AXERAMIS 10 mg Фильм-Coated Таблетки

Содержание инструкции

1. Axeramis 10 mg film-coated tablets
   1. What is Axeramis and what is it used for
   2. What you need to know before you take Axeramis
   3. How to take Axeramis
   4. Possible side effects
   5. How to store Axeramis
   6. Package Contents and Other Information
2. Axeramis 10 mg/ml oral drops, solution
   1. What is Axeramis and what is it used for
   2. What you need to know before you take Axeramis
   3. How to take Axeramis
   4. Possible side effects
   5. How to store Axeramis
   6. Package contents and other information

Axeramis 10 mg film-coated tablets

cetirizine dihydrochloride
Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Axeramis and what is it used for

Cetirizine dihydrochloride is the active ingredient of Axeramis. Axeramis is an antihistamine medicine.
In adults and children from 6 years of age, Axeramis is indicated:

• for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
• for the treatment of urticaria.

2. What you need to know before you take Axeramis

Do not take Axeramis:

• if you have a severe kidney disease (severe renal insufficiency with 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 (active ingredients of other closely related medicines).

Warnings and precautions
Talk to your doctor or pharmacist before taking Axeramis.
If you are a patient with renal insufficiency, ask your doctor for advice, if necessary, you will need to take a lower dose.
The new dose will be defined by your doctor.
Ask your doctor for advice if you have problems with urination (in conditions such as spinal cord injury or
bladder or prostate problems).
If you are an epileptic patient or a patient at risk of seizures, you must ask your doctor for advice.
No clinically significant interactions have been observed between alcohol (for blood levels of 0.5 per
mille (g/l) corresponding to a glass of wine) and cetirizine used at the recommended doses. However, no
data are available on safety when higher doses of cetirizine and alcohol are taken
simultaneously. Therefore, as with all antihistamines, it is recommended to avoid the simultaneous
intake of alcohol.
If you need to have an allergy test, ask your doctor if you need to stop taking Axeramis for a few
days before the test. This medicine may alter the results of the allergy test.

Children
The use of Axeramis in tablets is not recommended in children under 6 years of age, as this
formulation does not allow for appropriate dose adjustment.

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

Axeramis with food and drink
Food does not affect the absorption of Axeramis.

Pregnancy and breastfeeding

Pregnancy
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are breastfeeding,
ask your doctor for advice before taking this medicine.
Axeramis should be avoided during pregnancy. Accidental use of the drug by a pregnant woman does not produce any harmful effects on the fetus, however the medicine should only be taken if
necessary and under the advice of a doctor.

Breastfeeding
Cetirizine passes into breast milk. It is not possible to exclude a risk of adverse effects in breastfed infants.
Therefore, you should not take Axeramis during breastfeeding unless you have contacted your doctor.

Driving and using machines
Clinical studies have not shown impairment of attention, alertness and ability to
drive after taking Axeramis at the recommended dose. If you intend to drive vehicles,
engage in potentially dangerous activities or use machinery, you should not exceed the dose
recommended. You must carefully observe your response to the drug.

Axeramis film-coated tablets contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this
medicine.

3. How to take Axeramis

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist. The tablets must be taken with a glass of liquid.
The tablet can be divided into 2 equal parts.

Adults and adolescents starting from 12 years:
The recommended dose is 10 mg (1 tablet) once a day.

Children aged between 6 and 12 years:
The recommended dose is 5 mg (half a tablet) twice a day.

Patients with renal impairment
For patients with moderate renal impairment, the recommended dose is 5 mg (as half a tablet)
once a day.
If you suffer from severe kidney disease, contact your doctor or pharmacist who may adjust the dose of
consequently.
If your child suffers from kidney disease, contact your doctor or pharmacist who may adjust the dose
based on the child's needs.
If you feel that the effect of Axeramis is too weak or strong, inform your doctor.

