CETIRIZINE KERN PHARMA 10 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cetirizine KERN PHARMA 10 mg film-coated tablets EFG

Contents of the pack:

1. What Cetirizine Kern Pharma is and what it is used for
2. Before taking Cetirizine Kern Pharma
3. How to take Cetirizine Kern Pharma
4. Possible side effects
5. Storage of Cetirizine Kern Pharma
6. Further information

1. What Cetirizine Kern Pharma is and what it is used for

The active substance of Cetirizine Kern Pharma is cetirizine dihydrochloride.

Cetirizine Kern Pharma is an antiallergic medicine.

Cetirizine Kern Pharma is indicated in adults and children aged 6 years and above for:

• relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
• relief of chronic urticaria (chronic idiopathic urticaria).

2. Before taking Cetirizine Kern Pharma

Do not take Cetirizine Kern Pharma

• if you have severe kidney disease (severe renal impairment with creatinine clearance below 10 ml/min);
• if you know that you are allergic (hypersensitive) to the active substance of Cetirizine Kern Pharma, to any of its excipients (other components), to hydroxyzine or to piperazine derivatives (related active substances of other medicines).

Do not take Cetirizine Kern Pharma:

• if you have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Be careful with Cetirizine Kern Pharma

If you are a patient with renal insufficiency, consult your doctor; if necessary, a lower dose will be taken. Your doctor will determine the new dose.

If you are an epileptic patient or a patient at risk of convulsions, consult your doctor.

No interactions likely to have a significant impact have been observed between alcohol (with a blood level of 0.5 per thousand, corresponding to a glass of wine) and the use of cetirizine at normal doses. However, as with all antihistamines, it is recommended to avoid concurrent consumption of alcohol during treatment.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Due to the profile of cetirizine, no interactions with other medicines are expected.

Taking Cetirizine Kern Pharma with food and drinks

Food does not significantly affect the degree of absorption of cetirizine.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medicine.

As with other medicines, the use of Cetirizine Kern Pharma should be avoided in pregnant women. Accidental use of the medicine in pregnant women should not produce any harmful effect on the fetus. However, treatment with the medicine should be discontinued.

Do not take Cetirizine Kern Pharma during breastfeeding, as cetirizine is excreted in breast milk.

Driving and using machines

Clinical studies have not shown evidence that Cetirizine Kern Pharma causes alterations in attention, reduction of reaction capacity and ability to drive at the recommended dose.

If you intend to drive, perform potentially hazardous activities or use machinery, do not exceed the recommended dose. You should closely observe your response to the medicine.

If you are a sensitive patient, you may find that the simultaneous use of alcohol or other central nervous system depressants may also affect your attention and reaction capacity.

Important information about some of the components of Cetirizine Kern Pharma

Cetirizine Kern Pharma contains lactose; if your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Cetirizine Kern Pharma

How and when should you take Cetirizine Kern Pharma?

These recommendations apply unless your doctor has given you different instructions on how to use Cetirizine Kern Pharma. Follow these instructions, otherwise the treatment with Cetirizine Kern Pharma may not be fully effective.

The tablets must be swallowed with a glass of liquid.

Adults and adolescents over 12 years:

10 mg once a day as 1 tablet.

Children between 6 and 12 years:

5 mg twice a day, as half a tablet twice a day.

Patients with moderate to severe renal insufficiency:

It is recommended that patients with moderate renal insufficiency take 5 mg once a day.

If you notice that the effect of Cetirizine Kern Pharma is too weak or too strong, consult your doctor.

Duration of treatment:

The duration of treatment depends on the type and course of your symptoms and will be determined by your doctor.

If you take more Cetirizine Kern Pharma than you should

Inform your doctor if you think you have taken an overdose of Cetirizine Kern Pharma.

Your doctor will then decide what measures should be taken.

You can also call the Toxicology Information Service, telephone 91 562 04 20.

After an overdose, the following side effects may occur with greater intensity. The following side effects have been reported: confusion, diarrhea, dizziness, fatigue, headache, weakness, pupil dilation, paresthesia, irritation, sedation, somnolence, stupor, abnormal increase in heart rate, tremor, and urinary retention.

If you forget to take Cetirizine Kern Pharma

Do not take a double dose to make up for the forgotten dose.

If you stop taking Cetirizine Kern Pharma

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cetirizine Kern Pharma can cause side effects, although not everybody gets them.

The following side effects have been reported in post-marketing experience. The frequency is defined as follows: (frequent: affecting 1 to 10 in every 100 patients, infrequent: affecting 1 to 10 in every 1000 patients, rare: affecting 1 to 10 in every 10,000 patients; very rare: affecting less than 1 in every 10,000 patients)

• Blood and lymphatic system disorders:

Very rare: thrombocytopenia (low platelet count in blood)

• General disorders:

Frequent: fatigue

• Cardiac disorders:

Rare: tachycardia (heart beats too fast)

• Eye disorders:

Very rare: accommodation disorders, blurred vision, nystagmus (eyes have uncontrolled circular movement)

• Gastrointestinal disorders:

Frequent: diarrhea, dry mouth, nausea

Infrequent: abdominal pain

• General disorders and administration site conditions:

Infrequent: asthenia (extreme fatigue), malaise

Rare: edema (swelling)

• Immune system disorders:

Rare: allergic reactions, some severe (very rare)

• Hepatobiliary disorders:

Rare: abnormal liver function

• Investigations:

Rare: weight increase

• Nervous system disorders:

Frequent: dizziness, headache

Infrequent: paresthesia (abnormal skin sensation)

Rare: convulsions, movement disorders

Very rare: syncope, tremor, dysgeusia (taste disorder)

• Psychiatric disorders:

Frequent: somnolence

Infrequent: agitation

Rare: aggression, confusion, depression, hallucination, insomnia

Very rare: tic.

• Renal and urinary disorders:

Very rare: abnormal urine elimination

• Respiratory, thoracic and mediastinal disorders:

Frequent: pharyngitis, rhinitis

• Skin and subcutaneous tissue disorders:

Infrequent: pruritus, rash

Rare: urticaria

Very rare: edema, drug eruption

If you experience any of the side effects mentioned above, inform your doctor. At the first symptoms of hypersensitivity, stop taking Cetirizine Kern Pharma.

Your doctor will assess the severity and decide on the measures to be taken.

If you consider that any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Cetirizine Kern Pharma

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Cetirizine Kern Pharma after the expiry date which is stated on the packaging and blister, after EXP. The expiry date is the last day of the month indicated.

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

6. Further information

Composition of Cetirizine Kern Pharma

• The active substance of Cetirizine Kern Pharma is cetirizine dihydrochloride. One film-coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other components are: lactose monohydrate, microcrystalline cellulose, maize starch, anhydrous colloidal silica, magnesium stearate, talc, hypromellose, titanium dioxide (E 171), macrogol 4000 and sodium citrate.

Appearance of the product and packaging contents

White, biconvex, film-coated tablets with an "A" engraved on one face and a score line on the other.

Packaging with 20 tablets.

Marketing Authorisation Holder

Kern Pharma S.L.

Polígono Ind. Colón II

C/ Venus, 72

08228 – Terrasa (Barcelona)

Manufacturer

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Spain

This leaflet was approved in September 2010