Axeramis

Package leaflet: Information for the patient

Axeramis 10 mg film-coated tablets

cetirizine dihydrochloride
Equivalent medicine
Read this entire leaflet carefully before taking 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 personally. Do not give it to others, even if they have the same symptoms as you, because it could 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 Axeramis is and what it is used for
2. What you need to know before taking 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 Axeramis is and what it is used for

Cetirizine dihydrochloride is the active substance in Axeramis. Axeramis is an antiallergic medicine.
In adults and children aged 6 years and older, 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 taking Axeramis

Do not take Axeramis:

• if you have severe kidney disease (severe renal failure with creatinine clearance below 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 substances in other closely related medicines).

Warnings and precautions
Talk to your doctor or pharmacist before taking Axeramis.
If you have kidney impairment, consult your doctor; you may need to take a lower dose. Your doctor will determine the new dose.
Consult your doctor if you have difficulty urinating (in conditions such as spinal cord injury or bladder or prostate problems).
If you are an epileptic patient or at risk of seizures, you should consult your doctor.
No clinically significant interactions have been observed between alcohol (at blood levels of 0.5‰ (g/l), corresponding to one glass of wine) and cetirizine when used at recommended doses. However, there are no available data on the safety of concomitant use of higher doses of cetirizine and alcohol. Therefore, as with all antihistamines, it is recommended to avoid taking alcohol together with this medicine.
If you are due to have an allergy test, ask your doctor whether you should stop taking Axeramis a few days before the test. This medicine may alter the results of allergy testing.

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

Other medicines and Axeramis
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

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

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Axeramis should be avoided during pregnancy. Accidental use of the medicine by a pregnant woman does not produce harmful effects on the fetus; however, the medicine should only be taken if necessary and under medical advice.

Breastfeeding
Cetirizine passes into breast milk. A risk of adverse effects in breastfed infants cannot be excluded. Therefore, you must not take Axeramis while breastfeeding unless advised by your doctor.

Driving and using machines
Clinical studies have not shown any impairment of attention, alertness, or ability to drive following the recommended dose of Axeramis. However, if you intend to drive, perform potentially hazardous activities, or operate machinery, do not exceed the recommended dose. You should carefully observe your response to the medicine.

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

3. How to take Axeramis

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist. The tablets should be taken with a glass of liquid.
The tablet may be divided into two equal parts.
Adults and adolescents from 12 years of age:
The recommended dose is 10 mg (1 tablet) once daily.
Children aged 6 to 12 years:
The recommended dose is 5 mg (half a tablet) twice daily.
Patients with renal impairment
For patients with moderate renal impairment, the recommended dose is 5 mg (half a tablet)
once daily.
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 will adjust the dose according to the child's needs.
If you feel that the effect of Axeramis is too weak or too strong, inform your doctor.
Duration of treatment
The duration of treatment depends on the type, duration and course of your condition and will be determined by your doctor.
If you take more Axeramis than you should
If you think you have taken an overdose of Axeramis, 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, stupor, abnormal and rapid heart rate, tremor and urinary retention.
If you forget to take Axeramis
Do not take a double dose to make up for the forgotten dose.
If you stop taking Axeramis
If you stop treatment with Axeramis, itching (intense pruritus) and/or urticaria may rarely reappear.
If you have any questions about the use of Axeramis, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Axeramis may cause side effects, although not everybody experiences them.
The following side effects are rare or very rare. However, you must stop taking the
medicine and inform your doctor immediately if you notice any of the following:

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

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

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

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

• Agitation
• Paresthesia (abnormal skin sensation)
• Abdominal pain
• Itching (pruritic skin), skin rash
• Asthenia (extreme tiredness), malaise

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

• Allergic reactions, some severe (very rare)
• Depression, hallucinations, aggression, confusion, insomnia
• Seizures
• Tachycardia (increased heart rate)
• Abnormal liver function
• Urticaria
• Edema (swelling)
• Weight gain

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

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

Side effects with unknown frequency (frequency cannot be determined from the available data)

• Increased appetite
• Suicidal ideation (recurring suicidal thoughts or concerns), nightmares
• Amnesia, memory impairment
• Vertigo (sensation of spinning or movement)
• Urinary retention (inability to completely empty the bladder)
• Itching (intense pruritus) and/or urticaria following discontinuation of treatment
• Joint pain
• Skin rash with pustule-filled blisters
• Hepatitis (liver inflammation)

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 . Reporting side effects helps 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 stated on the carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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.

6. Package contents and other information

What Axeramis contains
The active substance 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 (composed 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 – carton box containing 20 divisible tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Dompé farmaceutici S.p.A., Via San Martino 12 - 20122 Milan
Manufacturer:
Doppel Farmaceutici S.r.l – Via Volturno, 48 – 20089 Quinto de' Stampi – Milan

Patient information leaflet

Axeramis 10 mg/ml oral drops, solution

Cetirizine dihydrochloride
Equivalent medicine
Please 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 other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult 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 taking 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 Axeramis is and what it is used for

Cetirizine dihydrochloride is the active substance of Axeramis. Axeramis is an antiallergic medicinal product.
In adults and pediatric patients from 2 years of age, Axeramis oral drops are 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 taking Axeramis

Do not take Axeramis:

• if you have severe kidney disease (severe renal insufficiency with creatinine clearance below 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 substances in other closely related medicines).