Duration of treatment
The duration of treatment depends on the type, duration and course of your disorders and is established by your
doctor.

If you take more Axeramis than you should
If you think you have taken an overdose of Axeramis, inform your doctor.
The doctor will decide what measures to take if necessary.
After an overdose, the undesirable effects described below may appear with increased
intensity. Adverse events such as confusion, diarrhea, dizziness, fatigue, headache,
malaise, pupil dilation, itching, restlessness, sedation, drowsiness, stupor, abnormal and rapid
heart rate, tremor and urinary retention have been reported.

If you forget to take Axeramis
Do not take a double dose to make up for a missed dose.

If you stop taking Axeramis
If you stop treatment with Axeramis, itching (intense tingling) and/or
urticaria may rarely reappear.
If you have any doubts about the use of Axeramis, ask your doctor or pharmacist.

4. Possible side effects

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

The following side effects are rare or very rare. However, you should stop taking the medicine and inform your doctor immediately if you notice the appearance of:

• Allergic reactions, including severe reactions and angioedema (a severe allergic reaction that causes swelling of the face or throat). These reactions may occur immediately after taking the medicine or later.

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

• Drowsiness
• Dizziness, headache
• Pharyngitis, rhinitis (in children)
• Diarrhoea, nausea, dry mouth
• Fatigue

Uncommon side effects(may affect up to 1 in 100 people)

• Agitation
• Paresthesia (abnormal skin sensation)
• Abdominal pain
• Pruritus (itchy skin), rash
• Asthenia (extreme fatigue), malaise

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

• Allergic reactions, some severe (very rare)
• Depression, hallucinations, aggression, confusion, insomnia
• Convulsions
• Tachycardia (fast heartbeat)
• Abnormal liver function
• Urticaria
• Edema (swelling)
• Weight gain

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

• Thrombocytopenia (low level of platelets in the blood)
• Tic (habitual spasm)
• Syncope, dyskinesia (involuntary movements), dystonia (prolonged abnormal muscle contractions), tremor, dysgeusia (altered taste)
• Blurred vision, accommodation disorder (difficulty focusing), oculorotation (eyes with uncontrolled circular movements)
• Angioedema (a severe allergic reaction that causes swelling of the face or throat), fixed drug eruption
• Abnormal urination (involuntary bladder emptying during nighttime sleep, pain and/or difficulty urinating)

Side effects with unknown frequency(frequency cannot be estimated based on available data)

• Increased appetite
• Suicidal ideation (recurring concerns or thoughts of suicide), nightmare
• Amnesia, memory impairment
• Vertigo (sensation of spinning or movement)
• Urinary retention (inability to completely empty the bladder)
• Intense itching and/or urticaria following discontinuation of treatment
• Joint pain
• Rash with blisters containing pus
• Hepatitis (inflammation of the liver)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 Axeramis

Keep this medicine out of the sight and reach of children.
Do not use Axeramis after the expiry date which is stated on the pack. The expiry date refers
to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Axeramis contains
The active ingredient of Axeramis is cetirizine dihydrochloride. One film-coated tablet contains 10 mg of
cetirizine dihydrochloride.
The excipients are: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, magnesium
stearate.
Coating: opadry II white (consisting of hypromellose, titanium dioxide (E171), polydextrose (E1200),
talc, maltodextrin, medium-chain triglycerides)

Description of the appearance of Axeramis and package contents
Film-coated tablet, PVC/aluminum blister – pack containing 20 divisible tablets

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Dompé farmaceutici S.p.A. Via San Martino 12 - 20122 Milano
Manufacturer:
Doppel Farmaceutici S.r.l – Via Volturno, 48 – 20089 Quinto dè Stampi – Milano

Axeramis 10 mg/ml oral drops, solution

Cetirizine dihydrochloride
Generic medicine

Read this leaflet carefully before taking this medicine as 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. Never give it to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Axeramis and what is it used for

Cetirizine dihydrochloride is the active ingredient of Axeramis. Axeramis is an antihistamine medicine.
In adults and paediatric patients from 2 years of age, Axeramis oral drops is indicated:

• for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
• for the treatment of urticaria.

