LORA ADGC

LORA ADGC tablets

Important notes (mandatory information)

Lora-ADCG Tablets. Active ingredient: Loratadine. Areas of application: for the treatment of complaints in the case of allergic rhinitis (e.g. hay fever) and in the case of chronic, idiopathic urticaria (nettle rash of unknown cause).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Lora-ADCG Tablets
Active ingredient: Loratadine 10 mg, tablets

Read the entire package leaflet carefully before you start taking Lora-ADCG, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as instructed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after 3 days, contact your doctor.

This package leaflet contains

1. WHAT IS LORA–ADCG AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO CONSIDER BEFORE TAKING LORA–ADCG?
3. HOW TO TAKE LORA–ADCG?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE LORA–ADCG?
6. FURTHER INFORMATION

1. WHAT IS LORA-ADGC AND WHAT IS IT USED FOR?

Lora-ADGC belongs to the group of antihistamines and is used to treat the symptoms of certain allergic diseases that are associated with increased histamine release. Areas of application: Lora-ADGC is used to treat the symptoms of allergic rhinitis (e.g. hay fever) and in the case of chronic, idiopathic urticaria (nettle rash of unknown cause).

2. WHAT DO YOU NEED TO CONSIDER BEFORE TAKING LORA-ADGC?

Lora-ADGC must not be taken if you are hypersensitive (allergic) to loratadine or any of the other ingredients of Lora-ADGC.

Special care must be taken when taking Lora-ADGC:

• if you suffer from severe liver dysfunction.
• if you are planning to have an allergy test. The use of Lora–ADGC should be discontinued at least 48 hours before skin tests are carried out, as antihistamines such as Lora–ADGC can otherwise prevent or weaken positive reactions to the skin test.

When taking Lora-ADGC and other medicines

Interactions with inhibitors of certain degradation enzymes (CYP3A4 and CYP2D6 inhibitors) are possible. This can lead to increased loratadine levels in the blood and thus to increased side effects. Please inform your doctor or pharmacist if you are taking or have recently taken other medicines, even if they are non-prescription medicines. The effect of alcohol is not increased by taking Lora-ADGC. No interactions were described in the clinical studies carried out.

Pregnancy and breast-feeding

No embryotoxic effect of loratadine was found in animal studies. The safety of using loratadine during pregnancy has not been proven. Therefore, the use of Lora-ADGC during pregnancy is not recommended. Since loratadine passes into breast milk, use during breast-feeding is not recommended. Ask your doctor or pharmacist for advice before taking or using any medicine.

Driving and using machines

Loratadine generally has little influence on the ability to react. Nevertheless, some people may experience drowsiness, which can impair the ability to drive or operate machinery. It is therefore advisable to wait and see how you react to taking Lora-ADGC before driving a vehicle or operating machinery.

Lora-ADGC contains lactose

Therefore, please only take Lora-ADGC after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE LORA-ADGC?

Always take Lora-ADGC exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not quite sure.

Dosage:
Unless otherwise prescribed by your doctor, the usual dose is:

• Adults and adolescents over 12 years: 1 Lora–ADGC tablet once a day (corresponding to 10 mg loratadine).
• Children from 6 to 12 years: With a body weight of over 30 kg: 1 Lora–ADGC tablet once a day (corresponding to 10 mg loratadine).
• With a body weight of 30 kg or less: 1/2 tablet once a day (corresponding to 5 mg loratadine).
• The efficacy and safety of Lora–ADGC in children under 6 years of age have not been proven.

Patients with severe liver damage

An initial dose of 1 Lora-ADGC tablet (corresponding to 10 mg loratadine) every other day is recommended for adults and for children with a body weight of over 30 kg. No dosage adjustment is required for elderly patients or for patients with renal insufficiency.

The tablet can be taken independently of meals. Please talk to your doctor or pharmacist if you have the impression that the effect of Lora-ADGC is too strong or too weak.

Method of administration
For oral use. The tablet is taken whole with a little liquid.

If you have taken more Lora-ADGC than you should
Drowsiness, rapid heartbeat (tachycardia) and headaches have been described in the case of an overdose of loratadine. If you have taken too many Lora-ADGC tablets, please inform your doctor or pharmacist immediately. In the case of an overdose, treatment tailored to the symptoms and supportive treatment must be initiated immediately and continued for as long as necessary. Activated charcoal dissolved in water can be administered. Gastric lavage can be considered. Loratadine is not removed by haemodialysis and it is not known whether loratadine is excreted by peritoneal dialysis. After emergency treatment, the patient must remain under medical supervision.

If you forget to take Lora-ADGC

Do not take double the dose if you have forgotten to take the previous dose. If you have forgotten to take a tablet on time, take it as soon as possible. Then continue as recommended.

If you stop taking Lora-ADGC

If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Lora-ADGC can have side effects.

The following frequency information is used to assess 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.

The list includes all known side effects under treatment with loratadine, including those under higher dosage or long-term therapy. Possible side effects

Immune system

Very rare: hypersensitivity reactions (anaphylaxis)

Nervous system

Common: nervousness
Very rare: dizziness

Heart/circulatory system

Very rare: rapid heartbeat (tachycardia), heart palpitations or racing heart (palpitation)

Gastrointestinal tract

Very rare: nausea, dry mouth, gastritis

Liver and biliary tract

Very rare: liver dysfunction

Skin and subcutaneous tissue

Very rare: rash, hair loss (alopecia)

General disorders

Common: headache, fatigue, drowsiness
Uncommon: insomnia, increased appetite

Reporting of side effects

If you notice 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 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 on the safety of this medicine.

5. HOW TO STORE LORA-ADGC?

Keep medicines out of the reach of children. Do not use the medicine after the expiry date which is stated on the folding box and blister strips.

6. FURTHER INFORMATION

What Lora-ADGC contains

The active ingredient is loratadine. Each tablet contains 10 mg loratadine. The other ingredients are: lactose monohydrate, maize starch, magnesium stearate, povidone K 25.

What Lora-ADGC looks like and contents of the pack

White to off-white, round tablets with a break notch on one side. The tablet can be divided into two equal halves. Lora-ADGC is available in packs of 20 tablets (N1), 50 tablets (N2) and 100 tablets (N3).

Pharmaceutical entrepreneur

KSK-Pharma Vertriebs AG
Finkenstr. 1
76327 Berghausen
Tel. 0721 / 20 19 0-0
Fax: 0721 /20 19 0- 11

Manufacturer

Artesan Pharma GmbH & Co. KG
Wendlandstr. 1
29439 Lüchow

This package leaflet was last revised in February 2015.

Source: Information from the package leaflet
Status: 10/2017
Active ingredient: Loratadine. Areas of application: for the treatment of complaints in the case of allergic rhinitis (e.g. hay fever) and in the case of chronic, idiopathic urticaria (nettle rash of unknown cause).