Surmenalit 200 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Surmenalit 200 mg coated tablets

sulbutiamine

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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. How to store Surmenalit 200 mg coated tablets
6. Contents of the pack and other information

1. What Surmenalit 200 mg tablets is and what it is used for

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

It is indicated for thiamine (vitamin B1) deficiency states in adults presenting 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 substance or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to milk proteins, as it contains casein.
• If you are allergic to vitamin B1 or any of its derivatives.

Warnings and precautions

Consult your doctor or pharmacist before taking Surmenalit 200 mg tablets

• If you are over 65 years of age. In this case, the dose should be reduced.
• If you experience mild agitation or symptoms of an allergic reaction to the medicine, stop treatment and consult your doctor.

Interference with diagnostic tests: If you are due to have any diagnostic tests (such as blood or urine tests), inform your doctor that you are taking this medicine, as it may alter test results—for example, tests for uric acid, urobilinogen, and theophylline.

Children and adolescents

This medicine must not be given to children and adolescents under 18 years of age, due to the lack of specific studies on the use of Surmenalit in this population.

Other medicines and Surmenalit

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Surmenalit may interact with the following medicines:

• Diuretics (used to treat high blood pressure): may increase urinary excretion of thiamine.
• Neuromuscular blockers (muscle relaxants): concomitant use of sulbutiamine with these drugs may enhance the effects of neuromuscular blockers.

Taking Surmenalit with food and drinks

Surmenalit may 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

If you become pregnant while being treated with sulbutiamine, consult your doctor so that they can evaluate the benefit of treatment versus the potential risk to the fetus.

Breastfeeding

It is unknown whether sulbutiamine is excreted in human milk.

Due to the lack of data on the potential risks of sulbutiamine to the newborn, its use during breastfeeding is not recommended, unless otherwise advised by your doctor.

Driving and using machines

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

Surmenalit 200 mg tablets contain sunset yellow FCF (E-110) and milk proteins

This medicine can cause allergic reactions because it contains sunset yellow FCF (E-110). It may cause asthma, particularly in patients allergic to acetylsalicylic acid.

This medicine may cause allergic reactions in patients allergic to bovine milk protein.

3. How to take Surmenalit 200 mg tablets

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

If in 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 daily).

Treatment should not exceed one month continuously. The maximum daily dose of 600 mg/day must not be exceeded.

Elderly patients

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

Patients with hepatic or renal impairment

There is insufficient information available on the use of sulbutiamine in patients with hepatic and/or renal impairment.

The tablets should be taken with a glass of water.

If taking 2 tablets, doses should be divided between breakfast and lunch, as taking them after midday may interfere with sleep.

If you feel that 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, symptoms such as agitation, euphoria, and tremor of the limbs may occur. These symptoms are generally transient and treatment will be symptomatic.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or contact the emergency department of the nearest hospital, and bring the medicine with you. You may also call the Toxicology Information Service at telephone number 91.562.04.20, indicating the medicine 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 stop taking Surmenalit

Do not stop treatment unless instructed by your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. The adverse effects of Surmenalit are uncommon if doses are adjusted according to the recommended levels, except in special circumstances.

The possible effects include:

Effects on the nervous system

Rare (affects between 1 and 10 out of 10,000 patients): tremors, headache.

Psychiatric effects

Rare (affects between 1 and 10 out of 10,000 patients): mild agitation, excitement, sleep disturbances.

Effects on the stomach and intestine

Uncommon (affects between 1 and 10 out of 1,000 patients): abdominal pain, nausea, vomiting.

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

Effects on the skin

Rare (affects between 1 and 10 out of 10,000 patients): skin rash.

General effects and administration site reactions

Rare (affects between 1 and 10 out of 10,000 patients): malaise.

*This medicine contains the colouring agent sunset yellow FCF (E-110), which may cause allergic reactions; it may trigger asthma, particularly in patients allergic to acetylsalicylic acid.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Surmenalit 200 mg tablets

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Sigre Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Contents of the package and other information

Composition of Surmenalit 200 mg tablets

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

Appearance of the medicine and contents of the pack

Each pack contains 30 orange 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 most recent review of this leaflet: September 2021

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