2. What you need to know before you take Axeramis

Do not take Axeramis:

• if you have a severe kidney disease (severe renal insufficiency with 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 (active ingredients of other closely related medicines).

Warnings and precautions
Talk to your doctor or pharmacist before taking Axeramis.
If you are a patient with renal insufficiency, ask your doctor for advice, if necessary, you will need to take a lower dose.
The new dose will be defined by your doctor.
Ask your doctor for advice if you have problems with urination (in conditions such as spinal cord injury or
bladder or prostate problems).
If you are an epileptic patient or a patient at risk of seizures, you must ask your doctor for advice.
No clinically significant interactions have been observed between alcohol (for blood levels of 0.5 per
thousand (g/l) corresponding to a glass of wine) and cetirizine used at the recommended doses. However, no
data are available on the safety when higher doses of cetirizine and alcohol are taken
simultaneously. Therefore, as with all antihistamines, it is recommended to avoid the simultaneous
intake of alcohol.
If you need to have an allergy test, ask your doctor if you need to stop taking Axeramis for a few
days before the test. This medicine may alter the results of the allergy test

Other medicines and Axeramis
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those available without a prescription.

Axeramis with food and drink
Food does not affect the absorption of Axeramis.

Pregnancy and breastfeeding

Pregnancy
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are breastfeeding with breast
milk, ask your doctor for advice before taking this medicine.
Axeramis should be avoided during pregnancy. Accidental use of the drug by a pregnant woman does not produce any harmful effects on the fetus, however the medicine should only be taken if
necessary and on the advice of a doctor.

Breastfeeding
Cetirizine passes into breast milk. It is not possible to exclude a risk of adverse effects in breastfed infants
Therefore, you should not take Axeramis during breastfeeding unless you
have contacted your doctor.

Driving and using machines
Clinical studies have not shown impairment of attention, alertness and ability to
drive after taking Axeramis at the recommended dose. If you intend to drive vehicles,
engage in potentially dangerous activities or use machinery, you should not exceed the dose
recommended. You must carefully observe your response to the drug.

Axeramis oral drops, solution contains methylparahydroxybenzoate (E218) and propylparahydroxybenzoate
(E216)
These ingredients may cause allergic reactions (sometimes delayed).

Axeramis oral drops, solution contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

Axeramis oral drops, solution contains propylene glycol.
This medicine contains 350 mg of propylene glycol in an adult dose (20 drops).

3. How to take Axeramis

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any
doubts, ask your doctor or pharmacist.
The drops must be poured into a spoon or diluted in water and taken orally.
If dilution is used, it must be considered, especially for administration in children, that the volume
of water to which the drops are added must be proportional to the amount of water the patient is able to
ingest. The diluted solution must be taken immediately.
When counting the drops, the bottle must be held vertically (inverted).
If the flow of drops stops and if the correct amount has not been dispensed, return the bottle to
an upright position, then invert it again and continue counting the drops.

Adults and adolescents starting from 12 years:
The recommended dose is 10 mg (20 drops) once a day.

Children aged between 6 and 12 years:
The recommended dose is 5 mg (10 drops) twice a day.

Children aged between 2 and 6 years:
The recommended dose is 2.5 mg (5 drops) twice a day.

Patients with renal impairment
For patients with moderate renal impairment, the recommended dose is 5 mg (as 10 drops) once
a day.
If you have severe kidney disease, contact your doctor or pharmacist who may adjust the dose
accordingly.
If your child has kidney disease, contact your doctor or pharmacist who may adjust the dose
based on the child's needs.
If you feel that the effect of Axeramis is too weak or too strong, tell your doctor.

Duration of treatment
The duration of treatment depends on the type, duration and course of your disorders and is established by your
doctor.

If you take more Axeramis than you should
If you think you have taken an overdose of Axeramis, inform your doctor.
The doctor will decide what measures to take if necessary.
After an overdose, the undesirable effects described below may occur with increased
intensity. Adverse events such as confusion, diarrhea, dizziness, fatigue, headache,
malaise, pupil dilation, itching, restlessness, sedation, drowsiness, stupor, abnormal and rapid
heart rhythm, tremor and urinary retention have been reported.

If you forget to take Axeramis
Do not take a double dose to make up for a missed dose.

If you stop taking Axeramis
If you stop treatment with Axeramis, itching (intense tingling) and/or
urticaria may rarely reappear.
If you have any doubts about the use of Axeramis, ask your doctor or pharmacist.

4. Possible side effects

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

The following side effects are rare or very rare. However, you should stop taking the medicine and inform your doctor immediately if you notice the appearance of:

• Allergic reactions, including severe reactions and angioedema (a severe allergic reaction that causes swelling of the face or throat). These reactions may occur immediately after taking the medicine or later.

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

• Drowsiness
• Dizziness, headache
• Pharyngitis, rhinitis (in children)
• Diarrhoea, nausea, dry mouth
• Fatigue

Uncommon side effects(may affect up to 1 in 100 people)

• Agitation
• Paresthesia (abnormal skin sensation)
• Abdominal pain
• Pruritus (itchy skin), rash
• Asthenia (extreme fatigue), malaise

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

• Allergic reactions, some severe (very rare)
• Depression, hallucinations, aggression, confusion, insomnia
• Convulsions
• Tachycardia (fast heartbeat)
• Abnormal liver function
• Urticaria
• Edema (swelling)
• Weight gain

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

• Thrombocytopenia (low level of platelets in the blood)
• Tic (habitual spasm)
• Syncope, dyskinesia (involuntary movements), dystonia (prolonged abnormal muscle contractions), tremor, dysgeusia (altered taste)
• Blurred vision, accommodation disorder (difficulty focusing), oculorotation (eyes with uncontrolled circular movements)
• Angioedema (a severe allergic reaction that causes swelling of the face or throat), fixed drug eruption
• Abnormal urine elimination (involuntary bladder emptying during nighttime sleep, pain and/or difficulty urinating)

Side effects with unknown frequency(frequency cannot be estimated based on available data)

• Increased appetite
• Suicidal ideation (recurring worries or suicidal thoughts), nightmare
• Amnesia, memory impairment
• Vertigo (sensation of spinning or movement)
• Urinary retention (inability to completely empty the bladder)
• Pruritus (intense itching) and/or urticaria following discontinuation of treatment
• Joint pain
• Skin rash with blisters containing pus
• Hepatitis (inflammation of the liver)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 Axeramis

Keep this medicine out of the sight and reach of children.
Do not use Axeramis after the expiry date which is stated on the pack. The expiry date refers
to the last day of that month.
Do not use after 6 months from first opening of the bottle
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Axeramis oral drops, solution contains
The active ingredient of Axeramis is cetirizine dihydrochloride. 1 ml corresponding to 20 drops of Axeramis contains
10 mg of cetirizine dihydrochloride. One drop contains 0.5 mg of cetirizine dihydrochloride.
The other ingredients are glycerol, propylene glycol, sodium saccharin, methyl parahydroxybenzoate (E218),
propyl parahydroxybenzoate (E216), trisodium citrate dihydrate, glacial acetic acid, purified water.

Description of the appearance of Axeramis and package contents
Axeramis oral drops is supplied in an amber glass bottle of 20 ml with a dropper

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Dompé farmaceutici S.p.A. Via San Martino 12 - 20122 Milano
Manufacturer:
Doppel Farmaceutici S.r.l. – Via martiri delle Foibe, 1- 29016 Cortemaggiore (PC)