CETIRIZIN

CETIRIZIN 10-1A Pharma film-coated tablets

Important notes (mandatory information)

Cetirizine 10 - 1 A Pharma 10 mg film-coated tablets. Active ingredient: Cetirizine dihydrochloride. Areas of application: for the relief of nasal and eye symptoms in seasonal and perennial allergic rhinitis and/or for the relief of hives (urticaria).

For risks and side effects, read the package leaflet and consult your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Cetirizine 10 - 1 A Pharma 10 mg film-coated tablets
Active ingredient: Cetirizine dihydrochloride

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse after 3 days, contact your doctor.

What this leaflet contains

1. WHAT IS CETIRIZINE 10 - 1 A PHARMA AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING CETIRIZINE 10 - 1 A PHARMA?
3. HOW TO TAKE CETIRIZINE 10 - 1 A PHARMA?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD CETIRIZINE 10 - 1 A PHARMA BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS CETIRIZINE 10 - 1 A PHARMA AND WHAT IS IT USED FOR?

Cetirizine dihydrochloride is the active ingredient of Cetirizine 10 - 1 A Pharma. Cetirizine 10 - 1 A Pharma is an antiallergic. In adults and children aged 6 years and over, Cetirizine 10 - 1 A Pharma is indicated for the relief of nasal and eye symptoms in seasonal and perennial allergic rhinitis and/or for the relief of hives (urticaria).

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING CETIRIZINE 10 - 1 A PHARMA?

Cetirizine 10 - 1 A Pharma must not be taken:

• if you have severe kidney disease (severe impairment of kidney function with a creatinine clearance below 10 ml/min).
• if you are allergic to cetirizine dihydrochloride or any of the other ingredients of this medicine listed in section 6, to hydroxyzine or other piperazine derivatives (closely related active ingredients of other medicines).

Warnings and precautions

Please talk to your doctor or pharmacist before taking Cetirizine 10 - 1 A Pharma. If you have impaired kidney function, please ask your doctor for advice; if necessary, you will take a lower dose. Your doctor will determine the new dose. If you have difficulty urinating (e.g. due to problems with the spinal cord, prostate or bladder), please ask your doctor for advice. If you are an epilepsy patient or are at risk of seizures, please ask your doctor for advice. No clinically significant interactions between alcohol (at a blood alcohol level of 0.5 per mille [g/l], equivalent to about 1 glass of wine) and cetirizine have been observed at recommended dosages. However, there is no safety data available when higher doses of cetirizine and alcohol are taken together. Therefore, as with all antihistamines, it is recommended to avoid taking Cetirizine 10 - 1 A Pharma and alcohol at the same time. If you are scheduled to have an allergy test, please ask your doctor whether you should stop taking Cetirizine 10 - 1 A Pharma for a few days before the test, as this medicine could affect the results of an allergy test.

Children

Do not give this medicine to children under 6 years of age, as the required dose cannot be adjusted with the film-coated tablets.

Taking Cetirizine 10 - 1 A Pharma with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Taking Cetirizine 10 - 1 A Pharma with food and drink

Food has no influence on the absorption of cetirizine.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Taking Cetirizine 10 - 1 A Pharma should be avoided during pregnancy. Accidental ingestion of the medicine by pregnant women should not lead to harmful effects on the fetus. Nevertheless, the medicine should only be taken if necessary and after consulting a doctor. Cetirizine passes into breast milk. Therefore, until you have consulted your doctor, you should not take Cetirizine 10 - 1 A Pharma while breast-feeding.

Driving and using machines

In clinical studies, cetirizine at the recommended dose did not cause any signs of impairment of attention, alertness and driving ability. If you intend to participate in road traffic, work without a secure hold or operate machinery, you should carefully observe your reaction to the medicine after taking Cetirizine 10 - 1 A Pharma. You should not use more than the recommended dose.

Cetirizine 10 - 1 A Pharma contains lactose

Please only take Cetirizine 10 - 1 A Pharma after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE CETIRIZINE 10 - 1 A PHARMA?

Always take this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The film-coated tablets should be taken unchewed with a glass of liquid. The film-coated tablets can be divided into equal doses.

• Adults and adolescents over 12 years of age: The recommended dose is 10 mg once daily as 1 film-coated tablet.
• Children between 6 and 12 years of age: The recommended dose is 5 mg twice daily as 1/2 film-coated tablet.
• Patients with renal impairment: Patients with moderate renal impairment are recommended to take 5 mg once daily.

