Pressac

PACKAGE LEAFLET

INFORMATION FOR THE USER
Pressac 5 mg tablets
Pressac 10 mg tablets
(amlodipine)
Read this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Never give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

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

1. WHAT PRESSAC IS AND WHAT IT IS USED FOR
Pressac contains the active substance amlodipine, which belongs to a group of medicines called calcium antagonists.
Pressac is used to treat high blood pressure (hypertension) or a type of chest pain known as angina, including a rare form called Prinzmetal's or variant angina.
In patients with high blood pressure, this medicine works by relaxing blood vessels so that blood can flow more easily. In patients with angina, Pressac improves blood supply to the heart muscle, delivering more oxygen and thereby preventing chest pain. The medicine does not provide immediate relief from angina-related chest pain.

2. BEFORE YOU TAKE PRESSAC
Do not take Pressac

• If you are allergic (hypersensitive) to amlodipine, to any of the excipients (see section 6), or to any of the calcium antagonists. The reaction may include itching, skin redness, or difficulty breathing.
• If you have severe low blood pressure (hypotension)
• If you have narrowing of the heart's aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body)
• If you suffer from heart failure following a heart attack

Take special care with Pressac:
Inform your doctor if you have or have had any of the following conditions:

• Recent heart attack
• Heart failure
• Severe high blood pressure (hypertensive crisis)
• Liver disease (hepatopathy)
• You are elderly and your dosage needs to be increased

Use in children and adolescents
Pressac has not been studied in children under 6 years of age. Pressac should only be used for hypertension in children and adolescents aged 6 to 17 years (see section 3).
For further information, consult your doctor.

Taking Pressac with other medicines:
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicine, including those not requiring a prescription.
Pressac may affect other medicines or other medicines may affect Pressac, such as:

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used in the treatment of HIV)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum (St. John's wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (infusion for severe disturbances in body temperature)
• simvastatin (a medicine used to reduce cholesterol)

Pressac may lower blood pressure even more if you are already taking other medicines for the treatment of hypertension.
Inform your doctor or pharmacist if you have recently taken any other medicine, even those without a prescription.

Taking Pressac with food and drink
People taking Pressac must not drink grapefruit juice, as grapefruit and its juice may increase the levels of the active substance amlodipine in the blood, which could enhance the blood pressure-lowering effect of Pressac.

Pregnancy
The safety of amlodipine in pregnant women has not been established. If you think you may be pregnant or are planning a pregnancy, inform your doctor before taking Pressac.

Breast-feeding
It has been shown that amlodipine passes into breast milk in small amounts. If you are breast-feeding or about to start breast-feeding, you must inform your doctor before taking Pressac.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Pressac may affect your ability to drive or operate machinery. If the tablets cause you to feel unwell, dizzy, tired, or give you headaches, avoid driving or operating machinery and contact your doctor immediately.

3. HOW TO TAKE PRESSAC

Always take this medicine exactly as your doctor has instructed you. If you are unsure,
consult your doctor or pharmacist.
The usual starting dose is Pressac 5 mg once daily. The dose may be increased to Pressac 10 mg once daily.
The medicine can be taken before or after food and drink. Take the medicine every day at the same time with a glass of water. Do not take Pressac with grapefruit juice.

Use in children and adolescents
For children and adolescents (aged 6 to 17 years), the usual starting dose is 2.5 mg daily. The maximum recommended daily dose is 5 mg. Amlodipine 2.5 mg is not currently available, and the 2.5 mg dose cannot be achieved with Pressac 5 mg tablets, as these tablets are not designed to be split into equal halves.

Continue taking the tablets for as long as your doctor tells you. See your doctor before stopping the treatment.

If you take more Pressac than you should
If you take too many tablets, your blood pressure may drop too much, which could be dangerous. You may experience dizziness, vertigo, weakness, or fainting. The drop in blood pressure could be so severe as to cause shock. Your skin may become cold and clammy, and you may lose consciousness. If you have taken too many Pressac tablets, contact your doctor immediately.

