Cetirizine IpsO Pharma: detailed information

Package leaflet: Information for the user

CETIRIZINE IPSO PHARMA 10 mg film-coated tablets

Cetirizine dihydrochloride
Generic medicine
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 yours, because it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Read all of this leaflet carefully before you take 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 instructed.

Keep this leaflet. You may need to read it again.
If you need more advice or information, talk to your doctor or pharmacist.
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

What Cetirizine Ipso Pharma is and what it is used for
What you need to know before taking Cetirizine Ipso Pharma
How to take Cetirizine Ipso Pharma
Possible side effects
How to store Cetirizine Ipso Pharma
Contents of the pack and other information

1. What Cetirizina Ipso Pharma is and what it is used for

Cetirizine dihydrochloride is the active substance in Cetirizina Ipso Pharma. Cetirizina Ipso Pharma is an antiallergic medicinal product.
In adults and children from 6 years of age, Cetirizina Ipso Pharma 10 mg film-coated tablets 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 Cetirizina Ipso Pharma

Do not take Cetirizina Ipso Pharma:

if you have severe kidney disease requiring dialysis;
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 Cetirizina Ipso Pharma.
If you have kidney impairment, consult your doctor; if necessary, you should 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 a patient with epilepsy 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 per mille (g/l), corresponding to one glass of wine) and cetirizine used at recommended doses. However, there are no available data on the safety of concomitant intake of higher doses of cetirizine and alcohol. Therefore, as with all antihistamines, it is recommended to avoid taking Cetirizina Ipso Pharma together with alcohol.
If you are due to have an allergy test, ask your doctor whether you should stop taking Cetirizina Ipso Pharma a few days before the test. This medicine may alter the results of allergy testing.

Children
Do not give this medicine to children under 6 years of age, as the tablet formulation does not allow for the necessary dose adjustments.

Other medicines and Cetirizina Ipso Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Cetirizina Ipso Pharma with food and drinks
Food does not affect the absorption of Cetirizina Ipso Pharma.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor for advice before taking this medicine.
Cetirizina Ipso Pharma 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 on medical advice.
Cetirizine passes into breast milk. A risk of adverse effects in breastfed infants cannot be excluded. Therefore, you should not take Cetirizina Ipso Pharma while breastfeeding unless you have consulted your doctor.

Driving and using machines
Clinical studies have not shown any impairment of attention, alertness, or ability to drive vehicles after taking Cetirizina Ipso Pharma at the recommended dose. However, you should carefully observe your response to the medicine after taking Cetirizina Ipso Pharma if you intend to drive, undertake potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.

Cetirizina Ipso Pharma film-coated tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Cetirizina Ipso Pharma

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed. 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 aged 12 years and older
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.
Other formulations of this medicine may be more suitable for children; please consult your doctor or pharmacist.

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 Cetirizina Ipso Pharma 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 symptoms and will be determined by your doctor.

If you take more Cetirizina Ipso Pharma than you should
If you think you have taken an overdose of Cetirizina Ipso Pharma, inform your doctor.
Your doctor will decide what measures, if any, are necessary.
After an overdose, the adverse effects described below may occur with increased intensity.
Adverse events reported include confusion, diarrhoea, dizziness, fatigue, headache, malaise (feeling unwell), dilated pupils, itching, restlessness, sedation, somnolence (drowsiness), stupor, abnormal and rapid heart rate, tremors, and urinary retention (difficulty completely emptying the bladder).

If you forget to take Cetirizina Ipso Pharma
Do not take a double dose to make up for the forgotten dose.

If you stop taking Cetirizina Ipso Pharma
If you stop treatment with Cetirizina Ipso Pharma, itching (intense pricking sensation) and/or urticaria may rarely reappear.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

Drowsiness (need to sleep)
Dizziness, headache
Pharyngitis (sore throat), rhinitis (stuffy or runny nose) (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
Itching (pruritic skin), skin rash
Asthenia (extreme tiredness), malaise (feeling unwell)

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

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

Increased appetite
Suicidal ideation (recurrent suicidal thoughts or concerns), nightmares
Amnesia (memory loss), 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
Arthralgia (joint pain), myalgia (muscle pain)
Generalized pustular exanthema (skin eruption with pus-filled blisters)
Hepatitis (inflammation of the liver)

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 Cetirizina Ipso Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.

6. Package contents and other information

What Cetirizina Ipso Pharma contains

The active substance is cetirizine hydrochloride. One film-coated tablet contains 10 mg of cetirizine hydrochloride.
The other components are: monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate. Coating: Opadry II white (composed of hypromellose, titanium dioxide (E171), polydextrose (E1200), talc, maltodextrin, medium-chain triglycerides).

Description of the appearance of Cetirizina Ipso Pharma and contents of the pack
White, oblong, film-coated tablet with a score line.
Pack of 20 tablets in PVC/aluminum blisters
Pack of 7 tablets in PVC/aluminum blisters

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Ipso Pharma S.r.l. – Via San Rocco, 6 – 85033 Episcopia (PZ)

Manufacturers

Doppel Farmaceutici S.r.l. - Via Volturno, 48 - 20089 Quinto de' Stampi - Milano
Vamfarma S.r.l. - Via Kennedy, 5 - 26833 Comazzo (Lo)

Package leaflet: Information for the user

CETIRIZINE IPSO PHARMA 10 mg/ml oral drops, solution

Cetirizine dihydrochloride
Equivalent medicine
Please read all of this 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 only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Cetirizine Ipso Pharma is and what it is used for
What you need to know before taking Cetirizine Ipso Pharma
How to take Cetirizine Ipso Pharma
Possible side effects
How to store Cetirizine Ipso Pharma
Contents of the pack and other information

