PRESSAC 5 mg Tablet

Зміст інструкції

1. Pressac 5 mg tablets, 10 mg tablets
   1. HOW TO TAKE PRESSAC
   2. POSSIBLE SIDE EFFECTS
   3. HOW TO STORE PRESSAC
   4. FURTHER INFORMATION

INFORMATION FOR THE USER

Pressac 5 mg tablets, 10 mg tablets

(amlodipine)
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 only for you. Never give it to others, even if their
symptoms are the same as yours, because it could be dangerous.
If you experience any side effects, including those not listed in this
leaflet, tell your doctor or pharmacist.
Contents of this leaflet:

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

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

2 BEFORE TAKING PRESSAC
Do not take Pressac

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

Take special care with Pressac:
Tell your doctor if you have or have suffered from the following conditions:

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

Use in children and adolescents
Pressac has not been studied in children under the age of 6 years. 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

medicines, including those without a prescription.
Pressac can have effects on other medicines or other medicines can have effects on Pressac
such as:

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

Pressac can lower blood pressure even more if you are already taking
other medicines to treat high blood pressure at the same time
Inform your doctor or pharmacist if you have recently taken any other medicines, even
those without a prescription.

Taking Pressac with food and drink
People taking Pressac should not drink grapefruit juice as grapefruit and
its juice can increase the levels of the active ingredient amlodipine in the blood, and
this may increase the hypotensive effect of Pressac.
Pregnancy

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

Amlodipine has been shown to passinto breast milk in small amounts. If you are
breastfeeding or are about to start breastfeeding, you should tell your doctor before taking Pressac
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Pressac may have an effect on your ability to drive or operate machinery. If the tablets make
you feel unwell, dizzy or tired, or give you a headache, 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. If you have any doubts

consult your doctor or pharmacist.
The usual starting dose is Pressac 5 mg once a day. The dose may be increased
to Pressac 10 mg once a day.
The medicine can be taken before or after food and beverages. You must take the medicine every
day at the same time with a little 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 per
day. The recommended maximum daily dose is 5 mg per day. Amlodipine 2.5 mg is not
currently available and a 2.5 mg dosage cannot be obtained with Pressac 5 mg tablets as these tablets are not produced to be divided into two equal parts
Continue to take the tablets for as long as your doctor has indicated. See your doctor
before stopping the tablets.

If you take more Pressac than you should
If you were to take an excessive number of tablets, your blood pressure could drop
too low and this could be dangerous. You may experience dizziness, lightheadedness, weakness or
fainting. The drop in blood pressure could be so severe as to cause you shock. Your skin may
become cold and clammy and you may lose consciousness. If you have taken an
excessive number of 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 to take the medicine for as long as your doctor tells you to. Stopping
treatment may cause your condition to worsen.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Pressac can cause side effects, although not everybody gets them.

If you notice any of the following very rare and serious side effects, consult

immediatelyyour doctor:

• Sudden onset of shortness of breath, chest pain, wheezing or difficulty breathing
• Swelling of the eyelids, face or lips
• Swelling of the tongue and throat which can cause difficulty breathing
• Severe skin reactions, including intense skin rash, hives, redness of the skin all over the body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Myocardial infarction, arrhythmia
• Inflammation of the pancreas which can cause severe abdominal and back pain accompanied by a feeling of severe malaise. The following common side effectshave been reported. If any of these occur or persist for more than one week, see your doctor.Common:may affect up to 1 in 10 people:
• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (feeling your heartbeat), flushing
• Abdominal pain, nausea
• Swelling of the ankles (edema), fatigue

In addition, the following side effects have been reported.
If any of these side effects worsen, or if you notice any other effect

Uncommon:may affect up to 1 in 1,000 people:

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

Rare:may affect up to 1 in 10,000 people:

• Confusion

Very rare:may affect less than 1 in 10,000 people:

• Low levels of white blood cells and platelets in the blood which can lead to unusual bruising or a tendency to bleed (damage to red blood cells)
• High blood sugar levels (hyperglycemia)
• A nervous disorder that can cause weakness, tingling or numbness
• Cough, gum swelling
• Abdominal bloating (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which can lead to changes in some clinical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin rash
• Sensitivity to light
• Disorders related to stiffness, tremor and/or movement disorders

Like all medicines Pressac (amlodipine) can have side effects, although not everyone gets them.

“Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this

leaflet. You can also report side effects directly through the national reporting system at

www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

. Reporting side effects helps to provide more information on the safety of this medicine.”

5. HOW TO STORE PRESSAC

T
Do not use this medicine after the expiry date which is stated on the pack after ‘EXP’. The
expiry date refers to the last day of the month.
. Store at a temperature not exceeding 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. FURTHER INFORMATION

What contains Pressac
A 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.
A 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 containing 28 tablets of 5 mg
Blister containing 14 or 28 tablets of 10 mg

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

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

REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY
This leaflet was updated…on