Cetirizine Mylan Generics

Package leaflet: Information for the user

Cetirizine Mylan Generics

10 mg film-coated tablets
Cetirizine dihydrochloride
Generic medicine
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Cetirizine Mylan Generics is and what it is used for
2. What you need to know before taking Cetirizine Mylan Generics
3. How to take Cetirizine Mylan Generics
4. Possible side effects
5. How to store Cetirizine Mylan Generics
6. Contents of the pack and other information

1. What Cetirizina Mylan Generics is and what it is used for

Cetirizina Mylan Generics contains the active substance cetirizine dihydrochloride.
Cetirizina Mylan Generics is an antiallergic medicinal product.
In adults and children from 6 years of age, Cetirizina Mylan Generics is indicated:

• for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
• for the treatment of chronic urticaria (chronic idiopathic urticaria).

2. What you need to know before taking Cetirizine Mylan Generics

Do not take Cetirizine Mylan Generics

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Cetirizine Mylan Generics.
If you have kidney problems, you may need to take a lower dose. Your doctor will determine the new dose.

• If you have problems when urinating (such as spinal, prostate, or bladder problems), consult your doctor.
• If you are an epileptic patient or a patient at risk of seizures.

Skin testing
If you need to undergo a skin allergy test, inform your doctor that you are taking these tablets, as this medicine may affect the results of the skin test. You must stop treatment three days before the test.
Children
This medicine is not recommended for children under 6 years of age.
Other medicines and Cetirizine Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Cetirizine Mylan Generics and alcohol
It is recommended to avoid alcohol consumption while taking this medicine.
Pregnancy and breastfeeding
The use of Cetirizine Mylan Generics should be avoided in pregnant women, as clinical experience with this treatment during pregnancy is limited.
You must not take Cetirizine Mylan Generics during breastfeeding because cetirizine passes into breast milk.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
There is no evidence of impairment of attention, alertness, or ability to drive after taking Cetirizine Mylan Generics at the recommended dose.
You should carefully observe your response to the medicine if you intend to drive, engage in potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.
Cetirizine Mylan Generics contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Cetirizine Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
How and when to take Cetirizine Mylan Generics
Follow these guidelines unless your doctor has given you different instructions regarding the use of
Cetirizine Mylan Generics.
Follow the instructions below, otherwise Cetirizine Mylan Generics may not be fully effective. The tablets should be taken with a glass of liquid.
The tablets may be divided into equal doses.
Adults and adolescents from 12 years of age:
The recommended dose is 10 mg once daily as one tablet.
Children aged 6 to 12 years:
The recommended dose is 5 mg twice daily as half a tablet twice daily.
Patients with moderate to severe renal impairment
For patients with impaired renal function, the dose will be determined by the doctor after evaluating renal function.
Duration of treatment
The duration of treatment depends on the type, duration and course of your condition and will be determined by
your doctor or pharmacist.
If you take more Cetirizine Mylan Generics than you should
If you think you have taken an overdose of Cetirizine Mylan Generics, inform your doctor.
Your doctor will decide which measures to take if necessary.
After an overdose, the side effects described below may occur with increased intensity.
Adverse events reported include confusion, diarrhoea, dizziness, fatigue, headache, malaise, pupillary dilation, itching, restlessness, sedation, somnolence, delirium, rapid abnormal heart rhythm, tremors and urinary retention.
If you forget to take Cetirizine Mylan Generics
Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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, shortness of breath, wheezing or difficulty breathing

If you experience any of the above effects, inform your doctor immediately.
Other possible side effects
Common (may affect up to 1 in 10 people)

• Tiredness
• Dry mouth
• Feeling unwell
• Dizziness
• Headache
• Sleepiness
• Sore throat and difficulty swallowing

Uncommon (may affect up to 1 in 100 people)

• Weakness
• General feeling of being unwell
• Tingling or numbness in the hands or feet
• Agitation
• Itching
• Rash
• Diarrhoea
• Stomach ache

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

• Fast heartbeat

• Abnormal liver function tests

• Weight gain

• Seizures

• Aggression

• Confusion

• Depression

• Seeing, hearing or sensing things that are not real

• Difficulty sleeping

• Hypersensitivity (usually occurs with skin reactions such as rashes, red and itchy skin)

• Swelling, fluid retention (oedema)
  Very rare (may affect up to 1 in 10,000 people)

• Bleeding or bruising more easily than normal

• Blurred vision, eyes with uncontrolled circular movements

• Fainting

• Tremor

• Disturbance or loss of taste

• Uncontrolled body movements

• Difficulty, pain or involuntary urination

Not known (frequency cannot be estimated from the available data)

• Memory loss
• Increased appetite
• Vertigo (spinning sensation)

Side effects in children and adolescents
In children and adolescents, the following side effects occur more commonly and may affect up to 1 in 10 people:

• Runny or blocked nose
• Diarrhoea

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cetirizine Mylan Generics

Keep Cetirizine Mylan Generics out of the sight and reach of children.
Do not use Cetirizine Mylan Generics after the expiry date stated on the label and on the carton.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
This medicine does not require any special storage conditions.

6. Other information

What Cetirizina Mylan Generics contains

• The active substance in Cetirizina Mylan Generics is cetirizine hydrochloride. Each film-coated tablet contains 10 mg of cetirizine hydrochloride.
• The other ingredients are monohydrate lactose (see section 2 “Cetirizina Mylan Generics contains lactose”), pregelatinized maize starch, povidone, magnesium stearate, hypromellose (E464), macrogol, titanium dioxide (E 171) and talc.

Description of the appearance of Cetirizina Mylan Generics and contents of the pack
Film-coated capsule-shaped white tablet, with a break line, marked “CZ” and “10” on one side and “G” on the other.
Pack sizes of 7, 10, 14, 15, 20, 30, 50, 50 (50x1), 60, 90, 100, 100 (10x10x1), 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani 20 – 20124 Milan, Italy

Responsible for batch release:
McDermott Laboratories (t/a Gerard Laboratories)
35/36 Baldoyle Industrial Estate, Grange Road
Dublin 13 – Ireland
Mylan B.V.
Dieselweg 25
3752 LB Bunschoten
The Netherlands

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium: Cetirizine Mylan 10 mg filmomhulde tabletten
Denmark: Cetirizin Mylan
Italy: Cetirizina Mylan Generics 10 mg compresse rivestite con film
Luxembourg: Cetirizine-Mylan 10 mg
Netherlands: Cetirizine diHCl Mylan 10 mg filmomhulde tabletten
Norway: Cetirizin Mylan
Portugal: Cetirizine Mylan Genericos 10 mg comprimidos revestidos
Spain: Cetirizina Mylan 10 mg, comprimidos recubiertos
Sweden: Cetirizin Mylan 10 mg filmdragerad tablett
United Kingdom: Cetirizine 10 mg Film-coated Tablets