FLORTITENS 4 mg Coated Tablet

Содержание инструкции

1. Flortitens 4 mg tablets, 8 mg tablets, 16 mg tablets, 32 mg tablets
   1. What is Flortitens and what is it used for
   2. What you need to know before taking Flortitens
   3. How to take Flortitens
   4. Possible side effects
   5. How to store Flortitens
   6. Package contents and other information

Flortitens 4 mg tablets, 8 mg tablets, 16 mg tablets, 32 mg tablets

candesartan cilexetil
Generic medicine

Read this leaflet carefully before you start 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 Flortitens is and what it is used for
• 2. What you need to know before you take Flortitens
• 3. How to take Flortitens
• 4. Possible side effects
• 5. How to store Flortitens
• 6. Contents of the pack and other information

1. What is Flortitens and what is it used for

The name of the medicine is Flortitens. The active ingredient is candesartan cilexetil. It belongs to a group
of medicines called angiotensin II receptor antagonists. It works by causing the
relaxation and dilation of blood vessels. This helps to reduce blood pressure.
It also ensures that the heart pumps blood more easily throughout the body.
This medicine is used for:

• treating high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to 18 years.
• treating 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 (MRA) cannot be used. (ACE inhibitors and MRAs are medicines used to treat heart failure)

2. What you need to know before taking Flortitens

Do not take Flortitens:

• if you are allergic to candesartan cilexetil or any of the other ingredients of Flortitens (see section 6);
• if you are pregnant for more than three months (it is best to avoid Flortitens even in the early stages of pregnancy - see Pregnancy);
• if you have a severe liver disease or obstruction of the bile ducts (a problem with the drainage of bile from the gallbladder);
• if the patient is a child under 1 year of age;
• 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 Flortitens.

Warnings and precautions
Talk to your doctor or pharmacist before taking Flortitens

• if you have problems with your heart, liver or kidneys or are undergoing dialysis
• if you have recently had a kidney transplant
• if you are vomiting, have recently had severe vomiting or have diarrhoea
• if you have a disease of the adrenal gland, known as Conn's syndrome (also called primary hyperaldosteronism)
• if you have low blood pressure
• if you have ever had a stroke
• tell your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Flortitens is not recommended in the early stages of pregnancy, and must not be taken if you are pregnant for more than three months, as it may cause serious harm to the baby if taken during this period (see Pregnancy)
• if you have just had your first menstrual period or if you have had your first menstrual period less than two years ago; your doctor will monitor the possibility of pregnancy and give you appropriate information and/or indicate the appropriate actions to prevent the risk of exposure to the drug during pregnancy
• 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 to treat heart failure (see “Other medicines and Flortitens”). Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also what is stated under "Do not take Flortitens".
Your doctor may need to see you more often and do tests if you experience any of these
conditions.
If you are going to have an operation, tell your doctor or dentist that you are taking Flortitens. This
is because Flortitens, when combined with certain anaesthetics, can cause a drop in blood
pressure.
Talk to your doctor if, after taking Flortitens, you experience abdominal pain, nausea, vomiting or
diarrhoea. The doctor will decide on the continuation of treatment. Do not stop
taking Flortitens on your own.

Children and adolescents
Flortitens has been studied in children. For more information, consult your doctor. Ratacand should not
be given to children under 1 year of age due to the potential risk to developing kidneys.

Other medicines and Flortitens
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines. Flortitens can affect the mechanism of action of other medicines, and some
medicines can have an effect on Flortitens. 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 as your doctor
may need to adjust the dose and/or take other precautions:

• other medicines that help lower 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 for relieving pain and inflammation)
• acetylsalicylic acid (if you are taking more than 3 g per day) (medicine for relieving pain and inflammation)
• potassium supplements or salt substitutes containing potassium (medicines that increase the level of potassium in the blood)
• heparin (a medicine for thinning the blood)
• cotrimoxazole (an antibiotic) also known as trimethoprim/sulfamethoxazole
• tablets that help you urinate (diuretics)
• lithium (a medicine for mental health problems).

If you are taking an ACE inhibitor or aliskiren (see also what is stated under: "Do not
take Flortitens" 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).

Flortitens with food, drinks and alcohol

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

Pregnancy and breastfeeding
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 Flortitens
before starting pregnancy or as soon as you become aware of being pregnant and
will advise you to take another medicine instead of Flortitens.
Flortitens is not recommended in the early stages of pregnancy, and must not be taken if you are pregnant for more than three months, as it may cause serious harm to the baby if taken after the
third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or if you are going to start breastfeeding. Flortitens is not recommended
for women who are breastfeeding and your doctor may choose another treatment for you if
you wish to breastfeed, especially if your baby is newly born or premature.

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

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

Flortitens contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take Flortitens

Take this medicine exactly as your doctor has instructed. If you have any doubts, consult your
doctor or pharmacist. It is important to continue taking Flortitens every day.
Flortitens can be taken with or without food.
Swallow the tablet with a sip of water.
Try to take the tablet at the same time each day. This will help you remember to
take it.

• The recommended dose of Flortitens is 8 mg once a day. Your doctor may increase this dosage up to 16 mg once a day and further up to 32 mg once a day depending on the blood pressure response.
• In some patients, such as those with liver problems, kidney problems, or who have recently lost fluids due to, for example: vomiting, diarrhea, or taking tablets that help with urination, the doctor may prescribe a lower starting dose.
• Some patients of Black race may respond to this medicine in a reduced manner when administered as monotherapy, and may need a higher dose.

Use in children and adolescents with high blood pressure:
Children aged 6 to 18 years:
The recommended starting dose is 4 mg once a day.
For patients weighing less than 50 kg: in some patients whose blood pressure is not
adequately controlled, the doctor may decide whether the dose should be increased up to a
maximum of 8 mg once a day.
For patients weighing 50 kg or more: in some patients whose blood pressure is not
adequately controlled, the doctor may decide whether the dose should be increased to 8 mg once a
day and to 16 mg once a day.
Heart failure in adults:

• the recommended starting dose of Flortitens is 4 mg once a day. Your doctor may increase this dosage by doubling the dose at intervals of at least 2 weeks up to 32 mg once a day. Flortitens can be taken together with other medicines for heart failure, and your doctor will decide which treatment is most suitable for you.

If you take more Flortitens than you should
If you take more Flortitens than prescribed by your doctor, contact a doctor or
pharmacist immediately for advice.

If you forget to take Flortitens
Do not take a double dose to make up for a missed tablet. Just take the next
dose as usual.

If you stop taking Flortitens
If you stop taking Flortitens, your blood pressure may increase again.
Therefore, do not stop taking Flortitens without first talking to your doctor.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Flortitens can cause side effects, although not everybody gets them.
It is important that you are aware of what these side effects may be.

Stop taking Flortitens and seek immediate medical help if you experience any of the

• difficulty in 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 in swallowing
• severe itching of the skin (with raised blisters).

Flortitens can cause a reduction in the number of white blood cells in the blood. Your resistance to
infections may decrease and you may notice tiredness, infection or fever. If this happens, contact
your doctor. Your doctor may occasionally perform blood tests to check if
Flortitens has had any effects on your blood (agranulocytosis).
Possible side effects include:

Common (affects 1 to 10 users out of 100)

• Feeling dizzy/lightheaded
• Headache
• Respiratory infection
• Low blood pressure. This may make you feel weak or dizzy
• Changes in blood test results:
• An increased amount of potassium in the blood, especially if you already have kidney problems or heart failure. If this is severe, you may also notice tiredness, weakness, an irregular heartbeat or tingling.
• Effects on the functioning of your kidneys, especially if you already have kidney problems or heart failure. In very rare cases, kidney failure may occur.

Very rare (affects less than 1 user out of 10,000)

• Swelling of the face, lips, tongue and/or throat.
• A reduction in red blood cells or white blood cells. You may notice tiredness, infection or fever.
• Skin rash, rash with swelling (urticaria).
• Itching.
• Back pain, joint and muscle pain.
• Changes in the functioning of the liver, including inflammation of the liver (hepatitis). You may notice tiredness, yellowing of the skin and the whites of the eyes and flu-like symptoms.
• Nausea.
• Changes in blood test results:
• A reduced amount of sodium in the blood. If this is severe, you may also notice weakness, lack of energy or muscle cramps.
• Cough.
• Intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Not known (frequency cannot be estimated from available data)

• Diarrhoea.

Additional side effects in children
In children treated for high blood pressure, side effects appear to be
similar to those observed in adults, but occur more frequently. Sore throat in children is a very common effect
not reported in adults, and runny nose (nasal congestion), fever and
increased heart rate are common in children but not reported in adults.
If any of these side effects get serious, or if you notice any side effect

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. 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
about the safety of this medicine.

5. How to store Flortitens

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging or on the blister
after Exp. The expiry date refers to the last day of the month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 Flortitens contains
The active ingredient is candesartan cilexetil.
Each Flortitens 4 mg tablet contains 4 mg of candesartan cilexetil.
Each Flortitens 8 mg tablet contains 8 mg of candesartan cilexetil.
Each Flortitens 16 mg tablet contains 16 mg of candesartan cilexetil.
Each Flortitens 32 mg tablet contains 32 mg of candesartan cilexetil.
The excipients are sodium docusate, lauryl sulfate, calcium carmellose, pregelatinized corn starch,
hydroxypropylcellulose, lactose monohydrate, magnesium stearate (E572), red iron oxide (E172)
(only for 16 mg and 32 mg tablets).

Description of the appearance of Flortitens and package contents
Flortitens 4 mg is available in the following packages:
Blisters with 28 white, round, biconvex tablets marked 04 with a fracture line.
Flortitens 8 mg is available in the following packages:
Blisters with 28 white, round biconvex tablets, marked 08 with a fracture line
Flortitens 16 mg is available in the following packages:
Blisters with 28 light red, round biconvex tablets, marked 16 with a fracture line.
Flortitens 32 mg is available in the following packages:
Blisters with 28 light red, elliptical biconvex tablets, marked 32 with a fracture line.
The notch serves to facilitate breaking for easier swallowing of the tablet and
not to divide it into equal doses.
Not all pack sizes may be marketed.

MARKETING AUTHORISATION HOLDER:
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (RM)
Italy

MANUFACTURER RESPONSIBLE FOR BATCH RELEASE:
Special Product's Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy