Cetirizin Apofri – Cetirizine Dihydrochloride Uses, Dose, And Side Effects

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Cetirizin Apofri 10 mg cetirizine dihydrochloride film-coated tablets 

What Cetirizin Apofri Is And What Cetirizin Apofri Used For?

Cetirizine Apofri is an anti-allergy. Cetirizine Apofri can be used in adults and children from 6 years of age for temporary allergic disorders such as red, watery, and itchy eyes, runny nose, nasal congestion, and sneezing. The allergic problems can be caused by, among other things, pollen, fur animals, mites, or dust.

Cetirizine dihydrochloride contained in Cetirizine Apofri may also be approved for treating other conditions not mentioned in this product information.

Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.

What Do You Need To Know Before You Take Cetirizin Apofri?

Do Not Take Cetirizin Apofri

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

Warnings And Cautions

  • If you have impaired kidney function, consult a doctor; the dose may need to be adjusted. The doctor determines the new dose.
  • 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.
  • If you are going to have an allergy test, ask your doctor if you should stop taking Cetirizin Apofri 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 unsuitable for necessary dose adjustments.

Other Medicines And Cetirizin Apofri

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Cetirizin Apofri With Food And Drink And Alcohol

The absorption of cetirizine is not affected by food. It has not been shown that alcohol (at 0.5 per mile in the blood, which corresponds to a glass of wine) and cetirizine interact when taken at the recommended dose.

However, no safety data is available regarding concomitant consumption of higher doses of cetirizine and alcohol. Therefore, as with all antihistamines, concomitant use of Cetirizine Apofri and alcohol should be avoided.

Pregnancy And Breastfeeding:

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

Pregnant women should avoid Cetirizin in pregnancy. 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 after consulting a doctor.
Cetirizine passes into breast milk. Therefore, you should not use Cetirizin Apofri during breastfeeding without consulting your doctor.

Driving And Using Machines

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

You are responsible for assessing whether you can drive a motor vehicle or perform work requiring sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and 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 Apofri Contains Lactose.

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

How To Take Cetirizine Apofri?

  • Always take this medicine 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 adolescents over 12 years of age: 
    • The recommended dose is 10 mg once daily as 1 tablet.
  • Children between 6 and 12 years of age: 
    • The recommended dose is 5 mg twice daily as a 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 have severe kidney disease, contact your doctor or pharmacist, who can adjust your dose.
    • If your child has kidney disease, contact a doctor or pharmacist who can adjust the dose according to your child’s needs.
  • Treatment time
    • If you need to use Cetirizin Apofri 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 include:
    • Confusion
    • Diarrhea
    • Dizziness
    • Fatigue
    • Headache
    • Malaise
    • Dilated pupil
    • Itching
    • Restlessness
    • Drowsiness
    • Stiffness
    • Abnormally high heart rate
    • Tremors
    • Difficulty throwing water has been reported.

If You Forget To Take Cetirizin Apofri:

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

If You Stop Taking Cetirizin Apofri:

In rare cases, intense itching and hives may occur when you stop taking Cetirizine Apofri. If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible Cetirizin Apofri Side Effects

This medicine can cause side effects like all medicines, although not everybody gets them. The following side effects are rare or very rare, but you must stop taking Cetirizin Apofri and contact your doctor immediately if you get any of the following symptoms ( angioedema ):

  • Swelling of the face, tongue, or throat
  • Difficulty swallowing
  • Hives and difficulty breathing

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

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

  • Dizziness
  • Headache
  • Somnolence
  • Fatigue
  • Dry mouth
  • Nausea
  • Diarrhea
  • Inflammation of the pharynx
  • Colds (swelling and irritation of the nose)

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

  • Restlessness
  • Paresthesia (abnormal sensations in the skin)
  • Abdominal pain
  • Rash
  • Pruritus ( itching )
  • General malaise
  • Asthenia (extreme weakness)

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

  • Allergic reactions
  • Aggressiveness
  • Confusion
  • Depression
  • Insomnia (insomnia)
  • Hallucinations
  • Seizures
  • Palpitation
  • Altered liver function
  • Hives
  • Swelling
  • Weight gain

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

  • Thrombocytopenia (easy to bleed and bruise)
  • Fainting
  • Tremors
  • Dyskinesia (involuntary movements)
  • Dystonia (abnormal elongated muscle contractions)
  • Dysgeusia (altered taste experience)
  • Tics (recurrent involuntary muscle twitching)
  • Difficulty focusing the gaze
  • Dimsyn
  • Ocular crisis (eyes have uncontrolled movements)
  • Fixed drug rash
  • Abnormal urination (bedwetting, pain when urinating, and difficulty urinating)

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

  • Increased appetite
  • Suicidal ideation (recurring thoughts of or preoccupation with suicide)
  • Memory loss, memory impairment
  • Vertigo (feeling of rotation or movement)
  • Urinary retention (inability to empty the bladder)

Reporting of side effects

Talk to your doctor, pharmacist, or nurse if you get any side effects. 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 Apofri?

  • Keep this medicine out of sight and reach of children.
  • Do not use this medicine after the expiry date 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 that are 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, maize starch, pregelatinized maize starch, talc, magnesium stearate, hypromellose, macrogol, and titanium dioxide (E171).

What The Medicine Looks Like And The Contents Of The Pack

  • White, oblong film-coated tablets with a scoreline on one side and a “10” embossed on the other.
  • The tablets can be divided into two equal parts.
  • Pack sizes: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or 30 tablets in blisters.
  • Not all pack sizes may be marketed.

Marketing Authorization Holder And Manufacturer

Marketing Authorisation Holder

Apofri AB

Box 120

182 12 Danderyd

Manufacturer

Evolan Pharma AB

Svärdvägen 19, Danderyd

Sofarimex- Indústria Química e

Pharmaceuticals, SA

Of. das Indústrias – Alto do Colaride

Cacém 2735-213

Portugal

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