LEVOCETIRIZIN-

LEVOCETIRIZINE Glenmark 5 mg film-coated tablets

Important notes (mandatory information)

Levocetirizine Glenmark 5 mg film-coated tablets. Active ingredient: Levocetirizine dihydrochloride. Areas of application: for the treatment of symptoms of allergic rhinitis (including persistent allergic rhinitis) and urticaria.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Levocetirizine Glenmark 5 mg film-coated tablets for adults and children aged 6 years and over
Active ingredient: Levocetirizine dihydrochloride

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take this medicine exactly as described in this leaflet or exactly as directed 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 experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse, talk to your doctor.

What this leaflet contains

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

1. WHAT IS LEVOCETIRIZINE GLENMARK AND WHAT IS IT USED FOR?

Levocetirizine dihydrochloride is the active ingredient of Levocetirizine Glenmark. Levocetirizine Glenmark is used to treat allergies. For the treatment of symptoms of allergic rhinitis (including persistent allergic rhinitis) and urticaria.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING LEVOCETIRIZINE GLENMARK?

Levocetirizine Glenmark must not be taken,

• if you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine or any of the other ingredients of this medicine listed in section 6.
• if you have severe kidney problems (severe renal insufficiency with a creatinine clearance below 10 ml/min).

Warnings and precautions

Please talk to your doctor or pharmacist before taking Levocetirizine Glenmark. If you are unable to empty your bladder completely (such as in the case of a spinal cord injury or an enlarged prostate), please consult your doctor for advice. If you are an epilepsy patient or at risk of seizures, please consult your doctor for advice, as the use of Levocetirizine Glenmark could increase seizures. If you are planning to have an allergy test, you should ask your doctor whether you should stop taking Levocetirizine Glenmark for several days. This medicine may affect the results of your allergy test.

Children

Levocetirizine Glenmark is not recommended for children under 6 years of age, as no dosage adjustment is possible with the film-coated tablets.

Taking Levocetirizine Glenmark 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.

Taking Levocetirizine Glenmark with food, drink and alcohol

Caution is advised when taking Levocetirizine Glenmark together with alcohol or other drugs that affect the brain. In sensitive patients, the concomitant use of Levocetirizine Glenmark and alcohol or other drugs that affect the brain could lead to an additional reduction in alertness and impaired performance. Levocetirizine Glenmark can be taken with or without meals.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Some patients may experience drowsiness/sedation, fatigue and exhaustion during therapy with Levocetirizine Glenmark. Be careful when driving or operating machinery until you know how this medicine affects you. However, in special studies, no impairment of attention, reaction time and driving ability was found in healthy test subjects taking Levocetirizine at the recommended dosage.

Levocetirizine Glenmark contains lactose

Therefore, please only take Levocetirizine Glenmark after consulting your doctor if you are aware that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE LEVOCETIRIZINE GLENMARK?

Always take this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose for adults and children aged 6 years and over is one film-coated tablet daily.

Special dosage instructions for special patient groups:

• Patients with kidney and liver disorders: Patients with impaired renal function may receive a lower dose, which is based on the severity of the kidney disease and, in children, also on body weight. The dose will be determined by your doctor.
• Patients with severely impaired renal function should not take Levocetirizine Glenmark.
• Patients with impaired liver function only should take the normal prescribed dose.
• Patients with impaired liver and kidney function may receive a lower dose, which is based on the severity of the kidney disease and, in children, also on body weight. The dose will be determined by your doctor.
• Elderly patients aged 65 years and over: No dosage adjustment is necessary in elderly patients if renal function is normal.
• Use in children: Levocetirizine Glenmark film-coated tablets are not recommended for children under 6 years of age.

How and when should you take Levocetirizine Glenmark?
For oral use. Levocetirizine Glenmark film-coated tablets should be swallowed whole with water. They can be taken with or without meals.

How long should you take Levocetirizine Glenmark?
The duration of treatment depends on the type, duration and course of your complaints and will be determined by your doctor.

If you have taken more Levocetirizine Glenmark than you should

If you have taken more Levocetirizine Glenmark than you should, adults may experience drowsiness. In children, excitation and restlessness may initially occur, followed by drowsiness. If you suspect an overdose of Levocetirizine Glenmark, please notify your doctor. He will decide on the measures to be taken, if any.

If you forget to take Levocetirizine Glenmark

Do not take double the amount to make up for a forgotten dose of Levocetirizine Glenmark. This also applies if you have taken a lower amount than prescribed by your doctor. Take the next amount at the next scheduled time.

If you stop taking Levocetirizine Glenmark

Stopping the intake should not have any harmful effects. However, in rare cases, pruritus (severe itching) may occur after discontinuation of intake, even if these symptoms were not present before treatment. The symptoms may resolve spontaneously. In some cases, the symptoms can be very severe and require resumption of treatment. After resumption of treatment, the symptoms should disappear.

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.

Common side effects (may affect up to 1 in 10 people)

Dry mouth, headache, fatigue and drowsiness/sedation.

Uncommon side effects (may affect up to 1 in 100 people)

Exhaustion and abdominal pain.

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

Other side effects such as palpitations, rapid heartbeat/tachycardia, cramps, tingling, dizziness, sudden loss of consciousness, tremors, impaired sense of taste, vertigo, blurred vision, blurred vision, oculogyration (uncontrollable, circular movement of the eyes), difficulty or painful urination, incomplete bladder emptying, increased fluid retention in the tissue (edema), swelling of the skin and mucous membranes, especially in the face and throat area (angioedema), itching, transient skin rash, hives (swelling, redness and itching of the skin), rash occurring at the same site (fixed drug eruption), shortness of breath, weight gain, muscle pain, joint pain, aggressive or agitated behavior, seeing or hearing things that are not real (hallucinations), depression, insomnia, frequent thoughts of or preoccupation with suicide, nightmare, liver inflammation (hepatitis), abnormal liver function tests, vomiting, increased appetite, nausea and diarrhea have also been reported. Pruritus (severe itching) after discontinuation.

At the first signs of a hypersensitivity reaction, stop taking Levocetirizine Glenmark and inform your doctor. Symptoms of a hypersensitivity reaction may include: swelling of the mouth, tongue, face and/or throat, difficulty breathing or swallowing (tightness in the chest or wheezing), hives, sudden drop in blood pressure leading to collapse or shock, which can be fatal.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this 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 about the safety of this medicine.

5. HOW TO STORE LEVOCETIRIZINE GLENMARK?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton after "Use by:" and on the container after "EXP". The expiry date refers to the last day of the month indicated. This medicinal product does not require any special storage conditions. Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you no longer use it. This helps to protect the environment. For more information, see www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Levocetirizine Glenmark contains

The active substance is levocetirizine dihydrochloride. One film-coated tablet contains 5 mg levocetirizine dihydrochloride. The other ingredients are microcrystalline cellulose, lactose monohydrate, highly dispersed silicon dioxide, magnesium stearate (Ph. Eur.) [vegetable], hypromellose (E464), titanium dioxide (E171) and macrogol 400.

What Levocetirizine Glenmark looks like and contents of the pack

The white, oval film-coated tablets have a break line on one side and the imprint G on both halves next to the break line and are plain on the other side. The tablets can be divided into equal halves. The tablets are packed in aluminium/aluminium blister packs or PVC/PVdC - aluminium blister packs.

Pack sizes

7, 10, 20, 21,28, 30, 50, 90 and 100 tablets Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

Glenmark Arzneimittel GmbH
Industriestraße 31
82194 Gröbenzell

Manufacturer

Glenmark Arzneimittel GmbH
Industriestraße 31
82194 Gröbenzell

This leaflet was last revised in May 2020.

Source: Package leaflet information
Status: 02/2022
Active ingredient: Levocetirizine dihydrochloride. Areas of application: for the treatment of symptoms of allergic rhinitis (including persistent allergic rhinitis) and urticaria.