Package leaflet: Information for the user

Mostaxyl 10 mg tablets

Rupatadine
Generic medicine
Please read 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 other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT Mostaxyl IS AND WHAT IT IS USED FOR

Rupatadine, the active substance of Mostaxyl, is an antihistamine.
Mostaxyl relieves symptoms of allergic rhinitis such as sneezing, runny nose, and itching of the eyes and nose.
Mostaxyl is also used to relieve symptoms associated with urticaria (an allergic skin rash), such as itching and wheals (localized redness and swelling of the skin).

2. WHAT YOU SHOULD KNOW BEFORE TAKING Mostaxyl

Do not take Mostaxyl

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

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.
If you have renal or hepatic impairment, consult your doctor. The use of Mostaxyl 10 mg
tablets is currently not recommended in patients with renal or hepatic impairment.
If you have low potassium levels in the blood and/or have an abnormal heart rhythm pattern
(known QTc interval prolongation on ECG), which may occur in certain forms of heart disease,
seek medical advice.
If you are over 65 years old, consult your doctor or pharmacist.
Children and adolescents
Mostaxyl is not indicated for children under 12 years of age.
Other medicines and Mostaxyl
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take medicines containing ketoconazole or erythromycin while using Mostaxyl.
If you are taking antidepressant medications acting on the central nervous system, statins (medicines used to treat high cholesterol levels), or midazolam (a medicine used for short-term sedation), consult your doctor before taking Mostaxyl.
Mostaxyl with food and drink
Mostaxyl must not be taken with grapefruit juice, as this beverage may increase the
level of Mostaxyl in the body.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not take Mostaxyl during pregnancy or breastfeeding unless clearly prescribed by a doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
At the recommended dose, Mostaxyl is not known to affect the ability to drive or operate machinery. However, when starting treatment with Mostaxyl, you should exercise caution and monitor how the treatment affects you before driving or operating machinery.
Mostaxyl contains lactose.
If you have been diagnosed by your doctor with an intolerance to certain sugars, contact him or her before taking this medicine.

3. HOW TO TAKE Mostaxyl

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Mostaxyl is indicated for adolescents (over 12 years of age) and adults. The usual dose is one tablet (10 mg of rupatadine) once daily, with or without food. Swallow the tablet with a sufficient amount of liquid (e.g. a glass of water).
Your doctor will determine how long you should continue treatment with Mostaxyl.
If you take more Mostaxyl than you should
Contact your doctor or pharmacist immediately if you have accidentally taken an excessive dose of the medicine.
If you forget to take Mostaxyl
Take the missed dose as soon as possible and then continue with your regular dosing schedule. Do not take a double dose to make up for forgotten individual doses.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Common adverse reactions (may affect up to 1 in 10 people) are:
drowsiness, headache, dizziness, dry mouth, feeling of weakness and fatigue.
Uncommon adverse reactions (may affect up to 1 in 100 people) are:
increased appetite, irritability, difficulty concentrating, nosebleed, nasal dryness, sore throat, cough, dry throat, rhinitis, nausea, abdominal pain, diarrhoea, indigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, thirst, general feeling of discomfort, fever, changes in liver function tests, and weight gain.
Rare adverse reactions (may affect up to 1 in 1,000 people) are:
palpitations, increased heart rate, and allergic reactions (itching, hives, and swelling of the face, lips, tongue, or mouth).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE Mostaxyl

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and packaging.
No special storage conditions required.
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. PACK CONTENT AND OTHER INFORMATION

What Mostaxyl contains
The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (as fumarate).
The other ingredients are monohydrate lactose, microcrystalline cellulose PH102, pregelatinized maize starch, red iron oxide (E-172), yellow iron oxide (E-172), and magnesium stearate.
Mostaxyl is presented as round, light salmon-coloured tablets, packaged in blisters containing 20, 30, 50 and 100 tablets.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder:
SF Group S.r.l.
Via Tiburtina, 1143
00156 Rome (IT)
Manufacturer:
Medreich PLC
Warwick House, Plane Tree Crescent, Feltham,
TW13 7HF,
United Kingdom
Tedec-Meiji Farma S.A.
Ctra. M-300, Km. 30.500, Alcala de Henares,
Madrid, 28802,
Spain