Galpent

Leaflet attached to the packaging: patient information

GALPENT

100 mg, tablets

Pentaerythritol tetranitrate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor. See section 4.

Table of contents of the leaflet

• 1. What is Galpent and what is it used for
• 2. Important information before taking Galpent
• 3. How to take Galpent
• 4. Possible side effects
• 5. How to store Galpent
• 6. Contents of the packaging and other information

1. What is Galpent and what is it used for

Galpent contains pentaerythritol tetranitrate, which is an organic nitrate used in stable coronary heart disease.

2. Important information before taking Galpent

When not to take Galpent

• if the patient is allergic to pentaerythritol tetranitrate or other nitrates or any of the other ingredients of this medicine (listed in section 6),
• if the patient has:
• shock, hypotension - including that associated with hypovolemia,
• myocardial infarction with low filling pressure - especially of the right ventricle,
• hypertrophic cardiomyopathy with outflow obstruction from the left ventricle,
• mitral stenosis, left ventricular outflow tract obstruction,
• cardiac tamponade,
• constrictive pericarditis,
• pulmonary heart disease,
• increased intracranial pressure, including stroke and head injury,
• significant anemia,
• glaucoma with a narrow angle of filtration.

Galpent should not be used in pregnant and breastfeeding women.
Galpent should not be used in children.

Contraindications for people taking pentaerythritol tetranitrate and other nitrates

Sildenafil (a medicine used to treat erectile dysfunction and primary pulmonary hypertension) is absolutely contraindicated due to the occurrence of side effects, with severe blood pressure reduction, posing a life-threatening risk.

These can lead to life-threatening hypotension.

Warnings and precautions

Before starting treatment with Galpent, the patient should discuss it with their doctor.
Galpent used in combination with other vasodilating medicines, beta blockers, diuretics, calcium antagonists, ACE inhibitors, and AT1 receptor antagonists, other antihypertensive medicines, neuroleptics, and tricyclic antidepressants, may cause unwanted, sudden decreases in blood pressure.
In combination therapy, the doctor may start with small doses of Galpent and gradually increase them.
The medicine should be used with caution in patients with hypothyroidism.
Caution is necessary when gradually increasing the dose in elderly patients and in patients with advanced liver or kidney failure - due to reduced excretion of the active metabolites of the medicine and the possibility of side effects, primarily sudden blood pressure reduction.

Children and adolescents

There is no data on the safety of using the medicine in children.

Galpent and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Concomitant administration of pentaerythritol tetranitrate with:

• diphenhydramine (an antihistamine) - increases (about 6-fold) the concentration of the active metabolite of pentaerythritol tetranitrate - pentaerythritol mononitrate,
• dihydroergotamine (a vasoconstrictor, mainly used to treat migraines) - increases its concentration in the blood, causing increased blood pressure. Non-steroidal anti-inflammatory drugs may reduce the effectiveness of pentaerythritol tetranitrate and other nitrates. Sildenafil and other phosphodiesterase type 5 inhibitors are absolutely contraindicated during treatment with pentaerythritol tetranitrate and other nitrates (including sublingual nitroglycerin), due to potentiation of the action of organic nitrates and other NO donors, with severe consequences of hypotension (myocardial infarction, stroke, sudden death), especially in patients after myocardial infarction, stroke, or with arrhythmias.

Galpent with food, drink, and alcohol

Since the absorption of the medicine and its active metabolites decreases in the presence of food in the intestines, it is recommended to take the medicine at least half an hour before eating or one hour after eating.
Alcohol enhances the action of nitrates, which lowers blood pressure.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or is planning to have a child, they should consult a doctor before taking the medicine.
The medicine should not be used in pregnant and breastfeeding women.

Driving and using machines

Due to the possibility of occurrence (most often at the beginning of therapy) of headache and dizziness, hypotension, and fainting, the patient should be particularly cautious and assess their reaction after taking a single dose of the medicine. If the above symptoms occur, the patient should not drive or operate machinery. Medical supervision is also recommended.

Galpent contains lactose and sucrose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Galpent

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor.
Recommended dose
For adults, a dose of 100 mg once a day, in the morning or evening, is recommended.
In some patients, it may be necessary to increase the dose to 2 times a day, 100 mg each time.
Taking Galpent in patients with kidney and/or liver function disorders
In patients with advanced liver and/or kidney failure, the smallest effective dose should be used and increased under medical supervision.
Taking Galpent in elderly patients
In elderly patients, the smallest effective dose should be used and increased under medical supervision.
Method of administration
Oral administration.
It is recommended to take the medicine at least half an hour before eating or one hour after eating.

