LEVOCETIRIZIN-

LEVOCETIRIZIN-ratiopharm 5 mg film-coated tablets

Important notes (mandatory information)

Levocetirizine-ratiopharm 5 mg film-coated tablets. Active ingredient: Levocetirizine dihydrochloride. Areas of application: for the treatment of symptoms in allergic diseases such as hay fever, year-round allergies such as house dust or pet allergies, chronic hives.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Levocetirizine-ratiopharm 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 even worse, contact your doctor.

What this leaflet contains

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

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

Levocetirizine dihydrochloride is the active ingredient in Levocetirizine-ratiopharm. Levocetirizine-ratiopharm is used to treat allergies. It is used to treat symptoms in allergic diseases such as hay fever, year-round allergies such as house dust or pet allergies, chronic hives.

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

Levocetirizine-ratiopharm 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 your kidney function is severely impaired (severe renal insufficiency with a creatinine clearance below 10 ml/min).

Warnings and precautions

Please talk to your doctor or pharmacist before taking Levocetirizine-ratiopharm. If you have impaired kidney function, please consult your doctor for advice; if necessary, you will take a lower dose. Your doctor will determine the new dose. If you may not be able 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 are at risk of seizures, please consult your doctor for advice, as the use of Levocetirizine-ratiopharm could increase seizures. If you are planning to have an allergy test, you should ask your doctor whether you should stop taking Levocetirizine-ratiopharm several days before the test. This medicine may affect the results of your allergy test.

Children

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

Taking Levocetirizine-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.

Taking Levocetirizine-ratiopharm with food, drink and alcohol

Caution is advised when Levocetirizine-ratiopharm is taken together with alcohol or other agents that affect the brain. In sensitive patients, the concomitant use of Levocetirizine-ratiopharm and alcohol or other agents that affect the brain can cause an additional reduction in alertness and an impairment of performance.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 weakness during therapy with Levocetirizine-ratiopharm. Caution is advised 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-ratiopharm contains lactose

Please take Levocetirizine-ratiopharm only after consulting your doctor if you are aware that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE LEVOCETIRIZINE-RATIOPHARM?

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.

Adults and children aged 6 years and over

The recommended dose for adults and children aged 6 years and over is 1 film-coated tablet daily.

Special dosage instructions for certain patient groups

Kidney and liver disorders

Patients with severely impaired kidney function must not take Levocetirizine-ratiopharm. Patients with impaired kidney function as well as 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. Patients with impaired liver function only should take the recommended dose (1 film-coated tablet daily).

Elderly patients aged 65 years and over

No dosage adjustment is necessary in elderly patients, provided that kidney function is normal.

Use in children

Levocetirizine-ratiopharm is not recommended for children under 6 years of age.

How and when should you take Levocetirizine-ratiopharm?
For oral use. The tablet should be swallowed whole with water. It can be taken with or without meals.

How long should you take Levocetirizine-ratiopharm?
The duration of use depends on the type, duration and course of your complaints. Please consult your doctor or pharmacist for advice.

If you have taken more Levocetirizine-ratiopharm than you should

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

If you forget to take Levocetirizine-ratiopharm

Do not take double the amount to make up for a forgotten dose of Levocetirizine-ratiopharm. Take the next amount at the next scheduled time.

If you stop taking Levocetirizine-ratiopharm

Discontinuing treatment with Levocetirizine-ratiopharm should not cause any harmful effects. Nevertheless, in rare cases, pruritus (severe itching) may occur after discontinuation of Levocetirizine-ratiopharm, even if these symptoms were not present before treatment. The symptoms may resolve spontaneously. In some cases, the symptoms may be very intense 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. At the first signs of a hypersensitivity reaction, stop taking Levocetirizine-ratiopharm 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.

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

• Dry mouth
• Headache
• Fatigue
• Drowsiness/sedation

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

• Lassitude
• Abdominal pain

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

• Increased appetite
• aggressive or agitated behavior, seeing or hearing things that are not really there (hallucinations), depression, insomnia, frequent thoughts of or preoccupation with suicide
• Convulsions, tingling, dizziness, sudden loss of consciousness, tremors, impaired sense of taste
• Vertigo
• Visual disturbances, blurred vision, oculogyration (uncontrollable, circular movement of the eyes)
• Palpitations or rapid heartbeat, accelerated heart rate
• Shortness of breath
• Nausea, vomiting, diarrhea
• Liver inflammation (hepatitis), abnormal liver function tests
• difficulty or painful urination, incomplete emptying of the bladder
• red spots that reappear at the same site on the skin or mucous membranes each time Levocetirizine-ratiopharm is taken
• Pruritus (itching), rash, hives (swelling, redness and itching of the skin)
• Pruritus (severe itching) after discontinuation
• Muscle pain, joint pain
• Swelling due to fluid accumulation in the tissue (edema)
• Weight gain

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 on the safety of this medicine.

5. HOW SHOULD LEVOCETIRIZINE-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 after "Use by". The expiry date refers to the last day of the month indicated. Store in the original package in order to protect from moisture. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you no longer use it. You help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Levocetirizine-ratiopharm contains

The active ingredient is levocetirizine dihydrochloride. Each film-coated tablet contains 5 mg levocetirizine dihydrochloride, corresponding to 4.2 mg levocetirizine. The other ingredients are: Tablet core: Microcrystalline cellulose, lactose monohydrate, highly dispersed silicon dioxide, magnesium stearate (Ph.Eur.) (E572). Film coating: Hypromellose (E464), titanium dioxide (E171) and macrogol 400.

What Levocetirizine-ratiopharm looks like and contents of the pack

The film-coated tablets are white to off-white and oval. One side of the tablet is embossed with "LC5", the other side of the tablet is plain. Levocetirizine-ratiopharm is available in blister packs of 7, 20, 50 or 100 film-coated tablets per folding box. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren

or

TEVA Pharmaceutical Works Private Limited Company
Teva Gyögyszergyar Zrt.
Pallagi üt 13
4042 Debrecen
Hungary

This leaflet was last revised in March 2019.

Source: Information from the package leaflet
Status: 07/2020
Active ingredient: Levocetirizine dihydrochloride. Areas of application: for the treatment of symptoms in allergic diseases such as hay fever, year-round allergies such as house dust or pet allergies, chronic hives.