CANDESARTAN 16 mg /12.5 Mg Tablets

Зміст інструкції

1. Candesartan and Hydrochlorothiazide Alter 16 mg/12.5 mg tablets, 32mg/12.5 mg tablets, 32mg/25 mg tablets
   1. What is Candesartan and Hydrochlorothiazide Alter and what it is used for
   2. What you need to know before taking Candesartan and Hydrochlorothiazide Alter
2. Candesartan e Idroclorotiazide Alter contains an active substance that may cause
   1. How to take Candesartan and Idroclorotiazide Alter
   2. Possible side effects
3. Candesartan and Hydrochlorothiazide Alter has had effects on your blood
   1. How to store Candesartan e Idroclorotiazide Alter
   2. Contents of the pack and other information

Candesartan and Hydrochlorothiazide Alter 16 mg/12.5 mg tablets, 32mg/12.5 mg tablets, 32mg/25 mg tablets

candesartan cilexetil, hydrochlorothiazide

Generic medicine

Read this leaflet carefully before taking this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not 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 Alter is and what it is used for
• 2. What you need to know before you take Candesartan and Hydrochlorothiazide Alter
• 3. How to take Candesartan and Hydrochlorothiazide Alter
• 4. Possible side effects
• 5. How to store Candesartan and Hydrochlorothiazide Alter
• 6. Contents of the pack and other information

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

Your medicine is called Candesartan and Hydrochlorothiazide Alter. 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 class of medicines known as angiotensin II receptor antagonists. It works by relaxing and widening 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 helps to reduce blood pressure.

The doctor may prescribe Candesartan and Hydrochlorothiazide Alter 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 Alter

Do not take Candesartan and Hydrochlorothiazide Alter

• if you are allergic to candesartan cilexetil or 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 may apply to you, consult your doctor.
• if you are pregnant for more than three months (it is best to avoid taking Candesartan and Hydrochlorothiazide Alter even in the early stages of pregnancy - see the section “Pregnancy”).
• if you have severe kidney problems.
• if you suffer from a severe liver disease or biliary obstruction (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 impaired kidney function and are being treated with aliskiren-based medicines that lower blood pressure.

If you are not sure if any of the above applies to you, ask your pharmacist or
doctor before starting treatment with Candesartan and Hydrochlorothiazide Alter.

Warnings and precautions
Talk to your doctor or pharmacist before taking Candesartan and Hydrochlorothiazide
Alter:
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 lip cancer (non-melanoma skin cancer). Protect your
skin from exposure to the sun and UV rays while taking Candesartan and
Hydrochlorothiazide Alter.
If you have had breathing or lung problems (including inflammation or fluid in the
lungs) following the use of hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after
taking Candesartan and Hydrochlorothiazide Alter, consult a doctor immediately.
Tell your doctor before taking Candesartan and Hydrochlorothiazide Alter if:

• you suffer from diabetes
• you have problems with your heart, liver or kidneys
• you have recently had a kidney transplant
• you are vomiting or have recently had severe vomiting or diarrhea
• you suffer from a disease of the adrenal gland known as Conn's syndrome (also called primary hyperaldosteronism)
• you have had a disease called systemic lupus erythematosus (SLE)
• your blood pressure is low
• you have had a stroke
• you have had allergies or asthma.
• you are taking aliskiren, a medicine to treat high blood pressure
• 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 have kidney problems associated with diabetes
• aliskiren
• you are taking an ACE inhibitor together with a medicine that belongs to the class of medicines known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see “Other medicines and Candesartan and Hydrochlorothiazide Alter”).

