Label: Information for the User

DURVITAN 300 mg

Extended-Release Hard Capsules

(Caffeine)

Read the entire label carefully as it contains important information for you.

This medication may be purchased without a prescription. For the best results, it should be used properly.

• Keep this label as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If symptoms worsen or persist after 7 days, consult your doctor.
• If you consider any of the adverse effects you are experiencing to be severe, or if you notice any adverse effect not mentioned in this label, inform your doctor or pharmacist.

Caffeine has a stimulating effect on the nervous system.

It is indicated for the relief of occasional and transient feelings of weakness or physical fatigue.

Do not take Durvitan 300 mg

• In cases of allergy (hypersensitivity) to caffeine (or derivatives of this, aminophylline, theophylline...) or to any of the other components of this medication.
• In mental alterations that are accompanied by nervous excitement, epilepsy, anxiety states, and insomnia (sleep problems).

In severe liver, heart, stomach ulcer, duodenum, or high blood pressure alterations.

Be especially careful with Durvitan 300 mg

• If you have any liver, thyroid, or stomach disease, you should consult your doctor before taking this medication.
• You should consult your doctor before taking this medication if you have or have had heart diseases (cardiac arrhythmia, myocardial ischemia, angina pectoris,...), especially when exercising or being in high-altitude locations.
• If you are diabetic, you should be aware that caffeine can elevate blood sugar levels.
• If you are sensitive to other xanthines such as, for example: theophylline, aminophylline..., you should consult your doctor before taking this medication.
• You should not take this medication in the 6 hours before going to sleep.
• This medication should not replace normal sleep or rest.

Use of other medications

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

Particularly, if you are using some of the following medications, it may be necessary to modify the dose of some of them or even interrupt treatment:

• Quinolone antibiotics (for example: oxolinite acid, ciprofloxacin), linezolid, and erythromycin.
• Oral contraceptives.
• Antidepressants, such as monoamine oxidase inhibitors (MAOIs) or lithium.
• Barbiturates (used as hypnotics-sleep alterations-, sedatives, and anticonvulsants).
• Adrenergic bronchodilators and theophylline (used to combat bronchial asthma).
• Cimetidine (used to treat excessive stomach acid and stomach ulcers).
• Disulfiram (used in treatments for alcohol consumption cessation).
• Phenytoin (used to treat epilepsy).
• Furazolidone (antidiarrheal).
• Iron (used to treat anemia).
• Mexiletine used for heart rhythm alterations (cardiac arrhythmias).
• Procarbazine (anticancer).
• Selegiline (used to treat Parkinson's disease).
• Thyroxine (used to treat thyroid diseases).

Interference with diagnostic tests:

If you are to undergo any diagnostic test (blood or urine analysis, ...), inform your doctor that you are taking this medication, as it may alter the results of these tests.

Additionally, diabetic patients should be aware that caffeine can increase blood glucose levels.

Taking Durvitan 300 mg with food and drinks.

Limit the consumption of caffeine-containing beverages (coffee, tea, chocolate, and cola drinks) while taking this medication.

Pregnancy

Consult your doctor or pharmacist before using any medication.

Lactation

Consult your doctor or pharmacist before using any medication.

Avoid taking Durvitan 300 mg, as, although caffeine passes into breast milk in small amounts (around 1%), it can accumulate in the infant.

Use in children

Do not use this medication in children under 12 years old.

Driving and operating machinery

No effects on the ability to drive and operate machinery have been described at the recommended doses.

Important information about some of the components of Durvitan 300 mg

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow these instructions unless your doctor has given you different ones. Consult your doctor or pharmacist if you have any doubts.

The patient should be aware that there are other sources of caffeine (coffee, tea, chocolate, cola soft drinks) that can produce a similar effect to this medication. Therefore, it is recommended to moderate the consumption of these beverages while taking Durvitan 300 mg.

Oral administration.

• Individuals over 12 years old:

Swallow 1 capsule with water or food. If necessary, up to 3 capsules can be taken per day, spacing the intake of each capsule at least 6 hours apart.

Do not take the last dose within 6 hours of bedtime to avoid insomnia.

Do not take more than 3 capsules per day, divided into several doses.

• Children under 12 years old: should not be used in this population.
• Patients with liver disease: should consult their doctor before taking this medication.

If you observe that the symptoms worsen, or if they persist for more than 7 days, you should consult your doctor.

If you take more Durvitan 300 mg than you should:

If you have taken Durvitan 300 mg in excess, consult your doctor or pharmacist immediately.

The symptoms of overdose are characterized by a first phase of excitement, followed by dizziness, vomiting, diarrhea, abdominal pain, and seizures. The treatment of overdose is more effective if it is performed within the first 4 hours after ingestion of this medication.

In case of overdose or accidental ingestion, visit your doctor or call the Toxicological Information Service (phone: 91.5620420), indicating the medication and the amount ingested.

Like all medications, Durvitan 300 mg may have adverse effects, although not all people may experience them.

Very frequently (in more than 1 in 10 patients), the following may occur: insomnia, restlessness, and excitement.

Frequently (in less than 1 in 10 but more than 1 in 100 patients), the following may occur: nausea, vomiting, diarrhea, stomach pain, headache, tinnitus, disorientation, heart rhythm disturbances, irritability, hot flashes, rapid breathing, and very abundant urine elimination.

At high doses, anxiety and anguish may appear.

In some cases, it may also cause hyperglycemia or hypoglycemia (elevated or decreased blood glucose).

Treatment should be immediately suspended if the patient experiences any episode of dizziness or palpitations.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

No special storage conditions are required.

Expiration Date

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

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Durvitan 300 mg

• Each prolonged-release hard capsule contains 300 milligrams of caffeine as the active ingredient.
• The other components (excipients) are: cornstarch, sucrose, povidone, Shellac lacquer, and talc.

Appearance of the product and contents of the package

They are prolonged-release hard capsules.

They are presented in boxes containing 1 blister with 10 prolonged-release hard capsules.

Holder of the marketing authorization

Pharmaceutical Notes, S.L. Carretera de Sant Cugat to Rubí, km1 1.

08174 Sant Cugat del Vallés. Barcelona (Spain)

Responsible for manufacturing

Sincrofarm, S.L.

C/ Mercurio, 10. Pol. Ind. Almeda

08940 - Cornellá de Llobregat. Barcelona (Spain).

This leaflet was approved in: April 2007