Package leaflet: information for the user

SERMION, 10 mg, coated tablets
Nicergoline
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Sermion is and what it is used for
Important information before taking Sermion
How to take Sermion
Possible side effects
How to store Sermion
Contents of the pack and other information

1. What Sermion is and what it is used for

Sermion belongs to a group of medicines known as peripheral vasodilators. Nicergoline, the active substance of this medicine, improves blood flow in the brain and has antiplatelet (anti-aggregation) properties.
Sermion is indicated in the treatment of mild to moderate dementia.

2. Important information before using Sermion

When not to use Sermion:

if the patient is allergic to the active substance, other ergotamine derivatives, or any of the other ingredients of this medicine (listed in section 6);
in patients who have recently had a myocardial infarction;
in case of bleeding;
in case of severe bradycardia;
in patients with a history of hypotension or orthostatic hypotension (reduction in blood pressure associated with a change in body position from lying down to standing);
when taking alpha- or beta-mimetic drugs simultaneously (e.g. drugs used in bronchial asthma and nasal mucosal inflammation).

Warnings and precautions:
Before starting treatment with Sermion, discuss this with your doctor or pharmacist:

if the patient has elevated blood uric acid levels;
if the patient has previously been diagnosed with gout;
if the patient is taking drugs that may affect uric acid metabolism and excretion.

Nicergoline may reduce systolic blood pressure, and to a lesser extent diastolic blood pressure, in patients with normal or elevated blood pressure.
The use of ergotamine derivatives may cause fibrotic reactions (e.g. in the lungs, heart, heart valves, retroperitoneal space).
If there are any doubts regarding the use of the medicine, consult a doctor or pharmacist.
In case of severe nausea, vomiting, diarrhoea, abdominal pain, or peripheral vasoconstriction, contact a doctor or pharmacist, as these symptoms may indicate ergotamine poisoning.

Patients with renal function disorders
The doctor may decide to reduce the dose of Sermion in patients with impaired renal function.

Elderly patients
There is no need to adjust the dose.

Sermion and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
Sermion may enhance the effect of antihypertensive drugs.
Sermion may interact with antiarrhythmic drugs, beta-adrenergic receptor blocking drugs used in the treatment of hypertension and certain heart diseases, and tricyclic drugs used in the treatment of depression. Sermion may increase the negative chronotropic (heart function suppressing) effect of beta-adrenergic receptor blocking drugs.
Concomitant use of Sermion with antiplatelet drugs (including acetylsalicylic acid) or anticoagulants may prolong bleeding time.
The use of drugs affecting uric acid metabolism (e.g. those used in the treatment of gout) may alter uric acid metabolism and excretion.

Sermion, food, drink, and alcohol
Sermion may be taken with food and drink (administration during breakfast and lunch is recommended).
Film-coated tablets should be swallowed whole with water.
As with other drugs acting on the nervous system, concomitant alcohol consumption may enhance adverse effects on the nervous system.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Sermion should not be used in pregnant women. If administration is absolutely necessary, it should be carried out under direct medical supervision.
It is unknown whether nicergoline passes into human milk. Sermion should not be used during breastfeeding.

Driving and operating machinery
No studies have been conducted on the effect of the medicine on the ability to drive vehicles or operate machinery.
However, when driving vehicles or operating machinery, consider the possibility of dizziness or drowsiness occurring.

Sermion contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

Sermion contains sucrose (cane sugar)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Sermion

This medicine should always be used exactly as directed by the physician. In case of doubts, consult
your doctor.
The physician determines the dosage and duration of treatment.
Nicergoline should be administered in doses ranging from 10 to 60 mg per day. The medicine should be taken
in two divided doses: during breakfast and lunch.
Prolonged administration of Sermion is recommended. After 6 months, the physician will evaluate whether
treatment should be continued.
Use of a higher than recommended dose of Sermion
If a dose higher than recommended is taken and symptoms indicating a significant drop in blood pressure
(dizziness, fainting) occur, the physician may recommend appropriate symptomatic treatment if necessary.
In acute poisoning, gastric lavage and administration of activated charcoal should be performed.
If a dose higher than recommended has been taken, seek immediate medical advice from a doctor or
pharmacist.
Missed dose of Sermion
Take the missed dose as soon as possible, except when it is almost time for the next dose. Do not take a
double dose to make up for a missed dose. In case of doubts, consult your doctor.
Stopping treatment with Sermion
Do not discontinue treatment without consulting your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The adverse reactions listed below are classified according to system organ classes and frequency of occurrence.
Common adverse reactions (may occur in 1 to 10 out of 100 patients): abdominal discomfort.
Uncommon adverse reactions (may occur in 1 to 10 out of 1,000 patients): restlessness, confusion, insomnia, somnolence, dizziness, headache, hypotension, facial flushing, constipation, diarrhoea, nausea, pruritus, increased blood uric acid concentration.
Frequency not known (cannot be estimated from the available data): feeling of warmth, rash, fibrosis (e.g. in lungs, heart, heart valves, retroperitoneal space).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C,
02-222 Warszawa,
Tel.: + 48 22 49 21 301,
Faks: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorisation holder or the representative of the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Sermion

Keep out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the stated month.

6. Contents of the packaging and other information

What Sermion contains
The active substance in Sermion is nicergoline.
One coated tablet contains 10 mg of nicergoline.
The other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium carboxymethylcellulose (see section 2 "Sermion contains sodium"), magnesium stearate.
Coating composition: gum arabic, sandarac gum, magnesium carbonate, titanium dioxide, carnauba wax, talc, rosin, cane sugar (see section 2 "Sermion contains sucrose (cane sugar)").

What Sermion looks like and contents of the pack
White, round, convex coated tablets.
Pack contains 25 or 50 coated tablets in PVC/PVDC-aluminium/PVDC blisters, packed in a cardboard box.

Marketing Authorisation Holder:
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Manufacturer:
Pfizer Italia S.r.l., Località Marino Del Tronto, 63100 Ascoli Piceno (AP), Italy

For further information, please contact the marketing authorisation holder's representative:
Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00