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 Alter.
Increased pressure in the eye, if left untreated, can lead to permanent vision damage. If you have previously experienced an allergy to penicillins or
sulfonamides, you are at high risk of developing this effect.
Tell your doctor if you think you may be pregnant (or if there is a possibility of
becoming pregnant). Candesartan and Hydrochlorothiazide Alter is not
recommended in early pregnancy and should not be taken after the third month of
pregnancy as it can cause serious harm to the baby if taken during that period
(see the section Pregnancy).
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 the information in the section “Do not take Candesartan and Hydrochlorothiazide
Alter”.
If you are about to undergo surgery, tell your doctor or dentist that
you are taking Candesartan and Hydrochlorothiazide Alter. This is because if Candesartan and
Hydrochlorothiazide Alter is combined with certain anesthetics, a drop in
blood pressure may occur.
Candesartan and Hydrochlorothiazide Alter may increase the sensitivity of your skin to the sun.
Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhea after taking Candesartan and Hydrochlorothiazide Alter. The doctor will decide on the
continuation of treatment. Do not stop taking Candesartan and
Hydrochlorothiazide Alter on your own.

Children and adolescents
There is no experience regarding the use of Candesartan and Hydrochlorothiazide Alter in children (under
18 years of age). Candesartan and Hydrochlorothiazide Alter should therefore not
be given to children.
Consult your doctor if you are an athlete who is about to undergo a doping control test, because

Candesartan e Idroclorotiazide Alter contains an active substance that may cause

positive results in doping tests.
For those who engage in sports: the use of the drug without therapeutic necessity
constitutes doping and may still result in positive doping tests.

Other medicines and Candesartan e Idroclorotiazide AlterAlter
Tell your doctor or pharmacist if you are taking, have recently taken or
may take any other medicines, including over-the-counter medicines.
Candesartan e Idroclorotiazide Alter can affect the mechanism of action of other
medicines, and some medicines can have an effect on Candesartan e
Idroclorotiazide Alter.
If you are taking certain medicines, your doctor may need to perform blood tests from time to time.
Your doctor may need to change your dose and/or take other precautions
if you are taking:

• an ACE inhibitor or aliskiren (see also the information under the paragraph “Do not take Candesartan e Idroclorotiazide Alter” and “Warnings and precautions”).
• an ACE inhibitor together with certain medicines for treating heart failure known as mineralocorticoid receptor antagonists (MRAs) (for example spironolactone, eplerenone).
• Other medicines to lower blood pressure, including aliskiren, 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 that relieve pain and inflammation).
• Acetylsalicylic acid (in doses higher 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, such as colestipol or colestyramine (a resin-like medicine to reduce lipids)
• Medicines for diabetes (oral tablets or insulin).
• Medicines to control heart rhythm (antiarrhythmic agents) such as digoxin and beta-blockers.
• Medicines whose action may be affected by blood potassium levels, such as some antipsychotic medicines.
• Heparin (medicine to thin the blood).
• Tablets that promote diuresis (diuretics).
• Laxatives.
• Penicillin (an antibiotic).
• Amphotericin (for the treatment of fungal infections).
• Lithium (medicine for the treatment of mental health problems).
• Steroids, such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines to treat cancer.
• 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).
• 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 the treatment of cancer) and some antipsychotic medicines. Consult your doctor if you are not sure which these medicines are.

Candesartan e Idroclorotiazide Alter with food, beverages and alcohol
Candesartan e Idroclorotiazide Alter can be taken with or without food.
During treatment with Candesartan e Idroclorotiazide Alter, consult your doctor
before drinking alcohol. Alcohol can cause dizziness or fainting.

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 e Idroclorotiazide Alter before you
become pregnant or as soon as you find out you are pregnant, they will advise you to
take another medicine instead of Candesartan e Idroclorotiazide Alter.
Candesartan e Idroclorotiazide Alter is not recommended in early pregnancy and
must not be taken after the third month of pregnancy as it can cause serious
harm to the baby if taken during that period.
Breastfeeding
Tell your doctor if you are breastfeeding, or if you are about to start breastfeeding.
Candesartan e Idroclorotiazide Alter is not recommended during breastfeeding and
your doctor may choose another treatment for you if you wish to breastfeed, especially
if your baby is newly born or was born prematurely.

Driving and operating machinery
Some people may feel tired or dizzy during
treatment with Candesartan e Idroclorotiazide Alter. If this affects you, do not
drive vehicles or use tools or machinery.

