CETIRIZIN ACTAVIS 10MG TBL N30

ATC code: R06AE07 

Active substances: Cetirizini Dihydrochloridum

Vendor, principal: Actavis Ltd. 

 Prescription drug (℞) 

CETIRIZIN ACTAVIS 10MG N10

Package leaflet: information for the user

Cetirizin Actavis, 10 mg film-coated tablets

Cetirizin dihydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

What is in this leaflet:

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

1. What Cetirizin Actavis is and what it is used for

Cetirizin Actavis is an antiallergic medication. The active ingredient of Cetirizin Actavis is cetirizin dihydrochloride.
Cetirizin Actavis is indicated in adults and children aged 6 years and above:
-   for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis;
-   for the relief of symptoms of chronic nettle rash (chronic idiopathic urticaria).

2. What you need to know before you take Cetirizin Actavis Do not take Cetirizin Actavis:

-   if you are allergic to cetirizin or any of the other ingredients of this medicine (listed in section 6);
-   if you are allergic to hydroxyzine or to piperazine derivatives;
-   if you have a severe kidney disease (severe renal insufficiency with creatinine clearance below 10 mL/min.).
Do not take Cetirizin Actavis tablets:
-   if you have a rare inherited glalctose intolerance, lactase deficiency or glucose-galactose malabsorption disorder.

Warnings and precautions

If you have renal insufficiency, please consult your doctor. If necessary, you will take a lower dose. Your doctor will prescribe a new dose.
If you suffer from urinary retention (due to spine injury or enlarged prostate), please consult your doctor.
If you have epilepsy or have a risk of convulsions, you should consult your doctor.
No significant interactions have been observed between alcohol (at the blood level of 0.5 per mille, corresponding to one glass of wine) and cetirizine used at the normal doses. However, as with all antihistamines, it is advisable to avoid concurrent consumption of alcohol.
Cetirizin Actavis may affect the allergy skin test results, therefore you should stop taking Cetirizin Actavis 3 days before performing the tests.

Other medicines and Cetirizin Actavis

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Cetirizin has no interactions with other medicines.

Canephron with food, drink and alcohol

Food has no significant effect on the absorption of cetirizin.

Pregnancy, breast-feeding and fertility

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.
Pregnancy
As with other drugs, use of Cetirizin Actavis should be avoided in pregnant women. Accidental use of the drug by a pregnant woman should not produce any harmful effects on the foetus. Nevertheless, the administration of the medicine should be discontinued.
Breast-feeding
Cetirizin Actavis should not be used during breast-feeding because cetirizine is excreted into breast milk.

Driving and using machines

Clinical studies have produced no evidence of impaired attention, alertness or driving capabilities after taking Cetirizin Actavis at the recommended dose.
If you intend to drive, engage in potentially hazardous activities or use machines, you should not exceed the recommended dose. You should closely observe your response to the drug. If you are sensitive to the medication, concomitant use of alcohol or other nervous depressant agents may additionally affect your attention and ability to react.

Cetirizin Acatvis contains lactose

Cetirizin Acatvis contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Cetirizin Actavis

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How and when should you take Cetirizin Actavis?

This instruction to use Cetirizin Actavis applies if your doctor has not instructed you otherwise.
Please follow these instructions, otherwise Cetirizin Actavis may not be fully effective.
The tablets need to be swallowed with a glass of liquid.
Adults and adolescents above 12 years old:
10 mg (one tablet) once daily.
Children between 6 and 12 years old:
5 mg (half a tablet) twice daily.
Patients with moderate to severe renal impairment:
Patients with moderate and severe renal impairment are recommended to take 5 mg once daily.
If you feel that the effect of Cetirizin Actavis is too strong or too weak, please consult your doctor or pharmacist.
Duration of treatment
Treatment duration depends on the type, duration and course of the disease. Treatment duration will be determined by your doctor.

