Converten

PACKAGE LEAFLET: INFORMATION FOR THE USER

CONVERTEN 5 mg, 20 mg tablets

enalapril maleate
Please read this leaflet carefully before taking this medicine.

• 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 personally. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

1. What CONVERTEN is and what it is used for
2. Before you take CONVERTEN
3. How to take CONVERTEN
4. Possible side effects
5. How to store CONVERTEN
6. Further information

1. WHAT CONVERTEN IS AND WHAT IT IS USED FOR

CONVERTEN contains an active substance called enalapril maleate. This active substance belongs to a group of medicines known as ACE inhibitors (angiotensin-converting enzyme inhibitors).
CONVERTEN is used:

• to treat high blood pressure (hypertension)
• to treat heart failure (weakening of heart function). It can reduce the need for hospitalization and may help some patients live longer
• to prevent signs of heart failure. These signs include: shortness of breath, fatigue after light physical activity such as walking, or swelling of the ankles and feet. CONVERTEN works by dilating your blood vessels. This lowers your blood pressure. The medicine usually starts to work within one hour, and the effect lasts for at least 24 hours. Some people may require several weeks of treatment before the full effect on blood pressure becomes apparent.

2. BEFORE TAKING CONVERTEN

Do not take CONVERTEN if:

• you are allergic (hypersensitive) to enalapril maleate or to any of the excipients of CONVERTEN (listed in section 6)
• you have previously had an allergic reaction to a medicine of the same type as CONVERTEN called an ACE-inhibitor
• you have previously experienced swelling of the face, lips, mouth, tongue, or throat causing difficulty in swallowing or breathing (angioedema) of unknown or hereditary origin
• you are more than 3 months pregnant. It is also better to avoid CONVERTEN during the early stages of pregnancy (see section Pregnancy). Do not take CONVERTEN if you have any of the above conditions. If you are unsure, speak with your doctor or pharmacist before taking CONVERTEN.

Warnings and precautions
Talk to your doctor or pharmacist before taking CONVERTEN:

• if you have a heart condition
• if you have a condition affecting the blood vessels in the brain
• if you have a blood disorder such as low number or absence of white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or reduced number of red blood cells (anemia)
• if you have a liver problem
• if you have a kidney problem (including kidney transplant). This may lead to increased potassium levels in the blood, which can be serious. Your doctor may need to adjust your dose of CONVERTEN or monitor your blood potassium levels
• if you are on dialysis
• if you have recently had episodes of excessive vomiting or severe diarrhoea
• if you are on a low-salt diet, taking potassium supplements, potassium-sparing agents, or salt substitutes containing potassium
• if you are over 70 years old
• if you have diabetes. Close monitoring for low blood glucose levels is necessary, especially during the first month of treatment. Blood potassium levels may also be higher
• if you have previously had an allergic reaction with swelling of the face, lips, tongue, or throat, causing difficulty in swallowing or breathing. You should know that black patients are at higher risk for these types of reactions to ACE-inhibitors
• if you have low blood pressure (you may feel faint or dizzy, especially when standing up)
• if you have a collagen vascular disease (e.g. systemic lupus erythematosus, rheumatoid arthritis, or scleroderma), are receiving immunosuppressive therapy, or are taking allopurinol or procainamide, or their combinations
• you must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). CONVERTEN is not recommended during early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause severe harm to the unborn baby (see section Pregnancy)
• if you are breastfeeding or planning to start breastfeeding (see section Breast-feeding)
• if you are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans – for example valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes
• aliskiren
  Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section "Do not take CONVERTEN".

You should know that in black patients, CONVERTEN reduces blood pressure less effectively than in non-black patients.
If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before taking CONVERTEN.
If you are about to undergo a procedure
If you are about to undergo any of the following procedures, inform your doctor that you are taking CONVERTEN:

• any type of surgery or anaesthesia (including dental anaesthesia)
• treatment to remove cholesterol from the blood called "LDL apheresis"
• desensitisation treatment to reduce the effects of allergy to bee or wasp stings
  If any of the above conditions apply to you, talk to your doctor or dentist before the procedure.

Other medicines and CONVERTEN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. This includes herbal medicines. This is because CONVERTEN may interfere with the action of some medicines, and some other medicines may interfere with the action of CONVERTEN.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• other medicines that lower blood pressure, such as beta-blockers or diuretics
• medicines containing potassium (including dietary salt substitutes)
• medicines for diabetes (including oral antidiabetics and insulin)
• lithium (a medicine used to treat a certain type of depression)
• medicines for depression called "tricyclic antidepressants"
• medicines for mental disorders called "antipsychotics"
• some cough and cold medicines and weight-reducing medicines containing a so-called "sympathomimetic agent"
• some medicines for pain or arthritis, including gold therapy
• non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (medicines that reduce inflammation and may help relieve pain)
• aspirin (acetylsalicylic acid)
• medicines used to dissolve blood clots (thrombolytics)
• alcohol
  If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before taking CONVERTEN. Your doctor may consider it necessary to adjust the dose and/or take other precautions:

If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "Do not take CONVERTEN" and "Warnings and precautions").

Taking CONVERTEN with food and drink
CONVERTEN can be taken with or without food. Most people take CONVERTEN with a glass of water.

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

Breast-feeding
Inform your doctor if you are breastfeeding or planning to start breastfeeding. Breast-feeding of newborns (first weeks after birth), and especially premature infants, is not recommended while taking CONVERTEN. For older infants, your doctor will advise you on the benefits and risks of taking CONVERTEN during breast-feeding compared to other treatments.

Driving and using machines
Dizziness or drowsiness may occur while taking CONVERTEN. If this happens, do not drive and do not operate tools or machinery.

Important information about some excipients of CONVERTEN
CONVERTEN contains lactose, which is a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, talk to your doctor before taking this medicine.

3. HOW TO TAKE CONVERTEN

Always take CONVERTEN exactly as prescribed by your doctor. If you have any doubts, you must consult your doctor or pharmacist.

• It is very important to continue taking CONVERTEN for as long as your doctor has prescribed it.
• Do not take more tablets than prescribed.

High blood pressure

• The usual initial dose ranges from 5 to 20 mg once daily.
• Some patients may need to start treatment with a lower dose.
• The usual maintenance dose is 20 mg once daily.
• The maximum maintenance dose is 40 mg once daily.

Heart failure

• The usual initial dose is 2.5 mg once daily.
• Your doctor will gradually increase the dose until the appropriate dose for you is reached.
• The usual maintenance dose is 20 mg daily, taken in one or two doses.
• The maximum maintenance dose is 40 mg daily, divided into two doses.

Patients with kidney problems
The dose of the medicine will vary depending on the function of your kidneys:

• moderately impaired kidney function - 5 to 10 mg daily
• severely impaired kidney function - 2.5 mg daily
• if you are on dialysis - 2.5 mg daily. On days when you are not undergoing dialysis, the dose may be adjusted according to your blood pressure.

Use in the elderly
The dose will be decided by your doctor and will be based on the function of your kidneys.
Use in children
Experience with the use of CONVERTEN in children with high blood pressure is limited. If the child is able to swallow tablets, the dose will be determined based on the child's weight and blood pressure. The usual initial doses are:

• weight between 20 kg and 50 kg - 2.5 mg daily
• weight above 50 kg - 5 mg daily.

The dose may be adjusted according to the child's needs:

• a maximum dose of 20 mg daily may be used in children weighing between 20 kg and 50 kg
• a maximum dose of 40 mg daily may be used in children weighing above 50 kg. CONVERTEN is not recommended in neonates (first weeks of life) and in children with kidney problems.

If you take more CONVERTEN than you should
If you take more CONVERTEN than you should, inform your doctor or go immediately to hospital. Take the medicine pack with you. The following effects may occur: lightheadedness or dizziness. This is due to a sudden or excessive drop in blood pressure.
If you forget to take CONVERTEN

• If you forget to take a tablet, skip the missed dose.
• Take your next dose as usual.
• Do not take a double dose to make up for the forgotten dose.

If you stop taking CONVERTEN
Do not stop treatment with this medicine unless your doctor tells you to.
If you have any doubts about using this product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, CONVERTEN may cause adverse reactions, although not everyone experiences them. The following adverse reactions may occur with this medicine:
Stop taking CONVERTEN and contact a doctor immediately if you notice any of the following symptoms:

• swelling of the face, lips, tongue or throat which may cause difficulty breathing or swallowing
• swelling of the hands, feet or ankles
• development of a rash with red, raised lesions (urticaria). You should know that black patients have a higher risk of developing this type of reaction. If you notice any of these symptoms, stop taking CONVERTEN and contact your doctor immediately.

