Candesartan and hydrochlorothiazide Alter: detailed information

Patient Information Leaflet: Information for the User

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

candesartan cilexetil, hydrochlorothiazide
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Candesartan and Hydrochlorothiazide Alter is and what it is used for
What you need to know before taking Candesartan and Hydrochlorothiazide Alter
How to take Candesartan and Hydrochlorothiazide Alter
Possible side effects
How to store Candesartan and Hydrochlorothiazide Alter
Contents of the pack and other information

1. What Candesartan and Hydrochlorothiazide Alter is 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 substances: 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 reduce blood pressure.
Hydrochlorothiazide belongs to a group of medicines called diuretics (medicines that help you pass urine). It helps the body eliminate water and salts such as sodium through the urine. This helps reduce blood pressure.

Your 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 should 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 unsure whether this applies to you, consult your doctor.
if you are more than three months pregnant (it is best to avoid taking Candesartan and Hydrochlorothiazide Alter even in the early stages of pregnancy - see section “Pregnancy”).
if you have severe kidney problems.
if you suffer from 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 aliskiren-containing medicines for lowering blood pressure.

If you are unsure whether any of the above conditions apply 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 previously had skin cancer or are developing 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 radiation while taking Candesartan and
Hydrochlorothiazide Alter.
If you have previously experienced respiratory or lung problems (including inflammation or fluid accumulation in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking Candesartan and Hydrochlorothiazide Alter, consult a doctor immediately.
Inform your doctor before taking Candesartan and Hydrochlorothiazide Alter if:

you have diabetes
you have heart, liver, or kidney problems
you have recently undergone a kidney transplant
you are vomiting or have recently experienced severe vomiting or diarrhea
you have a disorder 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 for treating high blood pressure
you are taking any of the following medicines used to treat high blood pressure:
an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems associated with diabetes
aliskiren
you are taking an ACE inhibitor together with a medicine belonging to the class known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see “Other medicines and Candesartan and Hydrochlorothiazide Alter”).

If you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure inside the eye and may occur from a few hours to weeks after taking Candesartan and Hydrochlorothiazide Alter.
Increased eye pressure, if untreated, may lead to permanent vision damage. If you have previously had an allergy to penicillins or sulfonamides, you are at higher risk of developing this side effect.
Inform 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 during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if taken during this period (see section “Pregnancy”).
Your doctor may regularly monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium).
See also the information in the section “Do not take Candesartan and Hydrochlorothiazide Alter”.
If you are about to undergo surgery, inform your doctor or dentist that you are taking Candesartan and Hydrochlorothiazide Alter. This is because combining Candesartan and Hydrochlorothiazide Alter with certain anesthetics may cause a drop in blood pressure.
Candesartan and Hydrochlorothiazide Alter may increase your skin’s sensitivity to sunlight.
Contact your doctor if, after taking Candesartan and Hydrochlorothiazide Alter, you experience abdominal pain, nausea, vomiting, or diarrhea. Your doctor will decide whether treatment should continue. 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). Therefore, Candesartan and Hydrochlorothiazide Alter must not be administered to children.
Consult your doctor if you are an athlete about to undergo doping control, as Candesartan and Hydrochlorothiazide Alter contains an active ingredient that may lead to positive doping test results.
For individuals engaged in sports: using the medicine without a therapeutic need constitutes doping and may result in a positive doping test regardless.
Other medicines and Candesartan and Hydrochlorothiazide Alter
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines.
Candesartan and Hydrochlorothiazide Alter may affect how other medicines work, and some medicines may affect Candesartan and Hydrochlorothiazide Alter.
If you are taking certain medicines, your doctor may need to perform blood tests from time to time.
Your doctor may need to adjust your dose and/or take additional precautions if you are taking:

an ACE inhibitor or aliskiren (see also information under the sections “Do not take Candesartan and Hydrochlorothiazide Alter” and “Warnings and precautions”).
an ACE inhibitor together with certain medicines used to treat heart failure known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone).
Other blood pressure-lowering medicines, 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 exceeding 3 g per day) (a medicine for relieving pain and inflammation).
Potassium supplements or potassium-containing salt substitutes (medicines that increase potassium levels in the blood).
Calcium or vitamin D supplements.
Medicines for lowering cholesterol, such as colestipol or cholestyramine (resin-type lipid-lowering medicines).
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 some antipsychotic drugs.
Heparin (a medicine to thin the blood).
Diuretic tablets (diuretics).
Laxatives.
Penicillin (an antibiotic).
Amphotericin (used to treat fungal infections).
Lithium (a medicine for treating mental health conditions).
Steroids, such as prednisolone.
Pituitary hormone (ACTH).
Medicines for treating 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 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 relieve spasticity), amifostine (used in cancer treatment), and certain antipsychotic medicines. Consult your doctor if you are unsure which medicines these are.

