Forus

PACKAGE LEAFLET

Package leaflet: information for the user

Forus 16mg/12.5mg tablets

candesartan cilexetil/hydrochlorothiazide
Equivalent medicine
Please 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Forus is and what it is used for
2. What you need to know before taking Forus
3. How to take Forus
4. Possible side effects
5. How to store Forus
6. Package contents and other information

1. What Forus is and what it is used for

The name of the medicine is Forus. 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 group of medicines called angiotensin II receptor antagonists. It causes relaxation and widening of the 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 eliminate water and salts such as sodium in the urine. This contributes to lowering blood pressure.
• FORUS may be used to treat heart failure in adult patients with reduced heart muscle function when angiotensin-converting enzyme (ACE) inhibitors cannot be used, or in addition to ACE inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRAs) cannot be used. (ACE inhibitors and MRAs are medicines used to treat heart failure).

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

2. What you need to know before taking Forus

Do not take Forus:

• If you are allergic to the active substances 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 this applies to you, consult your doctor
• If you are more than 3 months pregnant (it is better to avoid using Forus even in the early stages of pregnancy – see the section on pregnancy)

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• If you have severe kidney problems
• If you have severe liver disease or biliary obstruction (a bile drainage problem 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 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 Forus.

Warnings and precautions

Talk to your doctor or pharmacist before taking Forus:

• If you have diabetes
• If you have heart, liver or kidney problems
• If you have recently undergone a kidney transplant
• If you are vomiting, or have recently had severe vomiting or diarrhoea
• If you have a disorder of the adrenal gland known as Conn's syndrome (also called primary hyperaldosteronism)
• If you have had systemic lupus erythematosus (SLE)
• If you have low blood pressure
• If you have ever had a stroke
• If you have had allergies or asthma
• Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Forus is not recommended during early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see section on Pregnancy)
• If you are taking any of the following medicines used to treat high blood pressure:
• An "ACE inhibitor" (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes
• Aliskiren
• If 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 Forus")
• If you have previously had skin cancer or if you develop 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 exposure to sunlight and UV radiation while taking Forus
• 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 intraocular pressure, which may occur from a few hours to several weeks after taking Forus. This may lead to permanent loss of vision if not treated. If you have previously been allergic to penicillin or sulfonamides, you may be at higher risk of developing this condition
• If you have previously experienced respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking Forus, consult a doctor immediately.

Contact your doctor if, after taking Forus, you experience abdominal pain, nausea, vomiting or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking Forus on your own.

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

See also the information under the section "Do not take Forus".

Your doctor may need to monitor you more frequently and perform tests if you have any of these conditions.

If you are about to undergo surgery, tell your doctor or dentist that you are taking Forus. This is because Forus, when combined with certain anaesthetics, may cause a drop in blood pressure.

Forus may increase your skin's sensitivity to sunlight.

Children and adolescents

There is no experience with the use of Forus in children and adolescents (under 18 years of age). Therefore, Forus must not be given to children and adolescents.

For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Other medicines and Forus

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Forus may affect how other medicines work, and some medicines may affect Forus. If you are taking certain medicines, your doctor may need to perform blood tests from time to time.

In particular, tell your doctor if you are taking any of the following medicines:

• Other medicines that help lower blood pressure, including beta-blockers, ACE inhibitors such as enalapril, captopril, lisinopril or ramipril.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines used to relieve pain and inflammation).
• Acetylsalicylic acid (if you are 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 or vitamin D supplements.
• Medicines to lower cholesterol, such as colestipol or cholestyramine.
• Medicines for diabetes (oral tablets or insulin).
• Medicines to control heart rhythm (antiarrhythmics) such as digoxin and beta-blockers.
• Medicines whose action may be affected by blood potassium levels, such as certain antipsychotic drugs.
• Heparin (a medicine used to thin the blood).
• Medicines that help you urinate (diuretics).
• Laxatives.
• Penicillin (an antibiotic).
• Amphotericin (used to treat fungal infections).
• Lithium (a medicine used for mental health conditions).
• Steroids, such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines used to treat 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 oesophageal 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 used to relieve spasticity), amifostine (used in cancer treatment), and certain antipsychotic medicines.

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

• If you are taking an ACE inhibitor or aliskiren (see also the sections "Do not take Forus" and "Warnings and precautions").
• If you are being treated with an ACE inhibitor together with other medicines used for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Forus with food, drinks and alcohol

• You may take Forus with or without food.
• When Forus is prescribed for you, talk to your doctor before drinking alcohol. Alcohol may make you feel weak or dizzy.

Pregnancy, breastfeeding and fertility

Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Forus before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Forus is not recommended during pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Forus is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed.

Driving and using machines
Some people may feel tired or dizzy while taking Forus. If this happens to you, do not drive or operate tools or machinery.

Forus contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Forus

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
It is important to continue taking Forus every day.
The recommended dose 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 Forus than you should
If you take more Forus than prescribed by your doctor, contact a doctor or pharmacist immediately for
advice.
If you forget to take Forus
Do not take a double dose to make up for the forgotten tablet. Take only the next dose as usual.
If you stop taking Forus
If you stop treatment with Forus, your blood pressure may rise again. Therefore, do not stop treatment
with Forus without first talking to your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. It is important that you are aware of what these side effects may be. Some of the side effects of Forus are caused by candesartan cilexetil and some are caused by hydrochlorothiazide.
Stop taking Forus 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 blisters).

Forus 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 Forus has had any effects on your blood (agranulocytosis).
Other possible side effects include:
Common (occurs in 1 to 10 out of 100 users)

• Changes in blood test results:
  • Reduced amount of sodium in the blood. If this reduction is severe, you may experience weakness, lack of energy or muscle cramps.
  • 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, you may experience fatigue, weakness, irregular heartbeat or tingling sensations.
  • Increased levels of cholesterol, sugar or uric acid in the blood.
• Sugar in the urine.
• Dizziness, lightheadedness or weakness.
• Headache.
• Respiratory infection.

Uncommon (occurs in less than 1 out of 100 users)

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

Rare (occurs in less than 1 out of 1000 users)

• Jaundice (yellowing of the skin 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.
• Abnormal heartbeat.
• Breathing difficulties (including lung inflammation and fluid in the lungs).
• High temperature (fever).
• Inflammation of the pancreas. This causes mild to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels causing the appearance of small red or purple spots on the skin.
• Reduction in red blood cells, white blood cells or platelets. You may notice fatigue, infection, fever, or easy bruising (bruises).

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• Severe skin rash developing rapidly, with blistering and peeling of the skin and sometimes in the mouth.
• Worsening of existing lupus-like reactions or development of unusual skin reactions.

Very rare (occurs in less than 1 out of 10,000 users)

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

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

• Skin and lip cancer (non-melanoma skin cancer).
• Sudden decrease in distance vision (acute 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).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at 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 Forus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack, following "Exp."
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Forus contains

• The active substances are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• The other components are monohydrate lactose, maize starch, hydroxypropylcellulose, sodium croscarmellose, magnesium stearate, triethyl citrate.

Description of the appearance of Forus and contents of the pack
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Forus tablets are white, biconvex tablets with a score line on one side and engraved with "CH16" on the same side.
Pack sizes: 7, 14, 28, 30, 56, 70, 90, 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
S.F. Group S.r.l. – Via Tiburtina, 1143 – 00156 Rome, Italy

Manufacturer
Siegfried Malta Ltd.
HHF070 Hal Far Industrial Estate
Hal Far BBG 3000
Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following
names:
Italy Forus
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