Candesartan and hydrochlorothiazide Doc Generici: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics 8 mg+12.5 mg tablets, 16 mg+12.5 mg tablets

Generic medicine
Please read this leaflet carefully before 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics are and what they are used for
What you need to know before taking CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics
How to take CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics
Possible side effects
How to store CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics
Contents of the pack and other information

1. What CANDESARTAN and IDROCHLOROTHIAZIDE DOC Generici is and what it is used for

The name of the medicine is CANDESARTAN and IDROCHLOROTHIAZIDE DOC Generici 8 mg/12.5 mg tablets and CANDESARTAN and IDROCHLOROTHIAZIDE DOC Generici 16 mg/12.5 mg tablets.
This medicine contains two active substances: 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 works by relaxing and widening blood vessels. This helps reduce blood pressure.
Hydrochlorothiazide belongs to a group of medicines called diuretics (which help increase urination). It helps the body eliminate water and salts such as sodium through the urine. This contributes to lowering blood pressure.

Your doctor may prescribe CANDESARTAN and IDROCHLOROTHIAZIDE DOC Generici if your blood pressure has not been adequately controlled with candesartan cilexetil or hydrochlorothiazide alone.

2. What you should know before taking CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics

Generics
Do not use CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics:

if you are allergic to candesartan cilexetil or hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6).
if you are allergic to sulfonamide medicines. If you are unsure whether this applies to you, consult your doctor.
if you are more than 3 months pregnant (it is best to avoid using CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics even during early pregnancy – see section on Pregnancy).
if you have severe kidney problems.
if you have severe liver disease or biliary obstruction (a condition affecting bile drainage from the gallbladder).
if you have persistently low levels of potassium in your blood.
if you have persistently high levels of calcium in your blood.
if you have had gout.
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 and HYDROCHLOROTHIAZIDE DOC Generics.
Warnings and precautions
Talk to your doctor or pharmacist before taking CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics:

If you have diabetes.
If you have heart, liver, or kidney problems.
If you have recently undergone a kidney transplant.
If you are vomiting, or have recently experienced severe vomiting or diarrhea.
If you have an adrenal gland disorder known as Conn's syndrome (also called primary hyperaldosteronism).
If you have had systemic lupus erythematosus (SLE).
If you have thyroid or parathyroid problems.
If you have low blood pressure.
If you have ever had a stroke.
If you have had asthma or allergies.
Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics 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 if taken during this period (see section on Pregnancy).
If you are taking any of the following medicines for high blood pressure:
an “ACE inhibitor” (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
aliskiren.
If you have previously had skin cancer or develop unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, especially 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 radiation while taking CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics.

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 use CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics if”.
If you are about to undergo surgery, inform your doctor or dentist that you are taking CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics. This is because CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics, when used together with certain anesthetics, may cause a drop in blood pressure.
CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics may increase your skin’s sensitivity to sunlight.
Children and adolescents
There is no experience with the use of CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics in children and adolescents (under 18 years of age). Therefore, CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics must not be administered to children and adolescents.
Athletes should be cautious, as the hydrochlorothiazide contained in this medicine may lead to positive results in doping tests.
Other medicines and CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics may affect how other medicines work, and some medicines may affect CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics. If you are taking certain medicines, your doctor may need to perform blood tests periodically, adjust your dose, or take other precautions.
In particular, tell your doctor if you are taking any of the following medicines:

Other medicines that lower blood pressure, including beta-blockers, diazoxide, and angiotensin-converting enzyme (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 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).
Calcium supplements or vitamin D.
Medicines to lower cholesterol levels, such as colestipol or cholestyramine.
Medicines for diabetes (oral tablets or insulin).
Medicines to control heart rhythm (antiarrhythmics) such as digoxin and beta-blockers.
Medicines whose effects may be influenced by blood potassium levels, such as certain antipsychotic drugs.
Heparin (a medicine used to thin the blood).
Medicines that help you urinate (diuretics).
Laxatives.
Penicillin (an antibiotic).
Amphotericin (used to treat fungal infections).
Lithium (a medicine used for mental health conditions).
Steroids, such as prednisolone.
Pituitary hormone (ACTH).
Medicines used to treat cancer.
Amantadine (used to treat Parkinson’s disease or severe viral infections).
Barbiturates (a type of sedative also used to treat epilepsy).
Carbenoxolone (used to treat esophageal disease or oral ulcers).
Anticholinergic agents such as atropine and biperiden.
Cyclosporine, a medicine used in organ transplants to prevent rejection.
Other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine used to relieve spasticity), amifostine (used in cancer treatment), and certain antipsychotic medicines.
If you are taking an ACE inhibitor or aliskiren (see also sections “Do not use CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics” and “Warnings and precautions”).

CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics with food, drinks, and alcohol

You may take CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics with or without food.
When prescribed CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics, talk to your doctor before drinking alcohol. Alcohol may 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). Your doctor will usually advise you to stop taking CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.
CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics 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 if taken beyond the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics is not recommended for women who are breastfeeding. Your doctor may choose a different treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.
Driving and using machines
Some people may feel tired or dizzy when taking CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics. If this happens to you, do not drive or operate tools or machinery.
CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics contains lactose
CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
It is important to continue taking CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics every day.
The recommended dose is one tablet daily.
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.
The break line on the tablet is intended to facilitate splitting it in case you have difficulty swallowing it whole.

If you take more CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics than you should
If you take more CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics than prescribed by your doctor, contact a doctor or pharmacist immediately for advice.

If you forget to take CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics
Do not take a double dose to make up for the forgotten tablet. Take only the next dose as usual.

If you stop taking CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics
If you stop treatment with CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics, your blood pressure may rise again. Therefore, do not stop treatment with CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics without first discussing it with 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 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 DOC Generici are caused by candesartan cilexetil and some are caused by hydrochlorothiazide.
Stop taking CANDESARTAN and IDROCLOROTIAZIDE DOC Generici 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 blisters).

CANDESARTAN and IDROCLOROTIAZIDE DOC Generici 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 check whether CANDESARTAN and IDROCLOROTIAZIDE DOC Generici has affected your blood (agranulocytosis).
Other possible side effects include:
Common (may affect up to 1 in 10 people)

Changes in blood test results: Reduced sodium levels in the blood. If this reduction is severe, you may notice weakness, lack of energy or muscle cramps. Increased or decreased potassium levels 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, irregular heartbeat or tingling. Increased levels of cholesterol, sugar or uric acid in the blood.
Sugar in the urine
Dizziness, lightheadedness or weakness
Headache
Respiratory infection

Uncommon (may affect up to 1 in 100 people)

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

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

Jaundice (yellowing of the skin or whites of the eyes). If this occurs, contact your doctor immediately.
Effects on kidney function, especially if you already have kidney problems or heart failure.
Difficulty sleeping, depression, feeling restless.
Tingling or prickling sensations in the arms or legs.
Blurred vision for a short period.
Irregular heartbeat.
Breathing difficulties (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 small red or purple spots on the skin.
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 and peeling of the skin, and sometimes in the mouth.
Worsening of existing lupus-like reactions or appearance of unusual skin reactions.

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 whites of the eyes, and flu-like symptoms.
Cough.
Nausea.

Not known (frequency cannot be estimated from available data)

Skin and lip cancer (non-melanoma skin cancer).

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 website
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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 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 and HYDROCHLOROTHIAZIDE DOC Generici contains
The active substances are: candesartan cilexetil and hydrochlorothiazide. Each tablet contains 8/16 mg of
candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
The other components are: monohydrate lactose, maize starch, hydroxypropylcellulose,
sodium croscarmellose, magnesium stearate and triethyl citrate.

Description of the appearance of CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici and
packaged contents
CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici 8 mg + 12.5 mg is presented as white, biconvex tablets, with a break line on one side and the imprint CH8 on the same side.
Pack sizes: 7, 14, 28, 30, 56, 70, 90, 98 tablets.

CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici 16 mg + 12.5 mg is presented as white, biconvex tablets, with a break line on one side and the imprint CH16 on the same side.
Pack sizes: 7, 14, 28, 30, 56, 70, 90, 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici Srl, Via Turati 40, 20121 Milano

Manufacturer
Siegfried Malta Ltd.
HHF070 Hal Far Industrial Estate (P.O. Box 14)
BBG 3000 Hal Far
Malta
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany

This medicinal product is authorized in the European Economic Area countries under the
following names:
Austria: Candesartan/HCT ratiopharm Tabletten
Belgium: Co-Canderatio tablets
Estonia: Candesartan HCT-ratiopharm
Finland: Candexetil comp tabletti
Germany: Candesartan-ratiopharm comp. Tabletten
Luxembourg: Candesartan-ratiopharm comp. Tabletten
Norway: Candexetil comp tabletter
Netherlands: Candesartancilexetil/Hydrochloorthiazide ratiopharm tabletten
Portugal: Candesartan + Hidroclorotiazida ratiopharm
Slovakia: Candesartan HCT ratiopharm
Spain: Candesartan Hidroclorotiazida ratiopharm comprimidos EFG
Sweden: Candexetil comp tabletter

Package leaflet: Information for the user

CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics 32 mg + 12.5 mg tablets, mg + 25 mg tablets

Equivalent medicine
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could 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 CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics is and what it is used for
What you need to know before taking CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics
How to take CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics
Possible side effects
How to store CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics
Package contents and other information

2. What CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici is and what it is used for

The name of your medicine is CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici.
It is used to treat high blood pressure (hypertension) in adult patients. This medicine
contains two active substances: candesartan cilexetil and hydrochlorothiazide. Together, they lower blood pressure.

Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It works by causing relaxation and dilation of blood vessels. This helps reduce blood pressure.
Hydrochlorothiazide belongs to a group of medicines called diuretics. It works by increasing the excretion of water and salts such as sodium through the kidneys. This helps reduce blood pressure.

Your doctor may prescribe CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici if your
blood pressure has not been adequately controlled by candesartan cilexetil or
hydrochlorothiazide alone.

4. What you need to know before taking CANDESARTAN and HYDROCHLOROTHIAZIDE DOC

Generics
Do not use CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics:

if you are allergic to candesartan cilexetil, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).
if you are allergic to sulfonamide medicines. If you are unsure whether this applies to you, consult your doctor.
if you are more than 3 months pregnant (it is best to avoid taking CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics even in early pregnancy - see section on pregnancy).
if you have severe kidney problems.
if you have severe liver disease or biliary obstruction (a problem with bile drainage from the gallbladder).
if you have persistently low levels of potassium in your blood.
if you have persistently high levels of calcium in your blood.
if you have had gout.
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you have diabetes.
If you have heart, liver, or kidney problems.
If you have recently had a kidney transplant.
If you are vomiting, have recently vomited frequently, or have diarrhea.
If you have a disorder of the adrenal gland called Conn’s syndrome (also known as primary hyperaldosteronism).
If you have an inflammatory disease called systemic lupus erythematosus (SLE).
If you have low blood pressure.
If you have had a stroke in the past.
If you suffer from asthma or allergies.
Inform your doctor if you think you may be pregnant or could become pregnant. CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics 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 used at this stage (see section on pregnancy).
If you are taking any of the following medicines used to treat high blood pressure:
an “ACE inhibitor” (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes
aliskiren
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 CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals.
See also the section “Do not use CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics”.
If you are about to undergo surgery, tell your doctor or dentist that you are taking CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics. This is because CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics, when combined with certain anesthetics, may cause a drop in blood pressure.
CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics may increase your skin’s sensitivity to sunlight.
Children and adolescents
There is no experience with the use of candesartan/hydrochlorothiazide in children and adolescents (under 18 years of age). Therefore, candesartan/hydrochlorothiazide should not be given to children and adolescents.
Athletes should be aware that hydrochlorothiazide contained in this medicine may lead to positive results in doping tests.
Other medicines and CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics may affect how other medicines work, and some medicines may affect CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics. If you are taking certain medicines, your doctor may need to perform blood tests from time to time, adjust your dose, or take other precautions.
In particular, tell your doctor if you are taking/using any of the following medicines:

Other medicines that help lower 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 for pain and inflammation).
Acetylsalicylic acid (aspirin), if you are taking more than 3 g per day (a medicine used for pain and inflammation).
Potassium supplements or potassium-containing salt substitutes (medicines that may increase potassium levels in your body).
Calcium or vitamin D preparations.
Medicines to lower cholesterol levels, such as colestipol or cholestyramine.
Antidiabetic medicines (oral agents and insulin).
Medicines to control heart rhythm (antiarrhythmics) such as digoxin and beta-blockers.
Medicines that may affect potassium levels in the blood, such as certain antipsychotics.
Heparin (a medicine used to thin the blood).
Tablets that help you pass urine (diuretics).
Laxatives.
Penicillin (an antibiotic).
Amphotericin (treatment for fungal infections).
Lithium (a medicine used for mental health conditions).
Steroids such as prednisolone.
Pituitary hormone (ACTH).
Medicines used to treat cancer.
Amantadine (used to treat Parkinson’s disease or severe viral infections).
Barbiturates (sedatives, also used to treat epilepsy).
Carbenoxolone (used to treat esophageal disease or oral ulcers).
Anticholinergic agents such as atropine and biperidene.
Cyclosporine, a medicine used in organ transplants to prevent rejection.
Other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine to reduce spasticity), amifostine (used in cancer treatment), and certain antipsychotics.
If you are taking an ACE inhibitor or aliskiren (see also the sections “Do not use CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics” and “Warnings and precautions”).

CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics with food, drinks, and alcohol

You may take CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics with or without food.
If you drink alcohol, tell your doctor before taking CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics. Alcohol may make you feel weak or dizzy.

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead.
CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics 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 gestation.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics is not recommended for women who are breastfeeding, and your doctor may choose another treatment if you wish to breastfeed.
Driving and using machines
Some people may feel tired or dizzy when taking CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics. If this happens to you, do not drive or operate tools or machinery.
CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics contains lactose
CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

5. How to take CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
It is important to continue taking CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici every day.
The recommended dose is one tablet daily.
Swallow the tablet whole with a glass of water.
Try to take the tablet at the same time each day. This will help you remember to take it.
The tablet can be divided into equal parts.

