CANDESARTAN 8 mg /12,5 Mg Tabletki

Treść ulotki

1. CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici 8 mg+12.5 mg tablets, 16 mg+12.5 mg tablets
   1. What is CANDESARTAN and IDROCLOROTIAZIDE DOC Generici and what is it used for
   2. What you need to know before taking CANDESARTAN and HYDROCHLOROTHIAZIDE DOC
2. CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici may increase the skin's sensitivity to the sun
   1. How to take CANDESARTAN and IDROCLOROTIAZIDE DOC Generici
   2. Possible side effects
   3. How to store CANDESARTAN and IDROCLOROTIAZIDE DOC Generici
   4. Contents of the pack and other information
3. CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici 32 mg+12,5 mg tablets
   1. What is CANDESARTAN and IDROCLOROTIAZIDE DOC Generici and what is it used for
   2. What you need to know before taking CANDESARTAN and IDROCLOROTIAZIDE DOC
4. CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici may increase the skin's sensitivity to the sun
   1. How to take CANDESARTAN and IDROCLOROTIAZIDE DOC Generici
   2. Possible side effects
   3. How to store CANDESARTAN and IDROCLOROTIAZIDE DOC Generici
   4. Package contents and other information

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

Generic medicine

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 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 DOC Generici is and what it is used for
• 2. What you need to know before you take CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici
• 3. How to take CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici
• 4. Possible side effects
• 5. How to store CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici
• 6. Contents of the pack and other information

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

The name of the medicine is CANDESARTAN and IDROCLOROTIAZIDE DOC Generici 8 mg/12.5
mg tablets and CANDESARTAN and IDROCLOROTIAZIDE DOC Generici 16 mg/12.5mg
tablets.
This medicine contains two active ingredients: candesartan cilexetil and hydrochlorothiazide. These
act together to lower blood pressure

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It works by causing the relaxation and dilation of 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.

The doctor may prescribe CANDESARTAN and IDROCLOROTIAZIDE DOC Generici 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 DOC

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 not sure whether this condition applies to you, consult your doctor.
• if you are pregnant for more than 3 months (it is best to avoid using CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics even in the early stages of pregnancy - see the section on pregnancy).
• if you have severe kidney problems.
• if you have a severe liver disease or obstruction of the bile ducts (a problem with the drainage of bile 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 suffer from diabetes or your kidney function is impaired and you are being treated with a medicine 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 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 problems with your heart, liver or kidneys.
• If you have recently had a kidney transplant.
• If you vomit, have recently had severe vomiting or diarrhea.
• If you have a disease of the adrenal gland known as Conn's syndrome (also called primary hyperaldosteronism).
• If you have had a disease called 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.
• Tell your doctor if you think you might be pregnant (or if there is a possibility of becoming pregnant). CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics is not recommended in the early stages of pregnancy, and must 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).
• If 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 cancer in the past or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generics.

Your 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 stated under “Do not use CANDESARTAN and HYDROCHLOROTHIAZIDE
DOC Generics if”.
If you are about to have an operation, tell your doctor or dentist that you are taking CANDESARTAN and
IDROCLOROTIAZIDE DOC Generics. This is because CANDESARTAN and
IDROCLOROTIAZIDE DOC Generics, when combined with certain anesthetics, can cause a
drop in blood pressure.

CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici may increase the skin's sensitivity to the sun

to the sun.

Children and adolescents
There is no experience with the use of CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici in
children and adolescents (under 18 years of age). Therefore CANDESARTAN and
HYDROCHLOROTHIAZIDE DOC Generici should not be given to children and
adolescents.
For those who play sports, it is important to be careful because the hydrochlorothiazide contained
in this medicine may result in positive doping tests.

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

• Other medicines that help 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 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 potassium levels in the blood).
• Calcium or vitamin D supplements.
• Medicines to lower cholesterol levels, such as colestipol or colestyramine.
• Medicines for diabetes (oral tablets or insulin).
• Medicines to control heartbeat (antiarrhythmic agents) such as digoxin and beta-blockers.
• Medicines whose action may be affected by blood potassium levels, such as some antipsychotic drugs.
• Heparin (a medicine to thin the blood).
• Medicines that help you urinate (diuretics).
• Laxatives.
• Penicillin (an antibiotic).
• Amphotericin (for the treatment of fungal infections)
• Lithium (a medicine for mental health problems).
• Steroids, such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines to treat cancer.
• Amantadine (for the treatment of Parkinson's disease or severe infections caused by viruses).
• Barbiturates (a type of sedative also used to treat epilepsy)).
• Carbenoxolone (for the treatment of esophageal disease or oral ulcers).
• Anticholinergic agents such as atropine and biperidene.
• 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.
• If you are taking an ACE inhibitor or aliskiren (see also the section “Do not use CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici” and “Warnings and precautions”).

CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici with food and drink and alcohol

• You can take CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici with or without food.
• When you are prescribed CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici, 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). Usually your doctor will advise you to stop taking
CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici before starting a pregnancy or
as soon as you find out you are pregnant and will advise you to take another
medicine instead of CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici.
CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici is not recommended in early
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 gestation.

Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. CANDESARTAN and
HYDROCHLOROTHIAZIDE DOC Generici is not recommended for women who are breastfeeding and
your doctor may choose another treatment for you if you want 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 DOC Generici. If this happens to you, do not drive or use tools or
machinery.

CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici contains lactose
CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici contains lactose, which is a type of
sugar. If your doctor has diagnosed you with intolerance to some sugars, contact him before
taking this medicine.

3. How to take CANDESARTAN and IDROCLOROTIAZIDE DOC Generici

Take this medicine following the instructions of your doctor exactly. If you have doubts
consult your doctor or pharmacist.
It is important to continue taking CANDESARTAN and IDROCLOROTIAZIDE DOC Generici
every day.
The recommended dose is one tablet 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.
The score line is to facilitate breaking the tablet if you have difficulty swallowing it
whole.

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

If you forget to take CANDESARTAN and IDROCLOROTIAZIDE DOC Generici
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 DOC Generici
If you stop taking CANDESARTAN and IDROCLOROTIAZIDE DOC Generici, your
blood pressure may increase again. Therefore, do not stop taking CANDESARTAN and IDROCLOROTIAZIDE DOC Generici 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 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 can cause difficulty swallowing.
• severe skin itching (with raised blisters).

CANDESARTAN and IDROCLOROTIAZIDE DOC Generici 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 DOC Generici 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 the reduction is severe, then 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, then 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 may make you feel weak or dizzy.
• Loss of appetite, diarrhea, 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 the white of the eye). If this happens to you,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 pain in the stomach.
• Muscle cramps.
• Damage to blood vessels causing the appearance of red or purple spots on the skin.
• A reduction in red blood cells or 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.
• Worsening of existing lupus erythematosus-like reactions or the 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 inflammation of the liver (hepatitis). You may notice fatigue, yellowing of the skin and the white 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 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
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 IDROCLOROTIAZIDE 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 which is stated on the carton and blister after
“Exp”. The expiry date refers to the last day of that month.
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 DOC Generici contains
The active ingredients are: candesartan cilexetil and hydrochlorothiazide. Each tablet contains 8/16 mg of
Candesartan cilexetil and 12.5 mg of Hydrochlorothiazide.
The other ingredients are: lactose monohydrate, corn starch, hydroxypropylcellulose,
sodium croscarmellose, magnesium stearate and triethyl citrate.

Description of the appearance of CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici and
contents of the pack
CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici8 mg + 12.5 mg is available in
white, biconvex tablets, with a fracture line on one side and the printing CH8 on the
same side.
Pack sizes: 7, 14, 28, 30, 56, 70, 90, 98 tablets.

CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici16 mg + 12.5 mg is available in
white, biconvex tablets, with a fracture line on one side and the printing CH16 on the
same side.
Pack sizes: 7, 14, 28, 30, 56, 70, 90, 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici Srl, Via Turati 40, 20121 Milan

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 authorised in the Member States of the European Economic Area under the
following denominations:
Austria: Candesartan/HCT ratiopharm Tablets
Belgium: Co-Canderatio tablets
Estonia: Candesartan HCT-ratiopharm
Finland: Candexetil comp tablets
Germany: Candesartan-ratiopharm comp. Tablets
Luxembourg: Candesartan-ratiopharm comp. Tablets
Norway: Candexetil comp tablets
Netherlands: Candesartancilexetil/Hydrochloorthiazide ratiopharm tablets
Portugal Candesartan + Hidroclorotiazida ratiopharm
Slovakia Candesartan HCT ratiopharm
Spain: Candesartan Hidroclorotiazida ratiopharm comprimidos EFG
Sweden Candexetil comp tablets

CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici 32 mg+12,5 mg tablets

CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici 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 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 DOC Generici is and what it is used for
• 2. What you need to know before you take CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici
• 3. How to take CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici
• 4. Possible side effects
• 6. How to store CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici
• 6. Contents of the pack and other information

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

The name of your medicine is CANDESARTAN and IDROCLOROTIAZIDE DOC Generici.
It is used to treat high blood pressure (hypertension) in adult patients. This medicine
contains two active ingredients: 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 widening of the blood vessels. This helps to reduce blood pressure.
• Hydrochlorothiazide belongs to a group of drugs called diuretics. It works by promoting greater elimination of water and salt such as sodium by the kidneys. This helps to reduce blood pressure.

