Candesartan and hydrochlorothiazide Teva Italia: detailed information

Package leaflet: Information for the patient

Candesartan and Hydrochlorothiazide Teva Italia 8 mg/12.5 mg tablets, 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 their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Candesartan and Hydrochlorothiazide Teva Italia is and what it is used for

The name of this medicine is Candesartan and Hydrochlorothiazide Teva Italia. It is used to treat
high blood pressure (hypertension) in adults. It contains two active substances:
candesartan cilexetil and hydrochlorothiazide. These work together to lower blood pressure.

Candesartan cilexetil belongs to a group of medicines known as angiotensin II receptor antagonists. It allows blood vessels to relax and widen, thereby helping to reduce blood pressure.
Hydrochlorothiazide belongs to a group of medicines called diuretics. It helps the body eliminate water and salts, such as sodium, through the urine, thus contributing to lower blood pressure.
Your doctor may prescribe Candesartan and Hydrochlorothiazide Teva Italia if your blood pressure has not been adequately controlled with either candesartan cilexetil or hydrochlorothiazide alone.

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

DO NOT take Candesartan and Hydrochlorothiazide Teva Italia:

If you are allergic to candesartan cilexetil, 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 you are allergic, ask your doctor.
If you are more than 3 months pregnant (Candesartan and Hydrochlorothiazide Teva Italia should be avoided at the beginning of pregnancy – see section 2: Pregnancy and breastfeeding).
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 consistently have low levels of potassium in your blood.
If you consistently have high levels of calcium in your blood.
If you have suffered from 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 Teva Italia.
Warnings and precautions
Talk to your doctor or pharmacist before taking Candesartan and Hydrochlorothiazide Teva Italia if:

You have diabetes.
You have heart, liver, or kidney problems.
You have recently undergone a kidney transplant.
You are experiencing vomiting, have vomited frequently recently, or have diarrhoea.
You have a disorder of the adrenal glands called Conn’s syndrome (or primary hyperaldosteronism).
You have had systemic lupus erythematosus (SLE).
You have low blood pressure.
You have had a stroke.
You have a history of allergy or asthma.
You experience vision disturbances or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to weeks after taking Candesartan and Hydrochlorothiazide Teva Italia. This condition may lead to permanent vision loss if untreated. If you have previously experienced allergic reactions to penicillin or sulfonamides, you may be at higher risk of developing this condition.
Inform your doctor if you think you are (or might become) pregnant. Candesartan and Hydrochlorothiazide Teva Italia is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause severe harm to the fetus if used at this stage (see section 2: Pregnancy and breastfeeding).
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.
You are taking an ACE inhibitor together with a medicine belonging to a class known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see "Other medicines and Candesartan and Hydrochlorothiazide Teva Italia").
You have previously had skin cancer or are developing unexpected skin lesions 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 sun exposure and UV radiation while taking Candesartan and Hydrochlorothiazide Teva Italia. Your doctor may wish to monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under "Do not take Candesartan and Hydrochlorothiazide Teva Italia".
If you are scheduled for surgery, inform your doctor or dentist that you are taking Candesartan and Hydrochlorothiazide Teva Italia. This is important because, when combined with certain anaesthetics, Candesartan and Hydrochlorothiazide Teva Italia may cause a drop in blood pressure.
Candesartan and Hydrochlorothiazide Teva Italia may make your skin more sensitive to sunlight.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
There is no experience with the use of Candesartan and Hydrochlorothiazide Teva Italia in children (under 18 years of age). Therefore, Candesartan and Hydrochlorothiazide Teva Italia must not be given to children.
Other medicines and Candesartan and Hydrochlorothiazide Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Candesartan and Hydrochlorothiazide Teva Italia may affect how some other medicines work, and some medicines may affect Candesartan and Hydrochlorothiazide Teva Italia. If you take certain medicines, your doctor may need to perform regular blood tests.
In particular, inform your doctor if you are taking any of the following:

Other medicines that lower blood pressure, including beta-blockers and diazoxide.
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 that lower cholesterol, such as colestipol or cholestyramine.
Medicines for diabetes (tablets or insulin).
Medicines for controlling heart rate (antiarrhythmics), such as digoxin and beta-blockers.
Medicines that may be affected by blood potassium levels, such as certain antipsychotics.
Heparin (an anticoagulant).
Diuretics.
Laxatives.
Penicillin or cotrimoxazole (also known as trimethoprim/sulfamethoxazole) (antibiotics).
Amphotericin (used to treat fungal infections).
Lithium (a medicine for mental health conditions).
Steroids such as prednisolone.
Pituitary hormone (ACTH).
Medicines for cancer treatment.
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 oesophageal disorders or mouth ulcers).
Anticholinergic agents such as atropine and biperiden.
Cyclosporine, a medicine used after organ transplantation 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.

