Cetirizine Kern Pharma 10 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Cetirizine KERN PHARMA 10 mg film-coated tablets EFG
Read the entire leaflet carefully before you start taking this medicine
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Package leaflet:
- What Cetirizine Kern Pharma is and what it is used for
- Before you take Cetirizine Kern Pharma
- How to take Cetirizine Kern Pharma
- Possible side effects
- How to store Cetirizine Kern Pharma
- 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 antiallergy medicine.
Cetirizine Kern Pharma is indicated in adults and children aged 6 years and older 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 insufficiency with creatinine clearance below 10 ml/min);
- if you are allergic (hypersensitive) to the active substance in Cetirizine Kern Pharma, to any of its excipients (other components), to hydroxyzine, or to piperazine derivatives (active substances related to other medicines).
You should not take Cetirizine Kern Pharma:
- if you have hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
Take special care with Cetirizine 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 interactions likely to have a significant impact have been observed between alcohol (with a blood level of 0.5 per mille, corresponding to one glass of wine) and the use of cetirizine at normal doses. However, as with all antihistamines, it is recommended to avoid concomitant alcohol consumption during treatment.
Use of other medicines
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
Due to the profile of cetirizine, no interactions with other drugs are expected.
Taking Cetirizine Kern Pharma with food and drinks
Food does not significantly affect the extent of absorption of cetirizine.
Pregnancy and breastfeeding
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 is not expected to cause any harmful effects on the fetus. However, treatment with the medicine should be discontinued.
You should not take Cetirizine Kern Pharma during breastfeeding, as cetirizine is excreted in breast milk.
Driving and use of machines
Clinical studies have not shown evidence that Cetirizine Kern Pharma causes disturbances in attention, reduced reaction capacity, or impaired ability to drive at the recommended dose.
If you intend to drive, perform potentially dangerous activities, or operate machinery, do not exceed the recommended dose. You should closely monitor your response to the medicine.
If you are a sensitive patient, you may find that the concomitant use of alcohol or other central nervous system depressants may further affect your attention and ability to react.
Important information about some of the components of Cetirizine Kern Pharma
Cetirizine Kern Pharma contains lactose; if your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Cetirizina Kern Pharma
How and when should you 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 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 of age:
10 mg once daily as 1 tablet.
Children between 6 and 12 years of age:
5 mg twice daily, as half a tablet twice daily.
Patients with moderate to severe renal impairment:
Patients with moderate renal impairment are advised to take 5 mg once daily.
If you notice that the effect of Cetirizina 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 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 may also call the Toxicology Information Service at telephone number 91 562 04 20.
After an overdose, the adverse effects described below may occur with greater intensity. Adverse effects reported include confusion, diarrhea, dizziness, fatigue, headache, weakness, pupillary dilation, tingling, irritation, sedation, somnolence, stupor, abnormally increased heart rate, tremor, and urinary retention.
If you forget to take Cetirizina Kern Pharma
Do not take a double dose to make up for the missed dose.
If you stop treatment with Cetirizina Kern Pharma
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Cetirizine Kern Pharma may cause adverse effects, although not everyone experiences them.
The following adverse effects have been reported in post-marketing experience. Frequency is defined as follows: (common: affects between 1 and 10 in every 100 patients, uncommon: affects between 1 and 10 in every 1,000 patients, rare: affects between 1 and 10 in every 10,000 patients; very rare: affects fewer than 1 in every 10,000 patients):
- Blood and lymphatic system disorders:
Very rare: thrombocytopenia (low platelet levels in blood)
- General disorders and administration site conditions:
Common: fatigue
- Cardiac disorders:
Rare: tachycardia (heart beats too fast)
- Eye disorders:
Very rare: accommodation disorders, blurred vision, ocular nystagmus (eyes have uncontrolled circular movement)
- Gastrointestinal disorders:
Common: diarrhoea, dry mouth, nausea
Uncommon: abdominal pain
- General disorders and administration site conditions:
Uncommon: asthenia (extreme fatigue), malaise
Rare: oedema (swelling)
- Immune system disorders:
Rare: allergic reactions, some severe (very rare)
- Hepatobiliary disorders:
Rare: abnormal liver function
- Investigations:
Rare: weight gain
- Nervous system disorders:
Common: dizziness, headache
Uncommon: paraesthesia (abnormal skin sensation)
Rare: seizures, movement disorders
Very rare: syncope, tremor, dysgeusia (taste disturbance)
- Psychiatric disorders:
Common: somnolence
Uncommon: agitation
Rare: aggression, confusion, depression, hallucination, insomnia
Very rare: tic
- Renal and urinary disorders:
Very rare: abnormal urination
- Respiratory system disorders:
Common: pharyngitis, rhinitis
- Skin and subcutaneous tissue disorders:
Uncommon: pruritus, rash
Rare: urticaria
Very rare: angioedema, drug eruption
If you experience any of the adverse effects listed above, inform your doctor. At the first signs of hypersensitivity, stop taking Cetirizine Kern Pharma.
Your doctor will assess the severity and decide on the necessary measures.
If you consider any of the adverse effects you experience to be severe or if you notice any adverse 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 stated on the packaging and blister, after EXP. The expiry date refers to 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 and packaging that you no longer need. This will help protect the environment.
6. Additional Information
Composition of Cetirizina Kern Pharma
- The active substance in Cetirizina Kern Pharma is cetirizine dihydrochloride. One coated tablet contains 10 mg of cetirizine dihydrochloride.
- The other components are: monohydrate lactose, microcrystalline cellulose, corn starch, 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 pack
White, biconvex coated tablets, with an "A" engraved on one side and a score line on the other.
Pack containing 20 tablets.
Marketing Authorization Holder
Kern Pharma S.L.
Polígono Ind. Colón II
C/ Venus, 72
08228 – Terrasa (Barcelona)
Manufacturer Responsible
Laboratorios Alcalá Farma, S.L.
Avenida de Madrid, 82
28802 Alcalá de Henares (Madrid)
Spain
This leaflet was approved in September 2010