The doctor may prescribe CANDESARTAN and IDROCLOROTIAZIDE DOC Generici if the
blood pressure has not been adequately controlled by candesartan cilexetil or
hydrochlorothiazide alone.

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

Generics
Do not use CANDESARTAN and IDROCLOROTIAZIDE 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 not sure whether this condition applies to you, consult your doctor.
• if you are pregnant for more than 3 months (it is best to avoid taking CANDESARTAN and IDROCLOROTIAZIDE DOC Generics even at the beginning of pregnancy - see the section on pregnancy.).
• if you have severe kidney problems.
• if you have a severe liver disease or obstruction of the bile ducts (a problem with the drainage of bile 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 suffer from diabetes or your kidney function is impaired and you are being treated with a medicine 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 IDROCLOROTIAZIDE DOC Generics.

Warnings and precautions
Talk to your doctor or pharmacist before taking CANDESARTAN and IDROCLOROTIAZIDE
DOC Generics:

• If you have diabetes.
• If you have problems with your heart, liver or kidneys.
• If you have recently had a kidney transplant.
• If you vomit, have recently vomited a lot or have diarrhoea.
• If you have a disease of the adrenal gland called Conn's syndrome (also defined 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.
• Tell your doctor if you think you might be or could become pregnant. CANDESARTAN and IDROCLOROTIAZIDE DOC Generics is not recommended in the first months of pregnancy and should not be taken if you are beyond the third month, as it can cause serious harm to the baby if used at this stage (see the section on pregnancy)
• If 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 cancer in the past or if you are developing an unexpected skin lesion during 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 IDROCLOROTIAZIDE DOC Generics.

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 stated under “Do not use CANDESARTAN and IDROCLOROTIAZIDE
DOC Generics”.
If you are about to have an operation, tell your doctor or dentist that you are taking CANDESARTAN and
IDROCLOROTIAZIDE DOC Generics. This is because CANDESARTAN and
IDROCLOROTIAZIDE DOC Generics, when combined with some anaesthetics, can cause a
drop in blood pressure.

CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici may increase the skin's sensitivity to the sun

to the sun.

Children and adolescents
There is no experience in 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.
For those who engage in sports, it is important to be careful as the hydrochlorothiazide contained
in this medicine may result in positive doping tests.

Other medicines and CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici can affect
the mechanism of action of other medicines, and some medicines can have an effect on
CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici. If you are taking certain
medicines, your doctor may need to have you undergo blood tests from time to time,
adjust the dose and/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.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines used for pain and inflammation).
• Acetylsalicylic acid, if you are taking more than 3 g per day (medicine used for pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines that can increase the amount of potassium in your body).
• Preparations containing calcium or vitamin D.
• Medicines to lower cholesterol levels, such as colestipol or colestyramine.
• Medicines for diabetes (oral agents and insulin).
• Medicines to control the heartbeat (antiarrhythmic agents) such as digoxin and beta-blockers.
• Medicines that can affect the level of potassium in the blood, such as some antipsychotic drugs.
• Heparin (a medicine to thin the blood).
• Tablets that help you urinate (diuretics).
• Laxatives.
• Penicillin (an antibiotic).
• Amphotericin (treatment of fungal infections).
• Lithium (a medicine for mental health problems).
• Steroids such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines to treat cancer.
• Amantadine (for the treatment of Parkinson's disease or severe viral infections)
• Barbiturates (sedatives, also used for the treatment of epilepsy).
• Carbenoxolone (for the treatment of esophageal disease or oral ulcers).
• Anticholinergic agents such as atropine and biperidene.
• Cyclosporine, a drug used in organ transplantation to prevent rejection.
• Other medicines that can lead to an increase in the antihypertensive effect such as baclofen (a medicine to reduce spasticity), amifostine (used in cancer treatment) and some antipsychotics.
• If you are taking an ACE inhibitor or aliskiren (see also “Do not use CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici” and “Warnings and precautions”).

CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici with food, beverages and alcohol

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

Pregnancy and breastfeeding

Pregnancy
You must tell your doctor if you think you are pregnant (or if there is a possibility of becoming
pregnant). Usually your doctor will advise you to stop taking
CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici before starting a pregnancy or
as soon as you find out you are pregnant and advise you to take another
medicine instead of CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici.
CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici is not recommended in early
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 gestation.

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. CANDESARTAN and
HYDROCHLOROTHIAZIDE DOC Generici is not recommended for women who are breastfeeding and
your doctor may choose another treatment for you if you wish to breastfeed.

Driving and operating machinery
Some people may feel tired or dizzy when taking CANDESARTAN and
HYDROCHLOROTHIAZIDE DOC Generici. If this happens to you, do not drive or use tools or
machinery.

CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici contains lactose
CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici contains lactose, which is a type of
sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before
taking this medicine.

5. How to take CANDESARTAN and IDROCLOROTIAZIDE DOC Generici

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 DOC Generici
every day.
The recommended dose is one tablet a day.
Swallow the tablet whole 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.
The tablet can be divided into equal parts.

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

If you forget to take CANDESARTAN and IDROCLOROTIAZIDE DOC Generici
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 DOC Generici
If you stop taking CANDESARTAN and IDROCLOROTIAZIDE DOC Generici, your
blood pressure may increase again. Therefore, do not stop treatment with
CANDESARTAN and IDROCLOROTIAZIDE DOC Generici without first talking to your doctor.
If you have any doubts 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 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 skin itching (with raised blisters).

CANDESARTAN and IDROCLOROTIAZIDE DOC Generici 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, tell your doctor. The doctor may occasionally perform
blood tests to check if CANDESARTAN and IDROCLOROTIAZIDE DOC Generici 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 the reduction is severe, you may experience weakness, lack of energy or muscle cramps. An increased amount of potassium in the blood, especially if you already have kidney problems or suffer from heart failure. In severe cases, this condition can cause weakness, fatigue and irregular heartbeat or tingling. Increased levels of cholesterol, sugar or uric acid in the blood.
• Presence of sugar in the urine.
• Feeling dizzy/lightheaded.
• Headache.
• Respiratory infections.

Uncommon (may affect up to 1 in 100 people)

• Low blood pressure. This may cause dizziness and lightheadedness.
• Loss of appetite, diarrhea, 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 white of the eye). If this happens, contact your doctor immediately.
• Impaired kidney function, especially if you have already had kidney problems in the past or suffer from heart failure.
• Sleep disturbances, depression, restlessness.
• Tingling in the arms or legs.
• Blurred vision for a short period.
• Irregular heartbeat.
• Difficulty breathing (including lung infection and fluid in the lungs).
• High temperature (fever).
• Inflammation of the pancreas. This causes mild to moderate pain in the stomach area.
• Muscle cramps.
• Damage to blood vessels, resulting in the appearance of red or purple spots on the skin.
• Reduced 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 on the skin or in the mouth.
• Worsening of a pre-existing lupus erythematosus-like reaction or the appearance of 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 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 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
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 IDROCLOROTIAZIDE DOC Generici

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 carton, blister or
bottle after “Exp”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 ingredients 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 ingredients are lactose monohydrate, corn starch, hydroxypropylcellulose, croscarmellose
sodium, magnesium stearate and triethyl citrate.

Description of the appearance of CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici and
package contents
CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici 32 mg+12.5 mg tablets are
presented in oval, biconvex, white or off-white tablets, with a fracture line on both
sides and the inscription 32/12 on one side (approximately 7 x 12 mm).
CANDESARTAN and HYDROCHLOROTHIAZIDE DOC Generici 32 mg+25 mg tablets are presented in
oval, biconvex, white or off-white tablets, with a fracture line on both
sides and the inscription 32/25 on one side (approximately 7 x 12 mm).
Blisters in PVC-PVDC/Al
Packs: 7, 14, 20, 28, 30, 56, 60, 70, 90, 98, 100 tablets
HDPE bottle
Packs: 30, 100, 500 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici Srl, Via Turati 40, 20121 Milan

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 authorised in the Member States of the European Economic Area under
the following denominations:
Austria: Candesartan/HCT ratiopharm Tablets
Finland: Candexitil comp tabletti
Germany: Candesartan-ratiopharm comp. Tablets
Luxembourg: Candesartan-ratiopharm comp. Tablets
Norway: Candexitil comp tabletter
Portugal Candesartan + Hidroclorotiazida ratiopharm
Spain: Candesartan Hidroclorotiazida ratiopharm comprimidos EFG