PACKAGE LEAFLET: INFORMATION FOR THE USER

Amlodipine pensa 10 mg tablets

Equivalent medicine
The active substance is amlodipine besilate.
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 could 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. See section 4.

Contents of this leaflet:

What Amlodipine pensa is and what it is used for
Before taking Amlodipine pensa
How to take Amlodipine pensa
Possible side effects
How to store Amlodipine pensa
Contents of the pack and other information

1. WHAT AMLODIPINA PENSA 10 mg TABLETS IS AND WHAT IT IS USED FOR

Amlodipina pensa is used for the treatment of:

High blood pressure
Chest pain due to narrowing of the coronary arteries of the heart muscle (angina pectoris), or the less common form of chest pain caused by spasm of the coronary arteries of the heart muscle (vasospastic angina). If you have high blood pressure, amlodipine works by relaxing the blood vessels, allowing blood to flow more easily through them. If you have angina, amlodipine works by increasing blood supply to the heart muscle, thereby delivering more oxygen and preventing chest pain. Amlodipine does not provide immediate relief of chest pain caused by angina.

2. BEFORE TAKING AMLODIPINE PENSA 10 mg TABLETS

Do not take Amlodipina Pensa

If you are allergic to amlodipine or to similar calcium channel blockers (so-called dihydropyridine derivatives) or to any of the excipients (for a complete list of excipients, see section 6),
If you have very low blood pressure,
If you suffer from inadequate blood supply to tissues with symptoms such as low blood pressure, slow pulse, or rapid heartbeat (shock, including cardiogenic shock). Cardiogenic shock is shock due to severe heart problems,
If you suffer from chest pain related to the heart, even at rest or with minimal exertion (unstable angina pectoris),
If you have narrowing of the aorta (aortic stenosis),
If you have heart failure following acute myocardial infarction.

Warnings and precautions
Exercise special caution with Amlodipina Pensa

If you have liver disease,
If you suffer from diabetes mellitus,
If you have an artificial kidney (dialysis),
If you have kidney disease,
If you have congestive heart failure,
If you are pregnant or think you might be pregnant (see details below),
If you are breastfeeding (see details below),
If you have recently suffered a heart attack,
If you have had or currently suffer from severe high blood pressure (hypertensive crisis),
If you are elderly and your dose needs to be increased.

If you have any of the conditions listed above, inform your doctor before taking
Amlodipina Pensa.
Taking Amlodipina Pensa with other medicines
Inform your doctor if you are taking or have recently taken any of the following medicines,
as they may interact with Amlodipina Pensa:

Medicines called antifungal agents (such as ketoconazole or itraconazole), used to treat infections caused by fungi or yeasts, such as thrush or ringworm,
Medicines used to treat viral infections (antiviral agents), such as ritonavir used in the treatment of HIV infections,
Rifampicin, erythromycin, clarithromycin (antibiotics),
Herbal medicines used to treat depression, such as St. John’s wort,
Other medicines for treating high blood pressure, such as ACE inhibitors like enalapril or captopril, alpha-1 blockers like doxazosin or tamsulosin, beta-blockers like bisoprolol or sotalol, diuretics (mild diuretics) like furosemide or amiloride, and calcium antagonists like verapamil or diltiazem,
Dantrolene (infusion for severe body temperature abnormalities),
Statins such as simvastatin (medicines that reduce blood fat levels),
Tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the way the immune system works),
Cyclosporine (an immunosuppressant).

Amlodipina Pensa may still be suitable for you, but your doctor will be able to
decide what is appropriate for your condition.
Inform your doctor or pharmacist if you are taking or have recently taken
any other medicines, including those without a prescription.
Taking Amlodipina Pensa with food and drinks
No special precautions are required. Amlodipina Pensa can be taken before,
after, or during meals with a glass of water.
The intake of amlodipine with grapefruit or grapefruit juice is
not recommended, as in some patients it may increase blood levels of amlodipine
and consequently lead to an unpredictable increase in the antihypertensive effect of amlodipine.
Children and adolescents
Safety and efficacy have been studied in children and adolescents aged 6–17 years.
Amlodipina Pensa has not been studied in children under 6 years of age. For further
information, consult your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
There are insufficient adequate data on the use of amlodipine in pregnant women. Do not use
Amlodipina Pensa if you are pregnant or think you might become pregnant unless your doctor
decides it is absolutely necessary. Your doctor will provide further information on how this
decision was made. Use an effective contraceptive method while taking Amlodipina Pensa.
Breastfeeding
Do not breastfeed while taking Amlodipina Pensa. It has been shown that amlodipine passes
into breast milk in small amounts.
Fertility
In patients treated with calcium channel blockers, reversible biochemical changes in sperm
head have been reported. There are insufficient clinical data on the potential effect of
amlodipine on fertility. In a rat study, adverse effects on male fertility were observed.
Driving and use of machines
In patients experiencing dizziness, vertigo, headache, fatigue, or nausea, reaction ability may be
slightly to moderately impaired. Amlodipina Pensa has a minor to moderate influence on the ability to drive vehicles or operate machinery. Caution is advised, especially at the beginning of treatment.
Amlodipina Pensa contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially ‘sodium-free’.

3. HOW TO TAKE AMLODIPINE PENSA

Always take Amlodipine Pensa exactly as directed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Amlodipine Pensa should be swallowed whole with water, before, after, or during meals.
Unless otherwise recommended by your doctor, the usual starting dose is 5 mg
of amlodipine (1/2 tablet) once daily, with a maximum dose of 10 mg (1
tablet) once daily.
Amlodipine Pensa 10 mg tablets may be divided into two equal halves. It is recommended
to use a tablet-splitting device.
Your doctor will inform you how long the treatment will last.
If you take more Amlodipine Pensa than you should
If you have accidentally taken more than your prescribed dose, contact
your doctor or pharmacist immediately. Remember to bring the package and
any remaining tablets with you.
If too many tablets are taken, your blood pressure may become low or even dangerously low.
You may experience dizziness, lightheadedness, feel weak or fatigued. If the drop in blood pressure is severe, shock may occur.
You may feel cool, clammy skin and could lose consciousness. Seek immediate medical attention if you have taken too many Amlodipine Pensa tablets.
If you forget to take Amlodipine Pensa
Do not take a double dose or an extra dose to make up for the missed dose.
Take the next tablet at your usual scheduled time.
If you stop taking Amlodipine Pensa
Do not stop taking Amlodipine Pensa on your own. If you need to discontinue treatment with
Amlodipine Pensa, ask your doctor for an alternative therapy.
If you have kidney disease
The standard dosage is recommended. Amlodipine cannot be removed from the blood
by dialysis (artificial kidney). Amlodipine should be administered with particular
caution in patients undergoing dialysis.
If you have heart failure
Patients with heart failure should be treated with caution. Calcium channel blockers, including amlodipine, should be used cautiously in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality.
If you have liver impairment
Plasma concentrations of amlodipine are higher in patients with impaired liver function; dosage recommendations have not been established.
Treatment with amlodipine should therefore be initiated with the lowest available dose, and caution should be exercised both at the start of treatment and when increasing the dose.
Slow dose titration and careful monitoring may be required in patients with severe hepatic impairment.
Elderly patients
No special dosage adjustment is required for elderly patients; however, caution should be exercised when increasing the dose.
Use in children and adolescents
The recommended oral antihypertensive dose in children (aged 6 to 17 years) is 2.5 mg daily. The maximum recommended dose is 5 mg daily.
Amlodipine 2.5 mg is currently not available, and the 2.5 mg dose cannot be obtained from Amlodipine Pensa 5 mg tablets, as these tablets cannot be divided into two equal parts.
Children under 6 years of age
No data are available.
If you have any questions about the use of this product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Amlodipine pensa may cause adverse reactions, although not
everyone experiences them.
Contact your doctor immediately if any of the following very rare serious side effects occur
after taking this medicine.

Sudden shortness of breath, chest pain, difficulty breathing or breathlessness
Swelling of the eyelids, face or lips
Swelling of the tongue and throat causing severe breathing difficulties
Severe skin reactions including intense rash, urticaria, redness of the skin all over the body, severe itching, blisters, dryness and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
Heart attack, irregular heartbeat
Inflammation of the pancreas which may cause severe abdominal and back pain accompanied by feeling very unwell.

The most commonly reported side effects during treatment are drowsiness,
dizziness, headache, palpitations, flushing, abdominal pain, nausea, ankle swelling,
oedema and fatigue.
If these effects cause you problems or last for more than one week, you should
contact your doctor.
The following scale is used to classify adverse reactions:
Very common: more than 1 in 10 patients
Common: less than 1 in 10 patients, but not more than 1 in 100
Uncommon: less than 1 in 100 patients, but not more than 1 in 1000
Rare: less than 1 in 1000 patients, but not more than 1 in 10,000
Very rare: less than 1 in 10,000
Not known: frequency cannot be estimated from available data

Blood disorders:
Very rare: reduction in the number of white blood cells, which may cause unexplained fever, sore throat and flu-like symptoms (leucopenia), reduced number of platelets in the blood, which may cause bruising or nosebleeds (thrombocytopenia).

Immune system disorders:
Very rare: allergic reactions.

Metabolic disorders:
Very rare: increased blood sugar levels.

Psychiatric disorders:
Uncommon: sleep disturbances, depression, mood disorders including anxiety.
Rare: confusion.

Nervous system disorders:
Common: headache (especially at the beginning of treatment), dizziness, drowsiness.
Uncommon: uncontrollable trembling (tremor), tingling sensations (paraesthesia), altered taste, hypoesthesia, fainting, loss of sensitivity to pain.
Very rare: increased muscle tone or pain or numbness in hands and feet (peripheral neuropathy).

Eye disorders:
Common: vision problems (visual disturbances).

Ear disorders:
Uncommon: noises or ringing in the ears (tinnitus).

Cardiac disorders:
Common: rapid or irregular heartbeat (palpitations).
Uncommon: irregular heartbeat (including bradycardia, tachycardia, atrial fibrillation).
Very rare: heart attack (myocardial infarction).

Vascular disorders:
Common: flushing.
Uncommon: low blood pressure.
Very rare: inflammation of blood vessels.

Respiratory, thoracic and mediastinal disorders:
Common: breathing difficulties.
Uncommon: cough, inflammation of the nasal mucosa (rhinitis).

Gastrointestinal disorders:
Common: nausea, indigestion, stomach ache, diarrhoea, constipation.
Uncommon: vomiting, dry mouth.
Very rare: inflammation of the stomach lining (gastritis), inflammation of the pancreas (pancreatitis), swollen gums (gingival hyperplasia).

Hepatic disorders:
Very rare: altered liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may affect certain clinical tests.

Skin and subcutaneous tissue disorders:
Uncommon: increased sweating, skin prickling or tingling sensation (rash), itching, rash, hair loss (alopecia), skin discoloration, redness of the skin (purpura).
Very rare: allergic reaction with swelling of the skin of the face or extremities, swelling of the lips or tongue, swelling of the mucous membranes in the mouth and throat, resulting in shortness of breath and difficulty swallowing (angioedema). Seek immediate medical attention at an emergency department or contact a doctor in this case.
Allergic skin rashes with irregular red spots (erythema multiforme), photosensitivity, or severe allergic reactions with blistering of the skin and mucous membranes (exfoliative dermatitis, Stevens-Johnson syndrome).
Not known: severe skin reactions including intense skin rashes, urticaria, redness of the skin all over the body, severe itching, blistering, desquamation and swelling of the skin, inflammation of mucous membranes (toxic epidermal necrolysis).