Candesartan e Idroclorotiazide Alter contains lactose.
If your doctor has told you that you have an intolerance to some sugars, contact them before
taking this medicine

3. How to take Candesartan and Idroclorotiazide Alter

Take this medicine following exactly the instructions of your doctor. If you have any
doubts, consult your doctor or pharmacist. It is important that you continue to take
Candesartan and Idroclorotiazide Alter every day.
The recommended dose of Candesartan and Idroclorotiazide Alter is equivalent to 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 Alter than you should
If you take more Candesartan and Idroclorotiazide Alter than prescribed by your doctor, contact a
doctor or pharmacist immediately.

If you forget to take Candesartan and Idroclorotiazide Alter
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 Alter
If you stop taking Candesartan and Idroclorotiazide Alter, your blood pressure may
increase again. Therefore, do not stop taking Candesartan and Idroclorotiazide
Alter without first consulting 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 Alter are caused by
candesartan cilexetil and some are caused by hydrochlorothiazide.

Stop taking Candesartan and Idroclorotiazide Alter 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 Alter 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 Hydrochlorothiazide Alter has had effects on your blood

(agranulocytosis).
Other possible undesirable effects include:

Common (may affect up to 1 in 10 people):

• Changes in blood test results:
• Low levels of sodium in the blood. If this reduction is severe, you may notice weakness, loss 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 change 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 tract infections.

Uncommon (may affect up to 1 in 100 people)

• Lowering of blood pressure. This can cause fainting, make you feel weak and 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 and/or whites of the eyes). If this happens to you, 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 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.
• Inflammation of small blood vessels resulting in reddish or purplish discoloration of 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.
• Worsening of existing lupus-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 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.
• Acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).
• Intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting and diarrhea.

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

• Sudden myopia
• Rapid onset of reduced distance vision (acute myopia), decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• Diarrhea
• Skin cancer 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 e Idroclorotiazide Alter

• Keep this medicine out of the sight and reach of children.
• Store at a temperature below 30°C.
• Do not use Candesartan e Idroclorotiazide Alter after the expiry date indicated on the packaging and blister. The expiry date refers to the last day of the month.

Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to eliminate medicines that you no longer use. This will help to
protect the environment.

6. Contents of the pack and other information

What Candesartan and Hydrochlorothiazide Alter contains

• The active ingredients are candesartan cilexetil and hydrochlorothiazide.

Each Candesartan and Hydrochlorothiazide Alter 16 mg/12.5 mg tablet contains 16 mg
of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.

• The excipients are lactose monohydrate, pregelatinized starch, hydroxypropylcellulose, calcium carmellose, red iron oxide (E172), magnesium stearate and triethyl citrate.

Each Candesartan and Hydrochlorothiazide Alter 32mg/12.5 mg tablet
contains 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.

• The excipients are lactose monohydrate, pregelatinized starch, hydroxypropylcellulose, calcium carmellose, yellow iron oxide (E172), magnesium stearate and triethyl citrate.

Each Candesartan and Hydrochlorothiazide Alter 32 mg/25 mg contains 32 mg
of candesartan cilexetil and 25 mg of hydrochlorothiazide.

• The excipients are lactose monohydrate, pregelatinized starch, hydroxypropylcellulose, calcium carmellose, red iron oxide (E172), magnesium stearate and triethyl citrate.

Description of the appearance of Candesartan and Hydrochlorothiazide Alter and contents of the
pack
Candesartan and Hydrochlorothiazide Alter 32 mg/12.5 mg is an oblong, yellow tablet
with a fracture line on one side.
Candesartan and Hydrochlorothiazide Alter 32 mg/25 mg is an oblong, pink tablet
with a fracture line on one side.
Candesartan and Hydrochlorothiazide Alter 16 mg/12.5 mg is a round,
biconvex, pink tablet with a fracture line on one side.
The fracture line is only to break the tablet to facilitate swallowing
and not to divide the tablets into two equal parts.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Laboratori Alter S.r.l. Via Egadi, 7 - 20144 Milano

Manufacturer responsible for batch release
Laboratorios Alter, S.A. C/ Mateo Inurria, 30 – 28036 Madrid - Spain

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