Sermion

Package Leaflet: Information for the User

SERMION, 30 mg, coated tablets

Nicergoline

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Sermion and what is it used for

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

2. Important information before taking Sermion

When not to take Sermion:

• if you are 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 arterial hypotension or orthostatic hypotension (decrease in blood pressure related to a change in body position from lying to standing);
• in case of concomitant use of alpha- or beta-mimetic drugs (e.g., drugs used in asthma and rhinitis).

Warnings and precautions:

Before starting treatment with Sermion, discuss it with your doctor or pharmacist:

• if you have increased uric acid levels in your blood
• if you have a history of gout
• if you are taking medicines that may affect uric acid metabolism and excretion.

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

Patients with renal impairment

In patients with renal impairment, the doctor may decide to reduce the dose of the medicine.

Elderly patients

No dose adjustment is necessary.

Sermion and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
Sermion may enhance the effects of blood pressure-lowering medicines.
Sermion may interact with anti-arrhythmic medicines, beta-adrenergic blocking agents used in the treatment of hypertension and certain heart diseases, and tricyclic antidepressants. Sermion may increase the negative inotropic effects (inhibiting heart activity) of beta-adrenergic blocking agents.
Concomitant use of Sermion and anti-aggregant or anticoagulant medicines (including acetylsalicylic acid) may prolong bleeding time.
The use of medicines that affect 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 can be taken with food and drink (recommended to be taken during breakfast and lunch).
Coated tablets should be swallowed whole with water.
As with other medicines that act on the nervous system, concomitant consumption of alcohol may enhance the nervous system-related side effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Sermion should not be used in pregnant women. If administration is absolutely necessary, it should be done under direct medical supervision.
It is not known whether nicergoline passes into breast milk. Sermion should not be used during breastfeeding.

Driving and using machines

No studies have been conducted on the effects of the medicine on the ability to drive and use machines.
However, when driving or operating machines, consider the possibility of dizziness or drowsiness.

Sermion contains sodium

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

3. How to take Sermion

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Your doctor will decide on the dose and duration of treatment.
Nicergoline is used in doses of 10 to 60 mg per day. The medicine should be taken in two doses: one coated tablet during breakfast and one during lunch.
Long-term administration of Sermion is recommended; after 6 months, your doctor will consider whether treatment should be continued.

Taking more Sermion than prescribed

In case of taking a higher dose of Sermion than prescribed and experiencing symptoms indicating significant blood pressure lowering (dizziness, fainting), your doctor may prescribe appropriate symptomatic treatment if necessary. In acute poisoning, gastric lavage and activated charcoal should be administered.
If you have taken more than the prescribed dose, contact your doctor or pharmacist immediately.

Missing a dose of Sermion

Take the missed dose as soon as possible, except when the next dose is due. Do not take a double dose to make up for the missed dose. If in doubt, consult your doctor.

Stopping Sermion treatment

Do not stop treatment without consulting your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects listed below are classified by system organ class and frequency.
Common side effects(may affect up to 1 in 10 people): abdominal discomfort.
Uncommon side effects(may affect up to 1 in 100 people): agitation, confusion, insomnia, drowsiness, dizziness, headache, hypotension, facial flushing, constipation, diarrhea, nausea, itching, increased uric acid levels in the blood.
Frequency not known(cannot be estimated from the available data): feeling of heat, rash, fibrosis (e.g., lungs, heart, heart valves, retroperitoneal space).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 or its representative.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Sermion

Keep out of 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 month stated.

6. Contents of the pack and other information

What Sermion contains

The active substance of the medicine is nicergoline.
One 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.
Coating: hypromellose, silicon, 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-aluminum/PVDC blisters in a cardboard box.

Marketing authorization holder:

Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands

Manufacturer:

Pfizer Italia S.r.l., Località Marino Del Tronto, 63100 Ascoli Piceno (AP), Italy
To obtain more detailed information, contact the representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

tel. 22 546 64 00

Date of last revision of the leaflet: