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 directed by your doctor or pharmacist.

  • 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: 
1. What Cetirizine Teva is and what it is used for 
2. What you need to know before you take Cetirizine Teva 
3. How to take Cetirizine Teva 
4. Possible side effects 
5. How to store Cetirizine Teva 
6. Contents of the packaging and other information 

1. What Cetirizine Teva is and what it is used for

Cetirizine dihydrochloride is the active ingredient in Cetirizine Teva. Cetirizine Teva is a medicine against allergies.

Cetirizine Teva can be used in adults and children from 6 years of age

  • with temporary allergic symptoms such as red, watery, and itchy eyes well as runny nose, nasal congestion, and sneezing. The allergic problems can be caused by, among other things, pollen, fur animals, mites, or dust.

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

What you need to know before you take Cetirizine Teva

Do not take Cetirizine Teva

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

Warnings and cautions

Talk to your doctor or pharmacist before taking Cetirizine Teva.

If you have impaired kidney function, you should consult a doctor, you may need to take a lower dose. The new dose is determined by the doctor.

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

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

It has not been shown that alcohol (at 0.5 per mille in the blood, equivalent to a glass of wine) and cetirizine interact when cetirizine is taken at the recommended dose. However, there are no safety data for concomitant use of higher doses of cetirizine and alcohol. Therefore, as with all antihistamines, concomitant use of Cetirizine Teva and alcohol should be avoided.

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

Children

Do not give this medicine to children under 6 years of age as the tablet formulation is not suitable for necessary dose adjustments.

Other medicines and Cetirizine Teva

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

Cetirizine Teva 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 for advice before taking this medicine.

Cetirizine Teva should be avoided by pregnant women. If a pregnant woman inadvertently uses the drug, this 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 Cetirizine Teva during breast-feeding without consulting your doctor.

Driving and using machines

Clinical studies have not shown that cetirizine hydrochloride results in impaired attention, alertness, or ability to drive at normal doses.

You should be aware of how you react to the medicine if you intend to drive a motor vehicle, engage in activities that may be dangerous, or use machinery. 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 Teva 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 Teva

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.

Instructions for use

If your treatment with Cetirizine Teva requires you to split the tablet, you should preferably do it as follows.

Place the tablet on a hard, smooth surface (such as a tabletop or plate) with the notch facing up. Then, simultaneously with both of your index fingers (or thumbs), press quickly and hard on the outer edges to the left and right of the notch, as shown in the illustration below.

divide the tablet

Adults and young people over 12 years

The recommended dose is 10 mg (1 tablet) once daily.

Other forms of medicine may be more suitable for children, ask a doctor or pharmacist.

Use in children  between 6 and 12 years

The recommended dose is 5 mg (1/2 tablet) twice daily.

Other forms of medicine may be more suitable for children, ask a doctor or pharmacist.

Patients with renal impairment

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

If you suffer from severe kidney disease, contact your doctor or pharmacist who may then adjust the dose.

If your child suffers from severe kidney disease, contact a doctor or pharmacist who may then adjust the dose according to your child’s needs.

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

Treatment time

If you need to use Cetirizine Teva for more than 14 days, you should contact your doctor to rule out a more serious cause of the problem.

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

If you forget to take Cetirizine Teva

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

If you stop taking Cetirizine Teva

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

The following adverse event s are rare or very rare, but you have to stop taking the drug and contact your doctor immediately if you experience any of the following symptoms:

  • allergic reactions, including severe reactions and angioedema (a severe allergic reaction that causes swelling of the face or throat).

These reactions may start shortly after or later after you take the medicine.

Common (may affect up to 1 in 10 people)

  • somnolence
  • dizziness, headache
  • inflammation of the throat, runny nose (in children)
  • diarrhea, nausea, dry mouth,,
  • fatigue

Uncommon (may affect up to 1 in 100 people)

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

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

  • allergic reactions, sometimes severe (very rare)
  • depression, hallucinations aggression, confusion, insomnia
  • cramps
  • tachycardia (heart beating too fast)
  • abnormal liver function
  • hives
  • edema (swelling)
  • weight gain

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

  • thrombocytopenia (decreased platelet count )
  • tics (recurrent involuntary muscle twitching or movement)
  • fainting, dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremors, dysgeusia (altered taste)
  • blurred vision, accommodation disorders (difficulty focusing the gaze), oculogyration (uncontrolled circulating eye movements)
  • angioedema (a severe allergic reaction that causes swelling of the face and throat), fixed rash
  • abnormal urine output (bedwetting, pain when urinating and/or difficulty urinating)

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

  • increased appetite
  • suicidal thoughts (recurring thoughts of or preoccupation with suicide), nightmares
  • memory loss, memory impairment
  • dizziness (a feeling of rotation or movement)
  • urinary retention (inability to completely empty the bladder)
  • Intense itching and/or hives when the treatment is stopped
  • Joint pain
  • Rash with blisters

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 Cetirizine Teva

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. date. or 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 is cetirizine dihydrochloride. 1 film-coated tablet contains 10 mg cetirizine dihydrochloride.
  • The other ingredients are lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, titanium dioxide (E171), hypromellose (E464), and macrogol.

What the medicine looks like and the contents of the pack

The film-coated tablet is white to almost white, round biconvex with a notch on one side and about 6.5 mm in diameter.

PVC / PVDC / aluminum blister.

Cetirizine Teva is available as a blister of 7, 14, and 28 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Muhammad Nadeem

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