If you have severe kidney disease, please talk to your doctor or pharmacist, who can adjust your dose accordingly. If your child has severe kidney disease, please talk to your doctor or pharmacist, who can adjust the dose according to the child's needs.

If you have the impression that the effect of Cetirizine 10 - 1 A Pharma is too weak or too strong, please contact your doctor.

Duration of use

The duration of use depends on the type, duration and course of your complaints. Please ask your doctor or pharmacist for advice.

If you have taken more Cetirizine 10 -1 A Pharma than you should

If you think you have taken an overdose of Cetirizine 10 - 1 A Pharma, please tell your doctor. Your doctor will then decide what measures, if any, need to be taken. After an overdose, the side effects described below may occur with increased intensity. Undesirable effects such as confusion, diarrhea, dizziness, fatigue, headache, malaise, dilated pupils, itching, restlessness, sedation, drowsiness, stupor, rapid heartbeat, tremor and urinary retention have been reported.

If you forget to take Cetirizine 10 - 1 A Pharma

Do not take twice the amount if you have forgotten to take the previous dose.

If you stop taking Cetirizine 10 - 1 A Pharma for allergies

If you stop taking Cetirizine 10 - 1 A Pharma for allergies, pruritus (intense itching) and/or urticaria (hives) may recur in rare cases.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects occur rarely or very rarely. If you experience these side effects, you must stop taking the medicine immediately and contact your doctor: allergic reactions, including serious allergic reactions and angioedema (serious allergic reaction that causes swelling of the face and throat). These reactions can occur shortly after you have taken the medicine for the first time or later.

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

• Drowsiness
• Dizziness, headache
• Pharyngitis (sore throat), rhinitis (runny nose, in children)
• Diarrhea, nausea, dry mouth
• Fatigue

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

• Agitation
• Paresthesia (abnormal sensations on the skin)
• Abdominal pain
• Itching, rash
• Asthenia (extreme fatigue), malaise

Rare side effects (may affect up to 1 in 1,000 people):

• allergic reactions, some of them serious (very rare)
• Depression, hallucination, aggression, confusion, insomnia
• Convulsions
• Tachycardia (too fast heartbeat)
• abnormal liver function
• Urticaria (itchy rash)
• Edema (swelling)
• Weight gain

Very rare side effects (may affect up to 1 in 10,000 people):

• Thrombocytopenia (low platelet count)
• Tics (recurrent, nervous muscle twitches and vocalizations)
• Syncope (loss of consciousness), dyskinesia (involuntary movements), dystonia (abnormal, persistent, involuntary muscle tension), tremor (trembling), dysgeusia (altered sense of taste)
• blurred vision, accommodation disorders (disturbances in near/far adjustment of the eye), oculogyration (uncontrollable circular movement of the eyes)
• Angioedema (serious allergic reaction that causes swelling of the face or throat), anaphylactic shock, fixed drug eruption
• abnormal urinary excretion (bedwetting, pain and/or difficulty urinating)

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

• increased appetite
• Suicidal thoughts (recurrent thoughts of suicide or preoccupation with suicide), nightmares
• Memory loss (amnesia), memory impairment
• Vertigo (dizziness)
• Urinary retention (inability to completely empty the bladder)
• Pruritus (intense itching) and/or urticaria (hives) upon discontinuation of use
• Joint pain
• Rash with blisters containing pus
• Hepatitis (inflammation of the liver)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD CETIRIZINE 10 - 1 A PHARMA BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister pack after "use by". The expiry date refers to the last day of the month indicated. This medicinal product does not require any special storage conditions.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Cetirizine 10 - 1 A Pharma contains

The active substance is cetirizine dihydrochloride. 1 film-coated tablet contains 10 mg cetirizine dihydrochloride. The other ingredients are: microcrystalline cellulose, hypromellose, lactose monohydrate, macrogol 4,000, magnesium stearate (Ph.Eur.), highly dispersed silicon dioxide, titanium dioxide (E 171).

What Cetirizine 10 - 1 A Pharma looks like and contents of the pack

Cetirizine 10 - 1 A Pharma are white, oblong film-coated tablets with a break notch on one side. The film-coated tablets can be divided into equal doses. Cetirizine 10 - 1 A Pharma is available in packs of 7, 10, 20, 30, 50 and 100 film-coated tablets. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Phone: (089) 6138825-0

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben

This leaflet was last revised in August 2018.

Source: Information from the package leaflet
Status: 01/2020
Active ingredient: Cetirizine dihydrochloride. Areas of application: for the relief of nasal and eye symptoms in seasonal and perennial allergic rhinitis and/or for the relief of hives (urticaria).