1. What Cetirizina Ipso Pharma is and what it is used for

Cetirizina dicloridrato is the active substance of Cetirizina Ipso Pharma. Cetirizina Ipso Pharma is an antiallergic medicinal product.
In adults and pediatric patients aged 2 years and older, Cetirizina Ipso Pharma 10 mg/ml oral drops, solution 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 Cetirizina Ipso Pharma

Do not take Cetirizina Ipso Pharma:

if you have severe kidney disease requiring dialysis;
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 Cetirizina Ipso Pharma.
If you are a patient with renal impairment, consult your doctor; if necessary, you should 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 a patient at risk of seizures, you should consult your doctor.
No clinically significant interactions have been observed between alcohol (at blood levels of 0.5 per mille (g/l), corresponding to one glass of wine) and cetirizine used at recommended doses. However, there are no available data on safety when higher doses of cetirizine and alcohol are taken simultaneously.
Therefore, as with all antihistamines, it is recommended to avoid taking Cetirizina Ipso Pharma together with alcohol.
If you are due to undergo an allergy test, ask your doctor whether you should stop taking Cetirizina Ipso Pharma a few days before the test. This medicine may alter the results of allergy testing.

Other medicines and Cetirizina Ipso Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Cetirizina Ipso Pharma with food and drinks
Food does not affect the absorption of Cetirizina Ipso Pharma.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor for advice before taking this medicine.
Cetirizina Ipso Pharma 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.
Cetirizine passes into breast milk.
A risk of adverse effects in breastfed infants cannot be ruled out. Therefore, you must not take Cetirizina Ipso Pharma during breastfeeding unless you have consulted your doctor.

Driving and using machines
Clinical studies have not shown any impairment of attention, alertness, or ability to drive vehicles after taking Cetirizina Ipso Pharma at the recommended dose. However, you should carefully observe your individual response to the medicine after taking Cetirizina Ipso Pharma if you intend to drive, perform potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.

Cetirizina Ipso Pharma oral drops, solution contains methylparahydroxybenzoate, propylparahydroxybenzoate, propylene glycol and sodium.
Cetirizina Ipso Pharma oral drops, solution contains methylparahydroxybenzoate and propylparahydroxybenzoate, which may cause allergic reactions (including delayed reactions).
Cetirizina Ipso Pharma oral drops, solution contains 350 mg of propylene glycol per 10 mg dose (20 drops).
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take Cetirizina Ipso Pharma

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 dilution is used, 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 swallow. The diluted solution should be taken immediately.
When counting drops, the bottle must be held vertically (upside down).
If the flow of drops stops and the correct amount has not been dispensed, return the bottle to
an upright position, then turn it upside down again and continue counting the drops.

Adults and adolescents aged 12 years and older
The recommended dose is 10 mg (20 drops) once daily.

Use in children aged 6 to 12 years
The recommended dose is 5 mg (10 drops) twice daily.

Use in children aged 2 to 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 (10 drops) once
daily.
If you have severe kidney disease, contact your doctor or pharmacist, who can adjust the dose accordingly.
If the child has kidney disease, contact the doctor or pharmacist, who can adjust the dose based on the child's needs.

If you feel that the effect of Cetirizina Ipso Pharma 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 symptoms and is determined by
your doctor.

If you take more Cetirizina Ipso Pharma than you should
If you think you have taken an overdose of Cetirizina Ipso Pharma, inform your doctor.
Your doctor will decide which 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 (feeling unwell), pupil dilation, itching, restlessness, sedation, somnolence (need to sleep), stupor, abnormal and rapid heart rate, tremors, and urinary retention (difficulty completely emptying the bladder).

If you forget to take Cetirizina Ipso Pharma
Do not take a double dose to make up for the missed dose.

If you stop taking Cetirizina Ipso Pharma
If you stop treatment with Cetirizina Ipso Pharma, itching (intense prickling) and/or urticaria may rarely recur.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience 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 later on.

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

Somnolence (need to sleep)
Dizziness, headache
Pharyngitis (sore throat), rhinitis (stuffy or runny nose) (in children)
Diarrhea, nausea, dry mouth
Fatigue

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

Agitation
Paresthesia (abnormal skin sensations)
Abdominal pain
Pruritus (itchy skin), skin rash
Asthenia (extreme fatigue), malaise (feeling unwell)

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 (fast heartbeat)
Abnormal liver function
Urticaria (hives)
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 (fainting), dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremor, dysgeusia (altered taste)
Blurred vision, accommodation disorder (difficulty focusing), oculogyric crisis (eyes with uncontrollable circular movements)
Angioedema (severe allergic reaction causing swelling of the face or throat), fixed drug eruption
Abnormal urination (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 loss), 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
Arthralgia (joint pain), myalgia (muscle pain)
Generalized exanthematous pustulosis (skin eruption with pus-filled blisters)
Hepatitis (inflammation of the liver)

5. How to store Cetirizina Ipso Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last day of that month.
Do not use more than 6 months after first opening the bottle.
This medicine does not require any special storage conditions.

6. Package contents and other information

What Cetirizina Ipso Pharma contains

The active substance is cetirizine dihydrochloride. 1 ml (corresponding to 20 drops) 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 4-hydroxybenzoate, propyl 4-hydroxybenzoate, sodium acetate trihydrate, glacial acetic acid, purified water.

Description of the appearance of Cetirizina Ipso Pharma and the contents of the pack
Cetirizina Ipso Pharma oral drops are supplied in a pack containing an amber glass bottle of 20 ml with dropper.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Ipso Pharma S.r.l. – Via San Rocco, 6 – 85033 Episcopia (PZ)
Manufacturer
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC)