hydrochlorothiazide Sandoz and contents of the
pack
32 mg/ 12.5 mg tablets:
Light brown, mottled, oblong, biconvex, with “32” imprinted on one side and with a fracture line on both sides.
32 mg/ 25 mg tablets:
Reddish-brown, mottled, oblong, biconvex, with “H32” imprinted on one side and with a fracture line
on both sides.
The fracture line is designed to make it easier to break the tablet for easier swallowing and not to divide it into equal doses.
Candesartan and Hydrochlorothiazide Sandoz 32 mg/ 12.5 mg tablets:
Al/Al blister with desiccant: 7, 10, 14, 28, 30, 56, 60, 90, 98, 100 or 300 tablets.
HDPE bottle with PP cap and desiccant: 56, 100 tablets.
Candesartan and Hydrochlorothiazide Sandoz 32 mg/ 25 mg tablets:
Al/Al blister with desiccant: 7, 10, 14, 28, 30, 56, 60, 90, 98, 100 or 300 tablets.
HDPE bottle with PP cap and desiccant: 56 tablets.

Marketing Authorisation Holder
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)

Manufacturers
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia
Lek S.A., ul. Podlipie 16, 95-010 Stryków, Poland
Lek S.A., ul. Domaniewska 50 C, 02-672 Warszawa, Poland
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany