Flortitens

Patient Information Leaflet

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

candesartan cilexetil
Equivalent medicine
Please 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful. If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 Flortitens is and what it is used for

The name of the medicine is Flortitens. The active substance is candesartan cilexetil. It belongs to a group of medicines called angiotensin II receptor antagonists. It works by causing relaxation and dilation of blood vessels. This helps lower blood pressure. It also allows the heart to pump 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 excipients of Flortitens (see section 6);
• if you are more than three months pregnant (Flortitens should also be avoided during early pregnancy – see Pregnancy);
• if you have severe liver disease or biliary obstruction (a problem with bile drainage from the gallbladder);
• if the patient is a child under 1 year of age;
• 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 Flortitens.

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

• if you have heart, liver or kidney problems or are on dialysis;
• if you have recently undergone a kidney transplant;
• if you are vomiting, have recently experienced 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;
• inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Flortitens is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken during this period (see Pregnancy);
• if you have recently started menstruating or have had your first period less than two years ago; your doctor will monitor for possible pregnancy and provide you with appropriate information and/or advise necessary measures to prevent exposure to the medicine during pregnancy;
• if you are taking any of the following medicines used to treat high blood pressure:
  • an "ACE inhibitor" (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes;
  • aliskiren;
• if you are taking an ACE inhibitor together with a medicine belonging to a class of medicines known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see “Other medicines and Flortitens”). Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.

See also the section “Do not take Flortitens”.
Your doctor may need to examine you more frequently and carry out tests if any of these conditions apply.
If you are due to undergo surgery, tell your doctor or dentist that you are taking Flortitens. This is because Flortitens, when combined with certain anaesthetics, may cause a drop in blood pressure.
Contact your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Flortitens. Your doctor will decide whether treatment should continue. Do not stop taking Flortitens on your own.

Children and adolescents
Flortitens has been studied in children. For further information, please consult your doctor. Ratacand must 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 need to take any other medicines. Flortitens may affect how other medicines work, and some medicines may affect Flortitens. If you are taking certain medicines, your doctor may need to carry out occasional blood tests.
In particular, tell your doctor if you are taking any of the following medicines, as your doctor may need to adjust your 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 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);
• heparin (a medicine used to thin the blood);
• cotrimoxazole (an antibiotic), also known as trimethoprim/sulfamethoxazole;
• tablets that help you pass urine (diuretics);
• lithium (a medicine used for mental health conditions).

If you are taking an ACE inhibitor or aliskiren (see also the sections: "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 (MRAs) (e.g. spironolactone, eplerenone).

Flortitens with food, drinks and alcohol

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

Pregnancy and breastfeeding
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 Flortitens before starting a pregnancy or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Flortitens.
Flortitens is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken beyond the third month of pregnancy.

Breast-feeding
Inform your doctor if you are breast-feeding or intend to start breast-feeding. Flortitens is not recommended for women who are breast-feeding, and your doctor may choose an alternative treatment if you wish to breast-feed, especially if your baby was recently born or was born prematurely.

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

Flortitens contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them 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 prescribed by your doctor. 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 glass of water.
Try to take the tablet at the same time each day. This will help you remember to take it.

High blood pressure:

• The recommended dose of Flortitens is 8 mg once daily. Your doctor may increase this dose up to 16 mg once daily, and further up to 32 mg once daily, depending on your blood pressure response.
• In some patients, such as those with liver problems, kidney problems, or who have recently lost fluids (e.g., due to vomiting, diarrhoea, or taking tablets that increase urination), your doctor may prescribe a lower starting dose.
• Some black patients may have a reduced response to this medicine when used as monotherapy and may require 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 daily.
For patients weighing less than 50 kg: in some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose up to a maximum of 8 mg once daily.
For patients weighing 50 kg or more: in some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose to 8 mg once daily and then to 16 mg once daily.

Heart failure in adults:

• The recommended starting dose of Flortitens is 4 mg once daily. Your doctor may increase this dose by doubling it at intervals of at least 2 weeks up to a maximum of 32 mg once daily. Flortitens may 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 the forgotten tablet. Take only the next dose as usual.

If you stop taking Flortitens
If you stop treatment with Flortitens, your blood pressure may rise again. Therefore, do not stop treatment with Flortitens without first talking to your doctor.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Flortitens may cause side effects, although not everybody gets them.
It is important that you are aware of what these possible side effects may be.
Stop taking Flortitens 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 skin itching (with raised, itchy rashes)

Flortitens 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 Flortitens has affected
your blood (agranulocytosis).

Possible side effects include:
Common (may affect from 1 to 10 users in 100)

• Dizziness/spinning sensation
• Headache
• Respiratory infection
• Low blood pressure. This may make you feel weak or dizzy
• Changes in blood test results:
  • Increased potassium levels in the blood, especially if you already have kidney problems or heart failure. If this is severe, you may also experience fatigue, weakness, irregular heartbeat, or tingling sensations.
• Effects on kidney function, especially if you already have kidney problems or heart failure. In very rare cases, kidney failure may occur.

Very rare (may affect fewer than 1 user in 10,000)

• Swelling of the face, lips, tongue and/or throat
• Reduction in red or white blood cells. You may experience fatigue, infection, or fever
• Skin rash, rash with swelling (urticaria)
• Itching
• Back pain, joint and muscle pain
• Changes in liver function, including liver inflammation (hepatitis). You may notice fatigue, yellowing of the skin and whites of the eyes, and flu-like symptoms
• Nausea
• Changes in blood test results:
  • Reduced sodium levels in the blood. If this is severe, you may also experience weakness, lack of energy, or muscle cramps
• Cough
• 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)

• Diarrhoea

Additional side effects in children
In children treated due to 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 side effect not reported in
adults, and runny nose (rhinorrhea), fever, and increased heart rate are common in children but not
reported in adults.
If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your
doctor or pharmacist.
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
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 Flortitens

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 packaging or on the blister
after Exp. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater 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 Flortitens contains
The active substance 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, monohydrate lactose, magnesium stearate (E572), iron oxide red (E172)
(only for 16 mg and 32 mg tablets).

Description of the appearance of Flortitens and pack contents
Flortitens 4 mg is available in the following pack:
Blister pack containing 28 white, round, biconvex tablets marked "04" with a break line.

Flortitens 8 mg is available in the following pack:
Blister pack containing 28 white, round, biconvex tablets marked "08" with a break line.

Flortitens 16 mg is available in the following pack:
Blister pack containing 28 light red, round, biconvex tablets marked "16" with a break line.

Flortitens 32 mg is available in the following pack:
Blister pack containing 28 light red, elliptical, biconvex tablets marked "32" with a break line.

The score line is intended to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet 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

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