If you take more Cetirizin Actavis than you should

If you think you have taken Cetirizin Actavis more than prescribed, please contact your doctor immediately. You doctor will decide what measures, if any, should be taken.
After an overdose the side effects described below may occur with increased intensity. The following side effects have been reported: confusion, diarrhoea, dizziness, tiredness, headache, malaise, dilation of the pupil, itching, restlessness, sedation, sleepiness, lack of response to external stimuli (stupor), abnormally rapid heart rate, tremors and urinary retention.

If you forget to take Cetirizin Actavis

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

If you stop taking Cetirizin Actavis

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Following side effects have been reported in postmarketing experience.
The frequencies are defined as following:
very common (1 patient in 10),
common (1 patient in 100 to 1 patient in 10),
uncommon (1 patient in 1,000 to 1 patient in 100),
rare (1 patient in 10,000 to 1 patient in 1,000),
very rare (less than 1 patient in 10,000), and
not known (frequency cannot be estimated from the available data):
Blood and lymphatic system disorders:
very rare - thrombocytopenia (low levels of blood platelets).
Cardiac disorders:
rare - heart beating too fast (tachycardia).
Eye disorders:
very rare - accommodation disorders when focusing on objects at different distances, blurred vision, oculogyration (eyes having uncontrolled circular movements).
Ear and labyrinth disorders not known - vertigo.
Gastrointestinal disorders:
common - dry mouth, nausea, diarrhoea,
uncommon - lower abdominal pain.
General disorders and administration site conditions: uncommon - asthenia, malaise, rare - oedema (swelling).
Immune system disorders:
rare - hypersensitivity reactions, some severe (very rare).
Metabolism and nutrition disorders: not known - increased appetite.
Hepatobiliary disorders:
rare - liver function abnormalities.
Investigations:
rare - increased body weight.
Nervous system disorders: common - dizziness, headache,
uncommon - paraesthesia (abnormal sensations on the skin), rare - convulsions,
very rare - syncope (fainting), tremor, dysgeusia (altered taste), not known - memory loss, memory impairment.
Psychiatric disorders: common - somnolence, uncommon - agitation,
rare: aggression, confusion, depression, hallucination, insomnia, very rare - tics (convulsions), not known - suicidal thoughts.
Renal and urinary tract disorders: very rare - urinary dysfunction, not known - urinary retention.
Respiratory dysfunctions: common - pharyngitis, rhinitis.
Skin and subcutaneous tissue damage: uncommon - itching, rash; rare - nettle rash (urticaria); very rare - oedema, multi-shaped rash;
not known - acute generalized exanthemal pustulose (AGEP), which is characterized by a flushed scaly skin rash with subcutaneous nodules and blistering.

If you develop any of the side effects mentioned above, inform your doctor about it. When first signs of hypersensitivity reaction occur, stop taking Cetirizin Actavis. Your

doctor will asses the severity of the symptoms and decide on any further measures that may be necessary.

Reporting of side effects

If you develop any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cetirizin Actavis

Keep this medicine out of the sight and reach of children.
Store below 25 °C.
Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information What Cetirizin Actavis contains:

-   The active substance is cetirizin dihydrochloride. One film-coated tablet contains 10 mg cetirizin dihydrochloride.
-   The other ingredients are:
Tablet core: microcrystalline cellulose, lactose monohydrate, crospovidone, colloidal silica (anhydrous), magnesium stearate.
Tablet coating: hypromellose, makrogol stearate, microcrystalline cellulose, propylene glycol, titanium dioxide (E 171).

What Cetirizin Actavis looks like and contents of the pack

Film-coated, white or almost white convex, elliptical tablets with the letter “C” on one side, and the letters “J” and “E” on either side of a central division line on the reverse.
10 tablets in blister packs.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur Island
Manufacturer Actavis UK Limited Whiddon Valley,
Barnstaple N Devon EX32 8 NS,
United Kingdom
For any information about this medicine please contact the local representative of the Marketing Authorisation Holder.
Teva Estonian branch,UAB Sicor Biotech Eestonian branch Hallivanamehe 4 11317 Tallinn Phone: +372 6610 801

This leaflet was last revised in April 2018.