SURMENALIT 200 mg FILM-COATED TABLETS

Introduction

Leaflet: information for the user

Surmenalit 200 mg coated tablets

sulbutiamine

Read this leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of theleaflet

1. What Surmenalit 200 mg coated tablets are and what they are used for
2. What you need to know before 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. Package contents and additional information

1. What Surmenalit 200 mg tablets are and what they are used for

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

It is indicated in states of thiamine deficiency (vitamin B1) in adults with apathy and reduced activity.

2. What you need to know before taking Surmenalit 200 mg tablets

Do not take Surmenalit

• If you are allergic (hypersensitive) to the active ingredient or any of the other components of this medication (listed in section 6).
• If you are allergic to milk proteins since it contains casein.
• If you are allergic to vitamin B1 or 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 notice mild agitation or symptoms of allergy to the medication, discontinue treatment and consult your doctor.

Interference with analytical tests: If you are going to undergo any diagnostic tests (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 determining uric acid, urobilinogen, and theophylline.

Children and adolescents

This medication should not be administered to children and adolescents under 18 years of age, 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 recently used, or may need to use any other medication, including those purchased without a prescription.

Surmenalit may interact with the following medications:

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

Taking Surmenalit with food and drinks

Surmenalit can be taken with all types of food and non-alcoholic beverages.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become 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.

In case of becoming pregnant during treatment with sulbutiamine, consult your doctor to evaluate the benefit of treatment versus the risk to the fetus.

Breastfeeding

It is unknown whether sulbutiamine is excreted in breast milk.

Due to the lack of data on the potential risks of sulbutiamine in newborns, its use is not recommended during breastfeeding, unless your doctor indicates otherwise.

Driving and using machines

No studies have been conducted on the effects of Surmenalit on the ability to drive and use machines.

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

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

This medication may cause allergic reactions in patients with milk protein allergy.

3. How to take Surmenalit 200 mg tablets

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. Do not take more medication or more frequently than indicated. If you do, you may increase the possibility 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 continuously. The maximum dose of 600 mg/day should not be exceeded.

Elderly

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

Patients with hepatic or renal insufficiency

There is not enough information on the use of sulbutiamine in patients with hepatic and/or renal insufficiency.

Tablets should be taken with a glass of water.

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

If you think the effect 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 limbs may appear. These symptoms are usually transient, and treatment will be symptomatic.

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

If you forget to take Surmenalit

Do not take a double dose to make up for forgotten 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 indicates it.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them. The side effects of Surmenalit are rare if the doses are adjusted as recommended, except in special situations.

The effects that may appear are:

Effects on the nervous system

Rare(affect 1 to 10 in 10,000 patients): tremors, headache.

Psychiatric effects

Rare(affect 1 to 10 in 10,000 patients): mild agitation, excitement, sleep disturbances

Effects on the stomach and intestines

Uncommon(affect 1 to 10 in 1,000 patients): abdominal pain, nausea, vomiting.

Frequency not known(cannot be estimated from available data): diarrhea

Effects on the skin

Rare(affect 1 to 10 in 10,000 patients): skin rash

General effects and alterations at the administration site

Rare(affect 1 to 10 in 10,000 patients): discomfort

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

Reporting side effects

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

5. Storage of Surmenalit 200 mg tablets

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 thrown down the drain or into the trash. Deposit the packaging and unused medications at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

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, casein formalin, magnesium stearate (E-572), titanium dioxide (E-171), methacrylic acid copolymer, ethyl phthalate, and orange yellow S (E-110) dye.

Appearance of the product and package contents

Each package contains 30 orange-colored coated tablets.

Marketing authorization holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Date of the last revision of this leaflet: September 2021

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es