PATIENT INFORMATION LEAFLET

Cetirizine KERN PHARMA 10 mg Film-Coated Tablets

The active ingredient of Cetirizina Kern Pharma is cetirizine dihydrochloride.

Cetirizina Kern Pharma is an antihistamine medication.

Cetirizina Kern Pharma is indicated for 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 (idiopathic chronic urticaria).

Do not take Cetirizina Kern Pharma

• if you have a severe kidney disease (severe renal insufficiency with a creatinine clearance below 10 ml/min);
• if you know you are allergic (hypersensitive) to the active ingredient of Cetirizina Kern Pharma, to any of its excipients (other components), to hydroxyzine or to piperazine derivatives (related active principles of other medications).

Do not take Cetirizina Kern Pharma:

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

Be especially careful with Cetirizina Kern Pharma

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

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

No notable interactions 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 the joint consumption of alcohol during treatment.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

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

Taking Cetirizina Kern Pharma with food and beverages

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

As with other medications, Cetirizina Kern Pharma should be avoided in pregnant women. Accidental use of the medication in pregnant women should not cause any harmful effects on the fetus. However, treatment with the medication should be interrupted.

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

Driving and operating machines

Clinical studies have not shown evidence that Cetirizina Kern Pharma produces attention alterations, decreased 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 must closely observe your response to the medication.

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

Important information about some components of Cetirizina Kern Pharma

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

How and when to take Cetirizina Kern Pharma?

These recommendations apply unless your doctor has given you different instructions on how to use Cetirizina Kern Pharma. Follow these instructions, otherwise the treatment with Cetirizina 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:

Patients with moderate renal insufficiency are recommended to take 5 mg once a day.

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

Treatment duration:

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

If you take more Cetirizina Kern Pharma than you should

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

Your doctor will then decide what measures should be taken.

You can also call the Toxicological Information Service, phone 91 562 04 20.

After an overdose, the adverse effects described below may occur with greater intensity. Adverse effects such as confusion, diarrhea, dizziness, fatigue, headache, weakness, dilated pupil, tingling, irritation, sedation, drowsiness, stupor, abnormal increase in heart rate, tremor, and urinary retention have been reported.

If you forgot to take Cetirizina Kern Pharma

Do not take a double dose to compensate for the missed dose.

If you interrupt the treatment with Cetirizina Kern Pharma

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

Like all medications, Cetirizina Kern Pharma may cause side effects, although not everyone will experience them.

The following side effects have been reported in post-marketing experience. Frequency is defined as follows: (frequent: affects between 1 and 10 of every 100 patients, infrequent: affects between 1 and 10 of every 1,000 patients, rare: affects between 1 and 10 of every 10,000 patients; very rare: affects fewer than 1 of every 10,000 patients)

• Blood and lymphatic system disorders:

Very rare: thrombocytopenia (low platelet levels in blood)

• General disorders and administration site conditions:

Frequent: fatigue

• Cardiac disorders:

Rare: tachycardia (heart beats too quickly)

• Ocular disorders:

Very rare: accommodation disorders, blurred vision, nystagmus (eyes have an 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 gain

• Nervous system disorders:

Frequent: dizziness, headache

Infrequent: paresthesia (abnormal skin sensation)

Rare: convulsions, movement disorders

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

• Mental and behavioral disorders:

Frequent: somnolence

Infrequent: agitation

Rare: aggression, confusion, depression, hallucination, insomnia

Very rare: tic.

• Renal and urinary disorders:

Very rare: abnormal urination

• Respiratory, thoracic and mediastinal disorders:

Frequent: pharyngitis, rhinitis

• Skin and subcutaneous tissue disorders:

Infrequent: pruritus, urticaria

Rare: urticaria

Very rare: edema, drug eruption

If you develop any of the side effects described above, inform your doctor. At the first symptoms of hypersensitivity, stop taking Cetirizina Kern Pharma.

Your doctor will evaluate the severity and decide on the necessary measures.

If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

No special storage conditions are required.

Do not use Cetirizina Kern Pharma after the expiration date shown on the packaging and blister, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Cetirizina Kern Pharma

• The active ingredient of Cetirizina Kern Pharma is cetirizine dihydrochloride. A coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other components are: lactose monohydrate, microcrystalline cellulose, cornstarch, anhydrous colloidal silica, magnesium stearate, talc, hypromellose, titanium dioxide (E 171), macrogol 4.000, and sodium citrate.

Appearance of the Product and Contents of the Package

White, biconvex coated tablets, with an A engraved on one face and a groove on the other.

Package with 20 tablets.

Holder of the Marketing Authorization

Kern Pharma S.L.

Colón II Industrial Estate

C/ Venus, 72

08228 – Terrasa (Barcelona)

Person Responsible for Manufacturing

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Spain

This leaflet was approved in September 2010