Musculoskeletal and connective tissue disorders:
Common: ankle swelling, muscle cramps.
Uncommon: back pain, muscle and joint pain.

Renal and urinary disorders:
Uncommon: urinary disorders, increased need to urinate at night, increased urinary frequency.

Reproductive system and breast disorders:
Uncommon: inability to achieve an erection, breast enlargement in men.

General disorders:
Very common: oedema
Common: fatigue, asthenia
Uncommon: chest pain, tenderness, malaise.

Investigations:
Uncommon: weight gain or weight loss.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, inform your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE AMLODIPINE PENSA

Keep this medicine out of the sight and reach of children.
Do not use Amlodipine Pensa after the expiry date stated on the blister pack and carton.
The expiry date refers to the last day of the month.
Do not use Amlodipine Pensa if you notice any significant change in the colour or
appearance of the tablets.
Store the medicine in its original packaging.
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. PACK CONTENTS AND OTHER INFORMATION

What Amlodipine Pensa 10 mg tablets contain
The active substance is amlodipine besylate.
Each tablet contains 13.868 mg of amlodipine besylate, equivalent to 10 mg
of amlodipine.
The other components are microcrystalline cellulose, anhydrous dibasic calcium phosphate,
sodium carboxymethyl starch (type A) and magnesium stearate.

Description of the appearance of Amlodipine Pensa 10 mg tablets and pack contents
Amlodipine Pensa 10 mg tablets are white to off-white, round, biconvex tablets with a break line on one side and the number "10" embossed on the other side.
Amlodipine Pensa 10 mg tablets are available in packs of 14, 20, 30, 50 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
I-20124 Milan, Italy

Manufacturers:
Eczacibasi-Zentiva Saglik Urunleri Ve Ticaret A.S.,
Kücükkaristiran Mevkii, 39780 Lüleburgaz
Kirklareli, Turkey
Siegfried Generics (Malta) Ltd.
HHF070 Hal Far Industrial Estate
Hal Far BBG 3000
Malta

Batch release:
Siegfried Generics (Malta) Ltd.
HHF070 Hal Far Industrial Estate
Hal Far BBG 3000
Malta

This medicinal product is authorized in the Member States of the European Economic Area
under the following names:
Italy: Amlodipine Pensa

This leaflet was last approved on

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amlodipine pensa 5 mg tablets

Generic medicine
The active substance is amlodipine besilate.
Please read this leaflet carefully before taking this medicine.

Keep this leaflet. You may need to read it again.
If you have any questions, consult 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 worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Amlodipine pensa is and what it is used for
Before taking Amlodipine pensa
How to take Amlodipine pensa
Possible side effects
How to store Amlodipine pensa
Contents of the pack and other information

1. WHAT AMLODIPINE PENSA IS AND WHAT IT IS USED FOR

Amlodipine Pensà is used for the treatment of:

high blood pressure
chest pain due to narrowing of the coronary arteries of the heart muscle (angina pectoris), or the less common form of chest pain caused by spasm of the coronary arteries of the heart muscle (vasospastic angina). If you have high blood pressure, amlodipine works by relaxing blood vessels so that blood can flow more easily through them. If you have angina, amlodipine works by increasing blood supply to the heart muscle, thereby delivering more oxygen to the heart and preventing chest pain. Amlodipine does not provide immediate relief of chest pain caused by angina.

2. BEFORE TAKING AMLODIPINE PENSA

Do not take Amlodipina pensa

if you are allergic to amlodipine or to similar calcium channel blockers (the so-called dihydropyridine derivatives) or to any of the excipients (for a complete list of excipients, see section 6),
if you have very low blood pressure,
if you suffer from inadequate blood supply to tissues with symptoms such as low blood pressure, slow pulse, rapid heartbeat (shock, including cardiogenic shock). Cardiogenic shock is shock due to severe heart problems.
if you suffer from chest pain related to the heart even at rest or with minimal exertion (unstable angina pectoris),
if you have narrowing of the aorta (aortic stenosis),
if you have heart failure following acute myocardial infarction.

Warnings and precautions
Exercise special caution with Amlodipina pensa

if you have liver disease,
if you suffer from diabetes mellitus,
if you have an artificial kidney,
if you have kidney disease,
if you have congestive heart failure,
if you are pregnant or think you might be (see details below),
if you are breastfeeding (see details below),
if you have recently suffered a heart attack,
if you have or have suffered from a severe increase in arterial pressure (hypertensive crisis),
if you are elderly and your dose needs to be increased.

If you have any of the conditions listed above, inform your doctor before taking
Amlodipina pensa.
Taking Amlodipina pensa with other medicines
Inform your doctor if you are taking or have taken any of the following medicines,
as they may interact with Amlodipina pensa:

Medicines called antifungal agents (such as ketoconazole or itraconazole), used to treat fungal or yeast infections such as thrush or ringworm.
Medicines used to treat viral infections (antiviral agents), such as ritonavir used in the treatment of HIV infections.
Rifampicin, erythromycin, clarithromycin (antibiotics)
Herbal medicines used to treat depression such as St. John's wort.
Other medicines for the treatment of high blood pressure such as ACE inhibitors like enalapril or captopril, alpha-1 blockers like doxazosin or tamsulosin, beta-blockers like bisoprolol or sotalol, diuretics like furosemide or amiloride, and calcium antagonists like verapamil or diltiazem.
Dantrolene (infusion for severe body temperature abnormalities).
Statins such as simvastatin (medicines that reduce fat levels in the blood)
Tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to modify the way the immune system works).
Cyclosporine (an immunosuppressant).

Amlodipina pensa might still be suitable for you, but your doctor will decide
what is appropriate for you.
Inform your doctor or pharmacist if you are taking or have recently taken
any other medicine, even those without a prescription.
Taking Amlodipina pensa with food and drinks
No special precautions are required. Amlodipina pensa can be taken before,
after or during meals with a glass of water.
The administration of amlodipine with grapefruit or grapefruit juice is
not recommended, as in some patients blood levels of amlodipine may
increase, leading consequently to an unpredictable increase in the
antihypertensive effect of amlodipine.
Children and adolescents
Safety and efficacy have been studied in children and adolescents aged 6–17 years.
Amlodipina pensa has not been studied in children under 6 years of age. For further
information, consult your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
There is inadequate information on the use of amlodipine in pregnant women. Do not use
Amlodipina pensa if you are pregnant or think you may become pregnant unless your doctor
decides it is absolutely necessary. Your doctor will provide you with further information on
how this decision was made. Use an effective contraceptive method while taking
Amlodipina pensa.
Breastfeeding
Do not breastfeed while using Amlodipina pensa. It has been shown that amlodipine passes
into breast milk in small amounts.
Fertility
In patients treated with calcium channel blockers, reversible biochemical changes in sperm
heads have been reported. There are insufficient clinical data on the potential effect of
amlodipine on fertility. In a rat study, adverse effects on male fertility were observed.
Driving and using machines
In patients experiencing dizziness, vertigo, headache, fatigue or nausea, reaction ability may
be impaired. Amlodipina pensa 5 mg tablets may slightly or moderately affect the ability to
drive or use machinery.
Caution is recommended, especially at the beginning of treatment.
Amlodipina pensa contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially ‘sodium-free’.

