10 mg film-coated tablets 
cetirizine

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 has 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 within 3 days

This leaflet contains information about: 
1. What Cetirizin STADA is and what it is used for 
2. What you need to know before you take Cetirizin STADA 
3. How to use Cetirizin STADA 
4. Possible side effects 
5. How to store Cetirizin STADA 
6. Contents of the packaging and other information 

What Cetirizine STADA is and what it is used for

Cetirizine dihydrochloride is the active ingredient in Cetirizine Stada. Cetirizine Stada is an anti- allergy medicine .

Cetirizine Stada is used for adults and children over 12 years of age

  • allergies in the nose and eyes e.g. hay fever.
  • For children between 6 and 12 years, Cetirizin Stada is used for allergies in the nose, e.g. hay fever

Cetirizine dihydrochloride contained in Cetirizin Stada 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 Cetirizine STADA

Do not take Cetirizin STADA:

  • if you have severe kidney disease (severe renal impairment with 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), or to hydroxyzine or piperazine derivatives (closely related to other medicines).

Warnings and cautions

Talk to your doctor or pharmacist before taking Cetirizin Stada:

  • if you have impaired kidney function, consult a doctor; dose may need to be adjusted. 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.

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 demonstrated when cetirizine is taken at the recommended dose . However, there are no safety data available regarding concomitant consumption of higher doses of cetirizine and alcohol. Therefore, as with all antihistamines , concomitant use of Cetirizine Stada and alcohol should be avoided.

If you are going to have an allergy test , ask your doctor if you should stop taking Cetirizin Stada 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 STADA

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

Cetirizine STADA with food and drink

Absorption of Cetirizine Stada is not significantly 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.

Pregnancy

Cetirizine Stada 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.

Breast-feeding

Cetirizine passes into breast milk. Therefore, you should not take Cetirizin Stada while breast-feeding without consulting your doctor.

Driving and using machines

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

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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 STADA 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 use Cetirizine STADA

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

Adults and young people over 12 years

The recommended dose is 10 mg once daily as 1 tablet.

Use in children between 6 and 12 years

The recommended dose is 5 mg twice daily as a tablet twice daily.

Other forms of the 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 have severe kidney disease, contact your doctor or pharmacist, who can then adjust your dose .

If your child has a 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 Stada is too weak or too strong, talk to your doctor.

Method of administration 

The tablets should be swallowed with a glass of liquid.

The tablet can be divided into two equal doses .

Treatment time

If you need to use Cetirizin Stada for more than 14 days, you should consult a 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, dilated pupil, itching , restlessness, drowsiness, drowsiness, stiffness, abnormally high heart rate, tremors and difficulty throwing water have been reported.

If you forget to take Cetirizine STADA

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

If you stop taking Cetirizine STADA

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

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 Stada and seek medical attention immediately if you experience symptoms such as:

  • 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
  • Symptoms may include signs of hypersensitivity reactions, anaphylactic shock, and angioedema. These reactions are rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 users).

The following side effects have also been reported:

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

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

Less common side effects are (may affect up to 1 in 100)

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

Rare side effects are (may affect up to 1 in 1000)

  • 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 side effects are (may affect up to 1 in 10 000 users)

  • thrombocytopenia (decreased platelet count )
  • tics (recurrent involuntary muscle twitching)
  • fainting, dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremors, dysgeusia (altered taste)
  • blurred vision, accommodation disorders (difficulty focusing the gaze), oculogyration (eyes have uncontrolled circulating movements)
  • angioedema (severe allergic reaction causing swelling of the face and throat), recurrent rash
  • abnormal urinary excretion (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
  • vertigo (feeling of rotation or movement)
  • urinary retention (inability to completely empty the bladder)
  • intense itching and/or hives when treatment is stopped
  • rash with varicose veins
  • hepatitis ( inflammation of the liver).

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 STADA

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 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 is cetirizine dihydrochloride. One film-coated tablet contains 10 mg of cetirizine dihydrochloride.
  • The other ingredients are microcrystalline cellulose, lactose monohydrate , macrogol (400), magnesium stearate, colloidal anhydrous silica, titanium dioxide (E171), hypromellose (464).

What the medicine looks like and the contents of the pack

White, round tablet with a notch on one side, the opposite side is smooth.

Pack sizes: Printable packs of 7 or 14 tablets (without a prescription), 10, 15, 20, 21, 30, 40, 50 or 100 tablets (prescription).

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark

Muhammad Nadeem

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