PERITRATE 80 mg Modified-Release Tablet

Зміст інструкції

1. PERITRATE 80 mg modified-release tablets
   1. What is PERITRATE and what is it used for
   2. What you need to know before you take PERITRATE
   3. How to take PERITRATE
   4. Possible side effects
   5. How to store PERITRATE
   6. Contents of the pack and other information

PERITRATE 80 mg modified-release tablets

Pentaerythritol tetranitrate

Read this leaflet carefully before you start to take 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 their symptoms are the same as yours, 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 PERITRATE is and what it is used for
• 2. What you need to know before you take PERITRATE
• 3. How to take PERITRATE
• 4. Possible side effects
• 5. How to store PERITRATE
• 6. Contents of the pack and other information

1. What is PERITRATE and what is it used for

This medicine contains the active ingredient pentaerythritol tetranitrate, which belongs to the group of
vasodilator medicines, used in the treatment of some heart diseases. This medicine works
by dilating blood vessels and reducing the heart's workload.
PERITRATE is indicated to prevent chest pain caused by problems with blood circulation to the heart (angina
pectoris).

2. What you need to know before you take PERITRATE

Do not take PERITRATE

• if you are allergic to pentaerythritol tetranitrate or any of the other ingredients of this medicine (listed in section 6);
• if you have very low blood pressure (hypotension);
• if you have a decrease in blood volume (hypovolemia);
• if you have an enlargement of the heart (obstructive hypertrophic cardiomyopathy);
• if you have a narrowing (stenosis) of the aortic or mitral valve;
• if you suffer from inflammation of the pericardium, the lining of the heart (constrictive pericarditis);
• if you have low levels of red blood cells in the blood (severe anemia);
• if you have high pressure inside the skull following a trauma or bleeding (hemorrhage) in the brain;
• if you suffer from an eye disorder, characterized by an increase in eye pressure (closed-angle glaucoma);
• if you are taking sildenafil, a medicine used to treat impotence in men (see section “Other medicines and PERITRATE”).

Warnings and precautions
Talk to your doctor or pharmacist before taking PERITRATE.
Use this medicine with caution and under the direct supervision of your doctor in the following cases:

• if you suffer from severe liver or kidney problems (severe hepatic or renal insufficiency);
• if you suffer from a thyroid problem (hypothyroidism);
• if you are malnourished or if you have a low body temperature (hypothermia);
• if you have recently had a heart attack (myocardial infarction).

This medicine may cause headache, in which case your doctor may decide to reduce the dose
during the first few days of treatment or to associate a medicine to reduce the pain.
The use of this medicine may cause a reduction in the effectiveness (tolerance) of pentaerythritol
tetranitrate itself or of similar medicines such as nitrites and nitrates (cross-resistance).

Other medicines and PERITRATE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Do not take PERITRATE together with sildenafil, a medicine used to facilitate erection, as this
increases the effect of reducing blood pressure.
Your doctor will need to monitor you and possibly adjust the dosage of PERITRATE if you are
taking any of the following medicines:

• noradrenaline, used in emergency therapy for the treatment of low blood pressure;
• acetylcholine, a medicine used during some operations;
• histamine, used against allergies.

PERITRATE with alcohol
Avoid drinking alcohol during treatment with PERITRATE, as this may cause an excessive
reduction in blood pressure.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breastfeeding, take this medicine only in cases of
absolute necessity and under the direct supervision of your doctor.

Driving and using machines
No data are available to establish the effects on the ability to alter driving or using
machinery.

PERITRATE contains lactose
This medicine contains lactose monohydrate, a sugar. If your doctor has diagnosed you with
intolerance to some sugars, contact him before taking this medicine.

3. How to take PERITRATE

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet in the morning before breakfast and 1 tablet in the evening before
dinner.

If you take more PERITRATE than you should
Following the intake of an excessive dose of this medicine, nausea, vomiting,
weakness, restlessness, reduction of skin color (pallor), sweating and collapse may occur; these effects
increase if you have consumed alcohol.
In case of accidental intake/ingestion of an excessive dose of this medicine, inform
your doctor immediately or go to the Emergency Room of the nearest hospital.

If you forget to take PERITRATE
Do not take a double dose to make up for the missed tablet.
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:

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

• skin irritations (rashes);
• severe skin disorder (exfoliative dermatitis).

Not known(frequency cannot be estimated from available data)

• dizziness, headache (cephalalgia) sometimes severe and persistent, generally mild and transient;
• increased heart rate (tachycardia), increased awareness of heartbeats (palpitations), unpredictable decrease in heart rate (paradoxical bradycardia);
• feeling of dizziness when standing up due to a drop in blood pressure (postural hypotension);
• nausea, vomiting, abdominal pain;
• skin irritation (skin rash) that may require discontinuation of treatment;
• hot flushes, weakness, sweating.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
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 PERITRATE

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 packaging after “Exp”. The expiry date
refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater 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 PERITRATE contains

• The active ingredient is pentaerythritol tetranitrate: 1 tablet contains 80 mg of pentaerythritol tetranitrate.
• The other ingredients are: macrogol 4000, lactose, magnesium stearate, stearic acid, guar gum, carnauba wax, Yellow Orange S.

Description of the appearance of PERITRATE and contents of the pack
Pack containing 50 modified-release tablets of 80 mg.

Marketing Authorisation Holder
Teofarma S.r.l. - Via F.lli Cervi, 8 - Valle Salimbene (PV)

Manufacturer
Teofarma S.r.l. - Viale Certosa, 8/A - 27100 Pavia