Warnings and precautions
Talk to your doctor or pharmacist before taking Axeramis.
If you have renal insufficiency, consult your doctor; if necessary, you will need to take a lower dose. Your doctor will determine the new dose.
Consult your doctor if you have problems urinating (in conditions such as spinal cord injuries or bladder or prostate problems).
If you are an epileptic patient or at risk of seizures, you should consult your doctor.
No clinically significant interactions have been observed between alcohol (at blood levels of 0.5‰ (g/l), corresponding to one glass of wine) and cetirizine when used at recommended doses. However, there are no available data on the safety of concomitant use of higher doses of cetirizine and alcohol. Therefore, as with all antihistamines, it is recommended to avoid taking alcohol together with this medicine.
If you need to undergo an allergy test, ask your doctor whether you should stop taking Axeramis a few days before the test. This medicine may alter the results of allergy testing.

Other medicines and Axeramis
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

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

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor for advice before taking this medicine.
Axeramis should be avoided during pregnancy. Accidental use of the medicine by a pregnant woman does not produce any harmful effects on the fetus; however, the medicine should only be taken if necessary and under medical advice.
Breastfeeding
Cetirizine passes into breast milk. A risk of adverse effects in breastfed infants cannot be ruled out. Therefore, you must not take Axeramis during breastfeeding unless advised by your doctor.

Driving and using machines
Clinical studies have not shown any impairment of attention, alertness, or driving ability after taking Axeramis at the recommended dose. If you intend to drive, perform potentially hazardous activities, or operate machinery, do not exceed the recommended dose. You should carefully observe your response to the medicine.

Axeramis oral drops, solution contains methylparahydroxybenzoate (E218) and propylparahydroxybenzoate (E216)
These components 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 exactly as directed by your doctor or pharmacist. If you have any
doubts, consult your doctor or pharmacist.
The drops should be poured into a spoon or diluted in water and taken orally.
If using dilution, especially when administering to children, consider that the volume
of water to which the drops are added should be proportionate to the amount of liquid the patient is able
to ingest. The diluted solution must be taken immediately.
When counting drops, the bottle must be held vertically (upside down).
If the drop flow stops and the correct amount has not been dispensed, return the bottle to
an upright vertical position, then turn it upside down again and continue counting the drops.
Adults and adolescents from 12 years of age:
The recommended dose is 10 mg (20 drops) once daily.
Children aged between 6 and 12 years:
The recommended dose is 5 mg (10 drops) twice daily.
Children aged between 2 and 6 years:
The recommended dose is 2.5 mg (5 drops) twice daily.
Patients with renal impairment
For patients with moderate renal impairment, the recommended dose is 5 mg (i.e. 10 drops) once
daily.
If you suffer from severe kidney disease, contact your doctor or pharmacist, who may adjust the dose accordingly.
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 too strong, inform your doctor.
Duration of treatment
The duration of treatment depends on the type, duration and course of your condition and is determined 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 adverse effects described below may occur with increased intensity. Adverse events reported include confusion, diarrhoea, dizziness, fatigue, headache, malaise, pupillary dilation, itching, restlessness, sedation, somnolence, stupor, abnormal and rapid heart rate, tremor and urinary retention.
If you forget to take Axeramis
Do not take a double dose to make up for the missed dose.
If you stop taking Axeramis
If you discontinue treatment with Axeramis, itching (intense pruritus) and/or urticaria may rarely reappear.
If you have any doubts about the use of Axeramis, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Axeramis can cause side effects, although not everyone experiences them.
The following side effects are rare or very rare. However, you must stop taking the medicine and inform your doctor immediately if you notice:

• Allergic reactions, including severe reactions and angioedema (a severe allergic reaction causing 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)
• Diarrhea, nausea, dry mouth
• Fatigue

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

• Agitation
• Paresthesia (abnormal skin sensation)
• Abdominal pain
• Itching (pruritic skin), 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
• Seizures
• Tachycardia (increased heart rate)
• Abnormal liver function
• Urticaria
• Edema (swelling)
• Weight gain

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

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

Side effects with unknown frequency (frequency cannot be determined from available data)

• Increased appetite
• Suicidal ideation (recurring suicidal thoughts or concerns), nightmares
• Amnesia, memory impairment
• Vertigo (sensation of spinning or movement)
• Urinary retention (inability to completely empty the bladder)
• Itching (intense pruritus) and/or urticaria following discontinuation of treatment
• Joint pain
• Skin rash with pustules
• Hepatitis (liver inflammation)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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 Axeramis

Keep this medicine out of the sight and reach of children.
Do not use Axeramis after the expiry date stated on the carton. 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 medicines via wastewater 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 substance in 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 components are glycerol, propylene glycol, sodium saccharin, methyl p-hydroxybenzoate (E218), propyl p-hydroxybenzoate (E216), sodium acetate trihydrate, glacial acetic acid, purified water.

Description of the appearance of Axeramis and contents of the pack
Axeramis oral drops are supplied in a 20 ml amber glass bottle with dropper.

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