Pentaerithritol compositum

Leaflet attached to the packaging: patient information

PENTAERYTHRITOL COMPOSITUM

20 mg + 0,5 mg, tablets

Pentaerythritol tetranitrate + Glyceryl trinitrate

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Pentaerythritol compositum and what is it used for
• 2. Important information before taking Pentaerythritol compositum
• 3. How to take Pentaerythritol compositum
• 4. Possible side effects
• 5. How to store Pentaerythritol compositum
• 6. Package contents and other information

1. What is Pentaerythritol compositum and what is it used for

Pentaerythritol compositum has a coronary vasodilating effect.
It is used prophylactically and therapeutically in coronary heart disease and in exacerbation
of coronary heart disease.

2. Important information before taking Pentaerythritol compositum

When not to take Pentaerythritol compositum

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6),
• if the patient has hypotension, including that associated with hypovolemia (reduced blood volume),
• if the patient has had a myocardial infarction (especially of the right ventricle) and has low systolic blood pressure and (or) tachycardia (accelerated heart rate),
• if the patient has hypertrophic cardiomyopathy with left ventricular outflow tract obstruction,
• if the patient has mitral stenosis or aortic stenosis,
• if the patient has constrictive pericarditis,
• if the patient has increased intracranial pressure, including hemorrhagic stroke and head trauma,
• if the patient has cerebral hemorrhage,
• if the patient has significant anemia,
• if the patient has glaucoma with a narrow angle of filtration,
• if the patient has congestive venous disease or thrombotic disease,
• if the patient is taking phosphodiesterase type 5 inhibitors (e.g., sildenafil) used in erectile dysfunction.

Warnings and precautions

Before starting to take Pentaerythritol compositum, the patient should discuss it with their doctor.
Particular caution should be exercised:

• in patients with renal and (or) hepatic insufficiency,
• in patients with low blood pressure in the course of various diseases,
• in hyperthyroidism and hypothyroidism.

The patient should consult their doctor, even if the above warnings concern situations that have occurred in the past.

Using Pentaerythritol compositum in elderly patients

In elderly patients, it is not necessary to change the dosage.

Children

The safety and efficacy of the medicine in children have not been studied.

Pentaerythritol compositum and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This applies in particular to the following medicines, whose concurrent use may cause undesirable lowering of blood pressure with symptoms of hypotension:

• other vasodilating medicines,
• beta-adrenergic blockers,
• calcium antagonists,
• angiotensin II antagonists,
• diuretics,
• angiotensin-converting enzyme (ACE) inhibitors,
• neuroleptics, tricyclic antidepressants,
• other blood pressure-lowering medicines.

The patient should also inform their doctor about the use of the following medicines:

• non-steroidal anti-inflammatory drugs (may weaken the effect of nitrates),
• dihydroergotamine (may increase blood pressure).

When using Pentaerythritol compositum (and other nitrates), there is an absolute contraindication to taking phosphodiesterase type 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil) used in erectile dysfunction, due to the risk of severe, life-threatening side effects.

Pentaerythritol compositum with food, drink, and alcohol

The medicine should be taken at least half an hour before a meal or one hour after a meal.
Alcohol enhances the blood pressure-lowering effect of nitrates.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Before taking the medicine, the patient should consult their doctor.
Breastfeeding
Due to the penetration of nitrates into breast milk, the patient should consult their doctor before taking the medicine.

Driving and using machines

Pentaerythritol compositum has a moderate effect on the ability to drive and use machines.
At the beginning of treatment, it is possible to experience headache and orthostatic hypotension (hypotension in a standing position), and in particularly sensitive individuals, fainting may occur. If such symptoms occur, the patient should not drive or operate machines.

Pentaerythritol compositum contains sucrose

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

Pentaerythritol compositum contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Pentaerythritol compositum

This medicine should always be taken as directed by the doctor. If in doubt, the patient should consult their doctor.

Dosage

Adults
The recommended dose is 1 to 2 tablets 3 times a day.
A smaller initial dose (1 tablet 3 times a day) is recommended if the medicine is given for the first time, due to the possibility of hypotension (blood pressure below normal values).
Patient with renal and (or) hepatic insufficiency
In patients with renal and (or) hepatic insufficiency, the doctor may recommend smaller doses depending on the degree of renal and (or) hepatic insufficiency, and then increase the dose under control.

Method of administration

Oral administration. To accelerate the effect of the medicine, the tablet can be chewed and then swallowed.
The medicine should be taken at least half an hour before a meal or one hour after a meal.

Taking a higher dose of Pentaerythritol compositum than recommended

If a higher dose of the medicine than recommended is taken, the patient should immediately consult their doctor. In case of poisoning with this medicine, symptomatic treatment is used.
Symptoms of overdose include: flushing of the face, hypotension, restlessness, accelerated heart rate, headache, feeling of throbbing in the head, dizziness, weakness, increased sweating, nausea, vomiting, skin allergic reactions, methemoglobinemia (presence of abnormal hemoglobin in the blood).

Missing a dose of Pentaerythritol compositum

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

Stopping the use of Pentaerythritol compositum

Abrupt withdrawal of the medicine (except in case of occasional hypersensitivity) should be avoided. If treatment needs to be discontinued, the doctor will recommend gradual reduction of the medicine doses.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.
If the patient has any further doubts about the use of this medicine, they should consult their doctor.

4. Possible side effects

Like all medicines, Pentaerythritol compositum can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is as follows:

• very common (occurring in at least 1 in 10 people),
• common (occurring in at least 1 in 100 people but less than 1 in 10 people),
• uncommon (occurring in at least 1 in 1,000 people but less than 1 in 100 people),
• rare (occurring in at least 1 in 10,000 people but less than 1 in 1,000 people),
• very rare (occurring in less than 1 in 10,000 people),
• not known (frequency cannot be estimated from the available data).

Very common:

headache (usually mild and resolving after a few days of taking the medicine).

Uncommon:

flushing of the skin on the face, feeling of heat (resulting from vasodilation, sometimes requiring withdrawal of the medicine).

Rare:

severe headache (requiring withdrawal of the medicine), transient weakness, dizziness, increased intraocular pressure, gastrointestinal disorders: nausea, vomiting, abdominal pain (usually mild and transient).

Very rare:

severe hypotension, fainting, reflex bradycardia, increased intracranial pressure, rash, rosacea, erythroderma, flushing, skin inflammation, exfoliative dermatitis.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform 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.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Pentaerythritol compositum

Store in a temperature below 25°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 stated.
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. Package contents and other information

What Pentaerythritol compositum contains

• -The active substances of the medicine are: pentaerythritol tetranitrate 20 mg and glyceryl trinitrate 0.5 mg.
• -The other ingredients are: sucrose, potato starch, lactose monohydrate, talc, carboxymethyl starch sodium type A, magnesium stearate, gelatin.

What Pentaerythritol compositum looks like and what the package contains

Pentaerythritol compositum is available in the form of tablets. The tablet is white, round, and slightly convex on both sides.
The package contains 20 tablets in a glass vial with a polyethylene plug, in a cardboard box with a patient information leaflet.

Marketing authorization holder and manufacturer

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