LEVOCETIRIZINE BLUEFISH 5 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Levocetirizine Bluefish 5 mg film-coated tablets EFG

levocetirizine dihydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Levocetirizine Bluefish and what is it used for
2. What you need to know before you take Levocetirizine Bluefish
3. How to take Levocetirizine Bluefish
4. Possible side effects
5. Storage of Levocetirizine Bluefish

1. Contents of the pack and further information

1. What is Levocetirizine Bluefish and what is it used for

The active substance of Levocetirizine Bluefish is levocetirizine dihydrochloride. Levocetirizine is an antiallergic medicine.

It is used for the treatment of symptoms associated with:

• Allergic rhinitis (including persistent allergic rhinitis)

• Urticaria (hives)

2. What you need to know before you take Levocetirizine Bluefish

Do not take Levocetirizine Bluefish:

• 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 renal impairment (severe kidney failure with a creatinine clearance below 10 ml/min).

Warnings and precautions

Consult your doctor, pharmacist or nurse before taking levocetirizine.

If you have any condition that prevents you from emptying your bladder (such as spinal cord injury or enlarged prostate), please inform your doctor.

If you are epileptic or have a history of seizures, please consult your doctor, as the use of levocetirizine may worsen seizures.

If you are going to have an allergy test, ask your doctor if you need to stop taking levocetirizine a few days before. This medicine may affect the results of the allergy test.

Children

Levocetirizine is not recommended for children under 6 years of age, as the film-coated tablets do not allow for dose adjustment.

Other medicines and Levocetirizine Bluefish

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

Taking Levocetirizine Bluefish with food, drinks and alcohol

Caution is recommended if you take levocetirizine and alcohol or other substances that act on the brain at the same time.

In sensitive patients, taking levocetirizine with alcohol or other substances that act on the brain may cause additional decreased attention and decreased performance.

Levocetirizine can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 treated with levocetirizine may experience somnolence/drowsiness, fatigue and exhaustion. Be careful if you are driving or using machinery, until you know how this medicine affects you. However, in special tests conducted in healthy individuals, no alterations in attention, reaction capacity and ability to drive were detected after taking levocetirizine at the recommended dose.

Levocetirizine Bluefish contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Levocetirizine Bluefish

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose in adults and children from 6 years of age is one tablet per day.

Special dosing instructions for specific populations:

Renal and hepatic impairment

Patient with renal impairment should receive a lower dose according to the severity of their kidney disease and in children the dose will also be chosen based on body weight; the dose will be decided by your doctor.

Patient with severe renal impairment should not take levocetirizine.

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

Patient with hepatic and renal impairment should take a lower dose based on the severity of their kidney disease, and in children the dose will be based on body weight; the dose to be taken will be determined by your doctor.

Patient from 65 years of age

In elderly patients, no dose adjustment is necessary if renal function is normal.

Use in children

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

How and when to take Levocetirizine Bluefish

For oral use only

The tablets should be swallowed whole with water, with or without food.

How long should your treatment with Levocetirizine Bluefish last?

The duration of treatment depends on the type, duration and course of the symptoms and it is your doctor who must determine it.

If you take more Levocetirizine Bluefish than you should

If you take more levocetirizine than you should, in adults it may cause drowsiness. In children it may initially cause agitation and restlessness followed by drowsiness. Consult your doctor immediately who will advise you on the treatment you need.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, Phone: 91 562 04 20

If you forget to take Levocetirizine Bluefish

If you have forgotten to take levocetirizine, or if you take a lower dose than prescribed by your doctor, do not take a double dose to make up for forgotten doses. Continue taking your normal dose when it is due.

If you stop taking Levocetirizine Bluefish

If you stop treatment, it should not have negative effects. However, rarely, intense itching (pruritus) may appear when stopping levocetirizine, even when these symptoms were not present at the start of treatment. The symptoms may disappear spontaneously. In some cases, the symptoms may be intense and require that treatment with levocetirizine be restarted. The symptoms usually disappear when 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, fatigue and drowsiness.

Uncommon: may affect up to 1 in 100 people

Exhaustion and abdominal pain.

Frequency not known: cannot be estimated from the available data.

Other side effects have also been reported, such as palpitations, increased heart rate, seizures, tingling, dizziness, syncope, tremor, dysgeusia (altered sense of taste), sensation of rotation or movement, visual disturbances, blurred vision, oculogyric crisis (uncontrolled circular movements of the eyes), pain or difficulty urinating, inability to urinate, edema, pruritus (itching), rash, urticaria (swelling, redness and itching of the skin), skin eruption, shortness of breath, weight gain, muscle pain, joint pain, aggressive or agitated behavior, hallucination, depression, insomnia, recurrent thoughts or concern with suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea and diarrhea. Intense itching (pruritus) when treatment is stopped.

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levocetirizine Bluefish

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 packaging and label after “EXP”. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Levocetirizine Bluefish

• The active substance is levocetirizine dihydrochloride. Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate (E572) (core), and titanium dioxide (E171), hypromellose (E464) macrogol 400 and polysorbate 80 (coating).

Appearance and packaging

White, film-coated, scored, round, biconvex tablets engraved with “161” on one side and “H” on the other.

Levocetirizine Bluefish is available in blister packs of 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 90 or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Bluefish Pharmaceuticals AB

P.O.Box 49013, 100 28 Stockholm, Sweden

Manufacturer

Bluefish Pharmaceuticals AB

Gävlegatan 22, 113 30 Stockholm, Sweden

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Local representative:

Bluefish Pharma S.L.U.,

AP 36007, 2832094 Madrid, Sucursal 36 - Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: March 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.gob.es/