OLBAS

OLBAS drops

Important notes (mandatory information)

Olbas drops. Areas of application: Traditionally used for ingestion and inhalation for colds (cough, runny nose, hoarseness); for ingestion for mild, cramp-like complaints in the gastrointestinal tract; for external use for mild headaches, e.g. in the case of tension; for external use for localised (local) muscle pain after overexertion/incorrect strain.

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


PACKAGE INSERT: INFORMATION FOR THE USER

Olbas drops, for use in adolescents from 12 years of age and adults
Active ingredient: Distillate from peppermint oil, cajeput oil, eucalyptus oil
Traditional herbal medicinal product

Read the entire package insert carefully, as it contains important information for you. This medicinal product is available without a prescription. However, Olbas drops must be used as directed in order to achieve the best possible treatment results.

• Keep the package insert. 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 within one week, a doctor should be consulted.
• If any of the listed side effects affect you severely or if you notice side effects that are not listed in this package insert, please inform your doctor or pharmacist.

This package insert contains

1. WHAT ARE OLBAS DROPS AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE USING OLBAS DROPS?
3. HOW SHOULD OLBAS DROPS BE TAKEN OR USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD OLBAS DROPS BE STORED?
6. FURTHER INFORMATION

1. WHAT ARE OLBAS DROPS AND WHAT ARE THEY USED FOR?

Olbas drops are a traditional herbal medicinal product. Areas of application: Traditionally used for ingestion and inhalation for colds (cough, runny nose, hoarseness); for ingestion for mild, cramp-like complaints in the gastrointestinal tract; for external use for mild headaches, e.g. in the case of tension; for external use for localised (local) muscle pain after overexertion/incorrect strain. The medicinal product is a traditional medicinal product that is registered exclusively on the basis of many years of use for the area of application.

2. WHAT SHOULD YOU BE AWARE OF BEFORE USING OLBAS DROPS?

Olbas drops must not be used

For all types of application:

• if you are hypersensitive (allergic) to the active ingredients cajeput oil, eucalyptus oil and/or peppermint oil, to their main components cineole and/or menthol and to the other ingredients of Olbas drops,
• in the case of bronchial asthma or other respiratory diseases that are associated with pronounced hypersensitivity of the respiratory tract, as this can lead to a narrowing of the respiratory tract with shortness of breath,
• in infants and toddlers under 2 years of age (risk of laryngeal spasm resulting in severe breathing difficulties).

Internal use and inhalation

• in the case of diseases of the biliary tract, e.g. a blockage of the bile ducts or gallstones,
• in the case of liver diseases,
• in the case of inflammatory kidney diseases,
• in the case of known stomach diseases, e.g. achlorhydria (lack of stomach acid).

Special care is required when using Olbas drops

The user should consult a doctor or other qualified person in the healthcare profession if symptoms of illness persist or if side effects other than those mentioned in the package insert occur.

For internal use

• In patients who already suffer from heartburn or have a diaphragmatic hernia (hiatal hernia), taking peppermint oil-containing preparations can sometimes lead to an intensification of the existing symptoms. Treatment should then be discontinued.
• Peppermint oil should only be used with caution in the case of inflammatory and ulcerative diseases of the gastrointestinal tract.

Inhalation:

• When inhaling Olbas drops, avoid contact of the medicinal product with the eyes.

For use on the skin

• After using Olbas drops, hands should be cleaned thoroughly. Avoid contact with the eyes.
• Olbas drops should not be used on damaged or irritated skin.

When using Olbas drops with other medicinal products

Interactions with other medications have not been studied. No interactions with Olbas drops have been reported to date. Please inform your doctor or pharmacist if you are taking or using, or have recently taken or used, other medicines, even if they are non-prescription medicines.

Children

There are no sufficient studies on the use of this medicinal product in children for all of the indicated areas of application. It should therefore not be used in children under 12 years of age. Children and adolescents under 18 years of age should generally have headaches and gastrointestinal complaints clarified by a doctor. Olbas drops should therefore not be used in this age group as part of self-medication.

Pregnancy and breast-feeding

Internal use and inhalation

Olbas drops should not be used during pregnancy and breast-feeding due to insufficient studies. Due to the fat-soluble properties of the active ingredients, it is to be expected that they will pass into breast milk, but no studies have been conducted on this. Essential oils can change the taste of milk and lead to drinking problems.

External use

Olbas drops should not be used during pregnancy and breast-feeding due to insufficient studies.

Driving and operating machinery

No special precautions are required.

3. HOW SHOULD OLBAS DROPS BE TAKEN OR USED?

Always use Olbas drops exactly as described in this package insert. Please ask your doctor or pharmacist if you are not sure.

Dosage and type of application

Internal use for colds

Adults and adolescents over 12 years of age: Take 3 drops in a little lukewarm water 3 times a day. Use is not intended for children under 12 years of age.

Internal use for mild, cramp-like complaints of the gastrointestinal tract

Adults from 18 years of age: Take 3 drops in a little lukewarm water 3 times a day. Use is not intended for children and adolescents under 18 years of age.

