Lanex

Package leaflet: Information for the user

LANEX 5 mg tablets, 20 mg tablets

enalapril maleate
Equivalent Medicine
Please read all of 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 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, 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 taking 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 LANEX is and what it is used for

LANEX contains an active substance called enalapril maleate. This active substance belongs to a group of medicines known as 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 heart function);
• to prevent the onset 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 may require several weeks of treatment before the full effect on blood pressure becomes apparent.

2. What you need to know before taking LANEX

Do not take LANEX

• if you are allergic to enalapril maleate or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously had an allergic reaction to a medicine of the same type as this medicine, called an ACE inhibitor;
• if 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;
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren;
• if you are more than 3 months pregnant (see section “Pregnancy and breastfeeding”). Do not take this medicine if you have any of the above conditions. If you are unsure, speak with 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 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 LANEX 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 potassium-containing salt substitutes;
• if you are elderly;
• 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 of 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;
• 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 check your kidney function, blood pressure, and blood levels of electrolytes (such as potassium) at regular intervals.
See also the section “Do not take LANEX”.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). This medicine 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 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
Available information on the use of LANEX in children is limited.
If your child is able to swallow tablets, your doctor will determine the appropriate dose for them.
Give LANEX to your child once daily, as directed by your doctor.
LANEX is not recommended for children for conditions other than hypertension.
LANEX is not recommended in neonates and pediatric patients with kidney problems (glomerular filtration rate less than 30 ml/min/1.73 m²).

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 may interfere with the action of certain medicines. Some other medicines may also interfere with the action of LANEX.
In particular, inform 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;
• potassium-containing medicines (potassium-sparing diuretics, potassium supplements, or potassium-containing dietary salt substitutes);
• medicines for diabetes (including oral antidiabetics and insulin);
• lithium (a medicine used to treat a certain type of depression);
• antidepressant medicines called "tricyclic antidepressants";
• medicines for mental disorders called "antipsychotics";
• anaesthetic medicines;
• sympathomimetics;
• gold salt therapy;
• non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (medicines that reduce inflammation and may be used to help relieve pain);
• aspirin (acetylsalicylic acid). 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 LANEX” and “Warnings and precautions”).

LANEX and alcohol
Alcohol increases the blood pressure-lowering effect of ACE inhibitors.

If you are about to undergo a medical procedure
If you are about to undergo any of the following procedures, inform your doctor that you are taking LANEX:

• any type of surgery or anaesthesia (including from a 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 above conditions apply to you, talk to your doctor or dentist before the procedure.

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

Pregnancy and breastfeeding
If you are pregnant, think 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 know you are pregnant, and will recommend an alternative medicine to LANEX. This medicine is not recommended during early pregnancy (first 3 months), 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.

Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Breastfeeding is not recommended for newborns (first weeks after birth), especially premature infants, while taking this medicine. For older infants, your doctor will inform you about the risks and benefits of taking this medicine during breastfeeding compared to other treatments.

Driving and using machines
While taking this medicine, dizziness or drowsiness may occur occasionally. If this happens, do not drive or operate tools or machinery.

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

If you are unsure whether any of the above conditions apply to you, talk to your doctor or pharmacist before taking LANEX.

3. How to take LANEX

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
It is very important to continue taking this medicine for as long as prescribed by your doctor.
Do not take more tablets than prescribed.
The tablet may be divided into equal parts.

High blood pressure

• The usual recommended starting 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 recommended starting 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 how well your kidneys are functioning:

• moderate kidney problems - 5 to 10 mg daily
• severe kidney problems - 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.

Elderly patients
The dose will be decided by your doctor and will be based on the degree of your 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 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 equal to or greater than 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 equal to or greater than 50 kg. This medicine is not recommended in neonates (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. Take the medicine pack with you. The following effects may occur: feeling of light-headedness 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 your next dose as usual.
• Do not take a double dose to make up for the forgotten dose.

If you stop taking LANEX
Do not stop treatment with this medicine unless your doctor tells you to. If you have any doubts about using 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 a doctor immediately if you experience any of the following:

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

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

Other side effects include:

Very common (may affect more than 1 in 10 people)

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

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 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;
• skin tingling or numbness;
• dizziness;
• ringing in the ears (tinnitus);
• runny nose, sore throat and hoarseness;
• shortness of breath;
• slowed movement of food through the intestine (intestinal blockage), inflammation of the pancreas;
• vomiting, indigestion, constipation, loss of appetite;
• irritated stomach (gastric irritation), dry mouth, ulcer, renal dysfunction, kidney failure;
• increased sweating;
• itching or urticaria;
• hair loss;
• muscle cramps, hot flushes, general feeling of being unwell, high body temperature (fever), impotence;
• high levels of protein in the urine (detected by laboratory test);
• low blood sugar or sodium levels, high blood urea levels (all detected by blood tests).

Rare (may affect up to 1 in 1,000 people)

• "Raynaud's phenomenon", in which hands and feet may become very cold and white due to reduced blood flow;
• changes in blood test values such as reduced numbers of white blood cells (neutrophils) and red blood cells;
• reduced haemoglobin, reduced platelet count;
• reduced number of granulocytes (a type of white blood cell) circulating in the blood;
• reduced numbers of all blood cells (pancytopenia);
• bone marrow suppression;
• swollen lymph nodes;
• autoimmune diseases;
• altered dreams, sleep disorders;
• pulmonary infiltrates;
• inflammation of the nasal mucosa (rhinitis);
• allergic pneumonia;
• inflammation of cheeks, gums, tongue, lips, throat;
• decreased urine output;
• erythema multiforme;
• Stevens-Johnson syndrome, a serious skin condition characterized by redness and peeling of the skin, blistering or exposed ulcers, or separation of the outer layer of skin from deeper layers;
• skin redness, often with peeling (erythroderma);
• autoimmune blistering skin and mucosal disorders (pemphigus);
• skin peeling over large areas of the body (exfoliative dermatitis);
• toxic epidermal necrolysis;
• liver problems such as reduced liver function, liver inflammation (hepatitis), hepatitis including necrosis, cholestasis including jaundice (yellowing of the skin or eyes), increased liver enzymes or bilirubin (detected by blood tests);
• breast enlargement in men.

Very rare (may affect up to 1 in 10,000 people)

• intestinal swelling (intestinal angioedema).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor. 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 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 carton after the word
EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Pack contents and other information

What LANEX contains
The active substance is enalapril maleate.
LANEX 5 mg tablets
Each tablet contains: 5 mg of enalapril maleate.
The other components are: sodium bicarbonate; monohydrate lactose; maize starch; pregelatinized starch and
magnesium stearate.
LANEX 20 mg tablets
Each tablet contains: 20 mg of enalapril maleate.
The other components are: sodium bicarbonate; monohydrate lactose; maize starch; pregelatinized starch;
red iron oxide; yellow iron oxide and magnesium stearate.
Description of the appearance of LANEX and pack contents
LANEX is available as divisible tablets in the following pack sizes:
LANEX 5 mg in a cardboard box containing a blister with 28 tablets.
LANEX 20 mg in a cardboard box containing a blister with 14 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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