Package Leaflet: Information for the User

Surmenalit 200 mg Coated Tablets

sulbutiamine

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Table of Contents

1. What is Surmenalit 200 mg Coated Tablets and what it is used for
2. What you need to know before you start taking Surmenalit 200 mg Coated Tablets
3. How to take Surmenalit 200 mg Coated Tablets
4. Possible side effects
5. Storage of Surmenalit 200 mg Coated Tablets
6. Contents of the pack and additional information

Surmenalit is a derivative of vitamin B1 (also known as thiamine).

It is indicated in states of thiamine (vitamin B1) deficiency in adults who present with apathy and a reduction in activity.

Do not take Surmenalit

• If you are allergic (hypersensitive) to the active ingredient or to any of the other components of this medication (listed in section 6).
• If you are allergic to milk proteins as it contains casein.
• If you are allergic to vitamin B1 or to any of its derivatives.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Surmenalit 200 mg tablets.

• If you are over 65 years old. In this case, the dose should be reduced.
• If you observe mild agitation or symptoms of an allergic reaction to the medication, discontinue treatment and consult your doctor.

Interference with diagnostic tests: If you are to undergo any diagnostic test (such as blood tests, urine tests, etc.) inform your doctor that you are using this medication as it may alter the results, for example, in tests for uric acid, urobilinogen, and theophylline determination.

Children and adolescents

This medication should not be administered to children and adolescents under 18 years old, as there are no specific studies on the administration of Surmenalit in this population.

Other medications and Surmenalit

Inform your doctor or pharmacist if you are using, have used recently, or may have to use any other medication, including those purchased without a prescription.

Surmenalit may interact with the following medications:

• Diuretics (high blood pressure treatment): may increase the excretion of thiamine in urine.
• Neuromuscular blockers (muscle relaxants): concomitant use of sulbutiamine with these medications may increase the effects of neuromuscular blockers.

Surmenalit with food and beverages

Surmenalit can be taken with any type of food and non-alcoholic beverages.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Due to the lack of data on the use of sulbutiamine in pregnant women, its use is not recommended during pregnancy.

If you become pregnant during treatment with sulbutiamine, consult your doctor to evaluate the benefit of treatment against the risk to the fetus.

Breastfeeding

The excretion of sulbutiamine in breast milk is unknown.

Due to the lack of data on the possible risks of sulbutiamine in the newborn, its use is not recommended during breastfeeding, unless your doctor advises otherwise.

Driving and operating machinery

No studies have been conducted on the effects of Surmenalit on the ability to drive and operate machinery.

Surmenalit 200 mg tablets contain yellow-orange S (E-110) dye and milk proteins

This medication may cause allergic reactions because it containsyellow-orange S (E-110) dye. It may cause asthma, especially in patientsallergic to acetylsalicylic acid.

This medication may cause allergic reactions in patients with an allergy to cow's milk protein.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. Do not take more medication or more frequently than indicated. If you do, you may increase the risk of an overdose.

In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults

The recommended dose ranges from 400 mg to 600 mg per day, administered in 2 or 3 doses (1 coated tablet 2-3 times a day).

Treatment should not exceed one month of continuous use. Do not exceed the maximum dose of 600 mg/day.

Seniors

The recommended dose is 200 mg (1 coated tablet) per day.

Patients with liver or kidney insufficiency

There is not enough information available on the use of sulbutiamine in patients with liver and/or kidney insufficiency.

The tablets should be taken with a glass of water.

If taking 2 tablets, divide the doses between breakfast and lunch, as taking them after midday may interfere with sleep.

If you estimate that the action of Surmenalit is too strong or too weak, please inform your doctor or pharmacist.

If you take more Surmenalit than you should

In case of overdose, agitation, euphoria, and tremors of the extremities may appear. These symptoms are generally temporary, and treatment will be symptomatic.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or contact the nearest hospital emergency service and bring the medication with you. You can also call theToxicological Information Service Telephone 91.562.04.20, indicating the medication and the amount ingested.

If you forget to take Surmenalit

Do not take a double dose to compensate for the missed doses. If you forget to take a dose of Surmenalit, take the next dose at the usual time.

If you interrupt treatment with Surmenalit

Do not interrupt treatment unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them. Adverse effects of Surmenalit are infrequent if the doses are adjusted to the recommended levels, except in special situations.

The effects that may appear are:

Effects on the nervous system

Rare(affect between 1 and 10 of every 10,000 patients): tremors, headache.

Psychiatric effects

Rare(affect between 1 and 10 of every 10,000 patients): mild agitation, excitement, sleep disturbances

Effects on the stomach and intestines

Infrequent(affect between 1 and 10 of every 1,000 patients): abdominal pain, nausea, vomiting.

Unknown frequency(cannot be estimated from available data): diarrhea

Effects on the skin

Rare(affect between 1 and 10 of every 10,000 patients): skin rash

General effects and alterations at the site of administration

Rare(affect between 1 and 10 of every 10,000 patients): discomfort

*This medication contains yellow-orange colorant S (E-110) and may cause allergic reactions; it may cause asthma, especially in patients allergic to acetylsalicylic acid.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medications for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Surmenalit 200 mg tablets

• The active ingredient is sulbutiamine.Each coated tablet contains 200 mg of sulbutiamine.
• The other components (excipients) are:microcrystalline cellulose, formaldehyde casein, magnesium stearate (E-572), titanium dioxide (E-171), basic polymer of butyl methacrylate, ethyl phthalate andyellow-orange S colorant (E-110).

Appearance of the product and content of the packaging

Each package contains 30 coated tablets of orange color.

Holder of the marketing authorization

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Last review date of this leaflet: September 2021

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es