Candesartan/Hydrochlorothiazide Forte Stada Generics 32mg/25mg Tablets

Introduction

Package Leaflet: Information for the User

Candesartan/Hydrochlorothiazide Forte Stada Generics 32 mg / 25 mg film-coated tablets EFG

Candesartan cilexetil/Hydrochlorothiazide

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 further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Candesartan/Hydrochlorothiazide Forte Stada Generics is and what it is used for
2. What you need to know before you take Candesartan/Hydrochlorothiazide Forte Stada Generics

1. How to take Candesartan/Hydrochlorothiazide Forte Stada Generics
2. Possible side effects

1. Storage of Candesartan/Hydrochlorothiazide Forte Stada Generics

1. Pack contents and further information

1. What Candesartan/Hydrochlorothiazide Forte Stada Generics is and what it is used for

Your medicine is called candesartan/hydrochlorothiazide. It is used to treat high blood pressure (hypertension) in adult patients. It contains two active ingredients: candesartan cilexetil and hydrochlorothiazide. Both work together to lower blood pressure.

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It makes the blood vessels relax and dilate. This helps to lower blood pressure.

• Hydrochlorothiazide belongs to a group of medicines called diuretics. It helps the body get rid of excess water and salts, such as sodium, in the urine. This helps to lower blood pressure.

Your doctor may prescribe candesartan/hydrochlorothiazide if your blood pressure has not been adequately controlled with candesartan cilexetil or hydrochlorothiazide alone.

2. What you need to know before you take Candesartan/Hydrochlorothiazide Forte Stada Generics

Do not take Candesartan/Hydrochlorothiazide Forte Stada Generics:

• • 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 sulfonamides. If you are not sure if you are in this situation, please consult your doctor.
• if you are pregnant more than 3 months (it is also better to avoid candesartan/hydrochlorothiazide during the first months of pregnancy – see section Pregnancy).
• if you have severe kidney disease.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

• if you have severe liver disease or biliary obstruction (a problem with the drainage of bile from the gallbladder).
• if you have persistent low potassium levels in the blood.
• if you have persistent high calcium levels in the blood.
• if you have ever had gout.

If you are not sure if you are in any of these situations, consult your doctor or pharmacist before taking candesartan/hydrochlorothiazide.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Candesartan/Hydrochlorothiazide Forte Stada Generics:

• if you are diabetic.
• if you have heart, liver, or kidney problems.
• if you have recently had a kidney transplant.
• if you have vomiting, have recently had severe vomiting, or have diarrhea.
• if you have a disease of the adrenal gland called Conn's syndrome (also known as primary hyperaldosteronism).
• if you have ever had a disease called systemic lupus erythematosus (SLE).
• if you have low blood pressure.
• if you have ever had a stroke.
• if you have ever had an allergy or asthma.
• you should inform your doctor if you are pregnant (or if you think you might be). Candesartan/hydrochlorothiazide is not recommended during pregnancy, and you should not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby (see section Pregnancy).
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren
  • if you are taking an ACE inhibitor along with a medicine belonging to the class of drugs called mineralocorticoid receptor antagonists (MRAs). These medicines are for the treatment of heart failure (see "Taking Candesartan/Hydrochlorothiazide Forte Stada Generics with other medicines").
  • if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking candesartan/hydrochlorothiazide
  • 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 an increase in eye pressure and can occur within hours to weeks after taking candesartan/hydrochlorothiazide. This can lead to permanent vision loss if not treated. You may be at greater risk of developing this if you have previously been allergic to penicillin or sulfonamides.

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Candesartan/Hydrochlorothiazide Forte Stada Generics”.

If you are going to have surgery, inform your doctor or dentist that you are taking candesartan/hydrochlorothiazide. This is because candesartan/hydrochlorothiazide, in combination with some anesthetics, can cause a drop in blood pressure.

Candesartan/hydrochlorothiazide may increase the sensitivity of your skin to the sun.

Children

There is no experience with the use of candesartan/hydrochlorothiazide in children (under 18 years). Therefore, candesartan/hydrochlorothiazide should not be given to children.

Other medicines and Candesartan/Hydrochlorothiazide Forte Stada Generics

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Candesartan/hydrochlorothiazide may affect the way some medicines work and some medicines may affect the effect of candesartan/hydrochlorothiazide. If you are using certain medicines, your doctor may need to perform blood tests from time to time.

In particular, inform your doctor if you are using any of the following medicines:

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.

• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines to relieve pain and inflammation).
• Acetylsalicylic acid (if you take more than 3 g per day) (medicine to relieve pain and inflammation).
• Potassium supplements or salt substitutes that contain potassium (medicines to increase potassium levels in the blood).
• Calcium supplements or vitamin D.
• Medicines to lower cholesterol, such as colestipol or cholestyramine.
• Medicines for diabetes (tablets or insulin).
• Medicines to control heart rhythm (antiarrhythmic agents) such as digoxin and beta-blockers.
• Medicines that may be affected by potassium levels in the blood, such as some antipsychotic medicines.
• Heparin (a medicine to increase blood fluidity).
• Medicines that promote urine production (diuretics).
• Laxatives.
• Penicillin (an antibiotic).
• Amphotericin (for the treatment of fungal infections).
• Lithium (a medicine for mental health problems).
• Corticosteroids such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines for cancer treatment.
• Amantadine (for the treatment of Parkinson's disease or severe viral infections).
• Barbiturates (a type of sedative, also used to treat epilepsy).
• Carbenoxolone (for the treatment of esophageal disease or mouth ulcers).
• Anticholinergic agents such as atropine and biperiden.
• Cyclosporin, a medicine used in organ transplants to prevent rejection.
• Other medicines that may increase the blood pressure-lowering effect, such as baclofen (a medicine to relieve spasticity), amifostine (used in cancer treatment), and some antipsychotic medicines.

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 headings “Do not take Candesartan/Hydrochlorothiazide Forte Stada Generics” and “Warnings and precautions”)
• If you are being treated with an ACE inhibitor along with other specific medicines for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone).

Taking Candesartan/Hydrochlorothiazide Forte Stada Generics with food, drinks, and alcohol

• You can take candesartan/hydrochlorothiazide with or without food.
• Consult your doctor before drinking alcohol if you are taking candesartan/hydrochlorothiazide. Alcohol can make you feel weak or dizzy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Your doctor will normally advise you to stop taking candesartan/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of candesartan/hydrochlorothiazide. Candesartan/hydrochlorothiazide is not recommended during pregnancy, and you must not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby (see section Pregnancy).

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Candesartan/hydrochlorothiazide is not recommended during breastfeeding, and your doctor will choose a different treatment for you if you want to breastfeed.

Driving and using machines

Some patients may feel tired or dizzy when taking candesartan/hydrochlorothiazide. If this happens to you, do not drive or use tools or machines.

3. How to take Candesartan/Hydrochlorothiazide Forte Stada Generics

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are not sure, consult your doctor or pharmacist again. It is important that you continue to take candesartan/hydrochlorothiazide every day.

The recommended dose is one tablet once a day.

Swallow the tablet with a glass of water.

Try to take the tablet at the same time each day. This will help you remember to take it.

The tablet can be divided into equal doses.

If you take more Candesartan/Hydrochlorothiazide Forte Stada Generics than you should

If you have taken more candesartan/hydrochlorothiazide than prescribed by your doctor, contact your doctor or pharmacist immediately.

You can also contact the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Candesartan/Hydrochlorothiazide Forte Stada Generics

Do not take a double dose to make up for forgotten doses. Simply take the next dose.

If you stop taking Candesartan/Hydrochlorothiazide Forte Stada Generics

If you stop taking candesartan/hydrochlorothiazide, your blood pressure may increase again. Therefore, do not stop taking candesartan/hydrochlorothiazide 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 everybody gets them. It is important that you know what these side effects may be. Some of the side effects of candesartan/hydrochlorothiazide are due to candesartan cilexetil and others are due to hydrochlorothiazide.

Stop taking candesartan/hydrochlorothiazide and go to your doctor immediately if you have 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 bumps).

Candesartan/hydrochlorothiazide may cause a decrease in white blood cells. Your resistance to infections may decrease, and you may feel tired, have an infection, or have a fever. If this happens, inform your doctor. Your doctor may perform blood tests from time to time to check that candesartan/hydrochlorothiazide is not affecting your blood (agranulocytosis).

Other possible side effects include:

Common (may affect up to 1 in 10 people)

• Changes in blood test results:
• • A decrease in sodium levels in the blood. If severe, you may feel weak, lack energy, or have muscle cramps.
  • An increase or decrease in potassium levels in the blood, especially if you already have kidney problems or heart failure. If this situation is severe, you may feel tired, weak, have irregular heartbeats, or have tingling sensations.
  • An increase in cholesterol, glucose, or uric acid levels in the blood.
• Presence of glucose in urine.
• Feeling dizzy or weak.
• Headache.
• Respiratory infection.

Uncommon (may affect up to 1 in 100 people)

• Low blood pressure. This can make you feel weak or dizzy.
• Lack of appetite, diarrhea, constipation, stomach upset.
• Rash, hives (urticaria), skin reaction caused by sensitivity to sunlight.

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

• Jaundice (yellowing of the skin or the whites of the eyes). If this happens to you, contact your doctor immediately.
• Effects on kidney function, especially if you have kidney problems or heart failure.
• Difficulty sleeping, depression, restlessness.
• Tingling or pinching sensations in arms or legs.
• Blurred vision for a short period.
• Abnormal heartbeats.
• Breathing difficulties (including lung inflammation and fluid in the lungs).
• High temperature (fever)
• Pancreatitis. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels that produce red or purple spots on the skin.
• A decrease in red blood cells, white blood cells, or platelets. You may feel tired, have an infection, fever, or bruise easily.
• A severe skin reaction that develops rapidly, causing blisters or peeling of the skin, and possibly ulcers in the mouth.
• Worsening of existing lupus-like reactions or appearance of unusual skin reactions.

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

• Swelling of the face, lips, tongue, and/or throat.
• Itching.
• Back, joint, and muscle pain.
• Changes in liver function, including inflammation (hepatitis). You may feel tired, have a yellowing of the skin and the 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
• Diarrhea
• Skin and lip cancer (non-melanoma skin cancer)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan / Hydrochlorothiazide Forte Stada Generics

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 packaging and blister after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Candesartan/Hydrochlorothiazide Forte Stada Generics

• The active ingredients are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide.
• The other ingredients are mannitol (E421), corn starch, copovidone, glycerol, magnesium stearate, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the Product and Package Contents

Candesartan/Hydrochlorothiazide Forte Stada Generics 32 mg/25 mg tablets are peach-colored, oval, biconvex (~12 x 6 mm), uncoated, with a score line on one side, and engraved with the letters "C" and "H".

Candesartan/Hydrochlorothiazide Forte Stada Generics 32 mg/25 mg tablets are available in blisters of 7, 10, 14, 15, 28, 28x1 (unit dose), 30, 50, 50x1 (unit dose), 56, 56x1 (unit dose), 98, 98x1 (unit dose), 100, and 300 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

STADA Generics, S.L.

Frederic Mompou, 5

08960- Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

STADA ARZNEIMITTEL AG

Stadastrasse 2- 18

D-61118 Bad Vilbel

Germany

Or

DELORBIS PHARMACEUTICALS LTD

17 Athinon Str., Ergates Industrial Area

2643 Ergates, Lefkosia

Cyprus

Or

STADA ARZNEIMITTEL GMBH.

Muthgasse 36

A-1190 Vienna

Austria

This medicine is authorized in the EEA member states with the following names:

Portugal Candesartan + Hydrochlorothiazide Ciclum

Austria: Candesartan/HCT STADA GmbH 32 mg/25 mg Tabletten

Spain: Candesartan / Hydrochlorothiazide Forte STADA Generics 32 mg/25 mg tablets EFG

Italy: Candesartan and Hydrochlorothiazide EG STADA 32 mg/25 mg tablets

Sweden: Candesartan/Hydrochlorothiazide STADA 32 mg/25 mg tablets

Date of the Last Revision of this Leaflet:September 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/