Chelotifene Mylan Generics

Patient Information Leaflet

Chetotifene Mylan Generics 2 mg prolonged-release tablets

equivalent medicine
Please 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 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 may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Chetotifene Mylan Generics is and what it is used for

Chetotifene Mylan Generics contains the active substance ketotifen fumarate, which belongs to a group of medicines known as antihistamines. It works by blocking the release of substances responsible for allergic reactions, including histamine.
Chetotifene Mylan Generics is used to treat symptoms of allergic rhinitis (hay fever).

2. What you need to know before taking Chetotifene Mylan Generics

Do not take Chetotifene Mylan Generics

• if you are allergic to ketotifen or to any of the other ingredients of this medicine (listed in section 6)
• if you have epilepsy (seizures)
• if you are being treated with oral medicines for diabetes
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Chetotifene Mylan Generics.
Inform your doctor if:

• you suffer from asthma. This medicine is not effective for the prevention or treatment of acute asthma attacks. You must not stop your asthma treatment suddenly, even if you start treatment with Chetotifene Mylan Generics.
• you have diabetes. If you are taking oral antidiabetic medicines, you must not take Chetotifene Mylan Generics, as this may cause a reduction in the number of platelets in the blood (thrombocytopenia).
• you have a history of seizures (epilepsy). If you have epilepsy, you must not take Chetotifene Mylan Generics, as this medicine may lower the seizure threshold.

Pay particular attention to drowsiness, which may occur especially during the first days of treatment. If you experience reduced alertness due to the sedative effect of Chetotifene Mylan Generics, you must inform your doctor, who may prescribe a lower dose (see sections “Driving and using machines” and “Side effects”).

Other medicines and Chetotifene Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take Chetotifene Mylan Generics together with oral medicines for diabetes, as this may cause a reduction in the number of platelets in the blood (thrombocytopenia) (see section “Do not take Chetotifene Mylan Generics”).
Inform your doctor or pharmacist if you are taking or need to take:

• medicines that depress the Central Nervous System, including medicines used to induce sleep or relaxation (hypnotic-sedatives), or medicines used for allergies (antihistamines)
• medicines that slow down or prevent blood clotting (anticoagulants)
• medicines that dilate the bronchi to improve breathing (bronchodilators), as the number of doses of these medicines may need to be reduced when taken together with Chetotifene Mylan Generics.

Chetotifene Mylan Generics and alcohol
Do not consume alcohol during treatment with Chetotifene Mylan Generics, as alcohol may enhance its sedative effect.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Take Chetotifene Mylan Generics during pregnancy only if your doctor considers it strictly necessary.

Breastfeeding
Chetotifene Mylan Generics must not be used during breastfeeding (see section “Do not use Chetotifene Mylan Generics”).

Fertility
The effects of Chetotifene Mylan Generics on human fertility have not been studied.

Driving and using machines
Be especially careful if you intend to drive or operate machinery, as this medicine may cause drowsiness and reduce your reaction ability. This is particularly likely during the first days of treatment (see section “Warnings and precautions”).
If you are administering this medicine to a child, take care if the child rides a bicycle or uses other vehicles.

Chetotifene Mylan Generics contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Chetotifene Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Chetotifene Mylan Generics tablets should be taken whole.
The recommended dose is 1 tablet (2 mg) once daily, preferably in the evening.
If necessary, your doctor may prescribe 1 tablet (2 mg) twice daily, in the morning and evening, with 12 hours between doses.

Use in children over three years of age and adolescents
The recommended dose is 1 tablet (2 mg) once daily, preferably taken in the evening.

Use in elderly patients (65 years and older)
The recommended dose is the same as for adults.

Use in patients with liver problems
The effects of Chetotifene Mylan Generics in patients with liver problems have not been studied.

Use in patients with kidney problems
The effects of Chetotifene Mylan Generics in patients with kidney problems have not been studied.

If you take more Chetotifene Mylan Generics than you should
If you have taken too many Chetotifene Mylan Generics tablets, call a doctor immediately or go to the nearest hospital emergency department. Always bring the remaining tablets and the packaging with you so that the medicine can be easily identified.
Taking an excessive dose may cause:

• drowsiness, up to severe depression of reaction abilities (severe sedation)
• dizziness
• confusion and disorientation
• slowed or rapid heartbeat (bradycardia or tachycardia)
• low blood pressure (hypotension)
• excessive excitability or seizures, especially in children
• breathing difficulties (dyspnea or respiratory depression)
• reversible coma.

Healthcare professionals will treat an overdose of Chetotifene Mylan Generics according to your condition.

If you forget to take Chetotifene Mylan Generics
Do not take a double dose to make up for the missed dose.

If you stop taking Chetotifene Mylan Generics
If you have any questions about using 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.

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

• excitation
• irritability
• insomnia
• nervousness. These side effects have been observed mainly in children.

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

• inflammation of the bladder (cystitis)
• dizziness
• dry mouth

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

• weight gain
• reduced reaction abilities (sedation)

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

• severe, potentially life-threatening skin reactions such as, for example, erythema multiforme (red, spot-like rash) () and Stevens-Johnson syndrome (acute reaction due to hypersensitivity affecting the skin and mucous membranes) ())
• inflammation of the liver (hepatitis)
• changes in blood tests related to liver function

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

• drowsiness
• nausea
• vomiting
• headache
• seizures
• skin rash
• urticaria

Drowsiness, sedation, dry mouth and dizziness commonly occur at the beginning of treatment, but disappear spontaneously as treatment progresses.

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: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Chetotifene Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". 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 Chetotifene Mylan Generics contains

• The active substance is ketotifen fumarate: one tablet contains 2.75 mg of ketotifen fumaric acid (equivalent to 2 mg of ketotifen base).
• The other components are: monohydrate lactose, cellulose acetate phthalate, hypromellose, precipitated silica, magnesium stearate, talc, polyethylene glycol 6000, titanium dioxide (E171), yellow iron oxide (E172).

Description of the appearance of Chetotifene Mylan Generics and package contents
Each package contains a blister strip with 15 prolonged-release tablets of 2 mg.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
ABC Farmaceutici S.p.A.
Canton Moretti 29
Località San Bernardo, 10090 Ivrea (TO)