If you take more CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici than you should
If you take more CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici than prescribed by your doctor, contact a doctor or pharmacist immediately for advice.

If you forget to take CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici
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 and HYDROCHLOROTHIAZIDE DOC Generici
If you stop treatment with CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici, your blood pressure may rise again. Therefore, do not stop treatment with CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici without first talking to your doctor.

If you have any questions 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 what these side effects might be. Some of the side effects of CANDESARTAN and IDROCLOROTIAZIDE DOC Generici are caused by candesartan cilexetil and some are caused by hydrochlorothiazide.
Stop taking CANDESARTAN and IDROCLOROTIAZIDE DOC Generici 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 blisters).

CANDESARTAN and IDROCLOROTIAZIDE DOC Generici 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, inform your doctor. Your doctor may occasionally perform blood tests to check whether CANDESARTAN and IDROCLOROTIAZIDE DOC Generici has affected your blood (agranulocytosis).

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

Changes in blood test results: Reduced sodium levels in the blood. If this reduction is severe, you may experience weakness, lack of energy, or muscle cramps. Increased potassium levels in the blood, especially if you already have kidney problems or suffer from heart failure. In more severe cases, this condition may cause weakness, fatigue, irregular heartbeat, or tingling. Increased levels of cholesterol, glucose, or uric acid in the blood.
Presence of sugar in the urine.
Dizziness/lightheadedness.
Headache.
Respiratory infections.

Uncommon (may affect up to 1 in 100 people)

Low blood pressure. This may cause dizziness and lightheadedness.
Loss of appetite, diarrhoea, constipation, and stomach irritation.
Skin rash, including skin swelling, and rash due to sensitivity to sunlight.

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

Jaundice (yellowing of the skin or the whites of the eyes). If this occurs, contact your doctor immediately.
Changes in kidney function, especially if you have previously had kidney problems or suffer from heart failure.
Sleep disorders, depression, restlessness.
Tingling sensations in the arms or legs.
Brief episodes of blurred vision.
Irregular heartbeat.
Breathing difficulties (including lung infection and fluid in the lungs).
High body temperature (fever).
Inflammation of the pancreas. This causes mild to moderate pain in the stomach area.
Muscle cramps.
Damage to blood vessels, resulting in red or purple spots appearing on the skin.
Reduction in red blood cells, white blood cells, or platelets. You may notice fatigue, infection, fever, or easy bruising.
Severe and rapidly developing skin rash, with blistering or peeling of the skin or inside the mouth.
Worsening of pre-existing lupus-like reactions or unusual skin reactions.

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

Swelling of the face, lips, tongue, or throat.
Itching.
Back pain, joint pain, 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.
Cough.
Nausea.

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

Skin and lip cancer (non-melanoma skin cancer).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister or bottle after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 and HYDROCHLOROTHIAZIDE DOC Generici contains
The active substances are: 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 components are monohydrate lactose, maize starch, hydroxypropylcellulose, sodium
croscarmellose, magnesium stearate and triethyl citrate.

Description of the appearance of CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici and pack sizes
CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici 32 mg + 12.5 mg tablets are oval, biconvex, white or almost white tablets, with a break line on both sides and the imprint "32/12" on one side (approximately 7 x 12 mm).
CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici 32 mg + 25 mg tablets are oval, biconvex, white or almost white tablets, with a break line on both sides and the imprint "32/25" on one side (approximately 7 x 12 mm).
Blister packs in PVC-PVDC/Al
Pack sizes: 7, 14, 20, 28, 30, 56, 60, 70, 90, 98, 100 tablets
HDPE bottles
Pack sizes: 30, 100, 500 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici Srl, Via Turati 40, 20121 Milano, Italy

Manufacturer
Merckle GmbH, Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren, Germany
Siegfried Malta Ltd., HHF070 Hal Far Industrial Estate, Hal Far BBG3000, Malta
TEVA Pharmaceutical Works Private Limited Company, 4042 Debrecen, Pallagi út 13, Hungary
Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, Netherlands
Teva Czech Industries s.r.o., Ostravska 29, c.p. 305, 74770 Opava-Komarov, Czech Republic
TEVA PHARMA S.L.U., C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza, Spain
Teva Operations Poland Sp. z o.o., Ul. Sienkiewicza 25, 99-300 Kutno, Poland

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria: Candesartan/HCT ratiopharm Tabletten
Finland: Candexitil comp tabletti
Germany: Candesartan-ratiopharm comp. Tabletten
Luxembourg: Candesartan-ratiopharm comp. Tabletten
Norway: Candexitil comp tabletter
Portugal: Candesartan + Hidroclorotiazida ratiopharm
Spain: Candesartan Hidroclorotiazida ratiopharm comprimidos EFG