LORATADIN-

LORATADIN-ratiopharm 10 mg tablets

Important notes (mandatory information)

Loratadine-ratiopharm 10 mg tablets. Active ingredient: Loratadine. Areas of application: for the treatment of symptoms of allergic rhinitis (e.g. hay fever) and chronic, idiopathic urticaria (hives of unknown cause).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Loratadine-ratiopharm 10 mg tablets
Active ingredient: Loratadine

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

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to 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, contact your doctor.

What this package leaflet contains

1. WHAT IS LORATADINE-RATIOPHARM AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING LORATADINE-RATIOPHARM?
3. HOW TO TAKE LORATADINE-RATIOPHARM?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD LORATADINE-RATIOPHARM BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS LORATADINE-RATIOPHARM AND WHAT IS IT USED FOR?

Loratadine-ratiopharm belongs to the group of antihistamines and is used to treat the symptoms of certain allergic diseases that are associated with increased histamine release.
Loratadine-ratiopharm is used to treat the symptoms of allergic rhinitis (e.g. hay fever) and chronic, idiopathic urticaria (hives of unknown cause).

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING LORATADINE-RATIOPHARM?

Loratadine-ratiopharm must not be taken if you are allergic to loratadine or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Loratadine-ratiopharm:

• if you have severe liver dysfunction.
• if you are planning to have a skin test. The use of Loratadine-ratiopharm should be discontinued at least 48 hours before skin testing, as antihistamines such as Loratadine-ratiopharm can otherwise prevent or weaken positive reactions to the skin test.

Children

The efficacy and safety of Loratadine-ratiopharm in children under 2 years of age have not been established.

Taking Loratadine-ratiopharm with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. No significant interactions have been described in the clinical studies conducted.

Taking Loratadine-ratiopharm with food, drink and alcohol

The effect of alcohol is not increased by taking Loratadine-ratiopharm.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. No embryotoxic effects of loratadine have been found in animal studies. The safety of loratadine during pregnancy has not been established. Therefore, Loratadine-ratiopharm is not recommended during pregnancy. Since loratadine passes into breast milk, it is not recommended during breast-feeding.

Driving and using machines

In very rare cases, some people may experience drowsiness, which may impair their ability to drive or operate machinery. It is therefore advisable to wait and see how you react to taking Loratadine-ratiopharm before driving a vehicle or operating machinery.

Loratadine-ratiopharm contains lactose

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

3. HOW TO TAKE LORATADINE-RATIOPHARM?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

• Adults and children over 12 years: 1 tablet Loratadine-ratiopharm 10 mg (equivalent to 10 mg loratadine) once a day. No dosage adjustment is necessary in elderly patients (over 65 years) or in patients with renal insufficiency.
• Children from 2 to 12 years: With a body weight of over 30 kg: 1 tablet Loratadine-ratiopharm 10 mg (equivalent to 10 mg loratadine) once a day. With a body weight of 30 kg or less: 1/2 tablet Loratadine-ratiopharm 10 mg (equivalent to 5 mg loratadine) once a day. The efficacy and safety of Loratadine-ratiopharm in children under 2 years of age have not been established.

Patients with severe liver damage:

• Adults and children weighing over 30 kg: Initial dose: 1 tablet Loratadine-ratiopharm 10 mg every other day.
• Children weighing 30 kg or less: Initial dose: 1/2 tablet Loratadine-ratiopharm 10 mg every other day

Method of administration

For oral use. The tablet can be taken independently of meals.

Please talk to your doctor or pharmacist if you have the impression that the effect of Loratadine-ratiopharm is too strong or too weak.

If you have taken more Loratadine-ratiopharm than you should

Drowsiness, rapid heartbeat (tachycardia) and headache have been reported in cases of overdose of loratadine. If you have taken too many Loratadine-ratiopharm tablets, please inform your doctor or pharmacist immediately.

In the event of an overdose, immediate symptomatic and supportive treatment should be initiated and continued for as long as necessary. Activated charcoal dissolved in water can be administered. Gastric lavage may 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 Loratadine-ratiopharm

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

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. The list includes all known side effects under treatment with loratadine, including those under higher dosage or long-term therapy.

Common (may affect up to 1 in 10 people):

• Nervousness
• Headache, tiredness, drowsiness

Uncommon (may affect up to 1 in 100 people):

• Insomnia, increased appetite

Very rare (may affect up to 1 in 1,000 people):

• Hypersensitivity reactions (including angioedema and anaphylaxis)
• Dizziness, convulsions
• rapid heartbeat (tachycardia), palpitations
• Nausea, dry mouth, gastritis
• Liver dysfunction
• Rash, hair loss (alopecia)

Not known (frequency cannot be estimated from the available data):

• Weight gain

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, Dept. of Pharmacovigilance, 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 LORATADINE-RATIOPHARM BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister pack after "Use by". The expiry date refers to the last day of the month indicated. This medicinal product does not require any special storage conditions. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Loratadine-ratiopharm contains

The active substance is loratadine. Each tablet contains 10 mg loratadine. The other ingredients are: lactose monohydrate, microcrystalline cellulose, maize starch, magnesium stearate (Ph. Eur).

What Loratadine-ratiopharm looks like and contents of the pack

White, round, curved tablets with a break notch on one side Loratadine-ratiopharm is available in packs of 7, 20, 50 and 100 tablets.

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren

This leaflet was last revised in August 2018.

Source: Package leaflet information
Status: 07/2020
Active ingredient: Loratadine. Areas of application: for the treatment of symptoms of allergic rhinitis (e.g. hay fever) and chronic, idiopathic urticaria (hives of unknown cause).