3. HOW TO TAKE AMLODIPINE PENSA

Always take Amlodipine Pensa exactly as directed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Amlodipine Pensa should be swallowed whole with water, either before, after, or during meals.
Unless otherwise recommended by your doctor, the usual starting dose is 5 mg
of amlodipine (1 tablet) once daily, with a maximum dose of 10 mg (2
tablets) once daily.
Your doctor will advise you on how long the treatment should last.
If you take more Amlodipine Pensa than you should
If you have accidentally taken more than your prescribed dose, contact your doctor or
pharmacist immediately. Remember to bring the packaging and any remaining tablets
with you.
If too many tablets are taken, your blood pressure may become low or even dangerously low.
You may experience dizziness, lightheadedness, feel weak or fatigued. If the drop in blood pressure is severe, shock may occur. You may notice cool and moist skin and could lose consciousness. Seek immediate medical attention if you have taken too many Amlodipine Pensa tablets.
If you forget to take Amlodipine Pensa
Do not take a double dose or an extra dose to make up for the missed one.
Take the next tablet at your usual scheduled time.
If you stop taking Amlodipine Pensa
Do not stop taking Amlodipine Pensa on your own. If you need to discontinue treatment with
Amlodipine Pensa, consult your doctor for an alternative therapy.
If you have kidney disease
The standard dosage is recommended. Amlodipine cannot be removed from the blood
by dialysis (artificial kidney). Amlodipine should be administered with particular
caution in patients undergoing dialysis.
If you have heart failure
Patients with heart failure should be treated with caution. Calcium channel blockers, including amlodipine, should be used cautiously in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality.
If you have liver impairment
Plasma concentrations of amlodipine are higher in patients with impaired liver function; dosage recommendations have not been established.
Therefore, treatment with amlodipine should be initiated at the lowest dose, and caution should be exercised both when starting treatment and when increasing the dose.
Slow dose titration and careful monitoring may be required in patients with severe hepatic impairment.
Elderly patients
No special dosage adjustment is required for elderly patients; however, caution should be exercised when increasing the dose.
Use in children and adolescents
The recommended initial oral dose in children (aged 6 to 17 years) is 2.5 mg daily. The maximum recommended dose is 5 mg daily.
Amlodipine 2.5 mg is currently not available, and the 2.5 mg dose cannot be obtained from Amlodipine Pensa 5 mg tablets, as these tablets cannot be divided into equal halves.
Children under 6 years of age
No data are available.
If you have any questions about the use of this product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, Amlodipine pensa 5 mg tablets can cause adverse effects,
although not everyone experiences them.
Contact your doctor immediately if you experience any of the following serious, very rare side effects after taking this medicine.

Sudden shortness of breath, chest pain, difficulty breathing, or trouble breathing
Swelling of the eyelids, face, or lips
Swelling of the tongue and throat causing severe breathing difficulties
Severe skin reactions including intense rash, hives, redness of the skin all over the body, severe itching, blisters, dryness and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
Heart attack, irregular heartbeat
Inflammation of the pancreas that may cause severe abdominal and back pain accompanied by feeling very unwell

The most commonly reported side effects during treatment are drowsiness,
dizziness, headache, palpitations, flushing, abdominal pain, nausea, swelling of the ankles,
edema, and fatigue.
If these effects cause you problems or if they last for more than one week, you should
contact your doctor.
The following scale will be used to classify adverse effects:
Very common: more than 1 in 10 patients
Common: less than 1 in 10 patients, but not more than 1 in 100
Uncommon: less than 1 in 100 patients, but not more than 1 in 1,000
Rare: less than 1 in 1,000 patients, but not more than 1 in 10,000
Very rare: less than 1 in 10,000 patients
Not known: frequency cannot be estimated from the available data

Blood disorders:
Very rare: reduced number of white blood cells, which may cause unexplained fever, sore throat, and flu-like symptoms (leucopenia); reduced number of platelets in the blood, which may cause bruising or nosebleeds (thrombocytopenia).

Immune system disorders:
Very rare: allergic reactions.

Metabolic disorders:
Very rare: increased blood sugar levels.

Psychiatric disorders:
Uncommon: sleep disturbances, depression, mood disorders including anxiety.
Rare: confusion.

Nervous system disorders:
Common: headache (especially at the beginning of treatment), dizziness, drowsiness.
Uncommon: uncontrollable shaking (tremor), tingling sensations (paresthesia), altered taste, hypoesthesia, fainting, loss of pain sensation.
Very rare: increased muscle tone or pain or numbness in hands and feet (peripheral neuropathy).

Eye disorders:
Common: vision problems (visual disturbances).

Ear disorders:
Uncommon: noises or ringing in the ears (tinnitus).

Cardiac disorders:
Common: fast or irregular heartbeat (palpitations).
Uncommon: irregular heartbeat (including bradycardia, tachycardia, atrial fibrillation).
Very rare: heart attack (myocardial infarction).

Vascular disorders:
Common: flushing.
Uncommon: low blood pressure.
Very rare: inflammation of blood vessels.

Respiratory, thoracic and mediastinal disorders:
Common: difficulty breathing.
Uncommon: cough, inflammation of the nasal mucosa (rhinitis).

Gastrointestinal disorders:
Common: nausea, indigestion, stomach ache, diarrhea, constipation.
Uncommon: vomiting, dry mouth.
Very rare: inflammation of the stomach lining (gastritis), inflammation of the pancreas (pancreatitis), swollen gums (gingival hyperplasia).

Hepatic disorders:
Very rare: changes in liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may affect certain clinical tests.

Skin and subcutaneous tissue disorders:
Uncommon: increased sweating, skin itching and tingling (rash), pruritus, skin rash, hair loss (alopecia), skin discoloration, redness of the skin (purpura).
Very rare: allergic reaction with swelling of the skin of the face or extremities, swelling of the lips or tongue, swelling of the mucous membranes in the mouth and throat, resulting in shortness of breath and difficulty swallowing (angioedema). In this case, contact emergency services or a doctor immediately.
Allergic skin rashes with irregular red spots (erythema multiforme), photosensitivity, or severe allergic reactions with blistering of the skin and mucous membranes (exfoliative dermatitis, Stevens-Johnson syndrome).
Not known: severe skin reactions including intense skin eruptions, hives, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, inflammation of mucous membranes (toxic epidermal necrolysis).

Musculoskeletal and connective tissue disorders:
Common: swelling of the ankles, muscle cramps.
Uncommon: back pain, muscle and joint pain.

Renal disorders:
Uncommon: urinary disorders, increased need to urinate at night, increased urinary frequency.

Reproductive system and breast disorders:
Uncommon: inability to achieve an erection, breast enlargement in men.

General disorders:
Very common: edema.
Common: fatigue, asthenia.
Uncommon: chest pain, tenderness, malaise.

Investigations:
Uncommon: weight gain or weight loss.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE AMLODIPINE PENSA

Keep this medicine out of the sight and reach of children.
Do not use Amlodipine Pensa after the expiry date stated on the blister and carton.
The expiry date refers to the last day of the month.
Do not use Amlodipine Pensa if you notice any significant changes in the colour or
appearance of the tablets.
Store the medicine in its original packaging.
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. PACK CONTENTS AND OTHER INFORMATION

What Amlodipine pensa 5 mg tablets contain
The active substance is amlodipine besilate.
Each tablet contains 6.934 mg of amlodipine besilate, equivalent to 5 mg
of amlodipine.
The other components are microcrystalline cellulose, anhydrous dibasic calcium phosphate,
sodium carboxymethylstarch (type A), and magnesium stearate.

Description of the appearance of Amlodipine pensa 5 mg tablets and pack contents
Amlodipine pensa 5 mg tablets are white to off-white, round, biconvex tablets, embossed with "5" on one side.
Amlodipine pensa 5 mg tablets are available in packs containing:
20 tablets
28 tablets
50 tablets
100 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
I-20124 Milan, Italy

Batch release:
Siegfried Generics (Malta) Ltd.
HHF070 Hal Far Industrial Estate
Hal Far BBG 3000
Malta

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Amlodipina pensa

This leaflet was last approved on