Inhalation for colds

Adults and adolescents over 12 years of age: Add 2 - 4 drops to a container of hot water and inhale the rising vapours. The application can be repeated up to 3 times a day. Use is not intended for children under 12 years of age.

External use for mild headaches

Adults from 18 years of age: Apply 2 - 3 drops to the forehead, temples or neck 3 times a day. When applying to the forehead, Olbas drops must not accidentally get into the eyes. It causes unpleasant burning in the eyes. Use is not intended for children and adolescents under 18 years of age.

External use for muscle pain

Adults and adolescents over 12 years of age: Apply 2 - 3 drops carefully to the corresponding muscle areas 3 times a day. Use is not intended for children under 12 years of age. Also observe the precautions under point 2. Caution! Wash hands thoroughly after all applications so that Olbas is not accidentally rubbed into the eyes. It causes unpleasant burning in the eyes.

Duration of use

The traditional duration of use for colds is 1 - 2 weeks. Use for headaches and mild, cramp-like complaints in the gastrointestinal tract is only intended for short-term use (2 - 3 days) for acute complaints. If there is no improvement after one week of external use for muscle pain, you must consult a doctor in any case. It is recommended not to use the medicinal product externally on the skin for longer than 2 weeks. Also observe the precautions under point 2.

If you have taken more Olbas drops than you should

No overdose symptoms with Olbas drops have been reported to date.

For internal use

Overdoses may cause severe gastrointestinal complaints, diarrhoea, rectal ulcers, seizures, loss of consciousness, respiratory arrest (apnoea), nausea, cardiac arrhythmias, movement coordination disorders (ataxia) and other disorders of the central nervous system due to the menthol contained. In the event of an overdose, a gastric lavage should be performed. It should be further monitored and treated symptomatically if necessary. Kidney damage may occur in the case of long-term use and overdose of juniper berry oil-containing preparations.

For inhalation

Inhalation of large amounts of menthol can lead to dizziness, confusion, muscle weakness, nausea and double vision.

For use on the skin

No cases of overdose are known.

If you forget to use Olbas drops, do not take a double dose, but continue as described in the package insert.

If you stop using Olbas drops, you can stop using them at any time without hesitation.

If you have any further questions about the use of the medicinal product, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Olbas drops can have side effects, although not everybody gets them.

The following categories are used as a basis for the frequency of 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.

Possible side effects

Olbas drops can cause laryngeal spasm in infants and children up to 2 years of age, resulting in severe breathing difficulties. The frequency is not known.

For internal use:

• Heartburn, perianal burning, blurred vision, nausea and vomiting have been reported. The frequency is unknown.
• Local hypersensitivity reactions to menthol and peppermint oil with burning in the oral cavity, recurrent mucosal ulcers or lichen-like skin changes have been reported. The frequency is unknown.
• Allergic reactions to menthol with skin rash, skin redness and headache, shortness of breath, bradycardia, muscle tremors, movement coordination disorders (ataxia), allergic shock have been reported. The frequency is unknown.
• Menthol odour in urine and stool, pain when urinating (dysuria) and inflammation of the glans (balanitis) have been observed. The frequency is unknown.
• Kidney damage may occur in the case of long-term use and overdose of juniper berry oil-containing preparations.

For inhalation:

• Coughing, respiratory arrest (apnoea), bronchial and laryngeal spasm have been reported in hypersensitive patients. The frequency is unknown.

For use on the skin:

• Hypersensitivity reactions such as skin rash, contact dermatitis have been reported. The frequency is unknown.
• Irritation of the skin and mucous membrane, e.g. eye irritation, irritation of the nasal mucous membrane are possible after application. The frequency is unknown.

If side effects occur, the preparation should be discontinued for the time being and, if necessary, a doctor should be consulted. If you notice swelling in the face, mouth and/or throat or allergic reactions of the respiratory tract, acute shortness of breath, you should see a doctor immediately.

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 insert. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information about the safety of this medicine.

5. HOW SHOULD OLBAS DROPS BE STORED?

Medicines should not be used after the expiry date. Keep medicines out of the reach of children! Shelf life after opening: 12 months.

6. FURTHER INFORMATION

What Olbas drops contain

10 g (= 11.1 ml) of liquid contain: Distillate from active ingredients: peppermint oil 5.3 g, cajeput oil 2.1 g, eucalyptus oil 2.1 g. Other ingredients: juniper berry oil 0.3 g, Gaultheria oil 0.2 g.

What Olbas drops look like

Olbas drops is a clear liquid.

Dosage form and pack sizes

Pack of 1 dropper bottle of liquid at 12 ml and pack of 1 dropper bottle of liquid at 50 ml.

Pharmaceutical entrepreneur and manufacturer

Deutsche Olbas GmbH
Hutwiesenstr. 14
D-71106 Magstadt
www.olbas.de

This package insert was last revised in August 2014.

Source: Information from the package insert
Status: 02/2018
Areas of application: Traditionally used for ingestion and inhalation for colds (cough, runny nose, hoarseness); for ingestion for mild, cramp-like complaints in the gastrointestinal tract; for external use for mild headaches, e.g. in the case of tension; for external use for localised (local) muscle pain after overexertion/incorrect strain.