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

If you stop taking Pressac
You must continue taking the medicine for as long as your doctor prescribes it. Stopping treatment may cause your condition to worsen.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Pressac can cause adverse reactions, although not everyone experiences them.

If you notice any of the following very rare and serious adverse reactions, consult your doctor immediately:

• Sudden onset of shortness of breath, chest pain, breathlessness, or difficulty breathing
• Swelling of the eyelids, face, or lips
• Swelling of the tongue and throat that may cause difficulty breathing
• Severe skin reactions, including intense skin rash, urticaria, widespread redness of the skin, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
• Myocardial infarction, arrhythmia
• Inflammation of the pancreas that may cause severe abdominal and back pain associated with a strong feeling of malaise

The following common adverse reactions have been reported. If any of these occur or persist for more than one week, consult your doctor.
Common: may occur in 1 to 10 out of 100 patients:

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of heartbeat), flushing
• Abdominal pain, nausea
• Swelling of the ankles (edema), fatigue

In addition, the following adverse reactions have been reported.
If any of these adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.
Uncommon: may occur in 1 to 10 out of 1,000 patients:

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting, weakness
• Numbness or tingling sensation in the limbs; loss of pain sensation
• Visual disturbances, double vision, ringing in the ears (tinnitus)
• Low blood pressure
• Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
• Changes in bowel habits, diarrhoea, constipation, indigestion, dry mouth, vomiting
• Hair loss, increased sweating, skin itching, red patches on the skin, skin discoloration
• Urinary disorders, need to urinate at night, frequent need to urinate
• Inability to achieve an erection; discomfort or breast enlargement in men
• Weakness, pain, malaise
• Joint or muscle pain, muscle cramps, back pain
• Weight gain or weight loss

Rare: may occur in 1 to 10 out of 10,000 patients:

• Confusion

Very rare: may occur in less than 1 out of 10,000 patients:

• Low levels of white blood cells and platelets in the blood, which may lead to unusual bruising or tendency to bleed (damage to red blood cells)
• High blood sugar levels (hyperglycaemia)
• A nerve disorder that may cause weakness, tingling, or numbness
• Cough, swollen gums
• Abdominal swelling (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may lead to changes in certain laboratory tests
• Increased muscle tension
• Inflammation of blood vessels, often associated with skin rash
• Light sensitivity
• Disorders related to stiffness, tremor, and/or movement disorders

Like all medicines, Pressac (amlodipine) may have adverse reactions, although not everyone experiences them.
Following the instructions contained in this leaflet reduces the risk of adverse reactions.
“Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. Adverse reactions can also be reported directly via the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
. Reporting adverse reactions helps provide more information on the safety of this medicine.”

5. HOW TO STORE PRESSAC

T
Do not use this medicinal product after the expiry date stated on the carton after 'EXP'. The
expiry date refers to the last day of the month.
. Store below 25°C.
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 Pressac contains
One 5 mg tablet contains: amlodipine maleate 6.42 mg (equivalent to amlodipine base 5 mg).
Excipients: microcrystalline cellulose, povidone, colloidal silicon dioxide, sodium stearyl fumarate.
One 10 mg tablet contains: amlodipine maleate 12.84 mg (equivalent to amlodipine base 10 mg).
Excipients: microcrystalline cellulose, povidone, colloidal silicon dioxide, sodium stearyl fumarate.

PHARMACEUTICAL FORM AND CONTENT
Tablets
Blister pack containing 28 tablets of 5 mg
Blister pack containing 14 or 28 tablets of 10 mg

MARKETING AUTHORISATION HOLDER
Farmaceutici Damor S.p.A., Via E. Scaglione, 27 – 80145 Naples, Italy

MANUFACTURER
FINE FOODS & PHARMACEUTICALS N.T.N. S.p.A.
Via R. Follereau, 25 – 24027 Nembro (BG), Italy

REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY (AIFA)
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