LEVOCETIRIZIN beta 5 mg film-coated tablets, 100 pcs

Instructions for use for LEVOCETIRIZIN beta 5 mg film-coated tablets, 100 pcs

Application Notes

Children from 6 years and adults

1 Tablet

1 time per day

regardless of the meal

Application areas

Mode of action

How does the ingredient of the medicine work?

The active ingredient helps with allergies and calms the itching. It suppresses the effects of the body's own substance histamine and prostaglandins in two ways: First, it inhibits the release of substances from the mast cells (special defense cells) in the blood and tissue; secondly, it displaces the substances from their binding sites. As tissue hormones and messenger substances, histamine and prostaglandins play an important role in the development of inflammation and allergic reactions.

Composition

Contraindications

What speaks against an application?

- Hypersensitivity to the ingredients
- Severely impaired renal function

What age group do you need to consider?
- Babies and young children under the age of 2 years: The medicine should generally not be used in this age group.
- Children under 6 years of age: The medicine should not normally be used in this group. There are preparations that are more suitable in terms of the strength of the active ingredient and/or dosage form.

What about pregnancy and lactation?
- Pregnancy: consult your doctor. Various considerations play a role in whether and how the drug can be used during pregnancy.
- Breast-feeding: According to current knowledge, it is not recommended to use it. You may be to consider a weaning.

If you have been prescribed the drug despite a contraindication, talk to your doctor or pharmacist. The therapeutic benefit can be higher than the risk that the use entails in the event of a contraindication.

Side effects

What adverse effects may occur?

Adolescents from 12 years and adults
- Headache
- Drowsiness
- Dry mouth
- Fatigue
- Fatigue
- Stomach pain

Children and young people
- Diarrhea
- Vomiting
- Constipation
- Drowsiness
- Difficulty falling asleep and staying asleep
- Headache

If you notice any discomfort or changes during treatment, contact your doctor or pharmacist.

For the information at this point, side effects are primarily taken into account that occur in at least one in 1,000 patients treated.

Hints

What should you consider?
- Beware of intolerance to lactose. If you have to follow a diabetic diet, you should consider the sugar content.
- There may be medicines with which interactions occur. You should therefore generally tell your doctor or pharmacist about any other medicine you are already using before starting treatment with a new medicine. This also applies to medicines that you buy yourself, use only occasionally or have been using for some time.

Detailed instructions for LEVOCETIRIZIN beta 5 mg film-coated tablets, 100 pcs

Field of use

Levocetirizine beta 5 mg film-coated tablets (pack size: 100 pieces) is a drug from the group of antiallergics. It can be used in adults and children over 6 years of age to treat signs (symptoms) of:

allergic rhinitis (including persistent allergic rhinitis)

Hives (urticaria)

Mode of action

What is special about Levocetirizine beta 5 mg film-coated tablets (pack size: 100 pieces):

The active substance levocetirizine dihydrochloride has an antiallergic, antihistamine and anti-inflammatory effect. It prevents the release of various inflammatory substances from the so-called mast cells.

Active substances / ingredients / ingredients

Levocetirizine beta 5 mg film-coated tablets (pack size: 100 pieces) contains:

Active substance:
Levocetirizine
Levocetirizine is presented as levocetirizine dihydrochloride (5 mg), equivalent to 4.2 mg levocetirizine
1 film-coated tablet contains 5 mg levocetirizine dihydrochloride


Other ingredients:
Microcrystalline cellulose, lactose monohydrate (see section 2, Levocetirizine contains lactose), magnesium stearate (Ph.Eur) (tablet core) and hypromellose (E464), titanium dioxide (E171) and macrogol 400 (film coating)

Contraindications

Levocetirizine beta 5 mg film-coated tablets (pack size: 100 pieces) must not be taken

• if you have severe kidney disease (severe renal impairment with creatinine clearance below 10 ml/min).
• if you are allergic to levocetirizine dihydrochloride or any of the other ingredients of this medicine, to hydroxyzine or other piperazine derivatives (closely related active ingredients of other medicines).
• if you cannot empty your bladder completely (such as B. with a spinal cord injury or an enlarged prostate). Please ask your doctor for advice on this before taking it.
• if you have epilepsy or are at risk of convulsions, please ask your doctor for advice, as the use of levocetirizine may increase convulsions.
• by children under 6 years of age.
• if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.

dosage

Recommended use of Levocetirizine beta 5 mg film-coated tablets (pack size: 100 pieces):

Always take this medicine exactly as described or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults and children over 6 years 5 mg 1 film-coated tablet daily

Dosage for patients with kidney and liver disorders:
Patients with impaired kidney function may receive a lower dose, which depends on the severity of the kidney disease and, in children, also on their body weight. The dose will be determined by your doctor.

Patients with severely impaired kidney function should not take Levocetirizine 5 mg.

Patients with hepatic impairment only should take the normal prescribed dose.

Patients with impaired liver and kidney function may receive a lower dose, which depends on the severity of the kidney disease and, in children, also on the body weight. The dose will be determined by your doctor. The duration of treatment depends on the type, duration and course of your symptoms. Please ask your doctor or pharmacist for advice. Elderly patients over 65 years:
No dose adjustment is necessary in elderly patients provided renal function is normal.

Duration of use:
The duration of treatment depends on the type, duration and course of your symptoms. Please ask your doctor or pharmacist for advice.

Revenue

The film-coated tablets should be swallowed whole with a glass of liquid, preferably water. It can be taken with or without meals.

Patient notes

Warnings and Precautions

• Please talk to your doctor or pharmacist before taking this medicine.
• If you suffer from impaired kidney function, please ask your doctor for advice; if necessary, you will take a lower dose. Your doctor will determine the new dose.
• If you have difficulty urinating (e.g. due to problems with the spinal cord, prostate or urinary bladder), please ask your doctor for advice.
• If you have epilepsy or are at risk of convulsions, please ask your doctor for advice.
• No clinically significant interactions have been observed between alcohol (at a blood level of 0.5 per thousand [g/l], equivalent to approximately 1 glass of wine) and levocetirizine at recommended doses. However, there are no safety data when higher doses of levocetirizine and alcohol are taken together. Therefore, as with all antihistamines, it is recommended to avoid taking the drug and alcohol at the same time.
• If you are going to have an allergy test, ask your doctor if you should stop taking this medicine for a few days before the test, as this medicine could affect the result of an allergy test.

• Ability to drive and use machines
  • In clinical trials, levocetirizine at the recommended dose did not produce any evidence of impairment in alertness, alertness or driving ability.
  • If you intend to drive, work unstable or use machines, you should carefully monitor your reaction to the medicine after taking the medicine for allergies. You should not use more than the recommended dose.

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Hints

Not suitable for children under 6 years of age.

If you do not feel better or even worse after 3 days, contact your doctor.

Keep out of reach of children.

Levocetirizine contains lactose. Please do not take Levocetirizine Beta until you have consulted your doctor if you know that you have an intolerance to certain sugars.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.

Manufacturer: betapharm Arzneimittel GmbH, Kobelweg 95, 86156 Augsburg