FORUS 16 mg /12.5 Mg Tablets

Зміст інструкції

1. Forus 16mg/12,5mg tablets
   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. Contents of the pack and other information

Forus 16mg/12,5mg tablets

candesartan cilexetil/hydrochlorothiazide
Generic medicine

Read this leaflet carefully before taking this medicine, as 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 they have the same symptoms as you, as it may 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 Forus is and what it is used for
• 2. What you need to know before you take Forus
• 3. How to take Forus
• 4. Possible side effects
• 5. How to store Forus
• 6. Contents of the pack 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 ingredients: 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 the relaxation and widening of blood vessels. This helps to reduce blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics (which help to urinate). This helps the body to eliminate water and salts such as sodium in the urine. This contributes to reducing blood pressure.
• FORUS can be used to treat heart failure in adult patients with reduced heart muscle function when ACE inhibitors (angiotensin-converting enzyme inhibitors) cannot be used or in addition to ACE inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRA) cannot be used. (ACE inhibitors and MRAs are medicines used to treat heart failure).

The 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 ingredients 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 if this condition may concern you, consult your doctor
• If you are pregnant for more than 3 months (it is best to avoid using Forus even in the early stages of pregnancy - see the section relating to pregnancy)
• If you have severe kidney problems
• If you have a severe liver disease or obstruction of the bile ducts (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 your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

If you are not sure if 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 problems with your heart, liver or kidneys
• If you have recently had a kidney transplant
• If you vomit, have recently had severe vomiting or diarrhea
• If you have a disease of the adrenal gland, known as Conn's Syndrome (also called primary hyperaldosteronism)
• If you have had a disease called systemic lupus erythematosus (SLE)
• If you have low blood pressure
• If you have ever had a stroke
• If you have allergies or asthma
• Tell your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Forus is not recommended in early pregnancy, and must not be taken if you are pregnant for more than 3 months, as it can cause serious harm to the baby if taken during this period (see Pregnancy section)
• If 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 suffer from kidney problems related to diabetes
• Aliskiren
• If you are taking an ACE inhibitor together with a medicine that belongs to the class of medicines known as mineralocorticoid receptor antagonists (MRA). These medicines are used for the treatment of heart failure (see "Other medicines and Forus").
• 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 lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while using Forus.
• 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 from a few hours to weeks after taking Forus. This can lead to permanent vision loss if left untreated. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition.

The doctor may check your kidney function, blood pressure, and the amount of electrolytes
(for example potassium) in your blood at regular intervals.
See also what is reported in the section/paragraph "Do not take Forus”.
The doctor may need to visit you more often and do some tests if you experience any of these conditions.
If you are about to have surgery, tell your doctor or dentist that you are taking Forus. This is because Forus,
when combined with certain anesthetics, can cause a drop in blood pressure.
Forus may increase the sensitivity of your skin to the sun.
Use in children and adolescents
There is no experience with the use of Forus in children and adolescents (under 18 years of age). Therefore
Forus should not be given to children and adolescents.
For those who play sports: the use of the drug without a therapeutic need constitutes doping and may
still result in positive doping tests.

Other medicines and Forus
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Forus can affect the mechanism of action of other medicines, and some medicines can have an effect
on Forus. If you are taking certain medicines, your doctor may need to do 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.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen or diclofenac, celecoxib or etoricoxib (medicines to relieve pain and inflammation).
• Acetylsalicylic acid (if you are taking more than 3 g per day) (medicine to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines that increase the level of potassium in the blood).
• Calcium or vitamin D supplements.
• Medicines to lower cholesterol, such as colestipol or colestyramine.
• Medicines for diabetes (oral tablets or insulin).
• Medicines to control the heartbeat (antiarrhythmic agents) such as digoxin and beta-blockers.
• Medicines whose action may be affected by blood potassium levels, such as some antipsychotic drugs.
• Heparin (a medicine to thin the blood).
• Medicines that help you urinate (diuretics).
• Laxatives.
• Penicillin (an antibiotic).
• Amphotericin (for the treatment of fungal infections).
• Lithium (a medicine for 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 transplants to prevent rejection.
• Other medicines that can enhance the antihypertensive effect, such as baclofen (a medicine to relieve spasticity), amifostine (used for cancer treatment) and some antipsychotic medicines.

The doctor may need to adjust the dose and/or take other precautions:

• If you are taking an ACE inhibitor or aliskiren (see also what is reported in the section: "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 (MRA) (for example spironolactone, eplerenone).

Forus with food and drink and alcohol

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

Pregnancy and breastfeeding and fertility

Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). As a rule, your doctor will advise you to stop taking Forus before starting
pregnancy or as soon as you find out you are pregnant and will advise you to take
another medicine instead of Forus. Forus is not recommended during pregnancy, and must not be
taken if you are pregnant for more than 3 months, as it can cause serious harm to the baby if
taken after the third month of pregnancy.

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

Driving and operating machinery
Some people may feel tired or dizzy when taking Forus. If this happens to you, do not drive or
use tools or machinery.

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

3. How to take Forus

Take this medicine following the instructions of your doctor or pharmacist exactly as given. If you have
any doubts, ask your doctor or pharmacist.
It is important to continue taking Forus every day.
The recommended dose is 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 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 a missed tablet. Just take the next
dose as usual.

If you stop taking Forus
If you stop taking Forus, your blood pressure may rise again. Therefore, do not
stop taking Forus without first talking to 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 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 can cause difficulty swallowing
• severe skin itching (with raised blisters).

Forus 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 Forus has had any effects
on your blood (agranulocytosis).
Other possible side effects include:

Common (affects 1 to 10 users out of 100)

• Changes in blood test results:
• A reduced amount of sodium in the blood. If this reduction is severe, you may notice weakness, lack 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 increase or decrease 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 urine.
• Feeling dizzy/lightheaded or weak.
• Headache.
• Respiratory infection.

Uncommon (affects less than 1 in 100 users)

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

Rare (affects less than 1 in 1000 users)

• Jaundice (yellowing of the skin or the white of the eye). If this happens to you, contactyour doctor immediately.
• Effects on the function of your kidneys, 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.
• Damage to blood vessels causing the appearance of red or purple spots on 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 (affects less than 1 in 10,000 users)

• 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 the white of the eye, and flu-like symptoms.
• Cough.
• Nausea.

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

• Skin cancer and cancer of the lips (non-melanoma skin cancer)
• Sudden onset of short-sightedness (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).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. 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 Forus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack, after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Forus contains

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

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

Marketing Authorisation Holder
S.F. Group S.r.l. – Via Tiburtina, 1143 – 00156 Roma

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

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