LORATADIN STADA

LORATADINE STADA 10 mg tablets

Important notes (mandatory information)

Loratadine Stada 10 mg Tablets. Indications: for the treatment of symptoms of allergic rhinitis (e.g. hay fever) and of urticaria of unknown cause (chronic idiopathic urticaria).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Loratadine Stada 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 need 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 if you feel worse, contact your doctor.

What this package leaflet contains

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

1. WHAT IS LORATADINE STADA AND WHAT IS IT USED FOR?

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

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING LORATADINE STADA?

Loratadine Stada 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 Stada:

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

Children

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

Taking Loratadine Stada with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. Interactions with medicines that inhibit certain liver enzymes may occur. This can increase the blood levels of loratadine and thus lead to increased side effects (see section 4. What side effects are possible?).

Taking Loratadine Stada with alcohol

The effect of alcohol is not enhanced by taking Loratadine Stada.

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Studies in animals have shown no harmful effects of loratadine on the fetus. The data suggest that the use of loratadine during pregnancy does not lead to problems with the fetus. As a precaution, it is recommended to avoid taking Loratadine Stada during pregnancy.

Breastfeeding

Since loratadine passes into breast milk, it is not recommended for use during breastfeeding.

Driving and using machines

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

Loratadine Stada contains lactose

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

3. HOW TO TAKE LORATADINE STADA?

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.

Method of administration

For oral use. Swallow the tablet whole and unchewed with 1 glass of water. The tablet can be taken independently of meals. The score line is only to divide the tablet to make it easier to swallow, not to divide it into equal doses.

Unless otherwise prescribed by your doctor, the recommended dose is

Adults and children over 12 years of age take 1 tablet Loratadine Stada (equivalent to 10 mg loratadine) once a day.

Children and adolescents:

• Children from 2 to 12 years of age with a body weight of over 30 kg: 1 tablet Loratadine Stada (equivalent to 10 mg loratadine) once a day.
• With a body weight of 30 kg or less: The 10 mg tablet is not suitable for children with a body weight of up to 30 kg. The efficacy and safety of Loratadine Stada in children under 2 years of age have not been established.

Patients with severe liver damage

An initial dose of 1 tablet Loratadine Stada (equivalent to 10 mg loratadine) every other day is recommended for adults and children weighing over 30 kg. No dosage adjustment is necessary in elderly patients or in patients with impaired renal function.

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

If you have taken more Loratadine Stada 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 Stada tablets, please inform your doctor or pharmacist immediately.

If you forget to take Loratadine Stada

Do not take a double dose 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. Possible side effects

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

• Nervousness.
• Headache, fatigue, drowsiness.

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

• Insomnia, increased appetite.

Very rare (may affect up to 1 in 10,000 people):

• allergic reactions (including serious allergic reactions, associated with swelling of the face, mouth, tongue or throat [angioedema] and severe allergic reactions that can cause difficulty breathing or dizziness [anaphylaxis]).
• Dizziness.
• Seizure.
• rapid heartbeat (tachycardia), palpitations or heart 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 TO STORE LORATADINE STADA?

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 doing so, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Loratadine Stada 10 mg Tablets contains

The active substance is: Loratadine. 1 tablet contains 10 mg loratadine. The other ingredients are microcrystalline cellulose, lactose monohydrate, magnesium stearate (Ph.Eur.), corn starch.

What Loratadine Stada 10 mg Tablets looks like and contents of the pack

White, round, flat tablet with a score line on one side. Loratadine Stada 10 mg Tablets are available in packs of 20, 50 and 100 tablets.

Pharmaceutical entrepreneur

Stada Consumer Health Deutschland GmbH
Stadastraße 2 - 18
61118 Bad Vilbel
Phone: 06101 603-0
Fax: 06101 603-259
Internet: www.stada.de

Manufacturer

Stada Arzneimittel AG
Stadastraße 2 - 18
61118 Bad Vilbel

This leaflet was last revised in July 2020.

Source: Package leaflet information
Status: 10/2020
Indications: for the treatment of symptoms of allergic rhinitis (e.g. hay fever) and of urticaria of unknown cause (chronic idiopathic urticaria).