COFFEINUM

COFFEINUM N 0.2 g tablets

Important notes (mandatory information)

Coffeinum N 0.2 g Tablets Active ingredient: Caffeine anhydrous. Areas of application: taken for the short-term elimination of fatigue symptoms.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Coffeinum N 0.2 g Tablets
Active ingredient: Caffeine anhydrous

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment results, Coffeinum N 0.2 g must be used as prescribed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve, you must see a doctor in any case.
• If any of the listed side effects affect you significantly or you notice side effects that are not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. WHAT IS COFFEINUM N 0.2 G AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING COFFEINUM N 0.2 G?
3. HOW SHOULD COFFEINUM N 0.2 G BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD COFFEINUM N 0.2 G BE STORED?
6. FURTHER INFORMATION

1. WHAT IS COFFEINUM N 0.2 G AND WHAT IS IT USED FOR?

Coffeinum N 0.2g is a medicine with a stimulating effect on the central nervous system. Coffeinum N 0.2 g is taken for the short-term elimination of fatigue symptoms.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING COFFEINUM N 0.2 G?

Coffeinum N 0.2 g must not be taken if you are hypersensitive (allergic) to caffeine or any of the other ingredients of Coffeinum N 0.2 g. So far, no contraindications have become known when taking Coffeinum N 0.2g.

Special care should be taken when taking Coffeinum N 0.2 g in

Patients with cardiac arrhythmias, such as sinus tachycardia/extrasystoles (risk of intensification), patients with liver cirrhosis (risk of caffeine accumulation), patients with hyperthyroidism (risk of intensification of the caffeine side effect) and patients with anxiety syndromes (risk of intensification) should only receive caffeine in a low dosage (approx. 100 mg) or under medical supervision. Long-term abuse of high doses is warned against due to the possible occurrence of symptoms of caffeinism.

When taking Coffeinum N 0.2 g with other medicines

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines. Caffeine counteracts the calming effects of numerous substances, such as barbiturates, antihistamines, etc., and intensifies the heart rate-increasing effects of, for example, sympathomimetics, thyroxine, etc. In the case of substances with a broad spectrum of action, the interactions in detail can be different and not predictable (e.g. benzodiazepines). The promoting influence of caffeine on the absorption (resorption) of ergotamine and dihydroergotamine has not been sufficiently proven experimentally. Oral contraceptives (contraceptives), cimetidine and disulfiram reduce the caffeine breakdown in the liver, barbiturates and smoking accelerate it. The excretion of theophylline is reduced by caffeine. The simultaneous administration of antibiotics from the group of gyrase inhibitors (quinolones) can delay the excretion of caffeine and its degradation product paraxanthine. Caffeine increases the addiction potential of substances of the ephedrine type. In various studies, a 1.3 to 1.7 times stronger effect of the painkiller was found when 50 mg of caffeine and paracetamol or acetylsalicylic acid were administered at the same time. This can lead to a corresponding saving of the analgesic substance. There is no evidence that a possible addiction potential of analgesics such as acetylsalicylic acid or paracetamol is increased by caffeine. Even if it can be assumed due to theoretical considerations, an independent abuse potential of caffeine in combination with analgesics has not been proven based on the current knowledge.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking/using any medicine. During breastfeeding, the infant's condition and behaviour may be affected. The specified dosages should not be exceeded during pregnancy and breastfeeding.

Driving and operating machinery

When used as intended, caffeine does not impair the ability to drive or operate machinery. However, the possibility of compensating for reduced performance should not be overestimated. Caffeine does not compensate for the performance impaired by alcohol; in individual cases there is a risk of accelerated absorption (resorption) of alcohol.

Important information about certain other ingredients of Coffeinum N 0.2 g

This medicine contains lactose. Therefore, please only take Coffeinum N 0.2 g after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW SHOULD COFFEINUM N 0.2 G BE TAKEN?

Always take Coffeinum N 0.2 g exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure.
Unless otherwise prescribed by your doctor, the usual dose is: Take 1/2 tablet (if necessary 1 tablet) with liquid. This dose can be repeated if necessary, but not more than 2 times within 24 hours.

Type of application

Coffeinum N 0.2g is taken unchewed, preferably with a little water.

If you have taken a larger amount of Coffeinum N 0.2 g than you should

If an overdose is suspected, a doctor must be contacted immediately. The general therapeutic measures consist of inducing vomiting (if it has not already occurred spontaneously).

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Coffeinum N 0.2 g can have side effects, although not everybody gets them. The following frequency information is used to assess side effects: The occurrence of side effects depends on the individual sensitivity to caffeine and on the daily consumption of caffeinated beverages.

The following categories are used as a basis for the frequency information on side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	Frequency cannot be estimated from the available data.

Heart disease

Even low doses can lead to an increase in heart rate (tachycardia).

Nervous system disorders

Even low doses can lead to insomnia and restlessness. Even in less sensitive people, irritability, headaches and intensification of the natural, normally imperceptible muscle tremor (physiological tremor) can occur at doses above 200 mg. Headaches as well as fatigue, muscle pain, nervousness and vegetative symptoms can occur if abruptly discontinued after prolonged use of higher doses.

Gastrointestinal disorders

Even low doses can lead to gastrointestinal complaints.

Skin and subcutaneous tissue disorders

In individual cases, allergic reactions have been described.

Prolonged use of caffeine, especially in medium and high doses, leads to the development of tolerance to most effects, but also side effects.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Department of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW SHOULD COFFEINUM N 0.2 G BE STORED?

Keep medicines out of the reach of children. Do not use the medicine after the expiry date which is stated on the blister pack and the folding box. The expiry date refers to the last day of the month.

Storage conditions

This medicine does not require any special storage conditions. The medicine must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer need it. This measure helps to protect the environment.

6. FURTHER INFORMATION

The active ingredient is: Caffeine anhydrous. One tablet contains 200 mg of caffeine anhydrous. The other ingredients are: Magnesium stearate (Ph. Eur.), highly dispersed silicon dioxide, talc, lactose monohydrate, corn starch.

What Coffeinum N 0.2 g looks like and contents of the pack

Coffeinum N 0.2 g are almost white, round tablets, slightly curved on one side, with a faceted edge and a dividing groove on one side. Coffeinum N 0.2g is available in packs of 20 and 50 tablets.

Pharmaceutical entrepreneur

Mylan dura GmbH
Postfach 10 06 35
64289 Darmstadt

Manufacturer

Generics (UK) Ltd.
Station Close
Hertfordshire
EN6 1TL
United Kingdom

This package leaflet was last revised in April 2015.

Source: Information from the package leaflet
Status: 03/2016
Active ingredient: Caffeine anhydrous. Areas of application: taken for the short-term elimination of fatigue symptoms.