Your doctor may consider it necessary to adjust your dose and/or take additional precautions if:

You are taking an ACE inhibitor or aliskiren (see also the sections: "Do not take Candesartan and Hydrochlorothiazide Teva Italia" and "Warnings and precautions").
Candesartan and Hydrochlorothiazide Teva Italia with food, drinks, and alcohol
You may take Candesartan and Hydrochlorothiazide Teva Italia with or without food.

If you are prescribed Candesartan and Hydrochlorothiazide Teva Italia, consult your doctor before drinking alcohol. Alcohol may cause dizziness or make you feel weak.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Inform your doctor if you think you are (or might become) pregnant. Your doctor will certainly advise you to stop taking Candesartan and Hydrochlorothiazide Teva Italia before starting a pregnancy or as soon as you know you are pregnant, and will recommend an alternative medicine. Candesartan and Hydrochlorothiazide Teva Italia is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause severe harm to the fetus if used beyond the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Candesartan and Hydrochlorothiazide Teva Italia is not recommended for breastfeeding mothers. If you wish to breastfeed, especially if your baby is a newborn or premature, your doctor may choose a different treatment suitable for you.
Driving and using machines
No studies on the ability to drive or operate machinery have been conducted. Some people may feel tired or dizzy when taking this medicine. If you experience these symptoms, do not drive or operate tools or machinery.
Candesartan and Hydrochlorothiazide Teva Italia contains lactose
Candesartan and Hydrochlorothiazide Teva Italia contains lactose, a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, contact him or her before taking this medicine.
Candesartan and Hydrochlorothiazide Teva Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.

3. How to take Candesartan and Hydrochlorothiazide Teva Italia

Take Candesartan and Hydrochlorothiazide Teva Italia exactly as directed by your
doctor. Consult your doctor or pharmacist if you are unsure.
It is important that you take this medicine every day.
The recommended dose is one tablet daily. Swallow the tablet with water.
Try to take the tablet at the same time each day. This will help you remember to take it.
[dosages: 8 mg/12.5 mg, 16 mg/12.5 mg, 32 mg/12.5 mg] The break line on the tablet is intended only
to facilitate breaking the tablet if you have difficulty swallowing it whole.
[dosage 32 mg/25 mg] The tablet may be divided into equal doses.
If you take more Candesartan and Hydrochlorothiazide Teva Italia tablets than you should
If you take more tablets than prescribed by your doctor, contact your doctor or pharmacist immediately for advice.
If you forget to take Candesartan and Hydrochlorothiazide Teva Italia
Do not take a double dose to make up for the missed tablet. Simply take the next dose at your usual time.
If you stop taking Candesartan and Hydrochlorothiazide Teva Italia
Treatment for high blood pressure usually lasts a lifetime. Therefore, do not stop taking this medicine without first consulting your doctor.
If you have any doubts about how to use this medicine, consult 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 the side effects that may occur. Some of these side effects are caused by candesartan cilexetil, while others are caused by hydrochlorothiazide.
Stop taking Candesartan and Hydrochlorothiazide Teva Italia and consult your doctor immediately if you experience any of the following serious reactions:
Uncommon (may affect up to 1 in 100 people)

Severe itching of the skin (with raised skin rashes).

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

Breathing difficulties, with or without swelling of the face, lips, tongue and/or throat.
Jaundice (yellowing of the skin or whites of the eyes).

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

Swelling of the face, lips, tongue and/or throat, which may cause difficulty swallowing.

Candesartan and Hydrochlorothiazide Teva Italia may cause a reduction in the number of white blood cells. Your resistance to infections may decrease, you may feel tired, or you may develop an infection or fever. In such cases, consult your doctor. Your doctor may occasionally perform blood tests to monitor whether Candesartan and Hydrochlorothiazide Teva Italia has affected your blood (agranulocytosis).
Other possible side effects include:
Common (may affect up to 1 in 10 people):

Changes in blood test results:
- Reduction in the amount of sodium in the blood. If this reduction is severe, it may cause weakness, lack of energy, or muscle cramps.
- Increase or decrease in the amount of potassium in the blood, especially if you already have kidney problems or heart failure. If the increase in potassium is significant, you may experience tiredness, weakness, irregular heartbeat, or tingling sensations.
- Increased levels of cholesterol, blood sugar, or uric acid in the blood.
Sugar in the urine.
Dizziness/vertigo or weakness.
Headache.
Respiratory tract infection.

Uncommon (may affect up to 1 in 100 people):

Low blood pressure, which may cause dizziness or weakness.
Loss of appetite, diarrhoea, constipation, and stomach discomfort.
Skin rash, urticaria, or rash caused by sensitivity to sunlight.