Candesartan and Hydrochlorothiazide Alter with food, drinks, and alcohol
Candesartan and Hydrochlorothiazide Alter may be taken with or without food.
During treatment with Candesartan and Hydrochlorothiazide Alter, consult your doctor
before drinking alcohol. Alcohol may cause dizziness or fainting.
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). Usually, your doctor will advise you to stop taking Candesartan and Hydrochlorothiazide Alter before you become pregnant or will advise you to switch to another medicine as soon as you know you are pregnant.
Candesartan and Hydrochlorothiazide Alter 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 child if taken during this period.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed.
Candesartan and Hydrochlorothiazide 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 newborn or was born prematurely.
Driving and using machines
Some people may feel tired or dizzy while being treated with Candesartan and Hydrochlorothiazide Alter. If this applies to you, do not drive or operate tools or machinery.
Candesartan and Hydrochlorothiazide Alter contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Candesartan and Hydrochlorothiazide Alter

Take this medicine exactly as your doctor has told you. If
you have any doubts, consult your doctor or pharmacist. It is important that you continue taking
Candesartan and Hydrochlorothiazide Alter every day.
The recommended dose of Candesartan and Hydrochlorothiazide Alter is one
tablet once 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.
If you take more Candesartan and Hydrochlorothiazide Alter than you should
If you take more Candesartan and Hydrochlorothiazide Alter than prescribed by your doctor,
contact a doctor or pharmacist immediately.
If you forget to take Candesartan and Hydrochlorothiazide Alter
Do not take a double dose to make up for a forgotten tablet.
Take only the next dose as usual.
If you stop taking Candesartan and Hydrochlorothiazide Alter
If you stop taking Candesartan and Hydrochlorothiazide Alter, your blood pressure may
rise again. Therefore, do not stop taking Candesartan and Hydrochlorothiazide
Alter without first consulting your doctor.
If you have any questions about the use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets
them.
It is important that you are aware of which side effects may occur.
Some of the side effects of Candesartan and Hydrochlorothiazide Alter are caused by
candesartan cilexetil and some are caused by hydrochlorothiazide.
Stop taking Candesartan and Hydrochlorothiazide 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 may cause difficulty swallowing
Severe itching of the skin (with raised, itchy bumps).

Candesartan and Hydrochlorothiazide Alter 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
Hydrochlorothiazide Alter has affected your blood (agranulocytosis).
Other possible side effects include:
Common (occur in 1 to 10 out of 100 patients):

Changes in blood test results:
Low levels of sodium in the blood. If this reduction is severe, you may notice weakness, lack of energy or muscle cramps.
Increased or decreased levels 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, irregular heartbeat or tingling sensations.
Increased levels of cholesterol, glucose or uric acid in the blood.
Glucose in the urine.
Dizziness, lightheadedness or weakness.
Headache
Respiratory tract infections.

Uncommon (occur in less than 1 out of 100 patients):

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

Rare (occur in less than 1 out of 1,000 patients):

Jaundice (yellowing of the skin and/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.
Inflammation of small blood vessels resulting in red or purple skin discolouration.
Reduction in red blood cells, white blood cells or platelets. You may notice fatigue, infection, fever, or easy bruising.
Severe skin rash developing rapidly, with blistering and peeling of the skin, sometimes also affecting the mouth.
Worsening of existing lupus-like reactions or occurrence of unusual skin reactions.

Very rare (occur in less than 1 out of 10,000 patients):

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 whites of the eyes, and flu-like symptoms.
Cough.
Nausea.
Acute respiratory distress (symptoms include severe shortness of breath, fever, weakness and confusion).
Intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

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

Sudden onset of myopia
Rapid onset of nearsightedness (acute myopia), reduced vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
Diarrhoea
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
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Candesartan and Hydrochlorothiazide Alter

Keep this medicine out of the sight and reach of children.
Store below 30°C.
Do not use Candesartan and Hydrochlorothiazide Alter after the expiry date stated on the packaging and blister. The expiry date refers to the last day of the 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 Alter contains

The active substances are candesartan cilexetil and hydrochlorothiazide.

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

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

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

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

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

The excipients are monohydrate lactose, 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 score line on one side.
Candesartan and Hydrochlorothiazide Alter 32 mg/25 mg is an oblong, pink tablet with a score line on one side.
Candesartan and Hydrochlorothiazide Alter 16 mg/12.5 mg is a round, biconvex, pink tablet with a score line on one side.
The score line is intended only to facilitate tablet splitting for easier swallowing and does not ensure equal division of the tablet into two parts.
Not all pack sizes may be marketed.

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

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

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