When you start taking CONVERTEN, you may feel faint or dizzy. If this happens, lying down may help. This is caused by a drop in blood pressure. Symptoms should improve as you continue taking the medicine. If you are concerned, please contact your doctor.

Other adverse reactions include:
Very common (affects more than 1 in 10 people)

• dizziness, weakness or feeling unwell
• blurred vision
• cough

Common (affects less than 1 in 10 people)

• low blood pressure, changes in heart rhythm, rapid heartbeat, angina pectoris or chest pain
• headache, fainting (syncope)
• altered taste sensation, shortness of breath
• diarrhoea or abdominal pain, rash
• fatigue (tiredness), depression
• allergic reactions with swelling of the face, lips, tongue or throat, causing difficulty breathing or swallowing
• increased potassium levels in the blood, increased creatinine levels in the blood (both are usually detected by laboratory tests)

Uncommon (affects less than 1 in 100 people)

• sudden drop in blood pressure
• rapid or irregular heartbeat (palpitations)
• heart attack (possibly due to very low blood pressure in some high-risk patients, including those with circulatory problems affecting the heart or brain)
• anaemia (including aplastic and haemolytic anaemia)
• stroke (possibly due to very low blood pressure in high-risk patients)
• confusion, insomnia or drowsiness, nervousness
• sensation of tingling or numbness of the skin
• dizziness
• ringing in the ears (tinnitus)
• runny nose, sore throat and hoarseness
• asthma
• slowed movement of food through the intestine, inflammation of the pancreas
• vomiting, indigestion, constipation, loss of appetite
• stomach irritation (gastric irritation), dry mouth, ulcer, renal dysfunction, kidney failure
• increased sweating
• itching or hives
• hair loss
• muscle cramps, hot flushes, general feeling of discomfort, high body temperature (fever), impotence
• high levels of protein in the urine (detected by laboratory test)
• low levels of blood sugar or sodium, high levels of urea in the blood (all detected by blood tests)

Rare (affects less than 1 in 1,000 people)

• "Raynaud's phenomenon", in which hands and feet may become very cold and pale due to reduced blood flow
• changes in blood values such as decreased number of white blood cells and red blood cells, decreased haemoglobin, decreased platelet count
• bone marrow depression
• autoimmune diseases
• altered dreams, sleep disturbances
• pulmonary infiltrates
• inflammation of the nose
• pneumonia
• inflammation of cheeks, gums, tongue, lips, throat
• decreased amount of urine produced
• erythema multiforme
• Stevens-Johnson syndrome, a serious skin condition characterized by redness and skin peeling, blistering or exposed ulcers, or detachment of the outer layer of skin from deeper layers
• liver problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin or eyes), increased liver enzymes or bilirubin (detected by blood tests)
• breast enlargement in men

Very rare (affects less than 1 in 10,000 people)

• intestinal swelling (intestinal angioedema)

If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist. Ask your doctor or pharmacist for further information about adverse reactions and a more complete list of possible side effects.

5. HOW TO STORE CONVERTEN

Keep out of the reach and sight of children.
Do not use CONVERTEN after the expiry date stated on the blister and carton after the word
EXP. The expiry date refers to the last day of the month.
Do not store CONVERTEN above 25°C. Store in the original packaging
to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. OTHER INFORMATION

What CONVERTEN contains

• The active substance is enalapril maleate (5 mg or 20 mg).
• The other excipients are monohydrate lactose, sodium bicarbonate, corn starch, pregelatinized corn starch, magnesium stearate. The 20 mg tablets also contain red iron oxide (E172) and yellow iron oxide (E172).

Description of the appearance of CONVERTEN and pack contents
CONVERTEN is available in the following pack sizes:
CONVERTEN 5 mg in aluminum blisters containing 2, 14, 20, 28, 28 x 1, 30, 49 x 1, 50, 60, 98 or
100 tablets.
CONVERTEN 20 mg in aluminum blisters containing 10, 14, 20, 28, 28 x 1, 30, 49 x 1, 50, 56, 60,
84, 90, 98, 100 or 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Teofarma S.r.l.
Via F.lli Cervi, 8 – 27010 Valle Salimbene (PV)
Fax 0382/525845
e-mail: [email protected]

Manufacturer:
Doppel Farmaceutici S.r.l.
Via Volturno, 48 – Quinto de’ Stampi
20048 Rozzano (Milan)

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