LEVOCETIRIZINE 5 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

What is in this leaflet:

• 1. What Levocetirizine 5 mg film-coated tablets are and what they are used for

• 2. What you need to know before you take Levocetirizine 5 mg film-coated tablets

• 3. How to take Levocetirizine 5 mg film-coated tablets

• 4. Possible side effects

• 5. How to store Levocetirizine 5 mg film-coated tablets

• 6. Contents of the pack and other information

1. What Levocetirizine 5 mg Film-coated Tablets are and what they are used for

Levocetirizine dihydrochloride is the active ingredient of Levocetirizine 5mg Film-coated tablets.

Levocetirizine is an antiallergic medication. For the treatment of signs of illness (symptoms) associated with:

• allergic rhinitis (including persistent allergic rhinitis);
• nettle rash (urticaria).

2. what you need to know before you take levocetirizine 5 mg film-coated tablets

Do not take Levocetirizine 5 mg Film-coated Tablets

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Levocetirizine 5 mg film-coated tablets.

If you are likely to be unable to empty your bladder (with conditions such as spinal cord injury or enlarged prostate), please ask your doctor for advice.

If you suffer from epilepsy or are at risk of convulsions, please ask your doctor for advice as use of Levocetirizine 5mg film-coated tablets may cause seizure aggravation.

If you are scheduled for allergy testing, ask your doctor if you should stop taking Levocetirizine 5mg film-coated tablets for several days before testing. This medicine may affect your allergy test results.

Children

The use of Levocetirizine is not recommended in children less than 6 years since the currently available film-coated tablets do not allow for dose adaptation.

Other medicines and Levocetirizine 5 mg Film-coated Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Levocetirizine 5 mg Film-coated Tablets with food, drink and alcohol

Caution is advised if Levocetirizine 5 mg Film-coated Tablets is taken at the same time as alcohol or other agents acting on the brain.

In sensitive patients, the concurrent administration of Levocetirizine 5mg film-coated tablets and alcohol or other agents acting on the brain may cause additional reductions in alertness and impairment of performance.

Levocetirizine 5mg Film-coated tablets can be taken with or without food.

Pregnancy, breast-feeding and fertility

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.

Driving and using machines

Some patients being treated with Levocetirizine may experience somnolence/drow­siness, tiredness and exhaustion. Use caution when driving or operating machinery until you know how this medicine affects you. However, special tests have revealed no impairment of mental alertness, the ability to react or the ability to drive in healthy test persons after taking levocetirizine in the recommended dosage.

Levocetirizine 5 mg Film-coated Tablets contains lactose

These tablets contain lactose, if you have been told by your doctor that you have an intolerance to some sugars you should contact your doctor before taking them.

3. how to take levocetirizine 5 mg film-coated tablets

Always take this medicine exactly as your doctor or pharmacist has told you. 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 tablet daily. Children under 6 years of age should not take this medicine.

Special dosage instructions for specific populations: Renal and hepatic impairment

Patients with impaired kidney function may be given a lower dose according to the severity of their kidney disease and children the dose will also be chosen on the basis of body weight; the dose will be determined by your doctor.

Patients who have severe impairment of kidney function must not take this Levocetirizine 5mg Film-coated tablets.

Patient who only have impaired liver function should take the usual prescribed dose.

Patients who have both impaired liver and kidney function may be given a lower dose depending on the severity of the kidney disease, and in children the dose will also be chosen on the basis of body weight; the dose will be determined by your doctor

Elderly patients aged 65 years and above

No adaptation of the dose is necessary in elderly patients, provided their renal function is normal.

Use in Children

Levocetirizine 5mg Film-coated tablets is not recommended for children under 6 years of age.

How and when should you take Leveocetirizine 5 mg Film-coated Tablets

For oral use only

Levocetirizine 5mg film-coated tablets should be swallowed whole with water and may be taken with or without food.

How long should you take Leveocetirizine 5 mg Film-coated Tablets

The duration of use depends on the type, duration and course of your complaints and is determined by your physician

If you take more Levocetirizine 5 mg Film-coated Tablets than you should

If you take more Levocetirizine 5mg film-coated tablets than you should somnolence can occur in adults. Children may initially show excitation and restlessness followed by somnolence.

If you think you have taken an overdose of Levocetirizine, please tell your doctor who will then decide what action should be taken.

If you forget to take Levocetirizine 5 mg Film-coated Tablets

If you forget to take Levocetirizine, or if you take a dose lower than that prescribed by your doctor, do not take a double dose to make up for a forgotten dose. Take your next dose, at your normal time.

If you stop taking Levocetirizine 5 mg Film-coated Tablets

Stopping treatment should have no negative effects. However, rarely pruritus (intense itching) may occur if you stop taking Levocetirizine 5mg film-coated tablets, even if those symptoms were not present before treatment initiation. The symptoms may resolve spontaneously. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.

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

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• dry mouth
• headache
• tiredness
• somnolence/drow­siness

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

• exhaustion
• abdominal pain

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

Other side effects such as palpitations, increased heart rate, fits, pins and needles, dizziness, syncope, tremor, dysgeusia (distortion of the sense of taste), sensation of rotation or movement, visual disturbances (blurred vision), oculogyration (eyes having uncontrolled circular movements), painful or difficult urination, inability to completely empty the bladder, oedema, pruritus (itchness), rash, urticaria (swelling, redness and itchiness of the skin), skin eruption, shortness of breath, weight increase, muscular pain, joint pain, aggressive or agitated behavior, hallucination, depression, insomnia, recurring thoughts of or preoccupation with suicide, nightmare, hepatitis, abnormal liver function, vomiting, increased appetite, nausea and diarrhea have also been reported. Pruritus (intense itching) upon discontinuation.

At the first signs of a hypersensitivity reaction, stop taking Levocetirizine 5mg film-coated tablets and tell your doctor. Hypersensitivity reaction symptoms may include: swelling of the mouth, tongue, face and/or throat, breathing or swallowing difficulties (chest tightness or wheezing), hives, sudden fall in blood pressure leading to collapse or shock, which may be fatal.

Reporting of side effects

If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Levocetirizine 5 mg Film-coated Tablets contains

• The active substance is levocetirizine dihydrochloride.

Each film-coated tablet contains 5 mg levocetirizine dihydrochloride.

• The other ingredients are microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, hypromellose (E464), titanium dioxide (E171), and macrogol 400.

What Levocetirizine 5 mg Film-coated Tablets looks like and contents of the pack

The 5mg film-coated tablets are white, oval, with a G breakline G on one side and the other side is plain. The tablet can be divided into equal doses.

The tablets are packed in either Aluminium/ Aluminium blisters or PVC / PVdC – Aluminium blisters.

Pack Sizes

• 7, 10, 20, 21, 28, 30, 50, 90 and 100 tablets

Manufacturers

Glenmark Pharmaceuticals s.r.o.

Fibfchova 143, 566 17 Vysoke Myto

Czech Republic

Tillomed Laboratories Ltd.

3 Howard Road, Eaton Socon, St.Neots

Cambridgeshire, PE19 8ET

United Kingdom

Glenmark Pharmaceuticals Europe Limited

Building 2, Croxley Green Business Park

Croxley Green, Hertfordshire, WD18 8YA

United Kingdom

This leaflet was last revised in Nov/2019.

5. How to store Levocetirizine 5 mg Film-coated Tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after Exp. The expiry date refers to the last day of that month.