Here you will find important information on how to take or use your medicinal product.

Tablets should normally be taken in an upright sitting position with a sufficient amount of liquid (at least 125 ml water).

Time of administration

To achieve the best possible effectiveness and tolerability, it is important to take the medicine at the right time. For certain drugs, such as antibiotics it is particularly important to pay close attention to the correct time of administration in order to achieve an optimal and steady concentration of the active ingredient. Even when the signs of the illness subside, the duration of treatment prescribed by the doctor needs to be strictly adhered to, otherwise the effect of the therapy may be delayed or reduced. If an antibiotic therapy is stopped prematurely, resistance to antibiotics may develop.

Frequency of use

• Once a day:
  The medicines should always be taken at the same time each day.
• Twice a day:
  In order to keep the level of active ingredients in the body sufficiently high, it should be taken every twelve hours.
• Three times a day:
  The medicinal product should be taken every eight hours. When choosing the actual time of administration, the sleeping time should be taken into account so that the interval of eight hours is not exceeded.

Influence of meal times

• Independent of a meal:
  The medicines can be taken independently of the meal, i.e. before, during or after the meal.
• On an empty stomach:
  The medicine should be taken 30 to 60 minutes before meals or at the earliest two hours after meals.
• Before a meal:
  The medication should be taken 30 to 60 minutes before the meal.
• With a meal:
  Some medicines (e.g. certain painkillers) may cause stomach irritation when fasting and should therefore be taken with or shortly after food.
• After a meal:
  It should be taken two hours after eating so that the food has already left the stomach.

Time of day

For some active ingredients, the time of day at which the medicinal product is taken is important. Certain bodily functions depend on the natural body rhythm (e.g. function of the gastrointestinal tract, the kidneys or the cardiovascular system). This can also influence the effect of medicinal products.

• in the morning:
  Ideally, thyroid hormones and cortisone preparations should be taken early in the morning, unless otherwise prescribed by the doctor.
• in the evenings:
  Certain rheumatism remedies are better tolerated in the evening. Some antidepressants should be taken in the evening because of their sleep-promoting effect.

So-called dosage aids (“pill boxes”) provide a better overview. These are particularly helpful if a patient needs to take several different medicines.

Breakability of tablets

In principle, tablets should only be divided if this is explicitly highlighted in the package leaflet. In this case, many tablets have a score line specially designed for this purpose. If the information as to whether division is possible is not included in the instructions for use, the tablet should only be divided (halved or quartered) after consultation with the doctor or pharmacist.

If tablets are divided, the patient should ensure equal-sized pieces to ensure that each portion contains the same amount of active ingredient. Here a so-called tablet divider can be used.

The following dosage forms should under no circumstances be divided without consulting the doctor or pharmacist:

• Film-coated tablets
  Film-coated tablets have a coating that protects the active ingredient from stomach acid, so that it is only released in the intestine. The film also makes it easier to swallow and masks a potentially unpleasant taste. For these reasons, film-coated tablets should not be broken but swallowed whole.
• Prolonged-release tablets/capsules
  In prolonged-release dosage forms, the release of the active ingredient is delayed or slowed down. Even if taken only once a day, this form of medication can maintain a certain drug level in the blood throughout the day. If the prolonged-release tablet is divided or a prolonged-release capsule is opened, the active ingredient is suddenly released into the body and an overdose can occur.

The diligent and correct intake of medicines is a prerequisite for ensuring optimal efficacy and safety. The simultaneous intake of food and medicines can have negative consequences. A delayed absorption of the active substance (resorption) or a change in the mechanism of action may occur. For the most parts, delayed absorption affects active substances that are mainly absorbed in the intestine. The reason for this is the delayed emptying of the stomach due to food. This mechanism also exists, for example, in paracetamol, a medicine frequently used in pain and fever. Paracetamol therefore works much faster when taken on an empty stomach.

In general, the rate of absorption is very important for short-term therapy (e.g. headaches). In long-term therapies it is more important to ensure a constant and sufficient concentration of the active substance.

