Sermion

Package Leaflet: Information for the User

SERMION, 10 mg, effervescent 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, please inform 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 that dilate peripheral blood vessels. 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 case of severe bradycardia;
• in patients with 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., asthma and rhinitis medications).

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 been diagnosed with gout in the past
• if you are taking medications 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 the medicines you are taking, or have recently taken, and any you plan to take.
Sermion may enhance the effects of blood pressure-lowering medications.
Sermion may interact with anti-arrhythmic medications, beta-adrenergic receptor blockers used to treat hypertension and certain heart diseases, and tricyclic antidepressants. Sermion may increase the negative inotropic effect (inhibiting heart activity) of beta-adrenergic receptor blockers.
Concomitant use of Sermion and anti-aggregant or anticoagulant medications may prolong bleeding time.
The use of medications that affect uric acid metabolism (e.g., those used to treat gout) may alter uric acid metabolism and excretion.

Sermion with food, drink, and alcohol

Sermion can be taken with food and drink (recommended during breakfast and lunch).
Effervescent tablets should be swallowed whole, with a glass of water.
As with other medications that affect the nervous system, concomitant consumption of alcohol may enhance the nervous system-related side effects.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
Sermion should not be used during pregnancy. If administration is absolutely necessary, it should be done under the direct supervision of a doctor.
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 effect 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 it is considered "sodium-free".

Sermion contains sucrose (sugar cane)

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

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 dosage and duration of treatment.
Nicergoline is used in doses of 10 to 60 mg per day. The medicine should be taken in two doses: during breakfast and lunch.
Long-term administration of Sermion is recommended; after 6 months, your doctor will consider whether treatment should be continued.

Overdose of Sermion

In case of overdose and symptoms indicating significant hypotension (dizziness, fainting), your doctor may prescribe appropriate symptomatic treatment.
In acute poisoning, gastric lavage and activated charcoal should be administered.
If you have taken more than the recommended dose, contact your doctor or pharmacist immediately.

Missed 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 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, Sermion 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, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 the sight and reach of children.
Store in a temperature 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 Sermion is nicergoline.
One effervescent 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:arabic gum, sandalwood gum, magnesium carbonate, titanium dioxide, carnauba wax, talc, shellac, sucrose (see section 2 "Sermion contains sucrose (sugar cane)").

What Sermion looks like and contents of the pack

White, round, convex effervescent tablets.
The pack contains 25 or 50 effervescent 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: