Caffeine has a stimulating action on the nervous system.

It is indicated for the relief of the occasional and temporary sensation of lack of strength or physical weakness.

Do not take Durvitan 300 mg

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

In severe disorders of the liver, heart, stomach ulcer, duodenum or high blood pressure.

Take special care with Durvitan 300 mg

• If you suffer from any disease or disorder of the liver, thyroid, or stomach, you should consult your doctor before taking this medicine.
• You should consult your doctor before taking this medicine if you suffer or have suffered from heart diseases or disorders (cardiac arrhythmia, myocardial ischemia, angina pectoris, ...), especially when performing physical exercise or being in high altitude places.
• If you are diabetic, you should be aware that caffeine can raise blood sugar levels.
• If you are sensitive to other xanthines such as: theophylline, aminophylline ..., you should consult your doctor before taking this medicine.
• You should not take this medicine in the 6 hours before you go to sleep.
• This medicine should not replace normal sleep or rest.

Use of other medications

Please inform your doctor or pharmacist if you are using or have recently used any other medicines, even those obtained without a prescription.

In particular, if you are using some of the following medicines, it may be necessary to change the dose of some of them or even stop treatment:

• Anti-infectives from the group of quinolones (for example: oxolinic acid, ciprofloxacin), linezolid and erythromycin.
• Oral contraceptives.
• Antidepressants, such as monoamine oxidase inhibitors (MAOIs) or lithium.
• Barbiturates (used as hypnotics -for sleep disturbances-, sedatives and anticonvulsants).
• Adrenergic bronchodilators and theophylline (used to fight bronchial asthma).
• Cimetidine (used to treat excess gastric secretion and stomach ulcer).
• Disulfiram (used in treatments to stop drinking alcohol).
• Phenytoin (used to treat epilepsy).
• Furazolidone (antidiarrheal).
• Iron (used to treat anemia).
• Mexiletine used for heart rhythm disturbances (cardiac arrhythmias).
• Procarbazine (anticancer).
• Selegiline (used to treat Parkinson's).
• Thyroxine (used to treat thyroid diseases).

Interference with diagnostic tests:

If you are going to perform a diagnostic test (blood tests, urine tests,…), tell your doctor that you are taking this medicine, as it may alter the results of these tests.

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

Taking Durvitan 300 mg with food and drink.

Limit consumption of beverages that contain caffeine (coffee, tea, chocolate, and cola drinks) while you are taking this medication.

Pregnancy

Consult your doctor or pharmacist before taking any medicine.

Lactation

Consult your doctor or pharmacist before taking any medicine.

The intake of Durvitan 300 mg should be avoided, since, although caffeine passes into breast milk in small amounts (about 1%), it can accumulate in the infant.

USE IN CHILDREN

DO NOT USE THIS MEDICINE IN CHILDREN UNDER 12 YEARS OLD.

Driving and using machines

No effect on the ability to drive and use machinery has been reported at the recommended doses.

Important information about some of the ingredients of Durvitan 300 mg

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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

The patient should take into account that there are other sources of caffeine (coffee, tea, chocolate, cola soft drinks) that can produce an effect similar to that of this medicine. Therefore, it is recommended to moderate the consumption of these drinks while taking Durvitan 300 mg.

Orally.

• Over 12 years :

Take 1 capsule with water or some food. If necessary, you can take up to 3 capsules a day, spacing the intake of each capsule at least 6 hours.

You should not take the last dose in the 6 hours before going to bed, to avoid possible insomnia.

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

• Children under 12 years : should not be used in this population.
• Patients with liver diseases : should consult a doctor before taking this medicine.

If you notice that the symptoms get worse, or if they persist for more than 7 days, you should consult a doctor.

If you take more Durvitan 300 mg than you should:

If you have taken Durvitan 300 mg more than you should, consult your doctor or pharmacist immediately.

Overdose symptoms are characterized by a first phase of excitement, followed by dizziness, vomiting, diarrhea, abdominal pain, and seizures. Treatment of overdose is most effective if it is carried out within the first 4 hours after ingestion of this medicine.

In case of overdose or accidental ingestion, see your doctor or call the Toxicology Information Service (telephone: 91.5620420), indicating the medicine and the amount ingested.

Like all medicines, Durvitan 300 mg can have side effects, although not everyone gets them.

Very frequently (in more than 1 in 10 patients), it can occur: insomnia, restlessness and excitement.

Frequently (in less than 1 in 10 but in more than 1 in 100 patients), the following may occur: nausea, vomiting, diarrhea, stomach pain, headache, ringing in the ears, disorientation, heart rhythm disorders, irritability, flushing, rapid breathing, very heavy urine output.

With high doses, anxiety and distress can appear.

In some cases, hyperglycemia or hypoglycemia (increase or decrease in blood glucose) may also occur.

The treatment should be suspended immediately, in the case in which the patient experiences an episode of dizziness or palpitations.

If you consider that any of the side effects you suffer is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

It does not require any special storage conditions.

Expiration

Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unneeded medicine and containers. This 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 ingredients (excipients) are: cornstarch, sucrose, povidone, Shellac lacquer and talc.

What the product looks like and contents of the pack

They are prolonged-release hard capsules.

It comes in boxes containing 1 blister with 10 prolonged-release hard capsules.

Marketing authorization holder

Anotaciones Farmacéuticas, SL Carretera de Sant Cugat a Rubí, km1 1.

08174 Sant Cugat del Vallés. Barcelona, Spain)

Responsible for manufacturing

Sincrofarm, SL

C / Mercurio, 10. Pol. Ind. Almeda

08940 - Cornellá de Llobregat. Barcelona, Spain).

This leaflet was approved in: April 2007