The following foods and medications should not be taken together:

• Alcohol
  Alcohol is broken down in the liver in the same way as many drugs. Taking certain medicines at the same time, such as certain antibiotics (cephalosporins, metronidazole) and antifungals (ketoconazole, griseofulvin) can lead to a higher concentration of active substances in the organism and an increased or prolonged effect. The combination with painkillers, sleeping pills, sedatives or antidepressants should also be avoided, as the central damping effect and side effects can be considerably increased. Alcohol should generally be avoided when taking drugs.
   
• Coffee, tea
  Iron tablets which are used for example for anaemia, should not be taken together with coffee or tea. Coffee and tea contain tannic acid. In the stomach this acid binds to the iron and thus prevents it from being absorbed by the body. Orange juice, on the other hand, can support better absorption.
   
• Grapefruit juice
  Grapefruits contain certain substances that inhibit the breakdown of many drugs in the liver. Thus, the concentration of active substances can be increased by three times, which can result in a severe overdose. This applies, for example, to some blood pressure-lowering drugs (calcium antagonists), cholesterol-lowering drugs (statins) and drugs that inhibit the body's own immune system (immunosuppressants).
   
• Milk
  The calcium contained in milk can influence its effect when taken together with a medicine. Certain antibiotics and bisphosphonates (drugs against bone loss - osteoporosis), together with calcium form sparingly soluble compounds and are therefore less easily absorbed by the body.
   
• Vitamin K-containing foods
  Vitamin K plays an important role in blood coagulation. It is found mainly in green vegetables (broccoli, lettuce, cabbage, asparagus, spinach, peas, beans) and eggs. The effect of blood-thinning drugs (e.g. Marcoumar), which are used after a heart attack or at risk of thrombosis (danger of blockage of a blood vessel due to the formation of a blood clot), can be reduced by vitamin K-containing foods. It is important to note that this does not apply to heparins.
   
• Liquorice
  When taken with diuretic drugs, liquorice can increase the potassium loss and thus increase side effects, such as muscle weakness, fatigue or cardiac arrhythmia.
   
• Salami, cheese, Sauerkraut and white beans
  The protein product tyramine, which is included in salami, cheese and Sauerkraut is usually broken down in the body by the enzyme monoaminooxidase. While taking certain antidepressants, so called monoaminooxidase inhibitors tyramine cannot be broken down. Elevated blood pressure, headaches and at worst, cerebral haemorrhages can result.

When taking medicines, always pay attention to the instructions in package leaflet in order to avoid interactions between medicines and foods. If you have any questions, contact your doctor or pharmacist.

The European Medicines Agency (EMA) recommends the following measures to ensure the safe and successful use of adrenaline auto-injectors:

• Introduction of new training material
• For safety reasons, patients should always carry two auto-injectors with them

Measures at the EU level 

Adrenaline auto-injectors are used for emergency self-treatment of anaphylaxis (severe allergic reactions) during the period when the patient is waiting for emergency medical care.

The European Medicines Agency (EMA) carried out a review due to concerns that the auto-injectors currently available only transport adrenaline under the skin rather than into the muscle, thereby delaying efficacy. After evaluating the available data, the Committee for Medicinal Products for Human Use (CHMP) concluded that intramuscular administration can ensure a faster, more effective onset of action in the treatment of anaphylaxis. The CHMP states that several factors are responsible for whether the adrenaline administered actually enters the muscle as intended, such as the length of the needle, the thickness of the subcutaneous fat layer, the functioning of the auto-injector (with or without spring activation), the angle at which the device is placed on the skin, the force used to activate the device, and whether sufficient attention is paid to the instructions for use.

The CHMP concluded that user training is of paramount importance. Regulatory holders marketing adrenaline auto-injectors are therefore encouraged to develop more effective teaching materials for patients and health professionals to ensure optimal use. Training equipment will be provided to enable patients to practice and audio-visual training material will be provided to illustrate the use of the auto-injector. In addition, a checklist for physicians should ensure that patients are adequately informed before using the auto-injector.

