LANEX 5 mg Coated Tablet

Зміст інструкції

1. LANEX 5 mg tablets, 20 mg tablets
   1. What is LANEX and what is it used for
   2. What you need to know before taking LANEX
   3. How to take LANEX
   4. Possible side effects
   5. How to store LANEX
   6. Contents of the pack and other information

LANEX 5 mg tablets, 20 mg tablets

enalapril maleate
Generic Medicine

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

1. What is LANEX and what is it used for

LANEX contains an active ingredient called enalapril maleate. This active ingredient belongs to a
group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors). This
medicine works by dilating blood vessels. This lowers your blood pressure.
LANEX is used:

• to treat high blood pressure (hypertension);
• to treat symptomatic heart failure (weakening of the heart function);
• to prevent the signs of symptomatic heart failure in patients with asymptomatic left ventricular dysfunction.

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. What you need to know before taking LANEX

Do not take LANEX

• if you are allergic to enalapril maleate or any of the other ingredients of this medicine (listed in section 6);
• if you have previously had an allergic reaction to a medicine of a type similar to this medicine called an ACE inhibitor;
• if you have previously experienced swelling of the face, lips, mouth, tongue or throat which caused difficulty swallowing and breathing (angioedema) of unknown or hereditary origin;
• 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 pregnant for more than 3 months (see section “Pregnancy and breastfeeding”). Do not take this medicine if you have any of the problems listed above. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

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

• 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 LANEX 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, are taking potassium supplements, potassium-sparing agents, or salt substitutes containing potassium;
• if you are elderly;
• if you have diabetes. You need to carefully monitor if a lowering of blood glucose levels occurs, especially during the first month of treatment. The potassium level in the blood may also be higher;
• if you have had an allergic reaction in the past 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 collagen vascular disease (e.g. lupus erythematosus, rheumatoid arthritis or scleroderma), are undergoing immunosuppressive therapy, are taking allopurinol or procainamide, or combinations thereof;
• 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

The doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in the blood at regular intervals.
See also what is stated under "Do not take LANEX".
You should inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). This medicine 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 section Pregnancy and breastfeeding).
You should know that in black patients this medicine reduces blood pressure less effectively than in non-black patients.

Children
The information available on the use of LANEX in children is limited.
If your child is able to swallow the tablets, your doctor will assess the right dosage for him.
Give LANEX to your child once a day and according to your doctor's instructions.
Lanex is not recommended in children for indications other than hypertension.
LANEX is not recommended in newborns and pediatric patients with kidney problems (glomerular filtration rate less than 30 ml/min/1.73 m).

Other medicines and LANEX
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
This is because LANEX can interfere with the mechanism of action of some medicines. Also, some other
medicines can interfere with the mechanism of action of LANEX.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• other medicines that lower blood pressure, such as angiotensin receptor blockers, diuretics;
• medicines containing potassium (potassium-sparing diuretics, potassium supplements or 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 problems called "antipsychotics";
• anesthetic medicines;
• sympathomimetics;
• gold salt therapy;
• non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (medicines that reduce inflammation, and which can be used to help relieve pain):
• aspirin (acetylsalicylic acid). The 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 what is stated under "Do not take LANEX” and "Warnings and precautions”). LANEX with alcoholAlcohol increases the blood pressure lowering effect of ACE inhibitors.

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

• any type of surgery or anesthesia (even from the dentist);
• 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 listed above apply to you, talk to your doctor or dentist before the
procedure.

LANEX with food and drink
LANEX can be taken with or without food. Most patients take LANEX with a glass
of water.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Your doctor will advise you to stop taking LANEX before becoming pregnant or
as soon as you find out you are pregnant and will advise you to take another
medicine instead of LANEX. This medicine is not recommended in early pregnancy (first 3
months), and must not be taken if you are pregnant for more than three 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 intend to start breastfeeding. Breastfeeding of
newborns (first weeks after birth), especially premature infants, is not recommended during the use of this medicine.
In the case of older children, your doctor will inform you about the risks and benefits associated
with taking this medicine during breastfeeding, compared to other treatments.

Driving and using machines
Dizziness or drowsiness may occasionally occur while taking this medicine. If this
happens, do not drive vehicles and do not use any tools or machinery.

LANEX contains lactose
LANEX contains lactose, which is a type of sugar. If your doctor has diagnosed you with an intolerance
to certain sugars, contact him before taking this medicine.

If you are not sure if any of the above conditions apply to you, talk to your doctor or
pharmacist before taking LANEX.

3. How to take LANEX

Take this medicine always following exactly the instructions of your doctor or pharmacist. If you have
doubts consult your doctor or pharmacist.
It is very important to continue taking this medicine until it is prescribed by your doctor.
Do not take more tablets than those prescribed.
The tablet can be divided into equal parts.

High blood pressure

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

Heart failure

• The usual recommended starting dose is 2.5 mg in single daily dose.
• The 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 according to the function of your kidneys:

• 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 according to your blood pressure.

Elderly patients
The dose will be decided by the doctor and will be based on the degree of kidney function.

Use in children
Experience with the use of LANEX 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 equal to or greater than 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 equal to or greater than 50 kg. This medicine is not recommended in newborns (first weeks of life) and in pediatric patients with kidney problems.

If you take more LANEX than you should
If you take more LANEX than you should, inform your doctor or go immediately to the nearest hospital. Bring
with you the package of the medicine. 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 LANEX

• 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 LANEX
Do not stop treatment with the medicine unless your doctor tells you to. If you have any
doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with this medicine, stop taking LANEX and contact your doctor immediately if you notice any of the following:

• swelling of the face, lips, tongue or throat which can cause difficulty 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 LANEX and contact your doctor immediately.

When you start taking this medicine 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(may affect more than 1 in 10 people)

• feeling of dizziness, weakness or unwellness;
• blurred vision;
• cough;
• nausea.

Common(may affect up to 1 in 10 people)

• low blood pressure, changes in heart rate, fast heartbeat, angina pectoris or chest pain;
• headache, fainting (syncope);
• altered sense of taste;
• shortness of breath;
• diarrhoea;
• 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(may affect up to 1 in 100 people)

• sudden decrease in blood pressure;
• fast or irregular heartbeat (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;
• tingling skin sensation or numbness;
• vertigo;
• ringing in the ears (tinnitus);
• nasal secretion, sore throat and hoarseness;
• shortness of breath;
• slowed transit of food in the intestine (intestinal blockage), 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(may affect up to 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 (neutrophils) and red blood cells;
• decrease in haemoglobin, decrease in the number of platelets;
• decrease in the number of granulocytes (a type of white blood cells) circulating;
• decrease in the number of all cells present in the blood (pancytopenia);
• bone marrow suppression;
• enlargement of the lymph nodes;
• autoimmune diseases;
• altered dreams, sleep disorders;
• lung infiltrates;
• inflammation of the nasal mucosa (rhinitis);
• allergic 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 scaling of the skin, blistering or exposed ulcers, or detachment of the superficial layer of the skin from the deep layers;
• skin erythema, often with scaling (erythrodermia);
• autoimmune blistering dermatoses of the skin and mucous membranes (pemphigus);
• scaling of the skin on large areas of the body (exfoliative dermatitis);
• toxic epidermal necrolysis;
• problems with the liver such as reduced liver function, inflammation of the liver (hepatitis), hepatitis including necrosis, cholestasis including 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(may affect up to 1 in 10,000 people)

• swelling in the intestine (intestinal angioedema).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor. 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 LANEX

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 blister and the outer packaging after the words
EXP. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
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 LANEX contains
The active ingredient is enalapril maleate.

LANEX 5 mg tablets
Each tablet contains: 5 mg of enalapril maleate.
The other ingredients are: sodium bicarbonate; lactose monohydrate; corn starch; pregelatinized starch and
magnesium stearate.

LANEX 20 mg tablets
Each tablet contains: 20 mg of enalapril maleate.
The other ingredients are: sodium bicarbonate; lactose monohydrate; corn starch; pregelatinized starch;
red iron oxide; yellow iron oxide and magnesium stearate.

Description of the appearance of LANEX and contents of the pack
LANEX is available in divisible tablets in the following packs:
LANEX 5 mg in a cardboard box containing blister packs with 28 tablets.
LANEX 20 mg in a cardboard box containing blister packs with 14 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00040 Pomezia (RM)
Italy

Manufacturer
Special Product’s Line S.p.A.
Strada Paduni, 240
03012 Anagni (FR)
Italy