Package leaflet: Information for the user

Fristamin 10 mg tablets

Loratadine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you to.

Keep this leaflet. You may need to read it again.
If you need more advice or information, ask your pharmacist.
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.
Talk to your doctor if you do not notice any improvement or if you notice a worsening of symptoms. See section 4.

Read all of this leaflet carefully before you start 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, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Fristamin is and what it is used for

The full name of this medicine is Fristamin tablets.
What Fristamin is
Fristamin tablets contain the active substance loratadine, which belongs to a class of medicines called "antihistamines".
How Fristamin works
Fristamin helps reduce allergic symptoms by blocking the effects of a substance called "histamine", which is produced by the human body when you are allergic to something.
When to take Fristamin
Fristamin relieves symptoms associated with allergic rhinitis (for example, hay fever), such as sneezing, runny nose, itchy nose, and eye redness and itching.
Fristamin is also used to relieve symptoms of urticaria (itching, redness, and number and size of wheals).
The effect of Fristamin lasts for a full day and should help you continue your normal daily activities and sleep.
Consult your doctor if you do not notice any improvement or if your symptoms worsen.

2. What you need to know before taking Fristamin

Do not take Fristamin if

you are allergic (hypersensitive) to loratadine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Fristamin if:

you have liver problems
you need to undergo skin tests for allergies. Do not take Fristamin within the two days prior to testing, as this medicine may interfere with the test results.

If any of the above apply to you (or if you have any doubts), talk to your doctor, pharmacist or nurse before taking Fristamin.
Children
Do not give Fristamin tablets to children under 6 years of age or to children weighing equal to or less than 30 kg. For children under 6 years of age or weighing 30 kg or less, other formulations more suitable for this age group are available.
Children under 2 years of age
The safety and efficacy of Fristamin have not been established. No data are available.
Other medicines and Fristamin
The side effects of Fristamin may increase when taken together with medicines that affect the function of certain liver enzymes responsible for drug metabolism.
However, in clinical studies, no increase in loratadine side effects has been observed with products that affect these enzymes.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including those without a prescription.
Fristamin and alcohol
It has not been demonstrated that taking Fristamin together with alcoholic beverages enhances its effects.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
As a precautionary measure, it is preferable to avoid using Fristamin during pregnancy. Do not take Fristamin if you are breastfeeding.
Loratadine is excreted in breast milk.
Driving and using machines
In clinical studies assessing driving ability, no negative effects were observed in patients treated with loratadine. At the recommended dose, Fristamin is not expected to cause drowsiness or reduced attention. However, drowsiness has very rarely occurred in some individuals, which may affect the ability to drive or operate machinery.
Fristamin contains lactose
Fristamin contains lactose; therefore, if your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Fristamin

Take this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
Take this medicine exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The break line is intended only to facilitate breaking the tablet if you have difficulty swallowing it whole.

What dose to take of Fristamin:

Adults and children aged 6 years and older with a body weight above 30 kg:
Take one tablet once daily, with a glass of water, with or without food.

Body weight equal to or less than 30 kg:
Do not administer Fristamin. Other formulations are more suitable for children under 6 years of age or with body weight equal to or less than 30 kg.
Fristamin is not recommended in children under 2 years of age.

Adults and children with severe liver problems:
Adults and children weighing more than 30 kg:
Take one tablet every other day, with a glass of water, with or without food.
However, before taking this medicine, you must consult your doctor, pharmacist, or nurse.

If you take more Fristamin than you should
If you take more Fristamin than prescribed, contact your doctor or pharmacist immediately.
Serious problems are unlikely to occur, but symptoms such as headache, increased heart rate, or drowsiness may appear.

If you forget to take Fristamin

If you forget to take your dose, take it as soon as you remember, then continue your treatment as usual.
Do not take a double dose to make up for the missed dose.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects most commonly reported in adults and children over 12 years of age are:

drowsiness
headache
increased appetite
difficulty sleeping.

The side effects most commonly reported in children aged between 2 and 12 years are:

headache
nervousness
fatigue

The following very rare side effects (may affect up to 1 in 10,000 people) have also been observed during post-marketing experience with loratadine:

severe allergic reaction (including swelling)
dizziness
seizures
fast or irregular heartbeat
nausea (feeling unwell)
dry mouth
stomach discomfort
liver disorders
hair loss
rash
fatigue

Frequency not known:

Weight gain

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at 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 Fristamin

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister after Exp.. The expiry date refers to the last day of that month.
Do not use this medicine if you notice any changes in the appearance of the tablet.
Do not dispose of any medicine 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 Fristamin contains

The active substance is loratadine. Each tablet contains 10 mg of loratadine.
The other components are monohydrate lactose, maize starch, and magnesium stearate.

Description of the appearance of Fristamin and contents of the pack
Tablet.
White to almost white oval tablet, with a beaker and mortar imprinted on one side, a score line, and the number "10".
Fristamin tablets are available in packs containing 2, 5, 7, 10, 14, 15, 20, 21, 28, 30, 50, 60 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
F.I.R.M.A. S.p.A. - Via di Scandicci, 37 - Florence, Italy
Manufacturers:
Schering-Plough Labo NV, Industriepark 30, B-2220 Heist-op-den-Berg, Belgium
Schering-Plough – Rue Louis Pasteur 2 – F-14200 Herouville Saint Clair – France

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Fristamin
Belgium, Luxembourg: Loratadine SP