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

Effects on kidney function, especially if you already have kidney problems or heart failure.
Sleep disturbances, depression, restlessness.
Tingling or prickling sensations in arms or legs.
Blurred vision for short periods of time.
Irregular heartbeat.
Breathing difficulties (including lung inflammation and fluid accumulation in the lungs).
Increased body temperature (fever).
Inflammation of the pancreas, causing mild to severe stomach pain.
Muscle cramps.
Damage to blood vessels leading to the appearance of small red or purple spots on the skin.
Reduction in red blood cells, white blood cells, or platelets. You may feel tired, develop an infection or fever, or bruise easily.
Severe and rapid skin rash with blistering or peeling of the skin, and possible blistering in the mouth.
Worsening of existing skin reactions resembling lupus erythematosus or appearance of unusual skin reactions.

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

Back pain, joint pain, and muscle pain.
Liver function abnormalities, 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 the available data)

Sudden onset of myopia.
Decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
Systemic and cutaneous lupus erythematosus (an allergic condition causing fever, joint pains, skin rashes which may include redness, blistering, peeling, and lumps).
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 www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Candesartan and Hydrochlorothiazide Teva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after the word "Exp.". The expiry date refers to the last day of the month.
Store below 25°C.
Do not dispose of any medicine 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 Teva Italia Contains

The active substances are candesartan cilexetil and hydrochlorothiazide.
Candesartan and Hydrochlorothiazide Teva Italia 8 mg/12.5 mg tablets contain 8 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
Candesartan and Hydrochlorothiazide Teva Italia 16 mg/12.5 mg tablets contain 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
Candesartan and Hydrochlorothiazide Teva Italia 32 mg/12.5 mg tablets contain 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
Candesartan and Hydrochlorothiazide Teva Italia 32 mg/25 mg tablets contain 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide.
The other components are pregelatinized maize starch, povidone K-30, calcium carmellose, poloxamer 188, microcrystalline cellulose, lactose monohydrate (spray-dried), magnesium stearate, iron oxide red (E172). [Only in Candesartan and Hydrochlorothiazide Teva Italia 16 mg/12.5 mg and 32 mg/25 mg tablets].

Description of the Appearance of Candesartan and Hydrochlorothiazide Teva Italia and Contents of the Package
[Candesartan and Hydrochlorothiazide Teva Italia 8 mg/12.5 mg tablets]

Biconvex, capsule-shaped, white to off-white tablet. One side of the tablet has a score line with the letters “C” to the left of the score and “8” to the right. The other side has a score line.
[Candesartan and Hydrochlorothiazide Teva Italia 16 mg/12.5 mg tablets]
Biconvex, capsule-shaped, light pink tablet. One side of the tablet has a score line with the letters “C” to the left of the score and “16” to the right. The other side has a score line.
[Candesartan and Hydrochlorothiazide Teva Italia 32 mg/12.5 mg tablets]
Biconvex, capsule-shaped, white to off-white tablet. One side of the tablet has a score line with the letters “C” to the left of the score and “32” to the right. The other side has a score line.
[Candesartan and Hydrochlorothiazide Teva Italia 32 mg/25 mg tablets]
Biconvex, capsule-shaped, light pink tablet. One side of the tablet has a score line with the letters “H” to the left of the score and “25” to the right. The other side has a score line with the letters “C” to the left of the score and “32” to the right.

Candesartan and Hydrochlorothiazide Teva Italia is available in packs of 7, 14, 15, 28, 30, 50, 56, 90, 98, 100, 300 tablets and in blisters of 28x1, 50x1, 56x1 and 98x1 unit doses (EAV/hospital pack).

Marketing Authorization Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4 - 20123 Milano
Italy

Manufacturers
Teva Pharmaceutical Works Private Limited Company
Pallagi út, 13, 4042 Debrecen - Hungary
TEVA UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN 22 9AG - United Kingdom
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem - The Netherlands
Teva Operations Poland Sp. z.o.o.
ul. Mogilska 80, 31-546 Krakow - Poland
PLIVA Hrvatska d.o.o.
Prilaz baruna Filipovica 25, 10000 Zagreb - Croatia

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
Belgium: Co-Candesartan Teva
Germany: Candesartancilexetil-ratiopharm comp.
Spain: Candesartán/HCTZ Teva 16/12.5mg, 32/12.5mg & 32/25mg comprimidos EFG
France: Candesartan /hydrochlorothiazide TEVA SANTE
Italy: Candesartan e Idroclorotiazide Teva Italia
The Netherlands: Candesartan cilexetil/Hydrochloorthiazide Teva
Portugal: Candesartan + Hidroclorotiazida Teva
Sweden: Candesartan/Hydrochlorothiazide Teva