CONVERTEN 20 mg Tabletki

Treść ulotki

1. CONVERTEN 5 mg, 20 mg tablets
   1. WHAT CONVERTEN IS AND WHAT IT IS USED FOR
   2. BEFORE TAKING CONVERTEN
   3. HOW TO TAKE CONVERTEN
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE CONVERTEN
   6. OTHER INFORMATION

CONVERTEN 5 mg, 20 mg tablets

enalapril maleate
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. In fact, this medicine may be dangerous for other individuals, even if their symptoms are the same as yours.
• If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, tell 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 called ACE inhibitors (angiotensin converting enzyme inhibitors).
CONVERTEN is used:

• to treat high blood pressure (hypertension)
• to treat heart failure (weakening of the heart function). It can reduce the need to go to hospital and can help some patients to live longer
• to prevent the signs of heart failure. The signs include: shortness of breath, fatigue after light activity such as walking, or swelling of the ankles and feet. CONVERTEN works by widening 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 will need several weeks of treatment before the best effect on blood pressure can be seen.

2. BEFORE TAKING CONVERTEN

Do not take CONVERTEN if:

• you are allergic (hypersensitive) to enalapril maleate or any of the excipients of CONVERTEN (listed in section 6)
• you have previously had an allergic reaction to a medicine similar to CONVERTEN called an ACE inhibitor
• you have previously experienced swelling of the face, lips, mouth, tongue or throat that caused difficulty swallowing and breathing (angioedema) of unknown or hereditary origin
• you are pregnant for more than 3 months. It is best to avoid CONVERTEN even in the early stages of pregnancy (see section Pregnancy), 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. Do not take CONVERTEN if you have any of the problems listed above. If you are not sure, talk to your doctor or pharmacist before taking CONVERTEN.

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

• if you have a heart problem
• if you have a condition involving blood vessels in the brain
• if you have a blood problem such as a low number or absence of white blood cells (neutropenia/agranulocytosis), a low number of platelets (thrombocytopenia) or a reduction in the number of red blood cells (anemia)
• if you have a liver problem
• if you have a kidney problem (including kidney transplant). This can lead to an increase in potassium in the blood, which can be serious. Your doctor may need to adjust the dose of CONVERTEN or monitor your blood potassium levels
• if you are on dialysis
• if you have recently experienced episodes of excessive vomiting or severe diarrhea
• if you are following a low-salt diet, taking potassium supplements, potassium-sparing agents, or salt substitutes containing potassium
• if you are over 70 years of age
• if you have diabetes. Blood glucose levels should be carefully monitored if a decrease occurs, especially during the first month of treatment. Potassium levels in the blood may also be higher
• if you have had a previous allergic reaction with swelling of the face, lips, tongue or throat with difficulty swallowing or breathing. You should know that black patients are at higher risk for these types of reactions to ACE inhibitors
• if you suffer from low blood pressure (you notice this when you feel faint or dizzy, especially when standing up)
• if you have a connective tissue disease (e.g. lupus erythematosus, rheumatoid arthritis or scleroderma), are undergoing immunosuppressive therapy, are taking allopurinol or procainamide, or combinations thereof
• you must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). CONVERTEN is not recommended in early pregnancy, and should 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 section Pregnancy)
• if you are breastfeeding or planning to start breastfeeding (see section Breastfeeding);
• 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), especially if you have kidney problems related to diabetes.
• aliskiren 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 the section "Do not take CONVERTEN”.

You should know that in black patients CONVERTEN reduces blood pressure less effectively
compared to non-black patients.
If you are not sure whether any of the above conditions apply to you, talk to your doctor or
pharmacist before taking CONVERTEN.

If you are going to have a procedure
If you are going to have any of the following procedures, tell your doctor that you are taking
CONVERTEN:

• any type of surgery or anesthesia (including from the dentist)
• a treatment that removes cholesterol from the blood called "LDL apheresis"
• desensitization treatment to reduce the effects of an allergy to bee or wasp stings. If any of the conditions above 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 may take
any other medicines, including those obtained without a prescription. This includes herbal medicines. This is because CONVERTEN can interfere with the mechanism of action of some
medicines. Also, some other medicines can interfere with the mechanism of action of
CONVERTEN.
In particular, tell 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 potassium supplements)
• 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 health problems called "antipsychotics"
• some medicines for coughs and colds and weight loss medicines that contain a so-called "sympathomimetic agent"
• some medicines for pain or arthritis including gold therapy
• non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines that reduce inflammation, and which can be used to help relieve pain)
• aspirin (acetylsalicylic acid)
• medicines used to dissolve blood clots (thrombolytics)
• alcohol If you are not sure whether any of the above conditions apply to you, talk to your doctor or pharmacist before taking CONVERTEN. Your doctor may need to adjust the dose and/or take other precautions:

If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also
the section "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 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 CONVERTEN before
starting pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of CONVERTEN. CONVERTEN is not
recommended in early pregnancy, and should 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. Breastfeeding of newborns (first
weeks after birth), and especially premature babies, is not recommended while taking
CONVERTEN. In the case of older babies, the doctor must inform you of the benefits and
risks associated with taking CONVERTEN during breastfeeding, compared to other treatments.

Driving and operating machinery
Dizziness or drowsiness may occur while taking CONVERTEN. If this happens, do not
drive and do not use any tools or machinery.

Important information about some of the excipients of CONVERTEN
CONVERTEN contains lactose, which is a type of sugar. If you have been told by your doctor that you have a
intolerance to some sugars, talk to your doctor before taking this medicine.

3. HOW TO TAKE CONVERTEN

Always take CONVERTEN exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.

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

High blood pressure

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

Heart failure

• The usual starting dose is 2.5 mg in a single daily dose.
• Your doctor will gradually increase the dose to reach the appropriate dose for you.
• The usual maintenance dose is 20 mg per day, taken in one or two doses.
• The maximum maintenance dose is 40 mg per day, divided into two doses.

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

• moderate kidney problems - 5 to 10 mg per day
• severe kidney problems - 2.5 mg per day
• if you are on dialysis - 2.5 mg per day. On days when you are not undergoing dialysis, the dose may be varied depending on your blood pressure.

Use in the elderly
The dose will be decided by your doctor and will be based on your kidney function.

Use in children
Experience with the use of CONVERTEN in children with high blood pressure is limited. If the child
is able to swallow the tablets, the dose will be established based on the child's weight and blood pressure. The usual starting doses are:

• weight between 20 kg and 50 kg - 2.5 mg per day
• weight over 50 kg - 5 mg per day.

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

• a maximum dose of 20 mg per day may be used in children weighing between 20 kg and 50 kg
• a maximum dose of 40 mg per day may be used in children weighing over 50 kg. CONVERTEN is not recommended in newborns (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, tell your doctor or go to hospital immediately. Bring
the medicine packaging with you. The following effects may occur: feeling of lightheadedness or dizziness. This is due to a sudden or excessive decrease in blood pressure.

If you forget to take CONVERTEN

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

If you stop taking CONVERTEN
Do not stop treatment with the medicine unless your doctor tells you to.
If you have any questions about the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, CONVERTEN can cause side effects, although not everybody gets them.
With this medicine the following side effects may occur:

Stop taking CONVERTEN and contact your doctor immediately if you notice any of the
following:

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

When you start taking CONVERTEN you may feel faint or dizzy. If this happens,
it may be helpful to lie down. This is caused by a lowering of blood pressure. It should
improve as you continue to take the medicine. If you are worried please contact your doctor.
Other side effects include:

Very common(affects more than 1 in 10 people)

• feeling of dizziness, weakness or unwell
• blurred vision
• cough. Common(affects less than 1 in 10 people)
• low blood pressure, changes in heart rhythm, fast heartbeat, angina pectoris or chest pain
• headache, fainting (syncope)
• altered sense of taste, shortness of breath
• diarrhoea or abdominal pain, skin rash
• tiredness (fatigue), depression
• allergic reactions with swelling of the face, lips, tongue or throat with difficulty breathing or swallowing
• increased levels of potassium in the blood, increased levels of creatinine in the blood (both are usually found with a laboratory test).

Uncommon(affects less than 1 in 100 people)

• sudden drop in blood pressure
• fast or irregular heartbeats (palpitations)
• heart attack (possibly due to very low blood pressure in some high-risk patients, including those with circulatory problems at the level of the heart or brain)
• anaemia (including aplastic and hemolytic anaemia)
• stroke (possibly due to very low blood pressure in high-risk patients)
• confusion, insomnia or drowsiness, nervousness
• feeling of pins and needles or numbness
• vertigo
• ringing in the ears (tinnitus)
• nasal secretion, sore throat and hoarseness
• asthma
• slowed transit of food in the intestine, inflammation of the pancreas
• vomiting, difficulty digesting, constipation, loss of appetite
• irritated stomach (gastric irritations), dry mouth, ulcer, kidney dysfunction, kidney failure
• increased sweating
• itching or urticaria
• hair loss
• muscle cramps, hot flushes, general feeling of unwellness, high body temperature (fever), impotence
• high level of protein in the urine (measured with a laboratory test)
• low level of sugar or sodium in the blood, high level of urea in the blood (all measured with a blood test). Rare(affects less than 1 in 1,000 people)
• "Raynaud's phenomenon" in which hands and feet can become very cold and white due to low blood flow
• changes in blood values such as a decrease in the number of white blood cells and red blood cells, decrease in haemoglobin, decrease in the number of platelets
• bone marrow depression
• autoimmune diseases
• altered dreams, sleep disorders
• lung 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 in which there is redness and peeling of the skin, blistering or exposed ulcers, or detachment of the superficial layer of the skin from the deeper layers
• problems with the liver such as reduced liver function, inflammation of the liver, jaundice (yellowing of skin or eyes), increased liver enzymes or bilirubin (measured with a blood test)
• enlargement of the mammary glands in men. Very Rare(affects less than 1 in 10,000 people)
• swelling in the intestine (intestinal angioedema)

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist for more information about side effects and for a more complete list
of side effects.

5. HOW TO STORE CONVERTEN

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

6. OTHER INFORMATION

What CONVERTEN contains

• The active ingredient is enalapril maleate (5 mg or 20 mg).
• The other excipients are lactose monohydrate, 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 contents of the pack
CONVERTEN is available in the following packs:
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 Authorisation Holder and Manufacturer
Marketing Authorisation 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 (Milano)