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Mylan Healthcare GmbH

COFFEINUM N 0.2 g tablets 20 pc Caffeine, elimination of signs of fatigue

COFFEINUM N 0.2 g tablets 20 pc Caffeine, elimination of signs of fatigue

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Caffeinum N 0.2 g tablets, Caffeine, elimination of signs of fatigue
Active substance: Caffeine, anhydrous Area of
application:
For the short-term elimination of signs of fatigue

Active substance: Caffeine

Coffeinum N 0.2 g tablets Active ingredient: Caffeine anhydrous. Indications: Taken for the short-term relief 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 directed.

  • Keep this leaflet. You may want to read it again later.
  • Ask your pharmacist if you need further information or advice.
  • If your symptoms worsen or do not improve, you must definitely consult a doctor.
  • If any of the side effects listed affect you seriously or if you notice side effects not listed in this 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 I TAKE COFFEINUM N 0.2 G?
  4. WHAT SIDE EFFECTS ARE POSSIBLE?
  5. HOW SHOULD COFFEINUM N 0.2 G BE STORED?
  6. MORE INFORMATION



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

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

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

Coffeinum N 0.2 g should not be taken if you are hypersensitive (allergic) to caffeine or any of the other ingredients of Coffeinum N 0.2 g. To date, no contraindications have been identified for taking Coffeinum N 0.2 g.

Special caution is required when taking Coffeinum N 0.2 g in the following cases:
Patients with cardiac arrhythmias, such as sinus tachycardia/extrasystoles (risk of exacerbation), patients with liver cirrhosis (risk of caffeine accumulation), patients with hyperthyroidism (risk of exacerbation of caffeine side effects), and patients with anxiety syndromes (risk of exacerbation) should only receive caffeine in low doses (approx. 100 mg) or under medical supervision. Long-term abuse of high doses is cautioned due to the possible occurrence of symptoms of caffeinism.

When taking Coffeinum N 0.2 g with other medications:
Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, including medicines obtained without a prescription. Caffeine counteracts the sedative effects of many substances, such as barbiturates, antihistamines, etc., and increases the heart rate-increasing effects of sympathomimetics, thyroxine, etc. With substances with a broad spectrum of action, the interactions can vary from individual to individual and cannot be predicted (e.g. benzodiazepines). The stimulating influence of caffeine on the uptake (absorption) of ergotamine and dihydroergotamine has not been sufficiently proven experimentally. Oral contraceptives, cimetidine and disulfiram reduce the breakdown of caffeine in the liver, barbiturates and smoking accelerate it. The excretion of theophylline is reduced by caffeine. The simultaneous administration of antibiotics from the gyrase inhibitor group (quinolones) can delay the excretion of caffeine and its metabolite paraxanthine. Caffeine increases the addictive potential of ephedrine-type substances. Various studies have found that the simultaneous administration of 50 mg of caffeine and paracetamol or acetylsalicylic acid increases the effect of the painkiller by a factor of 1.3 to 1.7. This can lead to a corresponding reduction in the analgesic substance. There is no evidence that caffeine increases the potential for addiction to analgesics such as acetylsalicylic acid or paracetamol. Although this can be assumed based on theoretical considerations, current evidence does not support the independent abuse potential of caffeine in combination with analgesics.

Pregnancy and breastfeeding:
Consult your doctor or pharmacist before taking/using any medication. The well-being and behavior of the infant may be affected during breastfeeding. The stated dosages should not be exceeded during pregnancy and breastfeeding.

Ability to drive and operate machinery:
When used as directed, 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 performance impaired by alcohol; in individual cases there is a risk of accelerated absorption of alcohol.

Important information about certain other ingredients of Coffeinum N 0.2 g:
This medicinal product 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 YOU TAKE COFFEINUM N 0.2 g?

Always take Coffeinum N 0.2 g exactly as directed 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 (or 1 tablet if necessary) with liquid. This dose can be repeated if necessary, but not more than twice within 24 hours.

Method of administration:
Coffeinum N 0.2 g is swallowed whole, preferably with some water.

If you take more Coffeinum N 0.2 g than you should:
If an overdose is suspected, contact a doctor immediately. The general treatment consists of inducing vomiting (if this does not occur spontaneously).

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

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

The following categories are used to indicate the frequency of side effects:
Very common: more than 1 in 10 treated patients
Frequently: 1 to 10 treated patients out of 100
Occasionally: 1 to 10 patients treated in 1,000
Rarely: 1 to 10 treated patients out of 10,000
Very rare: less than 1 in 10,000 treated
Not known: Frequency cannot be estimated based on 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 individuals, doses above 200 mg can cause irritability, headaches, and an increase in natural, normally imperceptible muscle tremors (physiological tremor). If the drug is abruptly discontinued after prolonged use of higher doses, headaches, fatigue, muscle pain, nervousness, and autonomic symptoms can occur.

Gastrointestinal disorders:
Even low doses can lead to gastrointestinal discomfort.

Skin and subcutaneous tissue disorders:
Allergic reactions have been reported in isolated cases.

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

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

5. HOW SHOULD COFFEINUM N 0.2 G BE STORED?

Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister pack and carton. The expiry date refers to the last day of that month.

Storage conditions:
This medicine does not require any special storage conditions. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

The active ingredient is: Caffeine anhydrous. One tablet contains 200 mg 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 what the pack contains:
Coffeinum N 0.2 g are almost white, round tablets, slightly convex on one side, with a faceted edge and a scoring line on one side. Coffeinum N 0.2 g is available in packs of 20 and 50 tablets.

Pharmaceutical Entrepreneur:
Mylan dura GmbH,
Postfach 10 06 35,
64289 Darmstadt, Germany

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

This leaflet was last revised in April 2015.

Source: Information from the package leaflet.
Version: 03/2016Active ingredient: Caffeine anhydrous. Indications: Taken for the short-term relief of fatigue symptoms.

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