10 mg film-coated tablets 
cetirizine dihydrochloride

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

  • Save this information, you may need to read it again.
  • Contact the pharmacy staff if you need more information or advice.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.
  • You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

In this leaflet you will find information about: 
1. What Cetirizin Sandoz is and what it is used for 
2. What you need to know before taking Cetirizin Sandoz 
3. How to take Cetirizin Sandoz 
4. Possible side effects 
5. How to store Cetirizin Sandoz 
6. Contents of the packaging and other information 

What Cetirizine Sandoz is and what it is used for

Cetirizine dihydrochloride is the active ingredient in Cetirizine Sandoz.

Cetirizin Sandoz is an anti-allergy.

Adults and children over 12 years: Allergies in the nose and eyes e.g. hay fever.

Children 6-12 years: Allergies in your nose, e.g. hay fever. Cetirizine dihydrochloride contained in

Cetirizine Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you take Cetirizin Sandoz

Do not take Cetirizin Sandoz

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

Warnings and cautions

Talk to your doctor or pharmacist before taking Cetirizin Sandoz.

If you have problems emptying your bladder (such as spinal cord problems or prostate or bladder problems), consult your doctor.

If you have impaired kidney function, consult a doctor; dose one may need to be reduced. The new dose is determined by the doctor.

If you have epilepsy or are at risk of seizures, consult your doctor.

If you are going to have an allergy test, ask your doctor if you should stop taking Cetirizin Sandoz several days before the test. This medicine may affect the results of allergy tests.

No clinically relevant effect between alcohol (at 0.5 per mille [g / l] in the blood, equivalent to a glass of wine) and cetirizine has been shown when cetirizine is taken at the normal dose. However, there are no safety data available regarding concomitant consumption of higher doses of cetirizine and alcohol. Therefore, as with all antihistamines, concomitant consumption of alcohol should be avoided.

Other medicines and Cetirizin Sandoz

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

Cetirizin Sandoz with food and drink

The absorption of cetirizine is not affected by food.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Cetirizine Sandoz should be avoided by pregnant women. Accidental use of the drug by a pregnant woman should not cause any adverse effects on the fetus. However, the drug should only be given if necessary and after consulting a doctor.

Cetirizine passes into breast milk. Therefore, you should not use Cetirizin Sandoz during breast-feeding without consulting your doctor.

Driving and using machines

Clinical studies have not shown that Cetirizin Sandoz impairs the alertness, alertness, or ability to drive at normal doses.


If you intend to drive a motor vehicle, engage in potentially dangerous activities, or use machinery, you should know how you react to the medicine. You should not exceed the recommended dose.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Cetirizine Sandoz contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Cetirizine Sandoz

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The tablets should be swallowed with a glass of liquid.

The tablet can be divided into two equal doses.

Adults and young people over 12 years

10 mg once daily as 1 tablet.

Children between 6 and 12 years

5 mg twice daily as a tablet twice daily.

Patients with renal impairment

The recommended dose for patients with moderate renal impairment is 5 mg once daily.

If you have severe kidney disease, contact your doctor or pharmacist, who can then adjust your dose.

If your child has kidney disease, contact a doctor or pharmacist who can then adjust the dose according to your child’s needs.

If you have the impression that the effect of Cetirizin Sandoz is too weak or too strong, talk to your doctor.

Treatment time

You must contact a doctor if symptoms worsen or do not improve within 14 days. 
For the treatment of more than 2 weeks, the doctor should be consulted.

The doctor decides on any measures.

Following an overdose, the side effects described below may occur with increasing intensity. Side effects such as confusion, diarrhea, dizziness, fatigue, headache, malaise, dilated pupil, itching, restlessness, drowsiness, drowsiness, dizziness, abnormally high heart rate, tremors, and difficulty urinating have been reported.

If you forget to take Cetirizin Sandoz

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

If you stop taking Cetirizin Sandoz

In rare cases, intense itching and/or hives may occur when you stop taking Cetirizine Sandoz.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Cetirizin Sandoz and seek medical attention immediately if you experience the following symptoms:

  • swelling of the mouth, face, and/or throat
  • difficulty breathing (pressure over the chest or wheezing)
  • a sudden drop in blood pressure with subsequent fainting or shock.

These symptoms may be signs of an allergic reaction, anaphylactic shock or angioedema. These reactions may start shortly after you take the medicine, or later.

The list below lists additional side effects according to how often they occur:

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

  • fatigue
  • dry mouth, nausea, diarrhea
  • dizziness, headache
  • somnolence
  • pharyngitis (sore throat), rhinitis (swelling and irritation of the nose).

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

  • violent restlessness
  • abdominal pain
  • asthenia (extreme weakness), feeling sick
  • paresthesia (abnormal sensations in the skin)
  • itching, rash.

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

  • tachycardia (heart beating too fast)
  • edema (swelling)
  • abnormal liver function
  • weight gain
  • cramps
  • aggression, confusion, depression, hallucinations, insomnia
  • hives

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

  • thrombocytopenia (low platelet count, leading to bleeding or bruising more easily than normal)
  • accommodation disorders (difficulty focusing the gaze), blurred vision, okolugyr crisis (eyes have uncontrolled circulating movements)
  • fainting, tremors, dysgeusia (change in taste), involuntary movements, abnormal prolonged muscle contractions
  • tics (recurrent, involuntary muscle twitching)
  • abnormal urinary excretion
  • fixed drug rash

Has been reported (occurs in an unknown number of users)

  • memory loss, impaired memory
  • increased appetite
  • dizziness (feeling of rotation or movement)
  • urinary retention (inability to empty the bladder completely)
  • nightmare
  • hepatitis ( inflammation of the liver)
  • joint pain
  • rash with varicose veins
  • intense itching and/or hives when treatment is stopped
  • suicidal thoughts (recurring thoughts about or fixation on suicide). 
    If you get such thoughts, stop taking the tablets and contact your doctor.

Reporting of side effects

If you get 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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Cetirizin Sandoz

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 carton and blister after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance in Cetirizine Sandoz is cetirizine dihydrochloride.

One film-coated tablet contains 10 mg of cetirizine dihydrochloride.

Other ingredients are:

Tablet core: microcrystalline cellulose, lactose monohydrate, magnesium stearate, anhydrous colloidal silica.

Tablet cover: hypromellose, lactose monohydrate, macrogol 4000, titanium dioxide (E 171).

What the medicine looks like and the contents of the pack

White, oblong film-coated tablet, scored on one side.

PVC blisters with aluminum seal: 7, 10, 14, 20, 21, 28 and 30 tablets (over-the-counter packaging).

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, D-39179 Barleben, Germany

or

Lek SA ul. Domaniewska 50 C, 02-672, Warsaw, Poland

Muhammad Nadeem

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