Taking a higher dose of Galpent than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult a doctor.
There is no data on overdose cases. The symptoms of potential overdose of the medicine are similar to those observed after overdose of nitroglycerin. Most often, they may include: severe headache and dizziness, nausea and vomiting, and significant reduction in blood pressure, especially when standing up and in a standing position (orthostatic hypotension), weakness, and in more severe cases, especially after alcohol consumption - fainting and loss of consciousness with tachycardia (accelerated heart rate) or bradycardia (slowed heart rate).
Severity of clinical symptoms of overdose depends on the dose of Galpent taken, other medicines used at the same time, and the patient's condition: heart failure, acute coronary syndromes, especially myocardial infarction with reduced blood flow to the left ventricle.
Procedure in case of overdose
Treatment of mild overdose is symptomatic. Hypotension is usually controlled by placing the patient on their back with their legs raised above the level of the chest. If there is no rapid improvement, the doctor will administer intravenous fluids. Oxygen therapy is recommended. In case of bradycardia, 1 mg of atropine is usually administered intravenously.
Severe cases of nitrate overdose require treatment in the intensive care unit with monitoring of the patient's condition.

Missing a dose of Galpent

A double dose should not be taken to make up for a missed dose.

Stopping treatment with Galpent

Abrupt withdrawal of the medicine should be avoided (except in very rare cases of hypersensitivity).
In case of necessity to stop the medicine, the doctor will gradually reduce the doses.
In case of any further doubts regarding the use of this medicine, consult a doctor.

4. Possible side effects

Like all medicines, Galpent can cause side effects, although not everybody gets them.
The side effects of pentaerythritol tetranitrate are characteristic of the entire group of organic nitrates.
The frequency of side effects listed below is defined as follows:

• very common (occurring in more than 1 in 10 people),
• common (occurring in less than 1 in 10 people),
• uncommon (occurring in less than 1 in 100 people),
• rare (occurring in less than 1 in 1000 people),
• very rare (occurring in less than 1 in 10,000 people),
• unknown (frequency cannot be estimated from available data).

Very common:

• headaches (usually mild, observed during the first few days of treatment, occurred in 4.9% - 25% of treated patients).

Common:

• dizziness (occurred in 0.8% - 7% of treated patients),
• orthostatic hypotension (sudden decrease in blood pressure when changing from a lying to a standing position, occurred in 0.8% - 2.3% of treated patients),
• reduction in blood pressure (mainly observed in patients with hypertension). There is a possibility of increased intracranial and intraocular pressure.
• weakness (occurred in 0.8% - 2.3% of treated patients).

Rare:

• nausea, vomiting, abdominal pain,
• reflex tachycardia (heart rate acceleration),
• transient flushing of the face,
• allergic reaction to nitrates.

Very rare:

• skin allergic reactions,
• in sensitive individuals, under the influence of alcohol, and also with concomitant administration of vasodilating medicines, episodes of hypotension with fainting or syncope and reflex bradycardia may occur, mainly after nitroglycerin.

Unknown:

• rosacea and erythroderma (confluent redness and usually profuse desquamation).

Methemoglobinemia has been observed only after intravenous administration of nitrates.
After administration of a therapeutic dose of nitroglycerin sublingually or intravenously, a sudden decrease in blood pressure and fainting to loss of consciousness, as well as bradycardia, which can lead to cardiac arrest, have been observed in the initial period of treatment. This reaction has not been observed after administration of pentaerythritol tetranitrate.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Galpent

Store in a temperature below 30°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Galpent contains

• The active substance of the medicine is pentaerythritol tetranitrate. One tablet contains 100 mg of pentaerythritol tetranitrate.
• The other ingredients (excipients) are: lactose monohydrate, potato starch, sucrose, gelatin, magnesium stearate, talc.

What Galpent looks like and what the packaging contains

Galpent is available in the form of tablets. The tablet is white, round, and slightly convex on both sides.
Available packaging:
30 tablets - 3 blisters of 10 tablets each.
The packaging consists of blisters made of aluminum foil and PVC film in a cardboard box.

Marketing authorization holder and manufacturer

Pharmaceutical Cooperative "GALENA"
Dożynkowa 10 Street
52-311 Wrocław
Phone: +48 71 710 62 01
Date of last update of the leaflet:28.10.2022