10 mg film-coated tablets 
cetirizine dihydrochloride

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

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– 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.

This leaflet contains information on: 
1. What Cetirizin Mylan is and what it is used for 
2. What you need to know before you use Cetirizin Mylan 
3. How to use Cetirizin Mylan 
4. Possible side effects 
5. How to store Cetirizin Mylan 
6. Package contents and other information

What Cetirizine Mylan is and what it is used for

Cetirizine dihydrochloride is the active ingredient in Cetirizine Mylan.

Cetirizine Mylan is a medicine for allergies.

Cetirizine Mylan is used for adults and children from 6 years of age

  • relief of symptoms from the nose and eyes in seasonal and chronic rhinitis(allergic rhinitis ) 
  • relief of chronic hives ( chronic idiopathic urticaria )

Cetirizine contained in Cetirizine Mylan may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 use Cetirizine Mylan

Do not use Cetirizine Mylan

– if you have severe kidney disease (severe renal impairment with creatinine clearance below 10 ml/min).

– if you are allergic to Cetirizine, any of the other ingredients of this medicine (listed in section 6), hydroxyzine, or piperazine derivatives (closely related substances in other medicines).

Warnings and cautions

Talk to your doctor or pharmacist before taking Cetirizine

  • If you have impaired kidney function, your 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 problems with the prostate or bladder).
  • If you have epilepsy or are at risk of seizures.

Allergy test

If you need to have an allergy test, tell your doctor that you are taking these tablets as this medicine may affect your test results. You need to stop treatment 3 days before the test.

Children

This medicine is not recommended for children under 6 years.

Other medicines and Cetirizine Mylan

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

Cetirizine and alcohol

Concomitant consumption of alcohol is not recommended.

Pregnancy and breastfeeding

Cetirizine Mylan should be avoided during pregnancy, as experience in treating pregnant women is limited.

You should not use Cetirizine Mylan during breast-feeding as cetirizine passes into breast milk.

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.

Driving and using machines

There is no evidence that Cetirizin Mylan impairs impaired attention, alertness, or ability to drive at the recommended dose.

You should know how to react to a medicine if you intend to drive, use machines, or perform work that requires sharp attention.

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 Mylan contains lactose

Cetirizine Mylan film-coated tablets contain 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 Mylan

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

How and when to take Cetirizine Mylan

These guidelines apply unless your doctor tells you how to use Cetirizine Mylan.

Follow these instructions, otherwise, Cetirizine Mylan may not be fully effective.

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:

The recommended dose is 10 mg once a day as a tablet.

Children between 6 and 12 years:

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

Patients with moderate to severe renal impairment:

For patients with renal impairment, dose one will be determined by your doctor depending on your renal function.

Treatment time

The duration of treatment depends on the type, duration, and cause of your problems and is determined by your doctor or pharmacist.

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 urinating have been reported.

If you forget to take Cetirizine Mylan

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

4. Possible side effects

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

Some side effects can be serious:

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

Sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue, or other parts of the body, or shortness of breath.

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

• Suicidal thoughts

• Difficulty urinating

If any of the above symptoms occur, consult a doctor immediately.

Other possible side effects are

Common (may affect up to 1 in 10 people)

• Fatigue

• Dry mouth

• Nausea

• Dizziness

• Headache

• Sleepiness

Sore throat or discomfort when swallowing

Uncommon (may affect up to 1 in 100 people)

• Weakness

• General malaise

Tingling or numbness in the hands or feet

• Outrage

• Itching

• Rash

• Diarrhea

• Magont

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

• Heart palpitations

• Abnormal liver samples

• Weight gain

• Cramps

• Aggressiveness

• Confusion

Depression

• Hallucinations

• Insomnia

• Allergic reaction (usually with skin reactions such as rash and itchy red skin)

Swelling, fluid retention in the body ( edema )

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

• Bleeding or getting bruises more easily than normal

Blurred vision, okolugyr crisis (eyes have uncontrolled movements)

• Fainting

Tremors, tremors

• Taste effect or loss of taste

• Uncontrolled body movements

• Difficulty urinating, pain when urinating or involuntary urination

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

• Memory loss

• Increased appetite

• Scams

Additional side effects are in children and adolescents

In children and adolescents, diarrhea and runny or stuffy nose occur more frequently and occur in up to 1 in 10 users.

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 Mylan

Keep out of 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.

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.

No special storage instructions.

6. Contents of the packaging and other information

Content declaration

– The active substance is cetirizine dihydrochloride. Each tablet contains 10 mg of cetirizine dihydrochloride.

The other ingredients are lactose monohydrate (see section 2), pregelatinized maize starch, povidone, magnesium stearate, hypromellose (E464), macrogol 400, titanium dioxide (E171), talc.

What the medicine looks like and the contents of the pack

Film-coated tablet (white, capsule-shaped tablet with a scoreline. The tablet is marked with “CZ” and “10” on one side and “G” on the other side).

Blister: 2, 7, 10, 14, 15, 20, 30, 50, 60, 90, 100, 10x10x1 (endos), 50×1 (endos) tablets.

Jar: 30, 100, or 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan AB

Box 23033

104 35 Stockholm

Manufacturer :

McDermott Laboratories Limited (t / a Gerard Laboratories)

35-36 Baldoyle Industrial Estate, Grange Road

Dublin 13, Ireland

Mylan BV

Dieselweg 25

3752 LB Bunschoten

Netherlands

Muhammad Nadeem

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