The Summary of Product Characteristics (SmPC) and the package leaflet will be accompanied by further warnings, including a recommendation that patients should always carry two auto-injectors for safety reasons. There should also be instructions for family members, caregivers or teachers on how to use the auto-injector.

These CHMP recommendations will now be sent to the European Commission for a legally binding decision.  

Recommendations of the BASG

• Recommendations for patients:

Adrenaline auto-injectors are used to treat severe allergic reactions while the patient is waiting for emergency medical attention. They are designed to be used by the patient himself or by caregivers.

A review showed that in order to ensure successful and safe use of auto-injectors, further training for patients is required.

All patients are trained by their doctor or nurse in the use of the adrenaline auto-injector. A training device is being developed so that people can practice before the auto-injector is needed in an emergency. A training video is provided to illustrate the use of the injector. It is important that the auto-injector is used correctly to ensure that the adrenaline gets into the muscle to work as quickly as possible.

If you have been prescribed an adrenaline auto-injector because you have an increased risk of allergic reactions, you should be familiar with its use and always carry the injector with you.

Your doctor will probably recommend that you always have two injectors handy in case one dose is not enough.

Family members, caregivers, or teachers should be familiar with correct use.

If you are unsure how to use it, ask your doctor or pharmacist to explain it to you again.

• Recommendations for health professionals:

A review of adrenaline auto-injectors has shown that intramuscular administration is the preferred method of administration to ensure effective treatment of anaphylaxis.

Several factors are responsible for whether the administered adrenaline actually enters the muscle: needle length, subcutaneous fat tissue, the way the auto-injector works (with or without spring activation), the angle of insertion, and the force required to activate the device.

Due to the uncertainty of the release of adrenaline, it is recommended to prescribe two auto-injectors, one for the patient and the other for the patient.

Various training materials are being developed to ensure effective use by patients or caregivers. This includes a training device that allows patients to practice in advance, audio-visual teaching material and a checklist for the prescribing physician.

A 2013 study by Brown et al. showed that 15% of mothers were unable to successfully use the auto-injector on their children. This circumstance supports the introduction of appropriate training and comprehensive training material for patients and health professionals.

Marketing authorisation holders of adrenaline auto-injectors are encouraged to conduct pharmacokinetics / pharmacodynamics studies to better understand the mechanism by which adrenaline enters body tissue through the auto-injector.

Press release of the European Medicines Agency

Transdermal patches, also known as "Transdermal Therapeutic Systems" (TTS), contain a drug reservoir and continuously release a precisely defined amount of the drug. This is absorbed directly into the bloodstream via the skin. This has the advantage that the active ingredient is not influenced by digestion, e.g. by gastric and intestinal juices or the degradation in the liver ("first pass effect").

Types of Transdermal Therapeutic Systems (TTS)

• With the matrix plaster, the active ingredient is evenly distributed over a matrix and applied directly to the skin with the aid of an adhesive layer.
• With the membrane patch, the active ingredient is in a reservoir and is released to the skin via a membrane. With a injury of the diaphragm the danger exists that suddenly large quantities of the active substance are set free (dose-dumping).

TTS can contain various active ingredients, such as

• Pain patches are used to treat severe pain, such as back or tumor pain. They contain pain-relieving substances such as diclofenac or opioids such as fentanyl.
• Nicotine patches are used to support smoking cessation.
• The hormone patches are used, among other things, to prevent or treat menopausal symptoms. 
• Heat patches are used to treat muscle pain.

General instructions for the use of transdermal plasters:

• Read the entire instructions for use carefully before use.
• After removing the protective film, do not touch the adhesive layer with your fingers, as the patch may not stick well. After the adhesive has been applied, press the patch on with your flat hand to achieve an optimal adhesive effect.
• The plasters may only be cut with scissors if this is expressly possible according to the instructions for use.
• The area of skin to which the patch is to be applied should not be greasy, injured or irritated.
• Increased temperatures (e.g. in the sauna) could accelerate the release of the active ingredient or reduce the adhesive strength of the plaster.

Please refer to Disposal of medicinal products for special notes on disposal of transdermal patches.