Package leaflet: Information for the user

SERMION, 30 mg, coated tablets
Nicergolinum
Please read carefully all the information in this leaflet before using this 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 questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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 cerebral blood flow and has antiplatelet (anti-aggregation) properties.
Sermion is indicated for 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 with recent myocardial infarction;
in case of bleeding;
in severe bradycardia;
in patients with a history of hypotension or orthostatic hypotension (decrease in blood pressure related to change in body position from lying to standing);
when used concomitantly with alpha- or beta-mimetic drugs (e.g. drugs used in bronchial asthma and nasal mucosal inflammation).

Warnings and precautions:
Before starting treatment with Sermion, consult a 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 medications that may affect uric acid metabolism and excretion.

Nicergoline may reduce systolic arterial blood pressure, and to a lesser extent diastolic arterial blood pressure, in patients with normal or elevated blood pressure.
Ergotamine derivatives may cause fibrotic reactions (e.g. in 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
In patients with impaired renal function, the doctor may decide to reduce the dose of the medicine.

Elderly patients
There is no need to adjust the dose.

Sermion with other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient intends to take.
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 with food, drink and alcohol
Sermion may be taken with food and drink (administration during breakfast and lunch is recommended).
The coated tablets should be swallowed whole with water.
As with other medicines 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 must 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 must not be used during breastfeeding.

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

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

3. How to use Sermion

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult your doctor.
The doctor decides on 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: one coated tablet during breakfast and one during lunch.
Long-term administration of Sermion is recommended. After 6 months, the doctor will assess whether treatment should be continued.
Taking more Sermion than prescribed
If a higher than recommended dose of Sermion is taken and symptoms indicating a significant drop in blood pressure occur (dizziness, fainting), the doctor may recommend appropriate symptomatic treatment. In acute poisoning, gastric lavage should be performed and activated charcoal administered.
If you have taken more than the prescribed dose of the medicine, seek immediate medical advice from a doctor or pharmacist.
Missing a dose of Sermion
Take the missed dose as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for a missed one. In case of doubt, consult your doctor.
Stopping Sermion treatment
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, drowsiness, 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 of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C,
02-222 Warsaw,
Tel.: + 48 22 49 21 301,
Fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder or the representative of the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 is nicergoline.
Each coated tablet contains 30 mg of nicergoline.
The other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium carboxymethylcellulose (see section 2 "Sermion contains sodium"), magnesium stearate.
Tablet coating composition: hydroxypropylmethylcellulose, silicone, polyethylene glycol 6000, yellow iron oxide (E172), titanium dioxide, carnauba wax, talc.
What Sermion looks like and contents of the pack
Yellow, round, biconvex coated tablets.
The pack contains 30 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